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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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Doctor’s Doubts Imperil Lucrative Diabetes Drugs

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

31diabetes-article

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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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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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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Depuy Hip Replacement Recall

admin » 30 August 2010 » In Mass Tort, Recall » No Comments

Depuy Hip Replacement Recall

Johnson & Johnson’s (JNJ) orthopedic-device unit is recalling hip replacement parts implanted in about 93,000 people worldwide because of a high rate of repeat surgeries needed, adding a new quality problem for the health-products company.

A Johnson & Johnson spokesman said Thursday the company is still evaluating the financial impact of the recall, which does not require patients to have implants removed. Instead, the company’s DePuy Orthpaedics subsidiary advised patients with its ASR hip parts to visit their surgeons for evaluation of device performance. It also recommended yearly monitoring and said it plans to cover “reasonable and customary costs” linked to the recall.

Very few of these hip systems remain on the market, DePuy said, since the company decided to discontinue sales last year due to declining demand and to focus on new products. Problems leading to repeat surgery included loosening parts, infections, fractures, dislocation, sensitivity to metal and pain, the company said.

The recall announcement comes on the heels of a recent Food and Drug Administration warning letter to DePuy, disclosed earlier this week, saying the company was marketing some different replacement-joint products without required approval. DePuy said it had received the FDA’s letter and would respond to the agency’s request for information.

The recalled devices are called the ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the ASR Hip Resurfacing System. Resurfacing involves implanting a cup and capping the ball at the top of the thighbone in a procedure that preserves more bone than traditional replacements, and is geared toward younger patients. The ASR XL system was first launched in 2004 and sold worldwide, while the resurfacing system was launched in 2003 but has only been approved outside the U.S.

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Avandia: GlaxoSmithKline Accused Of Covering Up Heart Risks

admin » 13 July 2010 » In FDA, Mass Tort, Recall » No Comments

Avandia: GlaxoSmithKline Accused Of Covering Up Heart Risks

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Avandia May Be Recalled

admin » 09 July 2010 » In Defective Products, FDA, Legal News, Mass Tort, Recall » No Comments

Avandia May Be Recalled

A review by federal health scientists reinforces potential ties between the diabetes pill Avandia and heart attack and death, opening the door for government action, including a possible withdrawal of the once blockbuster drug.

The Food and Drug Administration posted an exhaustive 700-page review of the GlaxoSmithKline drug online Friday ahead of a meeting next week to review the safety of Avandia, which is used by hundreds of thousands of diabetics in the U.S.

FDA scientists reviewed dozens of studies of Avandia, including one which Glaxo has pointed to as proof of the drug’s safety. But an FDA reviewer said the study was plagued by “serious flaws” and actually supports the case against Avandia.

The FDA holds a special two-day meeting starting Tuesday to help decide what course of action to take. A panel of outside expert physicians will vote on a range of recommendations for Avandia including:

– adding additional warning labels

– limiting which doctors can prescribe the drug

– pulling the drug from the market

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New risks that may be associated with the diabetes drug Avandia

The European Medicines Agency said the drug was authorized for use but with warnings about prescribing for patients with heart failure or a history of heart failure, or to patients with heart problems.

Two years ago, the European committee, known as CHMP, concluded that the drug “retained a small, if diminishing, place in diabetes Type 2 therapy.”

A study published in the United States last month linked Avandia to a higher risk of heart problems, strokes and deaths in older adults, and called it more dangerous than a rival drug, Actos.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, said Dr. David Graham, lead author of the study and a scientist for the FDA. He wants the pill banned.

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Toyota fined record $16.4 million

admin » 19 April 2010 » In Defective Products, Recall » No Comments

Toyota fined record $16.4 million

Toyota Motor Corp. agreed Monday to pay a record $16.4 million fine for failing to properly notify U.S. authorities about a dangerous accelerator pedal defect, but denied allegations it broke the law.

Transportation Secretary Ray LaHood, announcing the largest-ever penalty paid by an automaker to the U.S. government, said that “by failing to report known safety problems as it is required to do under the law, Toyota put consumers at risk.”

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“I am pleased that Toyota has accepted responsibility for violating its legal obligations to report any defects promptly,” LaHood said, noting that the U.S. government was continuing to investigate “whether the company has lived up to all its disclosure obligations.”

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Lawyers Play Speed-Date in Toyota Suit Tussle

admin » 29 March 2010 » In Defective Products, Recall » No Comments

Lawyers Play Speed-Date in Toyota Suit Tussle

It was the legal world’s equivalent of speed-dating. Two dozen attorneys crowded into a courtroom here Thursday and made impassioned, two-minute pleas before a panel of judges.

Lawyers Play Speed-Date in Toyota Suit Tussle

The lawyers are seeking home-court advantage for where the growing number of lawsuits filed against Toyota Motor Corp. will be heard.

One attorney argued for a Wyoming court setting, telling the U.S. Judicial Panel on Multidistrict Litigation how quickly cases move through the system there. Another sung the praises of a Louisiana judge who managed to keep cases moving along even as Hurricane Katrina barreled down. A third pitched for California, where Toyota’s U.S. headquarters is based, saying it was the “center of gravity” of the cases.

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Toyota acceleration problems

admin » 25 March 2010 » In Defective Products, Recall » No Comments

Toyota acceleration problems

As lawsuits over Toyota acceleration problems multiply, a federal court hearing will decide whether dozens of cases will be consolidated before a single judge.

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