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Day 28: Linda Gross v. Ethicon Verdict Day $3.35 Million

Day 28 Verdict Day!

Day 28 Verdict Day!

February 25, 2013 ~ Jurors in the Linda Gross v. Ethicon trial awarded the 47-year old woman from South Dakota and her husband $3.35 million today in an Atlantic City, New Jersey Courtroom.

Jurors have been deliberating 5 days now in the product liability trial.

Jurors decided the Prolift was not defectively designed by a 9-0 vote.

By a 7-2 vote the jurors decided there was a failure to provide adequate warning to Dr. Benson the implanting surgeon.

By a 7-2 vote jurors decided the Prolift was the proximate cause of injury to Ms. Gross.

By a 7-2 vote jurors decided there was no fraudulent misrepresentation to Dr. Benson, her implanting surgeon.

By a 7-2 vote plaintiffs proved a fraudulent misrepresentation was made to Ms. Gross and that was the proximate cause of injury to Linda Gross.

Linda Gross

Linda Gross

MONETARY AMOUNTS

What amount  of money compensates Linda Gross from her past pain and future pain of suffering, disability loss of enjoyment of life  $1.1 million.

For her past wages- $180,000.

For her future wages $500,000.

For the reasonable value of past medical services  $385,000.

For the reasonable cost of future medical treatment and household services $1 million.

Compensation to Jeff Gross $185,000 for loss of the companionship of his wife.

Punitive damages will now be considered by the court which could be five times compensatory damage or $350,000, which ever is greater.

The $3.35 million was awarded because Ethicon failed to properly warn of the risks of the vaginal mesh to Linda Gross and made fraudulent misrepresentations. The plaintiff did not prove the mesh had a defective design.

Linda Gross as jury verdict was read

Linda Gross as jury verdict was read

Late add here* Jurors were instructed by Judge Carol Higbee to call in at 4pm EST to see if the case was over or if they should return back tomorrow morning to decide punitive damages. Interestingly,  when the jury was polled, Juror #7 said he didn’t think the pain and suffering awarded ($1.1 million) was a “fair amount.”

Late Late Add* 4:15 pm- Judge Higbee has called the jurors back to the courtroom at 9:30 tomorrow morning (Tues, Feb 26) to discuss punitive damages.

Linda Gross and her attorneys say Ethicon, a division of Johnson & Johnson, produced a defective Prolift transvaginal mesh used to treat prolapsed organs, and failed to tell doctors about the dangers. The plaintiffs also claimed Ethicon used deceit and fraudulent misrepresentation to promote Prolift.

Attorney Adam Slater looks back at Linda Gross

Attorney Adam Slater looks back at Linda Gross

BACKGROUND

The Prolift Pelvic Floor system was an innovative new transvaginal mesh that for the first time would be sold pre-cut in a kit with hook like trocars of metal implanting devices.

Made by Ethicon, the medical device division of Johnson & Johnson, Prolift would use the Gynemesh soft prolene (PS) used for hernia repair.

During the trial jurors saw that the marketing team always worked closely with Research & Development and Regulatory Affairs with a targeted March 2005 launch date.  The date was important. Ethicon wanted to take advantage of the market and beat out the upcoming competition and charge a “premium price” for the Prolift, according to internal company records.

But as late as January 2005 the launch team was hearing from its French scientists who developed the TVM procedure (how to use new tools to place the mesh).  Evidence was presented that showed they suggested a different type of mesh be used to replace the Gynemesh because early indications on cadaver and animal testing showed a 21 percent and higher complication rate with Gynemesh placed in the pelvis.

Prolift kit

Prolift kit

Gynemesh was called the “worst of a bad lot” of meshes and some inside the company thought it caused too many complications.

Ms. Gross who had worked as a hospice nurse, is now unable to sit any more than 20 minutes. She has to self-catheterize in order to urinate and has chronic pain in her legs and pelvis. She has undergone 9 mesh removal operations and over “400 medical encounters” since the Prolift was implanted in July 2006.

Her story painted a sympathetic picture of a woman who does not resemble her former self.

Linda

Linda

What was not introduced before the jury was the fact that Ethicon decided to bypass any approval by the FDA and instead just began marketing and selling Prolift, under the radar.

On the stand, the head of Regulatory Affairs Sean O’Bryan said the company thought the mesh was similar enough to the Gynemesh used for hernia repair, even though the technical implantation was entirely different and the area of the body it would be placed was a new applications.

Ethicon did not run any human clinical trials and did not study how best to remove the mesh if there were complications.  Despite the red flags before launch, Prolift met its March 2005 date.

The case show how different “tiers” of doctors were chosen to be trained in Prolift. Some were “preceptors” used to teach other doctors on the new product. Often there was compensation for the doctors and large dinners and events to promote the product to new doctors. Within the company, the upper “tier” of doctors feared the lower “tiers” or less skilled doctors were not understanding how to implant the mesh in the “blind” procedure practiced during weekend cadaver teaching sessions.

An expert witness for Ethicon said Ms. Gross multiple removal surgeries caused her pelvic muscle to spasm and she never gave her body enough time to recover between surgeries.

Last year, Ethicon decided to remove Prolift and three other transvaginal meshes from the market in a phased stages over 18 months. An investigation by MDND recently found it can be purchased on eBay and is still sold overseas.

Last June, a California jury awarded $5.5 million to a woman injured by the C.R. Bard Avaulta mesh, another pelvic organ prolapse mesh that comes precut in a kit. That ruling is on appeal. (Story here)

So District West Virginia SealAs of February 25, there were 2,182 cases against Ethicon filed in New Jersey Superior Court and 3,887 consolidated in federal court in the Southern District of West Virginia.

Other cases naming Ethicon are filed in various state courts around the country. #

 

 

 

15 Comments

  1. `Tammy says:

    Heavenly Father, be with Mrs Gross and her family………

  2. God Bless Linda Gross … I am so pleased at the outcome. I believe this to be JUSTICE for all of us that have been damaged by this abominable torture instrument called Surgical Mesh …

  3. Anna says:

    Praise God…Thank you Linda for your bravery and strength.

  4. InAz says:

    Maybe not necessarily defective design but certainly a harmful chemical material were used to make the mesh.

  5. rose beck says:

    my prayers are with you. love ya linda lou!

  6. rose beck says:

    hope you and jeff will be home soon, prayers, love ya linda lou!

  7. Mary Wakefield says:

    Praise God! Maybe someday the pharmaceutical companies will stop using women as lab rats. There is no amount of money that can buy health. When you are mutilated and your health is taken from you, you can’t buy it back. Hopefully, the settlement will help Linda get the treatment and assistance she will need for the rest of her life. Not having to worry about finances will help ease her suffering. Thank God for the jury. Unlike, Ethicon and the other mesh makers, the jury had compassion and THEY cared about Linda.

  8. MarieAnn says:

    Praying for Linda and Jeff. I saw where they break down the award. The $185,000 to Jeff for the loss of companionship of his wife is pathetic. Proverbs 31:10-11. An excellent wife, who can find one? For her WORTH is far above jewels. The heart of her husband trusts in her,and he will have no lack of gain… My husband of 30+ years can’t believe that amount. To me it says something is very wrong with how women and wives are viewed in this society and there are six women on the jury. Very sad.

  9. terri says:

    I am so happy for Linda and her Husband, speaking from experence the award is nothing compared to what she has gone through,and will continue too. I pray her attorneys are good and honest,and make sure she receives as much of the award as possible.Many of the attorneys are taking advantage of the women,they are representing.Sad ,but true.Pray that Gods will be done.

  10. Maria Smit from the Netherlands (Europe) says:

    I am very happy with this outcome, though for the poor Linda and her family it would have been far better if none of this would have been necessary and Linda would have been able to live her life the way she used to, without disabilities or pain. I hope one day there will be a medical solution for all the – by vaginal mesh – damaged women all over the world, who suffer severe pains and major functional problems day and night.

    Because all these women have to make an awful lot of medical costs and most of them are not able to work anymore, it seems completely normal and reasonable to me that all the mesh sufferers worldwide are to be attributed an significant amount of money.

  11. Shelly Heuer says:

    Congrats Linda, I truly wish this was bringing you relief from even some of your suffering. My prayers are with you now and in the years to come. I pray this will make things a little easier for you and your family. Shelly

  12. I have just endured mesh removal and urethra reconstuction this past week in The United Kingdom.

    This evil stuff has decapitated my bladder neck and had all but destroyed my urethra.

    Linda Gross deserves every penny and more.

    We women The United Kingdom do not have anyone to represent us for mesh litigation. I wonder why?

    One firm in London Rosenblatts who where supposed to be dealing with mesh litigation have had all my medical records for one and half years and have not had the decency to return them to me.

    Other women also given them personal papers which have not been returned and for some women there timescales have run out and still these solicitors do not have the decency to tell us that they are not doing mesh litigation for us women.

    It all sounds so corrupt and a cover up.

    I am so glad that for Linda and her family this courtroom ordeal is over and to say that she is a very brave woman.

    Teresa Hughes meshies united uk

  13. Nonie Wideman says:

    I am happy for Linda…but I am not happy that the product was not established in this trial as being defective….a permanent implant should not be able to degrade as does polypropylene meshes do when attacked by the chemicals produced by a chronic foreign body response in people who have baciscally an allergic response to polypropylene…….without a test to ascertain biocompatability in all patients to recieve the mesh implants, this implant material should have at least been classifed as a class 3 device to alert the medical community of the seroiusness of mesh complications that can arise in approximately 30% or more of the population implanted with polypropylene based meshes……….I am hoping another lawyer in another mesh trial will be able to establish mesh is not always a biocompatible product and therfore is defective….

  14. George says:

    Nonie,

    The information is out there already, check out the Material Safety Document for Teflon/PTFE used in many composite mesh devices to reduce adhesion growth.

    Dupont is trying get their name out of the mesh debacle – they own the Teflon brand.

    I guess the FDA is illiterate .

    MDS Teflon® PTFEVersion 2.2Revision Date 05.07.2006 Ref. 130000019186

    16. OTHER INFORMATION

    Recommended restrictions

    Do not use in medical applications involving permanent implantation in the human body. For other medical applications see DuPont caution bulletin No. H-50102.

    http://msds.dupont.com/msds/pdfs/EN/PEN_09004a2f806ab36e.pdf

    http://www2.dupont.com/FuelCells/en_US/assets/downloads/h50102.pdf

    Greed trumps health in the medical device word G

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