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Ethicon Wants Another Chance to Overturn Huskey Pelvic Mesh Case

Christy Jones, from Linda Gross Trial

Mesh Medical Device News Desk, February 21, 2017 ~Ethicon Wants Another Chance to Overturn the Huskey Pelvic Mesh Case by arguing that the defense team should have been able to introduce assurances about safety and efficacy by the Food and Drug Administration concerning the TVT-O transvaginal mesh. 

On February 9, 2017, Ethicon filed for a rehearing of the Huskey v Ethicon case (Fourth circuit No. 15-2118) in an attempt to reverse the appellate decision which affirmed the jury award.

In essence, J&J wants a second bite of the apple.

Following the nine-day Jo Huskey trial, which concluded September 5, 2014,  the jury returned a verdict for Jo Huskey and her husband on their design defect, failure to warn, and loss of consortium claims over her TVT-O implant. Huskey was awarded $3.27 million.

Huskey and Christy Jones, art by J. Akre

Ethicon immediately appealed and asked for a judgment in its favor, or for a new trial.

Both were denied.

Then on January 26, 2017, the Fourth Circuit Court of Appeals issued its ruling by deciding to uphold the jury verdict, essentially ending the appeals process for J&J.

Here is the appeals court decision.  That should have been the end of the appeals process.

 

EN BANC

On February 10th Ethicon tried again with the Fourth Circuit, asking it to review its decision upholding Huskey v Ethicon.

If Judge Goodwin’s ruling is allowed to stand, it will essentially bar any FDA discussion from the 60,000 or so product liability cases pending before Judge Goodwin, argues Ethicon.

Charles Lifland, O’Melveny & Myers LLP for Ethicon

“The clear takeaway from the Panel’s decision is that district courts may now exclude all FDA evidence in trials addressing the safety of FDA-regulated Class II devices. Indeed, if the FDA’s conclusion after a comprehensive post-market review that a device is “safe and effective” is not admissible, then no FDA evidence is,” says the petition, written by Charles Lifland of O’Melveny & Myers LLP, representing Ethicon.

 

With that dire prediction, J&J lawyers want a rehearing En Banc (meaning all eligible, active judges of the Fourth Circuit).

Listen (here) to the arguments recorded here of Dave Thomas (Ethicon) and Fidelma Fitzpatrick (Plaintiffs).

The defense is represented by lawyers from O’Melveny & Myers LLP, Christy Jones (Butler Snow) and Dave Thomas of Charleston, WV.

 

WHAT WAS DECIDED  

Judge Joseph R. Goodwin, overseeing bellwether mesh trials

In the Huskey trial, Judge Goodwin disallowed discussion of the 510(k) approval process of the Food and Drug Administration to be presented to the jury under Federal Rule of Evidence 403.

It was the TVT-O that was implanted in Ms. Huskey which the jury decided was defectively designed.  J&J argued the Goodwin court erred in denying it a judgment in its favor as a matter of law on all five claims – strict liability and negligent design defect; strict liability and negligent failure to warn; and loss of consortium – claiming Huskey’s lawyers didn’t prove their claims.

The appeals court said they did.

The Huskeys proved that polypropylene mesh will incite a foreign body reaction when implanting that “will continue to attack it in this way until it’s removed or destroyed or it’s gone.” That was according to their expert in chemical engineering.

Dr. Rosenzweig, from his promotional materials

Dr. Bruce Rosenzweig echoed the same design defect when he said the more mesh the more foreign body response, especially heavyweight mesh.

Ethicon’s former employee Dr. Brigitte Hellhammer said lighter weight mesh could treat SUI and that heavier mesh would likely shrink.

Dr. Jerry Blaivas testified Mrs. Huskey had severe scarring and suffered chronic pelvic pain, a “reaction to the mesh.”

Dr. Jerry Blaivas, urologist

That added up to the conclusion that Ethicon’s use of heavyweight polypropylene mesh in the TVT-O was a design defect that caused inflammation and pelvic pain in Ms. Huskey.

The jury’s decision was not contrary to the clear weight of the evidence the appeals court decided in upholding the jury verdict.

The panel also rejected Ethicon argument under “comment K” that some products are unavoidably unsafe, though not unreasonably dangerous, shielding Ethicon from liability.

Huskey is from Illinois and state law determines if a specific product is covered by comment k doctrine (here).

 

WHAT’S LEFT TO DECIDE? THE FDA

J&J lawyers say there were four pieces of evidence that were excluded from the Huskey trial that would have made a difference for the company.

The 510(k) evaluation process

The 2011 FDA Advisory Committee said mesh slings are safe and effective

A 2013 published FDA guidance on the Advisory committee’s conclusions

The fact that Ethicon’s Prolene suture is made of polypropylene like the TVT-O

 

Judge Goodwin excluded the FDA discussion in Huskey because it could confuse the issues and mislead the jury, not to mention take jurors down the long, complicated and jargon-filled world of FDA rules and regulations.

Lawyers for J&J say the FDA “comprehensively regulates medical devices,” including the TVT-O, considered the “Gold Standard” by medical societies.  They go on to praise the FDA and its “robust regulatory history.”  The defense team heralds the FDA’s 510(k) clearance of the TVT-O mesh kit (implanted in Ms. Huskey) along with its presumption of safety and efficacy.

J&J contents that the FDA approved Prolene suture that makes up the TVT-O kit was cleared “based on their established history of safe and effective use.”

J&J says the en banc should “consider this critically important issue.”

Most readers of Mesh News Desk understand that the 510(k) approval process can not accurately be called robust.  Rather, medical devices make it to market, after a shuffling of paperwork and a declaration by the manufacturer that its new device is substantially similar to one already on the market. There are no clinical trials required.

 

 

LANA KEETON

Lana Keeton, Spirit of Justice Statue Dec 2014

Lana Keeton, a woman implanted with an Ethicon pelvic mesh, a medical device expert and patient advocate, plans on filing an Amicus Curae (Friends of the court) Brief in Huskey v Ethicon. She wants mesh off the market and rejects the cry of some law firms “not kill the company,” according to Keeton.

“Justice is not being served in the transvaginal mesh litigation and I’m going to the Department of Justice,” she tells MND. Here are her contentions found on her website: http://www.lanakeeton.com.  

  1. The prolene suture is not the same as the heavyweight prolene mesh used in the TVT-O.

  2. The FDA did not hold its Ob-Gyn Panel meeting September 8-9, 2011 because of lawsuits. Truth in Medicine and my meetings with the FDA presenting scientific evidence of the complications of Polypropylene mesh, in addition to the over 6,000 adverse events filed by mesh injured women, precipitated the meeting and the warnings issued July 13, 2011.

  3. Ethicon completely misrepresents the FDA’s 510(k) PreMarket Notification clearance process. I testified before the Institute of Medicine multiple times in 2010 and am fully aware of the actual legal process.

  4. An FDA employee involved in the clearance of many of Ethicon’s mesh products has also worked for, and been paid by, Ethicon for over 20 years. I have absolute proof of this.

I am also calling on the hundreds of thousands of mesh injured patients worldwide affected by this through my online presence and my organization, Truth in Medicine, to support this effort. Ethicon/Johnson & Johnson will be defeated.

Yours truly,

Lana C. Keeton

 

16 Comments

  1. Christy R says:

    I am wondering why attorneys with more then say 2000 cases are not lowering their percentage per case so the actual VICTIMS FOR LIFE receive payment for the irreparable damage?

  2. K says:

    I say Judge Goodwin should then allow the evidence that Ethicon destroyed all emails and evidence.

  3. Lordhelpus says:

    I think the Huskey’s, if anything, are being insulted time and again. The set amount for each case should be AT LEAST $5,000,000 which would not even put a dent in their bank accountMaybe then they’ll end all this mesh abuse….Sadly though, even that won’t be enough to cover a life time of suffering.

  4. Waiting for Justice says:

    What a joke! TVT-O the “Gold Standard “. Give me a break! My wife was implanted with this garbage back in 2013 and has been in 24/7 pain ever since. Her groin pain is constant and it is only getting worse with time. I have watched her life decay before my eyes on a daily basis. She used to be so full of life and energy and now it is gone thanks to Ethicon mesh. Her symptoms are the same as most other TVT-O recipient’s so I would be wasting my time posting them all. I feel bad for her and all the injured mesh victims who have had their lives ruined by pelvic mesh. It angers me when I think of the greedy money hungry Johnson and Johnson/ Ethicon big wheels who are purposely dragging their feet when it comes to paying these women for their injuries. Once again no amount of money can buy their health back but at least they wouldn’t have to go out and try to scratch out a living working in pain. Johnson and Johnson has spent BILLIONS trying to defend itself. Why don’t they just Man up, Pay up and let these poor injured try to put this awful chapter of their lives behind them? If not I hope they keep getting hammered in court and maybe then they might begin to cry uncle and do what’s right!

  5. Emmie says:

    https://youtu.be/lBxj4h8C36M

    What Ethicon knew about the Prolift. Very upsetting to watch.

  6. Lana Keeton says:

    Number 1. How in heaven’s name are there 100,000 cases of anything, anywhere? Number 2. The plaintiff’s attorneys are not fully prosecuting the cases OR Ethicon would never be able to file a Petition for Re-hearing. The plaintiff’s attorneys should have re-butted Ethicon’s position years ago. Number 3. THE PLAINTIFF’S ATTORNEYS, in particular Ed Wallace at Wexler Wallace who is lead attorney for Jo Huskey, and Fidelma Fitzpatrick, of Motley Rice, ACCEPT the position MESH IS THE GOLD STANDARD and do not rebut it. Number 4. Co-lead Counsel for the entire 100,000 cases, Henry Garrard III, philosophy is “Don’t kill the company”. Not good for 100,000 mesh injured women.

    • Anon says:

      Victims………….Please be very leery of any firm that represents mesh victims but make statements like “Don’t kill the company”. J J Ethicon is a $70 Billion Annually company, we (mesh victims) will never be able to bankrupt this pharmaceutical giant. This firm’s loyalty is questionable.

  7. Mary Pat says:

    Lana – you go girl! Our prayers are with you! It was your website, Truth In Medicine, that first revealed to me the truth about mesh. I am amazed that you have the health and stamina to keep fighting! God is with you! My prayers are with you! Thank you for your efforts. God bless you!

  8. Lana Keeton says:

    Mary Pat. Thanks for the prayers! Much needed. And donations. While the companies have billions to keep us meshies down and we do not unite, THEY WIN. I stepped out of the public arena because I lack the health and financial resources to stay at it. Donate to my personal PayPal account on http://www.lanakeeton.com to help me help the 100,000 + women in the mesh MDL’s DEFEAT ETHICON & all the other criminal corporations mutilating women with mesh. Blessings, Lana

  9. CAROLINE M says:

    I was implanted with the ethicon mesh, and after having it removed in 2015 the condition has worsened. The mesh implant was painful enough, but it deteriorated so much so that when the surgeon removed it she had to virtually take it out piece for piece because of the deterioration. Now after pelvic therapy for pain, the left side of my abdomen pain, and the left hip where the mesh moved and was pressing has developed severe arthritis. Physician after physician have stated the only alternative left is a hip replacement because of this internal injury to my hip and pelvis. The last two years have been a nightmare trying to walk and work and sit and sleep. I also was very active and had a lot of energy now I am virtually crawling around. It would truly be uncharacteristic and a big surprise to me that such a large company like J&J would do the right thing for all of us who have had our lives turned around because of this product.

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