Prolift, from Sumsuro, Japan
Mesh Medical Device News Desk, September 5, 2018 ~ The Philadelphia Court of Common Pleas has been a problem venue for Johnson & Johnson in its pelvic mesh litigation. So far, the device maker has won just one pelvic mesh product liability case with one hundred more to be heard.
The basis for the latest appeal is venue, but that too has not been successful for the healthcare giant.
Johnson & Johnson wanted another bite of the apple.
A Pennsylvania appeals court has denied Ethicon’s request for an enbanc rehearing (typically with a panel of three judges), on issues raised in a June appeals court decision. Ethicon, a division of J&J, had wanted a rehearing on jurisdiction, statute of limitations, and on causation.
In December 2015, Hammons was awarded $12.85 million, which included $7 million in punitive damages due to the injuries she suffered from the Prolift pelvic mesh device, which was implanted with in 2009.
Ethicon, argued that the Indiana woman’s case should never have been heard in Pennsylvania claiming it was the wrong jurisdiction for Hammons to bring a civil lawsuit.
In an 82-page decision, filed June 19, 2018, Superior Court Judge Victor P. Stabile told the company to pay the damages.
Hammons was represented by Shanin Specter of Kline Specter, a Philadelphia law firm.
Her complaint, filed in May 2013, included not just Ethicon, but Secant Medical and Secant Medical LLC, a manufacturer of surgical mesh located in Perkasie, Pennsylvania, lending credence to Pennsylvania as the proper venue for this civil action.
In November 2015, the trial court granted summary judgment to Ethicon on the manufacturing defect claim, saying there was no evidence that Prolift deviated from its intended design.
That left a design defect and failure-to-warn claim, which the plaintiffs proved at trial.
Dr. Daniel Elliott, Mayo Clinic Urology, Rochester MN
At trial, Dr. Daniel Elliott was an expert witness who testified that the Prolift mesh contains too much suture for implantation through the vaginal wall and approximately 260 yards of a plastic material foreign to the body. The mesh is over-engineered, too heavy and dense, with small pores to perform as intended, he said.
Dr. Uwe Klinge, mesh expert for Plaintiff
Dr. Uwe Klinge, M.D. testified Ethicon should have used a mesh with pores larger than three millimeters. He said the the Prolift pores collapse with any movement of the pelvic region. Dr. Elliott testified that mesh causes a chronic foreign body reaction and inflammatory response and Prolift does so in direct proportion to the large amount of plastic used.
The inflammmatory response and scar formation bridge the mesh, making it contract and become rigid. When that happens, it can erode layers of vaginal tissue and neighboring organs, can expose in the vagina in an open wound, and damage the bladder, intestines and other organs. Pulling or contracting mesh causes pelvic floor muscle spasms and chronic muscle pain.
Dr. Anne Weber, from Linda Gross trial.
At trial, Drs. Anne Weber and Elliott concluded the Prolift is unsafe.
Ethicon argued that Pennsylvania is not the correct jurisdiction because Ms Hammons is from Indiana and J&J or Ethicon have no business in Pennsylvania.
This is important because of a U.S. Supreme Court decision in 2017. Bristol-Myers Squibb v. Superior Court of California held that non-residents could not bring an action against a non-resident drug manufacturer unless they were prescribed the drug in that state, lived there, or purchased the drug there.
In Bristol- Myers, the decision to contract with a California company to distribute Plavix, did not provide enough basis for personal jurisdiction. The intended outcome of the decision was to prevent "judge shopping" for a favorable jurisdiction.
Ethicon was hoping Bristol-Myers might knock Ms. Hammons out of court, however there was enough evidence presented the Pennsylvania was the the home of at least some of Ethicon's businesses.
Ethicon supervised the manufacturing and design in Pennsylvania with Secant Medical of Bucks County, providing the polypropylene filament to Secant and material specifications for the weaving of the mesh as well as specs on the elasticity, mass, and density of the mesh.
E-mails showed the company communicated repeatedly and Ethicon employees and visited Secant’s plant in Pennsylvania to observe the mesh-making process.
Ethicon worked closely with Dr. Vincent Lucente, M.D. from Allentown, Pennsylvania, in developing Prolift. He was retained as an investigator for three clinical studies, funded by Ethicon on Prolift (Gynemesh PS study of Prolift mesh materials, the US TVM study of Prolift prototype, and Lucente IIS study).
Additionally, Lucente was consulted on marketing and development strategy for Prolift including lifting the word “experimental” from an American College of Obstetricians and Gynecologists publication, opening up the way for insurance coverage, according to trial testimony.
For his work, Ethicon paid Dr. Lucente more than $1.7 million.
Dr. Lucente, preceptor for Ethicon
Interestingly, according to the appeals court document, Dr. Lucente “advised it would be a “disaster” for women to need revision surgery with Prolift.”
All of those factors supported the exercise of specific jurisdiction over Ethicon in Pennsylvania, writes Judge Stabile in June.
In July, Ethicon requested the Superior Court consolidate Hammons with the Carlino case ($13.5 million) to hear arguments about jurisdiction following the Bristol-Myers decision. The application (here) was denied.
At this writing, McFarland v Ethicon is underway in the Philadelphia Court of Common Pleas, while Emmett v Ethicon is due to go to trial in the same court, November 19, 2018.
Ironically, Johnson & Johnson has been accused of “judge shopping” by asking Philadelphia Judge Kenneth J. Powell to recuse himself from the Perigo trial in August. The healthcare giant also sought to have the Hammons’ verdict assigned to a different appeals court panel.
In a Motion (here) filed in July, J&J attorney, Joseph O’Neil (Lavin, O’Neil, Cedrone & Disipio), argued that Judge Powell’s mother is a plaintiff in a lawsuit against Johnson & Johnson in a mass tort action over an allegedly defective product, which goes unnamed. A judge is supposed to act “at all times in a manner that promotes public confidence in the independence, integrity, and impartiality of the judiciary, and shall avoid impropriety and the appearance of impropriety,” according to the Code of Judicial Conduct Rule 1.2
“Your honor’s mother’s case against Johnson & Johnson companies implicates issues that could very well arise in the current litigation,” writes attorney O’Neil.
Shanin Specter filed a response saying Ethicon “appears to be judge shopping.” Judge New did not respond when it was brought to his attention earlier in the year, according to law.com.
Judge Powell denied the recusal request. The Perigo trial, which was set to begin August 27, settled prior to the start of trial.
June 19, 2018, Judge V. Stabile responds to Ethicon appeal (here)
MND, June 20, 2018 Hammons Prolift Case $12.8 Million verdict Upheld (here)
MND, December 22, 2015, Philadelphia Prolift Mesh Case Yields $12.5 Million Verdict for Plaintiff (here)