Congress Considering Restoring Patients’ Ability to File Defective Medical Device Lawsuits

Last year’s Supreme Court ruling in Riegel v. Medtronic took away patients’ right to sue makers of defective medical devices that seriously harmed them or their loved ones. The court said in the 2008 ruling that patients may not file these legal claims because they are explicitly preempted by language in federal law. In response, Congress introduced the Medical Device Safety Act of 2009, which would correct that decision with language that explicitly says federal law does not preempt state-court lawsuits against makers of dangerous medical devices. On April 9, the New England Journal of Medicine published an editorial supporting the legislation, on the belief that it would make patients safer.
The editorial noted that thousands of medical device lawsuits have been thrown out of court since Riegel, regardless of how deserving the injured patients might be. In particular, it cited dismissal of more than 1,000 lawsuits filed by victims of the defective Medtronic Sprint Fidelis defibrillator, which is surgically implanted directly into the patient’s chest. The device has a defective wire that’s unreasonably likely to break, causing it to stop working or shock the patient internally at random times until it can be surgically removed. As the New York Times noted April 7, that surgery is very risky and should ideally be performed by a doctor who specializes in removing the wires. Medtronic itself notes that there have been 13 related deaths so far — but thanks to Riegel, victims and their families have no legal recourse.
The editorial called for the Medical Device Safety Act’s passage for two major reasons, most importantly, patient safety. The decision shielded medical device makers from the potential consequences of not disclosing risks — and as a defective medical device lawyer, I know all too well that some pharmaceutical companies are willing to hide risks in order to protect their profits. Restoring the right to sue would remove that risk and improve safety. It would also bring the law on dangerous medical devices in line with the law on defective drugs, the editorial said. The Supreme Court recently ruled in Wyeth v. Levine that federal law does not preempt state-court claims that a medication is defective, a decision the writers find inconsistent with Riegel. The proposed bill would level the playing field between drugs and devices, they wrote.
I strongly agree, and not just because this issue affects my practice as a defective drug and medical device attorney. Medical device safety, effectiveness and disclosure are literally life-or-death situations for many patients. The high-profile cases of drugs like Vioxx and Seroquel make it clear that not all manufacturers are putting safety ahead of profits, and mistakes or lax regulation by the FDA show that we can’t rely on that agency as our only safeguard. Allowing litigation in the cases that slip through the regulatory cracks would give medical device companies the accountability that American patients deserve. As the editorial said, “lawsuits by injured patients… have been an important part of the regulatory framework and very effective in keeping medical devices safe.”
Based in St. Louis, the Lowe Law Firm represents clients throughout the United States who have been seriously harmed or lost a loved one because of a defective prescription drug or medical device. If you or a loved one was hurt after taking a drug, and you believe the manufacturer failed to disclose important safety information about it, our Missouri defective pharmaceutical lawyers can help. To speak to us about your situation and your legal rights, please contact us online as soon as possible or call toll-free from anywhere in America at 1-877-678-3400.