Boston Scientific prevails in defibrillator whistleblower case - Reuters

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• Judge finds company gave relevant information to the FDA
• Declines to rule on motions to exclude expert testimony
• Boston Scientific was earlier sanctioned for discovery violations

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(Reuters) - Boston Scientific Corp has won summary judgment against a long-running whistleblower lawsuit accusing it of selling defective implantable cardiac defibrillators.

U.S. District Judge Joan Ericksen in Minneapolis, Minnesota ruled Friday that she did not need to address dueling motions to exclude expert testimony from the company and whistleblower Steven Higgins, because no reasonable jury could find in favor of Higgins even if only his experts were allowed to testify.

Daniel Miller of Walden Macht & Haran, a lawyer for Higgins, did not immediately respond to a request for comment. Neither did Boston Scientific nor its attorney Frederick Robinson of Reed Smith.

Higgins, a doctor who served on a Boston Scientific advisory board, filed the lawsuit in 2011 under the False Claims Act, which allows whistleblowers to sue companies on the government's behalf to recover taxpayer money paid out based on false claims.

He alleged that Boston Scientific concealed from the U.S. Food and Drug Administration that the company's Cognis CRT-D and Teligen ICD defibrillator devices suffered from major defects while the agency was considering their approval. The devices use electrical leads to connect heart tissue to a pulse generator that can deliver a shock in the event of an abnormal heart rhythm.

Ericksen wrote Friday that Higgins' allegations failed to support his claim that the company concealed any relevant reports of adverse events linked to the devices.

For example, she said, Higgins alleged the company misclassified as electrical "noise" events showing problems with a part of the pulse generator, but the full details of these events were reported to the agency.

"No reasonable jury could find that the supposed misclassification or burying of these events constituted misrepresentations by omission," she wrote. "Because the events were reported, no reasonable juror could find they were omitted."

Because the FDA had the relevant information, Ericksen wrote, Higgins could not prove that Boston Scientific deceived the agency.

"The undisputed facts show that the FDA was sent the underlying data and, with that data fully in hand, approved the devices," she said.

The litigation was marked by a heated dispute over discovery. A magistrate judge in February 2020 sanctioned Boston Scientific for failing to disclose the identity of two potential witnesses and ordered it to pay fees in connection with the sanctions motion.

The case is U.S. ex rel Higgins v. Boston Scientific Corp, U.S. District Court, District of Minnesota, No. 11-cv-2453.

For Higgins: Daniel Miller and Jonathan DeSantis of Walden Macht & Haran and Joy Clairmont, Susan Thomas, William Ellerbe and E. Michelle Drake of Berger & Montague

For Boston Scientific: Frederick Robinson and Lesley Reynolds of Reed Smith

Read more:

Boston Scientific balks at fee request, saying sanctions motion didn't need 'army of lawyers'

Boston Scientific sanctioned again in defibrillator whistleblower case

Boston Scientific loses bid to dismiss defibrillator whistleblower case

Brendan Pierson

Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.

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