Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) have followed the lead of House lawmakers and introduced a Senate counterpart of the Medical Device Safety Act of 2008 to ensure individuals are not prevented from seeking legal recourse against devicemakers selling defective products under state tort laws. (FDAnews Device Daily Bulletin, Aug. 12, 2008, Vol. 5, No. 157, “Senators Introduce Their Version of Anti-Preemption Bill." See also 08/01/08 Statement of Senator Leahy.)

The bill seeks to reverse the United States Supreme Court’s February 20, 2008 decision in Reigel v. Medtronic in which the Supreme Court severely curbed the rights of injured victims. Specifically, this harsh decision held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA.

Baxter and other drug manufacturers argue that Riegel should be even further expanded to include medical drugs. They argue that regardless of misconduct or failures on their part, Americans injured by defective drugs or medical devices should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

As discussed in previous blogs, this argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Without accountability of companies who unapologetically put profits over people, innocent Americans will continue to die from unsafe drugs and medical devices.

To read Senator Leahy’s powerful statement regarding the bill and the dangers of preemption, click here.

We thank Senators Leahy and Kennedy for their efforts to protect the American public from unsafe drugs and medical devices.

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