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Montana reaches $5.9M settlement in pharmaceutical case

admin » 12 March 2014 » In Legal News, Mass Tort » No Comments

HELENA – Montana Attorney General Tim Fox announced Thursday that a $5.9 settlement has been reached in a lawsuit filed against a large pharmaceutical company, and money will be used to pay for a new prescription drug abuse prevention program, mental health services and ongoing consumer protection services.

The Attorney General’s Office filed a lawsuit in 2008 against Janssen Ortho LLC and Janssen Pharmaceuticals, Inc. The lawsuit alleged the company employed illegal, unfair and deceptive practices in the marketing of Risperdal, an antipsychotic drug used to treat certain psychological disorders in adults.

The lawsuit alleged Janssen deceived Montana physicians and consumers when it promoted Risperdal as safe and effective for a variety of conditions, but was aware that research showed dangers associated with its use and hid that research from the public.

Janssen’s own studies of Risperdal demonstrated it had the potential to cause weight gain and diabetes, cerebrovascular complications in the elderly, as well as other severe adverse side effects.

Janssen agreed to settle the lawsuit for $5.9 million last month. The settlement also restricts Janssen from making misleading claims in the promotion of its drugs, and present information about the benefits and risks of its product in promotional materials.

Janssen did not admit wrongdoing through the settlement.

Fox said about $1.5 million of the settlement will be used to bolster the state’s Prescription Drug Abuse Prevention Program. A public education specialist will be hired to create a student education program, look for ways to expand prescription drug drop box locations across the state, and create a public awareness campaign about the dangers of prescription drug addiction.

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Judge denies settlement motion in NFL concussion lawsuit

admin » 14 January 2014 » In Legal News, Verdicts » No Comments

NFL_concussion

A federal judge denied preliminary approval of a $765 million settlement of NFL concussion claims, fearing it may not be enough to cover 20,000 retired players.

U.S. District Judge Anita B. Brody asked for more financial information from the parties, a week after players’ lawyers filed a detailed payout plan for her review.

‘‘I am primarily concerned that not all retired NFL football players who ultimately receive a qualifying diagnosis or their (families) … will be paid,’’ Brody wrote in a 12-page opinion filed Tuesday morning.

The proposed settlement, negotiated over several months, is designed to last at least 65 years.

The awards would vary based on an ex-player’s age and diagnosis. A younger retiree with Lou Gehrig’s disease would get $5 million, those with serious dementia cases would get $3 million and an 80-year-old with early dementia would get $25,000.

Some critics have argued that the NFL, with more than $9 billion in annual revenues, was getting away lightly. But the players’ lawyers said they will face huge challenges just to get the case to trial. They would have to prove the injuries were linked to the players’ NFL service and should not be handled through league arbitration.

Layn R. Phillips, a former federal judge from California hired by Brody to lead settlement negotiations, had called the deal fair.

The NFL would also pay an additional $112 million to the players’ lawyers for their fees and expenses, for a total payout of nearly $900 million.

More than 4,500 former players have filed suit, some accusing the league of fraud for its handling of concussions. They include former Dallas Cowboys running back Tony Dorsett and Super Bowl-winning quarterback Jim McMahon, who suffers from dementia.

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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.

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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 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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Bard Loses $2 Million Verdict in Vaginal-Mesh Trial

admin » 19 August 2013 » In Defective Products, FDA, Legal News, Verdicts » No Comments

C.R. Bard Inc. was told by a jury to pay $2 million to a woman who alleged the company hid flaws within some of its vaginal-mesh implants in the first federal trial of claims over the devices.

Jurors in Charleston, West Virginia, deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable for injuries Donna Cisson blamed on its Avaulta line of devices. The jury awarded $250,000 in compensatory damages for Cisson’s injuries plus $1.75 million in punitive damages.

Bard, based in Murray Hill, New Jersey, still faces more than 8,000 other claims over its Avaulta devices, which Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP) and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through vaginal incisions, shrink over time.

“This jury sent a message that Bard needs to change its ways,” Henry Garrard, one of Cisson’s lawyers, said after the punitive-damages verdict was announced. “The jury is telling them this kind of conduct won’t be tolerated.”

Bard officials said they dispute the jury’s finding that Cisson’s injuries were caused by the vaginal implant and will appeal.

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Avaulta Transvaginal Mesh Lawsuit Trial Begins Today

admin » 09 July 2013 » In Legal News, Mass Tort » No Comments

The first of four bellwether trials regarding C.R. Bard transvaginal mesh lawsuits began today in the U.S. District Court in the Southern District of West Virginia, with the plaintiff of the first transvaginal mesh multi-district litigation trial alleging to have suffered injuries from C.R. Bard’s Avaulta transvaginal mesh device. The woman claims that the transvaginal mesh device was made from a resin-based plastic not suitable to be implanted in the human body.

Transvaginal mesh has been commonly used to treat urinary incontinence and pelvic organ prolapse in women. However, transvaginal mesh devices are currently facing scrutiny for the numerous health problems associated with the implantation of the transvaginal mesh device in the body. Shrinkage of the transvaginal mesh device due to the body’s natural foreign body response after implantation can ultimately lead to the destruction of nerves, tissue, and organs surrounding the transvaginal mesh device.

“Multi-district litigation trials are important in encouraging defendants to recognize the damage and harm that their products have caused and compensate all victims of their defective devices accordingly. If C.R. Bard should learn anything from the past, it would be the need for their company to have performed adequate testing and to convey proper warnings. In the absence of an effort to protect public safety, they should be found liable for the harm that they produce” said Robert Price, a transvaginal mesh attorney with the law firm of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.

Thousands of women implanted with faulty transvaginal mesh devices have filed lawsuits against C.R. Bard and other manufacturers of defective transvaginal mesh products. In June 2012, a woman was awarded a $5.5 million verdict by a California jury for injuries she suffered from an Avaulta transvaginal mesh device.

An Atlantic County, New Jersey jury ruled against Johnson & Johnson with an $11.11 million verdict, in which the plaintiff was awarded $3.35 million in compensatory and $7.76 million in punitive damages from injuries she suffered from ProLift, a recalled transvaginal mesh device manufactured by Ethicon, a subsidiary of Johnson & Johnson.

“Often times, the manufacturers of these faulty transvaginal mesh devices are aware of the serious health risks associated with their products,” commented Daniel Nigh, a transvaginal mesh attorney also with the law firm of Levin, Papantonio. “However, companies such as C.R. Bard and Johnson and Johnson failed to warn consumers of the risks and continued to market their products as safe and effective. Now, they are being held accountable for their negligence.”

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Could Statins Raise Diabetes Risk?

admin » 11 June 2013 » In FDA, Legal News, Mass Tort » 1 Comment

Some popular brands associated with high blood sugar levels in study, but odds of problems are low

Certain statins — the widely used cholesterol-lowering drugs — may increase your chances of developing type 2 diabetes, a new study suggests.

The risk was greatest for patients taking atorvastatin (brand name Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor), the study said.

Focusing on almost 500,000 Ontario residents, researchers in Canada found that the overall odds of developing diabetes were low in patients prescribed statins. Still, people taking Lipitor had a 22 percent higher risk of new-onset diabetes, Crestor users had an 18 percent increased risk and people taking Zocor had a 10 percent increased risk, relative to those taking pravastatin (Pravachol), which appears to have a favorable effect on diabetes.

Physicians should weigh the risks and benefits when prescribing these medications, the researchers said in the study, which was published online May 23 in the journal BMJ.

This does not, however, mean that patients should stop taking their statins, the experts said. The study also showed only an association between statin use and higher risk of diabetes; it did not prove a cause-and-effect relationship.

“While this is an important study evaluating the relationship between statins and the risk of diabetes, the study has several flaws that make it difficult to generalize the results,” said Dr. Dara Cohen, a professor of medicine in the department of endocrinology, diabetes and bone disease at the Icahn School of Medicine at Mount Sinai in New York City. “There was no data regarding weight, ethnicity and family history — all important risk factors for the development of diabetes.”

Cohen added that there was no information on the patients’ cholesterol and blood sugar levels, and that higher-risk patients might automatically be prescribed stronger statins such as Lipitor, Crestor and Zocor.

Finnish doctors wrote in an accompanying editorial that this potential risk should not stop people from taking statins.

“The overall benefit of statins still clearly outweighs the potential risk of incident diabetes,” researchers from the University of Turku said. Statins have been proven to reduce heart problems, they said, adding that the medications “play an important role in treatment.”

Other statins did perform more favorably than Lipitor, Crestor and Zocor in terms of diabetes, the research found.

“Preferential use of pravastatin and potentially fluvastatin … may be warranted,” the study authors said in a journal news release, adding that Pravachol may even be beneficial to patients at high risk of diabetes. Fluvastatin (Lescol) was associated with a 5 percent decreased risk of diabetes and lovastatin (Mevacor) a 1 percent decreased risk.

In previous research, Crestor was associated with a 27 percent higher risk of diabetes, while Pravachol was linked to a 30 percent lower risk.

For this study, the researchers used patient information from three Canadian databases on 66-year-old men and women who were newly prescribed statins and followed for up to five years. Lipitor accounted for more than half of all new statin prescriptions, followed by Crestor, Zocor, Pravachol, Mevacor and Lescol.

The researchers said between 162 and 407 patients would have to be taking statins of various kinds for one extra patient to develop diabetes.

Results were similar for patients already diagnosed with heart disease and those taking statins to prevent it. Older patients using Lipitor and Zocor were at an increased risk regardless of dose, the researchers found.

People with type 2 diabetes have higher than normal blood sugar levels because their bodies don’t make or properly use insulin. The researchers said it is possible that certain statins impair insulin secretion and inhibit insulin release, which could help explain the findings.

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Doctor’s Doubts Imperil Lucrative Diabetes Drugs

admin » 30 May 2013 » In Defective Products, FDA, Legal News, Mass Tort, Recall » 1 Comment

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LOS ANGELES — Dr. Peter C. Butler initially declined a request by the drug maker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.

“I said, I’m not interested in your money, go away,” Dr. Butler recalled.

Merck no doubt now wishes it had. When Dr. Butler finally agreed to do the study, he found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer. The discovery, in early 2008, turned Dr. Butler into a crusader whose follow-up studies now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9 billion annually and are used by hundreds of thousands of people with Type 2 diabetes.

“I knew some stuff that I thought was a worry and I was obliged to pursue it,” said Dr. Butler, the chairman of endocrinology at the University of California, Los Angeles.

Based on his latest study, both the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on the drugs, or even to their removal from the market.

Or they could result in no action at all.

Dr. Butler faces powerful opponents in the makers of the drugs and many diabetes specialists, who say his studies are contradicted by other evidence.

“The data are inconclusive,” said Dr. Robert Ratner, chief scientific and medical officer of the American Diabetes Association. He said even if there were some excess risk, it would be “exceptionally low.”

Nancy Thornberry, who heads diabetes drug development at Merck, said that clinical trials, the gold standard of medical evidence, had found no increased risk of pancreatic disease from Januvia, even when results of trials were pooled to achieve greater numbers. “In fact, my mother takes sitagliptin,” she added, referring to Januvia by its generic name.

Questions about whether the drugs raise the risk of pancreatitis, a painful and possibly lethal inflammation of the pancreas, arose soon after the first one, Byetta, now sold by Bristol-Myers Squibb and AstraZeneca, was approved in 2005. The drugs’ labels already contain warnings about that. What is new and potentially more serious is a possible risk of pancreatic cancer, which is virtually untreatable and kills most victims within a year.

Many people in the field compare Dr. Butler to Dr. Steven Nissen, the well-known Cleveland Clinic cardiologist whose warnings about Avandia, a different type of diabetes drug, led to its being banned in Europe and highly restricted in the United States.

Both men have faced criticism from those who call them zealots. The F.D.A. is about to examine data suggesting that Avandia might not be so dangerous after all. Some critics say Dr. Butler overstates his conclusions and that his findings have not been replicated by others.

“Basically, no one in the entire world over the last 10 years, with thousands of animals,” has found what Dr. Butler found, said Dr. Daniel J. Drucker, a professor of medicine at the University of Toronto and a consultant to many drug companies.

Still, Dr. Butler is not easy to write off. He is a former editor of Diabetes, the flagship journal of the American Diabetes Association. And he has some defenders.

“He should be an American hero, actually, a rugged individualist who is not going to be browbeaten,” said Dr. Edwin Gale, professor emeritus at the University of Bristol in Britain, who recently wrote a commentary with Dr. Butler on the drugs.

Dr. Butler was born in Kenya to British parents, though he has worked in the United States since 1987 and is an American citizen. His wife, Dr. Alexandra E. Butler, a pathologist who occupies the office next to his, has also worked on some of the studies.

In the last month, lawyers defending drug companies against a lawsuit claiming that Byetta had caused a patient’s pancreatitis, subpoenaed virtually all of Dr. Butler’s records.

“I think the message here is they want him out of business,” said Brian Depew, a lawyer representing the plaintiff, Ross Hubert of New Hampshire, who claims that Byetta caused him to get pancreatitis. Dr. Butler said U.C.L.A. told him not to comment on the subpoena.

More than 100 lawsuits representing 575 plaintiffs around the country are claiming injury from Byetta, mostly pancreatitis, according to the latest quarterly regulatory filing from Bristol-Myers. Forty-three suits claim that Januvia caused pancreatic cancer, according to Merck.

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What a Company Knew About Its Metal Hips

admin » 06 May 2013 » In FDA, Legal News, Mass Tort » No Comments

All-metal hip replacements have failed at a high rate and harmed many patients in recent years. Now there is evidence that a major manufacturer was aware of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.

The all-metal hips, in which a ball and a cup component are both made of metal, were thought to be superior in some respects to traditional hip replacements made of plastic and metal. Some 500,000 people in this country received all-metal devices over the past decade. They were not adequately tested because of regulatory loopholes the Food and Drug Administration is now moving to close, and began failing not long after implantation.

Thousands of patients have had to replace them in painful operations; hundreds more have suffered internal damage. Court documents now show that a major manufacturer, the DePuy Orthopaedics division of Johnson & Johnson, buried the bad news about a model known as the Articular Surface Replacement, the most failure-prone of the implants. The implants were recalled in 2010, but the documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies. By the time of the recall, the device had been implanted in about 93,000 patients around the world.

Surgeons have largely stopped using the device; even so, the company is facing more than 10,000 lawsuits in this country related to past implantations. Though the company says the evidence will ultimately show that it acted appropriately, it clearly has a lot of explaining to do.

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J&J Must Pay $8.3 Million Over Defective Hip, Jury Says

admin » 08 March 2013 » In Defective Products, Legal News » No Comments

Johnson & Johnson (JNJ)’s DePuy unit defectively designed a metal-on-metal hip implant, a California jury decided in the first of 10,750 lawsuits over the device to go to trial.
The Los Angeles jury awarded a total of $8.3 million in damages to Loren “Bill” Kransky, a retired Montana prison guard who alleged DePuy’s design of its ASR hip caused his injuries. Jurors said J&J was negligent even though the company properly warned of the risks, and didn’t owe punitive damages.

J&J, the world’s largest seller of health-care products, recalled 93,000 of the implants in August 2010, when it said 12 percent failed within five years. Last year, 44 percent failed in Australia within seven years. Analysts say the lawsuits could cost J&J billions of dollars to resolve.

“This is not an imperfect hip, this is a public health disaster,” Kransky’s attorney Michael Kelly said in closing arguments on Feb. 28. “Somebody needs to tell them, ‘Don’t make Bill Kransky come to court. Build these things right. Don’t let this happen again.’”

Patients such as Kransky complain in lawsuits of dislocations, pain, and follow-up surgeries known as revisions. Kransky’s lawyers argued that DePuy failed to test the device adequately before selling it in the U.S. in 2005, buried surgeon complaints of mounting failures, and studied a redesign of the ASR before scrapping that effort in 2008.
Medical Expenses
Kransky’s lawyer Brian Panish had asked for compensatory damages of $5.3 million and punitive damages of as much as $179 million. The jury’s verdict, which came on the sixth day of deliberations, included $338,136 in damages for medical expenses and $8 million for physical pain and emotional suffering.

“This is the first day of reckoning for DePuy,” Panish said after the verdict. “We’ve learned a lot from this trial. We’ll get punitive damages in the next trial.”

One juror, David Vega, said after the verdict that “I wanted punitive damages” based on the evidence that DePuy found the problem and took so long to resolve it.

J&J, based in New Brunswick, New Jersey, says the ASR isn’t defective and the company adequately warned doctors of the risk of injury.

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