Supreme Court Will Hear Arguments in Riegel Vs. Medtronic

On Tuesday, AdvaMed General Counsel Christopher White issued a statement with regards to oral arguments presented before the U.S. Supreme Court on the matter of Riegel v. Medtronic, Inc.

AdvaMed member companies include everyone from the largest to the smallest medical technology innovators and companies.

"As was made clear in today's arguments, the safety and efficacy of medical technologies are best determined by FDA scientists -- not by lawsuits filed in courtrooms across the country...A state-law liability approach to assessing safety and effectiveness would undermine [the FDA's scientific] approach to patient safety. It also would override the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies...We are hopeful the Supreme Court will re-affirm the two previous lower court rulings in this case which made clear that the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act expressly provide for FDA's ultimate regulatory authority in these matters," stated White.

Critics of the stance taken by AdvaMed say that while the FDA is involved with regulation, it is not involved in prosecuting those medical technology companies that violate those regulations, and thus state courts should be permitted to hear cases of possible violations. They also opine that state courts act as checks against possibly politically-motivated opinions or testimonials given by a large federal government agency such as the FDA.

The contention of backers of the stance say that the trial-by-jury process in state courts won't work in these matters because the average juror simply lacks the education and medical technology expertise to accurately judge whether or not a company was in clear violation of a regulation.

In the case at hand, Charles and Donna Riegel decided to sue medical device giant Medtronic directly when its now-discontinued Evergreen catheter exploded during Charles' angioplasty in 1996. Charles died of brain cancer in 2004, but Donna is continuing to seek approximately $5 million in damages on the grounds that the malfunction left her husband seriously disabled for the remainder of his life.

The opinion among the federal circuit courts, and the one that has previously been upheld by the Supreme Court, based on a 1976 amendment, is that a manufacturer cannot be sued by the public for the failure of an FDA-approved device. The stamp of approval from the feds trumps random instances of faulty manufacture.

Medtronic has insisted that the presiding physician misused its device, and that the cause of Charles' death cannot be linked with the failed operation.

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