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

Philadelphia Court of Common Pleas

Philadelphia Court of Common Pleas

MND, January 14, 2016 ~ 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. 

TVT mesh breaks apart, Wisbech Standard, UK

TVT mesh breaks apart, Wisbech Standard, UK

Defendant notes “the fact that some Ethicon employees made inadvertent mistakes with respect to document retention is not a basis to taint the upcoming trial with plaintiffs’ spoliation allegations. This trial should be about whether the TVT product at issue is defective; whether it carried appropriate warnings; and whether it caused the specific injuries alleged by Ms. Carlino. Injecting spoliation evidence into the plaintiffs’ presentation to the jury would overshadow the trial, confuse the jurors and distract them from making those critical determinations. “

 

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.

 

TVT Secur, Megamed Services

TVT Secur, Megamed Services

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.

Dr. Klinge

Dr. Klinge

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.

Peggy Pence, PdD and team at Symbion Research Intl.

Peggy Pence, PdD and team at Symbion Research Intl.

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).

 

Solyx Sis System

Solyx Sis System

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.

Dr. Raz and Suzanne M.

Dr. Raz and Suzanne M.

 

Trials Also Ahead:

Way v. C.R. Bard, 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

 

LEARN MORE:

Philadelphia Court of commons list of upcoming trials

https://www.courts.phila.gov/apps/clc/caselist.asp?search=pel

 

 

 

13 Comments

  1. Pam says:

    So, there’s not been a final decision on the Shearer trial as of this date? I can’t imagine that the jury can sustained all of the pertinent information to make a sound decision. We can only Pray at this time that evidence is great against BS.

    Sure looks as if J&J is getting scared. With good reason.

    I’d really love to hear what the European scientific research has to share. I’m sure it’ll be upsetting for all of us victimize by MESH, but again it’s answers to the illnesses we have to battle each painful day. 37 cases in 1 trial, & I’m sure that number alone facing any defense has the odds stacked against them. That’ll be a very interesting trial, & I truly wish I could afford to be there for that.

    If anyone is in the Florida area planning to support Elizabeth trial, then please message me or email. I’m planning on attending, & wanting to make a few shirt design for us to wear and color choices too. That should certainly get a jury’s attention that we are Mesh Victims & Surviving the battle of chronic illness & pain! We have faces a long with a voice behind all the pain were just gentle humans trying to be heard & validated.

    Prayers for us all, & God Speed! May we all have the courage & strength to the end of this journey

  2. Toni says:

    So now with the new FDA ruling J N J is going to use that as a defence is how I am reading that. Any more news on Sheerer trial outcome?

  3. Toni says:

    Wow I don’t understand how all these manufacturers are even being allowed to stay in business. They are fraudulent and criminal in there actions. Why do we have to wait for them to help us right the wrong so we can get help from doctors and survive the pain and suffering . Can’t our government step in and help us get the help we need and deserve? Sickening really!

    • Bejah Blue says:

      Toni, The government only bails out corporations not the people. We are on our own.

      Bejah

      • Bejah Blue says:

        And let us not forget who it was that bailed out the banks in the 2008 crises….it was the people, it was us!!!! Leaves me speechless. Something is very wrong with this country.

        Bejah

        • Still Standing says:

          Hi Bejah. Im having a rest afternoon before a trip tomorrow so I Have enjoyed reading your posts. Where dd you go? You know me by know and the fact that I like to give different perspectives from time to time. Ive been interested in the bank bailouts since my husband was in banking before he retired.(no, he didnt OWN a bank. He worked at one. So, actually the government has made about $ 264 billion on the bailouts. Here is a link below to read about it. We always here the beginning of a story, but journalists rarely go back and report on the longitudinal outcomes. Here is the link:

          https://projects.propublica.org/bailout/

  4. anonymous says:

    Jane, can you please elaborate on the following, including how plaintiffs (injured with cases filed) with TVM manufactured by J&J might be affected: “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”?

    Being unfamiliar with preemption, protections, etc. and also being confused by the Medtronic ruling, I apologize if misunderstanding. Does this mean one or more of the companies may try to prevent further litigation or possibly not be held accountable for TVM injuries? How is it that FDA approval or classification can prevent litigation when one or all of these pertain to a product that caused injury:

    A. made from a material sold with label stating “not to be implanted in the human body.”

    B. few to no sizeable studies proving safety and effectiveness OR studies indicate significant failures and/or complications

    C. lack of or missing warnings to physicians and patients

    I also don’t understand how a company, aware of complications, can get by without thoroughly studying the removal of an implanted device. It seems many physicians assumed or were led to believe it was possible to completely remove TVM implants when, in fact, some are either extremely difficult to remove or cannot be removed without causing damage.

    Also, Jane, did the recent POP implant reclassification help or hurt current litigation (the plaintiffs)? Thank you!

    • Jane Akre says:

      Under Riegel v. Medronic, when Charles Riegel was harmed by the Medtronic product, it had been approved by the FDA through premarket approval. The FDA approval then, supersedes any litigation, and the maker cannot be sued. If mesh is reclassified to class III requiring PMA, AND if it is put on the market after 30 months….. then presumably the Riegel/federal preemption could apply. Those are a lot of hurdles to clear though….I’m not a lawyer, other readers who are are perhaps more artful in fully explaining the Riegel decision. Basically federal approval with a PMA trumps any state law challenges. What then if you challenge a PMA in federal court?

      • anonymous says:

        Jane – Thank you for the helpful explanation. I thought the ruling (federal preemption) could be applied at this time, which didn’t make sense. Thanks again!

  5. kitty says:

    Do u mean Barack Obama?

  6. kitty says:

    Wher the heck is msm? Did she get her settlement and leave the rest of us out to dry?

    • Bejah Blue says:

      I hope not Kitty but that is a very human, if unfortunate, response. It reminds me that we should make a commitment to donate to this website and perhaps a fund for victims if we win a case and/or receive a settlement. I hope some of us will do that. I am sure Jane would be grateful for any amount. Please think about this people.

      Bejah

  7. Bejah Blue says:

    I still do not understand how they can get away with preventing testimony of expert witnesses. They do it repeatedly and get away with it. Why? How?

    Bejah

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