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.
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Showing posts with label MDL. Show all posts
Showing posts with label MDL. 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.



Friday, September 22, 2017

J&J ASR Hip Defense Verdict is Overturned in Chicago



Amanda Bronstad, The National Law Journal
September 21, 2017  
A Chicago judge has granted a new trial in one of the only verdicts involving DePuy Orthopaedics Inc.’s ASR XL hip implants.
Tuesday’s ruling by Cook County Circuit Court Judge Deborah Mary Dooling reversed a 2013 defense verdict that came out just before DePuy reached a $2.5 billion global settlement resolving about 8,000 cases. The judge found that a key scientific expert for plaintiff Carol Strum should have been allowed to testify at the trial about the wear on the hip implants. The lawsuits claimed the devices caused pain, grinding or clicking in the hips and high metal content in blood tests.
“He was going to provide objective proof of the amount of metal loss on the device versus the amount that should be lost,” Strum’s lawyer, Peter Flowers, said of the expert, Dr. David Langston. “The lack of objective proof of that certainly played a large role in the ultimate outcome.”
On Thursday, Dooling told both sides to return next week with possible trial dates.

“We believe the verdict arrived at by the jury in 2013 was consistent with the facts in this case,” wrote Stela Meirelles, a spokeswoman for DePuy, which is a subsidiary of New Jersey’s Johnson & Johnson. “DePuy’s actions concerning the product were appropriate and responsible."
The ruling is a big win for the plaintiffs bar, whose scientific evidence and experts at several mass tort trials have been criticized as “junk science.” It has come up in litigation involving Johnson & Johnson’s baby powder, acne drug Accutane and cholesterol drug Lipitor
In her ruling, Dooling relied on a scientific evidentiary test established in Illinois called the Frye standard, named for the U.S. Court of Appeals for the District of Columbia Circuit’s 1923 holding in Frye v. United States. Under the standard, evidence can be admitted that is “generally accepted” in the scientific community. Dooling concluded that her original definition of that field was “too restrictive” and that Langton’s methodologies were generally recognized, even by scientists at the U.S. Food and Drug Administration.
“Surely the FDA, the agency responsible for ensuring safety for patients who have medical devices implanted, would not request a device manufacturer to perform testing that was not generally accepted in the scientific community,” she wrote. 
Strum had the device implanted in 2008 due to arthritis in her left hip. Two years later, DePuy recalled the ASR. After suffering pain, Strum had another surgery in 2011 to replace the implant.
Her case wasn’t the first to go to trial over the ASR hip implant. Months earlier, a jury in Los Angeles awarded $8.3 million to Loren Kransky after finding the ASR was defectively designed. But many lawyers considered that case, which was bumped up for trial due to Kransky’s poor health, to be an outlier. DePuy reached its global settlement before the first bellwether trial in the federal cases began.
But thousands of plaintiffs have been excluded from the deal, which limited payouts to those who had revision surgeries as of Aug. 31, 2013.
As of Sept. 15, there were more than 1,600 cases still pending over ASR hip implants in the federal multidistrict litigation in Ohio, according to the U.S. Judicial Panel on Multidistrict Litigation. Flowers, of Chicago’s Meyers &  Flowers, said dozens of ASR lawsuits remain in Illinois, including Strum’s case, which was excluded from the settlement because it went to trial.
That doesn’t mean it couldn’t settle, rather than go to trial.
“It very well could,” Flowers said. “That remains to be seen.”
  • http://www.nationallawjournal.com/id=1202798576803/Judge-Grants-New-Trial-Over-JJ-Hip-Implant?mcode=1202615432600&curindex=1&slreturn=20170821171902


Contact Amanda Bronstad at abronstad@alm.com.

Saturday, September 16, 2017

Surgical Mesh: Harm-for-Profit Crimes Against Women


$57.1 Million Verdict Against Johnson and Johnson
$57.1 million was awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.
$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal both cases to a higher court.
Transvaginal mesh bellwether trials and settlements are updated as follows:
MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 38,956 Total Closed: 7718  Past verdicts and settlements include:
  • Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
  • Edwards v. Ethicon, Inc., et al., 2:12-cv-09972-  Dismissed
  • Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
  • Carolyn Lewis v. Ethicon, et al. Defense Judgment
  • Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
  • Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed
MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,127  Total Closed: 17,248
MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation–  Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs.  Total Cases: 15,491  Total Closed: 10,452  Past verdicts and settlements include:
  • Wise, et al. v. C. R. Bard, Inc. – Settled
  • Donna Cisson v. Bard, Inc.  – $2 Million Verdict
  • Wanda Queen v. Bard, Inc. 2:11-cv-00012  – Settled
  • Carolyn Jones v. Bard, Inc. 2:11-cv-00114 – Settled
MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Settlements in process with no trials scheduled. Total Cases: 25,029   Total Closed: 15,101   Past verdicts include:
  • Jeanie Blankenship – $4.25 million +  $1 million punitive damages
  • Chris Wilson – $3.75 million +  $1 million punitive damages
  • Carol Campbell – $3.25 million + $1 million  punitive damages
  • Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
  • Juana Betancourt – $6.5 + million
  • Mania Nunez – $6.7 + million; and
  • Margarita Dotres – $6.7 + million;
  • Amal Eghnayem – $6.7 + million
MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al.  Total Cases: 629 Total Closed: 123
MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled and the judge is conducting settlement conferences. Total Cases: 2610 Total Closed: 2397
MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125
Transvaginal Mesh Verdicts 
A chronology of the verdicts, settlements, manufacturers, products, and jurisdictions follows:
  1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA
  2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
  3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
  4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
  5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  – TX
  6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
  7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
  8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
  9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX
  10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
  11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
  12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
  13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
  14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV
  15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
  16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
  17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
  18. 2/15: Settled – Wise v. Bard in the MDL
  19. 3/15: Settled  – Bellew v. Ethicon (Prolift) in the MDL;
  20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
  21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
  22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
  23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima –  TX
  24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
  25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) –  PA
  26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
  27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT)  – PA
  28. 4/17:  $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
  29. 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
  30. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA
TVM Verdicts and Trials
On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant. 
This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction. 
On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th,  2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.  
As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements.  Boston Scientific, Coloplast, AMS and Bard have begun offering settlements. 
A  California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed  because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice.
Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market. 
Bard Bellwether Case Settles Before Trial
Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount.  On February 12, 2015,  Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”
$26.7 Million and $18.5 Million Verdicts Against Boston Scientific 
$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded  $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.
The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include: 
  1. Amal Eghnayem – $6.7 + million;
  2. Margarita Dotres – $6.7 + million;
  3. Mania Nunez – $6.7 + million; and
  4. Juana Betancourt – $6.5 + million
The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include: 
  1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages;
  2. Chris Wilson – $3.75 million +  $1 million punitive damages;
  3. Carol Campbell – $3.25 million + $1 million  punitive damages;
  4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
Transvaginal Mesh Adverse Events
Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations
Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:
  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse
Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications. 
In July 1, 2012, Bard stopped selling the Avaulta Mesh in the United States because the FDA required additional clinical trials and testing.
On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.
History of Warnings
Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.
Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.
However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.
On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.
On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.
On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.
Transvaginal Mesh Products & Manufacturers 
Ethicon
  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo
C. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex
American Medical Systems 
  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc
Boston Scientific
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System
Coloplast
  • T-Sling-Universal Polypropylene Sling
  • Aris-Transobturator Sling System
  • Supris-Suprapubic Sling System
  • Novasilk-Synthetic Flat Mesh
  • Suspend-Tutoplast Processed Fascia Lata
  • Exair-Prolapse Repair System
  • Axis-Tutoplast Processed Dermis
  • Restorelle
  • Smartmesh
  • Omnisure
  • Minitape
Cook 

  • Surgisis
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