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.

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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.”

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$688 Million Settlement of Lawsuits Against Merck
Civil lawsuit settlements against drug maker Merck for lying about benefits of drug Vytorin were announced yesterday. The lawsuits alleged that Merck had known for over two years that Vytorin was no better than other statins on the market but falsely advertised Vytorin as having better results.
These lawsuits were brought by shareholders of the company that bought stock in the company based upon the expected sales of Vytorin.
This is not the first time that drug maker Merck has been sued for fraud.
Merck agreed to a multibillion dollar settlement for lying about the safety of its popular pain medication Vioxx a few years ago. In the Vioxx lawsuits it was shown that Merck manipulated medical studies to hide incidences of heart attacks. Merck knew that its sales would suffer if it was known that Vioxx could increase the incidence of heart attacks in some patients.
Unfortunately, it has become commonplace for pharmaceutical and medical device companies to misrepresent science when it suits their financial interests. Another example of this is playing out in a Los Angeles courtroom this week in the Kransky v. DePuy ASR hip implant trial. In that case evidence has been presented that DePuy Orthopedics knew for years that the ASR XL metal hip implant was failing at an extremely high rate and left it on the market to be implanted in thousands more unsuspecting patients. Most of these patients will likely need expensive and painful revision surgery.
There are currently over ten thousand ASR hip implant lawsuits pending in the United States.

Johnson & Johnson Adept Hip Replacement Recalled
Spokeswomen for J&J’s DePuy Orthopaedics unit said Thursday that the company recalled the ”Adept” brand all-metal total hip replacement system starting last month because a higher-than-expected percentage of them had to be replaced. Such replacements, called revision surgeries, usually are needed when an artificial joint starts causing pain, difficulty walking or other problems.
This recall includes all 7,500 Adept implants shipped worldwide between 2004 and September 2011. That is when it sold the product back to the company that had developed Adept and had sold the rights to it to the DePuy business in 2009.
According to J&J, the implants were sold in Germany and 20 other countries, but not in the United States.
J&J said it notified surgeons and hospitals about the recall on Jan. 14 after reviewing data from national registries on joint replacements in two countries. A registry in the United Kingdom found that 12.1 percent of patients needed their implants replaced within seven years, while a registry in Australia found 7.1 percent of patients needed replacements within three years.
The DePuy spokeswomen did not know how many of the recalled implants were implanted in patients. Any who have the implants and are having problems with them should contact their doctor.
The recall was reported Thursday by the German newspaper Handelsblatt.
J&J noted the recall does not involve a product called Adept Hip Resurfacing Femoral Components.
J&J, the world’s biggest provider of health care products, has issued more than 30 product recalls since 2009. Shares rose 15 cents to $75.81.

ASR Hip Implant Trial Shows Inadequate Testing and Early Knowledge of Design Flaw
Damaging testimony continues to pile up against Johnson & Johnson in the first A.S.R. related lawsuit to go to trial. More recently released documents seem to indicate that the company’s orthopedic unit had used inadequate or incorrect standards in their risk assessment of the metal-on-metal A.S.R. hip replacement joint that was used in over 90,000 patients.
In Los Angeles Superior Court, the lawsuit against the DePuy Orthopedics division of Johnson & Johnson represents the first of more than 10,000 similar lawsuits that have been filed in the United States. Internal documents from DePuy show that the company had concerns about the A.S.R. joint long before it was recalled in 2010. In addition, while the company knew of abnormally high failure rates with the device, it continued to market it aggressively in the United States.

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A front page article in the January 23 New York Times, Maker Aware of 40% Failure in Hip Implant, revealed that Johnson & Johnson knew of widespread failure with the troubled all-metal hip joint it had recalled in 2010. Even as the company became aware of the extent of the products failure, it continued to publicly play down similar findings from the British implant registry.
The internal study, conducted by Johnson & Johnson, is just one of hundreds of documents expected to be made public as the first of over 10,000 lawsuits begins this week in California superior court in Los Angeles.
In the analysis, Johnson & Johnson found that nearly 40 percent of the patients who received the now-recalled Articular Surface Replacement, or ASR joint, would experience failure within five years. It also found that thousands more patients will likely experience premature failure in up-coming years and be forced to undergo painful and costly replacement surgery.
The trial is expected to uncover what officials of Johnson & Johnson’s DePuy Orthopedics division knew about the device’s problems, both pre- and post-recall, and what actions they took. This episode represents one of the biggest medical device failures in decades and these early documents bring into question how forthright DePuy was in dealing with the problem. Even after the company recalled the device in 2010 it continued to challenge the validity of the British registry findings, which had found a failure rate in at least one-third of patients with the device.
Metal hip implants made by all manufacturers have been failing at an unacceptable rate for years. The DuPuy ASR joint was only the first to be recalled. 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.
As a result of these failures the FDA recently posted a proposed order addressing metal hip implants. The new order, if approved, will require all hip implant manufacturers to go through Premarket Approval Process to keep any existing metal-on-metal hip implant on the market or to put a new metal on metal product on the market.
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. Ironically the new order and PMA process faced by these manufacturers might allow them to avoid recalls. By citing the prohibitive cost of preparing a PMA application they can simply cease production without ever acknowledging an admission of failure in the joints.
So, as the trial prepares to begin in California this week, the early release of documents showing that DePuy long knew of the high failure rate while simultaneously trying to downplay the situation would indicate the company was more concerned with limiting its financial liability than being forthright with patients. Even after the company instituted its own recall of the suspect joint in 2010 it methodically continued to challenge medical findings that indicated a high failure rate.
Continued public disclosure of documents from the civil lawsuits and the data collected by the FDA will help protect the public from companies that put their own profits ahead of safety.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2011-N-0661]
Effective Date of Requirement for Premarket Approval for Two Class III Preamendments
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order.
SUMMARY: The Food and Drug Administration (FDA) is proposing to require the filing of a
premarket approval application (PMA) or a notice of completion of a product development
protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal
semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal
semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also
summarizing its proposed findings regarding the degree of risk of illness or injury designed to be
eliminated or reduced by requiring the devices to meet the statute’s approval requirements and
the benefits to the public from the use of the devices. In addition, FDA is announcing the
opportunity for interested persons to request that the Agency change the classification of any of
the aforementioned devices based on new information. This action implements certain statutory
requirements.
DATES: Submit either electronic or written comments on the proposed order by [INSERT
DATE 90 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FDA
intends that, if a final order based on this proposed order is issued, anyone who wishes to
2
continue to market the device will need to file a PMA or a notice of completion of a PDP within
90 days of the publication of the final order. See section X of this document for the proposed
effective date of a final order based on this proposed order.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-N-0661, by any
of the following methods:
Electronic Submissions

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New FDA Proposed Order Will Take Metal on Metal Hips Off the Market
The FDA released a proposed Order today that will likely remove most metal on metal hips from the marketplace. Metal on metal hips had been grandfathered in and allowed to be sold for a decade because they were similar to polymer hips and ceramic hips.
Today’s proposed FDA Order, if finally approved, will require that “anyone who wishes to continue to market the device” (metal on metal hip) will have to submit an application for Premarket Approval called a PMA. A PMA application requires very expensive clinical studies that the manufacturers are unlikely to spend the money to complete. The metal on metal hip manufacturers are unlikely to spend the money for the PMA studies because it is unlikely that a PMA for a metal hip implant would ever be approved. There is enough evidence out there already that these hips are failing at a high rate to indicate that they are not safe or effective.
The hip implant products affected by this proposed Order are: the Biomet Magnum, the DePuy Pinnacle, the Wright Profemur Conserve, the Wright Dynasty, the Wright Linaege, the Zimmer Trabeculer, and the Encore. These products are currently on the market.
The DePuy ASR and the Smith & Nephew R3 have already been recalled. The Smith and Nephew Birmingham hip, the BHR, which is a resurfacing device has already received a PMA approval and will likely stay on the market.
Today’s action by the FDA is a step forward in patient safety and an acknowledgement that these metal on metal hips should never have been placed on the market without an adequate study of the dangers of cobalt and chromium in the blood.