Justine Cadet, News Editor

Preemption arises from the Constitution, which under the Supremacy Clause invalidates all state laws that conflict or interfere with federal law. Over the past year, the Supreme Court has heard two preemption cases in which they considered whether to legally protect medical device manufacturers and pharmaceutical companies against lawsuits related to faulty products that have previously been approved by the FDA. The court will hear the final case in that series—the show stopper—next week.

In Riegel v. Medtronic, the Supreme Court determined that federal medical device regulations trump state product-liability lawsuits unless the medical device company violated FDA policy in an 8-1 ruling reached in February.

Justice Antonin Scalia wrote in the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which states that federal laws regulating medical devices take precedence over state damages claims that are brought without a parallel FDA violation. He added that jurors would probably not be in a position to weigh the benefits and dangers of medical devices as effectively as agency experts.

This highly controversial decision led members of the House and the Senate to introduce the Medical Device Safety Act of 2008, which proposes to preserve state product liability lawsuits.

When he introduced the Act, Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Subcommittee on Health, said that the Supreme Court decision in Riegel “ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers.”

In Warner-Lambert v. Kent, the court divided evenly on patient lawsuits over federally approved drugs in a decision that allowed 27 Michigan patients to sue Pfizer regarding Rezulin, a diabetes drug that was pulled from the market in 2000. The split ruling upheld a lower court decision, allowing the patients to take legal action against Pfizer despite a Michigan law that prevents lawsuits against drugs that are FDA approved.

However, on Nov. 3, the court will hear Wyeth v. Levine that could potentially have more far-reaching impact on the industry. Riegel only affected PMA-approved medical devices, which equates to about 50 devices annually. Kent affected only states with statutes granting some kind of immunity subject to a fraud on the part of the FDA exception.  

A decision either way is going to either give prescription drug manufacturers freedom from civil scrutiny or it will allow individuals to pursue the rights that they presently posses in the individuals states where they live.

On Monday, the justices will have to decide if federal law displaces all product liability claims brought against all makers of prescription drugs—their decision will affect every drug maker in all 50 states. Many entities have posited their opinions on the matter—including NEJM editors who filed a “friends of the court” brief that defended the right of the consumer. Such pressures have not always swayed the court in the past.

Since the same justices that ruled in the landslide verdict of Riegel are set to preside over Wyeth, it may be difficult to overturn the precedent set in February. However, rest assured that we will keep you informed of the proceedings.

On these topics, or any others, feel free to contact me.

Justine Cadet, News Editor
jcadet@cardiovascularbusiness.com