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.
Draft guidelines from NICE say the implants should only be used for research - and not routine operations.
Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.
One expert said it is highly likely the NHS will take up the recommendation.
However, the organisation is not compelled to act on findings it receives from NICE.
Both NHS England and NICE declined to comment.
'Life-changing consequences'
In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".
It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".
One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.
"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.
"These can last from two to six hours at a time and is like having a heart attack," she said.
Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.
She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.
The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through"
The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.
They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".
He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.
But he said it had come too late.
"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."
He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.
The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".
Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.
About one in 11 women has experienced problems, the data suggests.
The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.
In Scotland, former Scottish Health Secretary Alex Neil requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed hundreds of operations have been performed since.
A number of Scottish health boards have stopped using mesh implants altogether.
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.
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
million in punitive damages against DePuy.
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 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.
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.
Written by Laura Dyrda | Friday, 03 November 2017 17:06
The American Joint Replacement Registry released its 2017 Annual Report, outlining data on hip and knee replacements.
The report, released at the 2017 American Association of Hip and Knee Surgeons Annual Meeting in Dallas, Nov. 2 to Nov. 5, includes data from 654 institutions and 4,755 surgeons who performed 860,080 hip and knee replacements.
"The AJRR has seen significant growth since the previous report; this year's report has a 101 percent increase in procedures, a 57 percent increase in reporting institutions and a 50 percent increase in surgeons," said AJRR Board of Directors Chairman Daniel Berry, MD. The data includes primarily procedures performed in the hospital, although eight ASCs reported data for 1,020 procedures.
Key highlights from the report include:
1. Hip revision surgery burden: 8.6 percent (down from 14.6 percent in 2012)
2. Knee revision burden: 5.1 percent (down from 6.2 percent in 2012)
3. Primary knee implant design:
• Posterior stabilized: 48.5 percent
• Cruciate retaining: 35.3 percent
• Ultracongruent: 5.6 percent
• Other: 8 percent
4. Unicompartmental knee replacements: 3.2 percent of all primary knee replacements
DALLAS — Pseudotumor formation occurred in 52% of patients who underwent metal-on-metal total hip arthroplasty performed with two different designs of prostheses and later underwent metal artifact reduction sequence MRI or MARS MRI of the hip, a presenter said at the American Association of Hip and Knee Surgeons Annual Meeting
“So overall prevalence and severity, over half of our patients had a pseudotumor and nearly 40% either had a type 2 or type 3 lesion,” Daniel E. Goltz, BS, said.
The 207 hips that underwent MARS MRI received an ASR THA prosthesis or a Pinnacle prosthesis with Ultamet liner (both DePuy) metal-on-metal (MoM) hip implant. The patients represented just the patients who had MARS MRI and had any pseudotumors graded among 178 patients with ASR prostheses and 788 patients with Pinnacle prostheses who were operated on between 2002 and 2013 and had a minimum 2-year follow-up and average 8-year follow-up.
Goltz and colleagues analyzed the factors associated with a pseudotumor and found those patients were significantly more likely to have higher cobalt levels, a higher cobalt-chrome ratio, a high-offset femoral stem and a larger size acetabular cup.
“Patients with thick-walled cystic or solid masses were more likely to be revised than those with thin-walled cystic masses (P < .001),” the investigators wrote in the study abstract.
In his presentation, Goltz said, “Interestingly, we found that symptoms may not be the best reliable indicator of whether or not a patient has a pseudotumor or its severity.”
The study definition of being symptomatic after MoM THA was pain, weakness or a limp, he noted.
“Sixty percent of our cohort actually ended up having symptoms,” Goltz said. However, among the asymptomatic patients, 47% had a pseudotumor, he said.
“It is our hope that this work will be able to guide all of you as clinicians as you make what may come to be a challenging decision in terms of which patients to revise and the timing for that revision,” Goltz said. – by Susan M. Rapp
Reference:
Kleeman L, et al. Paper #39. Presented at: American Association of Hip and Knee Surgeons Annual Meeting; Nov. 2-5, 2017; Dallas.
Disclosure: Goltz reports no relevant financial disclosures.
