A Minnesota federal judge dismissed 4 of the 5 claims in a trio of lawsuits brought against St. Jude Medical (NYSE:STJ) over its recalled Riata defibrillator leads, ruling them preempted by federal statute.
Richard Pinsonneault, Joseph Houlette and Gary Rouse sued St. Jude over the Riata leads, alleging that the St. Paul, Minn.-based company (1) failed to manufacture the leads with uniform insulation thickness; (2) failed to 2 apply a controlled, uniform degree of force when crimping the lead wires; (3) failed to comply with approved methods and specifications for curing; (4) failed to consistently apply a lubricious interface between the inner and outer insulation; and (5) failed to comply with approved methods and specifications for sterilizing, according to court documents.
St. Jude asked Judge Patrick Schiltz of the U.S. District Court for Minnesota to dismiss the case, arguing that the claims are preempted by federal law because the FDA approved the Riata leads under its pre-market approval program. Schiltz agreed on all but 1 of the claims, dismissing the other 4, according to the documents.
"With respect to the 5th alleged defect – failure to comply with approved methods and specifications for sterilizing the leads – St. Jude admits that the PMA requires the Riata leads to be sterilized in a particular manner, but contends that the leads were in fact sterilized in that manner. The court agrees with plaintiffs, however, that this issue goes to the merits of plaintiffs’ claims rather than to the issue of preemption and is therefore beyond the scope of this motion. For that reason, St. Jude’s summary-judgment motion is denied without prejudice insofar as that motion pertains to plaintiffs’ sterilization claims," Schiltz wrote.
But the ruling came with a caveat from Schiltz.
"Needless to say, unless plaintiffs obtain evidence that what St. Jude says is untrue – i.e., evidence that St. Jude did not, in fact, sterilize the leads in the manner required by the PMA – plaintiffs should voluntarily withdraw their sterilization claims and not require St. Jude to bring (and this Court to rule on) another summary-judgment motion," he wrote.
