Ethicon discovery

Mesh Medical Device News Desk, August 23, 2017 ~ The trial of Ella Ebaugh got underway earlier this month and the pelvic mesh case is close to going to the jury.

Ebaugh, 51, was implanted with two pelvic meshes made by the defendant Ethicon, (Johnson & Johnson) – the TVT-SECUR and the TVT (tension-free vaginal tape).

The case is the latest and the sixth pelvic mesh product liability case to be heard before jurors in the Philadelphia Court of Common Pleas, which has been a favorable venue to plaintiffs in the past.

Johnson & Johnson has not had a good week.

It began with a record $417 million verdict in the plaintiffs’ favor in a talcum powder-ovarian cancer case in California. See the Mesh News Desk story here.

J&J vows to appeal, despite the fact that the plaintiff, Eva Echeverria, is suffering end stage ovarian cancer.

Now another case is getting close to being wrapped up, this one a pelvic mesh defective product case.

Ebaugh v Ethicon, Case # 130700866 is being held in the same Philadelphia court that has seen five of six juries delivering compensatory damages to the mesh-injured plaintiffs.

Mesh News Desk has transcripts from inside the courtroom and will deliver a series of reports leading up to the verdict, which could come as early as next week.

Philadelphia Court of Common Pleas

 

THE PLAINTIFF

Ebaugh, photo contest entry, York, PA

Ms Ella Ebaugh, and her husband, Marvin, live in Pennsylvania. By age 39, she had delivered five children vaginally and was experiencing incontinence.

She had a TVT- Secur sling made by Ethicon (J&J) implanted on May 31, 2007, at Apple Hill Surgical Center in York PA by Paul Douglass, MD.  He reasoned since she was so young and had a very active lifestyle, it was the most minimally-invasive procedure that would allow her to get back playing sports, like softball, with her children.

Dr. Douglass retired in 2011, but not before he implanted close to one hundred TVT products, according to the defense.

Ms. Ebaugh had to have corrective surgery because of a mid-urethral erosion on July 12, 2007.  At that time, she was implanted with another mesh, a TVT.

On June 14, 2011, she had a corrective surgery, due to mesh complications, done by Howard Mirsky, MD at York Hospital in Pennsylvania. On March 14, 2102 she had her fourth surgery, and third corrective procedure, at the University of Maryland Medical Center with surgeon, Dr. Toby Chai.

Dr. Chai did an ultrascope and thought mesh was in her bladder. He didn’t find any but removed a few strands of mesh from the urethra. Finally, in 2016, a Dr. Wright did surgery to remove more mesh because she was still experiencing complications.

The Ebaugh trail began July 31 in the Philadelphia Court of Common Pleas where there have been four victories and one partial victory for mesh-injured women.

The action alleges design defect, negligence on the park of J&J, product liability. It does not include a failure to warn. (*Correction from earlier post).

Dr. Tom Margolis, female pelvic surgeon , expert for PL

Some of the experts we’ve seen in previous pelvic mesh trials will appear here as well – M. Tom Margolis, MD, Dr. Bruce Rozenzweig, MD, Dr. Uwe Klinge, MD,  Peggy Pence, Vladimir Iakovlev, Chevron MSDS, and Daniel Elliott, MD.

J&J wanted allegations of spoliation  (destruction of documents by J&J) out of the trial and Judge Michael Erdos agreed.

The judge also ordered plaintiffs not to introduce evidence that the IFU (instructions for use) was defective, however, they may introduce evidence related to the IFU – its risks and warnings in general. The plaintiffs may not introduce evidence of a “David and Goliath” argument, however plaintiffs may introduce evidence of the defendant’s sales figures and profit motive.

Lawyers for the defense include Melissa Merck of Drinker Biddle & Reath LLP, Philadelphia;  Kat Gallagher and W. Curt Webb of Beck Redden, Houston, TX.; Phillip Combs and Daniel Higginbotham of Thomas Combs and Spann, Charleston WV;  Julie Callsen of Tucker Ellis, Cleveland; Jordan Walker of Butler Snow.

Kila Baldwin, Kline Specter

Lawyers for Ms. Ebaugh include Lee Balefsky, Kila Baldwin, who delivered the opening to jurors, Christopher Gomez and Tracie Palmer of Kline & Specter, Philadelphia.

The jury is made up of all African Americans, six female and six males, mostly middle-aged.

 

Plaintiffs’ Open

On August 4, Ms. Ebaugh’s attorney Kila Baldwin delivered her opening statement to the 12 jurors.

Judge Erdos reminded the jurors that the plaintiffs have the burden of proof based on the credibility, truthfulness, accuracy and weight of the testimony and other evidence. The jurors were instructed not to talk about the case, even to each other and even in a casual setting, and not to do any independent research, including an Internet search.

Jurors are allowed to take notes during the proceedings, but not the opening or closing statements, however, they cannot take the notes out of the courtroom.

Friday afternoon, Ms. Baldwin reminded the jurors the TVT-Secur was sold only from 2006 until 2012 when it was removed from the market. The TVT is still sold. See the 510(k) approval to sell clearance by the FDA here.

“These defective products have literally mangled Ella Ebaugh’s urethra,” said Ms. Baldwin.  Pain, incontinence will cause her to suffer with this for the rest of her life.

Ethicon is a company worth $70,418,000, said Baldwin, while Ethicon is worth $2,762,000, she said.  This defendant makes decisions with money in mind. She showed a logo from “Ethicon’s Women’s Health and Urology. Show me the money,” internal documents from the marketing department in 2007.

“This is what Ethicon was concerned about when it marketed its TVT line of products, which includes the two that are at issue in this case.

In the case of TVT-S they never tested it in humans in a robust study before the y put it on the market.   In the case of TVT, they paid for the results and never verified the underlying data, said Baldwin.

“Ella Ebaugh is a casualty of the reckless conduct.”

Ethicon produced a different mesh with larger pores that didn’t cause scar plate formation. Ultrapro is made of half polypropylene and half Monocryl, absorbable mesh. Its larger pore size avoids scar plate formation and bridging fibrosis, a larger solid scar plate that causes mesh to shrink.

Ethicon has another mesh with medium sized pores, Dynamesh, which was also never used in the TVT line of products.

Scar plate formation is the first indication the mesh is defective, chronic inflammation is the second defect, said Baldwin. Inflammation is the body’s reaction to a foreign body, in this case the Prolene plastic that is not inert. The reaction does not fade over time. This chronic foreign body response is also known as giant cell reaction which comes with more mesh in the body as compared to a tiny suture, jurors were told.

Erosion, mesh migration are also indication the mesh is defective. Ebaugh had three erosions with five perforations to her urethra. The jurors are shown blue inside her urethra along with calcium deposits.

TVT SEcur from Russian website

The TVT-S also has felt tips to hold it in place. They aren’t working, said Baldwin. The mesh migrates around the body and can easily get out of place increasing the risk of erosion.  TVT-S is a laser cut mesh, which is three time as rigid as mechanical cut mesh, making it more likely to erode.

Before mesh there was a Burch procedure, using stitches to hold up the vagina and support the urethra.  There is another surgical option, the MMK procedure using animal tissues a porcine graft or a cadaver tissue or tissues from your own body to provide a sling support. If they don’t work there are almost no long-term problems, she said.

TVT, TVT-S 

TVT was launched after Ethicon bought the device for $24 million, paid to developer to Ulf Ulmsten, MD, whose name has been mentioned in many of these product liability mesh trials.  That was 1996. By 2004, the TVT was worth $100 million to the company, or 91% profit.

It was a good investment, Baldwin said.

TVT-S was developed by Dan Smith, an Ethicon engineer, in order for Ethicon not to lose market share with its competitors.

It couldn’t be tested before marketing because of budget constraints. What was done on the TVT-S was five weeks of randomized control trial on 31 women.  The results were never published, Baldwin said, in thirty percent of the women, it failed within five weeks.  Ethicon launched the product anyway.

An executive at Ethicon in Germany said “The more procedures, the more problems” referring to TVT-S. The TVT-S validation studies are referred to as a big steaming pile of dot, dot dot, said internal Ethicon documents. Another says TVT-S is “pretty awful.”

“How can we spin it?” referring to the data…”How can we jazz it up?” says another exhibit.

TVT-S was pulled from the market in Australia in 2006 by the Ethicon medical director, Aran Maree, MD, but it continued to be sold in the U.S. until mid 2012.

Key opinion leader Dr. Vincent Lucente, who was paid more than $2 million by Ethicon, had a horrible failure rate, 60% with TVT-S, but that data was never published, the jurors were told.

Dr. Paul Douglass, implanted Ebaugh

When the TVT-S didn’t work, put in another mesh right on top, recommended the company.

Dr. Douglass, who implanted Ms. Ebaugh, is quoted as saying, ‘Yeah, I like the TVT, I like to do it in outpatient centers because that way I could put more products in in one day.”

Ethicon/ Johnson & Johnson had an $800 million prelaunch marketing budget for the TVT-S, some of that money going to pay key opinion leaders such as Lucente, and to sponsor industry events such as AUGS, the American Urogynecologic Society; the Society of Urodynamics; Female Pelvic Medicine; and Urogenital Reconstruction.

Ebaugh today has a mangled urethra, covered in scar tissue near the opening and middle. She has almost no control and has been diagnosed with Intrinsic Sphincter Deficiency, which includes uncontrolled spasms of the bladder.

She cannot get a good night’s sleep because she has to urinate during the night.  She’s a prisoner of her house now.

“What she wants is a normal life.” ###