The long awaited first jury trial in the DePuy ASR hip implant federal multidistrict litigation was set to begin on June 3, 2013. Judge Katz moved the trial to September 2013. Judge Katz is the federal judge in charge of the vast majority of DePuy ASR cases which are in the federal court system. Lawyers for the injured patients argued for a shorter postponement of only a few weeks but the judge thought that due to the number of unsettled legal issues and the fact that the next open trial date on his calendar was not until September that the trial would be moved to September.
In August it will be three years since the DePuy ASR hip implant recall and DePuy has yet to make any fair offers to settle these cases. I believe that at this point only repeated jury trial will force this company to the table to settle these cases. They cannot try 11,000 lawsuits so they have to institute a settlement program at some point.
So far, there have been two jury trials in the state courts of California and Illinois. The first verdict was in California for 8.3 million dollars and the second jury verdict in Chicago was zero for the plaintiffs.
Saunders and Walker and other law firms around the country are continuing to fight for victims of this greedy company and we hope that justice will prevail sometime soon in the future.
Two years ago the Supreme Court unknowingly created a two-tiered system for the liability faced by drug makers. In Pliva v. Mensing, the court severely limited the conditions under which consumers of generic drugs could sue the manufacturers.
The court ruled that since makers of generic drugs did not have control over the content of warning labels, they could not be held liable for failing to alert patients to the risks of taking their drugs.
Now, the Supreme Court is set to decide a number of cases that challenge that earlier ruling.
At issue is a group of three consolidated cases brought by women who took the generic equivalent of Reglan for stomach ailments and developed a serious neurological disorder. Appeals courts ruled against the drug makers, saying that the federal regulatory regime did not block claims under state law.
If the makers of generics can’t be held liable, who can? The position of the generics is one in which they would be immune from liability for selling a product with inadequate warnings — even though the name-brand company selling the same drug with the same warnings would be liable.
That position would leave the women who were harmed by the generic version of Reglan with no recourse.
In another similar case heard by the court recently, Bartlett v. Mutual Pharmaceutical Company, defendant Karen Bartlett developed a rare but severe reaction to the anti-inflammatory drug Sulindac after a doctor prescribed it to treat shoulder pain in 2004.
Sulindac, similar to Ibuprofen, is in a class of drugs known as nonsteroidal anti-inflammatory drugs — or Nsaids — which are in widespread use and was approved by the FDA in 1978. Within weeks of taking the generic version of Sulindac, Bartlett developed toxic epidermal necrolysis, a severe form of a related condition called Stevens-Johnson Syndrome. The reaction permanently damaged her lungs and esophagus and rendered her legally blind.
Bartlett sued Mutual Pharmaceutical Company, which made the generic drug she took, arguing that the drug’s design was dangerous and defective. A jury in the Federal District Court in Concord, N.H., awarded her $21 million. An appeals court upheld the verdict.
Now Mutual Pharmaceutical Company has appealed the case to the U.S. Supreme Court, maintaining it can’t be held liable since it had no control over the drug’s warning label or design.
If the court agrees with Mutual and rules that generic companies cannot be sued for defective products, what recourse will patients have who were injured by a generic drug? Then the question becomes can a generic manufacturer be held liable for anything?
It is worth noting that currently 70 percent of prescriptions in the U.S. are being filled with generic drugs and of that number, a third of generics have no brand-name competitors.
If the Supreme Court rules in favor of the makers of generic drug in these cases, who will remain liable if the drugs harm patients?
Karen Bartlett is desperate to know the answer to that question.
A jury in Chicago rejected claims this week that the DePuy orthopedics unit of Johnson & Johnson inappropriately marketed an artificial hip, which the company recalled in 2010.
This comes in direct contrast to the $8.3 million dollar verdict awarded last month against DePuy in Los Angeles District Court which found that the company had knowingly marketed a faulty hip implant that it later recalled.
This verdict came in the second trial of over 10,000 pending lawsuits involving the all-metal device, which was known as the Articular Surface Replacement or A.S.R. This was part of a once-popular class of metal-on-metal hip implants developed almost a decade ago. It was an attempt to improve on traditional joints that were made of metal and plastic. But shortly after the release of the A.S.R., complaints started coming from patients and doctors about implant failure and tissue and bone damage caused by metallic debris. Patients typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.
The evidence presented against DePuy in both trials was remarkably similar and centered on the fact that the company continued to market the device even after they learned the joint was defective. In both trials internal DePuy documents were introduced that showed beyond a doubt that company officials knew that the design of the A.S.R. was flawed long before they recalled the device and even considered redesigning the implant. The documents also showed that they never shared that information with doctors and patients
It remains unclear why the juries returned such differing verdicts, but in both trials the evidence against DePuy was staggering.
In the Chicago trial the jury was concerned whether the plaintiff’s need for a revision surgery was because of the defect in the product or for some other reason. Apparently, the injured plaintiff in this case continued to have pain and problems even after the DePuy ASR was removed. The DePuy attorneys had argued that the plaintiff had a metal sensitivity to any metal in her body and that her problem would have occurred no matter what type of metal implant she had.
In my experience as a trial lawyer, juries frequently demand stronger evidence than the law requires before they will award millions of dollars in a case. In cases where they have questions about the strength of the evidence they render a defense verdict.
I believe that the evidence is very strong that the DePuy ASR is a defective and dangerous product and that is why it was recalled. The verdict in Chicago certainly did not affirm that the DePuy ASR is a good product. Rather the verdict hinged on the causation of the plaintiff’s pain, not whether the product was defective or not.
The company’s strategy in both trials has so far been one of denial. In his opening statement in Chicago, DePuy attorney Richard Sarver stated, “We absolutely didn’t say the product is a defective product.” To say the recall “is an admission of a defect, it is absolutely absurd.”
Yet in both trials internal documents were introduced that showed consulting surgeons had warned officials at DePuy the implant was faulty and that, by 2008, they knew the cup needed to be redesigned. Even more telling was that DePuy’s own internal estimates that indicated the joint was projected to fail within five years in about 40 percent of the patients. That represents a failure rate eight times higher than most orthopedic implants
DePuy president Andrew Ekdahl downplayed the internal findings and testified that the device was withdrawn, not because it was defective, but simply because “it didn’t meet clinical expectations.”
Yet in the interim between the two trials a study was released by the American Academy of Orthopedic Surgeons, AAOS, which puts the current revision rate of patients with ASR implants at a staggering 40 percent. This number was eerily similar to the 40 percent failure rate DePuy arrived at internally. While the company can continue to attempt to discount its own findings, the study by AAOS is harder to counter.
There are numbers of other jury trials scheduled this year and each case has variations and differences, if DePuy continues with its defense strategy I believe in the end most of the verdicts will be against them. DePuy executives knowingly marketed a defective product and yet they insisted — right up to a moment the device was recalled — that it was safe.
The ASR is one of the worst hip implants ever put on the market and for that reason there is no need to be discouraged by an early defense verdict. With thousands of trials remaining, it will be the job of trial lawyers to fight for the rights of injured consumers and protect them from major corporations like DePuy. The rights of patients, not profits, should always be paramount.
The DePuy A.S.R. is part of the biggest medical device failures in decades and it was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.
One of the primary reasons for hip replacement is to allow patients to restore the quality of life they had before their hips became a problem. The ability to regain lost mobility and go back to work and exercise are at the top of patients’ list of reasons why they had hip-replacement surgery.
But there is one important quality of life issue that’s almost never mentioned when considering a hip-replacement . . . sex.
In a recent article in the New York Times, (“Surprise Path to Better Sex: Hip Surgery,” April 8, 2013), Tara Parker-Pope writes of how many patients had given up sexual activities because of pain and loss of motion in their joints. But after joint replacement, pain was greatly decreased and motion improved. Most patients reported being able to enjoy pain-free sex again.
In the past decade, the number of hip-replacement surgeries has risen by 85 percent. In 2010 alone, there were over 300,000 hip-replacement surgeries performed. In active middle-age adults, 45-65, the number of hip-replacement surgeries tripled, accounting for 128,000 of that total. In terms of quality of life, a healthy sex life is important, especially in this demographic.
“It’s certainly a topic that is on everyone’s mind, but it’s not a topic that is always spoken about openly,” says Dr. Charles Cornell, clinical director of orthopedic surgery at the Hospital for Special Surgery in New York. Many patients are still hesitant to talk about how joint pain has affected their sex lives.
But it’s beginning to change. Dr. Claudette Lajam, an orthopedic surgeon at New York University Langone Medical Center, said that so many patients have questions about intimacy after joint replacement that she added a page to her Web site devoted to sex. “That page gets the most hits of any page on my Web site,” Lajam says.
Another sign the issue of sex and joint replacement is growing in the public consciousness is when celebrities openly discuss the problem. In a recent interview, the actress and fitness guru Jane Fonda spoke openly of what her hip-replacement meant, “…I’m happier, the sex is better and I understand life better. I don’t want to be young again.”
Along with improving sex lives, hip-replacements can also help improve relationships. When a member of a partnership becomes disabled, it challenges that partnership. The early failure of a hip implant causes significant suffering on the part of both partners in an intimate relationship.
The lawsuits that our firm is filing against hip implant manufacturers DePuy, Stryker, Zimmer, Biomet, Wright Medical and Smith & Nephew all include consortium claims for spouses for the suffering sustained by them and the damage to the sex life of both partners.
A legal consortium claim is much more than just loss of sexual activity it includes all the types of suffering and changes in lifestyle of both partners as a result of a hip implant recall and surgery to replace the defective hip implant. Consortium compensation can include lost companionship, anguish and worry for their partner and for their relationship.
At a jury trial in most states the jury is charged with coming up with a separate figure to compensate the non-physically injured partner for their losses in this category. The recent New York Times article and other public discussion about the sex issue should help jurors hearing lawsuits involving hip implants have a better understanding of what these implant patients and their partners have been going through. This in turn may help increase jury verdict wards for loss of consortium claims in hip implant lawsuits.
Pope Francis I Catholic Church Sexual Abuse
Cardinal Jose Maria Bergoglio of Argentina has been elected by the College of Cardinals as the next pope. It was announced from the balcony of St. Peter’s Basilica Wednesday evening. He will take the name of Francis and is the 266th pontiff of the Catholic Church.
Bergolio’s selection came at the end of the first full day of the conclave and was sealed on only the fifth ballot. It would indicate that the College of Cardinals was in agreement but came as a surprise to many outsiders. Going into the conclave Bergoglio wasn’t considered to be one of the favorites, in spite of being the rumored as the runner-up in the 2005 conclave that elected Pope Benedict.
Formally the Bishop of Buenos Aires, Bergoglio will be the first non-European pope and seen as a nod to the growing significance of the church in the global south. In 2001 Archbishop Bergolio was elevated to Cardinal by Pope John Paul II, and began serving as an administrator of the Roman Curia – the administrative apparatus of the entire Catholic Church – which operates out of the Vatican.
The new pope inherits a Catholic Church mired in turmoil, much of it made worse by his predecessor pope Benedict. One of the first things Pope Francis must face is a sexual abuse crisis that has undermined the church’s moral authority around the globe.
As the College of Cardinals convened there were charges being brought against pedophile priests on every continent the Catholic Church operates. While the Vatican continues to downplay the crisis, new allegations emerge almost daily. Even during the conclave Cardinal Keith O’Brien, the archbishop of Scotland, was forced to resign amidst allegations of improper sexual relations going back 30 years.
On the same day Pope Francis was named, Cardinal Roger Mahoney of Los Angeles was receiving fresh attention for his role in the cover-up of sexual abuse by priests. The Archdiocese of Los Angeles agreed to pay a total of nearly $10 million to settle four child sex abuse cases brought against them. There is stark evidence that while he was bishop there, Mahoney helped a confessed pedophile priest evade law enforcement by sending him out of state to a church-run treatment center, then placing the priest back in the Los Angeles ministry.
Surveys of American Catholics reveal that they see sex abuse as the biggest problem facing the Catholic Church. Under Benedict the Church’s handling of the sex abuse scandals was cloaked in secrecy, and the impact was disastrous. In Europe, South America, and in the United States thousands of young men and women were victimized, and millions of dollars have been paid in settlements. This great tragedy is far from over.
As Cardinal, Bergoglio gave only three interviews, as Pope Francis he will be forced into the public spotlight. Until now the church’s reaction to the scandal has been entirely reactionary and relied on downplaying accusations or by using religion to bludgeon critics.
It is a pivotal moment for the church. The new pope must speak publically about the issue if he is serious about changing the church and putting an end to this epidemic of sexual abuse. Remaining dedicated to the Church’s current conservative principles will ignore the suffering of the victims and only allow this horrible tragedy to continue.
DePuy ASR Settlement
Today in Los Angeles a jury awarded $8.3 million to a former prison guard who accused Johnson & Johnson’s DePuy Orthopedics subsidiary of knowingly marketing a faulty hip implant that it later recalled.
In the first of over 10,000 lawsuits filed against DePuy, jurors found that the now-recalled ASR implant had caused Loren Kransky, 65, to suffer from metal poisoning and other health problems after he underwent hip-replacement surgery in 2007.
Since DePuy introduced the ASR, almost 93,000 patients have received the implant. Roughly one-third of those recipients were in the United States. From the beginning there were complaints from patients and doctors about the device. The joint failed at an unacceptable rate and doctors discovered tissue damage caused by metal debris from the implant. Common complaints from patients with an ASR included pain- and joint-dislocations, infections and bone fractures. This led Johnson & Johnson to recall the device in 2010.
This suit came to trial first under a California statute that allows for cases involving plaintiffs with terminal diseases to be expedited. Kransky, a retired Montana prison guard, suffers from kidney cancer and other ailments. Jurors were able to see past these health problems and recognize the intense pain and suffering caused solely by the defective ASR joint. This sets a strong precedent as the other suits prepare to go forward.
In spite of the decisive verdict, Loire Gawreluk, a DePuy spokeswoman, said the company plans to appeal.
The trial’s evidence was overwhelming that DePuy had long known of problems with the ASR. Internal documents from DePuy showed that the company had concerns about the ASR joint long before 2010. It was aware of abnormally high failure rates with the device yet it continued to market it aggressively in the United States. Company head Andrew Ekdahl was told by consultants to DePuy as early as 2008 that the device was faulty and failing at alarming rates.
DePuy continues to deny it knew early on the device was defective. It claimed in the trial that ASR failure was entirely the result of surgeons implanting the device improperly.
The jury rebuked that argument completely and, despite the promise of an appeal, the verdict will set a starting price for other plaintiffs in settlement discussions.
Johnson & Johnson has set aside more than $3 billion to cover the ASR recall. Yet rather than settle the almost 11,000 law suits filed against it, the company intends to proceed on a case-by-case basis. This initial verdict in Los Angeles calls this strategy into question.
In closing arguments, Kransky’s attorney Michael Kelly said, “This is not an imperfect hip, this is a public health disaster. Somebody needs to tell them, ‘Build these things right. Don’t let this happen again.’ ”
While Johnson & Johnson continue to resist a settlement, analysts predicted that the decision will begin to make the company reconsider. Continued litigation will be onerous and expensive and the company will be forced to offer a national settlement under which thousands of hip plaintiffs would likely take what is offered rather than face years of litigation and appeals.
The ASR represents only a part of the biggest medical device failure in decades. Since its recall in 2010, the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination, but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.
The verdict in favor of Loren Kransky vindicates the thousands who suffer as a result of having ASR implants. DePuy will continue to insist it acted appropriately. But this trial refutes executives’ claims. Instead the evidence showed a corporation that placed profits above the health of its patients, the welfare of the corporation above the people it served.
New Jersey Jury adds $7.76 Million in Punitive Damages to $3.35 Million Ethicon Prolift Vaginal Mesh Verdict
Today the Atlantic City jury in Linda Gross v. Ethicon found that Johnson & Johnson and its Ethicon Division was guilty of culpable negligence in disregarding health of patients in pursuit of profits in the marketing of the Ethicon Gynecare Prolift transvaginal mesh implant. This verdict sends a message to medical product manufacturers that jurors will not tolerate a company that puts corporate greed above the safety of the public. The $7.76 million in damages to punish the company was in addition to the $3.35. million that the jury awarded Monday to compensate for the injuries that were caused by the mesh.
Linda Gross had suffered horrible pain and injuries when the transvaginal mesh that was implanted in her moved and shrank damaging her body. She has endured multiple painful surgeries to try to remove the mesh and fix the damage done to her body. The Gynecare Prolift mesh was marketed as safe and effective to treat pelvic organ prolapse but had never been clinically tested before the marketing campaign to doctors. The evidence at the trial demonstrated that Ethicon mislead doctors about the degree of testing that had been done and that Ethicon concealed emerging evidence that the Prolift product was unsafe. The Prolift was finally recalled last year after the FDA ordered the manufacturers to conduct a proper study on the safety of the device.
There are thousands of other lawsuits pending around the United States involving the Ethicon Prolift as well as other transvaginal mesh products (TVM) manufactured by Bard, Boston Scientific, American Medical Supply (AMS) and Coloplast. The FDA has ordered all of these companies to conduct safety studies on their TVM products.
All of these TVM products were marketed under the 510(k) loophole in the FDA regulations that allow manufacturers to “grandfather in” a new product because it is similar to a product already on the market. This is so even though the products already on the market have never been proven to be safe or effective. This is the same loop hole that allowed the widespread sale of metal on metal hips such as the DePuy ASR, Zimmer Durom Cup, Wright Converse, Stryker Rejuvenate ABG II, and Biomet Magnum without any clinical testing. There are thousands of lawsuits pending by hip implant patients with failed hip implants with these products as well.
Please be sure to visit our dedicated sexual abuse and priest / church sexual abuse website Abuse Advocate.
And our main firm website:
View imageAs the College of Cardinals begins to gather for the upcoming Papal Conclave, the sexual abuse scandals that plague the Catholic Church continue to overshadow the event.
At least a dozen of the Cardinals now in Rome to prepare for the conclave have faced accusations of failing to remove priests who were accused of sexually abusing minors. In several cases, there is mounting evidence that — in addition to trying to cover-up cases of sexual abuse — several Cardinals may have manipulated church funds to hide assets from victims seeking settlements.
Advocates for abuse victims have also begun to gather in Rome to protest what they see as the blatant hypocrisy of the Catholic Church. While Pope Benedict had repeatedly apologized to the victims of sexual abuse, he never instituted any serious reform. During his Papacy not a single prelate was removed, even after court cases and documents revealed Cardinals who had put children at risk by failing to report pedophiles or remove them from the priesthood. Now those same prelates meet to pick Benedict’s successor and their new defender.
Much of the anger has been directed at Cardinal Roger Mahoney, retired from the diocese of Los Angeles. When sexual abuse charges were brought against priests in Los Angeles it was revealed in thousands of pages of church documents that Cardinal Mahoney attempted to cover-up and shield priests charged with abuse. His failure was so great that it has even prompted a rare rebuke from the church. Prominent Italian Cardinal Velasio De Paolis said that Mahoney’s presence at the conclave would be “troubling” and privately asked him not to come.
But to the dismay of his critics, Mahoney will attend the conclave. Hours after the Pope’s resignation he tweeted, “Am planning to be in Rome and vote for the next Pope.”
Days before he left for Rome, Cardinal Timothy Dolan of New York was also questioned behind closed doors in a legal deposition concerning the sexual abuse of children by priests in Milwaukee, where he was Cardinal for seven years. At present, 575 people have filed abuse claims against priests in the Milwaukee diocese. While Dolan’s role in the cover-up continues to be examined, he is widely seen as the leading American candidate for Pope.
Cardinal Francisco Javier Errázuriz of Chile, Cardinal Sean Brady of Ireland, Cardinal Marc Ouellet of Canada — all of whom have been implicated in abuse cover-ups and been widely criticized in their home countries — will attend the conclave and are expected to vote for the new Pope.
The church continues to be rocked by abuse scandals worldwide, yet the Vatican remains silent as the College of Cardinals convene. Critics continue to hope that the next Pope will have the courage to address the sexual abuse crisis in the church. But how much hope for change can there be when many of those selecting the next Pope have been complicit in the very crisis all along? Will they want the next Defender of the Faith to protect the Cardinals or the victims of sexual abuse?
New Jersey Jury Awards 3.35 million in Transvaginal Mesh trial against Ethicon.
The Atlantic City jury found Johnson & Johnson’s Ethicon Company liable for selling a defective Prolift vaginal mesh product that injured plaintiff Linda Gross causing multiple painful surgeries. The trial of this lawsuit had been going on for several weeks. Judge Higbee who was the trial judge is now deciding whether the evidence justifies having the jury assess punitive damages to punish Ethicon for putting its own profits above the safety of patients.
Linda Gross’s attorneys had argued that the Ethicon Prolift Mesh was defective because of a bad design that allowed for shrinkage of the mesh and that the design of the mesh was not appropriate to implant into the human body.
There are thousands of transvaginal mesh (TVM) lawsuits pending in the United States. Most of the cases in federal court have been assigned to the multidistrict litigation proceedings in Charleston, West Virginia. These cases involve Boston Scientific, AMS, Bard, and Coloplast in addition to Ethicon. A number of those cases are currently being set for jury trials.
In 1943, Robert Wood Johnson, the chairman and founding family member of Johnson & Johnson put forth the credo that he intended to forever guide the company’s decision making – Put the needs and well-being of the people we serve first.
But evidence continues to mount that Johnson & Johnson has abandoned the lofty ideals put forth in the corporate credo. As initial lawsuits involving the company’s troubled hip implant device, the Articular Surface Replacement (A.S.R.), continue in Los Angeles, it’s clear that profits — not patients — are now the driving force at Johnson & Johnson..
Evidence introduced against the company has included a memo from a doctor to executives at Johnson & Johnson informing them that the A.S.R. was so poorly designed that the company should slow its marketing efforts until it understood why patients were getting hurt. The memo was written almost two years before the company recalled the device in 2010. In those two years before the recall, knowing the device was poorly designed; evidence suggests the company actually increased their marketing efforts.
The plaintiff’s lawyers have also painted a picture of executives who systematically placed profits above the welfare of their patients. When a plan was developed to fix the flawed implant, it was scuttled by Johnson & Johnson because it was too expensive. The company’s DePuy orthopedic division continued to aggressively market the A.S.R. worldwide in spite of knowing of widespread failures with the joint.
In 2009 Andrew Ekdahl, then a senior marketing executive at DePuy elected not to reveal to any other countries where the A.S.R. was marketed that the United States had stopped sales of the replacement joint. Later that year when questioned by the New York Times regarding the concerns raised by the F.D.A., Ekdahl said that any reports of safety issues with the A.S.R. were, “simply untrue.”