Dr. Donald Kapps went to the Mayo Clinic for treatment of his atrial fibrillation (irregular and high-speed heartbeat). His surgeon used a recycled Biosense “lasso catheter,” which was labeled “for single use only.”
Contrary to manufacturer instructions, however, the Mayo Clinic had sent it out to be refurbished to Ascent (the “Play it Again Sports” of lasso catheters, apparently). (The Mayo Clinic is famed not only for world-class care, but low cost, as well.) That did not work out so well.
The lasso catheter broke inside the patient having looped around part of his heart, resulting in an unplanned open heart surgery, “a porcine prosthesis” (more commonly known as a pig’s heart valve), and “various health problems” as a result of the surgery.
This week, U.S. District Court Judge Patrick J. Schiltz (D. Minn.) ruled on motions for summary judgment (brought by everyone), motions to exclude experts (brought by defendants), and a motion to add a claim for punitive damages (brought by plaintiff).
Summarizing the detailed 68-page opinion which should be required reading for anyone interested in medical device products liability, Judge Schiltz ruled in favor of Biosense, the original manufacturer, because it seems that plaintiff was unable to identify any actual problem with the catheter prior to its refurb. For the most part, Judge Schiltz ruled against “Play it Again”/Ascent although he did reject a punitive damages claim and some of the more creative theories of liability that plaintiff had levied against Ascent.
Inquiring readers may wonder why the Mayo Clinic itself and its physicians were not sued for using a medical device that specifically warned against reuse but courts have a way of focusing on the litigants and the claims before them. They tend not to cater to obvious questions of curious bystanders. (Sometimes courts cannot resist. Judges are human, after all (for the most part). When judges succumb to temptation, they call such detours “obiter dicta,” roughly translated as, “I really shouldn’t be saying this but….”. The Court stayed “on task” in this decision, however.)
Minnesota Litigator (“ML”) could speculate as to half a dozen possible explanations for why the Mayo Clinic and the surgeons were not named in this suit but will resist the temptation (and, no, the answer is not that the clinic and doctors “settled out” of this lawsuit). Comments from ML readers, particularly any with more expertise in this fairly specialized area of practice, however, are welcome.