Personal Injury Law
A Georgia Lawyer 
Personal Injury forms and articles from a lawyer working for consumers and injured people in Georgia.
Post Frequency: 71.8/day Last Entry: November 18, 2009 at 08:04:00 Recent Entries: 359
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Vertebral Body Replacement Recall - Georgia/Florida News
Posted on November 18, 2009I wrote about the recall in a prior post. Here's the lot information: The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:? Part No...
Vertebral Body Replacement Recall
Posted on November 17, 2009Our office is investigating these claims:FDA has notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body...
FDA: Alcohol and Caffiene -Safe Together?
Posted on November 16, 2009The FDA has contacted nearly 30 makers of caffeinated alcoholic beverages that it will look into the legality and safety of the products. The FDA has not approved the use of caffeine in alcoholic drinks, so the drinks can only be lawfully marketed if the substance is "Generally Recognized As Safe," or GRAS...
FDA issues Class I recall of Edwards Lifesciences aortic catheter
Posted on November 13, 2009The FDA has issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures.The device is a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, "may spontaneously rupture during surgery," according to the FDA recall...
Thank you Veterans
Posted on November 11, 2009Today I hope folks will take a moment to say thank you to those veterans who have served our country in good times and bad, in the USA and elsewhere. They stand ready to make the ultimate sacrifice for our country. In our groups of friends, I'm lucky to call one of our active military a friend...
Recall of Certain Lots of Tylenol Arthritis
Posted on November 10, 2009Good to see the folks at McNeil Consumer Healthcare taking a pro-active stance. From their site: In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is initiating a voluntary recall of a limited number of product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP...
Last week, the Georgia Court of
Posted on November 09, 2009Last week, the Georgia Court of Appeals issued an opinion holding that State Farm, as a UIM carrier could pursue UM subro against a tortfeasor even though the insured hadsigned a Limited Release. Will this decision make it more difficult to settle a claim if the UM carrier doesn't waive subrogation? Stay tuned...
Accusure Insulin Syrine Recall
Posted on November 05, 2009Accusure insulin syringes (Qualitest Pharmaceuticals, Inc) distributed nationwide from January 2002 through October 2009 are being voluntary recalled because of the possibility of detachment of the needles from the syringes.The current recall is an expansion of a recall made in August for syringes produced between January 2007 and June 2008 as a result of the manufacturer receiving a complaint about a syringe not included in the first recall...
Recall: Madol,Tren, Turinsabol and Andro
Posted on November 05, 2009The business Bodybuilding.com has recalled 65 dietary supplement products sold online that may contain steroids, says the U.S. Food and Drug Administration.The national and international recalls announced by the Boise, Idaho-based company include all lots and expiration dates of dietary supplements that might contain ingredients that are or should be classified as steroids, including "Superdrol," "Madol," "Tren," "Turinabol," and "Androstenedione...
Prempro Verdict Appeal
Posted on November 04, 2009Pfizer Inc. doesn?t have to pay more than $27 million in punitive damages to an Arkansas woman who blamed her breast cancer on the company?s menopause drugs, an appeals court ruled in ordering a new trial on the award.The U.S. Court of Appeals in St. Louis today upheld a jury?s March 2008 finding that the hormone-replacement drugs helped cause Donna Scroggin?s cancer and its award of actual damages...
You may have seen more information
Posted on October 29, 2009You may have seen more information about Levaquin®, which is an Ortho-McNeil-Janssen pharmaceutical, also called a fluoroquinolone, prescribed for the treatment of lung, sinus, skin and urinary tract infections in adults. Levaquin® has been associated with medical complications serious enough to have required FDA involvement...
Prempro Verdict - Don't Ask I Can't Tell You
Posted on October 28, 2009A Philadelphia jury awarded punitive damages to an Illinois woman who said Wyeth's Prempro hormone replacement therapy caused her breast cancer, but the world will have to wait at least another month before anyone knows how much.As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc...
Friday Link: New Georgia Family Law
Posted on October 23, 2009I don't usually link to others' blogs, but my good friend C.J. Remboldt has a family law blog that is worth a read. You can find her blog here. Here's a post from her blog:GA Trial Court Lacks Authority to Modify Terms of Child Support OrderA GA trial court may not deny a child support contempt hearing because the Temporary Protective Order, ordering father to pay child support, would expire before the hearing date because a trial court lacks authority to modify the terms of a child support order nor may it forgive any child support in arrears...
Georgia Supreme Court rules against State Senator in Accident Case
Posted on October 23, 2009State Sen. Cecil Staton did not prevail before the Georgia Supreme Court this week.The court said Staton, a Republican from Macon, was not entitled to additional coverage ($200,000) in coverage after a truck accident near Rome that broke his leg. Staton contended he should be allowed to ?stack? $100,000 policies on three vehicles owned by his company, Smyth & Helwys Publishing, even though only one of the three cars was actually in the crash...
Zometa Verdict in Montana
Posted on October 22, 2009A Missoula jury on Wednesday awarded $3.2 million to a woman suing the maker of a bone-strengthening drug in a decision that could have a bearing on hundreds of cases against the company nationwide.Peggy L. Stevens, 57, of Missoula filed suit against Novartis Pharmaceuticals Corp...
Safety Investigation of Certain Medical Device Power Cords
Posted on October 21, 2009The power cords on a variety of medical devices may cause sparking, charring, and fires, according to reports received by the FDA.Device manufacturer Hospira has recalled all affected power cords, while Abbott Nutrition has recalled its Flexiflo Quantum Entreal Pumps, used for feeding patients through tubes...
FDA Checking Claims on Food Labels
Posted on October 21, 2009U.S. regulators areexamining the growing number of nutrition claims found on thefront of food packages after complaints that they give amisleading picture of their health benefits, officials said ina warning to food companies on Tuesday. The Food and Drug Administration is trying to determine ifany claims violate federal food labeling rules and "will takeenforcement action against any egregious examples," FDACommissioner Margaret Hamburg told reporters...
Defective Women's Robes Recalled (Blair LLC)
Posted on October 14, 2009Blair LLC. has reported 162,000 of its defective products -- women's robes -- after six women reportedly died when the chenille robes caught fire. Some of the robes caught fire while cooking, according to an MSNBC news report. The U.S. Consumer Product Safety Commission (CPSC) issued an alert stating that women who own these robes should stop using them...
Vytorin Litigation
Posted on October 14, 2009An amended lawsuit filed over the Schering-Plough pension plan alleges that executives at the company suspected as early as 2005 that the ?Enhance? Vytorin trial was a bust. Citing a ?confidential informant,? it also names.The Plaintiffs claim: "Defendants had intimate knowledge of, or an active role in, improper business activities that allowed Schering-Plough to artificially inflate and manipulate the Company?s earnings...
Trials
Posted on October 14, 2009I've been a little scarce on here for the past couple of weeks. Was preparing for multiple trials, and actually went to trial last week on a case. I'll discuss the trial in a later post. For those lawyers who read this blog, I will tell you a few key items from the trial: Always prepare a Trial Notebook for the Judge...
MDL Update: Hydroxycut, Chantix, and Yasmin
Posted on October 13, 2009The MDL Joint Panel has been busy the last couple of weeks. The JPML had ordered the Iovate (Hydroxycut) MDL to the Southern District of California. The Order may be found here. It's MDL 2087.An MDL as to Chantix will be sent to Judge I. Johnson in the USDCT of Alabama...
McDonald's Hot Coffee Documentary 10/13/09 in Atlanta
Posted on October 12, 2009Remember the film Super-Size Me? That film opened up the eyes of consumers. More people than ever found themselves concerned with the nutritional content?or lack thereof?in fast food. Six weeks after the film premiered, McDonald?s discontinued their ?Super-Size? option...
Georgia Supreme Court holds SOL Tolled while Traffic Citation Pending
Posted on September 29, 2009The Supreme Court held yesterday that O.C.G.A. § 9-3-99 tolls the statute of limitations for any tort action from the date of the defendant?s traffic offense until the prosecution of the traffic offense becomes final or is terminated, as long as that time does not exceed six years...
Exjade and the FDA
Posted on September 26, 2009The US Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients who are prescribed deferasirox (Exjade). This information suggests there may be a greater risk for adverse events such as kidney failure, gastrointestinal haemorrhage, and deaths in patients with myelodysplastic syndrome (MDS) compared with patients without these conditions...
Januvia/Sitagliptin: Pancreatitis Risk?
Posted on September 26, 2009The Food and Drug Administration said on Friday that there may be a connection between Merck & Co.'s diabetes treatment Januvia/Sitagliptin and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.'s Byetta.From the FDA site:FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products...
Tylenol Infants and Children Recall (Certain Lots)/More
Posted on September 26, 2009It?s a voluntary recall, which according to NY Pediatrician Dr. Seth Gordon came because ?examination of bulk raw material detected that one of the inactive ingredients contained gram-negative bacteria Burkholderia cepacia (B. cepacia). The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product...
Tylenol Infants and Children Recall (Certain Lots)
Posted on September 24, 2009From tylenol.comYou may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' TYLENOL® liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U...
Seroquel Litigation News
Posted on September 24, 2009A federal judge in Orlando, Florida, ordered AstraZeneca to unseal certain sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians? names on privacy grounds...
FDA Bans Flavored Cigarettes
Posted on September 23, 2009The FDA this week banned cigarettes with fruit, candy or clove flavors.Authorized by the Family Smoking Prevention and Tobacco Control Act enacted in June, the ban represents an effort to reduce an easy entry point for youth into smoking and tobacco addiction...
Study Finds a Possible Link Between Denture Cream and Imbalance
Posted on September 21, 2009From ABC.com:Thirty- four million Americans rely on dentures to replace their missing teeth. But a small number of denture wearers have had difficulty with balance and walking -- a medical mystery that some experts have linked to their denture creams...
Necrosis Caused by Intra-arterial Injection of Promethazine: Case Report
Posted on September 21, 2009I found this report after hearing more about the recent black box warning issued by the FDA regarding Promethazine:"The first reported cases of intra-arterial promethazine (Phenergan) injection causing complications were in the late 1960s." There have been literature reports of adverse outcomes after accidental intra-arterial injections of drugs since the 1940s...
STLA Meeting in Asheville Sept. 24 and 25, 2009
Posted on September 21, 2009This week the Southern Trial Lawyers Association meets in Asheville, N.C.The essential mission of the Southern Trial Lawyers Association is as simple as it is straightforward: To promote fellowship, learning, and networking among trial lawyers throughout the 13 southern states...
Flooding in Atlanta
Posted on September 21, 2009It's bad here. Real bad. A North Georgia city has been evacuated because of levee failure fears. The above pic is of downtown Atlanta during rush hour today.
FDA warns about eyelash thickener claims
Posted on September 18, 2009The FDA has warned Allergan Inc. that the Web site for its eyelash thickener Latisse is misleading because it avoids or downplays risks associated with the product.In a letter dated Sept. 10 and posted to the FDA Web site Wednesday, the agency said the Latisse site either doesn't mention potential side effects including bacterial eye infection, allergic reactions, excess hair growth outside the intended treatment area, and permanent changes in iris and eyelid pigmentation, or presents them in small text that is much less prominent than statements about the product's effectiveness...
Promethazine Gets Black Box Warning for Tissue Damage/Amputation Risk
Posted on September 17, 2009Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday...
GA Supreme Court to Hear Oral Argument on Damages Caps on 9/14
Posted on September 14, 2009Supreme Court to Hear Oral Arguments on Caps on DamagesStatute is challenged after a medical malpractice victim?s faceliterally falls off after surgeryAtlanta, GA-- On Tuesday, September 15, 2009, the Georgia Supreme Court will hear oral arguments regarding the constitutionality of the provision that caps the amount of damages a victim of medical malpractice can secure from a jury...
Conmed Recall of Surgical Instruments
Posted on September 13, 2009Medical device maker Conmed Corp. on Wednesday issued a voluntary recall of certain surgical instrument products, saying the devices may self-activate and cause injury in rare cases.Conmed said the recall affects certain model numbers of its PRO5 and PRO6 series battery hand pieces manufactured before May 31, 2008...
Penumbra Catheter Recall
Posted on September 13, 2009Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death...
Window Blinds Recall
Posted on September 13, 2009The Consumer Product Safety Commission is announcing a major recall on several types of winder blinds and shades. Here are three of the largest recalls.The first set of shades on our recall list is the kind that rolls up. It's called the Oval Roll-Up Blinds...
Levaquin and Link to Vision Problems?
Posted on September 10, 2009From the journal Opthamology:According to World Health Organization criteria, the relationship between fluoroquinolone therapy and diplopia is ?possible.? This causality assessment is based on the time relationship of drug administration and ADR development, the multiple positive dechallenge and rechallenge reports, and the plausible mechanism by which diplopia could occur: Possible tendinitis of the extraocular muscles...
Zyprexa: Allegations that Lilly Paid Docs to Prescribe it
Posted on September 10, 2009From Bloomberg:Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers? program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives...
Fosamax: Jury Deliberations Marked by Threats and Intimidation?
Posted on September 10, 2009From CNNMoney.com I can tell you I've never heard of any Judge offering to have court officers escort jurors home: A U.S. judge called for a daylong "cooling off" period in a product-liability case over Merck & Co.'s (MRK) osteoporosis drug Fosamax after jury deliberations became tense on Wednesday...
Actiq Deaths
Posted on September 02, 2009Actiq is a powerful narcotic painkiller in the form of a lollipop that is manufactured by Cephalon, Inc. The drug is delivered to the bloodstream by a lollipop-like lozenge; when placed against the inner cheek, pain is relieved in minutes. Actiq is also administered by transdermal patches and by injection...
Steam Dietary Supplement Recalled
Posted on September 01, 2009Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug...
College Football Arrives
Posted on September 01, 2009Tailgating at Ole Miss in the GroveMy passions are typically every day ones - my labs, the outdoors. This week (Thursday, actually) is the start of the real passion/religion 'down here' in the South - big time college football. My team? The Gators.What's it like for me and others in SEC Country? Here is a comparison of North v...
Stella awards
Posted on August 31, 2009The Stella Awards® were inspired by Stella Liebeck, the Plaintiff in the McDonald's coffee case. Some folks may know that The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body,including her inner thighs, perineum, buttocks, and genital and groin areas...
Stella Awards, Part II
Posted on August 31, 2009Good stuff from my friend Jere Beasley:The annual Stella Awards list, a list of the years seven ?most outlandish lawsuits and verdicts in the U.S.,? is nothing more than a fraud on the public. The so-called awards deal primarily with fiction, and many of the lawsuits listed never happened...
Katrina: New Orleans Four Years Later
Posted on August 30, 2009It's easy for many to simply forget that Katrina hurt much more than New Orleans. It devastated parts of lower Mississippi and damaged coastal Alabama as well. I flew out of New Orleans the weekend before Katrina hit. I was there this weekend, on the 4th Anniversary of the storm's passing...
Diet Drug Reviewed by FDA: Orlistat (Xenical)
Posted on August 26, 2009The FDA said it has received 32 reports of serious liver injury -- including six cases of liver failure -- among users of diet drug orlistat, which is sold as a prescription drug under the trade name Xenical and as an over-the-counter diet aid under the name Alli...
Tamifoxen News
Posted on August 26, 2009A report recently released suggests that a drug used to prevent the recurrence of breast cancer may have a rare but dangerous side effect: increasing the odds that long-term users may develop an uncommon but aggressive new tumor.The report was called into question right away, noting clinical trials had repeatedly found that the drug, tamoxifen, reduced the recurrence and spread of common breast cancers and that its benefits exceeded any possible risks...
Sports and the Law
Posted on August 25, 2009A few items of interest for me, given my love of sports. Always a fun read when law intersects with Sports:Delaware Lottery and NFL? Scratch that. "In a rare move, the appellate court not only found that a lower court judge had erred in refusing to issue a preliminary injunction, but declared that the answer to the ultimate question in the case was indisputably clear -- and that a permanent injunction must be issued...
Yaz & Yasmin Injury, Georgia
Posted on August 25, 2009Our office is investigating claims of injury related to the birth control pills known as Yaz or Yasmin:Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc...
Xolair- Investigate for Link to Cardiac Problems?
Posted on August 17, 2009In Canada news:The safety of the asthma drug Xolair is under review to investigate a potential link to cardiovascular problems.The probe was triggered by interim findings in an ongoing U.S. study into the long-term safety of Xolair, known generically as omalizumab...
Cellcept Warning Label Updated
Posted on August 17, 2009A warning of a risk of pure red cell aplasia (PRCA) has been added to the label and prescribing information for mycophenolate mofetil (CellCept).Drug manufacturer Roche reported 41 cases of PRCA in patients given mycophenolate mofetil. In 16 of the cases, reduction of the dose or discontinuation resolved the condition...
What Should a Solo/Small Firm Focus on to build a practice?
Posted on August 14, 2009I have been reading on several sites the opinions of what a solo lawyer or small law office should do when it comes to building a client base. There can never be a set list of what is important, but I do shudder when (at least in the consumer law/personal injury field) I see people blindly touting Social Networks as the key to all things, or a key building block...
Actos and Avandia News
Posted on August 13, 2009A large study from British Columbia, Canada is pointing to an increased fracture risk with thiazolidinediones (TZDs), used in the treatment of type 2 diabetes [1]. The study, which reviewed fracture risk in more than 84 000 patients receiving either rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) vs a sulfonylurea, found that both men and women are at increased risk of broken bones when taking a TZD and hints that pioglitazone may be more strongly associated with fracture risk...
Permax Information
Posted on August 13, 2009Earlier in 2007, the FDA announced that Permax (generic: pergolide) was withdrawn. There are additional drugs in the same class that can be substituted. Studies had been released linking Permax with heart valve damage. A study by Italian researchers found that approximately one-fourth of Parkinson's patients taking Permax had moderate to severe heart valve troubles...
Fosamax: First Trial Approaches
Posted on August 11, 2009Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial this week. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three cases to go this summer...
Avandia - Diabetes Drug- Heart Attack Link?
Posted on August 11, 2009Avandia is manufactured by GlaxoSmithKline for type 2 diabetes. It was first approved for use in 1999. Since then more than 6 million people worldwide have taken this drug. Avandia helps sensitize the body to insulin and helps control blood sugar. According to a recent study by the New England Journal of Medicine, patients taking Avandia have a 43% higher rate of heart attacks...
Fentanyl Patch Recall News
Posted on August 10, 2009Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies...
Courts: Remand Order Worth a Read
Posted on August 05, 2009Below is a link to a recent US District Court Order regarding a case that had been removed from a State Court (in Alabama) to a Federal Court based on diversity as well as Defendants' claim that the jurisdictional amount had been met. The Federal Court Judge assigned to the case wrote: "The question [before the Court[ is whether this specific settlement demand, given all the evidence presented, established by a preponderance of that evidence that the amount in controversy exceeds $75,000 ...
FDA: Botox Warning
Posted on August 04, 2009From the FDA:The U.S. Food and Drug Administration announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009...
Study: Texting While Driving Increases Crash Danger by a Huge %
Posted on July 28, 2009Should come as no surprise:"After studying the behavior of real truck drivers covering more than 6 million miles of road, the Virginia Tech Transportation Institute says people who send text messages while driving are 23 times more likely to be in a crash (or what they call a near crash event) than non-distracted drivers...
Tort Reform Champion Loses Med Mal Case
Posted on July 28, 2009I pulled this from my good friend Chris Hellum's blog, analabamalawyer Elliott Kaplan is a prominent Kansas City attorney. For years, he railed against judges, juries, and trial attorneys, as he and his firm, Robins Kaplan Miller & Ciresi got big bucks to represent big companies...
Court Decisions: Sealed Container Defense Rejected in AL as to Retailers
Posted on July 22, 2009News regarding an Alabama Supreme Court decision, and cases are before the Court on a certified question from the United States District Court for the Northern District of Alabama. The USDCT concluded that it was not clear under Alabama law whether claims alleging the breach of the implied warranties of merchantability and fitness for a particular purpose are subject to the defense of the sealed-container doctrine...
Medtronic Recalls Lots of Paradigm® Quick-Set® Infusion Sets in the United States
Posted on July 14, 2009Medtronic, Inc. has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days...
FDA News Regarding Darvon and Propoxyphene
Posted on July 08, 2009The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses...
News from A Friend's Firm: Lawsuit in MD
Posted on July 02, 2009I count Rick Kuykendall as one of those lawyers whom I trust. He's with the Murphy Firm in Baltimore, and there is this news this week: The Murphy Firm of Baltimore and Henry & Associates of Largo have announced the filing of a 12-count civil suit that charges Prince George's county officials and some of the County's correctional and law enforcement officers with responsibility for the 2008 death of 19-year-old Ronnie L...
Weight Loss Supplements Recalled
Posted on June 26, 2009The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes...
Dietary Supplement Recall
Posted on June 26, 2009Hi-Tech Pharmaceuticals and the FDA have notified healthcare professionals and consumers of a nationwide recall of all products sold under the name Stamina-Rx. An FDA lab analysis found that the product contained the undeclared ingredient, benzamidenafil...
FDA To Discuss Liver Risks With Tylenol,Other Painkillers
Posted on June 26, 2009Image via WikipediaThe FDA will be taking a look at painkillers such as Tylenol next week. The issue front and center relates to acetaminophen, a drug found in Excedrin as well as NyQuil and Theraflu, that can cause liver damage. Acetaminophen is the most widely used drug in America...
Problems With Homeopathic Remedies?
Posted on June 19, 2009An Associated Press analysis of the FDA's side effect reports has found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide. According to reports:The AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies...
Zicam Recalled
Posted on June 16, 2009Intranasal spray Zicam is being recalled as the FDA warns of 130 cases of anosmia- loss of the sense of smell.Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms did not appear until multiple doses had been administered...
From Public Citizen and other sources:une
Posted on June 15, 2009From Public Citizen and other sources:une 12 (Bloomberg) -- Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn?t work for such patients, according to unsealed internal company documents...
Calrcon Skin Product: Partial Recall and Warning
Posted on June 09, 2009he Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement...
Liberty National Life Insurance News: Florida Licensure At Risk?
Posted on June 09, 2009Liberty National Life Insurance could have its license suspended or revoked in Florida for refusing to write life policies based on nationality or travel to certain countries, state insurance regulators said Thursday.Investigators from Florida's Office of Insurance Regulation spent nearly five months reviewing life insurance policy applications from Florida residents and found that consumers of Haitian descent were more likely than others to have their applications denied...
Recent Avandi Medical Article
Posted on June 08, 2009Avandia doesn't increase overall heart risks, according to final results of a large clinical study sponsored by the world's second largest drugmaker.The study does seem to confirm that the medicine doubles the risk of heart failure -- a chronic condition where the heart struggles to pump enough blood around the body -- and also increases the danger of bone fractures...
Graves Disease Drug: Increased Risk for Liver Injury?
Posted on June 05, 2009The FDA warned physicians that a drug used for 62 years to treat Graves' disease -- propylthiouracil, or PTU -- carries an increased risk for life-threatening liver injury.The FDA said it has received 32 adverse event reports -- 22 in adults and 10 in children -- including 12 deaths and six transplants among adult users of the medication...
412(i) Tax Shelter Litigation
Posted on June 03, 2009My friend Alabama attorney Chris Hellums is investigating abusive tax shelter creation. Here's his post from his blog:Typically, these transactions will include an Insurance company, accountant, tax attorney, and a promoter (someone with an insurance background, perhaps an actuary, who knows how to structure the policy itself)...
Reglan: No MDL For Litigation
Posted on June 03, 2009The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva...
Bausch and Lomb Settles Fungal Infection Lawsuits
Posted on June 02, 2009Image via WikipediaContact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits ? with dozens more individual claims yet to be resolved...
Reglan: JPML Hearing held in Louisville, KY
Posted on May 29, 2009A motion to form an MDL, or Multidistrict Litigation, was argued yesterday before the JPML sitting in Louisville, Kentucky. There are at least 15 Reglan lawsuits pending in 11 different district courts throughout the United States.Reglan is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying...
Life Investors Insurance Class Action: Deadline Looms
Posted on May 28, 2009Our firm is currently representing consumers who have cancer insurance policies with Life Investors Insurance Company of America as well as Transamerica.Good and honest people bought cancer policies for a simple reason - To provide for a reimbursement amount of ?actual charges? to be paid when incurred or billed...
Tech: PDF For Lawyers
Posted on May 25, 2009The site, that is. http://www.pdfforlawyers.com/ Is worth a look. Tips include: "Using Acrobat to put Exhibit stamps on digital documents." Also, learn how to OCR with the ScanSnap to create searchable PDF files at just the push of the ?scan? button?Worth your time...
Hydroxcut Lawsuit; Hypertensive retinopathy associated with Hydroxycut Usage
Posted on May 22, 2009Here's a report on the use of performance-enhancing and weight-loss supplements is prevalent in the United States. The report notes that with new restrictions placed on such products, companies have been marketing caffeine-based ephedra-free herbal supplements...
Hydroxycut Lawsuit Filed in Georgia State Court
Posted on May 20, 2009Our office filed in Georgia State Court a lawsuit where a consumer claims she suffered an injury related to her use of Hydroxycut. The multi-count lawsuit claims, among other things, what most would expect: Negligence, Breach of Warranty, and other claims of wrongdoing...
Flomax and Cataracts
Posted on May 20, 2009Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.It's not the first time that Flomax (tamsulosin) has been linked to cataract complications...
Reglan: FDA Video from YouTube
Posted on May 20, 2009Interesting that the FDA now uploads video to youtube.com
Reno Article: Reglan (Georga, Alabama)
Posted on May 18, 2009"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder...
David Hodge: $17 Million Dollar Verdict in AL on 5/13/09
Posted on May 13, 2009A guy who I consider a friend is David Hodge, a Birmingham, Alabama lawyer. Not too excitable, loves Bama football, family man, dog man like me. David went to Hale County, which is right here:His firm's client was Chapman Logging. The case involved the sale of a defective logging skidder equipped with a Cummins engine...
That Pesky Drug known as Cheerios
Posted on May 12, 2009Image via WikipediaSometimes you just shake your head in amazement. This warning letter from the FDA to the CEO of General Mills (never mind that people are getting ill or dying from bad foods):(FDA source)Ken PowellChairman of the Board and CEOGeneral MillsOne General Mills BoulevardMinneapolis, Minnesota 55426Dear Mr...
Lawyer Etiquette: Is Your Blackberry Use Hurting your Reputation?
Posted on May 11, 2009Image by Getty Images via DaylifeI attended a meeting of lawyers this month, and when about 5-6 of us were sitting together talking shop, one member of the group brought up a good subject. As we talked, that same person started typing away on his Blackberry...
Autism: Are Children able to "Recover?"
Posted on May 11, 2009A close friend has a child with autism, and the frustrations, worries and concerns are etched on his face when we get together. I could never imagine what he and his family must address each day.From several sources, including Yahoo, this article:"Leo Lytel was diagnosed with autism as a toddler...
Hydroxycut: UPC Codes Released today (Georgia, Alabama, Florida)
Posted on May 08, 2009Here's news on the Universal Product Codes related to the Hydroxycut products: Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide RecallContact:Jamie Moss201-493-1027FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc...
FDA: Testosterone Gel Puts Children at Risk
Posted on May 08, 2009From various sources, including the AP:The FDA issued a statement that adults using prescription testosterone gel should be cautious and avoid its contact with children to avoid causing serious side effects. This week a black box warning was added to several products, AndroGel and Testim...
Certain Epilepsy Drugs Get a Suicide Warning
Posted on May 05, 2009the FDA has approved new labels for epilepsy drugs that include warnings about an increased risk of suicidal thoughts and behaviors associated with the medicines.The labeling for the epilepsy drugs Topamax, Lamictal, Tegretol and Trileptal come after the FDA ordered the drugs' labels be updated with warnings about suicidal risks with the medications...
Botox Warnings
Posted on May 03, 2009Allergan Inc.will work with the Food and Drug Administration to appropriately update labeling for its Botox and Botox cosmetic products."We are pleased that the FDA has emphasized that the dosing units are different between the products," Chairman and Chief Executive David Pyott said on the earnings call, adding he was happy with Botox's first-quarter sales, which declined 5...
Hydroxycut Recall: TV Report (Georgia, Alabama, Florida)
Posted on May 03, 2009Image by size8jeans via FlickrFrom NBC and Tom Costello and NBC: The government issued an urgent warning to immediately stop using the dieting supplement after reports surfaced of liver damage and at least one death. FDA's limited ability to oversee is discussed...
Hydroxycut Lawsuit from 2003
Posted on May 02, 2009Found this from 2003, a press release from the then Missouri A.G.:Attorney General Jay Nixon today filed a lawsuit in St. Louis against the maker of Hydroxycut, marketed to consumers as a safe and tested over-the-counter way to lose bodyfat rapidly. Hydroxycut is sold in several retail store chains, through television ads and on several Web sites...
FDA Recalls Hydroxycut
Posted on May 01, 2009Government health officials are announcing the recall of popular weight loss pill Hydroxycut, after reports of liver damage and other health problems.The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc...
Hydroxycut News Part 2/Background
Posted on May 01, 2009Herbs that have been associated with liver disease include:- Black Cohosh? Buckthorn (Rhamnus cathartica).- Callilepsis laureola ( Impila)- Cascara Sagrada- Celandine ( also known as greater celandine) (Chelidonium majus)? Chaparral (also known as creosote bush or greasewood) (Larrea taridentata)...
Excessive Selenium Kills 21 Polo Ponies
Posted on April 30, 2009My office is investigating the damage selenium has caused to people who took an over the counter supplement known as Total Body Formula. This week there is news that selenium killed nearly two dozen horses: The 21 polo horses that died last week shortly before they were to compete in the U...
Nail Polish Remover Recall
Posted on April 30, 2009The U.S. Food and Drug Administration announced a nationwide recall of Personal Care-brand non-acetone nail polish remover because of a claimed safety hazard.The FDA said Personal Care Products Inc. of Bingham Farms, Mich., initiated the recall of the polish remover-conditioner enriched with gelatin because it doesn't meet product specifications and might cause chemical burns to the fingers of users.
Reglan: MDL Petition to be Heard on 5/28 in Louisville, KY
Posted on April 30, 2009Link to the Order here. I mentioned last week that counsel on cases (friends of mine) had file the Petition - looks like it will be argued next month. Early indications? Plaintiffs' lawyers want it in Las Vegas.
Botox - Unapproved Use Warning
Posted on April 30, 2009Health officials are warning doctors and patients about potentially deadly risks of using anti-wrinkle drug Botox and similar drugs for unapproved uses to treat muscle spasms.The Food and Drug Administration says Botox and two other injections have been linked to rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements...
Accu-Chek Insuling Pump Recall
Posted on April 30, 2009Another day another recall - how is the public expected to know about these nearly once a day recalls? Roche Holding AG(RHHBY) unit is recalling Accu-Chek Spirit insulin pumps that were sent to the U.S., the Food and Drug Administration said Thursday noted in a recall notice posted on its Web site...
Treanda and Stevens Johnson Syndrome
Posted on April 29, 2009The cancer drug Treanda, in combination with another therapy, may have caused two people taking it to develop a serious skin condition known as Stevens Johnson Syndrome and one has died.The patients developed a severe form of the condition known as toxic epidermal necrolysis, which is characterized by a blistering and peeling of the top layer of skin, causing it to peel off, leaving damaged areas which can become infected...
NSAIDS: Increase Risk of Dementia?
Posted on April 27, 2009Those who use non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen, shouldn't bank on the drugs helping them ward off dementia.A study in Neurology suggests that NSAID users do not have lower rates of dementia and that increased use of the pain relievers may actually raise the risk of cognitive decline...
Golimumab Approved, with a Black Box Warning
Posted on April 27, 2009Image via WikipediaSimponi Approved for Immune-Related ArthritisFrom HealthDay News:Simponi (golimumab) has been approved by the FDA to treat three forms of arthritis that occur when the body's immune system attacks the joints.The injected drug will be prescribed to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis...
Reglan: Generic Drug Makers and Metoclopramide
Posted on April 24, 2009Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.Four generic drug makers named as Defendants in a Reglan lawsuit that is pending in a USDCT in Vermont won't be granted an immediate appellate appeal the Trial Court?s decision not to grant a pending motion for summary judgment...
Advanced Bionics Cochlear Implant Recall
Posted on April 23, 2009Update on a cochlear implant recall: In 2004, Advanced Bionics issued a recall for the Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system. Advanced Bionics eventually began to distribute the HiRes90k. The FDA had, however, written to the company about the product...
Digoxin Recall
Posted on April 22, 2009Caraco Pharmaceutical Laboratories, has issued a nationwide recall of DIGOXIN, a medicine used to treat heart failure and abnormal heart rhythms. The tablets are being recalled because they may differ in size and could have more or less of the active ingredient, digoxin...
Late 2008 - Adverse Drug Event Reports Reach Record Numbers
Posted on April 22, 2009In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy. Almost 23,000 cases of serious ADEs?including 1,397 cases attributed to error?were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007...
Tysabri and PML
Posted on April 21, 2009I wrote an earlier post this week on PML. Today, there is this report: Biogen revealed another new case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient being treated with Tysabri.That means that six patients have developed the potentially deadly brain infection since Tysabri (natalizumab), which is partnered with Ireland?s Elan Corp, was reintroduced to the market in July 2006...
U.S. Supreme Court: Tuna/Mercury Poisoning Case
Posted on April 21, 2009Image via WikipediaAn interesting case, and the SCOTUS' decision to let stand a lower court ruling (thanks to the WSJ.com site):The Supreme Court left in place a lower court ruling that allowed a New Jersey woman to sue a tuna-fish producer over the mercury poisoning she allegedly suffered after her diet consisted almost exclusively of canned tuna for five years...
Fitness Balls Recalled by EB Brands Due to Fall Hazard;
Posted on April 21, 2009News this past week that three million fitness balls ... just like the one your spouse first used when it arrived a Christmas or two back have been recalled. From the CPSC site: Hazard: An overinflated fitness ball can unexpectedly burst while in use, causing the user to fall to the floor...
Reglan News: Lawyers seeking to Consolidate in Nevada
Posted on April 20, 2009What we are hearing: Lawyers have filed a Motion with the JPML, asking that all of the filed Reglan cases be consolidated and moved to a US District Court in Nevada. Reglan (metoclopramide) is a drug which is only approved for short-term use to treat gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying...
Raptiva pulled; An explanation of PML
Posted on April 20, 2009Raptiva is used to control moderate to severe cases of plaque psoriasis, the most common form of the autoimmune disease, which causes red scaly patches on the skin that can itch and hurt.PML is a serious infection of the nervous system caused by a virus...
Law Review Articles: Using Facebook in Litigation, and the Daubert Revolution
Posted on April 17, 2009From the Torts Prof Blog, links to a recent law review articles worth reading. Facebook:Here is an article worth reading on how Facebook.com's pages, in the context of Canadian Court. In the U.S., expect the same treatment. A quote from the article:Canadian courts have considered web-based networking sites such as Facebook and MySpace pages to be ?documents? subject to discovery...
Trucking: CVSA Out of Service Criteria Handbook
Posted on April 17, 2009Attending a lawyer convention this week, I had a chance to hear from a Public Safety Officer regarding truck inspections. The bible for an officer when conducting an inspection? A book called the North American Standard Out-of-Service Criteria. Part I details violations which place a driver out-of-service...
Intra Aortic Balloon Pump Recall
Posted on April 16, 2009Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters Recalled. The FDA announced a Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart...
FDA stops firm marketing unapproved cold medicines
Posted on April 13, 2009Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.The Food and Drug Administration said Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators...
Raptiva Recalled
Posted on April 08, 2009There will be a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.Raptiva has recently been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system...
Rhino ATV Recall
Posted on April 01, 2009Yamaha Motor Corp. USA recalled about 145,000 off-highway recreational vehicles Tuesday, after two models were involved in 46 deaths and hundreds of injuries.The two-passenger Rhino 450, 660 and 700 vehicles are designed for those older than 16 with driver's licenses, though some deaths involved children who were passengers or operated vehicles against recommendations, said the Consumer Product Safety Commission...
Nationwide Voluntary Recall of Propafenone HCL Tablets: Oversized Tablets
Posted on March 24, 2009One lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure. The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified...
Lexapro Maker Accused of Fraud
Posted on March 17, 2009The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.The complaint says that from 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives...
More on Reglan, Octamide and Maxolon
Posted on March 12, 2009Some have emailed asking what is Metoclopramide.Metoclopramide is used to treat the slow stomach-emptying that can occur in diabetes, and as a second-line treatment for heartburn caused by gastroesophageal reflux. It's sometimes used for the nausea and vomiting that accompany cancer treatment, and migraines...
Researcher Faked Data for 21 Studies
Posted on March 11, 2009Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr...
Bills Pending In the Georgia Legislature for 2009
Posted on March 10, 2009Just a few days remain before what is called crossover day - when a proposed bill must crossover to the other chamber. Here is a list of bills pending, with a hat tip to the GTLA blog:SB 39 and HB 277 - Two approaches to transportation funding are moving through the General Assembly...
FDA - Political Lobbying Drove Process on a Medical Device Application
Posted on March 10, 2009From the WSJ:"The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U...
Reglan Gets a Blackbox Warning: Tardive Dyskinesia
Posted on March 09, 2009News about Reglan:What is Reglan? Reglan is used for the short-term treatment of heartburn in patients who have already tried other medications but had no relief of symptoms. The way that Reglan works is that it increases the muscle contractions in the upper digestive tract, which in turn speeds up the rate at which the stomach empties into the intestines...
United States Supreme Court Rules for Consumer, against claim of Drug Preemption
Posted on March 04, 2009Alabama: Jury Orders Makers of Sandoz to Pay State $78.4M
Posted on February 25, 2009News from Alabama yesterday:Jurors ordered Sandoz Inc. pay the State Government of Alabama $78.4 million for causing the state Medicaid program to pay too much for prescription drugs from 1991 to 2005.Evidence at trial? The evidence included a company memo that said: "Go forward and take the position of a Roman legion, be greedy and take no prisoners...
Vytorin: Cancer Risk for This Heart Drug?
Posted on February 25, 2009From various sources, link below. Several larger studies say no, one smaller study suggests yes. Last year, a heart researcher (Terje Pedersen) released a from an 1,800 patient study. According to it, 47% of those taking the cholesterol drug Vytorin were more likely to develop cancer than those taking a placebo...
Happy Mardi Gras - From Our Family to Yours
Posted on February 24, 2009For my 1,000th post, I'm happy to say to folks today, Happy Mardi Gras. For many, the beads tossed have a less than family oriented connotation, but make no mistake - Carnival in New Orleans is heavily family oriented (Yes, the French Quarter and that certain street are exceptions)...
Outsourcing of Drug Trials
Posted on February 19, 2009The most recent issue of the NEJM, here discusses the globalization of clinical trials. Concerns noted in the article include: Wide disparities in education, economic and social standing, and health care systems may jeopardize the rights of research participants; There may be a relative lack of understanding of both the investigational nature of therapeutic products and the use of placebo groups; andIn some places, financial compensation for research participation may exceed participants' annual wages, and participation in a clinical trial may provide the only access to care for persons with the condition under study...
Tech Talk: Lawyer(s) Suddenly Laid Off? Looking to Set up an Office?
Posted on February 15, 2009A couple of friends across the USA have either suddenly been let go, or made the decision to depart before the ax fell. Most have the same problems: How to quickly set up an office presence if a lawyers decides to open up shop. Here are a few quick - perhaps interim only suggestions:1...
Peanut Butter Crisis: Georgia Company Declares Bankruptcy
Posted on February 14, 2009From the ajc.com:The company linked to a national salmonella outbreak, Peanut Corp. of America, filed for Chapter 7 bankruptcy Friday in federal court in Lynchburg, Va.In its filing, the company said its assets were between $1 million and $10 million, and its liabilities were between $1 million and $10 million...
FDA Targets Starcaps and Other Diet Pills
Posted on February 11, 2009The FDA says that certain weight-loss capsules, including StarCaps are promoted as natural dietary supplements using papaya, but could be hazardous to your health. In violation of the law, the FDA found, the capsules also contained a drug called bumetanide that can have serious side effects...
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs (Fentanyl)
Posted on February 11, 2009From the FDA's very own site:Certain ffected opioid drugs will be reviewed, and include brand name and generic products that are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks...
GA: Medical Malpractice Ruled Unconstitutional
Posted on February 11, 2009In Atlanta, State Court Judge Diane Bessen ruled that the Georgia statute that capped medical malpractice non-economic damages (O.C.G.A. Sec. 51-13-11) violated the Georgia Constitution. Known as the Nestlehutt decision, some highlights of the Order include: "A limit or cap on noneconomic damages ...
Consumers At Risk with Proposed Georgia Legislation
Posted on February 05, 2009From the GTLA: Governor Perdue wants to place the safety of Georgia?s citizens in the hands of a mismanaged federal bureaucracy Georgia lawmakers introduced SB 101. Senate Bill 101 would grant new protections from product-liability suits to Georgia companies whose products have Food and Drug Administration approval...
FDA Advisory Committee Hearing Will be Webcast 2/3/09
Posted on February 03, 2009Te Cardiovascular and Renal Drug Advisory Committee Meeting scheduled for February 3rd, 2009 will be webcast.The FDA's Cardiovascular and Renal Drug Advisory Committee Meeting is being held to decide whether or not to approve a competitor drug to Plavix, the second-biggest selling drug in the world...
Pres. Obama Weighs in on FDA: Critical Comments
Posted on February 03, 2009Nice to hear he is going to have a complete review of the agency that is failing Americans every day:"President Obama had critical words for the Food and Drug Administration yesterday in the midst of a massive recall of peanut products linked to a nationwide outbreak of salmonella illness that has killed eight people and sickened another 550...
Peanut Butter Recalls: Save Your Proofs of Purchases
Posted on January 31, 2009I've been reading (as have most) about the recall of tainted peanut butter products. I think bad advice is being given in an overly simplistic way - that is, advice to simply "throw away" the bad product. Obviously, most of the producers of the bad product hope most consumers throw away any proof they may have...
Peanut Butter Recall: Peanut Corp. of America
Posted on January 31, 2009The King Nut Food Supply Company announced an immediate recall of their institutional brands King Nut and Parnell's Pride peanut butter. Minnesota State Health officials linked the country's latest outbreak of Salmonella food poisoning to tainted peanut butter...
GTLA's 2009 Convention Highlights
Posted on January 28, 2009Georgia Trial Lawyers April 2009 convention has been revamped. From the GTLA site: With a completely redesigned format, this two-day extravaganza features multiple trackes covering a wide variety of topics for all practics areas! * Champions Trial Skills College * Civil Rights * Class Actions/Mass Torts * Criminal Defense * Ethics/Professionalsim * Evidence/Expert Witnesses * Family Law * Investor/Consumer Protection * Motor Vehicle/Premises Liability * New Plaintiffs Lawyers * Professional Negligence * Product Liability * Social Security * Technology * Trucking * Workers' Compensation
CEPAC
Posted on January 28, 2009Found this vendor at a recent lawyer seminar. Cepac provides: * Internet Advertising / Marketing using SEO, Social Media, PPC* Web Design for Lawyers - Law Firms , Single Attorney Web Site Designs Media Buying*Law Office Print Advertising - Brochures, Postcards, Direct Mail, Magazine Ads, Printing* Web 2...
FDA's Device Review Inadequacies: More
Posted on January 27, 2009Here's this tidbit:At least 228 medical devices between 2003 and 2007 were approved without a thorough evaluation, including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, despite assurances from FDA officials that holes in the approval process were being addressed, according to the report by the GAO...
FDA Heavily Criticized - Device Testing is Inadequate
Posted on January 24, 2009From the NYT:Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators from the GAO have concluded.'In recent years, the accountability office, Congress?s auditing arm, has chastised the F...
GA: Legislative Bill Tracker on GTLA's website
Posted on January 24, 2009The Georgia Legislature is in session now, and the Georgia Trial Lawyers Association has a good session tracker for bills that may impact consumers. You can see the work here. Sample layout:HB 0024 Work Evidence; revise, supersede, and modernize provisions; provide definitions Willard,Wendell 49thHouse Second Readers Judy - Pre-filed Bills Rules of Evidence This bill attempts to modernize Georgia's Rules of Evidence and bring those rules more in line with the Federal Rules, both with Civil and criminal, without making substantive policy changes...
Tip of the hat to The Complex Litigator
Posted on January 21, 2009Tip of the hat to The Complex Litigator for this post:A recent case deals with attempts to serve process, and the frustrations in locating a defendant to serve. From the opinion:On his third visit to [the] residence, Sheldon left a note for Brenneke to contact Barrister Support Service, but he did not do so...
FDA Warning Regarding Skin Numbing Products
Posted on January 20, 2009The Food and Drug Administration has issued an advisory to remind patients, caregivers and health professionals about the potentially serious hazards of using skin-numbing products -- topical anesthetics -- for relieving pain from conditions and medical tests, including mammograms...
Rhino MDL Hearing: 1/29/09
Posted on January 20, 2009The U.S. Consumer Product Safety Commission is currently considering new standards for Yamaha Motor Corp. USA's Rhino off-road vehicle and other currently unregulated "utility terrain vehicles." The Yamaha Rhino, which was first introduced in 2003 by Yamaha Motor Corp...
Sprint Fidelis Litigation: Court Dismisses Cases Based on Preemption
Posted on January 15, 2009My office investigated issues relating to Sprint Fidelis and their recall back in 2007. What are Sprint Fidelis Leads? Made by Medtronic Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart...
Study: Antipsychotic Drugs Increase MI Risks
Posted on January 15, 2009Heart attack risks were near two times great for those people taking antipsychotic drugs such as Zyprexa and Risperdal - at least that is what a study found, released by the NEJM. The article is here. The risk of heart attack for people getting the newer drugs, actually increased with their dosage, says thestudy authors...
Is the Current Economy Creating More "TV" Lawyers?
Posted on January 13, 2009Everyone has seen the injury lawyers on TV. Everywhere, and for many of us the ads from injury lawyers are inescapable. I travel extensively throughout the south, and in the past 4-8 months, and especially the last two months, I have seen lawyers advertising in areas other than personal injury...
FDA Scientists Complain to Obama About Managerial Misconduct
Posted on January 11, 2009Here is something worth watching: News from the FDA's scientists. A group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the FDA."The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, written on the agency's Center for Devices and Radiological Health letterhead...
Another Fentanyl Patch Recall
Posted on January 05, 2009PriCara®, announced that one lot of 50 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies...
Article Detailing Antibiotics' Dangers (Cipro, Levaquin)
Posted on January 04, 2009From the AJC and excellent reporter Alison Young:"When Dr. J.T. Cooper hobbles around his Marietta medical office, the boot brace on his right foot is a reminder of a danger posed by some of the most popular ?- and misprescribed ?- antibiotics on the market...
Healon D Recall News
Posted on January 02, 2009FDA Announces Class I Recall of Ophthalmic Surgical Device:The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif...
Georgialawyer's 09 Resolutions
Posted on December 31, 2008I make them every year. Each helps guide me, focus my office, and serve as a component of the office Business Plan. In no particular order, here they are: 1. Each employee will have two monitors. I have used two monitors, and I can tell you that productivity increased...
From the Blog Drug & Device Law 10 "Worst" Decisions of 08
Posted on December 30, 2008The Drug and Device Law Blog is a must read for me. This month, the folks there compiled a list of "worst" court decisions. Why are these the worst? Read on ... and read the complete list by going here: "1. Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal...
FDA News: Recall of a Medical Device: "Vibe"
Posted on December 30, 2008The Food and Drug Administration has issued a recall notice for a device made by a Colorado man that some claim cures cancer and other diseases. The FDA says the "Vibe" has not been shown to be safe and effective at curing or treating diseases.Source here.
Social Media for Lawyers
Posted on December 29, 2008I've been reading/catching up on Social Media for Lawyers. One site list the top myths regarding it, and here is one highlight:Myth: Social media tactics are too time consuming.Truth: Social media tactics could take hours and days, but they do not have to take that much time to be effective...
FDA Recalls Custom Stryker Cranial Implant Kits
Posted on December 26, 2008Stryker has had an interesting 2008. Pain pumps made by that company have been the subject of litigation. (The Stryker Pain Pumps are infusion devices designed to deliver controlled amounts of local anesthetics to the patient for post-operative pain management...
Season's Greetings
Posted on December 23, 2008a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://farm1.static.flickr.com/138/405111632_0e89c85330.jpg?v=0"img style="cursor:pointer; cursor:hand;width: 375px; height: 500px;" src="http://farm1.static.flickr.com/138/405111632_0e89c85330...
JPML Hearing for January of 2009
Posted on December 22, 2008To be held in Ft. Myers. You can find the Notice a href="http://www.jpml.uscourts.gov/Hearing_Info/HearingOrder1-29-09.pdf"here./a br /br /Rhino ATV litigation is on the docket.
ObTape Vaginal Sling: MDL in GA
Posted on December 22, 2008Between 2003 and 2006, approximately 35,000 women who underwent a transobturator surgical procedure to treat stress incontinence and bladder leakage received a defectively designed ObTape vaginal sling manufactured by Mentor. Estimates have suggested that 17% to 18% of these women could suffer severe and debilitating complications, including infection, vaginal extrusions and urinary tract erosions...
Gadolinium Lawsuits Line Up
Posted on December 22, 2008Lawyers for the plaintiffs and lawyers for the manufacturers of gadolinium based MRI contract agents have filed a joint list of 193 NSF lawsuits which are eligible to be among the first cases prepared for trial in the consolidated federal litigation.br /br /There are over 350 NSF lawsuits that have been filed in federal and state courts throughout the United States alleging that the manufacturers of five different gadolinium MRI contrast agents failed to adequately test their products or warn that they could cause a progressive and potentially fatal condition associated with the hardening and thickening of the skin, severely restricting movement...
Tainted Weight Loss Pills
Posted on December 22, 2008he FDA warned consumers Monday to neither consume nor purchase a slate of more than 25 different weight-loss products. Each may contain "undeclared, active pharmaceutical ingredients that may put consumers' health at risk," the FDA said in a release.br /br /The drugs the FDA warns could be tainted:br /br /# 2 Day Dietbr /# 3x Slimming Powerbr /# 3 Day Dietbr /# 5x Imelda Perfect Slimmingbr /# 7 Day Herbal Slimbr /# 7 Diet Day/Night Formulabr /# 8 Factor Dietbr /# 999 Fitness Essencebr /# Extrim Plusbr /# Fatloss Slimmingbr /# GMPbr /# Imelda Perfect Slimbr /# Japan Lingzhi 24 Hours Dietbr /# Lida DaiDaihuabr /# Miaozi Slim Capsulesbr /# Perfect Slimbr /# Perfect Slim 5xbr /# Phyto Shapebr /# ProSlim Plusbr /# Royal Slimming Formulabr /# Slim 3 in 1br /# Slim Express 360br /# Slimtechbr /# Somotrimbr /# Superslimbr /# TripleSlimbr /# Venom Hyperdrive 3...
2008 Resolution Recap
Posted on December 20, 2008Sitting in the South on a rainy weekend, I'm taking stock of some of my resolutions (those posted here), seeing how I did: br /br /Back about this time last year, I resolved these:br /br /span style="font-weight:bold;"1.When speaking with a person - client, attorney, etc...
FDA News: Antiepileptic Medications Must Carry Suicide Warnings
Posted on December 17, 2008News today from thea href="http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html" FDA/a: br /br /The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality)...
Study: Hormone Use Increases Cancer Risk
Posted on December 15, 2008From Yahoo News:Taking menopause hormones for five years doubles the risk for breast cancer, according to a new analysis of a big federal study that reveals the most dramatic evidence yet of the dangers of these still-popular pills.Even women who took estrogen and progestin pills for as little as a couple of years had a greater chance of getting cancer...
Did Wyeth Pay to have Journal Articles Written?
Posted on December 15, 2008A US Senator claims that Wyeth paid a company to ghostwrite medical journal articles about its hormone therapy products and seek academic scientists to sign them as authors.According to papers from lawsuits suggest the drugmaker hired DesignWrite Inc...
Weekend Post: First Christmas Without My Lab
Posted on December 14, 2008I tend to post simply about things that interest me: News regarding pharmaceutical litigation, tech items of interest. What most folks comment on in emails? The pictures of the dogs - to the right on this blog. This year, along with the happiness of the season, there is some sadness in my home...
FDA Panel Hearing Regarding Asthma Drugs
Posted on December 11, 2008FDA staffers who police drugs after approval spoke before an advisory panel this week. What did the FDA panel hear? That none of the medicines known as long-acting beta-agonists (LABAs) should be given to children with asthma. It was also argued that two Serevent and Foradil, should not be used by asthma patients of any age...
Hospira Recall News
Posted on December 09, 2008Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code LabelMedia Contact:Dan Rosenberg (224) 212-3366FOR IMMEDIATE RELEASE -- LAKE FOREST, Ill., Dec. 8, 2008 -- Hospira, Inc...
FDA: Asthma Drugs Serevent, Symbicort and Foradil Subject of Hearing
Posted on December 08, 2008The FDA has informed that three popular asthma medicines may increase risks of hospitalization and death in some asthma patients.The safety of the drugs - Serevent, manufactured by GlaxoSmithKline P.L.C.; Symbicort, made by AstraZeneca P.L.C.; and Foradil, from Novartis AG - will be reviewed by outside medical advisers to the FDA at a two-day hearing next week in Rockville, Md...
FDA: Drugmaker Suggested Off Label Use for Seroquel
Posted on December 08, 2008Seroquel is indicated for the treatment of both depressive episodes associated with bipolar disorder acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex as well for the treatment of schizophrenia...
Will Preemption Rules be Introduced?
Posted on December 05, 2008The clock is ticking for lawyers specializing in consumer safety litigation as they wait to see what "midnight regulations" the Bush administration squeaks through before leaving office in January. There are dozens of rules now under review by the administration that affect everything from prescription drug labeling to water quality to auto roof safety, according to the Office of the Federal Register, the government's official daily publication for rules, proposed rules and notices of federal agencies...
Is Rieperdal A Concern when used by Kids?
Posted on December 01, 2008From the WSJ Health Blog:Concerns about Risperdal use by kids: One particularly troubling side effect is the growth of breasts in some male patients taking Risperdal. The alleged problem stems from prolactin, a hormone involved in lactation, that can be elevated in males and females who take the medicine...
Starcaps FDA Recall Notice
Posted on November 30, 2008Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug IngredientFOR IMMEDIATE RELEASE -- November 26, 2008--- Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 ? 84810, sold in 30 capsule plastic bottles...
Starcaps Recall
Posted on November 19, 2008According to various papers/sources:Lab tests revealed a weight-loss supplement at the center of an NFL drug probe contained a prescription diuretic and a shipment of the product has been recalled, according to a company laqyer.An attorney for Balanced Health Products said a sample taken from a bottle of StarCaps tested positive for Bumetanide ? a drug commonly given to heart disease patients to reduce fluid retention ? and the company recalled a shipment of nearly 2,000 bottles from health food stores...
Tech: ReQall - A "Memory" Tool
Posted on November 19, 2008Playing around with ReQall now. From their site: "ReQall is the best memory tool you may ever have, connecting all the ways you communicate in one easy, seamless system. Best of all, reQall works with the technology you already use?nothing to buy, nothing to install...
Duragesic: Justice in Chicago
Posted on November 18, 2008My good friends at Heygood, Orr, Reyes, Pearson & Bartolomei received long due justice in a case involving a Duragesic pain patch for a client after a long trial in Chicago. The story: Janice DiCosolo, 38, of Cicero died on Feb. 15, 2004, while using a Duragesic patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy...
Vehicle Tires: Time to Replace Them?
Posted on November 12, 2008From my friend and fellow lawyer Rob Bunch, this article:With all of the information contained on a tire?s sidewall, it?s no wonder the average consumer has difficulty deciphering it all. While most know how to tell a tire?s size and width, the manufacturer, and the maximum inflation pressure, the tire?s DOT serial numbering system may not be so easy to understand...
Voluntary Recall of Potentially Oversized Tablets Expanded
Posted on November 11, 2008From the medical news site www.medpagetoday.com:ETHEX Corporation announced the voluntary recall of lots of five generic medications because they may contain more than the labeled amount of active ingredient, the FDA said.The recall applies to 150-, 225-, and 300-mg propafenone HCl tablets, 30- and 60-mg isosorbide mononitrate extended-release tablets, 15-mg morphine sulfate extended-release tablets, 15- and 30-mg morphine sulfate immediate-release tablets, and 10-mg dextroamphetamine sulfate tablets...
The Internet, Clients and My Law Office
Posted on November 10, 2008This recent report caught my eye:A report, released in August, says 40% of people 50 to 64 years old and 27% of adults 65 and older are getting information online every day, compared to about 55% of those 18 to 49. The study surveyed 2,251 adults 18 and older from April 8 to May 11 of this year...
Relion Syringe Recall
Posted on November 10, 2008From the FDA:FDA is urging patients and health care professionals to check packaging carefully for syringes labeled as 100 units for use with U-100 insulin from lot number 813900.The recall applies to the following product information:-- ReliOn 1cc, 31-gauge, 100 units The syringes were distributed by Can-Am Care and sold only at Wal-Mart stores and Sam's Clubs...
My Law Partner's Verdict For The Little Guy: $2.298Million
Posted on November 08, 2008One of my law partners just completed a retaliatory discharge case in Alabama involving Dollar General. A retaliatory discharge claim against an employer is generally allowed where an employee has been fired for exercising a right under state law, or the discharge of the employee violate public policy...
Preemption Before U.S. Supreme Court
Posted on November 04, 2008A good piece on the WSJ Law Blog regarding the Levine v. Wyeth case, which is front and center on the preemption issue.Preemption simply stated is the position that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling...
Avandia Update: Consumer Group Seeks Ban of Drug
Posted on October 31, 2008The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market...
Fen Phen Verdict - Primary Pulmonary Hypertension
Posted on October 24, 2008From Bloomberg.com:A recent verdict regarding Wyeth's Pondimin drug resulted in a decision that the cause of Gloria Stribling's primary pulmonary hypertension was caused by Fen Phen. The trial loss was Wyeth's first in four years in a case involving the often-fatal illness...
1 Million Cribs Recalled
Posted on October 24, 2008The recall announced by the U.S. Consumer Product Safety Commission involved older cribs that are no longer on the market but are often reused by families or sold at resale shops and online at sites such as Craigslist. The recall covered cribs sold in the U...
New Blog: Georgia Justice Blog
Posted on October 23, 2008You may find it here. http://georgiajustice.blogspot.com/What is it? It's the blog from the Georgia Trial Lawyers Assoc. The most recent post starts with a recap of this:A Great Escape and a Great ManThe Georgia Trial Lawyers Association honors Judge Anthony A...
Total Body Formula Litigation: MDL is in AL
Posted on October 23, 2008In the Total Body Formula lawsuits, the MDL for all of the litigation, including the Total Body Class Action, will be Birmingham, Alabama. Judge Proctor drew the cases. The Transfer Order may be found here. (PDF Alert)Expect an initial hearing in Birmingham soon.
Pfizer Settles Bextra and Celebrex
Posted on October 21, 2008From various sources:Pfizer has announced that is has offered a total of $894 million to settle heart attacks, strokes, and other damages caused by its painkillers Bextra and Celebrex.According to Pfizer, the settlement ends about 90 percent of the 7,000 personal injury lawsuits brought by those who were allegedly hurt by the painkillers...
FDA Regulators Missing Deadlines
Posted on October 21, 2008From Reuters:Several U.S. deadlines for reviewing new drugs have come and gone without a decision from the FDA. Here is a partial list: Prasugrel, a blood thinner from Eli Lilly and Daiichi Sankyo. A decision was due Sept. 26. The application remains pending...
FOIAs Reveal How Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority
Posted on October 15, 2008From the AAJ:"In a stealth effort coordinated at the highest levels of the Bush administration, multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections, according to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ)...
Vioxx Study: Heart Risks Last Nearly One Year
Posted on October 14, 2008From various sites:A long-term analysis of people who took the arthritis drug Vioxx confirms it doubles the risk of strokes and heart attacks. The risk seems to decline a year after people stop taking it. And other drugs in the same class of painkillers known as Cox-2 inhibitors may cause similar harm...
Price Gouging Update: GA does nothing, FL getting results
Posted on October 08, 2008Just after Hurricanes Gustav and Ike wreaked havoc, I posted on price gouging going on in Florida and Georgia. It's been about a month. What has happened? Florida: A Florida gas station accused of price gouging after Hurricane Ike has agreed to reimburse anyone with a receipt who was overcharged for gasoline, under a settlement with the state attorney general...
Eli Lilly to pay $62 million in Zyprexa settlement
Posted on October 08, 2008From Reuters:Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes...
Total Body Formula Lawsuit: State Court Hearing 10/13/08
Posted on October 08, 2008On Monday October 13, 2008 at 9:00 a.m. in Decatur, GA Judge A. Wong will hold the first hearing on cases involving folks who claim they were injured by a supplement known as Total Body Formula and Total Body Mega Formula. I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases...
Raptiva Brain Link?
Posted on October 03, 2008From Bloomberg:A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years...
More Misleading Pharma Ads (FDA sez)
Posted on September 30, 2008The FDA sent letters to Lilly, J&J, Novartis, Shire, and Covidien' Mallinckrodt with complaints about certain promotions.Shire drew objections for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington...
FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"
Posted on September 30, 2008From the FDA site:A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept...
Georgia Federal Court: Recent Daubert Ruling
Posted on September 30, 2008You can see it by going to Slideshare.net. The nutshell version: Daubert should only apply to junk science. Daubert Order GA LawView SlideShare document or Upload your own. (tags: georgia law)
Zimmer Hip Cup Recall
Posted on September 26, 2008Zimmer Holdings, the largest producer of orthopedic devices in the United States, recently halted sales of a hip replacement implant which has been failing in unacceptably high numbers. The Durom Cup hip socket implant, introduced by Zimmer in 2006, has been implanted in over 13,000 patients across the nation...
Ex-Medtronic Lawyer: Company took Docs to Strip Club
Posted on September 26, 2008From the Minneapolis paper:'A whistleblower lawsuit against Medtronic Inc. that highlighted perks allegedly paid to doctors was filed by one of the company's lawyers, according to a report today in the Wall Street Journal. The legal action was ultimately settled in 2006 for $40 million...
Spirivia and Atrovent Slammed by JAMA
Posted on September 26, 2008So says Medline Plus. You can access the JAMA abstract here. The drugs Spirivia and Atrovent are prescribed for chronic obstructive pulmonary disease (COPD), and according to a recent report, each is associated with an increased risk of heart attack, stroke and other cardiovascular problems...
Total Body Formula Update: MDL Hearing in Boston 9/25
Posted on September 24, 2008Our office is investigating claims of people who were hurt by a recalled dietary supplement called Total Body Formula. On September 25, 2008, one of my law partners will be attending a Federal Court hearing in Boston that will address a request to centralize the USDCT court cases in one court...
Tarceva: Two Deaths from Hepatorenal Syndrome
Posted on September 24, 2008The FDA has reported that the makers of the cancer drug erlotinib (Tarceva) have reported two deaths -- one from hepatorenal syndrome and one from rapidly progressing liver failure -- among patients taking the agent.As a result of the deaths, OSI Pharmaceuticals and Genentech, the makers of the epidermal growth factor receptor inhibitor, are revising the label to include new warnings about both liver and kidney risks...
Tech: Using Rocket Dock
Posted on September 23, 2008Rocket Dock is a free Mac dock "clone" that anyone is able to use on a Windows-based PC or notebook. Most desktops including mine are loaded up with junk. The Rocketdock I now use has just a few icons - Mozilla, a database icon, an icon for my WP system...
FDA News: Rituxan
Posted on September 22, 2008From the FDA: Genentech has informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study...
Atrovent News: Increased Risk for Cardiovascular Death
Posted on September 17, 2008In patients with COPD, an anticholinergic drug used to prevent bronchospasm, ipratropium bromide (Atrovent)increased the risk of cardiovascular death, researchers here reported. A nested case control study found that ipratropium use was associated with a 34% increase in risk of cardiovascular death (OR 1...
Gas Prices: Gouging in Hurricane's Wake?
Posted on September 16, 2008In Georgia as in many parts of the country people saw a run on prices for gasoline. In turn, many of us (including yours truly) were angered by what seemed to be gouging at the pumps. It's not just me; even a County Sheriff thinks so. In Florida: Florida?s agriculture and consumer services commissioner said Monday that he is issuing subpoenas for financial information from 16 major oil terminals in Florida...
Tech: Secure Instant Messaging for a Law Office
Posted on September 16, 2008In my office we rely on technology in many areas, including Instant Messaging ("IM"). What is it? IM is a text-based computer conference over the Internet between two or more people who must be online at the same time; Unlike email instant messaging software allows you to 'talk' to someone in real time by typing and receiving messages...
9/11/08: Voices To Bring 9/11 Museum Relics To Life
Posted on September 10, 2008As I sit down to write this blog post, I noticed that coincidentally this is post 911 on my blog .... From CBS.com:The artifacts awaiting their place in the Sept. 11 museum sit in storage - crushed emergency vehicles, dust-covered purses, a giant steel column covered with victims' pictures...
Drug Ads Subject of FDA Web Site for Consumers
Posted on September 10, 2008From a Yahoo Press Release:"EthicAd, a nonprofit organization devoted to improving public health through consumer education, announces the launch of a new FDA Web site created to help the general public better understand direct-to-consumer (DTC) advertising of prescription medications...
FYI: Lemon Law Blog
Posted on September 10, 2008Came across the Lemon Justice Blog: http://www.lemonjustice.com/blog/Worth a read. Here is one post:Car Complaints: The Dubious Honors Go To ?We?ve been discussing the 2008 cars that made their way to the top of the Center for Auto Safety?s Car Complaint Index...
FDA: 20 Drugs under a Safety Probe
Posted on September 10, 2008A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events. The first of this series of quarterly reports has been released. It includes adverse events reported between January 1 and March 31, 2008...
Diabetes Drugs (Avandia and Actos): Significant Cardiovascular Risks
Posted on September 02, 2008According to the Wake Forest University Baptist Medical Center's recent report. It refers to a generic form of Avandia and Actos. From several reports:A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members...
Antipsychotic Drugs: Double the Stroke Risk?
Posted on September 02, 2008People taking antipsychotic drugs -including Zyprexa and Seroquel -- are nearly twice as likely to have a stroke compared to those not on the treatment according to British researchers."The risk is even higher -- about 3.5 times -- for men and women with dementia, which means doctors should only prescribe such medicine to these patients as a last resort, the researchers said...
Weekend: College Football Has Begun
Posted on August 29, 2008Officially, that is. It began last night here in the South and parts elsewhere. Down here, however, it's different. Equal parts Christmas, St. Patrick's Day, Lundi Gras, and your birthday, college football unites as well as divides in the South. A business introducton in my South in the fall may often include - in addition to being asked your name - the question, "Who ya for?" And the questioner does not mean do you support McCain or Obama, but rather the Tide, the Bayou Bengals, or the Gators...
Byetta (Diabetes drug): Four Deaths reported
Posted on August 28, 2008Amylin Pharmaceuticals said there have been four deaths among patients with pancreatitis who took its diabetes drug, Byetta. This is in addition to the reports of two other deaths. The company said the four cases had not been reported last week to the FDA...
Hot Pockets Recall
Posted on August 26, 2008Yes, you read that right. From various sources:"Nestle Prepared Foods Company is recalling about 215,660 pounds of frozen stuffed pepperoni pizza sandwich products, known as Hot Pockets Pepperoni Pizza, because the product might contain small pieces of hard red plastic and other foreign material, which pose a risk of serious injury to consumers...
Daytrana Patch Recall
Posted on August 26, 2008From various sites:Noven Pharmaceuticals Inc. said its partner Shire Ltd. is voluntarily recalling two lots of the attention deficit hyperactivity disorder drug patch Daytrana because of a problem with the patch liner.In the recalled lots, the liner that needs to be released before the patch can be applied does not meet specifications, meaning patients might have difficulty removing the liner in order to apply the drug...
Tech Weekend: PC Mag's Top 100 "Undiscovered Sites
Posted on August 23, 2008Sites on the web you may not have heard about as you work. Link here.Some of the sites include:Tech Daily DoseRun by the National Journal, this is a site for those interested in the role technology plays in government would be hard-pressed to find a better news outlet than this National Journal-run blog...
What Happens After a Recall?
Posted on August 19, 2008As the news spreads about the voluntary recall of Total Body Formula, what is particularly striking to me is how the news of the recall makes it to consumers. From the many folks I talk with every month on a variety of matters, it seems that most consumers don't know of recalls, and as of yet there is no uniform method as to recalls...
Total Body Formula News Report
Posted on August 19, 2008My client was interviewed on a local Atlanta station:
Vioxx: Another Article (Annals of Internal Med.) Critical of Merck
Posted on August 19, 2008Did Merck "endanger" patients in 1999 when it disguised a marketing program as a scientific trial of its now-withdrawn painkiller Vioxx? That is what is claimed in an an article and editorial to be published in the Annals of Internal Medicine.From the Philadelphia Enquirer:"The editors of the Annals of Internal Medicine, which is based in Center City, said the journal's findings may point to a broader problem in the pharmaceutical industry...
Total Body Formula Article in Atlanta Journal Constitution (daily paper)
Posted on August 18, 2008This weekend the Atlanta Journal Constitution had a lengthy and well written article on Total Body Formula's recall and the recalled product had on several people. One person named in the article is a current client of mine. We've file several lawsuits, and are not part of any class action regarding Total Body Formula...
Powerful Antacid Drugs Raise Fracture Risk
Posted on August 13, 2008Aciphex, Nexium, Prevacid, Prilosec and Protonix are the drugs in question.From Health Day:"New Canadian research shows that long-term use of proton pump inhibitors for acid reflux, peptic ulcers and related disorders elevates the risk of osteoporosis-related fractures...
Drug Companies Don't Want to Disclose Lawsuit Defense Costs
Posted on August 13, 2008Several drug firms sent a letter last week accounting-rule lawmakers, arguing that mandatory disclosure of estimated costs of ongoing litigation is expensive, not helpful and won't provide worthwhile information for investors.Costs estimating of ongoing litigation is "highly subjective, subject to huge swings as underlying assumptions change, and unlikely to provide financial statement users with meaningful or reliable information," the companies said in a letter to the Financial Accounting Standards Board...
CLE: GTLA Torts Seminar 8/7-9/08
Posted on August 05, 2008Time for a seminar at the beach ... this weekend, the GTLA is holding its Summer Seminar in Sandestin. Here's the agenda, and note my time slot .. Saturday morning at 9 AM:Thursday, August 7800am Registration, Breakfast & Exhibits8:30am Welcome & Registration8:40am The Sun Was in My Eyes and Other Insurer Favorites ? Mike Neff, Law Office of Michael,Lawson Neff P...
At the Trial Lawyer Blog: Matt Garretson on Fee Agreements
Posted on August 05, 2008Good stuff at the TLRC blog:One of the attorneys at Matt Garretson's Firm has prepared a ?practice tip? sheet for updating a client fee agreement. Among other topics, the article incorporates the points addressed in NY Professional Ethics Committee Opinion (#739, July 7, 2008), which contains logic that is instructive no matter what state(s) you practice in...
Attorneys: Yellow Pages Ads Gather Dust
Posted on August 05, 2008From The Journal Record an article on what may seem obvious to some:"It?s pretty much required these days for a law firm to have a Web site," according to Jim Calloway, a member of the Oklahoma Bar Association.Read more here.
Anemia Drugs Label Change
Posted on August 04, 2008The FDA has ordered label changes on cancer patients' use of drugs with erythropoiesis- stimulating agents (ESA) made by the companies. The changes would be added to a "Black Box" warning. The drugs are Epogen and Aranesp. The FDA states that the new label must stated that the drugs are not to be used in cancer patients receiving chemotherapy when a cure of the cancer is anticipated...
Georgia Watch - Georgia State Court Annual Report
Posted on June 13, 2008The Georgia Court Watch issued its annual report on appellate courts.ATLANTA ? Court Watch today released its first annual report analyzing consumer-related decisions issued by the Supreme Court of Georgia and the Georgia Court of Appeals. Court Watch is a project of Georgia Watch, a nonprofit and nonpartisan group committed to strengthening the rights of consumers in Georgia ...
Did Glaxo Suppress Paxil Safety Data and "Bamboozle" the FDA?
Posted on June 13, 2008A U.S. Senator thinks so. From various reports: GOP Senator Grassley has asked the FDA to study an overseas report issued several months ago that concluded that Glaxo suppressed Paxil data going back to 1998. Glaxo had said risks came to light in in 2006...
FDA's Abysmal Failures
Posted on June 12, 2008This time, tomatoes.From various reports:"As foodborne illness outbreaks continue, FDA is missing valuable opportunities to reassure Congress and the public that it is doing all it can to protect the nation's food supply," said the report by the investigative arm of Congress...
Epilepsy Drugs (Topamax and others) to get Suicide Warning
Posted on June 09, 2008The FDA is in the final states of including language warning about suicidal behavior on labels of 11 epilepsy drugs. Sales of the affected drugs, widely used for nonepilepsy problems such as chronic pain, topped $8 billion last year.From various sources, including the WSJ Blog...
Regranex Warning from the FDA
Posted on June 09, 2008Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label...
News on Tumor Necrosis Factor Blockers
Posted on June 05, 2008Tumor Necrosis Factor blockers like Remicade, Enbrel, Humira, and Cimzia may be impacted by a recent FDA investigation. From the FDA:The FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults...
More Bad News on Chantix
Posted on June 03, 2008Hundreds of accidents have been linked to Chantix according to a study by outside researchers. The report was issued by the Institute for Safe Medication Practices.The researchers say the number of convulsions for people taking Chantix is at least 86 since the drug went on the market in 2006...
FDA: Baby Formula Recalled
Posted on June 02, 2008Two lots of baby formula have been recalled.Abbott Laboratories says it is voluntarily recalling two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder. The formula is specially designed for infants and children with hypercalcemia - high levels of calcium - in their blood...
Depo Provera Class Action in Canada
Posted on June 02, 2008From Bloomberg:Pfizer's being sued by Canadian women who claim the company failed to provide proper notice the contraceptive Depo-Provera causes loss of bone density. The pending case won a broad (for Canada) national class-action certification. For more go here.
Truckers: Don't Take Chantix
Posted on May 27, 2008The Federal Motor Carrier Safety Administration, which regulates the trucking and bus industries, says that anyone taking Chantix shouldn't be allowed to drive. The Department of Transportation has alerted the heads of its myriad sub-agencies to the Chantix study and told them to take note of its findings and recommendations...
Lawyers/Firms With Bad Web Sites: Why Bother?
Posted on May 23, 2008This week, not once but three times I have been searching out lawyers for various matters in other states. I am pretty sure that the litigators I sought out would not dare take even a basic deposition without being prepared, yet I am amazed at how little time is spent on a firm's web site...
Oral Hormone Therapy Doubles Clot Risk
Posted on May 23, 2008From Reuters:Menopausal women taking hormone-replacement therapy pills may be at risk in excess of two times normal of developing a blood clot."This meta-analysis ... showed that current use of oral oestrogen increases the risk of (blood clots) by two-fold to three-fold," Pierre-Yves Scarabin and Marianne Canonico of the Paul Brousse Hospital in France wrote...
Tech: Zombies Among Us?
Posted on May 22, 2008Tech Zombies that is. I am seeing what (to me) is a new phenomenon - texting or emailing while walking. I saw a man lurching oddly across a parking lot, and honestly thought something was wrong ... it was. Seems that he was working a phone --- hard --- while maneuvering the hazards of parking spaces...
Ad comes back to bite Life Lock
Posted on May 22, 2008Have you seen the Life Lock ad, the one where the company chief gives out his Social Security Number and dares anyone to use it?From the web:"Davis (the company honcho) acknowledged in an interview with The Associated Press that his stunt has led to at least 87 instances in which people have tried to steal his identity, and one succeeded: a guy in Texas who duped an online payday loan operation last year into giving him $500 using Davis' Social Security number...
The U.S. Supreme Court, the FDA and Reality
Posted on May 21, 2008While the U.S. Supreme Court traces the history of how a device gets approved, the reality of the FDA is to me much different. From the Denver Post:The Food and Drug Administration has finally acknowledged that it needs more resources to protect consumers from tainted food and drugs...
Google Health, Part 2
Posted on May 20, 2008I found this on the site: To join, users must agree to various terms of use, including this: "When you provide your information through Google Health, you give Google a license to use and distribute it in connection with Google Health and other Google services...
Google Health Debuts
Posted on May 20, 2008From the site, below. From the blog: "One of the most exciting and innovative parts of Google Health is our platform strategy. We're assembling a directory of third-party services that interoperate with Google Health. Right now, this means you'll be able to automatically import information such as your doctors' records, your prescription history, and your test results into Google Health in order to easily access and control your data...
Heparin: Quaid Testifies
Posted on May 19, 2008Compelling video last week on Heparin. Worth a look.
Spy on Your Friends
Posted on May 13, 2008Or so says the WSJ in today's paper version. There are tools/sites to make it easier to "snoop."The sites include:Zabasearch.com: The site's tagline is: Telephone Numbers and Addresses Revealed Free Wink.com:From the site - Wink People Search provides free people search across over 400 Million profiles from across the Internet - including Facebook, MySpace, LinkedIn, and all the other big social networks...
Tips: UpgradeYour Life
Posted on May 07, 2008I'm not talking about learning CPR or adopting a child, just everyday upgrades. From Lifehacker:A list that will help you start the handle the endless items each day that dog you. The list includes:Hack 8: Consolidate Multiple Email Addresses with GmailHack 12: Instantly Retrieve Files Stored on Your Hard DriveHack 21: Design Your Own PlannerTake the time to look at the post...
Walmart
Posted on May 06, 2008From the Walmart Releases:Beginning today, Wal-Mart, Neighborhood Market and Sam's Club pharmacies will fill prescriptions for up to 350 generic medications at $10 for a 90-day supply. This option will give customers an additional choice and save them time and money without the hassle of purchasing or signing-up for a pharmacy discount card...
Vioxx Deadline Extended: June 30, 2008
Posted on May 02, 2008Merck report this week that more than ninety percent of eligible U.S. claimants have elected to participate in its $4.85 billion proposed Vioxx settlement, and the drugmaker extended the deadline to opt in.Merck said that, while it was satisfied with signing up the vast majority of potential participants, it was extending by two months -- until June 30 -- the deadline for remaining eligible former users of its withdrawn arthritis drug to enroll in its proposed settlement...
Total Body Formula Lawsuit Filed in Georgia
Posted on May 01, 2008Today my office filed a lawsuit for a client who claims she was injured because of an unsafe supplement known as Total Body Formula.The Total Body Formula product was sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles...
Central United Class Action
Posted on April 30, 2008My friend and fellow attorney asked me to post this about a pending class action and a proposed $650 payment to certain class members:A national class action has been filed against Central United Life Insurance Company. Central United and the Class Representatives have agreed to enter into a settlement agreement in a state court in Alabama...
Total Body Formula Recalled
Posted on April 27, 2008A Supplement has been recalled because of an error in its preparation. The Total Body Formula products were sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta...
Audio: Heparin Hearings on Capitol Hill (From NPR)
Posted on April 24, 2008A report from NPR, with the requisite table pounding by a Congressman. FDA representative lectured because "you do not have the resources" to do the job the FDA is required to do. You can get the audio here on the NPR site. Most startling about the report? There is a claim that 80% of active ingredients in meds are produced overseas...
FDA Links Tainted Heparing to China
Posted on April 23, 2008From various sites: FDA reps said they have new evidence linking many serious adverse reactions and deaths among patients given the blood thinner heparin to a man-made contaminant introduced during production in China.The FDA traces the contaminant to 12 different Chinese companies and has been found in heparin batches shipped to 11 nations, all of it from China...
Trasylol MDL: West Palm Beach
Posted on April 20, 2008Judge Donald Middlebrooks, judge for the United States District Court for the Southern District of Florida will oversee the Trasylol Multi District Litigation. He served as General counsel to the Governor of Florida from 1974 - 1977, and in in 1997 was appointed by President Bill Clinton to serve as a United States District Judge...
Dangerous Plastic Bottles?
Posted on April 16, 2008From Yahoo ...A chemical in some plastic food and drink packaging including baby bottles may be tied to early puberty and prostate and breast cancer, the U.S. government said on Tuesday.Based on draft findings by the National Toxicology Program, part of the U...
Merck Hid Vioxx Dangers
Posted on April 16, 2008Merck suppressed documents that Vioxx could harm patients, according to a recent report. What a surprise. JAMA writers claim that Merck failed to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo...
Did Heparin Price Surge Increase Adulteration of the Drug?
Posted on April 15, 2008Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.The main ingredient produced for Heparin in China had a price increase of nearly double to the prior year. This was less than six months before hundreds of American patients began having severe and sometimes fatal allergic reactions to the medication...
Exubera: Lung Cancer Risk?
Posted on April 14, 2008Pfizer has report that clinical trials of the inhaled insulin Exubera found increased cases of lung cancer.The lung-cancer news is a setback to Exubera, which held the promise of letting diabetics avoid needle sticks.Pfizer has reported that six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer...
Heparin Update
Posted on April 09, 2008From the FDA site more information: The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA over the last fifteen months (i.e., from January 1, 2007 through March 31, 2008). * The reports are sorted according to the date of the medical event in the report, indicated in the first column...
Drug Makers May Near Goal of a Legal Shield
Posted on April 08, 2008The NYT has posted an insightful article about the realities of preemption, and specifically Johnson & Johnson and its Ortho Evra Patch. The shield is of course preemption. From the article:"For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents...
Two Monitors Are Better Than One
Posted on April 07, 2008At the recently completed GTLA Tech Seminar, my friends Landon Harlan and Dave Swanner were preaching the vitures of dual monitors. Why?Studies show dual monitors increase productivity. "Survey after survey shows that whether you measure your productivity in facts researched, alien spaceships vaporized, or articles written, adding an extra monitor will give your output a considerable boost ? 20 percent to 30 percent, according to a survey by Jon Peddie Research...
USDCT Denies Pfizer Attempt to Subpoena Journal Documents
Posted on April 07, 2008A federal district court in Chicago dened a Pfizer subpoena that would have "threatened the integrity of [the journals'] peer-review process," as Journal of the American Medical Association (JAMA) editor Dr Catherine D DeAngelis writes in JAMA. Magistrate Judge Arlander Keys ruled that the journals were not compelled to provide Pfizer with documents regarding how manuscripts are accepted/rejected, or hand over copies of rejected manuscripts, identities of peer reviewers and the manuscripts they reviewed, and comments by and among peer reviewers and editors...
Annuale
Posted on April 07, 2008You owe it to yourself to watch the spot on pharma spoof from the 4/5/08 SNL: Disclaimers include:Do not take Annuale if you plan to ever become pregnant, as it may turn your baby into a firemonster. In the days around your period, you may develop a leathery tail...
Report: Auto Accidents - Workers on Cellphones Cost Employers
Posted on April 04, 2008It should not surprise anyone that cellphones are a menace in the hands of some drivers. In my short commute to work, I see drivers backing up while on a cellphone, texting while driving more than 70 mph, and worse. In one congested intersection manned by police officers, even they are typically on cellphones...
The Growing Vytorin Problem
Posted on April 02, 2008Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines...
Celebrex a Risk at Higher Doses (400 mg+)
Posted on April 01, 2008If you type in Celebrex at the top of this blog and hit enter, you'll find a number of posts on that drug. From pharmalot.com and other sites, this 'news' which has been discussed for more than two years:Patients taking the largest dose of 400 mg twice a day tripled their chance of a heart attack or stroke, compared with people taking a placebo, according to a study presented today at the American College of Cardiology meeting...
Regranex: Diabetic's Topical Gel Increases Cancer Risk , FDA Informs
Posted on March 31, 2008The Food and Drug Administration said it believes there may be some evidence an increased risk of death from cancer in patients who have had repeated treatments with Regranex, a topical gel for the treatment of diabetic foot and leg ulcers.A recent study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not...
Singulair & Suicide Link?
Posted on March 31, 2008From CBS:Singulair, the popular asthma and allergy drug, is under investigation by the FDA for a possible link to suicide... .
Wish Me Luck?: ING 1/2 Marathon
Posted on March 27, 2008The good (and bad) about posting a resolution on a blog is that you better keep the resolution. My first major one looms this weekend: Running a 1/2 Marathon. I pondered my many excuses- injured knee, troublesome ankle, not enough long runs - when a good friend asked me if I was backing out...
The Public Library of Law
Posted on March 24, 2008From their site, which you can find here:"Welcome to the world's largest free law library.Searching the Web is easy. Why should searching the law be any different? That's why Fastcase has created the Public Library of Law -- to make it easy to find the law online...
More Bad News for Heparin?
Posted on March 24, 2008Another maker of the blood thinner Heparin has announced a recall, warning that the drug may be contaminated. B. Braun Medical Inc. has recalled 23 lots of Heparin but said in a press release that there had been no reports of adverse events.Last month, Baxter International Inc...
Florida Justice TV
Posted on March 21, 2008I'm a member of the Florida Justice Association, the FJS has launched Florida Justice TV.From the site:2008 Session Week 3 UpdateAn update from Frank Petosa on the events of week 3 of the legislative session in Tallahassee.
Georgia Technology CLE: 3/26/08
Posted on March 21, 2008It's not too late to register. Next week, I'm co-chair of a CLE Tech Seminar. Dave Swanner of sctriallaw.com as well as Angel Reyes are set to speak - the agenda is below: 8:30am Introduction to Morning Session9:35am-9:00am The Paperless Office: From Startup to ImplementationAndy Childers, Childers, Buck & Schlueter, LLP, Atlanta9:00am-9:25am Using the WWW in the Office: Sides, SEO, Google Adwords, & BlogsLandon Harlan, ejustice, San Diego, CA9:25am-9:55am Communicating with Clients in the Tech EraAngel Reyes, Heygood, Orr, Reyes, Pearson & Bartolomei, Dallas , TX9:55am-10:45am Using Technology for a Smoother Running OfficeDave Swanner, Attorney and Technology Consultant, Myrtle Beach , SC...
Philly Judge: No Preemption in a Paxil Case
Posted on March 18, 2008Collins adv. Glaxo, which you may find here.A Philadelphia State Court Judge has denied a defense MSJ which would have served to dismiss the state law claims of a family whose husband and father committed suicide while taking Paxil, in Collins v. SmithKline Beecham, d/b/a GlaxoSmithKline...
LawProse: Video of Interviews with Suprem Court Justices
Posted on March 17, 2008Compelling stuff, much of it is unvarnished. Enjoyable video footage:From the site: In 2006-2007, Bryan Garner interviewed eight of the nine Justices about legal writing and advocacy. These are the complete interviews. Because the files are large, the videos may take a few moments to start playing...
A New Website for Documents: JD Supra
Posted on March 17, 2008Worth a look. Not sure if it will ultimately succeed, as many organizations (such as a Georgia Trial Lawyers Association) have sites where documents are shared/stored. The site is new - and I hope it does well: http://www.jdsupra.com/From their site:For anyone in the legal community - lawyers, law firms, law schools, law professors & their students, public interest groups - JD Supra is not just a resource, it?s also a showcase: * As a legal professional, you post your court filings, decisions, forms and/or articles to JD Supra?s database, a free tool for legal research...
Zyprexa Litigation News
Posted on March 17, 2008In the news at the end of last week, the NYT reported that a Lilly executive had encouraged the promotion of its schizophrenia drug Zyprexa for a use not approved by federal regulators.The report said John Lechleiter, set to become chief executive in April, wrote an e-mail in 2003 discussing the use of Zyprexa by children and teenagers, although it is only approved for adults with schizophrenia or bipolar disorder...
Imported Heparin to be Tested
Posted on March 14, 2008Today the FDA ordered the detention of all imported supplies of heparin blood-thinner products so they could be tested for possible contamination. Heparin is derived from pig intestines, and used in dialysis and heart procedures, among other surgeries, to avoid blood clots...
Jargon and Tech: Speak English for Cryin' Out Loud
Posted on March 13, 2008This is a message (or plea) to those in the Tech World: Speak Englishh. I know it's hard. I know you get caught up using words like scalability, GIGO, WYSYWYG -- pronounced "wizz ee wig")and modularization. It makes you feel special. For me though, when you when you use tech jargon, I feel like I'm being bamboozled...
Pharma in bed with Democrats?
Posted on March 13, 2008From WaPo.com:The pharmaceutical industry is now saddling up to the Democratic Party, and it has worked to block Democrats top prescription-drug initiatives.From the article: "In the year since they took over on Capitol Hill, Democratic leaders have been unable to pass either a bill allowing reimportation of drugs from Canada or a measure requiring negotiation of drug prices under Medicare...
Tech Tip: Buy a .com With Your Telephone Number
Posted on March 12, 2008With domain names becoming somewhat scarce, one easy .com buy is: Buy your office telephone number. Attorney Bill Harrell has already done this, and it's a no brainer. The firm website is www.forjustice.com, and their number is 251-1111.com. Surely it is simply redirected to the main site...
Online File Sharing from EatLime.com
Posted on March 12, 2008EatLime speeds up online file sharing by allowing a recipient to begin downloading the file as soon as you start uploading it. So, no more waiting for the file to finish uploading before the download starts. File size up to 1GB will work. Thanks to Lifehacker...
Former NFL Player Challenges TX Malpractice Caps
Posted on March 11, 2008Former Dallas Cowboy football player Ron Spring has been in a coma since late 2007 after having surgery to remove a cyst; he is one of several plaintiffs challenging Texas' medical malpractice cap in a lawsuit filed at the end of February.In Springs' case, the claim is that anesthesiologist Joyce Abraham and plastic surgeon David Godat were negligent in a 2007 cyst removal procedure in which Springs suffered a severe reaction to anesthesia, resulting in cardiac arrest...
Jury Verdict for My Friend Angel Reyes and His Firm
Posted on February 19, 2008My friends at Heygood, Orr, Reyes, Pearson & Bartolomei pass along news of a great jury verdict for their client, Tony Alardin, in a partnership dispute regarding the development, manufacture and sale of wireless video surveillance trailer systems.In 2001, Mr...
Another Fentanyl Recall (Actavis and Abrika)
Posted on February 19, 2008Fentanyl patches were recalled for the second time in a week because of a problem that could cause patients or caregivers to overdose on the potent drug inside.Sold in the United States by Actavis South Atlantic, the newly recalled patches have both this name and the company's former name, Abrika Pharmaceuticals, on their packaging...
Could Drugmakers Use Journals to Promote Off Label Use?
Posted on February 18, 2008From Bloomberg.com:Drug and medical-device makers would be allowed to use medical journal articles to promote unapproved uses of their products under a U.S. proposal that drew immediate criticism on Capitol Hill.The Food and Drug Administration issued draft guidelines today explaining the circumstances in which companies could distribute ``truthful and non-misleading'' articles to health- care providers...
60 Minutes and Trasylol
Posted on February 18, 2008From CBS: "This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America...
Vytorin: Depression Added as a Side Effect
Posted on February 15, 2008The FDA has approved a change in the product labels for cholesterol drugs Vytorin and Zetia, adding depression as a possible side effect of the drug.In letters to the drugs' co-marketers, Schering-Plough Corp. (SGP) and Merck & Co. (MRK), the FDA said depression would be added to the section of the drugs' package insert concerning adverse reactions in post-marketing experience...
FDA Warning for Botox
Posted on February 11, 2008FDA Notifies Public of Adverse Reactions Linked to Botox UseOngoing safety review of Botox, Botox Cosmetic and Myobloc taking placeThe U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses...
Text Messaging Privacy
Posted on February 08, 2008Texting is omnipresent, and it's in the news quite a bit. Text messaging has become a huge part of people's lives, especially the under 30 set. How private it texting?According to various sources, here is some news: AT&T says it keep messages for up to 72 hours, Sprint PCS for two weeks, and Verizon says texts don't stay on the network for a long period...
Did Lipitor Commercials use a Body Double for Dr. Jarvik?
Posted on February 08, 2008From various sources: A congressional committee contends the creator of the first artificial heart could have have misled ad viewers by using a body double in advertisements for a popular cholesterol drug he touted in commercials. Yes you read that right, a body double...
Did we mean a $1B Zyprexa Settlement? Sorry, that was Confidential
Posted on February 07, 2008The news that Eli Lilly was working out a deal with with federal and state prosecutors over improper marketing of Zyprexa was the result of an inadvertent leak from one of the lawyers on the matter.A lawyer at Pepper Hamilton mistakenly sent an e-mail containing a confidential document to a reporter at The New York Times...
Merck VP: Vytorin's News is a "Media Event"
Posted on February 07, 2008From the WSJ Blog:Ken Frazier from Merck spoke in New York City recently, and he addressed the Vytorin frenzy in the media in recent ?We really feel that the Enhance data that has been put out into the public sphere has been mischaracterized,? he said...
FDA: Chantix Anti-smoking Drug Needs A Warning
Posted on February 04, 2008Chantix looks to be linked to serious psychiatric behavior, including suicide. Chantix is a smoking cessation medicine.The FDA reported that after an analysis of cases of depression, suicidal thoughts and other unusual behavior in patients on the medication, the evidence appears stronger of an association with Chantix...
Medtronic SynchroMed EL Implantable Infusion Pump
Posted on February 04, 2008Today's news brings news of another recall:The FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer...
Google's New Search Results: Timeline View
Posted on January 29, 2008I have the Google Blog on my RSS. Today there is something that may be a big help. From their site:"Introducing experimental views for search results. There have been a lot of recent improvements to web search, but the appearance of results themselves has been pretty constant -- 10 or so web pages in a vertical list...
OTC Eardrops: Possible Hearing Loss/Damage?
Posted on January 29, 2008Researchers at The Montreal Children's Hospital have revealed that certain over-the-counter earwax softeners can cause severe inflammation and damage to the eardrum and inner ear. The results of the study, recently published in The Laryngoscope, suggest that use of these medications should be discouraged...
Basxter: Voluntary Recall of Heparin 1,000 Units
Posted on January 29, 2008From the Baxter site:Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41; LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111 DEERFIELD, Ill...
FDA To Require Suicide Studies in Drug Trials
Posted on January 28, 2008From the New York Times:The FDA is now requiring drug makers to study closely whether patients become suicidal during clinical trials. Rules The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development...
Email? C U L8tr; Its a Txt wrld
Posted on January 28, 2008In our practice I am slowly starting to use texting to reach certain clients. It's easier, not web-dependent, and I almost always get a faster reply. Texting is mostly limited to clients under 35. For the uninitiated, texting is also known as text messaging or SMS (Short Message Service)...
Why are Lawyers Suing Vytorin Makers So Soon?
Posted on January 25, 2008I just shake my heads sometimes over the actions of lawyers. Just two weeks have passed since the hubbub over Vytorin. Lawsuits have been filed in federal courts in states including California, Florida, Louisiana, Minnesota, Mississippi, New Jersey, New York and Ohio, according to court documents and interviews with attorneys...
FDA Blasted By Congress Over Warning Label Proposals
Posted on January 24, 2008A group of Congressional Democratic leaders complained about a FDA proposal that would limit when drug and device companies can add warnings to product labels.In a letter to Commissioner Andrew von Eschenbach, several lawmakers said current FDA rules give companies latitude to make needed changes...
"Don't Get Worked Over"
Posted on January 24, 2008Says this Denver,CO lawyer on a youtube.com video. What do you think about this video?
Law Tech: Blackberry v. T-Mobile Sidekick
Posted on January 24, 2008Most lawyers use the Blackberry, but I'm sold on a recent addition, the Sidekick 3. From various reviews:In my experience with a BB ... it has an awkward interface that mocks rules of good design. Clicking on a link on a Web page should take you to a new page, but here it invokes a menu many items long...
Tech: Going Paperless
Posted on January 23, 2008One of my resolutions was to go paperless as much as possible, and to go that route inexpensively, efficiently, and in a way that is consistent with office operations. We started with the Fujitsu Scan S510 model:The ScanSnap S510 can convert up to 18 pages per minute into a PDF file at the click of a button...
FDA Will Not Preview Direct To Consumer Ads
Posted on January 23, 2008In the post below, "Trouble Sleeping" there is a concise commentary from C.R. dissecting a Sleep Aid ad. Here's the statement, thanks to the Pharma Mkting Blog:The FDA statement: User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Program Will Not Be Implemented AGENCY: Food and Drug Administration, HHS...
Trouble Sleeping?
Posted on January 23, 2008Consumer Reports has posted the second in our series of AdWatch videos that add commentary and context to widely seen pharmaceutical advertisements. The video mentions the ad with Abe Lincoln and a talking beaver It?s the one that has Abe Lincoln and a talking beaver offering consolation to an unfortunate insomniac...
FDA Warns Against Cold Drugs for Kids Under 2
Posted on January 23, 2008Children under 2 years old should not be given over-the-counter cough and cold medicines because they are too dangerous for that age group. Deaths, convulsions and rapid heart rates have been reported in rare cases in children younger than 2, the FDA has informed...
Legal Broadcast Network Video: Attorney Rick Kuykendall
Posted on January 22, 2008Mark Wahlstrom will bring his LBN team to the STLA Convention in New Orleans next week. You can view a video by LBN with attorneys Jan Schlictman and Rick Kuykendall by going here. From the LBN site: "The Legal Broadcast Network is the first online podcasting network specifically for trial lawyers, paralegals and others dedicated to the fight for civil justice and access to the courts for ordinary citizens...
Trucks in Canada: "They Suck"
Posted on January 22, 2008Or so says Sgt. Ray Boldt in British Columbia. From canada.com:Among 28,700 injuries and 460 fatalities from vehicle crashes in 2005, heavy-commercial-vehicle crashes (including those involving buses) injured more than 1,550 people and killed 82, according to the Insurance Corporation of B...
Timeline: How Vytorin Fell Short
Posted on January 22, 2008The fallout from Vytorin is national news. A recent study prompted The American College of Cardiology to weigh in after a study by Merck & Co. Inc. and Schering-Plough Corp. The study showed that Vytorin worked no better than the generic cholesterol drug simvastatin...
FDA Approves Update to Label on Birth Control Patch Ortho Evra
Posted on January 21, 2008From the FDA site:The U.S. Food and Drug Administration (FDA) approved on 1/18/08 additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills...
Chantix (Stop Smoking Med) Gets a Suicide Warning
Posted on January 21, 2008Chantix is classed as a selective nicotinic acetylcholine receptor partial agonist, and is the first smoking cessation drug that is not based on nicotine to come out in the last 10 years.Pfizer Inc. strengthened the warning for iChantix recently, and warned medical professionals to be on the lookout for for abnormal behavior after the shooting death of a rock musician using the drug led to added reports of side effects...
MLK Day: Parting the Waters
Posted on January 21, 2008In 1989 I was a recent law school graduate when I first heard of "Parting the Waters: America during the King Years," by Taylor Branch. I had a chance to hear him speak just after his book was published, and purchased the book right away. It's worth reading...
Resolutions 2008: Too Cold to Exercise? Try Another Excuse
Posted on January 18, 2008One of my resolutions this year is to complete a half marathon before June 1, 2008. That means running in the cold (cold for the South, at least). From the New York Times, you can read why it never really is too cold to exercise. Some folks you know may already cutting out on a New Year's resolution to exercise because of "the weather...
Extract Text From PDF, .Doc, and other Files
Posted on January 18, 2008Thanks to the folks at lifehacker and elsewhere for this tip, which I started using. It works, at least on early use here in the office. It's a program called Text Mining Tool:From the text mining site: Text Mining Tool is a freeware program for extraction of text from files of the next types:pdf, doc, rtf, chm, html without need to have installed any other programs like Word, Arcrobat, etc...
Vioxx Registration Deadline Passes: Merck Hopes 85% Take the Deal
Posted on January 17, 2008With the first milestone passing this week (1/15/08) Merck's confident it will reach the goals necessary to set a $4.85 billion Vioxx settlement into play. There are report that law firms representing more than 55,000 plaintiffs had registered their claims by the deadline...
Vytorin Video
Posted on January 17, 2008Reporting on the drug's troubles. It's two minutes long, but it's not on YouTube.com Go here to see it.
Bad News for Vytorin: "It just doesn't work"
Posted on January 16, 2008Vytorin is a combination of Zetia and Zocor. It is prescribed nearly 100,000 times a day, and sales topped $5 billion last year. Drug companies Merck and Schering split the profits from the medicines in equal parts.This week Merck and Schering-Plough revealed that the active ingredient in their cholesterol drugs Zetia and Vytorin had flunked a clinical trial measuring its effect on artery plaque...
National Clean Out Your Desk Day Today
Posted on January 14, 2008It's National Clean-Off-Your-Desk Day. Today is the day to fill your recycling bin to overflowing.You can use Jott to help you clean up that desk. Also high on my list is http://www.vitalist.com./ It handles do recurrent tracking, ticklers, in a basic way...
Did Avandia Contribute to Thousands of Heart Attacks?
Posted on January 13, 2008According to a November 2007 report by the Senate Finance Committee, an analysis by FDA scientists presented at a July 30, 2007, safety panel meeting estimates that Avandia has caused approximately 83,000 excess heart attacks since coming on the market...
STLA in New Orleans, 1/31-2/2
Posted on January 11, 2008Once again, the Southern Trial Lawyers will meet in New Orleans. You can read more about the STLA by going here.It's a lot of fun and worth your time.
Transfer Huge Files with PipeBytes
Posted on January 11, 2008After having just downloaded a huge legal file in three parts, I've gone back to find a better solution ... and found one. If you a need to transfer a large file but learn that the party sending the file is having trouble, try PipeBytes. It's free. From their site: No software to install...
NY State Court To Dismiss Celebrex Cases
Posted on January 11, 2008A state court judge has ruled that there is no: Plaintiffs suing Pfizer Inc. over its Celebrex do not have reliable scientific evidence to prove the drug can cause heart attacks and strokes at the 200-milligram dose. The 200 milligram dose is the most commonly prescribe dose of the medication...
Top 5 P.I. Attorney Web Site Mistakes
Posted on January 06, 2008From the abajournal.comOf the "best" sites reviewed, here is a list of the most common mistakes:-- Firms spend more time talking about themselves instead of their clients.-- The sites lack compassion.-- Photos are canned, stock art, rather than of real people...
Top 10 PDF Tricks
Posted on January 06, 2008Thanks to lifehacker, they include:Managing PDF files in iTunes: One of the lesser-known features of iTunes is that it can manage PDF files as well as music. Here.Another Top 10 is: Design your own DIY notepaper. "Check off your note-taking template options - with your name, project name, and optional hole-punch - and download a printable PDF of the result...
A Litigating MIST Cases Blog
Posted on January 04, 2008You can find it here:litigatingmistcases.com/What is MIST? Minimum Impact, Soft Tissue case. It's a site worth checking out. A recent blog post included this:"The ABA recently published my newest article on MIST cases. This article provides some basic tips on MIST cases...
Top 10 Obscure Google Search Tricks
Posted on January 03, 2008From lifehacker.comGood stuff, including:10. Get the local time anywhere.9. Track flight status.Good stuff, and you can find more here.
Organizing Your "To Do" List
Posted on January 03, 2008It's that time of year when folks resolve to get more organized. I'm one of them. I found a helpful post on Getting Things Done, and the excerpt is below. The post emphasizes a next action list, as opposed to a plain ol' "to do." "There is nothing more demotivating and numbing than a large, unwieldy and obscure to-do list...
Avandia Warnings: Did They Scare People From Therapy?
Posted on January 02, 2008"We believe that scrutiny of Avandia may have harmed the U.S. diabetic population by scaring some patients off of therapy. This is unfortunate, given lack of glucose control among diabetics and the growing diabetes epidemic in the country."So says David Risinger, go here for more.
Resolution Time: 2008
Posted on December 26, 2007I make and try to keep resolutions. For me it's been a year to remember: 2007 began with my decision to open my own law office. It was precipitated by a significant event at the end of 2006. This time last year my former "boss" tried to weasel out of a referral fee to another lawyer...
Retinopathy of Prematurity: Richard Shapiro and babyblindness.com
Posted on December 26, 2007Preeminent Attorney Richard Shapiro has his site up and it is impressive. www.babyblindness.com is a site that addresses and explains Retinopathy of Prematurity."Retinopathy of Prematurity (R.O.P) is a potentially blinding eye disorder that primarily affects premature infants weighing approximately three pounds or less, born before 31 weeks of gestation (A full-term pregnancy has a gestation of 38?42 weeks)...
30 Seconds of Ad Related Levity
Posted on December 20, 2007DeNiro - not law related - responds to 'direction' when cutting an ad:
Avandia: Higher Risk of Heart Attacks and Death
Posted on December 12, 2007Older people taking Avandia and Actos had a higher risk of heart attacks, failure and death than those taking other diabetes pills, says a study from Canada. Diabetics over 65 on the drugs were 40 percent more likely to suffer heart attacks, according to a study in the Journal of the American Medical Association...
Vioxx Settlement Agreement Documents
Posted on December 12, 2007You may find them at the Brown Greer site. The site informs: "BrownGreer PLC is the Claims Administrator for the Vioxx Settlement. The forms posted on this site may change, so be sure to check back often to get the most recent version. Also, legal developments and amendments to the Settlement Agreement may cause some of these documents to become outdated...
Merck Seeks OTC Approval for Mevacor (Cholestrol Drug)
Posted on December 11, 2007From Bloomberg.com:Merck is asking the FDA to make Mevacor (a cholesterol-lowering medicine) available on drugstore shelves without a prescription. Merck's try is its third in ten years. The FDA is unlikely to approve nonprescription Mevacor becuase of concerns raised by the 250,000-member American Medical Association...
Avandia Dropped by Two Pharma Benefit Managers
Posted on December 10, 2007Two dropped GlaxoSmithKline Plc's diabetes drug Avandia from their national formularies, based on concerns about safety. Prime and HealthTrans- the managers- issued separate statements, which claimedthat each made a thorough analysis of the clinical literature examining the safety and efficacy of Avandia...
Tim Tebow: Heisman Trophy Winner
Posted on December 10, 2007I'm a Gator, having graduated from the University of Florida. Saturday night, Gator QB Tim Tebow won the Heisman Trophy: It's not law related, but it is nonetheless fun to watch - unless you are a nole.
Prempro Verdict Tossed
Posted on December 10, 2007A woman who claimed that Wyeth's hormone-replacement drug caused her breast cancer failed to prove, with have sufficient evidence, that Wyeth's Prempro caused her damage. The opinion was written by Judge Ricardo C. Jackson. Four cases have gone to trial in Philly...
FDA's Shortcomings Put American Lives "At Risk"
Posted on December 03, 2007From Bloomberg:American lives are at risk because the U.S. Food and Drug Administration lacks the funding to keep up with scientific advances, according to FDA advisers. The FDA has an ``appallingly low'' rate of inspections and a lack of scientists who understand new technologies, a subcommittee of an outside panel said in the report, posted today on the FDA web site...
Celebrex MDL: Breyer to Toss Out 200 mg dosage of Celebrex
Posted on November 19, 2007The MDL Ruling from Judge Breyer came down mid-day today November 19, 2007. Based on Daubert, the science does not support claims of injury when a person took 200mg of Celebrex per day. Stay tuned.
Vioxx and New Orleans: A Busy Week in December
Posted on November 14, 2007December 10, 11 and 14 you won't be able to swing a dead cat in New Orleans without hitting a Plaintiff's lawyer. On December 10 and 11, Mealey's will host a Plaintiff's Only National Settlement Conference chaired by my friend Tom Girardi, and which will cover among other things, the "View From the Bench" and the "Role of the Special Master...
Trasylol Pulled from Market b/c of Claimed Link to Kidney Problems
Posted on November 13, 2007From AP, Reuters, Yahoo and others:Bayer AG last week voluntarily stopped worldwide sales of its antibleeding drug Trasylol after a Canadian clinical study found it could be linked to a higher risk of death than other drugs.Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots...
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