Supreme Court: Die from a medical device? Too bad sucker…


Richard Moore

February 21, 2008

Justices Shield Medical Devices From Lawsuits

WASHINGTON ‹ Makers of medical devices like implantable defibrillators or breast
implants are immune from liability for personal injuries as long as the Food and
Drug Administration approved the device before it was marketed and it meets the 
agency¹s specifications, the Supreme Court ruled on Wednesday.

The 8-to-1 decision was a victory for the Bush administration, which for years 
has sought broad authority to pre-empt tougher state regulation.

In 2004, the administration reversed longstanding federal policy and began 
arguing that ³premarket approval² of a new medical device by the F.D.A. 
overrides most claims for damages under state law. Because federal law makes no 
provision for damage suits against device makers, injured patients have turned 
to state law and have won substantial awards.

The Bush administration will continue its push for pre-emption in another F.D.A.
case that the court has accepted for its next term, on whether the agency¹s 
approval of a drug, as opposed to a device, pre-empts personal injury suits. 
Drugs and medical devices are regulated under separate laws.

The case before the court concerned only medical devices that had gone through 
the premarket approval process specified by the Medical Device Amendments of 
1976. Most devices now available reached the market through a different process,
under which the F.D.A. found them to be ³substantially equivalent² to those 
marketed before the 1976 law took effect.

The Supreme Court ruled in 1996 that this less rigorous approval process does 
not pre-empt state damage suits against the manufacturers of ³grandfathered² 

Devices subject to the premarket approval process, and thus affected by the 
court¹s opinion, tend to be more technologically advanced, expensive and, in 
some instances, risky.

Examples of devices that have been the subjects of recent lawsuits include an 
implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated
stent, an artificial heart valve, and prosthetic hips and knees.

It was not immediately clear how many of the thousands of lawsuits against 
medical device manufacturers would be affected, though some pending cases will 
almost certainly be nullified.

The decision, for example, does not foreclose lawsuits claiming that a device 
was made improperly, in violation of F.D.A. specifications. Cases may also be 
brought under state laws that mirror federal rules, as opposed to supplementing 

Next Monday, the court will hear another F.D.A. pre-emption case, on whether a 
state case can be based on the claim that a drug maker committed fraud by 
misrepresenting or withholding information from the agency during the approval 
process. The administration is supporting the manufacturer in that case, 
Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug 

Writing for the majority in Wednesday¹s case, Riegel v. Medtronic Inc., No. 
06-179, Justice Antonin Scalia said that permitting state juries to impose 
liability on the maker of an approved device ³disrupts the federal scheme,² 
under which the F.D.A. has the responsibility for evaluating the risks and 
benefits of a new device and assuring that it is safe and effective for its 
intended use.

A jury, looking only at the injured plaintiff, will tend to weigh only the 
dangers of a device and ³is not concerned with its benefits,² Justice Scalia 
said, adding, ³the patients who reaped those benefits are not represented in 

The decision affirmed the dismissal of a lawsuit by a patient who was injured 
during an angioplasty when a balloon catheter burst while being inserted to 
dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two 
years before the incident. The patient, Charles R. Riegel, died after the 
lawsuit was filed, and the case was carried on by his widow, Donna.

The medical device statute contains a pre-emption clause that bars states from 
imposing ³any requirement² related to a medical device that is ³different from, 
or in addition to² a federal requirement. The question of statutory 
interpretation at the heart of the case turned on what Congress meant by ³any 

Justice Scalia said that state tort law, by imposing duties of care on product 
makers, amounted to such an additional requirement. He said the 1976 law ³speaks
clearly to the point at issue,² regardless of the federal government¹s previous 
or current positions.

Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had 
misconstrued Congress¹s intent in adding the pre-emption clause to the 1976 law.
The purpose, she said, was to prevent individual states from imposing their own 
premarket approval process on new medical devices. Devices were not regulated 
under federal law at the time, and California and other states had stepped in to
fill the vacuum by setting up their own regulatory systems.

That was all that Congress had in mind, Justice Ginsburg said, not ³a radical 
curtailment of state common-law suits seeking compensation for injuries caused 
by defectively designed or labeled medical devices.² She said that Congress had 
passed the 1976 law ³to protect consumer safety,² not to oust the states from ³a
domain historically occupied by state law.² The decision was at odds with the 
³central purpose² of the 1976 law, Justice Ginsburg added.

Crucial Democratic lawmakers appear to agree with Justice Ginsburg, including 
Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Health, 
Education, Labor and Pensions Committee and was the sole Senate sponsor of the 
1976 legislation in question.

³In enacting legislation on medical devices, Congress never intended that F.D.A.
approval would give blanket immunity to manufacturers from liability for 
injuries caused by faulty devices,² Mr. Kennedy said in a statement. He added: 
³Congress obviously needs to correct the court¹s decision.²

Representative Henry Waxman, the California Democrat who is chairman of the 
House Committee on Oversight and Government Reform and was on the House panel 
that approved the 1976 bill, expressed a similar view.

³The Supreme Court¹s decision strips consumers of the rights they¹ve had for 
decades,² Mr. Waxman said. ³This isn¹t what Congress intended, and we¹ll pass 
legislation as quickly as possible to fix this nonsensical situation.²

The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates 
pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the 
administration is arguing in the case the court has accepted for its next term, 
Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of 
the statute.

The Supreme Court¹s interest in pre-emption is not limited to the medical arena.
In a similar case decided on Wednesday, this one unanimously, the court ruled 
that the federal law that deregulated the trucking industry in 1980 pre-empted 
two recent laws adopted by the State of Maine to regulate the shipment of 
tobacco products into the state.

The state laws were intended to prevent children who were not of legal age to 
buy cigarettes from ordering them over the Internet. The laws placed 
responsibility on shippers and delivery companies to verify the recipient¹s 
identity and age.

Justice Stephen G. Breyer, writing for the court in this case, Rowe v. New 
Hampshire Motor Transport Association, No. 06-457, said the state law ³produces 
the very effect that the federal law sought to avoid, namely, a state¹s direct 
substitution of its own governmental commands for competitive market forces² in 
a deregulated environment.

Barnaby Feder contributed reporting from New York and Gardiner Harris from 

Copyright 2008 The New York Times Company

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