Personal Injury Lawyers in New York

On February 20, 2008, the Supreme Court ruled 8-1 that manufacturers of medical devices which meet the FDA’s specification and have been approved for marketing, cannot later be sued for any personal injury claimed to have been caused by that device. In other words, FDA pre-market approval of a new medical device takes precedence over later state lawsuits.

Such state lawsuits have been filed in the past, and some patients have won large amounts for injuries held to have been caused by an approved medical device. Many such pending lawsuits will now be moot.

The case before the Supreme Court concerned a man who was injured when a balloon catheter burst as it was being inserted to dilate his coronary artery. The catheter had been approved by the FDA in 1994, two years previously.

Two Approval Processes

Up until 1996, FDA approval was done according to the Medical Device Amendments process of 1976. Since 1996, medical devices have been approved differently, where the FDA has deemed them “substantially equivalent” to the ones marketed before 1976. In 1996, the Supreme Court ruled that this second process does not pre-empt state lawsuits being brought against manufacturers of any “grandfathered” devices.

The situation is not fully clear at this point as to how many of the pending suits will be affected by the ruling. For example, devices which were FDA-approved but subsequently manufactured in a sub-standard way are not included in the 2008 Supreme Court ruling. Further, if a state has laws which mirror the federal laws (rather than differing and supplementing them), some cases may be permissible.

Some State Lawsuits “disrupt the federal scheme”

Justice Antonin Scalia, writing for the majority, said that allowing a state jury to assign liability to a manufacturer who has previously gone through the FDA approval process for the device in question “disrupts the federal scheme”. He noted too that juries see only the injured plaintiff’s situation and therefore tend to consider the dangers of a device more than its benefits. “The patients who reaped those benefits are not represented in court.”

Devices affected by this 2008 opinion tend to be more technologically sophisticated and include devices such as a heart pump, an implantable defibrillator, a drug-coated stent, an artificial heart valve, and artificial knees and hips.

If you have been injured by a medical device, or if you are wondering whether you have, it will help to contact us for a free case evaluation.