Its Guidant Corp. subsidiary delivered a rare bit of good news for Boston Scientific Corp. (NYSE:BSX), after a federal judge in California once again tossed a would-be class-action lawsuit over recalled Guidant pacemakers.
Judge Manual Real of the U.S. District Court for Central California granted a Guidant motion to dismiss the case, ruling that “all plaintiff’s state law claims are preempted by federal law,” according to court documents.
The U.S. Supreme Court ruled in Riegel vs. Medtronic (2008) 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, provided that the device was cleared via the more-rigorous pre-market approval process rather than via the 510(k) predicate device protocol.
Lead plaintiff Theodore Cohen was implanted with Guidant’s Insignia Plus DR Model 1298, a Class III medical device that was approved “under the equivalent of” the PMA process, according to the documents.
It’s the second time Real has tossed the suit. In November 2010 the judge granted Guidant’s first motion to dismiss, but gave Cohen et al a chance to amend their complaint. Guidant moved for another dismissal the next month.
Real also found that the amended complaint was just as flawed as the first, because it failed to link any defect in the Insignia device with specific FDA regulations. Cohen, whose pacemaker is still functioning, also failed to prove that the device is defective, the judge wrote.
“Plaintiff has not provided any factual support in his complaint that there is a defect in his pacemaker, much less that a defect occurred as a result of defendant’s violation of FDA regulations related to his device,” he wrote. “Plaintiff’s pacemaker was implanted in 2004 and has not failed. Even if plaintiff were able to plead adequately a defect in his device that resulted from defendants’ violation of FDA requirements, plaintiff has suffered no harm.”
The decision follows the resolution of another Guidant case that didn’t end so well for Boston Scientific. Another federal judge in Minnesota last month added three years of probation to a $296 million plea deal between Guidant and the U.S. Justice Dept.