Medtronic Inc. (NYSE:MDT) is fielding a pair of lawsuits, one accusing it of product liability over its Sprint Fidelis implantable cardiac defibrillator leads and another alleging that it falsely marked some of its Endeavor stents with a pair of U.S. patents.
The Minneapolis medical device monolith pulled the Sprint Fidelis leads from shelves worldwide in October 2007, but not before they were implanted in an estimated 268,000 patients. Because of fractures in the wires, defibrillators could either fail to deliver the shock needed to regulate a haywire heartbeat or send unneeded shocks. The defective leads are implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a “possible or likely contributing factor.”
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A federal judge in Minnesota dismissed 600 personal injury lawsuits over the device in October 2009, hewing to the preemption rule enshrined by the Supreme Court in Riegel v. Medtronic (PDF). In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law.
That didn’t stop Ed McGill, an Omaha man who was implanted with Sprint Fidelis leads in 2005, from suing Medtronic in the U.S. District Court for Nebraska. McGill’s lead had to be explanted in May 2009 after he experienced “a series of inappropriate and debilitating shocks delivered to his heart,” according to court documents.
McGill is seeking damages, payment of his medical expenses, disgorgement of Medtronic’s profits from the device and legal fees.
In the second lawsuit, filed in the U.S. District Court for Eastern Texas, Promote Innovation LLC alleged that Medtronic falsely marked its Endeavor Sprint drug-eluting stent system with a pair of patents the court had declared unenforceable. Medtronic had sued Boston Scientific Corp. (NYSE:BSX) in 2006, accusing its competitor of violating the patents, according to court documents. The patents “were declared unenforceable for fraud on the Patent Office by the United States District Court for the Eastern District of Texas on August 28, 2008,” according to court documents. Medtronic settled false marking claims made against it in the lawsuit in February 2009, asking that the claims be dismissed with prejudice and the ruling of unenforceability overturned. The court demurred, but Medtronic allegedly continued to mark the Endeavor under the patents, according to the lawsuit.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Promote Innovation is seeking $500 for every instance of false marking “or an alternative amount a determined by the Court, one-half of which shall be paid to the United States,” according to court documents.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
