| Developers: | Johnson&Johnson |
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2019
Johnson & Johnson agrees to pay $1 billion for defective hip endoprostheses
In early May 2019, Johnson & Johnson agreed to pay about $1 billion to settle most lawsuits involving defective metal hip endoprostheses.
In 2013, J&J discontinued Pinnacle's hip endoprosthesis model using a metal-to-metal friction pair after regulators tightened requirements for similar devices. Even earlier, in 2010, J&J recalled 93,000 Pinnacle Ultamet implants, since in 12% of cases the installation of endoprostheses did not bring the desired result. Pinnacle endoprostheses with a pair of friction from various materials continue to be sold in. USA
J&J officials said the company has received about 10,500 lawsuits over defective Pinnacle endoprostheses. The lawsuits were consolidated for consideration by U.S. District Judge Ed Kinkeade in Dallas. During the trial, J&J won the first case and lost the next two, including with a verdict of $1bn. Taking into account legal costs, the cost of this settlement for J&J amounted to more than $4 billion.
The company agreed to immediately allocate more than $400 million for preliminary settlement of lawsuits. The agreement covers about 95% of the 6,000 complaints filed against J&J and its DePuy division over the surgical replacement of Pinnacle implants. Endoprostheses had to be removed because the defects prevented patients from walking and experienced intolerable pain. In addition, during the proceedings, it was found that the implants cause the accumulation of metal ions in the blood, causing pain in the groin, allergic reactions, bone erosion and tissue death.
Another 4,500 lawsuits are pending - they concern patients who did not have to remove endoprostheses or who did not use completely metal implants. While J&J has agreed to resolve cases involving surgical removal of the endoprosthesis, it is not prepared to pay patients who fear they may need surgery in the future because of a defective implant. It is not yet clear how many of those cases will be settled, the source said.
Lawyers for J&J and its DePuy units did not create a global settlement program, but entered into separate deals with plaintiffs' lawyers. When exactly all cases will be resolved is unknown. Nevertheless, Mindy Tinsley, a spokeswoman for J&J, announced that negotiations to resolve Pinnacle's cases are ongoing and that the company has already allocated funds for litigation. According to unofficial sources, J&J intends to allow lawyers to distribute refunds to their clients on their own so that patients with more serious injuries receive more compensation.
The announced deal is set to complete high-profile legal proceedings lasting more than four years. However, J&J has yet to deal with other litigation, including a wave of cases against the potentially cancer-causing powder, as well as lawsuits accusing the company of developing an opiate epidemic. It is worth considering that since 2016, J&J should have already paid a refund to patients with Pinnacle endoprostheses in the amount of more than $1.5 billion. However, some patients received a much smaller refund than they were promised, and in some cases the case ended with an appeal still pending.
J&J declined to comment on the announcement.[1]
Survival rate of Johnson & Johnson implants 5% instead of 90% promised
At the end of January 2019, Johnson & Johnson (J&J) agreed to pay Michigan $120 million to settle fraud charges according to which the company sold defective metal-metal implants for several years. The side effects of such treatment were tissue death and bone erosion. The deal was sealed by the Attorney General of 46 US states, Letitia James.
The agreement would settle claims against J&J and its unit DePuy, a manufacturer of orthopedic and neurosurgical implants, including thigh joint prostheses, that caused the lawsuit, the attorney general said. DePuy's division knowingly misled customers about the effectiveness of its ASR XL and Pinnacle Ultamet implants, according to the charges.
The prosecutor claims that DePuy employees produced devices with an alleged five-year survival rate of more than 90%, while European health professionals have already found that these figures are about 5%. Patients who had to replace a defective ASR XL or Pinnacle Ultamet implant complained of persistent groin pain, allergic reactions, and tissue necrosis. In addition, they had an accumulation of metal ions in the blood.
According to the court verdict, as of January 2019, J&J and its DePuy division are required to support with scientific evidence statements about the durability and stability of their devices and implants, as well as maintain a post-registration surveillance program and, in particular, a patient complaint program. Prosecutors who held the company accountable note that manufacturers should not be allowed to mislead the public, especially when it comes to health issues, and that this settlement should serve as a reminder to others that deceptive and false medical actions are unacceptable and will be suppressed by law.
 | It is imperative that medical device companies meet their obligations to provide accurate and up-to-date information to both physicians and patients/consumers, prosecutors said in a written statement. - This settlement will help provide physicians with better information needed to adequately treat patients. |  |
However, Mindy Tinsley, a spokeswoman for the DePuy affiliate, said the companies did not admit responsibility for the complaints and did not believe they had committed misconduct. J&J denies the consumer claims and says it acted appropriately and responsibly in developing, testing and marketing the devices. According to Tinsley, the agreement applies only to metal-to-metal Pinnacle femoral prostheses, the rest of the implants have not yet been considered.
In its earnings report, J&J acknowledged that its legal costs in the fourth quarter of 2018 rose to $1.29 billion, partly due to claims over femoral implants. For 2017-2018, a jury at the Dallas Federal Court ordered the company to cover at least $1.7 billion in losses. J&J has also agreed to settle the same issue with the Indian government. According to Indian news media reports, patients who were fitted with defective ASR femoral prostheses between 2004 and 2010 are eligible for payments ranging from $42,390 to $172,413.[2]
2018: Johnson & Johnson begins paying $1.7 billion to victims of its defective endoprostheses
In mid-December 2018, Johnson & Johnson began paying patients who installed defective implants, which made people feel much worse. The company sold hip endoprostheses knowing they were faulty, according to the charges. The trial in this case lasted 7 years, and, judging by the claims, the company owed the victims of its defective endoprostheses at least $1.7 billion.
According to a December 9, 2018 U.S. federal court filing, about 3,300 of the 10,000 complaints from patients have come to a settlement or are in the process of being settled. The terms of the agreements have not been made public.
The plaintiffs allege that Johnson & Johnson's DePuy division released Pinnacle hip endoprostheses on the market without scrutiny and misled doctors about the device's safety profile, assuring that the risk of tissue damage is immaterial. Johnson & Johnson refutes these claims and says that the development and sale of the devices was carried out in accordance with regulatory requirements. Nevertheless, in 2013, Pinnacle endoprostheses were withdrawn from the market.
Pinnacle endoprostheses were not included in the list of devices, in connection with which Johnson & Johnson was already obliged to pay $2.5 billion. Johnson & Johnson recalled 93,000 such implants worldwide in August 2010, noting that within five years of their use, 12% of cases resulted in complaints about treatment failure or side effects.
Johnson & Johnson will be scheduled to appear in court Jan. 14, 2019, in Dallas to answer for deliberately withholding information about the risks of its Pinnacle endoprostheses. In a similar case in 2016, the company was sentenced to payments in the amount of $1 billion. In general, from 2016 to 2018, a jury ordered Johnson & Johnson to pay at least $1.7 billion for faulty endoprostheses. The amount could have been higher if the manufacturer had failed to appeal several lawsuits.
The lawsuits over the Pinnacle device complaints were consolidated by U.S. District Judge Ed Kinkeade. He has been monitoring the progress of these cases since 2011 and will preside over the trial on January 14, 2019. Instead of negotiating a global settlement, Johnson & Johnson regularly appeals in cases already decided, he said. As a result, she has not been able to pay the money due to the affected patients for seven years. At the same time, separate court cases on isolated complaints do not allow the jury and judges to assess the real extent of the problem and the damage caused to it. Johnson & Johnson uses the same tactic to resolve lawsuits over defective vaginal nets. Combining court cases will finally resolve most of the complaints and bring the manufacturer to justice, Judge Kincaid said.
Kincade also allowed plaintiffs to increase the share reserved in all agreements in the Pinnacle case to cover the costs of attorney fees. The judge allowed these costs to be raised to 25% in each individual case.
Johnson & Johnson officials agreed to pay an average of about $125,000 in each case to resolve about a third of the claims. The average payment in this amount for 3300 cases will cost the company $413 million. However, the plaintiffs have already filed complaints about the lack of transparency in the settlement process, including the lack of information on the development of compensation standards.
A spokesman for Johnson & Johnson's DePuy medical device division and lawyers for the company refrained from commenting on Bloomberg's requests.[3]
2017
Payment of $247 million for defective hip implants
On November 16, 2017, the Federal Court of Dallas ruled that Johnson & Johnson and its orthopedic division DePuy must pay $247 million to six patients who said they had suffered from defective Pinnacle implants.
The court concluded that the metal-lined, sheathed hip implants had been deformed and that the company had not warned buyers of such a risk.
Six New Yorkers who received such implants had tissue death, bone erosion and other injuries that they blamed on the device's flaws.
Johnson & Johnson, which has received more than 9,700 lawsuits over the defective Pinnacle implant, has filed an appeal. A spokeswoman for DePuy added that the implants of this type were supported by the experience of clinical studies that demonstrated their effectiveness.
The plaintiffs claimed the company mistakenly advertised the implant, which is more commonly used to treat osteoarthritis. In turn, the defendants argued that the metal implant would last longer than similar ceramic or plastic ones.
The court selected several cases in the "trial" lawsuit to set a precedent and evaluate the rest of the claims against the company, as well as the possibility of resolving this issue.
Johnson & Johnson won the first "trial case" for Pinnacle implants in 2014, but in subsequent proceedings a judge placed the company's shoulders on the responsibility. As a result of several lawsuits, Johnson & Johnson and DePuy must pay plaintiffs a total of up to $700 million.
DePuy stopped selling metal-lined hip implants with Pinnacle sheath in 2013 after the Food and Drug Administration (FDA) tightened requirements for appropriate implants.
Hundreds of people affected
The Johnson & Johnson (J&J) unit is accused of selling defective hip endoprostheses and harming the health of hundreds of patients. In October 2017, a trial on this matter began in London, Bloomberg reports.[4]
We are talking about hip implants under the brand name Pinnacle, produced by J & J-controlled company DePuy International Ltd. Lawyers representing the interests of 341 plaintiffs argue that metal particles from endoprostheses entered the body of patients and led to health problems. The manufacturer sold the product, incorrectly indicating that it had a low level of wear, the lawsuit says. At the same time, DePuy denies its responsibility.
As the law firm Leigh Day notes, speaking on behalf of the applicants, in the practice of British Themis, this is one of the largest group lawsuits regarding claims against the manufacturer on the quality of the products he produces. Lawyers say lawsuits have been filed in the country's courts against other companies producing hip prostheses with a metal friction pair, but those cases have been adjourned pending the outcome of DePuy's process.
The first phase of the proceedings will consider whether J&J's unit is liable for harm caused to the health of patients. In case of a positive decision, new hearings will be held, at which the amount of compensation to the victims will be determined.
According to the agency, a similar process for Pinnacle hip implants took place in the United States earlier. In December 2016, the court ordered Johnson & Johnson to pay $1.04 billion to patients who received defective endoprostheses, but in January 2017 the company achieved a review of the decision and reduced the amount by $500 million.[5]
2016: Court ruling on $1.04 billion fine for defective metal shell endoprostheses
In early December 2016, an American court fined Johnson & Johnson more than $1 billion for selling defective endoprostheses. This was reported by the Reuters news agency.
According to a federal jury in Dallas (Texas, USA), Johnson & Johnson and its "daughter" DePuy Orthopaedics must pay compensation to plaintiffs affected by faulty Pinnacle hip arthrostheses.
Due to the poor manufacturing of these medical devices, patients faced tissue death, bone erosion and other deviations that could lead to serious consequences. At the same time, the developers themselves claimed that their devices created from metal can last longer than ceramic or plastic analogues, the case file says.
Johnson & Johnson and DePuy were aware of possible problems with Pinnacle but did not warn about them, according to the authors of the class action lawsuit. In turn, the companies deny any violations committed in the development and promotion of products.
Johnson & Johnson and DePuy were fined $1.04 billion. The bulk of this amount falls on penalties, and only $32 million will go to pay compensation to affected patients. The companies intend to appeal the decision, against them a total of almost 8.4 thousand lawsuits related to defective endoprostheses and concentrated in the Federal Court of Texas. It is planned to consider several statements that will set a precedent for other similar cases.
DePuy stopped selling metal gasket and shell endoprostheses to Pinnacle in 2013 after the U.S. Food and Drug Administration (FDA) tightened hip endoprosthesis requirements. After that, many lawsuits fell on the company.[6]
Notes
- ↑ Johnson & Johnson to settle metal-hip lawsuits for about $1 billion, sources say
- ↑ J&J Pays $120 Million to Resolve State Suits Over Hip Marketing
- ↑ J&J Starts Settling Suits Over Pinnacle Hip Defect Claims
- ↑ J&J Unit Sued Over 'Defective' Hip Implants in U.K. Trial
- ↑ J&J Judge Slashes $1 Billion Verdict Over Pinnacle Hip Implants
- ↑ Johnson & Johnson hit with over $1 billion verdict on hip implants
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