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ethicon 2/27
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REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF ’98
Feb 26, 2015 | Mesh Medical Device News Desk
By Jane Akre
We trust that it is our right as United States Citizens to assume the safety of materials used in devices such as the fibers in Essure permanent birth control and Transvaginal Mesh procedures -
Doctors Refute Ms. Perry’s Mesh Injury Claims
Feb 26, 2015 | Mesh Mesdical Device News Desk
By Jane Akre
Medical doctors who treated or examined Ms. Coleen Perry, the plaintiff in Perry v. Ethicon, (1:13-cv-00729-AWI-JLT), took the stand to testify in the fifth week of her trial against Ethicon, a Johnson & Johnson (J&J) subsidiary, in a Bakersfield, California courtroom. -
Boston Scientific In Talks To Acquire Endo’s Medical Device Unit
Feb 26, 2015 | Trefis
...Boston Scientific faces litigation on faulty urology products. In September 2014, the company had to pay out $34 million to a woman who had been injured while using the vaginal mesh...
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REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF ’98
Feb 26, 2015 | Mesh Medical Device News Desk
By Jane Akre
Petitioning U.S. House of Representatives
This petition will be delivered to:
U.S. House of Representatives
REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF ’98
We, the undersigned, call on the United States House of Representatives to consider repealing the Biomaterials Access Assurance Act of 1998 and hold any supplier of raw material such as Dacron, Polytetrafluoroethylene (Teflon), and Polypropylene liable if they knowingly provide said material to a medical device company that does not intend to use the material to manufacture a medically necessary life saving device. While it is understood that there is really no way to track how these materials are being used, better regulation and research must be completed in order to eliminate the possibility of these toxic materials misuse. If there proves to be no way to account for the materials use, then the material need not be sold to the medical device company.
We trust that it is our right as United States Citizens to assume the safety of materials used in devices such as the fibers in Essure permanent birth control and Transvaginal Mesh procedures, have been thoroughly tested and proven safe without biased prior to FDA approval. Sadly, this is not the case.
In fact, these materials come with a warning…
First please watch these brief videos to get an understanding of how textiles/fibers used in Essure and Mesh are materialized. They are pure plastic chemical garbage!
https://www.youtube.com/watch?v=eYukgN1BRAk&feature=youtu.be
https://www.youtube.com/watch?v=SGXR14a3nRI&feature=youtu.be
Read more on the petition here:
https://www.change.org/p/u-s-house-of-representatives-repeal-the-biomaterials-access-assurance-act-of-98 -
Doctors Refute Ms. Perry’s Mesh Injury Claims
Feb 26, 2015 | Mesh Mesdical Device News Desk
By Jane Akre
**Update* At this writing, the Perry case has gone to the jury** MND will bring you the verdict when it becomes available.**
Medical doctors who treated or examined Ms. Coleen Perry, the plaintiff in Perry v. Ethicon, (1:13-cv-00729-AWI-JLT), took the stand to testify in the fifth week of her trial against Ethicon, a Johnson & Johnson (J&J) subsidiary, in a Bakersfield, California courtroom.Thanks to Courtroom View Network for access to live streaming video of the Perry v. Ethicon trial. Mesh News Desk is prevented from showing any plaintiffs or evidence or from quoting directly from the case.
Neither doctor supported Ms. Perry’s story that the TVT-Abbrevo pelvic mesh, implanted in 2011, caused her extreme pelvic pain, mesh erosion and dyspareunia.
Monday afternoon, Feb. 23, Ethicon attorney Burt Snell questioned Dr. Edward Charles Allen, an obstetrician/gynecologist from Bakersfield, California who continues to be Ms. Perry’s treating doctor. While Dr. Allen made it clear he is not an expert for either side, his story favored the defense (Ethicon, Johnson & Johnson), for whom he is still a consultant and preceptor (teacher). On more than one occasion, Dr. Allen said he is very good at his profession. He has implanted about 250-350 mesh slings to treat either incontinence or prolapse.
In March 2011, Ms. Perry, 50, received a TVT-Abbrevo (Ethicon/J&J) 12 cm polypropylene mesh sling, implanted by Bakersfield surgeon Dr. Luu. After a couple of years, Ms. Perry said she finally wanted to treat the incontinence which was disruptive to her active lifestyle. She claims since then, the implant has caused her pelvic pain and dyspareunia (painful sex), which has not subsided, despite the attempt by Dr. Allen to excise a portion of the Abbrevo sling in January 2012.Under questioning by attorney Snell, Dr. Allen said Ms. Perry did not complain of pain with sex in her follow-up well woman exam in October 2012. She did not discuss any problems with incontinence in 2012. On cross exam, the jury was reminded Ms. Perry was being treated by another doctor for hormonal issues with a non-drug natural approach and her husband previously testified that his wife is not a complainer.
Burt Snell, Ethicon attorney
Dr. Allen next saw her November 7, 2013 for another well woman exam. She had a slightly enlarged uterus then and did not tell her physician about ongoing pelvic pain, pain with sex, a burning feeling in her vagina or feelings like glass is inside, or any problems with incontinence. There was no evidence of a mesh exposure in 2013, said Dr. Allen. The next visit was Nov 10, 2014 and again there were no reports of pain or urinary incontinence. Dr. Allen said he believes his 2012 excision surgery was a success and he has felt no palpable mesh since that January 2012 revision surgery.
What then causes her dyspareunia? Dr. Allen opined it was vaginal shortness linked to her dyspareunia.
Richard Freese, Freese & Goss
On cross-examination, Perry attorney Richard Freese was pleasant but had no time for a conversational back and forth as had occurred with Mr. Snell.
He noted Dr. Allen did not tell the jury about his long relationship with Ethicon. Dr. Allen denied one of his roles for the company was to say good things about Ethicon (J&J) or to even use their products. He insisted he would use whatever medical device he thought worked best, not one that he was paid to promote.
Producing a May 6, 2011 signed a contract between Dr. Allen and Ethicon that would pay him $16,000 a year to be involved in educational summits and forums teaching other doctors about their products, Mr. Freese showed the jury an email about the contract specifics. In it, Dr. Allen insisted he own anything he discovered while working for Ethicon, not the other way around. Dr. Allen had an advantage at the time of this discussion. He was talking to Boston Scientific about being a preceptor or proctor for that mesh manufacturer. Under questioning by Mr. Freese, Dr. Allen didn’t remember having conversation with the two competitors at the same time.
Later, Dr. Allen said it is not unusual to have contracts with companies. It allows a doctor to monitor local doctors and to consult with other experts around the country. He didn’t make any money from the agreements, he said.
Ms. Perry’s Revision Surgery
Earlier that day during morning testimony, Dr. Allen said he removed part of the Abbrevo from Ms. Perry in a January 17, 2012 surgery. He noted a tight vaginal band and excised a mesh-like material with fine blue plastic sutures that measured 1.3 by .09 by .3 cm. He cut wider than the mesh, dissecting 2 to 3 cm on either side of the Abbrevo to cut past an infection to healthy tissue he felt was more likely to heal. The rest of the Abbrevo, which measure 12 cm in length, remains in her body today.
In a follow-up visit, Dr. Allen said he felt the patient was healing normally. Since then, he’s seen no palpable mesh or mesh erosion, laying a foundation of doubt as to whether her complaints of pain could be real.
Medical Expert for Ethicon
A trial that was supposed to take three weeks after its January 26 start is now in its fifth week to accommodate the court schedule of Superior Court of California, Kern County Judge Lorna Brumfield.
Friday, February 20, court was not in session but on Thursday, the 19th Dr. Brian Flynn took the stand. The medical doctor was retained as an expert for Ethicon and had examined Ms. Perry in preparation for trial.
Under questioning by Ethicon attorney Snell, Dr. Flynn opined Ms. Perry had not only urge incontinence before her Abbrevo surgery but also pelvic pain. Painful menses had necessitated an endometrial ablation surgery by a local Bakersfield doctor years earlier.
Dr. Flynn looked rather nonchalant and noncommittal giving his answers.
The University of Colorado urologist, hired as a medical expert in this case, specializes in reconstructive urology at the school of medicine. See the link here.
Dr. Brian Flynn, U of Colorado urologist
Dr. Flynn told jurors he was not there to state that Dr. Luu, the implanting physician, breached any standard of care or practiced malpractice. He was asked which surgical practices played a role that led to her complications. He answered her posteriorcolporrhaphy and perineoplasty surgery.
There was no evidence of mesh degradation. Based on his exam, Dr. Flynn said Ms. Perry’s prognosis is good.
Cross-Exam
On cross examination, Richard Freese questioned the credibility of Dr. Flynn. In preparing to testify at trial had he, Dr. Flynn, committed 70 hours of deposition preparation? Yes. Had he seen any Ethicon documents or talked to any Ethicon employees? No.
Freese established Dr. Flynn’s had a consulting relationship with Ethicon from 2004 to 2011. He pulled out the 2005 contract. While Dr. Flynn denied he had any role in the marketing of Ethicon’s mesh medical devices, he did admit under further questioning he helped launch the TVT Exact. The rest of the time he was involved in professional education and “dinner programs,” another form of education.
Over the last eight year, Dr. Flynn has made $160,000 as a result of consulting work for Ethicon including work as an expert in the Carolyn Lewis case, Lewis v. Ethicon, and in this Perry v. Ethicon.
The back and forth continued between Dr. Flynn and Mr. Freese with the attorney eliciting information about cadaver labs in which Dr. Flynn was a preceptor. You were telling doctors the Abbrevo and the TVT Secur were good and safe products weren’t you? Dr. Flynn said he did 200 procedures and did feel Abbrevo was a safe product. The two go back and forth over whether or not he has used Abbrevo in the last two or three years. (His deposition said he used it in 2013). Additionally, Dr. Flynn said he’s done about 50 mesh revision surgeries each year over the last three years, removing, or partially removing mesh used to treat both incontinence and prolapse.
Today Dr. Flynn still implants polypropylene mesh slings, but Mr. Freese elicited that he is taking one out for every one he puts in. Dr. Flynn is presently converting to the use of biologic meshes and returning to treat prolapse with burch procedures. #
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Boston Scientific In Talks To Acquire Endo’s Medical Device Unit
Feb 26, 2015 | Trefis
Boston Scientific (NYSE:BSX) is nearing a deal with Endo International (NASDAQ:ENDP) to buy its medical device unit, American Medical Systems (AMS), that was put up for sale last year. The deal is estimated to be valued at around $2 billion, according to a recent Reuters’ report. AMS makes medical devices for the treatment of pelvic disorders in men and women. [1] The potential deal could help Boston Scientific expand its Urology and Women’s Health portfolio. This division reported sales growth of 6% year-over-year (y-o-y) to around $535 million in 2014, contributing a little over 7% of the company’s total revenues.
Under the Urology division, Boston Scientific sells products for treating diseases such as urinary stone disease and benign prostatic hyperplasia (BPH). As part of its Women’s Health product offerings, the company offers products to treat diseases such as urinary incontinence and other pelvic disorders. ((Boston Scientific 10-K, SEC Filings)) For the nine months ending September 30 2014, AMS sales were flat y-o-y at $360 million. Within the AMS segment, sales of Women’s Health Devices witnessed an 8% decline y-o-y but Men’s Health and BPH Therapy sales grew by 1% and 5%, respectively. The addition of AMS is likely to help Boston Scientific increase its presence in the Urology and Women’s Health market and expand its top line. It is also likely to gain from certain revenue as well as cost synergies, but the details will only be clear if a deal is reached.
We have a price estimate of $15 for Boston Scientific, which is slightly below the current market price.
See our full analysis for Boston Scientific
Background of the Deal
Endo International acquired AMS for $2.9 billion in 2011. Three years after the acquisition and five months after paying out $830 million to settle lawsuits related to defective products, it put up AMS for sale at a discount to its acquisition price in August 2014. Endo plans to divest its AMS unit so that it can focus on its core market-leading products, which primarily include pharmaceuticals. Pharmaceuticals comprises of over 80% of the total revenue generated by Endo.
If the deal goes through, it will be the first major acquisition for Boston Scientific since it acquired stent maker Guidant in 2006. Investors must be hoping that this acquisition gives better returns than Guidant, which left Boston Scientific burdened with debt, litigation and product recalls. [2]
Litigation Charges
Boston Scientific faces litigation on faulty urology products. In September 2014, the company had to pay out $34 million to a woman who had been injured while using the vaginal mesh. Shortly after, in November 2014, the company lost a federal trial where it had to pay $26.7 million in compensatory damages to four women for a faulty vaginal mesh implant product. In this case, the company’s Pinnacle pelvic floor replacement kit was defective and the doctors and patients were uninformed about the risks associated with the device. The company currently faces charges from around 20,000 women who claim to have been injured by the defective vaginal mesh products. The company’s total litigation charges for 2014 were $1.03 billion.
AMS has also been involved in lawsuits related to faulty vaginal mesh implants. Last year it paid out $830 million to settle lawsuits related to its defective products. It will be interesting to see how both companies plan to manage their excessive litigation expenses related to such products and whether their association can help improve the quality of these products going forward. We will keep a tab on these developments.
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