That question is now before the Massachusetts Supreme Judicial Court, and the answer could significantly expand the legal options available to patients harmed by defective implanted devices in this state.
The case is Plourde v. Sorin Group USA, Inc., and it involves a heart valve that malfunctioned in young patients. The manufacturer, Sorin Group, allegedly knew about the failures and did not report them to the FDA as required by federal law. The First Circuit Court of Appeals has asked the SJC to decide whether that failure to report gives rise to liability under Massachusetts law. The SJC’s answer will set a precedent that affects every patient in the Commonwealth who has been harmed by a medical device whose dangers the manufacturer concealed.
What Happened in Plourde
The plaintiffs sued Sorin Group USA in Massachusetts state court, alleging negligence and failure to warn based on Sorin’s failure to report adverse events involving its Mitroflow aortic pericardial heart valve to the FDA. The Mitroflow valve was implanted in young patients, and the plaintiffs alleged that Sorin knew the device was malfunctioning and causing harm but did not file the mandatory adverse event reports that federal law requires of medical device manufacturers.
Sorin removed the case to federal court and moved for summary judgment, arguing that the plaintiffs’ state law claims were preempted by federal law, specifically that the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act barred state tort claims that imposed requirements different from or in addition to federal requirements. The trial court agreed and dismissed the case.
On appeal, the First Circuit identified a question it could not resolve without guidance from the Massachusetts courts: does Massachusetts law impose a duty on medical device manufacturers to report adverse events to the FDA, and if so, does a manufacturer’s failure to meet that duty give rise to civil liability? The First Circuit certified that question to the SJC, which means the SJC will now issue a binding answer that the First Circuit will apply to resolve the appeal.
Why Federal Preemption Is the Central Issue
Medical device litigation in federal court has been significantly constrained since the U.S. Supreme Court’s 2008 decision in Riegel v. Medtronic, which held that the MDA preempts state tort claims that impose requirements different from or in addition to federal requirements for Class III medical devices (the highest-risk category, which includes implanted heart valves). Under Riegel, a patient cannot sue a manufacturer for design defects if the device received FDA premarket approval, because those claims would effectively impose state-level design requirements on top of the federal approval process.
The narrow exception that survived Riegel is the so-called “parallel claim,” a state tort claim that does not impose additional requirements but instead enforces duties that are identical to what federal law already requires. The theory in Plourde is exactly that: Sorin was already required by federal law to report adverse events to the FDA, it didn’t, and patients were harmed as a result. A Massachusetts negligence claim based on that failure to report is not asking for anything beyond what federal law already demanded. It runs parallel to the federal duty rather than conflicting with it.
The question for the SJC is whether Massachusetts recognizes that parallel claim theory and whether the failure to report to a federal regulator, rather than directly to patients or physicians, is the kind of duty breach that gives rise to civil liability under state law.
What the SJC’s Answer Will Mean for Patients
If the SJC answers yes, Massachusetts patients harmed by medical devices will have a meaningful avenue to pursue manufacturers who knew their devices were causing harm and stayed silent. This matters enormously because the FDA’s adverse event reporting system is one of the primary mechanisms by which dangerous devices are identified and recalled. When manufacturers fail to file those reports, the system breaks down. Patients continue receiving implants that are failing. Doctors continue recommending devices they have no reason to know are dangerous. The harm compounds silently.
A ruling that Massachusetts law supports civil liability for that failure would create a real financial incentive for manufacturers to comply with their reporting obligations, the same kind of accountability mechanism that has driven safer outcomes in other product liability contexts. I’ve written before about how the Philip Morris verdict and the Roundup litigation both involved manufacturers who knew their products were causing harm and concealed that knowledge for years. The pattern is the same here. The legal theory is simply adapted to the specific regulatory framework that governs medical devices.
Who This Affects
If you or a family member has had a medical device implanted, including a heart valve, a joint replacement, a spinal implant, a hernia mesh, a pacemaker, or any other device that required FDA approval, and has since experienced complications, unexpected failures, or been told the device was subject to a recall or safety alert, the Plourde case is directly relevant to your situation.
The threshold questions in any medical device case are whether the device was defective, whether the manufacturer knew or should have known about the defect, whether it reported what it knew to regulators and to the medical community, and whether the defect caused your injury. The Plourde ruling will help define how Massachusetts courts handle the second and third of those questions when a manufacturer has failed to file required FDA reports.
Medical device cases are among the most technically demanding in personal injury law. They require engineering and medical experts, careful analysis of FDA regulatory history, and an understanding of both federal preemption doctrine and state tort law. The statute of limitations for these claims follows the same three-year Massachusetts rule that applies to other personal injury and medical malpractice claims, running from when you knew or should have known that the device caused your injury, but the analysis of when that clock starts can be complicated in cases involving latent device failures that weren’t publicly disclosed.
What to Do If You’ve Been Harmed by a Medical Device
The FDA maintains a publicly searchable adverse event reporting database called MAUDE where you can look up whether your specific device has been the subject of malfunction or injury reports. If your device appears there, or if you’ve received a recall notice or safety communication from your surgeon or the manufacturer, that is a starting point worth discussing with an attorney.
I’ve spent more than 35 years handling serious injury and wrongful death cases in Massachusetts, and the emergence of medical device liability as a recognized area of state law is something I’m watching closely. If you believe a defective device has caused you or a family member harm, I’m happy to talk through the facts and help you understand your options.
Call me at 508-775-3118 or email [email protected] for a free consultation.
Attorney Blair E. Weigand — Helping those with legal questions for 35 years and counting.