Atrium Medical defeats contaminated-mesh claim

  • Jury reaches defense verdict in Chicago federal court
  • FDA had warned factory about verifying sterilization

A federal jury in Chicago has cleared Atrium Medical Corp. of liability in a lawsuit by a patient who had accused the company of supplying adulterated surgical mesh for his 2013 hernia-repair surgery.

Following a six-day trial before U.S. District Judge Mary Rowland, the jury heard closing arguments on Tuesday, deliberated and returned a defense verdict the same day.

Randy Africano, represented by James Benak of Tetzlaff Law Offices, sued New Hampshire-based Atrium Medical in 2017. He claimed the mesh used by his surgeon for the hernia-repair procedure was not sterile and had caused an infection. He developed a buildup of fluid at the surgical site and had corrective surgery in 2016, according to his complaint.

Africano alleged that the surgeon used a batch of Atrium’s ProLite mesh that was manufactured in April 2013 -- seven months after the U.S. Food and Drug Administration had warned the company of problems with its system of verifying sterilization at its New Hampshire factory, and one month before Atrium submitted its Sterilization Response Quality Plan to the FDA.

Atrium, represented by Dechert, said the fluid buildup was a seroma – a known surgical complication unrelated to the mesh. It also said there was no evidence the mesh was non-sterile when it left the factory, noting that there have been no other complaints of infection from the batch.

Attorneys for Africano and Atrium did not respond to requests for comment on Wednesday.

Rowland has given both sides until Nov. 16 to file post-judgment motions.

Atrium Medical, a unit of Getinge Group’s Maquet Cardiovascular subsidiary, sold off its bio-surgical business, including all mesh lines, to Hong Kong’s HJ Capital 1 in 2018. However, Atrium retains liability for mesh products it sold before the transfer.

Separately, Atrium is facing about 3,000 product liability lawsuits over its C-Qur hernia mesh-repair products, which have been coordinated for pretrial proceedings in multidistrict litigation in the U.S. District Court in New Hampshire. The MDL plaintiffs allege the components of the C-Qur mesh -- polypropylene plastic and an omega-3 fatty acid gel – were unsuitable for internal use.

Atrium has denied that its FDA-approved products were unreasonably dangerous for their intended use.

The case decided Tuesday is Africano et al v. Atrium Medical Corp., U.S. District Court for the Northern District of Illinois, No. 17-7238.

For Africano: James Benak of Tetzlaff Law Offices

For Atrium: Mark Cheffo and Emily Van Tuyl of Dechert

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