Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label federal court. Show all posts
Showing posts with label federal court. Show all posts

Monday, November 13, 2017

Verdict $247M : J&J DePuy Pinnacle Ultamet 4th Bellwether Trial

https://www.youtube.com/watch?v=1hm37recd6A
Watch this video!

https://www.dallasnews.com/business/health-care/2017/11/16/dallas-jury-orders-johnson-johnson-pay-247-million-hip-implant-patients

Dallas Morning News

Johnson & Johnson was ordered Thursday by a Dallas jury to pay $247 million to half a dozen patients who claimed the company hid defects in its Pinnacle artificial hips, its third big-dollar loss over the products.
Officials of the company's DePuy unit, which makes the hips, knew the devices were defective but failed to properly warn doctors and patients about the risk that they would prematurely fail, the jury ruled. The panel awarded a total of $79 million in actual damages and $168 million in punitive damages to a group of six New York residents whose hips had to be surgically removed.
The number of lawsuits accusing J&J and DePuy of mishandling the metal-on-metal hips has grown by more than 13 percent over the past year, to 9,900, according to a regulatory filing. J&J stopped selling the devices in 2013 after the U.S. Food and Drug Administration toughened artificial-hip regulations.

"These companies' behaviors were so reprehensive that it demands repeated punishment," Mark Lanier, a lawyer for the hip recipients, said after the verdict. Lanier won the previous two verdicts against J&J and DePuy.
J&J officials said Thursday in an emailed statement they acted "appropriately and responsibly" in the development and marketing of the Pinnacle hips. "We will immediately begin the appeal process and remain committed to the long-term defense of the allegations in these lawsuits,'' Stella Meirelles, a spokeswoman for DePuy, said in the release.
Johnson & Johnson won the first Pinnacle hip case to go to trial in October 2014 after a federal court jury in Dallas rejected a Montana woman's claims that the devices were defective and gave her metal poisoning.
Another Dallas jury ordered J&J last year to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.
Earlier this year, a third Dallas jury ordered J&J and DePuy to pay more than $1 billion to six California residents whose hips had to be removed after failing. That award was later slashed by nearly half.


The Pinnacle devices weren't covered by New Brunswick, N.J.-based J&J's $2.5 billion settlement of claims over its ASR line of artificial hips. J&J recalled 93,000 of those implants worldwide in August 2010, saying 12 percent failed within five years.


The Pinnacle cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges and test trials. Kinkeade agreed to combine the six cases in the most recent trial.
The six New York plaintiffs in the current case are Uriel Brazel, an 88-year-old physician; Karen Kirschner, a 67-year-old elementary school teacher; Ramon Alicea, 61, a chauffeur; Hazel Miura, 60, a housing official; Eugene Stevens, 53, a health-care aide; and Michael Stevens, 52, a financial analyst.
The hip recipients argued DePuy officials rushed the Pinnacle hips to market with little testing and misled doctors about the device's safety profile, assuring them there was little risk of metal poisoning and tissue damage from the metal-on-metal product.
"They ran a grand seduction,'' Lanier, the group's lead lawyer, told jurors in closing arguments Nov. 14 "Surgeons were seduced into using metal-on-metal'' by DePuy executives' false assurances the company had "solved the metal-on-metal problem,'' the plaintiffs' lawyer added.
J&J's lawyers countered that the devices failed because of routine wear-and-tear rather than a flawed design and the company properly marketed the product.
"Not a single surgeon'' said they picked the Pinnacle hip "because of advertising or a brochure or any marketing,'' Steven Quattlebaum, J&J's lawyer, told jurors in his closing statement. "They had good experience with it before they implanted it in any of these patients.''
In their ruling, jurors found J&J DePuy relied on "intentional misrepresentations" about the hips' safety profile to bolster sales and engaged in "deceptive business practices" in their marketing of the devices, according to a verdict form.
Jef Feeley and Tom Korosec, Bloomberg

#HEALTH NEWSNOVEMBER 16, 2017 / 12:05 PM / 
Johnson & Johnson hit with $247 million verdict in hip implant trial


NEW YORK (Reuters) - A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.

The jury found that the metal-on-metal hip implants were defectively designed and that the companies failed to warn consumers about the risks.
Six New York residents implanted with the hip devices said they experienced tissue death, bone erosion and other injuries they claimed were caused by the implants’ design flaws.

_____________________________________________________
Law360, Dallas (November 16, 2017, 12:34 PM EST) -- A Texas federal jury on Thursday hit Johnson & Johnson and its DePuy Orthopaedics Inc. unit with a combined $247 million verdict in a bellwether trial over DePuy’s Pinnacle line of metal-on-metal hip implants, delivering the third consecutive nine-figure verdict in the multidistrict litigation.

The unanimous jury found J&J and DePuy liable for a series of design and manufacturing defects, fraud and deceptive business practices, and found the companies had acted with wanton, reckless or malicious conduct. They awarded $90 million in punitive damages against J&J and $78



For the six individual plaintiffs, each of whom is from New York, the jury awarded more than $77 million in past and future medical expenses and pain and suffering, including each plaintiffs’ actual past medical expenses, the amounts of which were stipulated to by the parties. Four of the plaintiffs’ spouses were awarded loss of consortium damages totaling $1.7 million.

"I'm stunned the amount was that high," Mark Lanier of The Lanier Law Firm, an attorney for the plaintiffs, said after the verdict. "I'm overjoyed for the clients."

Lanier said the verdict is notable because U.S. District Judge Ed Kinkeade excluded from evidence a number of inflammatory documents and emails that J&J has said shouldn't have been admitted in previous bellwether trials, and the jury still awarded nearly a quarter-billion dollars in damages.

“He kept out every piece of reprehensible evidence that he could, and I was scared to death we’d walk away with nothing," Lanier said.

Lanier said he looks forward to taking the full record of the case to the Fifth Circuit and believes the win would be upheld.

Yet J&J's lawyers said an August 31 ruling from a Fifth Circuit panel renders the verdict a "phyrric victory" for the plaintiffs. In that decision, a majority of the panel said Judge Kinkeade reached a “patently erroneous” result and clearly abused his discretion by holding J&J and DePuy had waived their right to object to his court in Texas conducting trials for plaintiffs from other states.

"This nine-week trial was a disservice to everyone involved because the verdict will do nothing to advance the ultimate resolution of this six-year old litigation," John Beisner of Skadden Arps Slate Meagher & Flom LLP said in astatement. "We will continue to seek further appellate guidance that will finally allow the fair, meaningful adjudication of these claims.”

The verdict followed a two-month trial, the fourth bellwether in multidistrict litigation that includes more than 9,000 cases alleging design defects in DePuy’s Pinnacle Ultamet line of metal-on-metal hip implants. In 2016, Texas juries found in favor of two groups of plaintiffs from Texas and California, awarding them $502 million and more than $1 billion in damages, respectively, though those verdicts were later reduced to $150 million and $543 million. In the first bellwether trial involving the Pinnacle Ultamet, a jury sided with J&J against a sole plaintiff from Montana.

The jury specifically found J&J and DePuy liable for design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, intentional misrepresentation to the surgeons who performed the initial hip implant surgeries on the plaintiffs, fraudulent concealment from the plaintiffs and from the surgeons and deceptive business practices as to the plaintiffs and the surgeons. The jury also found J&J liable for negligent undertaking of a duty to provide services to DePuy and for aiding and abetting DePuy in its tortious conduct. The jury did not find J&J or DePuy liable for intentional misrepresentation to the plaintiffs.

A spokeswoman for DePuy, Stela Meirelles, said in a statement that the company acted appropriate and responsibly in developing the metal-on-metal hip implant.

“We have no greater responsibility than to the patients who use our products," Meirelles said. "We will immediately begin the appeal process and remain committed to the long-term defense of the allegations in these lawsuits.”

During the trial, the six plaintiffs told jurors they’d suffered a range of injuries, including severe tissue damage that caused permanent muscle loss, intense pain, loss of hip movement and walking with a permanent limp. They say the Pinnacle product shed microscopic metal ions into their bodies, causing side effects that J&J and DePuy didn’t warn surgeons about and that could have been avoided with a safer design.

The plaintiffs alleged J&J and DePuy valued marketing above research and development and rushed the Pinnacle product into production without any testing in humans out of a desire to capture a greater market share. They claimed the companies pushed the Pinnacle product with an incorrect statistic that it was 99 percent successful; that they’d used cheaper, less safe alternatives in the manufacturing process to keep costs down; and that the alleged defects in the product turned people’s hips into “ticking time bombs.”

In his closing statement, plaintiffs' counsel Mark Lanier of The Lanier Law Firm asked the jury to punish J&J "for being indifferent to our health” through a large punitive damages award that would capture the attention of company executives who didn’t attend the trial.

J&J and DePuy made the case during the trial that metal-on-metal was a viable, reasonable option for hip implants and that its Pinnacle Ultamet product was offered to help doctors choose the device that best fit their patients. The companies said the metal-on-metal implant was developed to solve a bone degradation problem with an existing polyethylene hip implant on the market and denied putting profits above patient safety and long-term results.

In a closing statement, defense counsel Steve Quattlebaum of Quattlebaum Grooms & Tull PLLC said the plaintiffs had made an emotional appeal and told a good story but that their allegations were not backed up by evidence or science. Quattlebaum said there’s no evidence the surgeons who treated the six plaintiffs relied on or even saw the 99 percent statistic when choosing which kind of implant to use and said there’s no evidence the plaintiffs’ injuries were caused by the product specifications the plaintiffs had complained about during the trial.

The plaintiffs are represented by Mark Lanier of The Lanier Law Firm, Jayne Conroy of Simmons Hanly Conroy, Richard Arsenault of Neblett Beard & Arsenault and Wayne Fisher of Fisher Boyd Johnson & Huguenard LLP

The defendants are represented by John H. Beisner, Stephen J. Harburg and Jessica Davidson Miller of Skadden Arps Slate Meagher & Flom LLP, Steven W. Quattlebaum of Quattlebaum Grooms & Tull PLLC and Tracie J. Renfroe of King & Spalding LLP.

The consolidated cases are Alicea et al. v. DePuy Orthopaedics Inc. et al., case number 3:15-cv-03489; Barzel v. DePuy et al., case number 3:16-cv-01245; Kirschner v. DePuy et al., case number 3:16-cv-01526; Miura v. DePuy et al., case number 3:13-cv-04119; Stevens v. DePuy et al., case number 3:14-cv-01776; and Stevens v. DePuy et al., case number 3:14-cv-02341, in the U.S. District Court for the Northern District of Texas.

--Editing by Rebecca Flanagan.

Update: This story has been updated with comment from representatives for the parties.







Frances Scott discusses one significant day in the jury trial that ends tomorrow.





I will post the verdict here.  The closing arguments are happening tomorrow and the charges have already been read to the jury.  

With another potentially $1 billion verdict on the line, two heavyweight lawyers—plaintiffs' counsel W. Mark Lanier and defense lawyer John Beisner—are trading ever-escalating accusations and barbs in court papers in a high-stakes DePuy hip implant trial.
By Amanda Bronstad | October 18, 2017



With another potentially $1 billion verdict on the line, two heavyweight lawyers—plaintiffs’ counsel W. Mark Lanier and defense lawyer John Beisner—are trading ever-escalating accusations and barbs in court papers in a high-stakes DePuy hip implant trial.
Lanier and his team are complaining of improper conduct and frivolous objections, and lawyers for hip implant maker Johnson & Johnson’s DePuy Orthopaedics Inc. have accused plaintiffs’ attorneys of misleading the jurors and springing new evidence on them in a “trial by ambush.”
To be sure, it’s no surprise that lawyers in the fourth bellwether trial over Pinnacle hip implants are fighting tooth and nail. Two previous trials landed $502 million and $1.04 billion verdicts. And as in those trials, Johnson & Johnson faces consolidated claims made by multiple plaintiffs at the same time—six New York plaintiffs to be exact.

It’s also not the first time that Lanier and Beisner have traded barbs in the litigation, which involves more than 9,000 cases. Earlier this year, Beisner, of Skadden, Arps, Slate, Meagher & Flom in Washington, D.C., accused Lanier, of The Lanier Law Firm in Houston, of failing to disclose payments he made to two expert witnesses in the second bellwether trial.
But the accusations in the latest trial, which began on Sept. 19 in Dallas, have been excessively contentious. In the latest spat, Lanier raised questions about potential tampering with one of his witnesses—a revelation that U.S. District Judge Ed Kinkeade of the Northern District of Texas on Monday said could end up involving federal prosecutors and the FBI.
Lawyers on both sides already have slung more than a dozen motions and trial briefs at one another. Neither Lanier nor Beisner responded to calls seeking comment on this story.
Kinkeade has yet to rule on the series of motions. Here’s what’s been filed:
Plaintiffs’ lawyers have filed:
  • A Sept. 27 trial brief to stop defense lawyers from making “repetitive and meritless objections” during trial. “Defendants’ tactics are nothing more than improper attempts to delay and obfuscate the trial,” the brief says. Johnson & Johnson’s lawyers responded on Sept. 29 with: “The fundamental premise of plaintiffs’ brief is that defendants should only be allowed to make objections at trial if plaintiffs deem those objections to have merit. This proposal is as preposterous as it sounds.”
  • Trial briefs filed on Sept. 21 and Oct. 3 accuse Johnson & Johnson’s lawyers of improper conduct – in particular, telling the jury about the worldwide popularity of Pinnacle hip implants knowing that plaintiffs’ attorneys were barred from bringing up previous deferred prosecution agreements involving bribes to foreign government officials and payments to doctors. Johnson & Johnson’s lawyers, in a Sept. 26 response, accused plaintiffs’ attorneys of mischaracterizing those agreements.
  • At a hearing on Monday, Kinkeade heard arguments about the statements of doctor that a DePuy sales representative told him “there could be ramifications” for his medical practice in connection with his upcoming testimony for the plaintiff. “He said the lawyers were ‘on him like crazy,’” according to an Oct. 15 affidavit filed by Dr. David Shein. Kinkeade called the developments “certainly disturbing and disconcerting to me.” He said he wanted the U.S. Attorney’s Office and the FBI to interview the sale rep and any lawyers who contacted him.
Johnson & Johnson’s lawyers have filed:
  • An Oct. 11 motion for mistrial based on Lanier’s references during witness questioning to prior cases involving DePuy hip implants. The motion notes that Lanier has done this before. “As demonstrated by the last MDL trial—where similar improper questioning and testimony culminated in gargantuan verdicts—improper references to ‘hundreds of other lawsuits’ are uniquely prejudicial because they tend to inflate any damages award.” The motion claims Lanier’s references violate a motion in limine order and, although some of the defense’s objections were sustained, “the horse was already out of the barn and the damage had been done.” On Oct. 15, Lanier denied any violations of court orders and insisted that the references are necessary to show witness bias and establish claims for punitive damages.
  • An Oct. 9 motion to exclude or limit the testimony of Dr. Bernard Morrey—one of the experts whose payments Beisner accused Lanier of failing to disclose in an earlier trial. In a Sept. 18 order, Kinkeade allowed Morrey to testify as long as he provided a written report to Johnson & Johnson three days prior to testimony. The motion, which is Johnson & Johnson’s second in this case, says the report “essentially reprinted Dr. Morrey’s testimony” from an earlier trial “in bullet-point format.” If he testifies, the motion cautions, Morrey should not be permitted to mention his own patient experiences without medical records nor give opinions that are not in his report—as happened in previous trials. Lanier countered in an Oct. 10 response: “Defendants are fully aware of the testimony Dr. Morrey intends to offer at trial—and they have known it for a very long time.”
  • An Oct. 15 motion for a jury instruction on the duty to warn to “correct plaintiffs’ counsel’s misrepresentation.” Specifically, the motion accuses Lanier of “insinuating to the jury several times” that Johnson & Johnson had a duty to warn patients when, under New York law, that duty was to surgeons.
  • An Oct. 15 motion for a jury instruction to “disregard plaintiffs’ counsel’s misleading questioning” of a defense witness regarding assets he held in a nonprofit foundation. Plaintiffs’ attorneys, in an Oct. 17 response, insist that an instruction isn’t necessary.
  • A Sept. 19 motion to reconsider consolidation of the six plaintiffs into a single trial. The motion is sealed, but Johnson & Johnson has repeatedly fought consolidated trials as leading to larger verdicts and prejudicing defendants. In an Oct. 10 response, plaintiffs’ attorneys called consolidated trials “standard operating procedure” in mass torts.
It’s unclear how Kinkeade could approach the motions and trial briefs. In the last trial, Johnson & Johnson’s lawyers filed a trial brief complaining that the plaintiffs would end up with more time than they would. But according to a Nov. 17 transcript, Kinkeade criticized defense counsel for causing its own delays by asking witnesses multiple questions just “to get to the point.”

“It’s just every time you file one of those, if it’s deserved I’ll take it, and I think I’ve done that in this trial,” he said, referring to trial briefs and motions. “You’ve got a very clean trial, regardless of the fact y’all have filed two motions for mistrial. So be it.” 

In addition to Beisner, Johnson & Johnson’s team on the court papers includes Skadden’s Stephen Harburg, another Washington partner; Steven Quattlebaum of Quattlebaum, Grooms & Tull in Little Rock, Arkansas; and Tracie Renfroe, a Houston partner at King & Spalding.
On the plaintiffs’ team, Lanier is joined by Wayne Fisher of Fisher, Boyd, Johnson & Huguenard in Houston; Richard Arsenault of Neblett, Beard & Arsenault in Alexandria, Louisiana; and Jayne Conroy of Simmons Hanly Conroy in New York.


Amanda Bronstad

Amanda Bronstad is the ALM staff reporter covering class actions and mass torts nationwide. She is based in Los Angeles.



Tuesday, July 4, 2017

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.




Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.
“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.
Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.
“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.
“This is about accountability and ensuring this never happens again.”
The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.
Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."
The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.
Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."
The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.
More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.
Some of the products involved in the suit are still available to purchase.
“There’s too many women who are injured,” implant victim Joanne Maninon said.
“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.
Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.
A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.
“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.
“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.
“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.
http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.






Joanne McCarthy

4 Jul 2017, 12:04 p.m





LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.
Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.
The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.
Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".
Mr Bannon told the court the comments' message was "those of us who were in the know".
"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.
The landmark case, which has attracted international media attention, is expected to take six months.
Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.
"Their enjoyment of life has been seriously compromised,” he said.
"Their lives have been dramatically altered for the worse.”
Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.
The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.
The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.
They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.
Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.
They were more likely "mid-career doctors" who saw their practices as businesses.
The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.
The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".
Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.
He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.
The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.
One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.
Ms Manion was visibly upset through some of the evidence.

The hearing continues.
http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

Tuesday, February 18, 2014

Texas woman first in bellwether surgical mesh trial.

Read the ruling here.
NewJersey.com ruling article here.


http://www.charlestondailymail.com/policebrfs/201402120147
Wednesday February 12, 2014
Trial against pelvic mesh manufacturers ongoing

Daily Mail Staff
CHARLESTON, W.Va. -- A Johnson & Johnson president of North American businesses was the latest to testify in one of several cases against the manufacturers of pelvic mesh.
Trial began Monday in the case brought by women who say the mesh used to treat stress urinary incontinence led to pain and permanent injury because of its defective design.
Carolyn Lewis, Kenneth Lewis, Augistina Brown-Singletary, Andre Singletary-Smith, Karin Harrison, Robert Harrison, Patricia Headrick, Darrell Headrick, Katie Uszler, Nick Uszler, Kelly Young and Kenneth Young originally filed the lawsuit in July 2012 in the Northern District of Texas.
Lewis received surgery in 2009, where doctors implanted the TVT, or transvaginal tape. The lawsuit alleges because of the defective design of the product, Lewis experienced pain when she emptied her bladder and during sex.
Defendants in the case are Johnson & Johnson, Ethicon Inc., Ethicon Women's Health and Urology, Gynecare and American Medical Systems Inc. This is the first case against Ethicon.
Attorneys for the companies said the plaintiffs never complained about problems from the mesh until after they filed the lawsuit and said the product was not defective.
U.S. District Judge Joseph Goodwin is overseeing the consolidation of more than 26,000 similar cases alleging injury from plastic mesh devices used to treat bladder and other organ weaknesses.
Laura Angelini, who has served in several marketing positions at Johnson & Johnson and Ethicon, appeared in a pre-recorded video deposition.
In her video testimony, Angelini agreed with the attorney, saying a Swedish company and the inventor of the TVT signed an agreement that later led to the company being the exclusive supplier of the tape. She said the inventor was a 20 percent shareholder in the company.
Angelini said the TVT initially was launched in Europe and was launched in the U.S. in late 1998. She agreed the type of mesh was used in hernia repair.
In Monday's opening statements, Lewis' attorney, Thomas Cartmell, alleged Ethicon used mesh to treat hernias but problems caused by the heavy nature of the product and small pores required surgeries to remove it.
Cartmell said a Swedish inventor later contacted Ethicon saying he used the old mesh to treat stress urinary incontinence and experienced no complications.
In her video testimony, Angelini said the Swedish company and the inventor signed an agreement where his company would be the exclusive supplier of the TVT.
Under the agreement, Agenlini agreed Johnson & Johnson would pay $400,000 to the company if it received acceptable clinical trial results.
In her opening statements, Christy Jones, an attorney representing the mesh manufacturers, said there were several studies on the transvaginal tape, not just those conducted by the inventor.
She said those studies have shown the tape is effective to treat stress urinary incontinence and said it was deemed the gold standard to treat this condition.
In the video, the attorney read off the agreement, saying Johnson & Johnson would pay $20 million for the TVT and a second installment of $2 million. If 140,000 units of TVT were sold, then Johnson & Johnson would pay another $2 million to the seller.
Angelini agreed that if all payments were made, that would total more than $24 million for the TVT device.
The video also showed an email from Angelini in response to her colleagues in the U.S. The attorney asked if she wrote they should spin it to more of a safety aspect than the complications and asked if she had influenced the title of a medical presentation.
Angelini responded that she provided her perspective to provide a more balanced position to show the safety data they had.
Goodwin dismissed the jury early Wednesday and told them to come back at 9 a.m. today. According to the court calendar, the trial is scheduled to last through Feb. 25.
Contact writer Andrea Lannom at Andrea.Lan...@dailymailwv.com or 304-348-5148. Follow her at www.twitter.com/AndreaLannom.




Thursday, February 6, 2014

Here's $200k! (Only requirement: live with pain of a faulty hip the rest of your life.)


Mon Feb 3, 2014 11:30pm EST


(Reuters) - U.S. medical device maker Biomet Inc will pay at least $56 million to settle a multi-district lawsuit relating to defective metal hip replacements, a court filing showed, ending a protracted legal tussle.
The litigation involves Biomet's metal-on-metal hip replacement device known as M2a Magnum. Hundreds of plaintiffs claimed in various courts across the country that the hip device led to injuries.
The lawsuits were combined and jointly heard at the federal court of Indiana, the state where Biomet is headquartered. The multi-district litigation began in 2012.
As part of the settlement, Biomet will deposit $50 million into an escrow account and another $6 million into an attorney fee fund, the filing showed.
The agreement with the plaintiffs shall extend to all pending cases, and any future lawsuit filed in a federal court on or before April 15, 2014.
Plaintiffs who have received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was rectified more than 180 days after it was implanted shall receive a base award of $200,000.
Biomet, however, maintains that the injuries, losses and damages were not due to its hip implants.
"Plaintiffs and Biomet are mindful of the uncertainties engendered by litigation and are desirous of settling and compromising their differences by entering into this settlement agreement," Judge Robert Miller wrote in his order.
Biomet said in a statement late on Monday that it is pleased to reach a settlement and resolve the lawsuits.
The case is Biomet M2A Magnum Hip Implant Products Liability Litigation (MDL 2391), Case No. 12-02391, U.S. District Court, Northern District of Indiana.
(Reporting by Sakthi Prasad in Bangalore; Editing by Supriya Kurane)