Ethicon 1/15

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

Online Sources

1. Upcoming Pennsylvania Pelvic Mesh Trials Has J&J Motioning to Exclude Experts

   Jan 14, 2016 | Mesh Medical Device News Desk

   By Jane Akre
   
   
   A review of documents in two upcoming pelvic mesh trials, scheduled for this month and next, show defendant Ethicon, a subsidiary of Johnson & Johnson, filing motions to gut the Plaintiffs’ case.
2. J&J Takes $12.5 M Hit in Philly Transvaginal Mesh Trial

   Jan 14, 2016 | Drug Watch

   By Michelle Llamas
   
   
   Johnson & Johnson’s Ethicon unit took amulti-million dollar trial loss over its transvaginal mesh implant at the end of last year, and 2016 started off with the Food and Drug Administration re-classifying the controversial surgical implant to a high-risk device.
3. Boston Scientific Used Counterfeit Materials, RICO Suit Says

   Jan 14, 2016 | Law360

   By Kurt Orzeck
   
   
   ...The MDL against Johnson & Johnson unit Ethicon Inc. includes more than 23,000 cases, claiming that its mishandling of transvaginal surgical mesh devices caused serious injuries to patients.

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

Online Sources

1. Upcoming Pennsylvania Pelvic Mesh Trials Has J&J Motioning to Exclude Experts

   Jan 14, 2016 | Mesh Medical Device News Desk

   By Jane Akre

   A review of documents in two upcoming pelvic mesh trials, scheduled for this month and next, show defendant Ethicon, a subsidiary of Johnson & Johnson, filing motions to gut the Plaintiffs’ case.

   Carlino v. Ethicon, ~ January 25, 2016, Philadelphia.  Case No. 1306-03470,Philadelphia Court of Common Pleas.
   On or about August 18, 2005, Ms. Carlino was implanted with one or more of meshes and Gynecare TVT by her doctor, Andrew Blechman of Neptune Township, NJ.  She had two corrective surgeries to revise and/or remove the mesh in November 2007 and again in December 2010, both with Dr. Blechman.

   As a result she has sustained injuries including, “mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain and recurrent urinary incontinence,” which have led to corrective surgeries, mental and physical pain and financial losses.

   Plaintiffs plan to introduce evidence of J&J spoliation or document destruction which J&J argues will highly prejudice the case. See  Mesh News Desk background story here. 

   Claims include – Negligence, fraud, failure to warn, defective manufacturing and design, negligent misrepresentation, breach of warranty, violation of consumer protection law and gross negligent disregard for others. Also loss of consortium.

   McGee v. Ethicon, ~ Philadelphia, Kline & Specter, TVT Secur, February 22, 2016, Case No. 1306-03483

   Ms. McGee was implanted with an Ethicon (Johnson & Johnson) TVT-S (Secur)  in Mason City, Iowa by Dr. Charles Debrah on September 6, 2007.  She underwent corrective surgery March 7,  2008 also by Dr. Debrah and another corrective surgery July 21, 2008.

   Ethicon has filed motions to exclude experts – Dr. Uwe Klinge, is a biomedical researcher from Germany. At his Institute of Pathology at the Hospital of Duren are 485 pelvic mesh explants and  22 explanted TVT and TVT O samples, all made of J&J’s Prolene mesh. He will testify about the changes the mesh underwent in the body.

   J&J also wants excluded from the case Dr. Peggy Pence, who has previously testified in pelvic mesh litigation as an expert on FDA regulation, and Dr. Bruce Rosenzweig as an expert on the body’s reaction to mesh.

   Another filing suggests federal preemption may apply in that the Prolene mesh, which makes up hernia mesh and is the same mesh used in pelvic mesh repair, was approved by the FDA as a Class III medical device, therefore subject to federal preemption protections. See an explanation under Riegel v. Medtronic here.

   Only in 1990 was it reclassified as Class II allowing it to be marketed under the FDA’s 510(k).

   Sherrer ~ Editor’s Note* The plaintiffs’ case in Sherrer in Kansas City, Missouri has concluded. The case began on December 2, 2015 and  was interrupted in mid- December for the holiday season. The trial resumed January 4.  MND  will bring updates as we are able. The case number is 1216-CV27879, Sherrer v Boston Scientific and C.R. Bard and Truman Medical Center.   Here is a background story on the trial.

   The trial was interesting because Sherrer was implanted with two meshes, however a reader’s comment allegedly upset one member of the defense team who appealed to the judge to omit cameras in the court.  MND lost its access to the courtroom camera at that point, which was allowed to stay.

   Ms. Sherrer was reportedly only mildly incontinent when she was implanted with the Solyx (Boston Scientific) in October, 2010. The Solyx has tips that anchor into the pelvic region and its edges are detanged, meaning they are not raw but looped.  She was also implanted with the Align S (Bard) when the Solyx failed that surgery occurred January 3, 2011. Eventually she had a mesh removal by Dr. Shlomo Raz at UCLA.

   Trials Also Ahead:
   
   Way v. Ethicon, February 22, 2016, Volusia County Florida

   Mullins v. Ethicon, April 11, 2016, Charleston WV, (Case No. 2:12-cv-02952.)   This case consolidates 37 plaintiffs who have similar actions in one trial naming Ethicon/ Johnson & Johnson.  They all have a TVT (transvaginal tape) implant and were implanted by different surgeons in West Virginia. Those are the common issues of law and fact that allow them to be consolidated into one trial.

   Figueroa v. Boston Scientific, May 16, 2016, Dallas, Texas.

   Edwards v. Ethicon, June 3, 2016, Charleston, WV

   
   

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2. J&J Takes $12.5 M Hit in Philly Transvaginal Mesh Trial

   Jan 14, 2016 | Drug Watch

   By Michelle Llamas

   Johnson & Johnson’s Ethicon unit took amulti-million dollar trial loss over its transvaginal mesh implant at the end of last year, and 2016 started off with the Food and Drug Administration re-classifying the controversial surgical implant to a high-risk device.

   Patricia Hammons filed a lawsuit against J&J and its Ethicon subsidiary and claimed that the Prolift mesh implant caused her to suffer a variety of health problems and left her unable to have sex. Hammons, a Wal-Mart stocker from Indiana received mesh to treat a leaky bladder, but required multiple surgeries to treat complications. Even after revision surgery, she continued to suffer problems.

   The two-and-a-half-week trial in Philadelphia Common Pleas Court before Judge Mark Bernstein ended with a $12.5 million jury verdict for Hammons, $5.5 million in compensation for complications and $7 million in punitive damages. The jury awarded punitive damages to punish J&J for selling an unsafe product.

   “Every American depends on Johnson & Johnson to put safety ahead of selling,” Hammons’s lawyer, Shanin Specter told the Philadelphia Inquirer. “They aren’t doing that, and they need to engage in some honest soul-searching.”

   In response, Ethicon’s spokesman issued a statement, “We believe the evidence showed Ethicon’s … pelvic organ prolapse repair kit was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and the [mesh] was not the cause of the plaintiff’s continuing medical problems. We have always made patient safety a top priority and will continue to do so.”

   Transvaginal mesh devices are plastic, net-like implants used to treat incontinence and pelvic organ prolapse, a condition where women’s organs sink into the vagina. The controversial devices drew nearly100,000 lawsuits against manufacturers such as Ethicon, American Medical Systems and C.R. Bard. Plaintiffs claim manufacturers sold faulty products and hid risks.

   Ethicon plans to appeal the verdict.Expert: Mesh is a Surgical ‘Train Wreck’

   Part of the issue with the implant is that it was never designed to come out of the body. During the trial, one plaintiff’s expert described removing faulty meshfrom a woman’s body as a surgical “train wreck.”

   According to Scott Ciarrocca, an Ethicon product engineer who testified during the trial, the company never came up with a procedure to remove the implants if they failed. The implant was a huge financial success for Ethicon, and it raked in $108 million. The company pulled it from the market in 2012.

   Evidence presented at the trial showed Ethicon knew about painful sex complications from mesh since 2005, but did not include a warning on the label.

   J&J’s lawyer, Tarek Ismael, admitted the company made mistakes in the development of the Prolift but claimed it never wanted to cause harm.FDA Reclassifies Some Mesh as High Risk

   Five years after it released its first warnings on mesh, the FDA is finally making a move to reclassify the device. Previously, the agency classified the products as class II, meaning they were moderate risk devices. Many of the mesh products on the market were cleared through the 510(k) process and could be marketed without testing as long as another similar product was already on the market.

   The first week of January 2016, the FDA announced it reclassified mesh used to treat pelvic organ prolapse as a class III, meaning manufacturers must now provide data showing the product is safe and effective before sale.

   Across social media, mesh support groups are calling for the FDA to reclassify all mesh. Under the new regulations, mesh devices like the Prolift bladder sling used by Philadelphia plaintiff Hammons are still class II devices and do not require testing.

   “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health said in a statement. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

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3. Boston Scientific Used Counterfeit Materials, RICO Suit Says

   Jan 14, 2016 | Law360

   By Kurt Orzeck

    Boston Scientific Corp. is facing a proposed class action made public Thursday in West Virginia federal court that accuses it of violating the Racketeering and Corrupt Organizations Act by selling defective vaginal surgical mesh made of counterfeit supplies from China.
   
   The suit, filed Tuesday, claims Boston Scientific resorted to unverified and substandard materials after losing its U.S. supplier of the synthetic resin used to make surgical mesh. The medical device maker bought the resin from a known counterfeiter and smuggled it out of China through secret shipments — as if it were a “drug deal,” according the complaint.
   
   Plaintiffs are women who say they experienced bleeding and other complications from the plastic mesh implants. They want the court to block Boston Scientific immediately from selling any medical devices containing the allegedly harmful material.
   
   Their attorney Amber Mostyn of the Houston-based Mostyn Law Firm said in a Thursday statement that Massachusetts-based Boston Scientific has shown “disgusting and appalling” disrespect for women through the alleged international conspiracy.
   
   “We have asked for the court to shut down sales from this company and to protect women from the pain and suffering that can result from this dangerous product,” Amber Mostyn said.
   
   The suit is the latest among tens of thousands of lawsuits against the makers of vaginal mesh implants, including 15,000 against Boston Scientific, according to the Mostyn Law Firm’s statement.
   
   C.R. Bard Inc. faced the first jury trial in the seven multidistrict litigation suits over the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. It was hit with a $2 million verdict in August 2013.
   
   The MDL against Johnson & Johnson unit Ethicon Inc. includes more than 23,000 cases, claiming that its mishandling of transvaginal surgical mesh devices caused serious injuries to patients.
   
   Earlier this month, federal regulators finalized measures to reclassify transvaginal mesh devices as high-risk devices that need a safety evaluation by the U.S. Food and Drug Administration before they can be sold.
   
   Tuesday’s suit is the first to accuse Boston Scientific of engaging in an international conspiracy to import tainted plastic resin for the mesh, according to the Mostyn Law Firm.
   
   Chevron Phillips Chemical Co. in 2005 stopped selling its polypropylene resin for surgical mesh, known as Marlex, saying it shouldn’t be used in medical devices involving permanent implantation in the human body, Thursday’s statement said.
   
   Boston Scientific allegedly ignored those warnings and looked for another source for the resin pellets, according to Tuesday’s suit. Unable to find a U.S. supplier, the medical device maker in 2011 and 2012 bought 34,000 pounds of the material from EMAI Plastic Raw Materials Inc., the suit says.
   
   Boston Scientific allegedly divided the product into more than 500 bags that it sent through three ocean shipments on different dates, so as to lessen the risk of inspection by customs agents, the suit says.
   
   The defendant told Chinese authorities that the Marlex was made in that country, which meant it didn’t need certain paperwork for export, but then claimed the material was authentic Phillips Marlex, according to Tuesday’s class action.
   
   Boston Scientific makes $120 million in revenue from the mesh products, the firm said.
   
   The lead plaintiff in Tuesday’s suit is Teresa Stevens, a 46-year-old grandmother from West Virginia who had a mesh implant procedure in October 2014, according to the complaint. She has allegedly experienced pain, bladder infections and other complications.
   
   The suit seeks unspecified damages for thousands of women who have received the mesh product after September 2012 — as many as 55,000 each year, according to the Mostyn Law Firm.
   
   U.S. District Judge Joseph R. Goodwin on Wednesday refused to grant Stevens’ request for a temporary restraining order, saying her counsel hadn’t sufficiently informed Boston Scientific of their intention to file the motion. The judge thus ordered Stevens to notify the company about her request.
   
   Representatives for Boston Scientific didn’t immediately respond to requests for comment late Thursday.
   
   Stevens is represented by J. Steve Mostyn and Amber Mostyn of the Mostyn Law Firm and Harry F. Bell of the Bell Law Firm PLLC.
   
   Counsel information for Boston Scientific wasn’t immediately available.
   
   The case is Teresa L. Stevens v. Boston Scientific Corp. et al., case number2:16-cv-00265, in the U.S. Court for the Southern District of West Virginia.
   

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