Endo to divest AMS (rumor)

Consumer Group Says Destroyed Documents in J&J Transvaginal Mesh Litigation Should be Investigated

March 27, 2014 By administrator

U.S. attorney general Eric Holder Jr. should launch a criminal investigation into the destroyed documents in the J&J transvaginal mesh litigation, says consumer advocacy group Corporate Action Network. Magistrate Judge Cheryl Eifert of the U.S. District Court for Southern West Virginia previously deemed Johnson & Johnson subsidiary Ethicon’s loss or destruction of documents as “negligent”, but the group believes it may have been more than that. According to Mass Device, Corporate Action Network requested in an open letter that further probing should be done for potential criminal violations.

Eifert had also determined that “plaintiffs are entitled to monetary sanctions to compensate them for the additional time spent by their counsel piecing together missing custodial files and preparing for depositions of key employees for whom scant information was provided by Ethicon. In addition, the undersigned recommends to the presiding district judge that plaintiffs be permitted on a case-by-case basis to introduce evidence of spoliation at trial, when appropriate, and seek an adverse instruction in specific cases,”

Johnson & Johnson is facing thousands of lawsuits alleging that their transvaginal mesh devices, a product used to treat stress urinary incontinence and pelvic organ prolapse, caused serious injuries.

Pelvic mesh has been associated with many complications, including mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. The U.S. Food and Drug Administration (FDA) warned in 2011 that these complications are “not rare”. The agency also said that pelvic mesh may be more harmful compared to other methods for treating pelvic organ prolapse.

The Corporate Action Network says that Holder should use the U.S. Justice Department’s subpoena powers to investigate CEO and chairman Alex Gorsky, who oversaw Ethicon at the time when the documents were destroyed. In the letter they said , “We respectfully request that you investigate Johnson & Johnson Inc. and its top executives including chairman and CEO, Alex Gorsky, for 2 possible criminal violations.”

The group also cited the case of Dr. Vincent Lucente, a doctor who reportedly received $800,000 over 10 years as a consultant for J&J. Recently, it was revealed in corresponding emails that Lucente allegedly used his influence to remove the term “experimental” in describing transvaginal mesh in a medical trade publication by the American College of Obstetricians and Gynecologists.

Johnson & Johnson is not the only facing litigation over pelvic mesh. C.R. Bard, Boston Scientific, Endo Health Solutions, Cook Medical and Coloplast are also being sued over the devices.

 

J&J Must Pay Damages Mesh Incontinence Implant Verdict

By Jef Feeley Apr 4, 2014 12:29 AM ET

Johnson & Johnson (JNJ) was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.

Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.

J&J, based in New Brunswick, New Jersey, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.

The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. (BCR) and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.

Appeal Planned

J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.

“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.

J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.

“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.

NJ Verdict

Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.

Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.

In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was defective.

The Texas case is Batiste v. McNabb, No. 12-14350, District Court for the 95th Judicial District, Dallas County Texas (Dallas). The West Virginia case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston).

 

I could see rajiv selling Mens health and leave AMS with womens and prostate! Which would pave the way for BK. Neither are profitable. Not sure what that would do to the lawsuits if the company went out of business. Someone could step in and then buy the PH for cheap, someone like UHS or another mobile.

 

Not a rumor. Endo will try.

 

This is only a rumor. Its never been better at AMS as it is today!

 

Camille says its just a rumor and not to worry.

 

is that the same guy who said that culture eats strategy for lunch when he joined? that phrase is at least true. it's so sad to see what culture you've become all due to one person's self preservation tactics laced with anger and draped in arrogance. it was a nice run for me and i hope you find it again, but you won't without the emperor's clothes being changed.

 

Couldn't agree more. Camille has been the downfall of a great organization. He surrounded himself with people that had no experience in urology and most didn't even have device experience. The culture he's built is one of fear and intimidation. He wants to point fingers at the field, claiming we don't know our business but what has he done to help us since he got here? He blames marketing for not having data but he refuses to pay for it. And when he finally does he wants immediate return.
Take a look around Camille. The once strong castle you came into is crumbling at your feet. But you don't really care, do you? Once we're sold, we'll be better off and he'll have his money. Can't happen soon enough.

 

Very well put. But lets be realistic on who gets hurt. Its the run of mill employees with years of experience whose AMS careers are likely over. Camille will bail with his 3-7 million and then he will be able to go back to chicago and live in obscurity with a giant company, like baxter.

Honestly what has he done that will leave a lasting imprint on the future AMS? Nothing. When he came here everyone gave him the benefit of doubt, he talked a good game, fired Joe Martin and the rest of the Bihl puppets but brought his own puppets in. Camille is a classic ivy league president that believes in hiring outside consultants who will charge him to tell him what he wants to hear, specifically that the challenges that exist are the fault of sales people or marketing or regulatory or R&D or natural disaster and that Camille personally is doing a great job.

The funny thing is that Rajiv and Camille are oil and water. Camille would give his nuts to be in Rajivs shoes because when Rajiv sells ENDO thats when the real cash will pour in for him.

 

What has he done? How bout caused dozens and dozens of highly skilled, respected and regarded employees to leave. Bitterly leave. Caused our highest profile customers who have been with us 20+ yrs to question our direction and forget our history. Forget about the belittling of everyone in the field and at the home office. Help Rajeeve

 

Get over it. This is business. People stay. People leave. Those that left may have disagreed with the direction that the oracle has lead us to. Big deal.

Judge the one on the success of the business. This is where he has failed. It is in turmoil. Mens is the only reliable division. Prostate and womens are circling the drain. A real leader would recognize and admit that its not working and cut it loose.

Cam is an amateur. Cutting costs is not a business strategy. Thats easy. He has lead us no where.

 

B.I.N.G.O. on amateur! And add his two years of hissyfits and 'hands on" has diminished our value by over $1b! Nice resume Cam. Can you say subtraction by subtraction?! You own it Small One. Pls keep hiding on your trips to nowhere.

 

And yet, he will continue to blame the reps, the lack of data on the market, the lack of strategy and execution, the lack of focus, the litigation headaches, the weather, the back orders, the price of gasoline for our cars, the cost of doing to many dinners.

Trips to no where? hello Taipei how ya doing?

 

He'll blame the reps and the managers but all the other factors he sees as excuses from the salesforce.

 

well, if we are for sale and there's a new owner, there's hope. better to go that route than to be publicly berated and have your customers mad at you and turn to coloplast because of him than any other option. worst ever for sure. laughing stock.

ps everyone - wheres our new pump or pipeline?

 

Where's any new product? It's all about REMEDIATION.

 

Did you say pimp? I found him. He wears shirts with multiple collars and hundreds of buttons....no pimp cup though. He is Cam.

 

Trying to sell the remanent pieces for 40% discount and still the number looks shit. What a joke we have turned into.

 

I don't care what goes down but this crap we lived through last week was absolutely insane. My RM lost his or her mind and Kirk for certain lost his grip on reality. above all please for the sake of all of good men and women of ams quit with the awful hourly email updates. I guarantee you nobody likes them and don't ask your RM"s cause they will tell you what you want to hear. Peace out - Mike

 

Do everyone a favor and complain directly to your manager or someone within the company. Doing it on message boards such as this one is vapid and only harms yourself.