Disability Law

The CBS Evening News (9/2, story 5, 0:15, Rodriguez) reported that on Wednesday the government "hit Pfizer, the world's largest drugmaker, with a record $2.3 billion in fines for violating federal drug marketing rules. Among other things, Pfizer was accused of promoting the pain medication Bextra [valdecoxib] for unapproved uses."

 NBC Nightly News (9/2, story 6, 0:30, Williams) added that the penalties come from "admitting that the painkiller Bextra and 12 other drugs were promoted for what's known as off-label use, which the FDA says put public health at risk in the process."

ABC World News (9/2, story 2, 2:25, Gibson) reported that "Bextra became a blockbuster, bringing in $1.2 billion a year, as sales reps assured doctors it could be used not just for arthritis, but for any acute pain. The main whistleblower, a former company sales rep, said in a statement, 'at Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that.'" Meanwhile, "in exchange for hearing company sales pitches, doctors were paid up to $1,500 to attend meetings, and were treated to conferences at lush resorts, given air fare, hotels, meals, even massages."

The Washington Post reports, "Officials at the departments of Justice and Health and Human Services called the agreement with Pfizer and one of its subsidiaries a cautionary example of their strategy to team up with states to police errant healthcare businesses."

"The Justice Department described Wednesday's settlement as the largest in its history," according to the Los Angeles Times. "The settlement reflects an emphasis by the Obama administration on holding US healthcare corporations accountable for their activities, especially in trying to market drugs to patients and doctors for uses that have not been approved, Justice Department officials and legal experts said."

The New York Times adds, "Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud."

Pfizer subsidiary Pharmacia & Upjohn "must pay a $105 million criminal fine" under the agreement, USA Today reports. "Pfizer "will pay a criminal fine of $1.195 billion" and "has agreed to pay $1 billion in civil damages and penalties to compensate federal healthcare programs for false claims submitted as a result of its marketing Bextra and the other [three] drugs for off-label use or at unapproved dosages." The three other drugs include "Geodon [ziprasidone], an antipsychotic; Zyvox [linezolid], an antibiotic; and Lyrica [pregabalin], an anti-epileptic drug."

The Wall Street Journal noted that the settlement is the third since 2002 in which Pfizer has promised to change its marketing practices. The Journal notes previous agreements stemming from Lipitor (atorvastatin calcium) marketing in 2002 and Neurontin (gabapentin) marketing in 2004.

Mike Loucks, the US attorney in Massachusetts, "said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs," the AP reports. "To prevent backsliding this time, Pfizer's conduct will be specially monitored by the Health and Human Service Department inspector general for five years." The AP notes, "In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice."

In addition to the four drugs marketed for off-label uses, Bloomberg News notes that the "four-year investigation uncovered a range of practices, including kickback payments to doctors in the sale of nine other drugs, among them the impotence drug Viagra [sildenafil citrate] and cholesterol pill Lipitor, officials said."

The American Lawyer reports, "Lawyers for whistleblowers have been working on the cases for about three years, according to [W. Scott Simmer, a partner at Blank Rome] and Barbara Bonar, name partner at the Kentucky-based litigation boutique B. Dahlenburg Bonar," who both represented whistleblowers.

From the American Association for Justice news release.