Archive > August 2010

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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Kugel Hernia Patch Lawsuit Results in $1.5M Verdict

admin » 25 August 2010 » In Mass Tort, Verdicts » No Comments

Kugel Hernia Patch Lawsuit Results in $1.5M Verdict

A Rhode Island jury has awarded a North Carolina couple $1.5 million in a Kugel hernia patch lawsuit, but the couple is objecting to the federal judge’s decision not to allow them to pursue punitive damages.

The verdict, handed down on Monday, is the second in a series of “bellwether” trials for Kugel patch litigation and the first loss for the defendants, Davol, Inc. and C.R. Bard, Inc.

The Kugel hernia patch lawsuit was brought by Christopher and Laura Thorpe, of North Carolina, who alleged that a defective Composix Kugel patch implanted in Christopher Thorpe broke and caused him to suffer internal injuries and a sepsis infection.

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With Birth Control Pills, New Isn’t Always Better

admin » 23 August 2010 » In FDA, Mass Tort » No Comments

Bayer HealthCare, the leading maker of birth control pills, is coming out with a brand new pill.

Natazia, as it’s called, contains a form of estrogen that’s never been used in an oral contraceptive. It also has a novel dosing regimen. Women on Natazia will take four different combinations and doses of hormones or sugar pills each month.

The new launch coincides with growing problems for Bayer’s last new contraceptive, Yaz.

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Matt Cutts: How Google Social Search works

admin » 13 August 2010 » In Google, Social Media » No Comments

Matt Cutts: How Google Social Search works

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Roche to Face Hollywood Stars Sheen, Dennehy in New Jersey Accutane Trial

admin » 02 August 2010 » In Defective Products, Legal News, Mass Tort, Uncategorized » No Comments

Roche to Face Hollywood Stars Sheen, Dennehy in New Jersey Accutane Trial

Roche Holding AG faces a lineup of Hollywood stars in the New Jersey trial of an actor’s lawsuit alleging he suffered the loss of his colon after taking the company’s Accutane acne drug.

James Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men,” claims his acting career was derailed by his use of Accutane, which Roche no longer sells. Marshall will ask a jury to award at least $11 million in damages at a trial starting next week that will feature testimony from stars such as Martin Sheen and Brian Dennehy, according to court filings.

Sheen, Dennehy and director Rob Reiner will testify that Marshall, 43, was headed for stardom before bowel ailments allegedly caused by Accutane forced doctors to remove his colon, Michael Hook, the actor’s lawyer, said in an interview. Basel, Switzerland-based Roche faces thousands of lawsuits claiming it failed to warn patients that the drug could cause inflammatory bowel disease in some users, Hook said.

“The jury will hear that James Marshall had the potential to be the next James Dean-like star,” Hook said. “That dream is gone because he took something to treat acne.”

Roche said today that Accutane’s safety label has warned about the risks of inflammatory bowel disease for more than 20 years.

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