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Defense Granted Punitive Motion in J&J Pelvic Mesh Case

mallet and moneyThe pelvic mesh death case of Budke v. Ethicon continued Monday in a Camden Co. Missouri courtroom with the defense granted its motion to deny punitive damages to the plaintiffs.  

Last Friday, attorneys for  Johnson & Johnson, the parent company of Ethicon, requested that punitive damages be denied and the case be thrown out in a directed verdict in favor of J&J.  Defense claimed attorneys for the Budke family did not make their defective product case.

The directed verdict motion was denied, but punitive damages will not be allowed.

Joan Budke was implanted with a Prolift pelvic mesh to treat incontinence in April 2008. A series of infections originating in the pelvis had traveled to lodge in her lung, according to the plaintiffs’ theory. Budke died of a septic emboli and pneumonia in August 2009.

The only previous pelvic mesh trial involving a Prolift mesh, the Linda Gross case in Atlantic City, New Jersey nearly two years ago, saw a jury award of $7.76 million in punitive damages of a total $11.1 million jury award.  Punitive damages are intended to send a message to a corporation that its misdeeds will not be tolerated.  In a civil action where corporate executives are not imprisoned for wrongdoing, punitive damages are one way to send a clear and convincing message to a $70 billion a year company such as J&J.

DEFENSE CASE USES SAME EXPERT AS LINDA GROSS CASE  

Dr. Elizabeth Kavaler, from Linda Gross case

Dr. Elizabeth Kavaler, from Linda Gross case

The Budke v. Ethicon case in may ways echoes the Linda Gross case.   On Friday, Piet Hinoul appeared on the stand.  Dr. Elizabeth Kavaler from the Gross case appeared this week, Your editor is not in the courtroom any longer but is receiving reports from court watchers!  THANK YOU COURT WATCHERS.

Dr. Kavaler might be familiar. The Manhattan-based urogynecologist examined Linda Gross for the defense in the Gross v Ethicon trial in New Jersey Superior Court which concluded February 2013 with an $11.1 verdict in favor of the plaintiffs.

Elizabeth Kavaler, is appearing in this Camden Co Missouri courtroom on behalf of Ethicon.

Here are excerpts from the last time Dr. Kavaler appeared for the defense.  This is from the Linda Gross trial not the Budke v. Ethicon case.  Both women had the Prolift implanted.

DEFENSE CASE BUDKE V. ETHICON 

The  New York City-based doctor practices medicine at Lenox Hill Hospital and Cornell Medical School where she also teaches. About 80% of her patients are women who have problems with prolapse, incontinence, infections and pain. She told the jury in the Gross case she’s treated all kinds of patients with pelvic floor dysfunction.

See Background here: 

http://meshmedicaldevicenewsdesk.com/day-22-linda-gross-v-ethicon-case-wraps-with-expert-refuted

And here: 

http://meshmedicaldevicenewsdesk.com/day-21-linda-gross-v-ethicon-expert-says-prolift-did-not-injure-gross

Dr. Kavaler told jurors in that case that the cause of Ms. Gross’ pelvic pain was due to the number of pelvic surgeries she endured after the Prolift implant was used to treat prolapse in 2006.  Eventually she had many pelvic surgeries in an attempt to remove the Prolift after pelvic pain became intense and unrelenting.

Dr. Kavaler, indicating that in the Gross case, the Prolift had corrected the problem it was intended to treat.

“That spasm pain is what really has created the issues going forward.  Her body didn’t get a chance to heal from those spasms and she had operations and they continued to cause trauma and the spasms were kicked up. The Prolift was not the source! It’s the pelvic floor surgery. If she had time to heal I don’t think she’d be in the position she’s in,” said the doctor, negating the entire defective product case of Linda Gross before the jurors.

But a muscle spasm is painful and difficult to isolate because it’s so deep inside, she said. Similar to a back spasm, this pelvic floor dysfunction can cause difficulty urinating, defecating and pain with sexual activity. What causes it, asked Jones. Stress could be a factor,  so could surgical trauma.

FROM THE GROSS TRIAL 

At times Dr. Kavaler seemed to be second guessing the medical care Linda Gross received. Three doctors performed surgery to remove mesh, which the urogynecologist said she wouldn’t have done.

Describing pelvic spasms resulting from trauma of surgeries the doctor said, “They are painful. It takes time. It takes patience for these to resolve and mostly rest and recovery not necessarily lying in bed. The pelvic floor has to have a chance to quiet down. She’s had two surgeries in addition to the original one. The removal of mesh seems to be making it worse. The location of pain is not over the site of the mesh.”

Dr. Kavaler insisted that mesh does not move around within the pelvic area. “It does not have a life of its own,” she said.

In the Budke case, Ms. Budke had two remotal attempts. Her implanting physician Dr. Simpson excised the center portion of the Prolift mesh in January 2009. Dr. Neal excised or removed one of the mesh arms.

 

Christy Jones, from Linda Gross trial Feb 2013

Christy Jones, from Linda Gross trial Feb 2013

From the Linda Gross case – Christy Jones, attorney for Ethicon asked: ‘If she didn’t have pain before the Prolift surgery, how can you say the Prolift and mesh associated with Prolift didn’t cause her pain?”

Kavaler: “If she had pain from the Prolift, taking it out would help, but her pain got worse.”

Jones closed with her witness: “Based on your training and experience, was Prolift an effective medical treatment for her pelvic organ prolapse?  Yes it was, said the doctor.

Jones: “Did Prolift cause the plaintiff’s pain we’ve been talking about this morning?”

Kavaler: “In my opinion it is not the source of her migratory myofascial pain.”

 

BACKGROUND ON ELIZABETH KAVALER

In the Linda Gross case – Adam Slater established Dr. Kavaler charged $7,000 for the day of testimony and another $400 an hour to prepare for the case. But there was more.

Slater: “You’ve been an expert witness in 20-25 cases, all but one for the defense?

Kavaler: “Correct.”

Dr. Lucente, preceptor for Ethicon

Dr. Lucente, preceptor for Ethicon

Slater recounted her deposition where she said she “was a big mesh user.” That is what got her the attention of Dr. Vincent Lucente, an Ethicon consultant, who introduced her to Ethicon. Dr. Kavaler was driven to the company headquarters and attended a dinner in the Meat Packing District in New York City where she said she wanted to talk to other doctors.

After first being contacted by Ethicon in 2009, she began teaching courses for the company on the use of another mesh, Prosima.  She was also hired to proctor a cadaver lab.

Slater made the point – Before the Prolift, Linda Gross had no pelvic pain, no dyspareunia, no pudendal nerve damage. Correct said the doctor.

“You would have treated her different than other doctors right?’ he asked.  “I have the benefit of hindsight,” she said not wanting to disparage the treatment Ms. Gross had received.

Slater; “Linda is taking the advice and guidance of her doctors right?”

Kavaler: “Yes she is.”

Slater: “They are trying to deal with a very difficult situation.”

Kavaler: “Yes they are.

Slater said and the doctor agreed that there is a lack of any information about mesh extrusions, removals and Ethicon (Johnson & Johnson) was not informing surgeons then and even today what to expect.

Slater: “In 2006 there was much less information then there is now right?

Kavaler: “Yes, that’s right.” 

In a heated moment Slater and Kavaler disagreed over whether mesh moves. While mesh extruded in Linda’s body the doctor said mesh finds the incision line and extrudes there. Often it does not cause problems and she leaves it behind.

adam and kavalerSlater: “You certainly don’t think it’s a good thing for Linda to have pieces of mesh around her pelvis?”

Kavaler:   “I think it’s more hurtful to go after them.”

Slater: “He found mass of mesh and scar tissue actually enveloped one of her ureters.  He thought it was reasonable. It’s not normal for the mesh to envelope the ureter is it? Is it reasonable that a doctor from the Mayo Clinic remove it? It’s reasonable right?

Kavaler: “That’s not what I would have done.”

Slater: “Is that according to the Ethicon consultant book? Leave it in and hope for the best?”

She had a catastrophic outcome after her Prolift implant wouldn’t you agree, said Slater.

Dr. Kavaler: “I’d say she is in an unfortunate and painful place, I agree with that, I don’t agree the cause is the Prolift.”prolift box 200

On cross examination, Ethicon attorney Christy Jones (also representing the company in Butke v. Ethicon) asked, considering all of the procedures Linda Gross endured, would anything be considered to be a contraindication for another pelvic surgery involving Prolift?

“No,” answered Dr. Kavaler. “I think Prolift was a very good option for her.”

 

 

 

31 Comments

  1. Suzanne McClain says:

    I certainly hope the jury understands the repercussions of this, and makes therm pay dearly in compensatory damages! Mrs. Budke’s family deserves to be dearly compensated. The judge obviously has no compassion, and no common sense.

    • Aaron Leigh says:

      I don’t think the can understand the repercussions when they are not allowed to know extremely important facts like:

      1) Prolift was VOLUNTARILY taken off the market by JnJ.

      2) JnJ has 30k other cases pending in federal court.

      Now our juries are not even being given informed consent to make a good decision!

    • Kitty says:

      didn’t this happen with Linda Batiste?

  2. What a travesty of justice! Our laws are convoluted to protect the established businesses and corporations. It is like a body with arteries that are filled with calcium buildup: the original structure can no longer function as intended. Johnson & Johnson and other medical device/pharma companies are not good corporate citizens when they do not abide by free market principles that compete fairly so that the best product is delivered to the consumer at the best price. Suppressing patient outcome information of severe, permanent and irreversible harm so that doctors continue using surgical mesh and patients go like lambs to the slaughter because they are fed false information should be criminal. It is immoral! J&J knows that juries would be reviled by their business practices if they knew the truth. The WHOLE truth!

    • Terri White says:

      Seems to me the judge is protecting J & J. First he knows that there are thousands in the wings that have been effected by this product . He’s even admitted to not understanding whats going on.How could he make an informed decision ? Also knowing what has been kept from the jury. ALL THIS IS JUST WRONG !!! People are getting away with murder I KNOW IT, THEY KNOW IT, AND YOU KNOW IT !!! Pray God what is the answer ?

    • Aaron Leigh says:

      It is 100% immoral and 100% unethical. My entire family has been sent to slaughter by this assembly line of turned heads with blind eyes.

  3. Toni says:

    The injustice was perpetrated originally with the Pharma Co and then you have the Doctors the FDA and then it flows right down into the court system. There is so much corruption in every part of this that it makes me sick. Why should a judge have any say as to what can and can’t be brought out in court. Why can’t we tell them the whole truth and nothing but the truth. The media is also slanted do you think they want to loose advertizing dollars from these company’s that pay the media to push thier products. Were does it end. What has the foundation of our great nation come to. I believe in my country and the laws and ways of life, but I am fastly losing faith in our broken system. How do these people sleep at night. I know I don’t sleep well but it is because I am in constant pain . Apparently the world has made these people to loose some basic characteristics like a contience.

  4. Annumous says:

    I’m not getting this we have another Judge trying his best to get these manufactures to settle there mesh cases as these manufacturers are losing mesh cases as some are taking responsibility for the damages the mesh has done.Here this Judge says he’s confused surly he has talked to at her Judges over this case or at least read up about other mesh cases this is just horrible how they have put this poor family through this now they are bringing up a lost trial to see if they can benefit on that case to something has to change.

    • abandoned says:

      Perhaps he has talked to other Judges and that is the problem. Perhaps he has talked to Judge Goodwin. Perhaps, we need to see financials for Judges sitting on these cases. Perhaps, these decisions need to go to the Supreme Court, ask the Governors of each State to intervene, petition the Attorney Generals, start a HELP FUND ME and go Viral seeking reward money as an offering for Snitches to come forward and help with prosecutions….???

      Maybe start a FUND MY VOICE and ask people to picket in front of these courthouses to get Media, Jurors, and Judges attention. The defense knows we can’t do it, because we are crippled, sick and broken. GOD CAN send voices for Justice in our places.

      God is Greater than any of this…we must thank him for those who have gone against the system and spoken as witnesses on our behalf. We must ask him God to expose and reveal every dirty, greedy, lie and secret through all means possible.

      This is nauseating, unbelievable and disheartening. WE MUST STAY STRONG, BE CREATIVE, ASK EVERYONE THAT KNOWS SOMEONE to HELP SEE THAT JUSTICE IS SERVED. WE MUST PRAY THAT GOD WILL CHANGE THIS JUDGES HEART.

      • David says:

        Perhaps the U.S. government (via its federal judges and elected officials) is simply not interested in the human/civil rights and safety of its citizens (or in legally upholding its international obligations) and this issue needs to go before the United Nations, as a formal human rights abuse, to be effectively addressed.

        • David says:

          If everyone is willing to work together, there is a pathway through international law, which, I strongly believe, could bring about the meaningful change needed. To disrupt how long-term/permanently implanted, risky or dangerous medical devices are currently being marketed to patients (through the physician learned intermediary), and ultimately regulated on the pre-market side –to a future reasonable assurance of safety and effectiveness, could bring the global medical device industry to its knees. What justice can truly be found in U.S. Courts? –as this industry will only continue to be allowed, by the U.S. Government and other country’s governments, to prey upon the vulnerabilities of more, future unsuspecting patients.

          The satisfaction of justice = the contentment in knowing that there was meaning to your own suffering. Pain, therefore, can be more bearable in knowing that you (your experience lived) made a difference in preventing this industry’s deceptive, predatorily targeting of more future unsuspecting patients through use of its regressively trained surgeons. That, to me, is the face of justice.

  5. Aaron Leigh says:

    Our doctors don’t protect us.

    Our medical system doesn’t protect us.

    Our Congress doesn’t protect us.

    Our Executive branch doesn’t protect us.

    Our Judicial branch doesn’t protect us.

    Our “Free Press” is absent, except for the financial trade press, after the verdicts.

    How can we protect ourselves, in knowing the notion of informed consent doesn’t protect us.

    What is our next step?

    This is unacceptable behavior for an elected official.

    PERIOD.

  6. Aaron Leigh says:

    This is an absolutely untrue statement, for how else are inevitable erosions and migrations of the mesh to be accounted for?! These facts are proven in the records of many patients and doctors!

    Dr. Kavaler insisted that mesh does not move around within the pelvic area. “It does not have a life of its own,” she said.

    • Bev says:

      Well maybe mesh does not move. But the nearby organs do. My mesh cut my blatter, vagina wall, and bowels. That just what is in my medical records.

      It does harbor inflections and interfers with the nervous system. Further it renders women unable to work, have good sex, and causes a great deal of pain and makes urainary incontinence much worse.

      So there it is, this product does not solve the problem it was intended to solve.

    • David says:

      Blame shifting: “a tactic to always push fault on another person”.

      http://dictionary.reference.com/browse/blame%20shifting?s=t

      Or blameshifting: “the act of transferring responsibility for an error or problem to another”.

      http://dictionary.reference.com/browse/blameshifting

      • David says:

        “Who” was it, upon its “[undermining of the] doctor-patient [relationship],” that carried out its widespread, deceptive, systematic, predatory “exploitation of [unsuspecting] women” as a crime against humanity?

        “Who” has “[profited] from the unethical and illegal direct solicitation of women,” via its direct societal control over the practice of medicine, which has “undermined [the] doctor-patient [relationship]”?

        “Who” was it that carried out its predatory marketing “tactics that have violated women’s rights, put women at risk, and jeopardized the integrity of the judicial process”?

        “Who” is it that now wants to payout “30 up to 40 thousand dollars” towards a human being’s life-time of pain and complications ahead, or to each women currently, “adversely” experiencing its premeditated abuse – but not for every women exploited when her rights and life-time of safety were violated, following its intent to exploit a profit opportunity in her body?

        And, who is it that who continues to “[lie]” “an apparent effort to legitimize [its] message or [to again] engender [a] woman’s trust”?

        A HINT: “Corporations are people, my friend” as Mitt Romney said.

        “Not only do corporations have rights, their rights are stronger than yours,” as stated in the article: “Corporations Are People, And They Have More Rights Than You”…And “protecting women’s rights, according to the Court, isn’t a good enough reason for the government to force a business corporation….”

        http://www.huffingtonpost.com/adam-winkler/corporations-are-people a_b_5543833.html

        • Jan Urban says:

          “There is a higher court than the courts of justice and that is the court of conscience. It supercedes all other courts”. Mahatma Gandhi Satyagraha “adherence to truth” This is justice…and without adherence there is no justice.

    • Mesh Injured says:

      I wonder how willing parties (including Dr. Elizabeth Kavaler) will be to have the mesh kits they defend implanted in themselves, or any loved one. I am sooo thankful that Judge Hass didn’t allow a directed verdict to end the trial.

      I fear for the women of New York… and I am so thankful that Dr. Kavaler is not my physician. I am saddened that the truth has to be squelched in our honorable courts of law. We can’t inform the jury of the thousands of injured patients, yet a female “expert” can regurgitate pharma rhetoric. It would be interesting to know how many of Dr. Kavaler’s mesh implant patients are doing well. Is a limit on how many times an “expert” witness can testify? Or any criteria to determine who qualifies as an expert witness? I would hope that mesh trials don’t end up creating new professions for some expert witnesses.

  7. Dawn says:

    DOES NOT MOVE???

    Explain to me then how mine managed to wrap itself around both sides of my pelvic bones…

    FBR- the body does not like this toxic product and tries to flush it out. Hence, all the infections and autoimmune disorders produced by this polypropylene.

    Why are the lawyers not fighting this ?

  8. John says:

    Maybe the next step for the Budke family could be a wrongful death civil suit against J&J, maybe, just maybe J&J’s lies and document destruction would be brought out into the light of truth there

  9. Annumous says:

    How is it that the defendants seems to be getting everything said with no objections I don’t understand was the lawyers ill prepared for this case in other cases over mesh the lawyers for the mesh victims were loud and spoke to the jurors.What bothers me is the fact that professional people are going on the stand taking an oath and being deceptive as they know the truth but would rather have a pat on the back and a few bucks in there pockets.This company can not get away with this they are powerful they send there bullies to do there dirty work in the court rooms I remember a dictator in the thirties and forties who thought he was powerful and sent his SS to do his dirty work and look what happened to him we will prevail stay strong it’s not over until it’s over.

  10. stopmeshimplants says:

    A woman died.

    Joan was a wife and mother. Her life mattered.

    These court proceedings, attorney statements and expert testimony are absolutely sickening. I pray this family gets justice and the truth comes out. I guess am waiting for a miracle because no one, and I mean no one, really cares about the truth. This is so incredibly sad……

  11. Linda says:

    It’s time to turn out our u-tube videos. We need to include the facts from the FDA warning. We need one on the destruction of records. We need one on the number of women. We need one on the msds sheet that says not to be used internally. Continue to be hopefull, positive, and pray for positive results for this family. Someone pick a deadline for the utube videos . I decided I am going to put a big sign right in front of my house about mesh and Johnson and Johnson. Albuquerque has an ethicon plant here. Rally up ladies. We are creative and knowledable.

    RALLY UP

  12. cybil says:

    Dr. Elizabeth Kavaler – what happened to her hair? I think some of these defense doctors are getting their just punishment on Earth. I suggest Dr. Kavaler consult the “Hair Club” and – maybe she’d be able to go on TV and represent their success! She looks like “Tales from the Crypt” with that hair! Sorry, fellow followers – I just canNOT take this “smoke blowing” defense testimony anymore! Justice is NOT being served for the Budke family, (OR for any victims) when we have to sit and listen to these ridiculous and HIGHLY paid “whores” of the manufacturers. Let’s just get on with it. We definitely need to RALLY in another way – the courts and the justice system are not the answer here! The Judge is prejudice and the Defense has the upper hand. What happened to all the talk about class settlements??? Where are ALL the NEGOTIATORS! Remember, the AMS settlement for a total of $900,000,000 (almost one billion) – and, the victims supposedly got approx $24,000 a piece after the attorneys got $360,000,000???? Well, I guess life is good for those firms today and for the victims NOT.

    • Maria Garcia says:

      You don’t have to take a settlement and you do get your day in court. Your law firm may not want to support that concept but that should have been discussed up front before the case was accepted by the firm. I have been told by my lawyers that they will stand with me if I choose not to settle and if need be, I will get my day in court in a timely manner. Judge Goodwin stated that anyone who does not take the settlement offer will be placed on the docket far into the future. He cannot legally punt your case years down the road. If your case is strong, it will not be like the AMS settlement that I am sure.

  13. Maria Garcia says:

    The jury will hear everything and they will rule accordingly regardless of the lack of punitive damages. I am sure there is strong detailed evidence we have not been privy to which the Jury will use in their decision making process. We must all remember that Adam Slater is the BEST at what he does and he has not left any stones unturned. I know the outcome will be significantly in favor of Joan Budke and her family. The jury will not be deterred by the Judge or the defense lawyers and that is what I am praying for. Right now, I am speaking forth God’s Word in this case in the name of Jesus…AMEN!

    Let it be written…Let it be done – Ramses – The Ten Commandments Yul Brynner – I love that saying. Everyone please be at peace. The Holy Spirit is in Camden and the outcome will be great.

    • Annumous says:

      I hope your right Maria I really really do I had a talk with my lawyer a little while ago he said if they offer a settlement it might not make you rich but comfortable take it.What the heck does he mean by that my life is in shambles I can never work again it is so easy for these lawyers to say these things just because he won’t have to go to court and get paid.

  14. Linda says:

    Punitive damages are for willful, deliberate acts. This case and many like it should be able to seek those damages.J& J knew for years that these devices were untested and continued to make profit after profit with thousands of women harmed.My question to them is…if these were such safe medical products to use..implant them in your wives, mothers, sisters., daughters…enough is enough!

  15. sandy says:

    Let me make one thing perfectly clear I am a AMS victim I have not gotten a settlement of any kind nor has one been offered I know people keep saying like in the AMS settlement my dears many of us have not gotten anything and as for me I will not take what they are offering I know what I’ve been through I know the pain the agony and the hopelessness of my future so I just wanted to make that clear perhaps there are a few females out there that have accepted a settlement I don’t believe sometimes that they were hurt as bad as others I’m not making that statement its just something I wonder otherwise how can someone who has lost everything settle for mere pennies what is happen to this family is unthinkable in the United States of America today and I don’t know the answers until some Senator or congressman or somebody on TV steps up and does a story this it will never get out it would have to take a million women probably before someone would say enough is enough I just pray that this family can find a way to go on I have prayed so often cried and begged God for relief for an answer for an end then I’m beginning to wonder if he’s even listening.

  16. MarieAnn says:

    This is just evil run a muck! Withholding evidence of all the other cases and women harmed…that J $ J took the prolift off the national market, I do believe they are still having it stuffed in women abroad. If the judge is easily confused, maybe its time for him to retire?

    Compensatory damages are awarded according to “how much” a woman is worth, i.e.: what could she have been earning? wages lost… I do wonder how that will play out due to the fact that Joan was not earning a living, was elderly, so sad that the value of a human being comes down to what they can earn. I don’t know how the jury is to award compensation for all the heartache this poor family has suffered and this lovely lady that should not have been used as a guinea pig for profit.

    Where is the justice? I know it is not blind, very slanted it seems. Praying for the jury and this sweet family.

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