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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 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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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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Lipitor and Type 2 Diabetes in Women

admin » 25 July 2013 » In FDA, Mass Tort » No Comments

Women taking Lipitor have an increased risk of being diagnosed with type 2 diabetes. Lipitor (atorvastatin calcium) has been widely prescribed to regulate cholesterol and blood pressure since 1996. More than 29 million people in the United States have been prescribed the drug, according to Pfizer’s website.

In February 2012, the Food and Drug Administration (FDA) approved a warning label change for the drug, to include an increased risk for type 2 diabetes. Their decision was prompted by a clinical trial conducted in 2011, which found that people taking Lipitor had an increased risk of developing type 2 diabetes.

That study suggested that the increased risk was largely attributable to the fact that women with high blood sugar, high blood pressure and other known risk factors for type 2 diabetes were already predisposed to developing the disease. However, another study published in May 2013 in the British Medical Journal more clearly established a link between Lipitor and diabetes.

The study found that people treated with Lipitor, in comparison to other statins, including Zocor and Crestor, were 22 percent more likely to develop new onset diabetes. Of all the statins tested in the study, Lipitor had the highest incidence of diabetes.

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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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FDA says Zithromax can cause fatal irregular heart rhythm

admin » 12 March 2013 » In Defective Products, FDA, Mass Tort » 10 Comments

zithromax

FDA says Zithromax can cause fatal irregular heart rhythm

The Food and Drug Administration warned on Tuesday that the antibiotic azithromycin, sold as Zithromax, can cause a potentially fatal irregular heart rhythm in some patients.

A study in the New England Journal of Medicine last May compared the risk of cardiovascular death from different antibacterial drugs and found that the drug, which is made by Pfizer Inc and is also sold by generic drugmakers, had a higher rate of death.

In its warning, the FDA said the drug can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal heart rhythm known as prolonged QT interval, in which the timing of the heart’s contractions becomes irregular.

The FDA said doctors should use caution when giving the popular antibiotic to patients known to have this condition or who have certain risk factors. Those who may be at risk include people with low levels of potassium or magnesium, a slower than normal heart rate, or people who take certain drugs used to treat abnormal heart rhythms, or arrhythmias. The drug could also cause problems in people with torsades de pointes, a specific, rare heart rhythm abnormality.

However, the FDA noted that other drugs in the same class as azithromycin known as macrolides also have the potential for causing QT prolongation, as do non-macrolide antibiotics, such as fluoroquinolones, and doctors need to consider all of these risks when choosing an antibiotic.
Pfizer officials were not immediately available for comment.

Shares of Pfizer were down 0.5 percent at $28.10 on Tuesday morning on the New York Stock Exchange.

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Blood-thinner Pradaxa target of mass-claims suit

admin » 09 November 2012 » In Defective Products, FDA, Legal News, Mass Tort » No Comments

After taking the blood-thinning drug Pradaxa for three weeks, Charles Jackson experienced intestinal bleeding. His doctor told him to get off the drug, which he began taking after suffering a stroke last September.

Months later, Jackson, 75, a retired truck driver from the rural railroad community of Hohenwald, saw a television advertisement imploring patients who had complications with Pradaxa to dial 1-800-BAD-DRUG to learn more about joining a lawsuit against the drug company.

Now Jackson is among hundreds of other patients around the country who are teaming against an anti-stroke drug whose sales eclipsed $1 billion last year. Joining the suit thrusts Jackson into the high-dollar stream of product liability lawsuits, a burgeoning world of mass claims in which specialty law firms cast a wide net for injured consumers who represent the pitfalls of marketing risky products.

Spearheading the Pradaxa litigation is the San Antonio-based law firm of attorney Mikal Watts, a prominent product liability attorney and deep-pocketed Democratic fundraiser.

Watts, who recently hosted President Barack Obama at his home for a private fundraiser, filed tens of thousands of claims for redress after a $20 billion fund was set up to handle claims from the 2010 Gulf oil spill. He was responsible for an $800 million settlement after winning a case against Ford and Firestone alleging defective tires and vehicle parts, one of the country’s largest product liability payouts.

Pradaxa, Watts wagers, could be the country’s next blockbuster civil settlement.

Emily Baier, a spokeswoman for Pradaxa’s company, Boehringer Ingelheim, declined to comment on the lawsuit, though she said safety is the company’s chief priority.

The drug has been under attack by physicians groups and patient advocates since 3,781 adverse effects and 542 deaths associated with Pradaxa were reported last year to the Food and Drug Administration. Its adverse reports and deaths surpassed all other monitored drugs. The FDA is now conducting a safety review of the drug, which millions of people around the country take twice a day.

Yet some legal observers say the case exposes the seams of mass litigation: Clients like Jackson are treated as no more than a claim number. And the fairest outcome for Jackson and numerous others, experts say, will not result from a collective suit in which cherry-picked examples stand-in for hundreds of individual stories.

“It’s going to be one of the larger mass torts in the history of the United States,” said Ryan L. Thompson, attorney with Watts Guerra Craft, who is working on scores of cases including Jackson’s, with a team of 70 employees dedicated to the Pradaxa suit.

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