Prolift, from Sumsuro, Japan

Mesh Medical Device News Desk, May 18, 2019 ~ Mesh Medical Device News Desk,  The pelvic mesh trial of  Patricia Mesigian, 75 began in early April.

On Friday, more than one month later,  a Philadelphia jury awarded her $80.025 million as compensation for her Prolift mesh implant, made by Johnson & Johnson.

The verdict was delivered late Friday afternoon and includes $50 million in punitive damages.

Mesigian under went the implantation of a Prolift pelvic mesh in 2008. Prolift is one of J&J’s largest polypropylene mesh implants used to support falling pelvic organs. Ethicon is one medical device division of Johnson & Johnson.

It is also one of the most controversial because of the injuries it causes and mesh removal doctors say it is impossible to remove.

Mesigian experienced mesh erosion, chronic infection and inflammation, dyspareunia, chronic pain and scar tissue formation.  She had a removal surgery, but it failed to alleviate the symptoms.  It took the jury two days in the Philadelphia Court of Common Pleas to determine that the Prolift was defective and that the company failed to adequately warn doctors about the possible risks.

In April, Susan McFarland, another Pennsylvania woman, was awarded $120 million for her incontinence mesh implant.

J&J spokeswoman Mindy Tinsley says Ethicon’s Prolift device was properly designed. She added that the jury was not allowed to hear critical evidence related to the Food and Drug Administration and how it classifies mesh medical devices.

When Prolift entered the market to sell it was Class II (moderate risk) and did not require premarket clinical trials. However past trials ( Gross v. Ethicon) have shown that Ethicon did not even alert the FDA it planned to put Prolift on the market. Even though it was a novel design, precut, came in a kit with stainless steel trocar implanting devices, J&J decided the mesh itself was the same as its hernia mesh and bypassed federal regulators. It was only three years later (2008) when the company tried to have its next generation of Prolift (+M) approved that the FDA discovered Prolift was already being sold.  There were no sanctions imposed on J&J for the error.

As of mid 2016, pelvic organ prolapse (POP) mesh was reclassified as high risk or Class III and can no longer be sold in the U.S. unless and until it files premarket clinical trials, the strictest standard for safety and efficacy.

In mid 2102, J&J quietly removed Prolift from the market where it remains.

The company plans to appeal the verdicts.

The next case scheduled to be heard in the Philadelphia Court of Common Pleas is June 3, 2019  – is the case of Linda Dunfee v. Ethicon. She too was implanted with a J&J Prolift pelvic mesh.

There has been a steady stream of pelvic mesh cases tried in that venue since December 2015 that have yielded $346 million in verdicts for eight litigants.

The Philadelphia Court (here) currently has more than 80 pelvic mesh cases in line to be litigated against defendant, J&J.

Of the two defense verdicts, Atkins V. Ethicon (TVT-Secur)  was later reversed by the trial court.  The Legal Intelligencer  reports in that case, the judge determined the jury’s decision was inconsistent with the issue of whether the design defects caused her injuries. It is on its way to a damages hearing once it clears an appeal before the Pennsylvania Superior Court.

See Mesh News Desk, Mesh Trials so Far 

THIS STORY IS IN PRODUCTION! 

Earlier Story~ May 9, 2019 ~Mesigian Trial Underway.  The trial of Ms. Mesigian is currently underway in the Philadelphia Court of Common Pleas, which has seen a steady stream of plaintiff-friendly decisions amounting to hundreds of millions of dollars in this pelvic mesh litigation.

**Latest Update ** Expect a jury verdict sometime this week!  May 14, 2019*

The pelvic mesh case of Patricia and George Mesigian was filed in the Philadelphia court on February 5, 2014. Five years later, the Pennsylvania couple is currently having their day in court in this defective product case filed against Johnson & Johnson, its subsidiary Ethicon Women’s Health and Urology, Gynecare, and Secant medical, which sold mesh components. See Case ID: 140200399.

On or about September 25, 2008, Patricia Mesigian was implanted with a Gynecare Prolift during a surgical procedure by Dr. James Cosgrove at St. Francis Hospital in Wilmington, Delaware.  She underwent the surgery to correct incontinence and pelvic organ prolapse.

In July of 2009 and again in September of 2013, she had corrective surgery to revise and/or remove the Prolift by Dr. James Cosgrove and Dr. Jose Maceda at St. Francis Hospital in Wilmington, Delaware and Chester/Crozer Hospital in Upland, Pa.

According to the Complaint – The plaintiff has “suffered permanent injury, will require future corrective surger(ies) and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, not not limited to, obligations for medical services and expenses.”

Complications include irreversible injuries, dyspareunia, infection, mesh contraction, inflammation, scar tissue formation, organ perforation, pelvic floor damage, recurrent incontinence, and vaginal mesh erosion, says the Complaint.

The company knew of no way to remove the Prolift, even though it had a high failure rate and is one of the largest meshes in its family of products, yet it continued to mislead the medical community that their mesh were safe and effective, say lawyers for Mesigian.

Plaintiff law firm, Kline Specter has filed multiple counts – Negligence, failure to warn, defective manufacture and design, common law fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express warranty, breach of implied warranty, violation of consumer protection laws, gross negligence, and loss of consortium.

Mesigian is represented by Kila Baldwin, Charles Becker, Philip Pasquarello, Thomas Kline, and Michael Trunk, all of Kline Specter,
Butler Snow, Tucker Ellis, Drinker Biddle & Reath represent the defendant, J&J.

Judge Daniel Anders received the case April 25, 2019.


Limit Destruction of Document Evidence says Defendant 

Prolift, MedTech Marketing

Motions generally fly just before trial and that occurred in this case as well.

In a 109 page, April 1, 2019 filing, Reply of Defendant Ethicon and J&J Support of Defendants Motion in Limine  No 5 to Exclude Evidence of PL Allegations of Spoliation,  Ethicon calls evidence of the destruction of company documents in pending pelvic mesh litigation “highly prejudicial.”

That evidence is only allowed into court “where there is evidence of bad-faith destruction of materials that has interfered with an adversary’s ability to present his or her case.”

Ethicon wants the court to grant a motion in limine or limit and/or exclude any reference to allegations that Ethicon/ J&J destroyed documents that were on a pelvic mesh litigation hold, also known as spoliation.

Ethicon did not act willfully or intentionally, the defendant says.

In all, Ethicon destroyed more than 20,000 documents related to the development of the Prolift and other mesh devices, despite a preservation notice that was in effect for pelvic mesh litigation.

In the multidistrict litigation in West Virginia, Magistrate Judge Cheryl Eifert issued an 18-page opinion that rejected any sanctions based on spoliation, because the “evidence was negligent, not willful or deliberate.”

Ethicon claims that in September 24, 2009, a fire occurred inside the offsite facility destroying thousands of boxes including containing multi-center study research.  See Doc #1022-4 under 2:12-md-02327.

In a March 26 letter from attorney Michael Trunk to Judge Arnold New, the plaintiffs note that defendants have omitted numerous examples of the destruction of documents that were relevant to this litigation.

“Ethicon either at best failed to preserve or at worst, knowingly destroyed, portions of the custodial files of several highly ranked employees, each of which undoubtedly contained pertinent information regarding the design and development of Ethicon’s transvaginal mesh devices.”

For its part, Ethicon requested the court follow the rulings in Emmet, Adkins, Beltz, Engleman, Carlino and Blockus pelvic mesh cases.  Ethicon claims it had a procedure to review the legal files of departing employees and compare their electronic files against any Preservation Notices in effect,” according to James Mittenthal who worked for Ethicon.

However, due to “inadvertent oversight” electronic documents belonging to certain former employees that were subject to legal holds were not retained and neither were the hard drives. The motion blames the exiting employee who did not communicate to IT personnel that certain materials on the hard drive needed to be preserved.

On March 26, 2019 the Defendants Motion to exclude evidence of Spoliation was denied by Judge Arnold New.

The case of Dunfee v Ethicon is next in line in the Philadelphia court that has been seeing a steady stream of pelvic mesh cases tried since December 2015 that have yielded $266 million in verdicts for litigants.

Among those was the Emmett Prolift trial that concluded in January of this year where the jury reached a verdict of $41 million for the plaintiff.

 

 LEARN MORE:

J of ACOG August 2010,  Prolift 15.6% vaginal mesh erosion rate

MND, December 8, 2013, What was lost in Purge of J&J Documents 

MND, May 6, 2019, Pelvic Mesh Trials so Far

PTO # 100 Magistrate Cheryl Eifert on Document Destruction,   Doc #1069, Feb 4, 2014