Drug Liability Standards
States differ in drug liability standards and limitations. Arguments that are successful in some states, fall flat in others and in federal courts. For that reason, the first few Prempro liability cases have been closely watched by patients, physicians, lawyers, company officials, and stock analysts to see just how these early cases trend in state and federal courts.
So far, Wyeth has lost four out of seven cases brought against Prempro, the menopause drug used in the aborted Women’s Health Trial, since 2006 when Prempro lawsuits first began to be heard in state and federal courts. To date, these cases have been brought by women who developed breast cancer after taking Prempro for 17 months to 6 or more years.
FDA Tries to Carry A Bigger Stick
Prempro litigation began in earnest after an article appeared in the Journal of the American Medical Association (JAMA) in 2003, revealing increased risk of dementia and Alzheimer’s disease in women 65 years and older taking Prempro. Plaintiffs claimed that menopausal and postmenopausal women were being over-prescribed Prempro by their physicians and erroneously told to continue taking Prempro indefinitely, in the hope that the drug would protect the women against heart disease and osteoporosis, even though the drug was only approved for treatment of menopause symptoms. Inadequate Prempro labeling failed to fully alert women to the many dangerous side effects from taking the drug long-term.
Lawyers argued that it is the responsibility of the manufacturer to protect patients from harmful side effects and to warn of these on the label. But Wyeth, the maker of Prempro, had a shield against such arguments, or so they thought. The doctrine of “preemption,” Wyeth contended, absolved them from these burdens. Wyeth was referring to the FDA declaration that the agency possessed preemption power, an authority the agency had announced in the preamble of new rules for drug labeling the agency had issued on June 30, 2006. The preemption statement was an attempt to ban plaintiffs from filing lawsuits against a drug that the FDA had approved based on pre-market data.
Backdoor Preemption
While some courts have upheld the FDA’s preemption rights, others have not. Plaintiff attorneys say this was a backdoor attempt by the FDA at tort reform, giving the FDA new powers to trump state liability laws. But state courts have a legal right to police public health issues, and injured plaintiffs have a right to have their warning label claims heard by a jury, say attorneys for plaintiffs.
Unfortunately, the FDA didn’t monitor post-market adverse Prempro effects, at the time, and lawsuits were the only meaningful safety checks that remained to consumers. That is now remedied by the PDUFA of 2007, which goes into effect in 2009. The FDA’s role is parallel to, not in conflict with, the judiciary system. Further, the FDA statement in the preamble of a rule on drug labeling doesn’t have the force of law. The FDA did not go through the proper administrative rule-making procedures that are necessary for such an expansion of FDA authority. In the end, it is Congress that has the final legal authority to amend the functions and responsibilities of Executive agencies, not agency directors.
Both sides, in this legal standoff, believe it could come down to a decision by the US Supreme Court. Until the top court decides whether or not to rule on the matter, the action is in the appellate courts, and both sides are watching to see how things turn out there.
Defending Patients’ Rights
An extraordinary editorial in a July 2008 issue of the New England Journal of Medicine, written by the top editorial leadership of the journal, which is, arguably, one of the most prestigious publications in medicine, places medical science squarely on the side of the patient in the debate about preemption. The authors conclude that preemption will result in drugs and devices that are less safe and that will undermine national efforts to improve patient safety. Further, that approval of a new drug by the FDA is no guarantee of safety. Serious side effects come to light only after a drug is on the market for a while. But the FDA has no power to do anything about it, unlike other federal agencies, and is both beholden to and dependent on the manufacturers to reveal information about adverse patient experiences.
The editorial closed with a request that Congress put the matter of patient redress through the courts into law. As we move toward reform of the health care system, patient rights are going to be a flagship issue. Perhaps in the next administration, the FDA will resume a more balanced role as the arbitor of fairness in protecting both drugmakers and the public, rather than primarily a defender of corporations and the status quo.
Courts Reject Preemption
Perhaps the most significant event in the brief history of Prempro lawsuits was the news that Wyeth had settled lawsuits brought by two Nevada women who had taken Prempro and developed breast cancer, just before their trial was to start. In mid-July 2008, Wyeth avoided a trial by agreeing to settle with the two women, paying them an undisclosed dollar amount to resolve allegations that Wyeth had failed to adequately warn about breast cancer risks for women taking Prempro.
The Wyeth settlement comes on the heels of the US Supreme Court’s decision not to take up a case that would have determined whether FDA’s drug preemption authority supercedes state laws that allow plaintiffs to challenge a drug’s safety, efficacy or labeling. Drugmakers and the FDA argued that preemption exists as the FDA’s actions are considered the final word on drug safety and effectiveness. Earlier, a state judge in New Jersey, who is handling hundreds of Prempro lawsuits, ruled that a federal law does not bar state product liability lawsuits against drugmakers. This ruling is the third at the state level to find that a drug’s approval by the FDA does not protect drug companies from being sued. The FDA rulings are a floor, not a ceiling, and drug companies can always strengthen warnings and add new ones, the appellate Judge in the case ruled.
Wyeth Takes Stock
Now that the drug Industry’s preemption defense has been shot down by medical authorities and the courts, and the Supreme Court has decided not to get into the matter, Wyeth may have taken stock of what’s ahead and concluded that the courts may not be inclined to protect Wyeth’s bottom line. Meanwhile, Prempro lawsuits are clogging court calendars and continuing to draw media attention to women’s injuries from Prempro. Wyeth’s recent decision to settle two cases out of court may be a harbinger of what’s to come. Settling may be a way for the company to control costs and halt bad publicity from the tsunami of lawsuits waiting in the wings. We’ll keep you posted on this and other news on the patients rights and litigation front, so stay tuned!
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