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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


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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Doctor’s Doubts Imperil Lucrative Diabetes Drugs

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


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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FDA says Zithromax can cause fatal irregular heart rhythm

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


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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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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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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Glaxo Settles Cases With U.S. for $3 Billion

admin » 28 November 2011 » In Defective Products, FDA, Legal News, Mass Tort, Recall » No Comments

Glaxo Settles Cases With U.S. for $3 Billion

The British drug company GlaxoSmithKline said Thursday that it had agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs.

The settlement would be the largest yet in a wave of federal cases against pharmaceutical companies accused of illegal marketing, surpassing the previous record of $2.3 billion paid by Pfizer in 2009. In recent years, drug companies have been prime targets of federal fraud investigations, which have recovered tens of billions of dollars for Medicaid and Medicare.

The cases against GlaxoSmithKline include illegal marketing of Avandia, a diabetes drug that was severely restricted last year after it was linked to heart risks. Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug.

GlaxoSmithKline had already set aside cash for the settlement, which analysts said would remove legal uncertainty. The company’s stock rose 2.96 percent Thursday, to $44.55, near its 52-week high, amid a broader market advance of about 2 percent.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said in a statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”


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FDA Warns: ‘Serious Complications’ Arise From Vaginal Mesh Implants

admin » 09 August 2011 » In Defective Products, FDA, Mass Tort » No Comments

Vaginal Mesh Implants

FDA Warns: ‘Serious Complications’ Arise From Vaginal Mesh Implants

Surgical mesh implants used to treat weakening in the pelvic region, a particularly common problem after childbirth, may actually do more harm than good, the Food and Drug Administration (FDA) reports Wednesday.

In the last three years, the agency said, it has received almost 3,000 reports of complications from transvaginal mesh that was inserted surgically to treat pelvic organ prolapse.

Pelvic organ prolapse occurs when one of the pelvic organs — most commonly the bladder, but also possibly the urethra, uterus, vagina, small bowel or rectum — slips from its regular location to press against the vagina, causing pain and discomfort.

This occurs when the muscles and ligaments that should hold the organs in place are weakened or stretched. Most often a pelvic organ prolapse takes place after childbirth, or after a hysterectomy.

Doctors can use surgical mesh to repair those weakened tissues. Implants are put in to reinforce the vaginal wall, or to support the urethra to prevent urine leakage. MedPage Today, a news service for physicians, reports that at least 100,000 such procedures were performed in the U.S. in 2010.
However, in its advisory on Wednesday, the FDA reports:

[S]erious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare. Furthermore, it is not clear that transvaginal [pelvic organ prolapse] repair with mesh is more effective than traditional non-mesh repair in all patients [...] and it may expose patients to greater risk.

The most freqent complications reported, according to the FDA, were “mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.”


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J&J, Hip Makers Asked by FDA for Data on Metal in Patients

admin » 12 May 2011 » In Defective Products, FDA, Mass Tort, Recall » No Comments

J&J, Hip Makers Asked by FDA for Data on Metal in Patients

The U.S. Food and Drug Administration asked Johnson & Johnson, which is already facing more than 1,000 lawsuits over hip replacements, to study whether its implants raise the level of metal in patients’ blood to dangerous levels.

The FDA on May 6 sent the request to J&J and 20 other device makers, including Biomet Inc., Stryker Corp. and Zimmer Holdings Inc., asking them to study the levels of cobalt and chromium in patients for at least eight years after implantation. The request focuses on all-metal devices whose failure rates have prompted recalls and increased scrutiny from regulators.

The agency “is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems,” Karen Riley, an FDA spokeswoman, said in an e-mail to Bloomberg News. “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip- replacement system that had been implanted in 93,000 patients worldwide. DePuy cited unpublished data from the U.K. national joint registry that indicated a failure rate of 12 percent within five years of implantation.

DePuy “is seeking further clarification from the FDA and considering how to best meet the agency’s requirements,” Lorie Gawreluk, a spokeswoman, said in an e-mail.

Scope of Request

Garry Clark, a spokesman for Warsaw, Indiana-based Zimmer, said in an e-mail that his company was “working to understand the scope of the agency’s request.”

Stryker doesn’t make metal-on-metal implants, Russell Weigandt, a spokesman for the Kalamazoo, Michigan-based company, said in an e-mail. He declined to comment further.

The leading hip makers behind J&J are Zimmer and Stryker, according to a BMO Capital Markets report in February that said the worldwide hip replacement market would grow 3.2 percent this year from $5.28 billion in 2010.

J&J rose 81 cents, or 1.2 percent, to $66.57 at 4 p.m. in New York Stock Exchange composite trading. Zimmer fell 54 cents to $69.15 and Stryker rose 84 cents, or 1.4 percent, to $61.84.

The American Academy of Orthopaedic Surgeons and the leading makers of hip and knee implants last year started a pilot program designed to duplicate joint registries that track patients’ health in the U.K., Australia and other countries.


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