Ethicon Media Monitoring 10/26/16

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

Online Sources

1. Transvaginal Mesh Trials on the Horizon

   Oct 25, 2016 | Mesh Medical Device Newsdesk

   It has been quite some time since transvaginal mesh product liability trials were conducted. They are scheduled to begin in December and throughout 2017.
2. Lawsuits Scheduled for Ethicon’s Physiomesh Hernia Mesh

   Oct 25, 2016 | Mesh Medical Device Newsdesk

   The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended.
3. NJ Judge Sends Medical Device Co.'s Coverage Spat To Pa.

   Oct 25, 2016 | Law 360

   By Shayna Posses
   
   
   A New Jersey federal judge on Tuesday granted Federal Insurance Co.’s bid to transfer to Pennsylvania federal court hernia mesh maker Tela Bio Inc.’s suit seeking coverage for a competitor’s underlying trade secrets action.
4. Restore Those Lady Parts

   Oct 25, 2016 | OC Register

   By Jill Hamilton
   
   
   In France, they take care of their women post-childbirth. Postpartum women get 10 to 20 sessions of la rééducation périnéale, or vaginal re-education, paid for by the government, in which women learn to strengthen their perineal muscles so they can get right back to practicing the art of love.

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

Online Sources

1. Transvaginal Mesh Trials on the Horizon

   Oct 25, 2016 | Mesh Medical Device Newsdesk

   It has been quite some time since transvaginal mesh product liability trials were conducted.  They are scheduled to begin in December and throughout 2017.
   

   Judge Joseph Goodwin had given both sides in the transvaginal mesh litigation the word – Begin Settlement Talks.

   To a very small degree they have begun with Johnson & Johnson (Ethicon) and Boston Scientific representing the last companies to come to the settlement table.
   Each is facing thousands of product liability lawsuits filed throughout the country but centered in multidistrict litigation in Charleston WV, where Judge Goodwin presides over 97,000 lawsuits.

   See So District of WV here.

   For anyone interested in sitting in a transvaginal mesh trial, here is a list of those upcoming actions. Mesh News Desk always welcome court watchers who can help expand our coverage of the issues as they are revealed in court.

   DALLAS

   The 95th Judicial District Court, is overseen by Judge Ken Molberg,

   Figueroa v Boston Scientific, DC-13-03145 is set for December 5, 2016, and is scheduled to be a two-week trial.

   Judge Molberg presided over the case of Linda Batiste ($1.2 million) and the Martha Salazar trial ($73.5 million).

   PHILADELPHIA

   In the Philadelphia Court of Common Pleas there are 163 product liability cases naming mesh manufacturers pending.   These are defective product cases which alleges the mesh was defectively manufactured and its instructions to end user doctors were insufficient.  Punitive damages are allowed.

   The last two trials resulted in $12.5 million (Hammons) and $13.5 million (Carlino).

   Here is the Philadelphia Court of Common Pleas website.

   These cases are being represented by Kline & Specter, a Philadelphia law firm representing the mesh injured women.

   TRIAL DATE CERTAIN December 5, 2016  Beltz vs Ethicon Women’s Health and Urology
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130603835&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN    February 27, 2017  Sullivan vs Boston Scientific et al
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130700971&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN   March 13, 2017  Collins vs C.R. Bard et al
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130701187&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN    March 27, 2017  Veliz vs Johnson & Johnson
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=140200303&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN    April 10, 2017   Engleman vs Gynecare et al
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=140305384&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN  May 22, 2017   Adkins vs Johnson & Johnson Et Al
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130700919&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN  June 5, 2017,  Hubbard vs Ethicon Women’s Health and Urology
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130700431&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN  June 19, 2017   Blockus vs Ethicon Women’s Health and Urology
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130700707&genrc_par1=15&genrc_par2=&call_type=H

   TRIAL DATE CERTAIN   July 3, 2016,   Ebaugh vs Ethicon Women’s Health and Urology
   https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_05.zp_dktrpt_frames?case_id=130700866&genrc_par1=15&genrc_par2=&call_type=H

   http://www.meshmedicaldevicenewsdesk.com/transvaginal-mesh-trials-horizon/
   

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2. Lawsuits Scheduled for Ethicon’s Physiomesh Hernia Mesh

   Oct 25, 2016 | Mesh Medical Device Newsdesk

   The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended.  

   Medical professionals had until September 16, 2016 to return unused Physiomesh, hernia mesh, for a full refund after the product was recalled by its manufacturer, Ethicon, a division of Johnson & Johnson.  Ethicon issued a recall of Physiomesh last May after studies showed it failed when used in hernia surgeries when compared to other similar hernia meshes.

   The mesh was used in laparoscopoic and ventral and inguinal hernia repair surgeries.

   The voluntary recall was conducted by Ethicon, the U.S. Food and Drug Administration and its European counterparts.

   Here is the Urgent: Field Safety Notice.  Here are the  Product Code numbers.

   THE PROBLEM

   Two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, suggested its failure rate for laparoscopic ventral hernia surgeries were higher than the other meshes used on patients in these registries.

   “The recurrence/reoperation rates (retrospectively after laparoscopic ventral hernia repair using Ethicon Physiomesh compositve Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”

   Physiomesh is made of polypropylene but the studies found it broke down in its structure which can allow the hernia to recur or cause bacterial infections and swelling at the surgery site, requiring another surgery.  Ethicon suggests surgeons replace it with Proceed surgical mesh, Prolene, Prolene Soft, or Ultrapro mesh, all made by Ethicon.

   Physiomesh was approved under the 510(k) clearance of the FDA in April 2010, which does not require clinical trials for safety and efficacy.

   Physiomesh is made of a flexibile composite mesh “composed of nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh.”

   Ethicon developed Physiomesh Open the latest version of the type of mesh and it was introduced in 2014.  Both messes were marketed following the fast tracked 510(k) approval process by the FDA. Physiomesh Open is not involved in this recall.

   On its website Ethicon claims “ Physiomesh Open is built on the proven technology of the #1 selling tissue-separating mesh Open Flexible Composite Mesh, and optimized for open ventral hernia repair.”

   LAWSUITS FILED

   A number of lawsuits have already been filed.  Matthew Huff was implanted with Physiomesh in 2013 to repair a ventral hernia.  In July 2015, he developed severe abdominal pain, ever, chills, nausea and redness.  He was treated for an infection and two abscesses and an intestinal fistula.  His case is set for January 22, 2018  in the Southern District of Illinois.   Case No. 3:16-cv-00368.

   Another product liability lawsuit was filed in the U.S. District Court Middle District of Florida September 22nd claims the mesh is defective and caused her persistent abdominal pain, diminished bowel motility and bowel obstruction.

   Here is an adverse event report submitted to the FDA that says the mesh pulled away from he abdominal wall resulting in a second surgery.

   In June 2012, Ethicon removed four transvaginal meshes from the market- Prolift, ProliftM+, TVT  Secur and Prosima Pelvic Floor Repair System.  The company said the removal was for business reasons. 

   http://www.meshmedicaldevicenewsdesk.com/lawsuits-scheduled-ethicons-physiomesh-hernia-mesh/
   

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3. NJ Judge Sends Medical Device Co.'s Coverage Spat To Pa.

   Oct 25, 2016 | Law 360

   By Shayna Posses

   New York (October 25, 2016, 8:45 PM EDT) -- A New Jersey federal judge on Tuesday granted Federal Insurance Co.’s bid to transfer to Pennsylvania federal court hernia mesh maker Tela Bio Inc.’s suit seeking coverage for a competitor’s underlying trade secrets action.
   
   U.S. District Judge Freda L. Wolfson agreed that the Eastern District of Pennsylvania is the better forum for the coverage spat stemming from an underlying suit accusing the mesh maker of misappropriating Acelity LP unit LifeCell Corp.’s trade secrets and poaching a number of its employees, pointing to factors like Tela Bio having its principal place of business in Pennsylvania and negotiating the insurance contract with a broker in the state.
   
   “A substantial part of the events giving rise to plaintiffs’ insurance coverage dispute occurred in that district,” the judge said.
   
   The dispute stems from LifeCell’s March 2015 state-court suit accusing Tela Bio, which was founded by a former employee, and its executives of willfully misappropriating trade secrets and proprietary information to develop a hernia repair product that is being introduced to replace an existing LifeCell product called Strattice.

   Tela Bio and the two executives sought coverage from Federal in January and filed the instant suit the next month in New Jersey federal court. The Federal commercial general liability policy, which covers January 2013 through January 2014, includes personal injury coverage for claims rooted in libel or slander, according to court papers.
   
   In a March brief, Tela Bio and the executives asked for partial summary judgment, contending that the underlying suit contains allegations of implicit defamation that conceivably fall within the scope of its Federal policy.
   
   Federal shot back in a motion to dismiss or transfer later that month that the underlying complaint doesn’t trigger coverage, but even if it did, LifeCell alleges infringement of trade secrets and proprietary information, which the policy expressly excludes. The insurer also contended that the Eastern District of Pennsylvania was the appropriate forum for the suit because the coverage claim arose in that state.
   
   Judge Wolfson sided with Federal on Tuesday, holding initially that the action could have been brought in the insurer’s requested district.
   
   While Malvern, Pennsylvania-based Tela Bio and the executives argue that their choice of forum should be given substantial weight, the judge said that isn’t the case because the company decided to file suit in a foreign jurisdiction. On top of that, their claims against Federal arose in Pennsylvania, she said.

   Also, Pennsylvania is more convenient for the parties and witnesses, and the documents that would be needed for trial also seem to be mostly in that state, Judge Wolfson said, concluding that the private factors weigh in favor of transfer.
   
   The public factors do as well, the judge held, rejecting Tela Bio and the executives’ claims that New Jersey is the proper venue because the underlying suit is pending in state court there. As there is no possibility of consolidating the suits, the parties aren’t the same and the issues are different, the location of the LifeCell suit doesn’t have any effect, she said.
   
   Ultimately, New Jersey has little interest in adjudicating the dispute, since the central facts occurred in Pennsylvania and the matter involves whether a Pennsylvania company is entitled to insurance coverage, the judge said.
   
   Judge Wolfson denied the pending partial summary judgment and dismissal motions, saying the parties can refile them in the new venue.
   
   Tela Bio is represented by Eugene Killian Jr. of The Killian Firm PC.
   
   Federal is represented by Katherine E. Tammaro of Tressler LLP.
   
   The case is Tela Bio Inc. et al. v. Federal Insurance Co., case number 3:16-cv-0866, in the U.S. District Court for the District of New Jersey.

   --Additional reporting by Melissa Daniels and Jeff Sistrunk. Editing by Brian Baresch.

   http://www.law360.com/articles/855698/nj-judge-sends-medical-device-co-s-coverage-spat-to-pa-
   

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4. Restore Those Lady Parts

   Oct 25, 2016 | OC Register

   By Jill Hamilton

   In France, they take care of their women post-childbirth. Postpartum women get 10 to 20 sessions of la rééducation périnéale, or vaginal re-education, paid for by the government, in which women learn to strengthen their perineal muscles so they can get right back to practicing the art of love.

   Here women are largely on their own, left to wonder if it’s normal to have pain or urinate when they sneeze. And unfortunately those things are normal – childbirth really does a number on parts down below.

   “Women’s bodies change significantly in the weeks and months after giving birth,” said Dr. Michael Niccole, founder and medical director of CosmetiCare Plastic Surgery Center & MedSpa in Newport Beach (cosmeticare.com). “They may experience a wide range of postpartum issues, from urinary incontinence to pelvic organ prolapse (POP) or vaginal atrophy. Urinary incontinence, which can begin during pregnancy, is that little bit of leakage that can happen when you sneeze, laugh, jump or run and is more common if you’ve had a vaginal delivery.”

   “POP happens when the pelvic floor is weakened or damaged, causing pelvic organs – including the vagina, cervix, uterus, bladder, urethra, intestines and rectum – to drop. In mild-to-moderate cases, POP causes women to feel discomfort during daily activities, such as exercise or sexual intercourse, and experience incontinence.

   Urogenital atrophy – more commonly called vaginal atrophy – is an inflammation of the vagina and outer urinary tract caused by thinning and shrinking tissue and decreased lubrication. These symptoms are due to a lack of estrogen, a reproductive hormone, which declines naturally during perimenopause and postmenopause. Women who are breast-feeding or use certain medications to treat endometriosis may experience the condition.”

   So what can you do, short of high-tailing your battered womanly parts to France? Kegel exercises are the first line of defense for incontinence and vaginal strength. You can do them on your own by tighteing the muscles you use to urinate and holding for a count of five.

   Or go digital and try a “Kegel fitness device” like OhMiBod’s Lovelife Krush that comes with an insertable silicone apparatus and an app to guide your sessions and record your progress.

   For dryness and discomfort, you can try an over-the-counter vaginal moisturizer like Replens or Lubrin or a topical estrogen-based therapy like Estrace, Premarin, Estring or Vagifem.

   If those methods don’t help, you can opt for laser vaginal rejuvenation. “Laser vaginal rejuvenation is a minimally invasive way to combat serious health concerns and consequences women experience following childbirth and menopause, including urinary incontinence, pelvic or vaginal pain, or difficulty emptying the bladder. Laser vaginal rejuvenation is a safe and comfortable alternative to strengthen weak or atrophied muscles,” said Niccole.

   The procedure involves a series of three 30-minute in-office treatments spaced four to six weeks apart and involves a probe inserted into the vagina that delivers “precise laser energy into the tissue.” Despite the terms “vagina,” “probe” and “laser,” the procedure is virtually painless, and most patients get back to regular activities within a few days. The cost is $3,000-$4,000.

   “The best candidates are women who suffer from urinary incontinence, pelvic organ prolapse or vaginal atrophy. … It also helps women combat issues like vaginal dryness and increases sensitivity,” said Niccole.

   Plastic surgery on the vagina “offers both urogynecological health benefits and aesthetic results.”

   Besides those benefits – and not wetting your pants is certainly a biggie – the treatment has some delightful side effects, according to Niccole: “sleeker contour and increased sexual sensation.”

   http://www.ocregister.com/articles/vaginal-733286-women-incontinence.html
   

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