Ever since the U.S. Supreme Court’s decision in Riegel v. Medtronic, defective medical device attorneys like me have had a limited ability to claim financial compensation for our clients. That’s because Riegel took away the ability to make failure to warn claims, in which the injured person alleges that the manufacturer failed to warn patients about a risk it knew or should have known about. The case established that such claims are expressly preempted by federal law. Since then, it has been harder, though not impossible, to make a defective medical device claim, requiring special circumstances or creative legal theories. One case that has successfully avoided dismissal on preemption grounds is Howard v. Zimmer, Inc., in which Brian and Suzanne Howard allege per se negligence by Sulzer Orthopedics, leading to a failed knee implant for Brian.
Brian Howard, a doctor, received a knee implant manufactured by Sulzer, but it did not succeed. The Howards’ lawsuit alleges that the implant was doomed because it was covered with an oily residue, in violation of federal regulations on medical devices. Violating those regulations made Sulzer per se negligent, the Howards argued. The case was originally part of consolidated multidistrict litigation, where it was dismissed on preemption grounds, but the Sixth U.S. Circuit Court of Appeals reversed. On remand, the case was moved to the Howards’ home district in Oklahoma. A district court there dismissed again, saying Oklahoma law did not permit a negligence per se claim. The Tenth U.S. Circuit Court of Appeals asked the Oklahoma Supreme Court to decide whether that was true.
In a lengthy opinion, the Oklahoma court decided that private individuals like Howard may make a “parallel claim” for negligence per se based on a violation of an exclusively federal regulation. A federal law reserving the right to enforce federal regulations exclusively to the federal government does not forbid plaintiffs from bringing state-law claims based on violation of the state regulation, the high court said. Indeed, it noted that the U.S. Supreme Court expressly approved of such claims in Riegel. It also observed that violations of safety regulations like the one at issue here are highly relevant when determining whether negligence occurred. It then remanded the case back to the Tenth Circuit. That court had already rejected an argument that the case was impliedly preempted. With the Oklahoma Supreme Court’s answer in hand, the Tenth reversed and remanded the case to district court.
As a pharmaceutical liability lawyer, I applaud this decision. Though medical device manufacturers will undoubtedly continue to try to apply preemption to every product defect lawsuit filed against them, this case shows that well-pleaded cases with the right facts can survive. In my opinion, this is not the act of a rogue state Supreme Court; the “parallel actions” logic is drawn from Riegel itself, which means it has a good chance if the issue goes back to the U.S. Supreme Court. In general, I believe it’s unwise for society to exempt medical device manufacturers from lawsuits over the safety of their devices, because removing that accountability gives them no incentive at all to make sure their products are safe. And as a dangerous medical device attorney, I’ve seen the resulting suffering and financial expenses firsthand.
If you or someone in your family suffered a serious injury or medical complications because of a defective medical device, don’t wait to call Carey, Danis & Lowe to discuss how we can help. We represent clients across the United States from our offices in St. Louis. You can reach us toll-free at 1-877-678-3400 or send us a message online.
Similar blog posts:
Oklahoma Supreme Court Permits Negligence Claim in Medical Device Injury – Howard v. Zimmer, Inc.
Ninth Circuit Rules Medtronic Pain Pump Claims Expressly or Impliedly Preempted – Stengel v. Medtronic
Fifth Circuit Resurrects Defective Medical Device Claim Involving Hip Replacement – Bass v. Stryker Corp. et al.