Healthy Skepticism Library item: 10716

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Supreme Court reviews FDA protection
The New Jersey Star-Ledger 2007 Jun 26
http://www.nj.com/business/ledger/index.ssf?/base/business-0/1182831995173690.xml&coll=1

Full text:

WASHINGTON — The Supreme Court yesterday agreed to consider whether federal regulatory approval of medical devices shields manufacturers from most product liability lawsuits in state courts.

The decision could upend a growing consensus in the federal appeals courts that the Food and Drug Administration’s regulation of the devices — particularly the agency’s stringent pre-marketing approval process — generally does protect the companies from lawsuits.

The justices ignored the advice of the Bush administration, which agreed with a federal appeals court and recommended last month the court turn down the case. The Clinton administration had taken the opposite position — that liability lawsuits could proceed — in a similar case nine years ago.

In the dispute before the justices, a New York couple, Charles and Donna Riegel, sued Medtronic when its Evergreen balloon catheter burst during Charles Riegel’s angioplasty. The balloon catheter is used to open patients’ clogged arteries.

The 2nd U.S. Circuit Court of Appeals in New York last year upheld a lower court ruling that dismissed the suit. The appeals court noted medical de vice manufacturers cannot alter their products, once on the market, without FDA approval.

As a result, a jury verdict deeming a product unsafe would put companies in a difficult position, the appeals court said. It is possible different ju ries could reach different conclusions about the same medical devices, the court said, “thus rendering it almost impossible” for a device to comply with both the conditions set by the FDA and the varying jury verdicts.

The case won’t be heard until the court’s next term, which begins in October. It could impact other leading medical device makers, including Johnson & Johnson, based in New Brunswick, N.J.

In a separate decision yesterday, the high court refused to consider a lawsuit alleging two pharmaceutical companies conspired to monopolize the market for a drug used to treat breast cancer.

Consumers who filed the suit asked the justices to consider when an agreement not to market a generic drug is a violation of federal law. The 2nd U.S. Circuit Court of Appeals upheld a federal judge, who concluded the agreement between the two companies did not restrain trade in viola tion of federal law.

In 1992, a federal judge ruled that As traZeneca’s patent for the drug ta moxifen was invalid. The decision came in a dispute between AstraZe neca and Barr Laboratories, which wanted to market a generic version of tamoxifen.

Barr, based in Woodcliff Lake, N.J., abandoned its successful challenge in exchange for the right to begin selling a competing tamoxifen product under a distributorship agreement with As traZeneca, well before the expiration of the patent. Barr also received a $21million payment and AstraZeneca also agreed to pay $45million over 10 years to Barr’s intended supplier.

Lawyers for the consumers say the ar rangement resulted in tamoxifen remaining “a single-source, monopoly product,” with Barr distributing un branded tamoxifen at a price 5 percent less than Zeneca’s Nolvadex brand.

Generic drugs, lawyers for the consumers alleged, are usually priced 30 percent to 80 percent below brand- name products.