Two recent Supreme Court cases on federal pre-emption have made a mess of tort law, confusing and endangering consumers by holding that a patient who is injured by a dangerous drug can sue the manufacturer, but a patient injured by a dangerous medical device cannot. How this happened, and what to do about it, inside.
The recently decided Wyeth v. Levine held that a patient who was harmed by a poorly labeled drug (in this case, an anti-nausea drug whose label specified several ways it could be administered, one of which could, and did, cause gangrene and amputation) could sue the drug maker for failing to warn medical staff of the dangers of the drug.
On the other hand, the Court in Riegel v. Medtronic held that a patient injured by a poorly designed and labeled medical device (in this case, a heart catheter that exploded and killed the patient) could not sue the device maker.
The question in both of these cases was whether the FDA’s approval of a drug or device should be enough to shield (pre-empt) the manufacturer from liability, even when the manufacturer knew of the dangers. Considering how dysfunctional the FDA is, and how unscrupulous drug and device manufacturers can be, we’re not comfortable leaving things entirely up to them.
Neither is Congress, which has introduced the Medical Device Safety Act. The MDSA simply reverses the Court’s decision in Riegel and holds that state law regulating medical devices will be upheld. The bill has attracted bipartisan support and already has 69 cosponsors in the House. Now the New England Journal of Medicine has gotten involved and endorsed the MDSA in its latest issue:
Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts.