Ethicon Media Monitoring 10/19/16

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. No More Vaginal Mesh Suits, MDL Judge Says

   Oct 18, 2016 | Law 360

   By Kat Sieniuc
   
   
   The Georgia federal judge overseeing multidistrict litigation alleging that a Johnson & Johnson unit's defective pelvic mesh implants caused painful infections declared on Tuesday that the usefulness of the MDL has run its course.
2. AUGS President Calls Out Anti-Mesh Movement While Admitting to Mistakes

   Oct 18, 2016 | Mesh Medical Device Newsdesk

   The president of the American Urogynecologic Society (AUGS) admits some doctors were not in the 98th percentile in their ability to place transvaginal mesh while he called out the anti-mesh movement.
3. Ethicon Denied Summary Judgment on Design Defect, Negligence Claims in TVT-Secur Mesh Action

   Oct 18, 2016 | HarrisMartin Publishing

   The judge overseeing the Ethicon transvaginal mesh multidistrict litigation has allowed a design defect claim to proceed in a TVT-Secur action, ruling that the plaintiff produced evidence of a purported safer alternative design.
4. Ethicon Hernia Physiomesh Recall Over High Failure Rates

   Oct 18, 2016 | The Legal Examiner

   By Shezad Malik
   
   
   Johnson & Johnson’s Ethicon unit has recalled its blockbuster hernia repair mesh medical device from the market worldwide, after it was found to cause severe side effects and surgical revisions.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. No More Vaginal Mesh Suits, MDL Judge Says

   Oct 18, 2016 | Law 360

   By Kat Sieniuc

   Law360, New York (October 18, 2016, 6:41 PM EDT) -- The Georgia federal judge overseeing multidistrict litigation alleging that a Johnson & Johnson unit's defective pelvic mesh implants caused painful infections declared on Tuesday that the usefulness of the MDL has run its course.
   
   U.S. District Judge Clay D. Land asked the U.S. Judicial Panel on Multidistrict Litigation to stop transferring tagalong actions and accepting new direct-filing actions to the MDL, which has grown to include more than 850 cases from the 22 first filed in 2008.
   
   “All good things must eventually come to an end. And that is true for this MDL,” Judge Land said.
   
   Judge Land warned plaintiffs counsel last month that frivolous lawsuits would no longer be tolerated and could trigger sanctions, saying he had spent a considerable amount of time and judicial resources deciding summary judgments in consumer lawsuits against Mentor Corp. that plaintiffs counsel should have dismissed earlier or that should have never been brought in the first place.
   
   And indeed, enough was enough on Tuesday: “The court finds that the primary purposes of consolidation have been accomplished, and the benefit of accepting new cases is marginal,” Judge Land said.
   
   Derek H. Potts, an attorney for the plaintiffs, said Tuesday that it's the second time in recent weeks a judge has closed a mesh-related MDL. The other was a case in West Virginia federal court involving Neomedic International SL, he said.
   
   A representative of Mentor did not immediately respond to a request for comment Tuesday.
   
   Hundreds of women allege that once Mentor's transobturator vaginal sling known as ObTape was implanted into their bodies, they suffered erosion of internal bodily tissues, including vaginal walls, and most women needed multiple surgeries to correct the problem.
   
   Mentor, which discontinued the product in 2006, is also accused of inadequately testing the device before introducing it in 2003. The JPML consolidated the ObTape suits into Judge Land’s court in early 2015.
   
   Since then, Mentor has settled one of the six designated bellwether cases, and it won summary judgment in three others in late 2015. Judge Land found at the time that the patients in the three suits all knew or should have known that their medical problems were linked to the ObTape sling years before they sued, putting their claims beyond the statute of limitations.
   
   In September, Judge Land indicated that he has started seeing more cases filed by lawyers who “seem to think that their case will be swept into the MDL where a global settlement will be reached, allowing them to obtain recovery without the individual merit of their cases being scrutinized.”
   
   “This attitude explains why many cases are filed with little regard for the statute of limitations and with so little prefiling preparation that counsel apparently has no idea whether or how she will prove causation,” Judge Land wrote in September. “This phenomenon produces the perverse result that an MDL ... becomes populated with many nonmeritorious cases that must nevertheless be managed by the transferee judge — cases that likely never would have entered the federal court system without the MDL.”
   
   At a minimum, then, transferee judges should be aware that they may need to take an approach that weeds out more nonmeritorious cases “early, efficiently and justly,” the judge said. “Hopefully the robust use of Rule 11 will help.”
   
   The plaintiffs are represented by Derek H. Potts of the Potts Law Firm LLC, Douglas A. Kreis and Edward Blizzard of Aylstock Witkin Kreis & Overholtz PLLC, C. Calvin Warriner of Searcy Denney Scarola Barnhart & Shipley PA and Mark DiCello of The DiCello Law Firm.
   
   Mentor is represented by Dustin B. Rawlin, Rebecca W. Gutierrez and John Q. Lewis ofTucker Ellis LLP.
   
   The MDL is In re: Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, case number 4:08-md-02004, in the U.S. District Court for the Middle District of Georgia.
   
   --Additional reporting by Steven Trader. Editing by Brian Baresch.

   http://www.law360.com/articles/852923/no-more-vaginal-mesh-suits-mdl-judge-says
   

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2. AUGS President Calls Out Anti-Mesh Movement While Admitting to Mistakes

   Oct 18, 2016 | Mesh Medical Device Newsdesk

    The president of the American Urogynecologic Society (AUGS) admits some doctors were not in the 98th percentile in their ability to place transvaginal mesh while he called out the anti-mesh movement.
   
   AUGS, the American Urogynecologic Society, was born in an Orange County, California living room in 1979.

   Founder, Dr. Don Ostergard, was there, so was Jack Robertson, MD the first president, and four others.  The first AUGS conference was held in New Orleans and attended by about 60 physicians from around the U.S. and Europe.

   Last month, the society held its 37th annual conference in the Denver Convention Center. During the President’s Address, Dr. Douglass Hale, MD said the society has grown by leaps and bounds and now numbers just under 2,000 members.

   He called “almost unreal” the AUGS $3.5 million cash infusion in 2015, a growth of almost 300 percent. See his comments here.
   
   The AUGS annual conference bring in more than half of its annual revenue of $5 million in 2015. As a non-profit corporation, that means donations are tax deductible, and more than half of the support of this conference came from mesh manufacturers and related industries.

   The 2014 record shows 64% of AUGS Pelvic Floor Disorders is sponsored by industry.

   See the  2016 corporate support page

   AUGS has, since its inception, been an industry magnet. Timing was everything.

   Urogynecology was in its infancy when AUGS was born. The subspecialty of gynecology focused on female incontinence and prolapse, pelvic medicine and reconstructive surgery.

   The Food and Drug Administration’s (FDA) 510(k) provided a fast-tracked avenue to market where untested medical devices such as transvaginal mesh could be sold bypassing the costly burden of clinical trials.

   For example, in 1996, Boston Scientific’s ProteGen hit the market and by 1998 Ethicon’s TVT (Johnson & Johnson) was ready to be sold in the U.S.  Early adopter physicians flew to Europe eager to jump ahead of the pack to bring TVT technology to the U.S.

   AUGS growth got its first industry injection in 1997 when Kimberly Clark provided an endowment to create the June Allyson Foundation. Four years later the first AUGS resident scholars would be sponsored by Eli Lilly & Co.

   It’s no surprise then that one cannot turn one’s head in the exhibit hall today and not be reminded of the industry presence – Medtronic, Allergan, Boston Scientific, Coloplast- Platinum, Gold and Silver sponsors spending hundreds of thousands of dollars to make their presence known.

   AUGS AND ITS SUPPORT

   The closing of Astora Women’s Health division last March “came as a complete shock,” said Dr. Hale to the nearly full room of 1,300 AUGS physicians attending the conference.

   Astora was the division of Endo International that bought American Medical Systems in 2011. Unfortunately it also bought its liabilities. Facing future product liability litigation concerns, Endo/Astora shuttered its business operation last March.

   Dr. Hale characterized it as a “business decision,” and he added thankfully there are four vendors they can still rely on to provide mid-urethral slings – J&J, Boston Scientific, Coloplast and Caldera Medical (which earlier this year said it was insolvent. See the story here).

   And in a rare moment of introspection, Dr. Hale admitted not all physicians are up to the task of placing pelvic mesh.

   “Are all slings wonderful, all slings given to surgeons, obviously not,” he said, pointing out that some doctors imagine themselves in the 98 percentile. But that’s not true.  Not everyone operates at the 98 percentile.

   “Surgeons are no different. Pick the surgery to match what you can deliver,” he warned.

   Calling slings the “most studied procedure of all time,” he said thousands of patients have been satisfied with its outcome.

   Like anything in medicine it comes with its risks, complications, he admitted, that have come from low volume users, doctors who do an occasional procedure.

   AUGS has met with the remaining mesh makers to formulate a plan to “help protect the decision between a patient and her physician whether that decision is for a native tissue surgery or for a mesh surgery.”

   Hale said the treatment decision should be based on science and not an “irrational” response, especially in this age of social media.

    

   THE ANTI-MESH MOVEMENT
   
   “The #PFDWeek hashtag has already been attacked by the anti-mesh movement and unfortunately, that’s not a surprise to us. That’s what we’re up against,” said Dr. Hale, not elaborating further (here).

   The short-term plan was to answer the anti-mesh movement was to issue a positive statement by all of the coordinated medical societies, AUGS, SUFU, AAGL, ACOG, Society of Gynecological Surgeons, American Urological Association, and National Association for Continence, Women’s Health Foundation.  They all joined together and “put their egos aside” to create a position statement that supported a mesh option in June here.
   
   Hale called a “new low” the act of some unnamed doctors who fly out patients to have a mesh removal surgery.  After she has her sling removed, she expects her doctor back home to take care of her.  The removal doctor never met the patient, examined or followed up after the mesh removal, he said critical of the entire process.

    

   SUI SURGICAL REGISTRY

   Big changes are afoot in the collection of electronic healthcare records which may allow the society to understand outcomes for the mesh implanted, something that didn’t happen during the late 90’s and into the mid 2000’s during the height of the use of polypropylene mesh.

   Doctors can now perform their own data analysis to “inform better clinical decision-making” says the society.   The American College of Cardiology and the Society of Thoracic Surgeons already use disease registries in this manner so AUGS is partnering with FIGmd, Inc. to develop AQUIRE, the AUGS Urogynecology Quality Registry, a stress urinary incontinence electronic surgical registry to monitor patient care, and evaluate patient outcomes.

   The data will be used to determine physician reimbursement working with CMS (Center for Medicare and Medicaid Services) and its requirement of new physician benchmark tools.

   AQUIRE will track performance measures against peers at the national and regional levels and act as post-approval monitoring, something not done before pelvic mesh was introduced  into the market.

   As Donald Ostergard, MD opined in 2007, clinical observations are not always accurate about the effectiveness of a particular material because women do not return to a doctor who they perceive has harmed them.

    

   PELVIC FLOOR DISORDERS REGISTRY
   
   The Pelvic Floor Disorders Registry (PFDR) is a multi-centered observational study of patients following treatment for pelvic organ prolapse (POP) to evaluate the outcomes of transvaginal/transabdominal native tissue repair, versus transvaginal mesh repair and sacrocolpopexy and a non-surgical management with a pessary.

   By 2015 it had collected data from more than 1,000 patients.

   It is supported by grants from industry including ACell, Astora ( Endo) Boston Scientific and Coloplast.

   The registry will also fulfill the FDA’s request for the 522 post market surveillance for transvaginal mesh for POP, including industry-sponsored studies.  AUGS is working with industry to give POP mesh one last chance after the FDA moved to reclassify it as high-risk.  Manufacturers can conduct clinical trials to prove safety and efficacy or the FDA may allow manufacturers to rely on post approval monitoring to satisfy the three year monitoring and prove POP mesh is safe.

   AUGS OUTREACH

   AUGS is reaching out to the public through its funded,Take the Floor: Voices for PFD website was launched in 2011 to talk about pelvic organ prolapse.

   The “Voices” are underwritten in part through educational grants from Allergan, Astellas Boston Scientific, Medtronic and Pfizer.   Women can dialogue with doctors through a Mobile Voices App or find a urogynecologist, part of AUGS.

   Take the Floor tells the public that mesh may be appropriate for repair of pelvic organ prolapse in some cases.

   “AUGS does not support the routine use of transvaginal mesh for the repair of pelvic organ prolapse, but there may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate. Placement of transvaginal mesh for pelvic organ prolapse should be used cautiously by experienced surgeons with extensive training in pelvic surgery.”

   Dr. Hale said AUGS has launched into the world of public relations and hopes to put out a positive message to the media.

   In terms of future outreach, AUGS is hoping to have a presence at a 1.5 day conference March 30, 31, 2017 with the National Institutes of Health urinary incontinence conference “to stimulate research for the treatment of urinary incontinence” and to get in front of the NIH.

   NORTH CAROLINA

   Even though AUGS picks conference sites five years in advance, the organization has pulled out of Charlotte, North Carolina, as the site for the 2017 AUGS conference.

   “We need to protect our members,” said Dr. Hale.

   He was referring to the North Carolina discrimination bill, signed by the governor in March, that prevents local municipalities from passing anti-discrimination protections for gay, lesbian, bisexual and transgender individuals.

   Hale said, “This is not a political statement,” but he admitted AUGS checked with industry before it made such a move.

   Fearing a financial repercussion, Dr. Hale added that the PFD Research Foundation is a 501c3 and it has its own budget and there was no financial risk to the nonprofit for making such a move.

   So in 2017, the AUGS conference will instead be held in Providence, Rhode Island. ###

   http://www.meshmedicaldevicenewsdesk.com/augs-president-calls-anti-mesh-movement-admitting-mistakes/
   

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3. Ethicon Denied Summary Judgment on Design Defect, Negligence Claims in TVT-Secur Mesh Action

   Oct 18, 2016 | HarrisMartin Publishing

   CHARLESTON, W. Va. — The judge overseeing the Ethicon transvaginal mesh multidistrict litigation has allowed a design defect claim to proceed in a TVT-Secur action, ruling that the plaintiff produced evidence of a purported safer alternative design.

   In an Oct. 4 order, Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia also denied Ethicon’s motion for summary judgment on the plaintiff’s negligence claims, noting that she proffered evidence that Ethicon knew the TVTS had a high failure rate, but did not share that information in the Instructions For Use.

   Texas resident Cheryl Lankston ...

   Subscription required, for full story:  http://harrismartin.com/article/21461/ethicon-denied-summary-judgment-on-design-defect-negligence-claims-in-tvt-secur-mesh-action/
   

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4. Ethicon Hernia Physiomesh Recall Over High Failure Rates

   Oct 18, 2016 | The Legal Examiner

   By Shezad Malik

   Johnson & Johnson’s Ethicon unit has recalled its blockbuster hernia repair mesh medical device from the market worldwide, after it was found to cause severe side effects and surgical revisions. According to Johnson & Johnson the exact mechanism for the failures are unknown, and the company conveniently blamed patient factors and implanting doctors for the complications.

   The Ethicon Physiomesh recall was announced recently in an Urgent Field Safety Notice sent to doctors and hospitals worldwide.

   The FDA has classified the action as a “Market Withdrawal”, and Johnson & Johnson is requiring doctors and hospitals to return unexpired products for a refund.

   What is Ethicon Physiomesh?

   Ethicon uses plastic or polypropylene to make the base layer of the Physiomesh. The Physiomesh is used for laparoscopic ventral (abdominal) and inguinal (groin) hernia repair.

   Polypropylene is the same material that Ethicon used to make their transvaginal mesh and bladder slings. Ethicon is exposed to thousands of lawsuits over its polypropylene transvaginal mesh and bladder slings. Ethicon added an absorbable film coating to each side of the polypropylene to create the Physiomesh. The coating on each side of the Physiomesh is composed of slightly different compounds.

   German and Danish Medical Registries found the problem

   The Ethicon Physiomesh Flexible Composite Mesh stealth recall was issued after an analysis of data found that the products have higher than average recurrence and re-operation rates following laparoscopic ventral hernia repair. The data came from the Herniamed German Registry and the Danish Hernia Database.

   Unfortunately here in the U.S. we do not have a nationwide registry of side effects or failures associated with our medical products. And when patients or doctors complain or raise an issue with a product, they tend to get swept under the rug and the big medical device makers deny any problems until it is too big to contain or it may come to light from whistle blower action.

   According to the Urgent Field Notice, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.

   Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”

   Recalled Ethicon Physiomesh Lots

   The action affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R.

   The recall does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.

   Ethicon Physiomesh Lawsuits

   Patients and surgeons have been complaining about the complications and the need for re-do surgery when the abdominal or inguinal hernia recurred.

   The Physiomesh device was a big hit for Johnson & Johnson. Before the Physiomesh recall, Ethicon developed the Physiomesh Open. Ethicon submitted a 510(k) application for the Physiomesh Open in June, 2014, and received clearance in October, 2014.

   Ethicon gave the Physiomesh Open about half a year to gain market traction before they finally decided to “voluntarily withdraw” the regular Physiomesh from the market.

   Several Physiomesh lawsuits have been filed against Ethicon and Johnson & Johnson, with the first one slated to go to trial in January 2018. Ethicon has been battling lawsuits for years against its transvaginal mesh products, which are also made from polypropylene.

   According to the lawsuits, the Physiomesh products were defectively designed and manufactured, using plastic materials that react to human tissues, causes infections and can migrate to other parts of the body. The lawsuits also indicates that the plastic mesh can cut tissues and fails to actually perform as intended leading to recurrence of the hernias.

   http://fortworth.legalexaminer.com/defective-dangerous-products/ethicon-hernia-physiomesh-recall-over-high-failure-rates/
   

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