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 

BMS schedules settlement talks over novel hep C drug claims.

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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. 

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

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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." 

Lawsuit concerning burns from hot tea bears similarities to '92 coffee case.

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The Detroit Free Press (12/10, Allyn, 280K) reports that a year ago, a passenger on a Southwest flight bound for Houston spilled hot water for a cup of tea into her lap and "suffered skin blisters and second-degree burns, according to her attorney Rob Anderson, who filed an $800,000 negligence lawsuit against Southwest on her behalf." According to the Free Press, the plaintiff did not have a drop-down table on which to place her cup of tea because she was sitting in the front row. The article notes that "the case echoes one involving a New Mexico woman who won a settlement after spilling a piping hot cup of McDonald's coffee on herself in 1992." The story goes on to say that although the 1992 case was cited by many advocates of tort reform as an example of greed and abuse in the civil justice system, many legal experts argue that the facts and outcome of the case were distorted by time and by propaganda. Daniel Clayton, a medical malpractice attorney, "said the propaganda about the case has helped marshal public opinion in favor of lawsuit reform," adding that such legislation ends up hurting those who have been harmed in some way. The article also describes the coffee case and its effects in further detail.

Portable baby recliner comes under scrutiny following five infant deaths.

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The AP (12/6, Kerr) reports that "the government is taking action against the makers of a portable baby recliner called the Nap Nanny after five infant deaths." The story notes that the US Consumer Product Safety Commission "filed an administrative complaint Wednesday alleging that the new model of the Nap Nanny, called the Chill, and two earlier versions 'pose a substantial risk of injury and death to infants.'" The CPSC is now "seeking an order that would require Nap Nanny maker Baby Matters LLC of Berwyn, Pa., to notify the public about what the agency deems a serious product defect," and it also wants the firm to offer consumers a full refund.

        The Boston Globe (12/6, Lipka, 250K) "Consumer Alert" blog reports that "The lawsuit was filed today against Baby Matters, LLC, of Berwyn, Pa., which makes Nap Nanny and Nap Nanny Chill. The CPSC said it was aware of the deaths of four infants in Nap Nanny Generation Two recliners and another in a Nap Nanny Chill." The blog post adds, "The first set of Nap Nanny recliners were recalled in July 2010 - and consumers were offered an $80 coupon for a newer model recliner as well as improve warnings and instructions."

        CNN (12/6, Sperry) reports on its website that "the Nap Nanny recliner is designed for sleeping, resting and playing and includes a shaped foam base with an inclined indentation for the baby to sit and a fitted fabric cover with a three-point harness," according to the CPSC. CPSC Commissioner Nancy Nord is quoted as saying, "My heart goes out to the parents and families of children who are injured or lose their lives in incidents associated with consumer products."

        USA Today (12/6, O'Donnell, 1.71M), Reuters (12/6) and the NBC News (12/6) website also cover this story. 

Another person dies from poisonous mushrooms at senior care facility.

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The AP (11/27) reports that "a fourth person has died from eating a soup made with poisonous mushrooms earlier this month at senior care facility in Northern California, authorities said Tuesday." Local police authorities have identified the latest victim as 92 year-old Dorothy Mary Hart. The article points out that "three others at the six-bed Gold Age Villa care facility in Loomis died from eating the mushrooms in what sheriff's investigators characterize as an accident." According to the AP, "all of the victims were sickened Nov. 8, including the caretaker who made the soup after picking mushrooms in the backyard of the facility." California's Department of Social Services is currently investigating the incident.

        In its "L.A. Now" blog, the Los Angeles Times (11/28, Pool, 692K) notes that "wild mushrooms are in season now, including poisonous North American amanitas that resemble edible mushrooms that are popular in Asia. White with a sprinkling of brown over the cap and known as the 'death cap,' the mushrooms sicken hundreds each year in California." According to the blog, "health officials say toxins in the mushrooms cause liver damage and can lead to comas and, occasionally, death, especially with older people." 

Caffeinated energy drink cited in reports of 13 deaths over last four years.

www.med-art.comThe Wall Street Journal (11/15, Esterl, Subscription Publication, 2.08M) reports that the US Food and Drug Administration on Wednesday acknowledged that it has received reports of 13 deaths during the last four years that may be related to the caffeinated energy drink 5-Hour Energy, which is distributed by Living Essentials LLC. According to the Journal, the FDA has said that there is no evidence so far linking the drink to deaths or hospitalizations, but that the agency is continuing to investigate the reports.

        The New York Times (11/15, Meier, Subscription Publication, 1.23M) reports that since 2009, "5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of F.D.A. records reviewed by The New York Times showed." The Times mentions that this disclosure of reports marks "the second time in recent weeks that F.D.A. filings citing energy drinks and deaths have emerged." The FDA acknowledged last month that it had received five fatality filings mentioning the energy drink Monster Energy.