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Johnson & Johnson in Deal to Settle Hip Implant Lawsuits

admin » 20 November 2013 » In FDA, Legal News, Mass Tort, Verdicts » 2 Comments

Johnson & Johnson and lawyers for patients injured by a flawed hip implant announced a multibillion-dollar deal on Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants.

Under the agreement, the medical products giant would pay nearly $2.5 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device.

hip lawsuits II

Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to $3 billion, people familiar with the proposal said.

Under the plan, the typical patient payment for pain and suffering caused by the device would be about $250,000 before legal fees. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners.

The proposed settlement, which was submitted on Tuesday to a federal judge in Toledo, Ohio, must receive the support of 94 percent of eligible claimants to go forward. Whether it will reach that goal is unclear. Some patients might decide to seek more through individual lawsuits. Some patients would receive relatively small payouts and others would see payments reduced because the plan imposes a user’s fee on awards based on how long a patient had the implant.

Some patients, many of whom suffered severe pain and injury from metallic debris generated by the device, spent years trying to convince doctors that there was a problem while Johnson & Johnson was denying one.

The now-recalled device, known as the Articular Surface Replacement, or A.S.R., ranks as one of the most-flawed medical implants sold in recent decades. The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 percent of the patients who received it.

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J&J to pay $2.5B to settle hip replacement suits

admin » 19 November 2013 » In Defective Products, FDA, Mass Tort, Recall » No Comments

Johnson & Johnson says it will pay $2.5 billion to settle thousands of lawsuits brought by hip replacement patients who accuse the company of selling faulty implants that led to injuries and additional surgeries.

The agreement presented in U.S. District Court in Ohio is one of the largest ever for the medical device industry. It resolves some 8,000 cases of patients who had to have the company’s metal ball-and-socket hip implant removed or replaced. J&J pulled the implant from the market in 2010.

J&J’s DePuy unit said in a statement it expects to make most of the payments to patients in 2014.

The artificial hip, known as the Articular Surface Replacement, was sold for eight years to some 35,000 people in the U.S.

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J&J agrees to pay more than $2.2 billion in Risperdal accord

admin » 04 November 2013 » In Defective Products, FDA, Legal News, Mass Tort » 2 Comments

J&J EARNS

Johnson & Johnson agreed to pay more than $2.2 billion to resolve criminal and civil probes into the marketing of the antipsychotic drug Risperdal and other medicines in one of the largest U.S. health-care fraud cases.

J&J’s Janssen unit will plead guilty to a misdemeanor criminal charge over misbranding Risperdal for uses not approved by the Food and Drug Administration, including for elderly patients with dementia. Under the plea deal announced Monday, Janssen will pay a $334 million fine and forfeit $66 million.

Janssen also settled civil claims that it marketed Risperdal without approval for the elderly, children and mentally disabled, and that it paid kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes. The civil accord covered off-label marketing of Risperdal, another antipsychotic, and Natrecor, a heart failure drug.

“These companies lined their pockets at the expense of the American taxpayers, patients and the private insurance industry,” Att. Gen.l Eric Holder said. J&J “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly, and the disabled.”

“Today we reached closure on complex legal matters spanning almost a decade,” Michael Ullmann, J&J’s general counsel, said in a statement. “This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world.”

J&J said the company had previously accrued the settlement amounts, and no other charge to earnings will be recorded.

The agreement is the government’s third-biggest with a pharmaceutical company, behind a $3 billion settlement that GlaxoSmithKline Plc reached last year over marketing of medicines, including Paxil, Avandia and Wellbutrin, and the $2.3 billion accord that Pfizer Inc. entered in 2009 over marketing of the painkiller Bextra and other drugs.

J&J’s settlement doesn’t end Risperdal claims brought by several U.S. states, including Louisiana and South Carolina.

The civil settlement, which involves the Justice Department and 45 states, resolves several lawsuits filed by whistleblowers under the False Claims, which lets citizens sue on behalf of the government and join in any settlement. The Justice Department joined those cases.

The U.S. government has been probing Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses.

U.S. and state investigators examined whether J&J improperly promoted the drug for treating elderly patients with dementia, a use never approved by regulators, and for children before the Food and Drug Administration first approved pediatric uses in 2006.

While doctors may prescribe an approved drug for any reason, companies can market them only for purposes authorized by the FDA.

Risperdal has been linked to excessive weight gain and diabetes. The drug, once J&J’s biggest seller, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007. After that, J&J lost patent protection and sales declined.

The FDA approved Risperdal in 1993 for psychotic disorders including schizophrenia. That market is limited, and J&J’s Janssen unit sought to sell Risperdal for bipolar disorder, dementia, mood and anxiety disorders and other unapproved uses, according to court filings. The drug was later approved for other uses.

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