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J&J Wants New Trial After $3.27 Huskey Verdict

Byrd Federal Courthouse, Charleston WV

Byrd Federal Courthouse, Charleston WV

On October 14, Johnson & Johnson (J&J) filed a Motion in federal court asking that the Jo Huskey verdict be overturned and that  the company receive a new trial.

See Huskey Doc #438 J&J asks for a new trial October 20142:12-cv-05201.

In September, Mrs. Huskey won a $3.27 million judgment against the medical device maker, alleging the mesh was defectively designed and the warnings to the implanting physician were inadequate.

Before the case went to the jury,  J&J had asked for a directed verdict in its favor.

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph Goodwin denied that motion but also denied the Huskey team the ability to seek punitive damages, which could have resulted in a higher award.

In its motion,  J&J argues that Plaintiff Huskey failed to offer a “legally sufficient evidentiary basis” for her claims.

Transvaginal tape obturator (TVT-O)  is used to treat incontinence with a length of polypropylene that supports the urethra and exits through a woman’s groin area.

J&J says its TVT-O “meets the standard of care” and because of that it cannot be unreasonably dangerous.

Prolene Mesh

Prolene Mesh

Adequate Warning

The implanting physician is the end user of any medical device and it is the company’s responsibility to keep him/her informed about the dangerous potential of a product. J&J argues the product warnings did include pain, dyspareunia and erosion, the complications Mrs. Huskey suffered.

J&J argued that implanting physician, Dr. Byrkit,  still uses TVT-O in her practice and would use it again if a patient presented with the same symptoms.  At trial, the implanting physician also said she would  likely not use TVT-O if  it was contraindicated for athletic women and that information was contained in the product label or Instructions for Use (IFU).  Jo Huskey was an avid kayaker, liked to exercise, walk and work out regularly. At trial, Dr. Byrkit said if the warning was on the label that TVT-O should not be used in athletic women, she would have reconsidered using it on Mrs. Huskey.

Dr. Jerry Blaivas, brought in as the expert to testify for Mrs. Huskey, testified that active women should not be implanted with a TVT-O.

J&J argues Dr. Byrkit did not rely on the TVT-O IFU and in fact hadn’t relied on it for years. Who then informed her about the product’s dangers? Was it the sales rep? Dr. Byrkit said she did not rely on company representatives to make prescribing decisions and pointed to “independent sources of information” including talking to other doctors.

Mrs. Huskey’s lawyers pointed out that Dr. Byrkit never testified the doctor did not rely on the IFU.

Risk-Benefit Test

Since Mrs. Huskey is from Illinois, the federal court must defer to its definition of a design-defect. Under Illinois law a product is unreasonably dangerous if it does not meet the consumer expectation or it fails the risk-utility test, which requires the plaintiff to present overwhelming evidence that the dangers outweigh the use of the product as designed. Plaintiffs failed to do so, said attorneys for J&J.

At most, the opinions of Dr. Blavais and Dr. Bruce Rosenzweig, both presented by the plaintiffs, disagreed with the medical societies (AUA, AUGS) which support the safety of TVT-O. Even though J&J says the “vast majority of the medical community” support its safety, there has been no individual polling of members to substantiate that claim.  Many doctors who belong to those medical societies do not agree with the leadership’s positions.

The plaintiffs alleged there were six defects to the TVT-O – it is made with Prolene mesh that 1- undergoes oxidative degradation; 2- shrinks; 3-deforms; 4-is too heavy and causes a chronic foreign body reaction; 5-is placed in the obturator space; and 6-is laser cut.

Ethicon attny, Christy Jones during Linda Gross trial, Feb. 2013

Ethicon attny, Christy Jones during Linda Gross trial, Feb. 2013

J&J says the plaintiffs presented no evidence that the implant in Mrs. Huskey shrank deformed or degraded. J&J argues that attorneys for Mrs. Huskey did not show by competent expert testimony that her injuries resulted from a specific defect design defect.

J&J has made the argument before and it was rejected by Judge Goodwin but again in this motion defense claims that Prolene filaments cannot be the basis of a lawsuit because the Prolene fibers underwent Food and Drug Administration approval, therefore under federal preemption, J&J cannot be held accountable.

See the Riegel v. Medtronic decision for that definition.

J&J asks Judge Goodwin for a new trial in federal court due to the “erroneous and prejudicial evidentiary rulings.”

The motion was filed by Ethicon attorney Christy Jones (Butler Snow) who represented J&J at the Huskey trail and is listed as Document #438.

Learn More:

Huskey Trial, $3.27 Million Verdict, September 5, 2014

http://meshmedicaldevicenewsdesk.com/patient-profiles/awesome-jury-deciedes-for-huskey-3-27-million/

Huskey Case Survives Summary Judgment,  Riegel v. Medtronics,July 24, 2014

http://meshmedicaldevicenewsdesk.com/legal-news/huskey-v-ethicon-case-survives-summary-judgment/

 

December 4, 2007 Riegel v. Medtronic, Cornell Law

http://www.law.cornell.edu/supct/html/06-179.ZS.html

 

 

9 Comments

  1. msm says:

    Ethicon isn’t just asking for a new trial, but a do-over so they can do a better job in defense. I hope there aren’t any “mulligans” just because they figured out some other ways of distorting the truth and conning a new jury into a different verdict. They knew the evidence before the trial. The only thing they didn’t know going into the trial was what the jury would decide. The truth is the truth and it was heard loud and clear by the jury.

    About the punitive damages, I don’t understand the differences but they must exist.

    “In an order issued on October 9th a West Virginia judge has permitted transvaginal mesh plaintiffs to continue seeking punitive damages in seven federally-filed claims against Boston Scientific Inc.” Punitive damages were not allowed in the Huskey trial. I know it goes back to state law, but it seems in some cases it falls to the state in which the injury occurred, or where the product was manufactured, or where the case was originally filed, or the state to which it has been transferred. Difficult to get me head around.

    • Jane Akre says:

      msm- as an observer at the trial, it appeared that Judge Goodwin split the baby in half – that is, denying a directed verdict but also denying the punitive damages possibility. This is an observation from a non lawyer but they happened at the same time. Others have concurred, that is what happened. Although there may be no comparison, Judge Goodwin should look at the decisions by Judge Molberg in Dallas who seems to have no problem allowing the plaintiffs to put on their entire case, without compromise. That opens up a case to be challenged in the future, but we know industry will challenge these losses anyway. Again, the opinion/observation of a non-lawyer.

  2. All Meshed Up says:

    A “do over” is exactly what J&J is asking for. You go over the evidence, the testimony and the findings away from the Court room. Then you can over the same stuff but have a “better” argument against the Plaintiff if you are able to get back in Court. My hopes are that this will be denied and a check will be cut with no further delay.

    I still would like to find out who from these settlements has ACTUALLY been paid off yet. Or is all of this still hung up in Court with Appeals? After suffering for many years and then having to go through the Court process, has any of these women ( I am including any MDL cases ) received what they were awarded or even promised? From the little I have found out about the Bard/Kugel Rhode Island MDL, most people involved did not receive any thing close to what they expected and some were called and asked to be down graded. I would hope that these women did not get a run around or be asked to be down graded, maybe to increase the Lawyers take.

    I hope that a Fund will be set up so that ALL Mesh Victims could be compensated and not with $4500, $24,000 or even $40,000. Our lives and the amount of suffering and pain we have endured and will have to endure for the rest of our lives is worth more than what these MDL’s are coming up with. I don’t need $31 Million dollars but $300,000 or a bit more would ensure that I could live comfortably for my remaining years. And along with monetary compensation there should also be medical care that is also associated with in depth research as to the long term effects of having a Polypropylene Mesh implant. That is something the Manufacturers did NOT do is Long Term Research. Their research went as far as the accountant and and the sales department. We, as the Guinea Pigs, should now be awarded a large chunk of any profits made by these Manufacturers for the sale of these Mesh monsters for OUR own use. Sorry ’bout that Stockholders!

    And again I will say this, “Why in the name of God, with all of the complaints on the MAUDE data base, the evidence presented in Court case indicating what Mesh can do in the body and with all of the Lawsuits today, why is the FDA totally silent about Surgical Mesh injuries?” No other product on the Market today, much less a Medical Device, has done so much damage to men and women without it being recalled, investigated, with Prosecution and imprisonment to follow. The amount of damage and the number of surgeries done to these women should be evidence enough to at least warrant a Congressional Investigation but it is election season! Any face time with a Congressman/women or Senator will be useless because all they are doing now is pandering to the peasants. After the election I will be calling my Representatives daily and will demand face time to give them the evidence that shows exactly what Mesh is about. If they do not listen, I will intensify my strategy to the point where they will not be able to ignore me anymore. I hope that you will too. Next year we march on Washington! Best Wishes……….

    • msm says:

      Well said.

      The National Highway Traffic Safety Administration starts recall procedures when as little as .02% have resulted in an injury even if it hasn’t been fully proven that the defect caused the injury. The FDA does nothing until well over 1% are injured and it is proven that the device caused the injury or death. The proof doesn’t come from evidence presented in court. It comes from post-market surveillance studies conducted by the makers of the device. Auto recalls are made public EXCEPT when secret settlements are made. That is one reason the GM ignition defect wasn’t made public sooner.

      What I want to say is that the FDA needs to take product safety as seriously as the NHTSA. The recalls and investigations should be equally publicized and hearings should take place before Congress just as it did with GM.

      The FDA has too much responsibility to approve everything from catfish to drugs to deep-brain stimulators. That’s not making an excuse for their lack of oversight, but a statement that the Federal Government has little if any oversight of the FDA. Health and Human Services needs to step up and take stock of what the FDA is really doing or not doing. Can the FDA do the job ? Obviously no.

  3. Disgusted says:

    It amazes me that they are fighting this – it probably shouldn’t. I looked for an IFU that warned their claims – This is the only one I could find. I did not see dypareunia listed. Although pain and erosion were; after the statement of transitory foreign body response. Which Judge Goodwin referred to in the first trial.They may be asking for more trouble – the next time punitive damages may be back on the table. This is no doubt a nightmare for the courts and more so for the Huskey’s. That this is still being battled in civil court and not criminal is despicable. It is criminal that a loop hole in the 510K would allow for such wide spread destruction of women and families. Arguing that it is widely accepted doesn’t make it right. We now have a new industry coming out of this devastation and there is no standard of care for mesh complications. This was not thought through to begin with, and no plans were made to cover complications – which equals negligence. A permanent implant that goes through major muscle groups, not tested on live women and put into the general population. Labeled minimally invasive. A recipe for disaster. We are seeing the mess now!

    This is from the current site as of 2014. It appears through their own website 2005 is the last time they updated the IFU. Under adverse reactions below; It is stated that there may transient local irritation at the wound site which may cause erosion, extrusion or a fistula to appear. It also states that there may be transient leg pain from 24 to 48 hours which can be managed by mild analgesics. They also state an animal study that shows minimal foreign body response. No human trials are shown – because there were none! See for yourself-

    Link: http://hostedvl106.quosavl.com/cgi-isapi/server.dll?8000?IFUs?rkumar12@its.jnj.com?GetOneDocPureFullTxt?omcd8duk8j5ktcid3pl9n2h2g4?3

    From the 2005 IFU Gynecare TVT-O:

    WARNINGS AND PRECAUTIONS

    • Do not use GYNECARE TVT Obturator procedure for patients who are on anti-coagulation therapy.

    • Do not use GYNECARE TVT Obturator procedure for patients who have a urinary tract infection.

    • Users should be familiar with surgical technique for urethral suspensions and should be adequately trained

    in the GYNECARE TVT Obturator procedure before employing the GYNECARE TVT Obturator device.

    • Acceptable surgical practice should be followed for the GYNECARE TVT Obturator procedure as well as for

    the management of contaminated or infected wounds.

    • The GYNECARE TVT Obturator procedure should be performed with care to avoid large vessels, nerves,

    bladder and bowel. Attention to patient anatomy and correct passage of the device will minimize risks.

    • Bleeding may occur post-operatively. Observe for any symptoms or signs before releasing the patient from

    hospital.

    • Although bladder injury is unlikely to occur with this technique, cystoscopy may be performed at the

    discretion of the surgeon.

    • Do not remove the plastic sheaths until the tape has been properly positioned.

    • Ensure that the tape is placed with no tension under the mid-urethra.

    • Do not perform this procedure if you think the surgical site may be infected or contaminated.

    • Since no clinical information is available about pregnancy following sub-urethral sling procedure with the

    GYNECARE TVT Obturator System,

    the patient should be counseled that future pregnancies may negate the effects of the surgical procedure and the patient may again become incontinent.

    • Since no clinical information is available about vaginal delivery following a sub-urethral sling procedure

    with the GYNECARE TVT Obturator System, in case of pregnancy delivery via cesarean section should be

    considered.

    6

    P18070E_02.24.10.indd 6 18070E_02.24.10.indd 6 2/24/10 4:26 PM /24/10 4:26 PM7

    • Post-operatively, the patient should be advised to refrain from heavy lifting and/or exercise (e.g., cycling,

    jogging) for at least three to four weeks and intercourse for one month. The patient can usually return to

    other normal activity after one or two weeks.

    • The patient should be instructed to contact the surgeon immediately if dysuria, bleeding or other problems

    occur.

    • Transient leg pain lasting 24–48 hours may occur and can usually be managed with mild analgesics.

    • As with other incontinence procedures, de novo detrusor instability may occur following a sub-urethral

    sling procedure utilizing the GYNECARE TVT Obturator System. To minimize this risk, make sure to place

    the tape as described above.

    • Do not contact the PROLENE mesh with any staples, clips or clamps as mechanical damage to the mesh may

    occur.

    • Do not resterilize GYNECARE TVT Obturator device or its components. Discard opened, unused devices.

    • Prophylactic antibiotics can be administered according to the surgeon’s usual practice.

    ADVERSE REACTIONS

    • Punctures or lacerations of vessels, nerves, bladder, urethra or bowel may occur during needle passage and

    may require surgical repair.

    • Transitory local irritation at the wound site and a transitory foreign body response may occur. This

    response could result in extrusion, erosion, fistula formation or inflammation.

    • As with all foreign bodies, PROLENE mesh may potentiate an existing infection. The plastic sheaths initially

    covering the PROLENE mesh are designed to minimize the risk of contamination.

    • Over correction, i.e. too much tension applied to the tape, may cause temporary or permanent lower

    urinary tract obstruction.

    ACTIONS

    Animal studies show that implantation of PROLENE mesh elicits a minimal inflammatory reaction in tissues,

    which is transient and is followed by the deposition of a thin fibrous layer of tissue, that can grow through the

    interstices of the mesh, thus incorporating the mesh into adjacent tissue. The material is not absorbed, nor is it

    subject to degradation or weakening by the action of tissue enzymes.

    • Jane Akre says:

      Thank you for your research…..I recall Dr. Charlotte Owens, the doctor and medical director for Ethicon, saying at trial that the warnings to doctors were the same as dyspareunia. That was her explanation as to why it didn’t appear. Huh?

      • Disgusted says:

        I found the reference you mentioned:

        Slater: “The word dyspareunia doesn’t appear in the IFU, you know that right?

        Owens: ” I do know words are in there that are synonymous with dyspareunia to a surgeon.”

        This was from the Linda Gross trial: http://meshmedicaldevicenewsdesk.com/legal-news/day-21-linda-gross-v-ethicon-expert-says-prolift-did-not-injure-gross/

        I do not see anything above in the IFU that comes close to explaining dyspareunia. Unless they are saying that sex would be painful if you had other injuries caused from a transitory foreign body reaction. The word transitory lends one to believe it would not be permanent – temporary in nature. They recommend avoiding sex for one month after the implantation. Again not permanent. It is obvious that the prolene stitch is not the same as mesh, as all the discussions about pore size, etc. brought to light. That is not a problem with the stitches – they are not permanent implants. We will be watching to see what happens next.

        • msm says:

          Unfortunately, polypropylene sutures are sometimes permanent. The patients just don’t know it. Two sutures are often placed on each side to secure a fascial sling. Ethibond polyester sutures (some of which was recalled) are also used in some of the prolapse procedures. I have both types of sutures plus the remaining mesh. After the first removal surgery, I developed a serious allergic reaction to something. I thought I was free of foreign materials until I saw the records last week. Now I wonder about a foreign body reaction. They can’t figure out the what, why, and how of the reaction but it is severe. If the next specialist can’t fix it, then I want all of the involved anatomy removed. That part of my life is over anyway. After 5 years of mesh related issues, I just want to have a life again.

  4. David atwood says:

    It’s TIME THAT J&J settle all the claims. I hope a lot of people GET FIRED….

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