Buckman Co. v. Plaintiffs' Legal Committee (02/21/2001)

By: Erik Gabrielson, Medill News Service

Questions presented

Whether federal law preempts state-law tort claims alleging fraud on the Food and Drug Administration during the regulatory process for marketing clearance applicable to certain medical devices, in this case, orthopedic bone screws.

Brief

In September 1984, AcroMed Corporation attempted to secure Food and Drug Administration marketing clearance for its orthopedic bone screw device for use in spinal surgery.

Buckman Company, a regulatory consultant to medical device manufacturers, was hired by AcroMed to secure the clearance.

Orthopedic bone screws are regulated by the FDA in accordance with the Medical Device Amendment (MDA) of 1976. Congress enacted the MDA to address the concerns about the safety and effectiveness of new medical devices being marketed.

The MDA requires that medical devices be listed under one of three categories based on risk posed to the public. Class I devices are subject to general manufacturing controls because they are unlikely to cause harm, while Class II devices are potentially more harmful and subject to federal performance regulations.

Class III devices pose an ""unreasonable risk of illness or injury"" and are subject to the strictest regulation. Such devices cannot be sold until the manufacturer convinces the FDA with ""reasonable assurance"" that the device is safe and effective. To do this, the manufacturer must submit all known information about the device's effectiveness as well as a full statement of design, manufacturing and marketing plans. This FDA review process averages 1,200 hours.

But new Class III devices that are ""substantially equivalent"" to other devices already on the market are exempt from the full pre-market approval process. The procedure a manufacturer follows to get this exemption is known as the ""§ 510(k) process.""

For a new device to be approved under the 510(k) process, the FDA must find that it has the same technological characteristics, or is as safe and effective, as a device already on the market. The average 510(k) process lasts only 20 hours.

After Buckman filed a 510(k) request on behalf of AcroMed in 1984, the FDA found that the bone screws were not equivalent to any device already on the market and rejected the request.

A year later, in September 1985, Buckman filed another 510(k) request, and the request was again rejected.

Buckman filed two separate 510(k) requests in December 1985, splitting AcroMed's product into its two component parts that were renamed ""nested bone plates"" and ""cancellous bone screws."" Each request specified that the devices were for use in the long bones of the arms and legs rather than in spinal surgery, and that they were similar to other devices already on the market. The FDA approved the devices for this purpose in February 1986.

For the next ten years, AcroMeds orthopedic bone screw device was used in the long bones, but also in spinal surgery.

Thousands of people who claim they suffered injuries from the implantation of the bone screws into their spines filed suit in multiple federal courts, accusing Buckman of misrepresenting the use of AcroMed's medical device to the FDA and then marketing the device for spinal surgery.

In March 1995, after the cases were consolidated in the Eastern District of Pennsylvania, a federal judge dismissed the suit, finding that federal regulation of medical devices preempts state-law liability claims, and that any injuries suffered from AcroMed's medical device were caused by the doctors using the device.

On Nov. 17, 1998, the 3rd Circuit Court of Appeals, divided 2-1, reversed and reinstated the lawsuit. The court relied on the 1996 U.S. Supreme Court decision in Medtronic Inc. v. Lohr, which found that a pacemaker manufacturer was not exempt from product liability lawsuits under state law even though it complied with all federal law.

Calling its opinion ""narrow,"" the majority held that ""(1) the plaintiffs' ""fraud on the FDA"" theory of liability is not so at odds with traditional principles of tort law that Buckman is entitled to a dismissal of all claims against it at this stage; and (2) if the state law of fraudulent misrepresentation applicable in one or more of these cases would impose liability on Buckman in the circumstances alleged, that law would not be preempted by the MDA.""

The dissenting judge said the majority opinion ""creates dangerous confusion"" because Buckman never told doctors that the bone screws were approved by the FDA for spinal surgery. The judge further said: ""The FDA and the medical community have long recognized the importance of doctors' off-label uses of medical products (uses not indicated on the label or approved by the FDA). Doctors may, in the exercise of their professional judgement, decide that based on current medical research an unapproved use of a product best serves a patient's needs.""

On June 29, 2000, the U.S. Supreme Court granted certiorari, limited review to the question presented above, and allowed the Medical Device Manufacturers Association, Danek Medical, Inc., the Product Liability Advisory Council, Inc., and the Pharmceutical Research and Manufacturers of America to file amicus briefs in the case.

On Feb. 21, 2001, a unanimous Court reversed, dismissing the suit and holding that the class of injured plaintiffs cannot sue companies for allegedly defrauding the federal government to get approval of a new medical device.

Such lawsuits in state court are preempted by the federal regulatory plan for medical devices as outlined in the Food, Drug and Cosmetic Act, wrote Chief Justice William Rehnquist in the lead opinion.

Justices John Paul Stevens and Clarence Thomas, in a separate opinion by Stevens, agreed that the suit should be dismissed, but noted that in future cases, suits should be allowed in those cases in which the FDA finds that a company committed fraud and ordered a product removed from the market.