USA Supreme Court Favors Big Pharma
American Consumers no longer have any recourse from being harmed by defective drugs, vaccines or medical devices that carry the FDA seal of approval..The
Unless and until Congress acts to protect the American citizen(or plutocracy would be replaced by direct democracy – Justice Lover), let consumer beware.Do not for a split second trust prescription drug or medical device manufacturers–and by no means trust the FDA.
The FDA seal of approval is a license to market even poorly tested,defective drugs, vaccines and medical devices that kill.
High court reins in states’ reach on health issues
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By Joan Biskupic,
USA TODAY
WASHINGTON ”” The Supreme Court on Wednesday curtailed lawsuits against the makers of medical devices and struck down a state effort to keep youths from buying cigarettes on the Internet, in two disputes testing the line between state and federal power.
By an 8-1 vote, the court spurned a lawsuit based on New York law by the widow of a man injured when a Medtronic catheter ruptured during heart surgery in 1996. The justices said a U.S. statute requiring a rigorous “pre-market” screening by the Food and Drug Administration of certain devices barred the state lawsuit.
Separately, by a 9-0 vote, the court rejected a Maine law that imposed new delivery requirements on tobacco parcels, including forcing carriers to obtain proof of age from a recipient. The justices said a federal transportation law prevents such state regulation of carriers.
The rulings were a victory for business interests and a setback for state efforts to protect citizens in health-related areas when the federal government already has entered the field. The Medtronic decision could signal a favorable outcome for drug manufacturers in two pending Supreme Court cases. In those, drugmakers are trying to limit patients’ ability to sue if drugs have been approved by the FDA.
The high court stressed in Wednesday’s ruling that Congress gave the FDA the task of comprehensively weighing the benefits and risks of a medical device rather than state juries that would see defects only on a case-by-case basis.
“This is a very important decision, which ensures that patients continue to have appropriate access to innovative, lifesaving medical devices,” said Bill Hawkins, Medtronic president.
Allison Zieve, a lawyer with the Public Citizen Litigation Group representing the widow, said state suits are “an important complement to federal regulation because of the incentive they provide to make products as safe as can be.”
Charles Riegel and his wife, Donna, sued Medtronic in 1999, alleging its catheter violated New York law related to the design, labeling and manufacture of devices. Lower U.S. courts ruled that a 1976 federal law prevented the state suit. Riegel died while his case was on appeal.
Justice Antonin Scalia, who wrote the decision, said that under the U.S. law, the FDA spends about 1,200 hours reviewing each application and considering the device’s safety and effectiveness. He said the law bars any additional state product-liability requirements.
Justice Ruth Bader Ginsburg dissented.
In the Maine case, the state in 2003 passed rules for carriers who deliver tobacco packages. State officials were concerned about minors buying cigarettes over the Internet.
After the New Hampshire Motor Transport Association and other carrier groups sued, lower courts ruled that a federal transportation law pre-empted Maine’s rules. Backed by 36 states in its appeal, Maine said federal law does not block state efforts to protect public health.
Writing for the court, Justice Stephen Breyer said no such tobacco or public health exception exists. He said the federal law was intended to standardize delivery rules and stressed the importance of an efficient, competitive system.
Contributing: Julie Appleby