Automobile Recalls Are Likely To Remain High in 2015

Relying on an automotive industry warranty and recall study from the financial advisory firm Stout, Risius and Ross, the Detroit Bureau (2/26) reported that automotive recalls in 2015 are likely to be higher than normal, though unlikely to reach 2014 figures. The Bureau adds that the forecast is unsurprising, because the new head of the National Highway Traffic Safety Administration, Mark Rosekind, “has already predicted it would happen,” as he hopes to double the size of the NHTSA investigative staff.

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Judge Affirms Jury’s $2 Million Verdict in Bard Mesh Bellwether Case

West Virginia federal judge Joseph R. Goodwin has affirmed a $2 million jury verdict against C.R. Bard Inc. in a bellwether trial over alleged defects in its vaginal mesh implants. The Judge ruled that the company had not proven a miscarriage of justice and denied Bard’s motion for a new trial. But U.S. District Judge Goodwin also refused to find unconstitutional a provision in Georgia’s Tort Reform Act of 1987 that requires prevailing product liability Plaintiffs to pay 75 percent of their punitive damages to the state. The lawsuit was originally filed in Georgia before being transferred to the multidistrict litigation (MDL) in March 2011. The ruling dealt a blow to Plaintiffs Donna and Dan Cisson, who had been awarded $1.75 million in punitive damages and $250,000 in compensatory damages by a West Virginia federal jury in August 2013.

The case had been the first federal suit to go to trial within seven multidistrict litigations concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. In denying Bard’s motion for a new trial, Judge Goodwin said the court wasn’t wrong to exclude evidence relating to the fact that the device maker had complied with the U.S. Food and Drug Administration (FDA) rule requiring device makers to notify the agency 90 days prior to marketing a medical device.

With an eye toward submitting its case to the Fourth Circuit, Bard had asked the court to rule on its motion for a new trial, according to the opinion. The seven MDLs still contain more than 70,000 cases that are currently pending, of which approximately 10,000 are in the Bard MDL, according to the opinion. The Cissons are represented by Henry G. Garrard III, Gary B. Blasingame, James B. Matthews III, Andrew J. Hill III, and Josh B. Wages all with Blasingame Burch Garrard & Ashley, a firm located in Athens, Ga. The case is Cisson et al v. C.R. Bard, Inc., in the U.S. District Court for the Southern District of West Virginia.

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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.

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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.

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Hospira Recalls Contaminated Painkiller

The Wall Street Journal (2/12, Loftus, Subscription Publication, 5.67M) reported that Hospira, the manufacturer of a widely-used generic painkiller in hospitals, recalled over 60 lots of vials as a result of contamination by calcium-ketorolac crystals. Hospira said the contamination could cause side effects but that none have been reported. Hospira produces 95% of the ketorolac distributed in the US, so the recall has caused a shortage of the drug. The company is investigating the cause of the contamination.

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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.

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GM To Temporarily Stop Selling Some SUVs Due To Pending Goodyear Tire Recall

The Detroit Free Press (1/22, Priddle, 987K) reported that General Motors told dealers to stop selling 2015 Chevrolet Traverse, GMC Acadia and Buick Enclave utility vehicles due to a pending recall of the 18-inch tires on the 6,300. The article states that Goodyear is working with the NHTSA and expects recall 48,500 tires, “of which about 32,100 were made for GM’s family of full-size crossovers.”

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Medtronic Will Pay $2.8 Million To Settle Allegations Of Encouraging Off-Label Use Of Device To Doctors

Law 360 (2/6, Macagnone, 9K) is reporting that Medtronic will settle with the US Justice Department for $2.8 million regarding a False Claims Act Suit contending the company “paid doctors to push an unapproved use” of the company’s neuro-stimulation device, “SubQ stimulation treatment.” The Justice Department has accused Medtronic of paying out “tens of thousands of dollars” to urge physicians to make an off-label use of the device, and to seek Medicare payments for treatments “not approved by the U.S. Food and Drug Administration.”

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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.

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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.”

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