St. Jude to Face Products Claim Over Allegedly Faulty Medical Device

A Delaware federal magistrate judge ruled last week that St. Jude Medical Inc. must defend part of a products liability suit claiming the Minnesota-based medical device maker had negligently manufactured a spinal cord stimulator that was implanted in a Maryland woman.

The ruling, from U.S. Magistrate Judge Christopher J. Burke, jettisoned claims by Kathleen M. Freed that St. Jude had failed to live up public guarantees regarding the safety of its spinal cord simulator, which was surgically implanted in her during a procedure at Newark's Christiana Hospital in 2014. Though the procedure was intended to be permanent, Freed said she had the device removed less than one year later, after complaining that it had caused painful electric shocks and burning.

However, Burke said that Freed's revised complaint had laid out an initial case that the device was dangerous, and granted the Freed one more chance to show that St. Jude failed to warn her and her doctors of the risks associated with its product.

The 33-page memorandum opinion, issued Feb. 1, followed another judge's decision in 2017 to dismiss the suit without prejudice, finding that their state-law claims had been pre-empted by federal law.

According to court documents, medical products like St. Jude's spinal cord simulator undergo a rigorous federal oversight and pre-market approval process, which typically protect device-makers from having to face state claims in addition to those arising under federal law.

David G. Culley, an attorney for Freed and her husband, argued that their claims ran parallel to the federal statutes because Delaware law imposed additional requirements on the company regarding the "safety and effectiveness" of the device.

In the amended complaint, he said the defect was linked specifically to the neurostimulator and battery components, which had been implanted in his client's left buttocks, alleging that St. Jude had been forced to recall similar products in the past.

Burke said the changes were enough to support Freed's claim that the spinal cord stimulator was manufactured in violation of industry and regulatory standards, addressing a key concern raised earlier in the case.

"They now include allegations that can be fairly read to assert that the battery component of the spinal cord stimulator device (by itself, or in conjunction with the neurostimulator) was adulterated or defective," Burke said, adding that the revised complaint had helped "the reader draw reasonable inferences that these particular components of the device were adulterated due to federal violations."

While Burke dismissed three counts for various alleged breaches of warranty for pre-emption, he did provide Culley one more chance to plead a claim on behalf of his client for failure to warn.

The key issue there, he said, was "why it is plausible" that St. Jude's alleged failure to report problems with its product would have reached Freed and her doctors, thus impacting their decision to go forward with the surgery. St. Jude had argued for the claim to be dismissed without prejudice; however, Burke said the issue had not been previously addressed in the case and gave Freed and her husband "one final opportunity to amend their failure to warn claim in this regard."

Culley, a director with Tybout, Redfearn & Pell in Wilmington, was not immediately available to comment, and an attorney for St. Jude did not return a call Monday afternoon seeking comment on the ruling.

St. Jude is represented by Brian M. Rostocki and Benjamin P. Chapple of Reed Smith's Wilmington office and partners J. David Bickham and Lisa M. Baird in the firm's San Francisco and Miami offices.

The case is captioned Freed v. St. Jude Medical.