Articles Posted in Pharmaceutical Drugs

There is an editorial in this month’s New England Journal of Medicine on Riegel v. Medtronic, the preemption case that the Supreme Court shall soon side that has pharmaceutical and medical device companies sitting on the edge of their seats.

Quick background: A man suffered injuries when a balloon catheter exploded during an angioplasty. The manufacturer, Medtronic, moved to dismiss the case because the Food, Drug, and Cosmetic Act of 1976 immunizes Medtronic from any state law torts claims for medical devices because the device received pre-market approval from the FDA.

The authors of the New England Journal of Medicine editorial set forth the history and rationale of the Food, Drug, and Cosmetic Device Act, pointing out that arguments, in this case, are just another version of the same arguments Medtronic offered in Medtronic v. Lohr, a case in which the Supreme Court rejected the preemption of state court claims arguments. The authors note that this case addresses “just how reliable the FDA pre-marketing approval process is and how much weight to give it.” The authors do not explicitly answer this question, but it is hard to argue that the FDA is an effective watchdog of pharmaceutical and medical device companies.

For years, pharmaceutical drug manufacturers have argued that the FDA approval of a drug preempts a duty to warn claim. If this argument had succeeded, FDA preemption would bar claims for injuries caused by a manufacturers’ failure to warn about risks associated with their FDA-approved prescription drugs. President Bush’s administration has long supported this view, although the FDA has often been accused of not minding the store regarding the risks associated with the drugs it approves.

Today, President Bush decided not to spend to political capital on this issue, signing the Prescription Drug User Fee Reauthorization Act (PDUFA), H.R. 3580. This recent law creates new federal safety requirements for pharmaceutical companies. This bill makes crystal clear that regardless of FDA approval, the duty to warn remains with the pharmaceutical companies to adequately provide a meaningful warning about the risks associated with the use of their product. The manufacturer’s duty to warn the ultimate consumer of prescription drugs is limited, as it probably should be, to advising the prescribing doctor of the drug’s potential dangers in the absence of contrary FDA regulations. The FDA maintains the authority to require label changes, but the burden to warn rests with the pharmaceutical company. Pharmaceutical companies can no longer hide behind the FDA’s skirt and argue that FDA approval absolves them of the duty to warn. Drug companies can still argue to the jury that FDA approval is an indicia of the fact that no duty existed.

This is the first time Congress has made any comment on the labeling of pharmaceutical drugs. I have moderate political views and I try very hard not to make this blog about politics. But this bill never gets passed if the Democrats do not take control of both houses of Congress.

August 2021 Update: These Kugel hernia mesh cases settled for an average of about $70,000 for each victim.  The new hernia mesh cases involve Bard and two others:

• C-Qur
• Ethicon