NHTSA Data Shows That Vehicle Recalls More Than Doubled In 2014

According to The Detroit Bureau (2/14, Strong) automobile recalls in the US in 2014 surpassed recalls in 2013 by “more than 100%,” with 63.95 million vehicles having been recalled, according to NHTSA. General Motors accounted for most of the recalls at 27 million vehicles recalled in 84 different events. The article partially focused on NHTSA resources to handle recalls and monitor automobile safety nationwide, noting that NHTSA Administrator Mark Rosekind wants more funding for investigating possible vehicle issues, warning that more vehicles could be recalled this year than in 2014. Secretary Foxx agrees, having stated for the press earlier this week that “It’s no longer reasonable frankly to expect an office with 8 screeners and 16 defects investigators to adequately analyze 75,000 complaints a year.”
The International Business Times (2/14, Young, 1.19M), video from CNBC (2/14, 2.81M), and Law 360 (2/13, Field, 9K) also report with similar coverage.

Share

Chrysler To Be Sued Over Jeep Fuel Tanks

The AP (2/11) reported that a lawyer for the family of Kayla White, who burned to death after her Jeep Liberty was hit from behind last November, intends to sue Chrysler over its recall of certain fuel tanks. Many older Jeep models have “plastic fuel tanks mounted behind the rear axle,” which makes them vulnerable “to punctures and fires” during rear-end collisions. Chrysler announced a recall in June 2013, but attorney Gerald Thurswell contends that “the recall notice from Chrysler gives no sense” of the actual danger.

Share

The Department of Justice Is Investigating LifePoint Hospitals

Modern Healthcare (2/13, Schencker, Subscription Publication, 246K) is reporting that in a Feb. 12 filing with the Securities and Exchange Commission, Tennessee-based LifePoint Hospitals “revealed” that it is “the target of federal investigations, more than twelve individual lawsuits and two class action suits alleging the performance of improper interventional heart procedures.” After conducting “an internal review,” LifePoint “identified two cardiologists who ‘independently elected to place cardiac stents that may not have been clinically appropriate,’ according to a LifePoint statement released” yesterday. LifePoint “then self-reported the matter to the Department of Justice.” The two physicians no longer practice at any facilities affiliated with LifePoint, according to a company statement. Currently, the only LifePoint Hospital in Georgia is Rockdale Medical Center.

Share

Johnson & Johnson Has Abandoned Its Solicitation Probe In Transvaginal Mesh Cases

Reuters (2/11) is reporting that Johnson & Johnson has given up its request for a probe into what it claimed were illegal phone calls made to women about their use of transvaginal mesh devices made by its Ethicon subsidiary. The devices are the center of a multidistrict litigation in West Virginia by thousands of women who were injured by the transvaginal mesh.

Share

People Who Buy Used Cars Are Responsible For Asking About Hidden Safety Recalls

The New York Times (1/30, Tabuchi, Subscription Publication, 9.97M) reported, after several high-profile deaths of used cars involving airbag recalls, Federal laws “do not require used-car dealers to repair vehicles with safety defects before putting the cars back into public use. Nor are dealers required by law to disclose to customers that a vehicle is the subject of a recall.” Legislation to change this loophole has stalled in Congress leaving consumers on their own to check if a used vehicle has been recalled for a safety defect by either running a car’s VIN number through the Federal safety database, checking an automobile manufacturer’s website, or by purchasing a vehicle history report from a vendor such as Carfax. NHTSA will continue to push for Congress to “prohibit used-car dealerships from selling vehicles with an open recall and the rental of vehicles with an open recall.”

Share

FDA Releases Draft Guidance For Risks Included On Medicine Advertisements

The Wall Street Journal (2/6, Silverman, 5.67M) blog “Pharmalot” is reporting that the FDA has issued new draft guidance requesting that drugmakers refrain from including long lists of risks and concerns associated with drugs in favor of a mild summary in print ads and promotional materials. The summary would not have to include information about all side-effect or contraindication. In the draft guidance, the agency explained that not many consumers have the technical background needed to understand some of the information described in the warnings as they exist now. The intention of the summary is to focus on the broader risks and important information instead of an exhaustive list of every possible issue.

Share

Senators Request FDA Investigate Dietary Supplements

According to The Hill (2/5, Wheeler, 224K) Senators are encouraging the FDA to launch a “nationwide investigation after four major retailers were accused of selling mislabeled and tainted dietary supplements in their New York stores” by the state’s Attorney General Eric Schneiderman. Sen. Dick Durbin (D-IL) said in a statement, “Today, Sen. [Richard] Blumenthal [D-CT] and I are calling on the FDA to…take steps to protect all American consumers from an industry shown to be selling products they know are at best, ineffective, and at worst, truly harmful.” Sen. Blumenthal said in a statement, “The apparent widespread sale of fraudulently-labeled dietary supplements by four major national retailers should be a major wake-up call that the industry is in desperate need of additional oversight.”
The need for increased oversight over dietary substances is substantiated by the fact that US consumers “are nuts” for products they believe help them “boost their health and lose weight,” despite a “series of studies and investigations that have cast serious doubt on the safety and reliability of” dietary supplements, the Washington Post (2/5, Millman, 5.17M) “Wonkblog” reported. The popularity of dietary supplements is maintained by the “common public misperception that these products face the same rigorous oversight that pharmaceuticals receive from the FDA.” A report from the HHS Inspector General in 2012 “found that 20 percent of the weight loss and immune system support supplements they purchased made illegal claims about their ability to treat and cure disease,” and just a year later, researchers from Harvard “found that between 2004 and 2012, there were 237 recalls of dietary supplements — accounting for more than half of FDA recalls of Class 1 drugs,” which signifies that “the products contain substances that can cause death or serious health problems.”

Share

FDA Warns Apotex Regarding Indian Drug Manufacturing Facility

According to The Wall Street Journal (2/4, Silverman, 5.67M) the US Food and Drug Administration sent a warning letter to Apotex, for violations in its manufacturing of generic medications at a facility in Bangalore, India. The FDA has sent several similar letters to Apotex in the past.

Share

OSHA To Fine Ashley Furniture $1.7 Million For Safety Violations

According to The New York Times (2/3, Abrams, Subscription Publication, 9.97M) Ashley Furniture, a major global furniture maker, is facing $1.7 million in OSHA penalties “to settle charges that unsafe conditions at its manufacturing plant in Arcadia, Wis., led to more than 1,000 injuries.” OSHA “cited the company for dozens of violations, including disregard for safety standards that led to a number of gruesome injuries.”

Share

The FDA’s Adverse Reporting System Includes Numerous Incomplete Reports

The New York Times (2/3, B3, Thomas, Subscription Publication, 9.97M) is reporting that “the main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the” FDA, “according to a new study by” the Institute for Safe Medicine Practices (ISMP), “a nonprofit group that tracks drug safety issues.” An FDA spokesman “acknowledged that adverse-event reports were often incomplete, and said improving the system was ‘of great interest’ to the agency.” But, “doing so ‘is challenging because of the voluntary nature of the reporting.’”
Similarly, The Wall Street Journal (2/2, Silverman, 5.67M) “Pharmalot” blog reports that although the ISMP says reports can only be considered reasonably complete when they include patient age, gender and event date, only 49% of reports contained that information. Additionally, the analysis found that 67% of death reports were of limited value due to incomplete information about the cause of death and the possible role of a medicine. Thomas Moore, an ISMP senior scientist, attributes the lack of completeness in reporting in part to the fact that the FDA’s adverse-alert system has not been updated since 2001 despite the fact that the pharmaceutical market has evolved immensely, yielding new interactions between drugmakers, patient, and consumers.

Share