Lawmakers have introduced a bill that will in essence override the Supreme Court decision in February 2008 of Riegel v. Medtronic.

The decision had significant import to the medical device industry, as the Court held that the law providing authority for the FDA to regulate devices also significantly limits the right of patients to sue manufacturers of medical devices which caused injuries. The Medical Device Amendments to the Food, Drug, and Cosmetics Act contains explicit preemption language that prohibits states from establishing requirements different from, or in addition to, requirements in the federal statute that relate to the safety or effectiveness of the device.

Now Rep. Frank Pallone Jr. (D-NJ) has introduced H.R. 6381 the "Medical Device Safety Act of 2008," along with co-sponsors Rep. Henry Waxman (D-CA) and 61 other representatives. The Act is to "amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices." The bill apparently takes away the "preemption" effect by stating, "Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."

The amendment is significant, as it likely removes barriers to plaintiffs initiating private lawsuits against manufacturers. In the original decision, Justice Ruth Bader Ginsburg was the lone dissenter to the majority, stating that the original act was never intended "to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Concerning HR 6382, House Oversight and Government Reform Committee Chair Henry Waxman said in a press release that the Supreme Court decision "protects the financial interests of medical device companies at the expense of patients harmed by FDA-approved devices."

House Energy and Commerce Health Subcommittee Chair Pallone also stated in the release, "This bill reverses an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product."

Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-MA) and Judiciary Committee Chair Patrick Leahy (D-VT) are expected to introduce companion legislation in the Senate.

Organizations such as the Advanced Medical Technology Association, Medical Device Manufacturers Association and AdvaMed are opposing the bill, giving such reasons as needless delays, more lawsuits, and higher healthcare costs.

SOURCE: DOTmed.com

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