Pennsylvania's Supreme Court recently ruled that pharmaceutical companies may be held liable for negligently designing and marketing drugs. The case specifically centers on the now-discontinued drug Redux, which was created by Pfizer. Our team of dangerous drug lawyers explains what this Pennsylvania ruling means for future plaintiffs injured by pharmaceuticals.
Redux (dexfenfluramine) was a diet drug approved by the FDA in 1996 and pulled from the market just over a year later, in 1997. The drug was recalled along with fenfluramine in the infamous "fen-phen" heart valve disease debacle. There has been extensive litigation over fen-phen and Redux injuries, which is currently ongoing in Pennsylvania.
Pfizer attempted to argue that it was immune from most claims of negligence and particularly from negligent marketing. The plaintiff in this case, Patsy Lance, had a daughter who took Redux and ultimately died from pulmonary hypertension. Lance is now arguing that Redux was an excessively dangerous drug that should have never been sold in the first place.
Pharmaceutical plaintiffs in Pennsylvania typically sue drug companies under failure-to-warn claims, however, Lance is arguing much broader claims of negligence, including defective design and fraudulent marketing. She also claims Pfizer knew of the drugs' severe health risks and that they far outweighed the supposed benefits.
The 4-2 Pennsylvania Supreme Court ruling for Lance is significant because it could open up a plethora of opportunities for injured patients. It is important to note, however, that this ruling likely only extends to drugs that have been withdrawn from the market by the FDA.
It is also worth noting that the majority opinion for this ruling was penned by Justice Saylor, who is a Republican and who does not usually err on the side of plaintiffs. He wrote that pharmaceutical companies violate standards of care if it chooses to market a drug it knows to be harmful. He further asserted that Pfizer did not present a reasonable argument as to why it should be immune from responsibility in the death of Lance's daughter.
FDA Approval Process Widely Criticized
Much of Pfizer's argument relies on the notion that if the FDA approves a drug as safe and effective, patients must defer to that authority. The FDA's approval process, however, has come under immense fire in recent years, and is subject to extensive scientific criticism.
The highly-esteemed Journal of the American Medical Association recently released a series of reports and studies centering on FDA dysfunction, the results of which are very alarming. The report receiving the most public attention examined nearly 200 new drugs approved between 2005 and 2012, and found that one-third of them were approved based on one, short-term clinical trial (more on that study here). Researchers wrote that the flexibility of approval standards leads to differing, inconsistent levels of certainty over the actual risks and benefits of new drugs.
The FDA responded by citing its "extensive" post-market surveillance programs. These reporting systems, however, are notoriously lax, and fail to accurately reflect the actual harm done to patients by drugs and medical devices.