February 21, 2008 Leave a comment
On February 20, the US Supreme Court issued an opinion in Riegel v. Medtronic, Inc. that "bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA." The case focused on the "pre-emption" clause of the Medical Device Amendments of 1976, 21 U. S. C. §360k.
I’m not an attorney, but I wonder what, if any, implications this ruling may have for manufacturers of other devices that are subject to approval by federal agencies, such as the FAA. Riegel v. Medtronic, Inc. clearly turns on specific language in the Medical Device Amendments act, but it seems to be part of a trend. The court will soon hear a similar case, Warner-Lambert Co. v. Kent, that involves a pharmaceutical company. According to a story in today’s NY Times:
By an 8-1 vote, the court ruled a 1976 law creating federal safety oversight for medical devices bars state-law claims challenging safety or effectiveness of devices that have won premarket approval from the Food and Drug Administration…
The ruling could benefit other device makers, who have argued that the FDA’s judgment that a product is safe and effective should protect companies from being sued for liability in state court.
General aviation manufacturers and aviation associations have long complained that the makers of airframes, engines, instruments, and other aircraft components are unfairly held responsible for deaths and injuries resulting from aviation accidents even when those accidents are officially blamed on pilot error, weather, or other factors not related to the design or function of the aircraft or its parts. The industry has often cited FAA certification as evidence that aircraft and their components meet applicable and reasonable safety standards.
The General Aviation Revitalization Act of 1994 (GARA) provided some liability protection for manufacturers of general aviation aircraft (for a brief overview, see this 2006 report by the law firm Wilson Elser). According to GARA:
…no civil action for damages for death or injury to persons or damage to property arising out of an accident involving a general aviation aircraft may be brought against the manufacturer of the aircraft or the manufacturer of any new component, system, subassembly, or other part of the aircraft, in its capacity as a manufacturer if the accident occurred—
(1) after the applicable limitation period [18 years] beginning on—
(A) the date of delivery of the aircraft to its first purchaser or lessee, if delivered directly from the manufacturer;
(B) the date of first delivery of the aircraft to a person engaged in the business of selling or leasing such aircraft;
(2) with respect to any new component, system, subassembly, or other part which replaced another component, system,
subassembly, or other part originally in, or which was added to, the aircraft, and which is alleged to have caused such
death, injury, or damage, after the applicable limitation period beginning on the date of completion of the replacement or
But GARA hasn’t stopped folks from suing anyone and everyone who might have a connection to an aircraft involved in an accident. An infamous recent case involved a multi-million-dollar verdict against Parker Hannifin, a company that manufactured FAA-certified vacuum pumps. The company’s pumps were installed in a twin-engine Cessna 335 that crashed on October 16, 2000, killing three people, including Missouri Governor Mel Carnahan. The NTSB official report listed the probable cause of the accident as, "The pilot’s failure to control the airplane while maneuvering because of spatial disorientation. Contributing to the accident were the failure of the airplane’s primary attitude indicator and the adverse weather conditions, including turbulence." But the report does not blame either of the airplane’s two vacuum pumps, both of which were working at the time of the crash. Parker Hannifin has since stopped making vacuum pumps.
It will be interesting to see if the aviation industry finds new support against similar claims in light of the decision in Riegel v. Medtronic, Inc.