Doctors say medical device preemption rules don’t make sense

An opinion piece in the New England Journal of Medicine (NEJM) says that many doctors support legislation recently introduced by in Congress that would reverse the U.S. Supreme Court’s ruling in Riegel vs. Medtronic which said that patients injured by medical devices approved the U.S. Food & Drug Administration (FDA) could not sue manufacturers in state court.

The theory behind the ruling is that the FDA requires manufacturers to test these devices and follow FDA guidelines before products can be used on the market. However, as countless medical professionals and product liability attorneys have pointed out, the FDA is over-burdened and often relies only on manufacturer data before approving products, leaving patients at grave risk of injury – and without recourse.

The NEJM article featured the opinions of three doctors, Gregory Curfman, Jeffrey Drazen and Stephen Morrissey, who argued that the Court’s ruling wasn’t accurate and that lawmakers should act to reverse it.

Is the Supreme Court at odds over preemption?

That’s what many believe as another preemption case decided after Riegel ruled against preemption. In Wyeth vs. Levine, the Court ruled that plaintiff Diane Levine was not preempted from suing Wyeth Laboratories after she lost her arm due to taking one of Wyeth’s drugs. The Court upheld a lower court verdict awarding her $6.7 million in damages. Since the FDA oversees drugs and medical devices, many feel that there should not be a different standard between the two.

The Medical Device Safety Act of 2009 (MDSA) would disallow preemption and reinstate tort liability against medical device manufacturers at the state level to compensate those who have been injured by their products. Although the bill was never debated in the last Congressional session, many believe that it will be reintroduced soon.

Whether of not the bill becomes law, anyone injured by a defective medical device should contact an experienced products liability attorney to discuss their situation and evaluate their options. Every case is different and product liability lawyers generally offer free consultations.