The
Supreme Court of the United States ruled on Feb. 21, 2001 that people
who are injured by a medical device cannot sue for compensation
from a company that obtained FDA approval for the device through
fraud or misrepresentation.
Plaintiffs
were harmed by pedicle screws surgically implanted in their spines.
They sued the company that was hired by the manufacturer to obtain
FDA approval. Plaintiffs alleged that FDA's decision to allow the
devices on the market was based on the company's misrepresentation
of the intended use of the device.
The
Supreme Court, in an opinion by Chief Justice Rehnquist, held that
plaintiffs' state law actions were preempted as conflicting with
the federal regulatory scheme. Whether a federal agency was defrauded
and what consequences should follow is a matter exclusively between
the agency and the entities it regulates, the Court stated. It is
not a area traditionally handled by the states. Moreover, allowing
state lawsuits could lead companies to flood agencies with additional
information, burdening the agencies and interfering with the regulatory
process.
Justices
Stevens and Thomas, concurring, criticized the majority opinion
as overly broad. Focusing on a point that AAJ raised in its amicus
brief, Justice Stevens stated that where the FDA has determined
that it was defrauded and ordered the device off the market, suits
by the injured victims of the device would not conflict with the
federal scheme.
