Pharmaceutical Drugs

December 4, 2007

Riegel v. Medtronic: The FDA Preemption Super Bowl

Today, the Supreme Court will hear arguments in Riegel v. Medtronic. The issue is whether the Food, Drug, and Cosmetic Act forecloses state law personal injury lawsuits for injuries from the design, manufacture, and labeling of a Medtronic medical device that the Food and Drug Administration initially granted a pre-market approval. This case is a product defect case involving a Medtronic balloon catheter that killed the patient but, this case could have ramifications for the Medtronic lead recall lawsuits that are being filed all over the country. [Update: “Could” is the understatement of the decade.] While technically this case focuses on a specific statutory provision, it would surprise no one if the Supreme Court’s holding provides a comprehensive framework for preemption that would apply to all drug and medical device cases.

Naturally, the Bush administration has lined up squarely behind the pharmaceutical companies. This is ironic because there is a strong presumption against preemption, particularly where the issue involves the individual states’ power to protect public safety and health.

The Supreme Court has consistently found that preemption of state law does not apply unless “the nature of the regulated subject matter permits no other conclusion” or “the Congress has unmistakably so ordained.” Chicago & N.W.Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317(1981) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142 (1963)).

September 27, 2007

Preemption in Duty to Warn Cases Against Pharmaceutical Companies

by Ronald V. Miller, Jr.

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.

May 12, 2007

Kugel Hernia Patch Lawyers: The Kugel Mesh Hernia Patch Recall

by Ronald V. Miller, Jr.

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: