Preemption Motion Granted in Part in St. Jude Riata Lead Lawsuits

A federal judge in Minnesota has dismissed four out of five claims raised in a group of product liability lawsuits over St. Judge Riata defibrillator leads, finding that various allegations involving manufacturing defects are preempted by federal law.

St. Jude Riata leads are small wires used to connect implantable cardiac defibrillators (ICDs) to the heart, designed to monitor the heart’s rhythm’s and provide an electrical jolt if needed.

After about 227,000 of the lead wires were sold worldwide, the manufacturer acknowledged that problems with the St. Jude Riata may cause the insulation surrounding the wire may decay and erode, leaving exposed wires inside patients. This has caused many users to experience unnecessary shocks or for the defibrillator to fail when it was needed to deliver a life-saving jolt.

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In late 2010, St. Jude removed the leads from the market amid reports of insulation failure, and a warning letter was sent to doctors about the risk of problems in late 2011, which the FDA classified as a St. Jude Riata recall.

It is estimated that nearly 80,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is risky and doctors often recommend keeping the defective lead in place unless there is evidence that it has failed.

Over the few years, a growing number of St. Jude Riata lawsuits have been filed on behalf of individuals nationwide, alleging that the defibrillator leads were not manufactured in accordance with FDA approved standards, containing various defects that resulted in an unreasonable risk for patients.

In an order (PDF) issued June 24, U.S. District Judge Patrick Schiltz in the District of Minnesota dismissed most of the claims brought in a group of three lawsuits, finding that because the medical device was approved by the FDA under its pre-market approval program, the claims were pre-empted by federal law.

Plaintiffs in these lawsuits presented claims for (a) failing to manufacture the St. Jude Riata leads with uniform insulation thickness; (b) failing to apply controlled and uniform force when “crimping the lead wires”; (c) failing to follow the approved methods and specifications for curing the leads; (d) failing to consistently apply lubricous interface between the inner and outer insulation; and (e) failing to comply with approved methods and specifications for sterilization.

All of the claims were dismissed, except for the allegations relating to the sterilization methods. Judge Schiltz found that this issue goes to the merits of the plaintiffs’ claims, and therefore denied St. Jude’s motion for summary judgment on the basis of pre-emption. However, Judge Schiltz indicated that the plaintiffs must show evidence to support the claim about sterilization problems or they should withdraw the lawsuits.

The decision highlights the conflicting rulings being handed down in various St. Jude Riata lead lawsuits pending throughout the country, as a federal judge in California allowed five claims to proceed forward in January, finding that they were not pre-empted based on allegations that St. Jude violated FDA regulations and approved manufacturing processes.

Neither decision is binding for cases pending in other federal districts or at the state level.


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