The New York Times (1/23, B3, Singer, Pollack) notes that a recent study has indicated that people who take the prescription diet drug Meridia “had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.” However, the Times said that the data drew “two starkly different reactions” last week from European and American regulators. While the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing the drug, the US Food and Drug Administration “took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.” The agency “said it planned to wait for the company’s complete report on the study…before considering further action,” although “some obesity experts question the [FDA’s} decision to leave Meridia on the market for people who do not have cardiovascular disease.”
ABC World News (1/21, lead story, 3:10, Sawyer) reported, “Breaking news this evening. Toyota is recalling 2.3 million cars and trucks tonight, trying to tackle the frightening problem of cars suddenly speeding out of control.” The CBS Evening News (1/21, story 8, 0:20, Couric) noted that “late last year Toyota recalled more than four million vehicles because the accelerator pedal can get stuck in the floor mats. Well, today another huge recall. More than two million Toyotas covering eight model years from 2005 to 2010. The accelerator can get stuck in those vehicles as well, even without a floor mat.”
The most recent recall, according to NBC Nightly News (1/21, story 6, 0:20, Williams), “is in addition to 4.3 million Toyotas recently recalled for a floor mat problem that could cause the accelerator to stick.” The New York Times (1/22, B8, Bunkley) points out, “The first recall was to fix a design flaw that could cause the gas pedal to become trapped under the floor mat.” But Toyota “continued to be dogged by reports of unintended acceleration and stuck pedals even in cases where the floor mats had been removed, a stopgap measure recommended” by the company. The Times says the recall affects some year models of the Avalon, Camry, Tundra, Sequoia, RAV4, Corolla, Matrix, Highlander, and “the Pontiac Vibe, a mechanical twin to the Matrix.” Not affected are “Lexus or Scion models” or the Prius.
The AP (1/22, Strumpf, Manning) reports Toyota said yesterday’s “recall is due to potential problems with the actual gas pedal mechanism, causing the accelerator to become stuck regardless of whether the vehicle contains a floor mat.” That automaker “said in certain rare cases, the gas pedal mechanism wears down, causing the accelerator to become harder to press, slower to return or, in some cases, stuck.” The Wall Street Journal (1/22, Linebaugh) reports the last recall adds pressure on the Japanese automaker whose reputation in product safety and quality may be at stake due to a series of recalls in the US. The Los Angeles Times (1/22) and USA Today (1/22, Healey, et al.) also report the recall.
The FDA has determined that Johnson & Johnson’s McNeil Consumer Healthcare is responsible for failing to properly test their Tylenol pain reliever for contamination after a number consumer complaints in 2008. After receiving over 70 reports of a musty odor in Tylenol Arthritis Caplets, the FDA says the company didn’t initiate a formal investigation. McNeil spokeswoman Bonnie Jacobs said the company “is actively working in consultation with the FDA to address their concerns.”
Florida’s Palm Beach Post (1/20, Cerabino) reports, “A national health group called Aim at Melanoma is backing a statewide legislative effort to institute what would be a tough ban on the use of ultraviolet-light-emitting indoor tanning beds by Florida teenagers.” Currently, “in Florida, melanoma is the second most common cancer type for both men and women under the age of 40.” In light of that fact, state Sen. Eleanor Sobel (D) recently revived a “bill that banned teenagers under 16 from indoor UV tanning, and required in-person parental permission for 16- and 17-year-olds.” On Jan. 19, that measure “sailed through the Florida Senate’s Health Regulation Committee on a unanimous vote.”
The AP (1/14) reported, “The Florida Supreme Court says hospitals must warn patients about a state law that bars malpractice lawsuits for birth-related neurological injuries.” Patients who receive proper notification “cannot sue but receive limited no-fault compensation if something goes wrong.” But, “the justices Thursday ruled hospitals that fail to do so can then be sued even if a patient’s doctor provided a notice required by a law designed to reduce malpractice cases against obstetricians.”
In an op-ed in the Huffington Post (1/5), AAJ President Anthony Tarricone wrote, “Last week, two studies were released showing how the FDA lacks stringent scientific standards to evaluate cardiovascular medical devices. This underscores the need to pass the Medical Device Safety Act (MDSA), legislation that would help…hundreds of thousands of [patients] injured by faulty medical devices to hold the manufacturers accountable for their defective products.” The MDSA “would follow the Supreme Court’s decision in Wyeth v. Levine, which held that federal law does not preempt state-law claims with regard to drug warning labels.” Tarricone focuses on the story of Avery deGroh, who was three years old when “the Medtronic lead to her implanted heart defibrillator fractured, sending nine shocks to her heart, similar to the sensation of being electrocuted nine times.”
Bloomberg News (1/7, Fisk) reports, “The top five product-defect verdicts rose 52 percent in total value last year to $620 million as juror attitudes on companies soured amid the recession and rising unemployment, according to data compiled by Bloomberg.” Plaintiffs’ attorney Tobias Millrood, “winner of a $34 million verdict against Pfizer,” said, “It’s a reflection of the fact that Main Street is hurting.” Notwithstanding “the 2009 results, both plaintiffs and defendant companies are increasingly willing to take product liability cases to trial, said John Beisner, a lawyer who defends corporations in such suits.”
The AP (1/5, Perrone) reported, “The FDA approved 26 first-of-a-kind prescription drugs last year, up slightly from 25 in 2008,” according to data from investment research group Washington Analysis. The agency also “added 31 new or updated ‘black box’ warning labels to drugs already on the market,” down from “56 boxed warnings in” 2008. The figures “suggest a moderate approach to regulation,” in spite of the administration’s efforts to strike “a tougher stance on safety” following “a string of bungled drug safety issues.” President Obama appointed FDA Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein in an effort “to restore the agency’s credibility.”
The AP (12/31) reported, “An Oregon man whose 5-month-old son died last summer has filed a $5 million lawsuit against the maker of hammock-like baby beds. Jonathan Kuzma of suburban Gresham contends in the lawsuit filed Tuesday in Multnomah County Circuit Court that the bed made by Amby Baby USA of Minneapolis was defective and dangerous and led to the suffocation death of his son Matteo in August. The death of the Oregon infant and a 4-month-old in Georgia led to the Dec. 8 recall of about 24,000 Amby Baby Motion Beds.”
Central Florida News 13 (1/3, Kinsey) on its website reported, “While complaints keep pouring in about Chinese drywall, some state lawmakers want to make sure that tainted product doesn’t make it into Florida again.” State Sen. Dave Aronberg “said Florida needs to figure out ways to test as efficiently as possible.” The bill, “which will be up for debate in the spring legislative session, would require the state Department of Health and the Florida Building Commission to come up with new drywall standards.”