Monday, January 28, 2013

Trials begin in Los Angeles over allegedly defective hip implants.



The AP (1/26, Deutsch) reported that a jury in Los Angeles, California, "heard opening statements Friday in a lawsuit that accuses Johnson & Johnson of knowingly marketing a faulty hip implant that lawyers say left thousands of people with crippling problems or in need of replacement surgeries. The fraud and negligence suit is the first of thousands of similar cases to reach trial" in the US, related to the "all-metal ball-and-socket hip joint" that J&J subsidiary, DePuy Orthopedics Inc. "pulled from the market two years ago."
        According to Bloomberg News (1/25, Possley, Voreacos, Feeley), the "first of 10,000 lawsuits over the device to go to trial," involved Loren Kransky, a "retired prison guard who got an ASR XL hip implant in 2007, sued in state court in 2011 and had the device replaced last year." In his opening statement on Friday, Kransky's lawyer Michael Kelly told a Los Angeles jury that DePuy Orthopaedics "knew the ASR hips were failing and never told doctors." Kelly also "claimed that debris from the metal ball sliding against the metal cup caused metal ions to enter Kransky's bloodstream."
        On the front of its Business Day section, the New York Times (1/26, B1, Meier, Subscription Publication, 1.68M) noted that Kelly also "introduced a number of internal records that suggested that company executives' concern for profits might have exceeded their worries about patients." He said officials at DePuy never informed physicians "that the ASR had failed an internal performance test against another company hip." Moreover, Kelly alleged that company officials "changed the test and tested it against other things until they found one it could beat."
        Meanwhile, Reuters (1/26, Beasley) reported that in documents submitted to the court, J&J and DePuy contend that ASR hips do not leak poisons; and they assert that Kransky's extensive medical conditions are due to the fact that he is a life-long smoker, who suffers from diabetes and kidney disease - both of which were diagnosed prior to his having received the implant. Reuters also pointed out that the Food and Drug Administration on Jan. 24 released a proposed order to bar medical device manufacturers from selling metal-on-metal artificial hip joints until they are able to provide data to substantiate the safety of the products.www.med-art.com 

Wednesday, January 16, 2013

BMS schedules settlement talks over novel hep C drug claims.


www.med-art.com

The Wall Street Journal (1/16, B3, Rockoff, Subscription Publication, 2.29M) reports that Wednesday marks the start of a series of talks that Bristol-Myers Squibb Co. has scheduled in an effort to settle personal-injury claims related to its hepatitis C drug candidate, 094. Although BMS has not provided details, the Journal says that persons with knowledge of the matter, as well as court documents, indicate that the New York City-based pharmaceutical firm is facing claims, amounting to more than $500 million, for the injuries and one death that occurred last year during company-sponsored clinical trials to test the treatment in patients with hepatitis C. 

Monday, January 07, 2013

Pharmacy linked to meningitis outbreak places blame on its cleaning contractor.


www.med-art.com

The AP (1/4) reported, "The Massachusetts compounding pharmacy linked to a nationwide meningitis outbreak that has been blamed for 39 deaths and hundreds of illnesses is blaming its cleaning contractor." Attorneys for the New England Compounding Center recently "sent a letter to UniFirst Corp. demanding that it take legal responsibility for claims against the pharmacy." According to the AP, "UniFirst acknowledged that a subsidiary helped clean portions of the pharmacy's cleanroom facility in Framingham, but maintained its cleaning services were limited and it was not responsible for the contaminated drugs."