Supreme Court May Consider Exceptions to Medical Device Preemption Case – Medtronic v. Stengel

By October 11, 2013 April 18th, 2019 Defective Medical Device litigation

The U.S. Supreme Court may soon take up a case that could clear the way for more people to pursue defective medical device lawsuits. According to Reuters, the Court asked the Solicitor General of the United States Monday to weigh in on Medtronic Inc. v. Stengel, a case asking whether medical device lawsuits are preempted when the defendant has a state-law duty of care parallel to federal requirements, neither of which it met. The Ninth U.S. Circuit Court of Appeals ruled en banc that they are not, clearing the way for a lawsuit by Richard and Mary Lou Stengel of Arizona. Richard Stengel had a Medtronic pain medication pump and catheter implanted into his body, ultimately leading to permanent paralysis. The Stengels contend that Medtronic failed to notify the FDA about problems with the device, as required by law.
Stengel had the pain pump implanted in 2000. Five years later, he collapsed when his leg stopped working. Doctors diagnosed him with “ascending paralysis”; he is now permanently paraplegic. According to the Ninth Circuit’s en banc opinion, Medtronic knew there were problems with the device before Stengel’s collapse, but failed to warn the FDA despite a clear duty to do so in federal law. The FDA later sent a warning letter to Medtronic about this failure; the pump was pulled from the market in 2008. In Arizona federal court, the Stengels’ lawsuit was rejected as preempted; they moved to amend their suit to add an allegation that Medtronic’s failure to report to the FDA was parallel to a state-law duty to warn patients. The federal district court rejected this as also preempted, and a divided Ninth Circuit panel agreed. The en banc panel reversed, saying Supreme Court precedent does not make such “parallel” claims preempted.
Medtronic petitioned for certiorari—review by the U.S. Supreme Court—earlier this year. According to SCOTUSBlog, three amicus briefs were filed before the Stengels filed their response, suggesting there’s a lot of interest in the issue. The court has not yet decided whether to take the case, but as Reuters reported, it has invited the Solicitor General to weigh in on the topic. This suggests that at least some justices would like to take up the issue. That could clarify the court’s prior decision in 2008’s Riegel v. Medtronic, as well as similar, earlier cases that limited the ability of people like the Stengels to file dangerous medical device lawsuits. As things stand, medical device companies are free to argue that even their own illegal behavior is not a permissible basis for a lawsuit.
I believe the Supreme Court should take up this case and expressly rule that failure to follow FDA rules exposes medical device companies to “parallel” lawsuits like this one. Thanks to the Riegel decision and others like it, people who have been hurt by dangerous medical devices have almost no ability to sue. If Medtronic gets its way, it will be immune from nearly any medical device liability lawsuit, even ones like this that are based on its documented failure to follow basic safety rules. That’s not fair to consumers (or medical device manufacturers who do follow the rules), and it’s not a safe situation either. I look forward to hearing more about this case.


If a dangerous medical device hurt you or someone you love, and you’d like to talk to an experienced attorney about your legal options, don’t wait to call Carey, Danis & Lowe. Based in St. Louis, we represent clients across the United States in lawsuits over dangerous and defective medical devices and drugs. To learn more, call us today at 1-877-678-3400 or send us an email.
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Ninth Circuit Rules Medtronic Pain Pump Claims Expressly or Impliedly Preempted – Stengel v. Medtronic
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