Ethicon Loses $35 Million Prolift Pelvic Mesh Case in Indiana!

//Ethicon Loses $35 Million Prolift Pelvic Mesh Case in Indiana!

Ethicon Loses $35 Million Prolift Pelvic Mesh Case in Indiana!

Mesh Medical Device News Desk, March 9, 2018 ~ Once again Ethicon has challenged a mesh-injured woman in court and once again, the healthcare giant has lost!

The product liability trial of Kaiser v Ethicon began in Hammond, Indiana, February 26th.

One of the earliest pelvic mesh product liability cases filed eight years ago in multidistrict litigation in Charleston, WV, the case was remanded back to federal court to the Northern District of Indiana before the Honorable Judge Philip P. Simon to finally be resolved. 

On Thursday, March 8, the jury delivered its verdict in Kaiser’s favor – $35 million which includes $25 million in punitive damages.

The six women, three men jury returned the verdict after approximately six hours of deliberation.

In doing so they determined that Johnson & Johnson and its Ethicon medical device division, marketed, sold and recruited physicians worldwide to implant the Prolift pelvic mesh, an “unreasonably dangerous” pelvic mesh, defective in its design and in its warnings to end user physicians.

Thomas O. Plouff

Kaiser, 69, was represented by attorneys Ed Wallace (Wexler Wallace, Jeff Kuntz (Wagstaff Cartmell) and Indiana attorney Thomas O. Plouff, of Costello, McMahon & Burke, & Murphy Ltd., who said in a press release:

Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrong doing and they did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful  complications from mesh in their pelvic area.”

This was not the first trial for Prolift, a large, controversial polypropylene medical device used to treat pelvic organ prolapse (POP). It has been found defectively designed in both the Hyrmoc trial in New Jersey, the Beltz case in Philadelphia,  and the Hammons case in Pennsylvania.

J&J quietly removed Prolift from the market in June 2012, along with three other pelvic meshes, to avoid conducting three-years of post-market surveillance.

See Prolift trials, Gross, Hrymoc, and Hammons below.

 

PLAINTIFF BARBARA KAISER

Dr. Gregory Bales, implanting physician

Plaintiff Barbara Kaiser, was implanted with Ethicon’s Prolift mesh on January 27, 2009. She was being treated for prolapse as well as SUI (stress urinary incontinence) and Dr. Gregory Bales of Munster Community Hospital in Munster, Indiana decided the extra-large Prolift, with its six polypropylene arms should be the mesh of choice.

Kaiser suffers dyspareunia (painful sex), pelvic pain, levator myalgia, bladder spasms and groin pain. She underwent one attempted revision surgery.

The lawsuit claimed the polypropylene implant is incompatible with humans and leads to an immune reaction and severe adverse reactions.

“Defendants knew that the pelvic mesh products were not safe for their intended purposes and that the pelvic mesh products would cause, and did cause, serious medical problems, and in some patients, catastrophic and permanent injuries,” the complaint said.

Canadian Pathologist Vladimir Iakovlev was among the experts who appeared at trial. He studies the effects of mesh on the body. See more on Iakovlev here.

Ethicon said it was not to blame for the alleged injuries.  J&J continues to stand by its product, said a company spokeswoman. 

Bales, in his deposition, said he was probably one of the early users of Prolift, which came onto the market in March 2005. Bales said he had performed a couple hundred procedures with either total Prolift System or the Anterior Prolift System which incorporates the bladder.

Dr. Bales received some of his training on Prolift by Vince Lucente MD, a urogynecologist who has made millions as a consultant to Ethicon and has trained new doctors on the procedure and product.

Lucente’s name has been heard in the previous mesh trials of Linda Gross and Joan Budke where Dr. Lucente trained their doctors as well on the Prolift.

See Lucente mentioned in the Budke trial here and in the Gross trial here.

Dr. Vladimir Iakovlev on mesh eroding through the bladder

Dr. Bales admitted in his deposition that had he known about the complications associated with the use of Prolift, he “may not have started using the Prolift.”

Dr. Bales admitted that the “majority of the times the reps would be present,” referring to sales reps in the operating room. 

Ms. Kaiser later learned from Raphael Albert, MD that her complaints of lower pelvic pain could be related to the Prolift.

After her implant, she was attended by Dr. Douglass Hale, former head of the American Urogynecological Society (AUGS), who eventually stopped using Prolift.

Hale admits in his deposition  that he was a consultant to Ethicon as part of the original TVT studies (Tension-free vaginal tape) and that he authored a study that shows a 16.7% dyspareunia rate with Prolift pelvic mesh.

 

REMANDED 

Ed Wallace, attorney for Kaiser, Wexler Wallace

The Kaiser case was one of the earliest ones filed in U.S. District Court in Charleston, West Virginia where a pelvic mesh multidistrict litigation consolidated thousands of cases for trial.

The Kaiser case No. 2:12-cv-00887, was remanded to the Northern District of Indiana with a new case number 2:17-cv-00114  on March 15, 2017.

Lawyer Ed Wallace, one attorney for Ms. Kaiser says, “This is one of the first cases remanded and yes it will start to happen with others, hopefully.”

After eight years in his West Virginia federal court, Judge Goodwin has announced he wants the pelvic mesh MDL (multidistrict litigation) to finally be resolved.

Because Ms. Kaiser was implanted in Indiana, the Indiana Products Liability Act must be followed.

It requires the plaintiff to show a product is defective and unreasonably dangerous through design defect, its manufacturing defect or a failure to warn, all counts in the Kaiser claim along with negligence, strict liability defective product, common law fraud,  fraudulent concealment, constructive fraud, negligent infliction of emotional distress, breach of express warranty, breach of implied warranty and gross negligence.

The jury decided that Kaiser established her claims, that Prolift mesh was defective in design and there was a failure to warn doctors.

Also jurors agreed that J&J was malicious or wanton and willful in its disregard of the Kaiser’s rights.

 

 

 

TRIAL PREPARATION

In January of last year, Plaintiffs asked the court to exclude evidence related to the FDA and its 510(k) clearance process that allows most medical devices on the market with no clinical trials to assure safety and efficacy. There was no mention of the FDA at this trial and no introduction of evidence about spoliation, that is, the destruction of documents by J&J that were on a litigation hold for pelvic mesh cases.

Plaintiffs felt any mention of the U.S Food and Drug Administration (FDA) might add legitimacy to the device that had skirted through safety assurances through the fast-track 510(k) clearance-to-sell process.

To explain how the majority of medical devices make it to market would have required an extraordinary amount of time to delve into the FDA’s process that requires a manufacturer name a “predicate device” already in commerce similar to the new device. With that designation, no clinical trials are required unlike the FDA requirement for a new drug clearance.

For its part, the defendant wanted to exclude the “522 letters.” In January 2012, the FDA issued a mandate to mesh makers which required them to show the safety of their POP meshes in order to stay on the market.

What resulted was a mass, yet quiet removal of most POP meshes from the market including the Prolift, relieving the mesh makers of conducting expensive clinical trials proving the products were safe.

Prolift, MedTech Marketing

Never mind the thousands of women, like Barbara Kaiser, who live today with POP polypropylene meshes placed in their pelvic region and its consequences.

In January 2016, the FDA moved to reclassify POP mesh as a high risk device, requiring clinical trials to prove safety and efficacy.

To date no new POP meshes have attempted to clear that hurdle.  ###

 

LEARN MORE:

MND, December 14, 2017, Jury in Hrymoc Pelvic Mesh Trial Returns $15 Million to Plaintiff
https://www.meshmedicaldevicenewsdesk.com/hrymoc-product-liability-mesh-trial-jury/

MND Prolift Pelvic Mesh found Defectively Designed, December 21, 2015
https://www.meshmedicaldevicenewsdesk.com/prolift-pelvic-mesh-found-defectively-designed-plantiff-awarded-5-5-million-punitives-to-be-determined/

MND, Gross $11.1 Million Jury Verdict Survives Final J&J Challenge
https://www.meshmedicaldevicenewsdesk.com/linda-gross-11-1-m-jury-verdict-survives-final-jj-challenge/

 Radar- Documentary on Prolift, The Netherlands, February 22, 2017
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/

MND December 22, 2015, Philadelphia Prolift Mesh Case Yields $12.5 million Verdict for Plaintiff
https://www.meshmedicaldevicenewsdesk.com/philadelphia-prolift-mesh-case-yields-12-5-million-verdict-for-plaintiff/

MND, February 22, 2017 Documentary: J&J Knew Risks of Prolift
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/

MND, December 21, 2015, Prolift Pelvic Mesh Found Defectively Designed
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/

MND, January 9 2015, The Launch of Prolift Pelvic Mesh- What the Company Knew, Budke Trial
https://www.meshmedicaldevicenewsdesk.com/the-launch-of-prolift-pelvic-mesh-what-the-company-knew/

MND, January 23, 2018, Australia Pulls Ethicon TVT Mesh Devices from the Market
https://www.meshmedicaldevicenewsdesk.com/australia-pulls-ethicon-tvt-mesh-devices-market/

MND, June 5, 2012, Four J&J Vaginal Meshes Named Will be Removed from Market
https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/

MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders 
https://www.meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests/

Hale, Jones, Woodman, Does Prolift System Cause Dyspareunia?
https://www.ncbi.nlm.nih.gov/pubmed/18977469

Iglesia, Vaginal Mesh for Prolapse, a Randomized Controlled Trial, 2010
https://www.ncbi.nlm.nih.gov/pubmed/20664388

 

 

 

By | 2018-09-05T15:16:54+00:00 March 8th, 2018|Legal News|27 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

27 Comments

  1. Anon February 20, 2018 at 6:32 pm - Reply

    Confusing…This case shows closed on 2/22/2017 on the MDL 2327 caselist.

    • Jane Akre February 20, 2018 at 8:09 pm - Reply

      It was filed in Indiana in March 2017, so likely it showed it closed in the MDL. It was no longer in that venue.

      • Anon February 20, 2018 at 10:11 pm - Reply

        Thank you Jane…for the explanation.

      • Anon March 5, 2018 at 9:11 am - Reply

        So…..Jane, Is this true of other cases showing closed? Has other cases been remanded back to their originating districts for trial and we (mesh victims) are left in the dark as usual.

        • Jane Akre March 5, 2018 at 12:16 pm - Reply

          Not necessarily. You made be grouped in a settlement mode,,,,, astonishing that law firms don’t give you regular updates. Demand it!

  2. Susan February 23, 2018 at 9:51 pm - Reply

    Received plaintiff packet yesterday, with instructions to fill and get back to attorney as soon as possible, is it possible my case has been chosen to be a representive case? Faxed back this morning.

    • Still Standing February 25, 2018 at 11:42 pm - Reply

      Susan, is your case part of the MDL in West Virgnia? There are no more representational ( bellweather) cases that will be heard here. What plaintiff packet did you have to fill out and submit as soon as possible? Was it the plaintiff fact sheet? These are lengthy and detailed forms that ask you to attest to your medical history, including each mesh related surgery or hospitalizations. You must supply dates, physician information ( name, address, phone numbers), etc. these sheets should be explained in detail by your attorney and they should be available to clarify any questions you have. These sheets become evidence in your case, your testimony to what happened. They require attention to detail. I’m pretty sure mine had to be notarized. My attorney spent a couple of hours via phone going over the questions with me to make sure I understood them and they sent a large prepaid envelope to return it in when I had it completed. It certainly took me more than a day to complete. I was a Wave I case for a different manufacturer.

      Has your case landed in a Wave? These are cases that have been ordered by the court to be “trial ready”. This does not mean that it will go to trial. It is a way of getting the plaintiff and defense attorneys to enter serious settlement talks. However, In this MDL, it appears that most companies have already set their injury tiers based on number of surgeries so the fact sheet primarily serves as a confirmation of your surgeries. UTIs or other non surgical complications carry no weight . Unfortunately, preparing your case for trial adds significant actual case costs that will be ultimately deducted from your award or settlement. They are not part of the attorney’s contracted contingency fee. These additional costs come out of your net amount. If you have to move into the next phase of litigation to full discovery with depositions, these costs are substantial. Mine were $85,000 added to the attorney 40%. Yep, a lot of money.

  3. Susan February 23, 2018 at 9:54 pm - Reply

    I was implanted with an ethicon TVTO, that was supposed to have been pulled from hospitals 2 years before it was implanted. This was the biggest mistake of my life, my marriage is hanging by threads

    • Jane Akre February 25, 2018 at 4:31 pm - Reply

      Susan, I don’t understand what you mean when you say it was supposed to be pulled from hospitals. TVT-O is still on the market. Are you referring to another country outside of the US or some hospital in particular that banned its use? Thank you.

  4. Susan February 23, 2018 at 9:56 pm - Reply

    Implant Feb.2014 revision March 2014 revision April 2014 UTI’S every 17 days like clockwork. Partial removal October 2015.

    • Jane Akre February 25, 2018 at 4:30 pm - Reply

      Please check out the d-mannose offer through MND for those repeat UTIs. You can find the code here to the Amazon product.

      https://www.meshmedicaldevicenewsdesk.com/mnd-discounts-uti-fighter-d-mannose/

      • Gay Courter March 9, 2018 at 10:05 pm - Reply

        A simple urine culture should indicate if you have an antibiotic resistance issue like I did. There are some new treatments including Manurol which I take weekly and the UTI is conquered.

  5. Anon February 26, 2018 at 5:03 pm - Reply

    Did this trial begin today? anyone!

    • Jane Akre February 27, 2018 at 3:56 pm - Reply

      Yes Monday the 26th…I was going to have someone there. I’ve not heard from her.

  6. Anon March 9, 2018 at 8:09 pm - Reply

    Great News…….the awarded amounts keeps getting better and better.

  7. Chuck March 10, 2018 at 10:37 am - Reply

    Does anybody know of a Prosima case
    that has been successful for the
    plaintiffs?

  8. Dawn March 10, 2018 at 6:40 pm - Reply

    Happy J&J lost…. but why is it when they prove Mesh is harmful in one case that it can’t just be applied to all ?
    So much wasted time and money.
    The majority of plaintiffs will never see anything ????????????

    • Jane Akre March 11, 2018 at 11:17 am - Reply

      You make a lot of sense. One Pinto car found defective meant they all came off the market!

      • Dawn March 12, 2018 at 2:58 am - Reply

        Exactly… they didn’t need another 1000 to blow up to prove they weren’t safe.. but let’s slap another million of these mesh slings in women a make more money is the motto.

    • Jane Akre August 2, 2018 at 12:55 pm - Reply

      You make a good point,,, if it defective in that case, doesn’t that mean its defective in ALL cases?

  9. Susie March 16, 2018 at 12:06 pm - Reply

    Have you heard TVT-O trials? Seems to me this product have a lot of complications especially on groins areas. Why is it not been tried on court lately? And cause a lot of infections and hard to find during surgery to remove it.

  10. vickie March 16, 2018 at 11:51 pm - Reply

    Does anyone know of a doctor in Indiana that will remove mesh ? Could you please give me names. Thank you

  11. Jimmy March 17, 2018 at 12:49 am - Reply

    I dont understand. So did she only have one revision surgery and got that much?

    • Anon March 17, 2018 at 6:32 pm - Reply

      Jimmy…The answer to your question is Yes! only one attempted removal.

      • Jimmy March 23, 2018 at 1:40 pm - Reply

        So my mothers case was told it wasnt worth anything because she only had one attempted removal and her dr wont do more because of the fear she might bleed to death. So her lawyer has lied to my mother?

        • Still Standing March 24, 2018 at 3:11 am - Reply

          Your mothers case is not Barbara Kaiser’s case. Each case has to stand on its own merits and needs a law firm that can put up the money for a trial and can economically survive the possible loss of that court case

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