Congressional Democrats Move with a Good Legislation

by Internet Archive Book Images

Congressional Democrats have proposed a legislation which hopefully makes it easier to sue manufacturers of medical devices. Well, it is just a proposal! The question now is whether the proposed legislation has enough votes to pass. No doubt it will be a difficult measure to muster enough votes for either in the House or Senate.

The Medical Device Safety Act of 2009 would overturn the Court’s 2008 ruling in Riegel v. Medtronic, which dismissed a lawsuit over a ruptured catheter. That ruling brought whoops of joy from medical device firms, who had long lobbied for a position that federal law blocked, or preempted, such suits. But the Supreme Court changed the landscape yesterday in Wyeth v. Levine when it upheld a $ 6.7 million state jury verdict won by a musician from Vermont whose arm was amputated after being injected with an anti-nausea drug.

The question now is whether the proposed legislation has enough votes to pass, especially in the Senate where Minnesota Senator-elect Al Franken has yet to be seated.

No doubt it will be a difficult measure to muster enough votes for either in the House or Senate. Mark Hermann, a Jones Day lawyer who represents pharmaceutical and medical device companies, as well as a drug and device law blogger, noted that the federal law for medical devices contains a provision which specifically addresses the pre-empting of state laws and requirements, while the federal law pertaining to pharmaceuticals does not.

“If enacted, this legislation would effectively allow state courts to review medical devices and ultimately lead to a patchwork of inconsistent and confusing guidance on the use of medical treatments for patients and physicians, or limit their availability altogether,” wrote AdvaMed, in a news release.

Until a resolution ensues, plaintiff’s lawyers expect companies will continue seeking to dismiss liability lawsuits filed in state courts citing the Supreme Court’s 2008 decision. In January 2009, a federal judge in Minneapolis threw out lawsuits filed on behalf of thousands of patients who received heart defibrillators with wires capable of fracturing and producing lethal shocks.