The U.S. Supreme Court won’t consider a case involving injuries allegedly caused by a Boston Scientific Corp. (NYSE:BSX) subsidiary’s medical device.
The court on Monday effectively ended Michael McGuan’s and Lillian Johnson’s lawsuit against Guidant Corp. over its Ancure Endograft system, on grounds that the state laws underpinning the plaintiff’s suit are preempted by the Medical Device Amendments of 1976.
McGuan and Johnson appealed a ruling from the California Sixth Appellate District Court in which Judge Franklin Elia ruled that the plaintiffs are not entitled to punitive damages against Boston Scientific, which acquired Guidant in 2006. An appeals court concurred with the finding that the Food & Drug Administration’s pre-market approval of the Ancure device preempts state laws on medical device company liability, according to court documents.
The decision relied on the Supremes’ February 2008 decision in Riegel v. Medtronic (PDF), which noted that a clause in the MDA “bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration.”
McGuan and Johnson were implanted in 2002 with the Ancure device, at the time manufactured by Endovascular Technologies Inc. In 2004 McGuan (and Johnson in 2005) sued the company and then-parent Guidant, alleging that the abdominal aortic aneurysm treatment device caused severe injury. Guidant had recalled the device in March 2001, but it was re-approved by the FDA in August 2001, according to court documents.
Although the plaintiffs’ complaints were partly based on alleged defects in the design, testing, and manufacture of the Ancure device and Guidant’s failure to warn of all possible side effects, they did not allege that the company violated FDA regulations, according to court documents.
"Since the FDA re-approved the Ancure device prior to plaintiffs’ surgeries," Elia wrote, "the FDA gave its approval of the device’s design, testing, intended use, manufacturing methods, performance standards, and labeling. Thus, to the extent that plaintiffs’ complaints allege that the Ancure Device was unsafe and its warnings were inadequate, they are seeking to impose requirements that are ‘different from, or in addition to’ the MDA."
The FDA also approved the defendants’ warnings on the device after the recall, thereby pre-empting McGuan’s concealment fraud allegations in the suit. Johnson’s allegations of fraud were thrown out on the basis that states are not responsible for policing federal agencies such as the FDA, according to court documents.