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Plaintiffs’ lawyers are gearing up for a slew of pharmaceutical product liability trials in 2010.

While no case has the magnitude of the massive $4.85 billion Vioxx settlement in 2007, the trials represent a welcome return to courtroom action on the pharmaceutical front for plaintiffs’ lawyers.

Many cases were stalled while judges and lawyers awaited the U.S. Supreme Court ruling in Wyeth v. Levine last year.

“The door for taking in new drug business was almost slammed shut while Levine was working through the system,” said Houston personal injury lawyer Mark Lanier. “Once Wyeth v. Levine was resolved in favor of the consumer, the door reopened and lawyers were willing once again to engage in this litigation.”

With pharmaceutical litigation ramping up again, Lawyers USA asked several experts what they see on the horizon this year.

Full trial calendar

Plaintiffs’ lawyers anticipate a busy year.

A look at Lanier’s calendar alone shows a flurry of activity in pharmaceutical mass tort litigation.

In early March, he jumps into the ongoing hormone replacement therapy mass tort litigation in state court in Philadelphia to represent a plaintiff in one of 16 bellwether trials scheduled through April.

Later in the month, Lanier returns to U.S. District Court in Boston for the second trial in the Neurontin multi-district litigation.

The first trial ended bizarrely with a dismissal in July 2009, after an anonymous donor offered to put money in a trust fund for the 10-year-old daughter of a Massachusetts woman who committed suicide after taking the anti-seizure drug.

In a telephone interview, Lanier pledged to see the second trial through to completion.

Unlike the first trial, the patient in the second trial, Hartley Shearer, a Massachusetts man, had no history of suicide attempts before he killed himself after being prescribed Neurontin as an off-label pain medication.

“On a scale of one to 10, with 10 being the most challenging, the first trial was an 11,” Lanier said.

In May, Lanier is slated to try a third Neurontin case, which has been remanded and scheduled for trial in state court in Nashville, Tenn.

In early June, he is scheduled to represent the plaintiff in the first Avandia trial in Philadelphia, although it hasn’t been determined whether the trial will be in state or federal court.

Lanier said he expects his 2010 trial calendar will also include a Digitek  trial in West Virginia, additional HRT cases and several other drug injury lawsuits.

“I think you will see extensive litigation in the pharmaceutical area,” he said. “I don’t think big pharma has learned its lessons. I still think they play games with their information and studies. I don’t think they reveal everything to the FDA, and I don’t think they fully and fairly warn consumers of dangers and hazards.”

Industry eyes Circuit rulings

Industry lawyers, meanwhile, are looking to several federal circuit rulings to bolster their battered preemption argument.

The preemption argument in drug product liability cases has been largely withdrawn in the wake of Wyeth v. Levine. But defense attorneys continue to pursue preemption in a line of cases alleging that antidepressants in the class of SSRIs (selective serotonin uptake inhibitors) cause suicide.

Jim Beck, of counsel at Dechert in Philadelphia and author of the Drug and Device Law blog, said there is a trio of pending SSRI preemption appeals in the 7th and 10th Circuits.

“There are good fact patterns in these cases [for the defense],” said Beck. “One of the things the [Supreme Court] said in Levine is that the companies know more about their drugs than the FDA. That is not true in this case. The FDA asked for all the information about the different [SSRI] drugs and evaluated them itself.”

FDA regulation of off-label uses

Drug industry consumer watchdog groups are closely eyeing a suit filed by Allergan Corp., which is challenging the authority of the FDA to regulate off-label promotional activity by pharmaceutical makers.

Allergan, the maker of Botox, is challenging an FDA requirement instituted in August that Botox and another drug, Myobloc, carry a black box warning outlining the risks associated with unapproved uses, including limb spasticity in some cerebral palsy patients.

Allergan is claiming that the FDA’s effort to regulate off-label communications between the drug company and physicians about the uses of Botox runs afoul of the First Amendment. The suit was filed in U.S. District Court in Washington, D.C. in October 2009.

The central issue in the case is whether the FDA has the authority to prohibit “the inclusion in labeling of any ‘scientific claims about safety, effectiveness, contraindications, side effects and the like regarding prescription drugs’ where FDA has not ‘had the opportunity to evaluate’ those claims – even where bona fide scientific research established that the manufacturer’s scientific claims are true,” the complaint states.
The outcome of the case could have “profound effects upon both public health and safety,” Wells Wilkerson, staff attorney at Prescription Access Litigation, a Boston-based consumer group.

If Allergan is unsuccessful, it “could affect FDA authority to regulate direct-to-consumer advertising,” through both print and broadcast media, and through the emerging online forums, such as Twitter and social networking sites, he said.

Pharmaceutical whistleblower suits on the rise

Steve W. Berman, a principal at Hagens, Berman, Sobol, Shapiro in Seattle, a plaintiffs’ class action firm, predicted an increase in pharmaceutical industry whistleblower cases this year.

As a result of massive industry layoffs, “a lot of people are going to have axes to grind, and were witnesses to practices we know happened on a frequent basis, including off-label marketing and suppression of information that would have been material to the FDA,” Berman said.

In addition, two recent record settlements – $1.42 billion by Eli Lilly for illegal, off-label promotion of Zyprexa, and a record $2.3 billion by Pfizer over off-label marketing of its recalled Bextra painkiller and three other medicines – have sparked increased interest in whistleblower suits. (The whistleblower in the Pfizer lawsuit is reaping a $51.5 million award.)

Berman’s firm currently has five cases under seal involving off-label marketing, ghost-writing or suppression of information to gain FDA approval. Seals on several of the cases – which Berman described as “very significant” – are expected to be lifted this year.

Questions or comments can be directed to the writer at: nora.tooher@lawyersusaonline.com

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