The U.S. Supreme has ruled on preemption two times over the past six months. The first ruling was pro-medical device maker; the second concerned drug litigation and that ruling was pro-consumer. Certain Democratic members of Congress are planning on introducing legislation that would nullify the Court’s first ruling – allowing plaintiffs to sue medical device makers in state court.

Ruling #1 – Medical devices

The first ruling came down in a case called Riegel vs. Medtronic. In that case, the plaintiff’s husband had an angioplasty procedure. The balloon catheter used in the surgery, manufactured by Medtronic, burst and eventually led to the death of Riegel’s husband. She sued Medtronic, but the company claimed that she was preempted from doing so because the U.S. Food & Drug Administration (FDA) had the final say in approving the device for use on the market. The case made it all the way to the Supreme Court which held that the pre-emption clause in The Medical Device Amendments of 1976 “bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received pre-market approval from the FDA.”

Ruling #2 – Drug litigation

The second ruling came down in a case called Wyeth vs. Levine. In that case, Diane Levine – a musician – lost her arm after taking medication manufactured by Wyeth. She sued the manufacturer, but Wyeth also claimed that she was preempted from doing so because, again, the FDA had the final say in approving the drug for use on the market. In this case, the Supreme Court ruled in favor of Levine.

Making sense of the rulings

It’s no secret that the FDA lacks the funding to adequately do its job. In fact, it has come out and said exactly that. So, if drug and medical device makers are “putting the blame” on the FDA when their products cause injuries and the FDA lacks the funding to adequately monitor manufacturers – then who’s ultimately responsible?

That’s the question several members of Congress have asked. They disagree with the Court’s first ruling in the Medtronic case and are planning to introduce legislation that have would nullify the Court’s ruling and allow injured victims to sue medical device makers in state court – a move that companies like Medtronic don’t want to happen.

Medtronic’s Sprint Fidelis

Medtronic recalled its Sprint Fidelis defibrillator wire in October 2007 because it could fracture and cause severe injury or death. Thousands of patients sued the company alleging that it knew about the high fracture rate well before the recall. In fact, new information has recently been discovered showing that Medtronic underestimated the number of deaths associated with the Fidelis lead wire. The company initially reported that five deaths had been linked to wire; now it is saying that number is actually 13.

In the past two years, many judges have thrown those cases out based on the preemption argument. However, if the proposed legislation that nullifies the Supreme Court’s medical device ruling is passed; those cases could move forward – subjecting Medtronic and other medical device makers to millions, or billions, of dollars in damages.

If you’ve been implanted with the Sprint Fidelis or another dangerous or defective medical device, an experienced product liability lawyer will be able to evaluate your situation and discuss your options.