Medtronic Fights Pain Pump Claims in the 9th

     SAN FRANCISCO (CN) – A lawyer urged the en banc 9th Circuit to revive claims against Medtronic over a pain pump that allegedly paralyzed his client.
     Richard Stengel and his wife, Mary, sued Medtronic in Arizona state court after the pain pump he had surgically implanted in his abdomen caused inflammation that led to paralysis.
     The original suit brought claims of negligence, breach of warranty and product liability. The Stengels also sought to include a new theory that Medtronic caused Stengel’s paralysis not reporting defects to the Food and Drug Administration, as required by federal regulations.
     After affirming dismissal of the action, the 9th Circuit granted a rehearing.
     Tom Cotter, the Stengels’ attorney, emphasized the new claims at the hearing Wednesday.
     “Medtronic failed to provide an educational brief it created to the FDA,” Cotter said.
     An FDA audit of the Medtronic plant uncovered at least 37 problems with the pump that had previously eluded the FDA.
     If Medtronic had communicated better with the federal agency, doctors would have been warned before Stengel’s inflammation progressed, Cotter argued.
     “If what should have occurred had occurred, an earlier warning would have gone out,” he said.
     Chief Judge Alex Kozinski interrupted with a grammar gripe.
     “Would have gone out from where?” Kozinski asked. “You speak in passives, passives are always so annoying. Who would have issued the warning?”
     “Medtronic,” Cotter said. “Here, what happened is that they were required, as soon as their violation were discovered, they were required to do it. If those reports had gone out as soon as they should have, they would have been required earlier.”
     Medtronic attorney Michael Brown countered: “Each of the causes of action are expressly pre-empted. At the end of the day what they’re asking is that there be a warning that is different from or addition to the federally mandated warning.”
     Kozinski challenged this argument.
     “I don’t think so,” he said. “I didn’t hear that. Their claim is that your client should have notified the FDA sooner of these problems. And, had they done that, word would have gotten out, either by osmosis or by the FDA taking steps to advise them to warn. That’s the claim, not that they had to anything more than the FDA required but that they had to do it sooner.”
     Brown also said that the Stengels failed to skirt pre-emption since they failed to bring an established state-law claim that is “genuinely equivalent or identical” to federal law.

%d bloggers like this: