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RICHMOND, Va. — (Mealey’s) The Fourth Circuit U.S. Court of Appeals on March 2 affirmed a directed defense verdict last year in the first Ethicon pelvic mesh multidistrict litigation trial (Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 14-1244, 4th Cir.).
(Opinion available. Document #28-150305-017Z.)
In 2009, Carolyn Lewis was diagnosed with stress urinary incontinence. Her urogynecologist, Dr. Muriel Boreham, implanted a TVT pelvic mesh device made by the Ethicon division of Johnson & Johnson.
Lewis later complained of pain during sexual activity and intermittent pelvic pain during daily activities. In 2013, urologist Dr. Philippe Zimmern surgically removed parts of the TVT device.
Lewis said that after the partial removal, her pain noticeably decreased but she was still not “one hundred percent.”
Summary Judgment On Warning
In 2012, Lewis sued Johnson & Johnson and Ethicon in the U.S. District Court for the Northern District of Texas. Her case was transferred into the Ethicon pelvic mesh MDL in the U.S. District Court for the Southern District of West Virginia.
In 2013, the defendants moved for summary judgment on Lewis’ failure-to-warn claim. In 2014, the case went to trial on the remaining claim of design defect.
Prior to trial, Judge Joseph R. Goodwin granted summary judgment on the failure-to-warn claim. During trial, the judge excluded some expert causation testimony and granted a directed verdict on the design defect claim, finding that the defect did not cause Lewis’ injury.
Lewis appealed the summary judgment and directed verdict.
No Reliance On Warnings
In a per curiam decision, the Fourth Circuit panel affirmed summary judgment, agreeing that Lewis did not establish through Boreham’s testimony that Boreham considered or relied on a warning in a TVT brochure cited by Lewis. Neither did the plaintiff establish that Boreham relied on the TVT instructions, it added.
Instead, the panel said Boreham relied on Lewis’ symptoms in deciding to use the TVT.
“When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury,” the panel wrote. It said the fact that Boreham at one time read the instructions for use of the TVT is no rebuttal evidence that the doctor subsequently relied on the instructions in deciding to prescribe the device to Lewis.
The panel agreed with the District Court that Lewis did not offer sufficient evidence to create a dispute of material fact regarding whether a different warning would have changed Boreham’s prescribing decision.
Properly Limited Expert
Lewis also appealed the District Court’s exclusion of parts of Dr. Uwe Klinge’s expert testimony. Klinge was allowed to testify about the general characteristics of mesh samples explanted from Lewis, but Judge Goodwin concluded that Klinge was not qualified to offer testimony about specific causation.
The appeals panel said Judge Goodwin did not abuse his discretion because Klinge was a specialist in hernia surgery, not pathology or stress urinary incontinence. The court said Klinge did not treat Lewis and never performed surgery to treat stress urinary incontinence.
“The district court was clearly within its discretion in concluding that Dr. Klinge’s opinions regarding Lewis’s pain and mesh explant were beyond his expertise, and so did not abuse its discretion in excluding those portions of Dr. Klinge’s testimony,” the panel wrote.
5 Experts, No Causal Link
As to the directed verdict, the panel agreed “that Texas law required Lewis to present expert testimony establishing a causal link between these alleged defects in the TVT and her injuries.”
The panel also agreed with the District Court that Lewis failed to present expert causation testimony despite having five experts testify. “Not one of Lewis’s expert witnesses opined, let alone opined to a reasonable degree of medical certainty, that a defect in the TVT caused Lewis’s injuries,” the panel wrote.
The experts included Dr. Bruce Alan Rosenzweig, Bernd Klosterhalfen, Howard Jordi, Zimmern and Klinge.
“Lewis does not argue that the remaining testimony — by, for instance, employees of the defendant — establishes causation,” the panel concluded. “Thus, because Lewis failed to proffer any expert testimony that a defect in the TVT caused her pelvic pain, the district court did not err in directing a verdict for Ethicon.”
The Lewis panel consisted of Senior Circuit Judge Andrew M. Davis and Circuit Judges Diana Gribben Mota and Albert Diaz.
Defendants 2-2 In Trials
The defendants have won two directed verdicts in four pelvic mesh trials. In addition to Lewis, the defendants said that a directed verdict in a New Jersey state court trial in January resulted in that case being resolved. The New Jersey case involved an Ethicon Prolift pelvic mesh.
In the second MDL trial involving the TVT device, a plaintiff was awarded $3.27 million. In April, a Texas state court jury awarded $1.2 million in a TVT case.
A California state court jury on March 2 began deliberating in an Ethicon TVT Abbrevo case.
Some Devices Off Market
In 2012, Johnson & Johnson said it would stop selling the Gynecare Prosima, Gynecare Prolift, Gynecare PROLIFT + M, Gynemesh M and Gynecare TVT Secur pelvic mesh due to a lack of their commercial viability.
As of Feb. 17, the Judicial Panel on Multidistrict Litigation said there were 23,523 Ethicon cases pending the MDL.
Lewis is represented by Adam S. Davis of Wagstaff & Cartmell in Kansas City, Mo., and Julie L. Rhoades of Matthews & Associates in Houston.
The defendants are represented by David B. Thomas and Philip J. Combs of Tomas, Combs & Spann in Charleston, W. Va.; Charles C. Lifland of O’Melveny & Myers in Los Angeles; Stephen D. Brody and David K. Roberts of O’Melveny & Myers in Washington, D.C.; and Christy D. Jones of Butler Snow in Ridgeland, Miss.
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