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What is federal preemption and why should I take the time to care?

By Steve Lombardi

I grew up as a small boy in New England whose father died of lung cancer. He was twelve when he started to smoke and I was thirteen when he passed away. His wife, my mother was just thirty-seven and he left her with five children under fourteen. We didn’t have much and didn’t ask for much, except to be educated. Being scared to be poor is a cornerstone of my daily drive. If you’re not scared to be poor then you’re not as worldly as you might think. Dad didn’t believe in life insurance and when he died he left my mother that legacy. It was a tough road she walked with us five kids. She kept us happy by taking on all the worrying for her five little ones. I joke today with my mother that she worries about not having anything to worry about. She’s used to worrying and finds comfort in knowing she still counts. But worrying about feeding five children, about medical care, dental care, a college education, transportation, each of us having spending money may today sound nostalgic, but as those days following my father’s death and turned into years it had to have taken a toll on her. During my childhood I never knew my mother to take a vacation or for that matter a day off. It pained me to watch my mother always put on a show of strength but never to open up and have the simple luxury of someone’s shoulder to cry upon.

After finishing law school I enjoyed each minute of every news report of the tobacco industry being taken to task for lying about the link between smoking cigarettes and developing lung cancer. Watching my father die is probably why today I detest corporate liars and cheats.

In this month of October, 2008 we are addressing federal preemption, a little understood legal concept that affects many widows, orphans and supporting spouses of brain damaged men and woman who live in a nursing home or assisted-living facility. If you care about the life style you will live in the future you’d better care about federal preemption laws being considered by Congress. For my 80-year old mother her time has passed but for those of you who are in your twenties, thirties, forties and fifties - your time is now.

1. What is federal preemption?

Answer: Federal preemption is a legal doctrine that holds a federal law governs all claims that fall within it. In other words if the Congress passes a law creating federal preemption over pharmaceutical claims you will not have a traditional right to pursue a claim under state law.

2. How might it affect me?

Answer: The effect is you lose your right to pursue a traditional state law claim. Unless the federal law allows a claim there is nothing anyone can do to help you. You're just out of luck and must shoulder the economic consequences. For instance, if federal preemption prohibited filing a claim against those who wasted billions of dollars on risky sub-prime loans, you'd have no claim against them even though your retirement savings may now have evaporated into thin air.

3. Why should I care?

Answer: You should care for the same reasons you care about your insurance bill being paid. It won’t affect you until you need to file a claim; then you’re in serious trouble. Most of the lay people, the tax paying citizens, don’t appreciate the effects of federal preemption until they have the need to file a claim. And then they find out there is nothing any lawyer in their state can do for them. Let's say that your spouse has a stroke and suffers terrible brain damage. You move him to an assisted living facility and begin your new life running from home to the facility three times a day. You're tired but life goes on. Then you learn that the cause of the stroke was likely the daily meds he took; and that a ton of research showed the cause of strokes in people just like him, but no one ever brought it to your attention. Your family doctor who prescribed the meds didn't tell you either because no one ever told him about the probability of strokes in patients taking these meds. And he wasn't told because the studies were rigged which skewed the results.

Just when you think life can't get any worse you learn from the Social Security Administration about your future right to benefits. With your husband still alive the $950.00 per month in social security disability benefits doesn’t cover the monthly mortgage and other monthly living expenses. The SSA person tells you when he does pass your benefits will decrease.

You're curious about suing the pharmaceutical company over their failure to warn your husband's doctor, who in turn would have warned you and your husband to stop taking the meds. So you see the lawyer. Only then do you begin to realize how federal preemption fit into your life and why a long time ago you should have cared. Because the lawyer advises you there is no claim because the Congress took away your right to sue the pharmaceutical company; it was all part of The 2008 Job Protection Act. The one you knew nothing about and even if you read the title it would not have alerted you. Besides you didn't need the right to sue at that time; only greedy people sue for compensation.

But now you do and you've never seen yourself as greedy, just needy. But it's too late. That's federal preemption.

4. I don’t have time to write my Congressman.

Answer: I don’t have time today to write this blog post but I’m still doing it. You see you’d better take the time now to write to your Congressman to impress upon them that you do care, are listening and want them to vote against any legislation having to do with federal preemption of your right to bring a claim under state laws. Where to go to write to my Senators or House of Representatives.

5. I don’t understand why I should be so concerned with a bill title that says it’s in my best interest?

Answer: Oh really? Most bills that will do away with existing rights read something like this: It’s pink, fuzzy and will save you time. Yeah it’s a stiletto sheath made out of baby seal fur and it’s going to be used to cut out the heart of your claim. It will save you time, because you won’t be spending any time in any court of law trying to prove those multi-million-dollar-bonus-drug-company-executives knew of the risk of a stroke and didn’t let the information out so you could be warned, because they didn’t want bad news to depress their stock price.

Name	Company		Salary *	Total **	Unexercised Stock Options
C.A. Heimbold, Jr. W.C. Steere, Jr R.V. Gilmartin M.R. Goodes R.J. Kogan M.D. White S. Taurel J.R. Stafford G.M. Binder F. Hassan	BMS Pfizer Merck Warn-Lam Schering-Plough Abbott Lilly AHP AMGEN Pharm & Upjohn	$31,424,000 $15,159.000 $6,032,000 $16,486,000 $12,505,000 $4,381,000 $6,041,000 $4,093,000 $2,119,000 $2,366,000		$39,753,000 $38,983,000 $26,424,000 $22,061,000 $18,525,000 $16,272,000 $12,940,000 $11,779,000 $6,385,000 $5,042,000	$159,691,000 $107,115,000 $80,559,000 $250,681,000 $830,000 $33,667,000 $29,867,000 $104,506,000 $17,291,000

6. Why can’t I just rely on my Congressman to protect my family?

Answer: When a young man or woman first runs for Congress they are somewhat pure thinkers thinking only about doing good for the voters. They get elected and then begin to think about getting re-elected and how much it costs. Along come Mr. and Mrs. Pharmaceutical and Corporate Lobbyist with plenty of cash to donate to friendly politicians in Congress. See now you know why that pink sheath is pink and not black. It’s to give you the impression it’s being passed by your friendly Congressman and is there to help you or better yet, to save your tax dollars. In reality what is it? Go ahead you can say it, “It’s BS!” Yes it is, just ask the actor Dennis Quaid and his family.

Federal Preemption, the Hearing

The House Committee on Oversight and Government Reform held a hearing yesterday on federal regulation of medical devices, a session meant to set the stage for reversing federal preemption of state regulations -- such a reversal being a priority for trial lawyers wanting to sue in state courts.

Testimony by Dennis Quaid -- you remember, the actor? -- got the most attention, even showing up on local news broadcasts in D.C. Quaid and his wife are suing Baxter Healthcare for a Heparin overdose given to their twin infants.

We commend the testimony of John E. Calfee, Ph.D., of the American Enterprise Institute. You can read Calfee's conclusions here. Bottom line: Eliminating pre-emption will encourage litigation, an ineffective and expensive approach of promoting safety or advances in prescription drugs.

And for a classic example of one-side reporting, read this AP scene-setter, an article that accepts the thesis from the activists (trial lawyers and self-styled consumer groups) that the Bush administration is using regulations to lock in federal preemptions, sticking it to the little guy in the process. Five separate people are cited complaining about pre-emption, "balanced" by two people making neutral observations about the legal and political landscape. Did no one make a positive case for federal preemption?

P.S. Ah, we see the AP reporter reported on the committee hearing from the same vantage point, that of doubting preemption.

7. Why can’t I rely on the FDA and other federal agencies to protect my family?

Answer: Well it’s like the fox watching the hen house or trying to run a major corporation on a paper boy’s earnings. You can’t.

In 2008 the number of paid lobbyists totaled 17,170 and spent over $1.59 Billion lobbying elected officials and candidates, companies, labor unions and other organizations. If you doubt my research just do your own search of the Lobbying Database. Since 1998 over $20 Billion has been spent on lobbying efforts. The 2008 overview of lobbying dollars shows the House raised over $380 Million, the Senate over $194,929,656. The U.S. President they spent over $1.132 Billion. As you can surely appreciate it costs corporate American a lot of money to pay your elected official to take away your rights and to get a corporate free pass from being responsible for the damage they cause. What you don’t see is how your elected officials use your rights as leverage to get more and more money from the lobbyists for reelection campaigns. That’s a total of $1.7 Billion being spent to buy influence from your elected officials. And that's in my mind, The Rub!

“In addition to campaign contributions to elected officials and candidates, companies, labor unions, and other organizations spend billions of dollars each year to lobby Congress and federal agencies. Some special interests retain lobbying firms, many of them located along Washington's legendary K Street; others have lobbyists working in-house. We've got totals spent on lobbying, beginning in 1998, for everyone from AAI Corp. to Zurich Financial.”

In the case of the Food and Drug Administration the experts they rely on work for the drug companies or earn money speaking to your doctor. This system of regulation is supposed to work by doctors sending in reports about bad reactions from taking those morning meds. Ask your doctor how often he’s sent in a report. You’ll be surprised that many have never done so. And that’s a problem with the research and the reporting of adverse affects that create a basis for a warning. You aren’t going to get the warning because they are too busy practicing clinical medicine to file the reports; so the drug box warnings or those you might hear from your physician are woefully inadequate. And if you think the research done by the pharmaceutical industry is complete and always fully filed with the FDA, think again. It’s not. Remember the Tobacco Institute, the research arm of the tobacco industry and its lobbyists? We found out years later it was created and funded by those companies make billions from selling you cancer sticks. The role of the Tobacco Institute was to create research that could be used for men to take an oath before your Congress and to say there was no link between smoking cigarettes and lung cancer. Okay, now you understand and can draw the analogy to the FDA and some of the research being turned over to the FDA. I’m not saying the FDA is anything like the Tobacco Institute, but I am saying pharmaceutical company research is designed to prop up stock prices before it does anything to help you the consumer.

8. Won’t the Courts protect us?

Answer: The short answer is no; they point to Congress as having written the laws; the Court is there simply to interpret the law as written. The long answer is in the United States Supreme Court case involving a failed catheter. What that means is, if Congress passes federal preemption in the area and takes away your right to sue, then that's the last word. Your only recourse is to file for Medicare, Medicaid, Social Security or file with private insurance.

The U.S. Supreme Court has held that the “preemption clause” of the federal Medical Device Amendements of 1976 prevents a patient from suing for products liability for a failed catheter. See Reigel v. Medtronic, Inc. 128 S. Ct. 999 (2008).

9. Hey Lombardi who are you tell me what to do?

Answer: Because some day you may be sitting in my office telling me all about your spouse and how they live in an assisted living facility, that you’re too numb with the demands of your new life to think for yourself and your brain-damaged spouse; that never gets to go out and that you can’t afford to vacation any more with the monthly social security check just barely covering your monthly living expenses. You’ll be telling me, when you stop crying, that you haven’t had a vacation in over five years and just discovered that if your spouse dies, that your social security check will be cut to one-third of what it currently is. And after you pull another tissue from the box of Kleenex I’ve handed to you, you’ll ask me to explain why it is I don’t think you can pursue a claim against the pharmaceutical company. You’ll walk out thinking I don’t know what I’m talking about and should go back to law school to learn more about federal law. After you visit with the tenth attorney on this same subject you’ll tell your spouse that Lombardi was right in telling you this situation is hopeless.

In the end I get to tell you what to do because of my losing sleep every night since the Regan Administrations and having to tell nice people like yourself that federal preemption has eviscerated your right to bring a claim; that’s the main reason why I get to tell you what to do.

So, either write to your Congressman and Congresswoman NOW or don’t complain when you’re lifestyle evaporates literally overnight, after something like this happens to YOU. And so, for the record, that is why I get to tell you what to do.

So decide today if you care or not. Because for you; tomorrow may be too late. Tomorrow you and your brain damaged husband may be described as the "greedy plaintiff just out looking for a free ride and a litigation lottery ticket."

Waking up poor is a lot different than growing up afraid to be poor. Today’s reality can someday be your worst fear. Those daily meds your husband or wife takes today could be Charlie Lombardi’s twenty-minute break that never killed anyone.

Welcome to Dolly's America.

Originally posted at InjuryBoard by Steve Lombardi

Full post as published by Des Moines Personal Injury Lawyer on October 01, 2008 (boomark / email).