Chrysler Recalls 703,000 Vehicles Because Of Ignition-Switch Problems

Bloomberg News (3/8, Plungis, 2.94M) reported on Fiat Chrysler Automobiles NV’s “second recall of 703,000 minivans and SUVs with a defective ignition switch that can rotate out of position,” a problem similar to “the faulty General Motors Co. part tied to dozens of deaths.” NHTSA announced that the recall affects several models from the 2008-2010 years.

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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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20% Of Cars Have An Unfixed Recall

The Arizona Republic (2/11, Merrill, 1.14M) reported that according to the Neighborhood Auto Repair Professionals in Arizona, “one in five cars nationwide has an unfixed recall,” and “one in three minivans and one in five SUVs” have unfixed recalls. The repair group used research from Carfax to estimate that 46 million cars have unfixed recalls in the US.

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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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More Pre-Market Testing of Vaginal Mesh Products is Needed

An FDA Advisory Panel recommended on September 9, 2011, that vaginal mesh products be reclassified to Class III devices and that more stringent pre-market testing be required before approval.  Class III devices are required to undergo full pre-market approval, including safety
testing.  Special Controls can be instituted such as physician labeling, patient labeling, pre-market studies, performance standards, patient registry, and importantly, enhanced post market surveillance.  Most mesh products are exempt from pre-market testing.  Mesh products are approved under 510(k) review which only requires a showing that a device is substantially similar to another device previously approved.

Transvaginal mesh products are used to repair conditions in women such as pelvic organ prolapsed (POP) and stress urinary incontinence (SUI).  Pelvic organ prolapsed is the bulge of organs/structures surrounding the vagina into the vaginal opening or extending beyond the vaginal opening, caused by a laxity of supporting tissue of the vagina.  Stress Urinary Incontinence is the involuntary leaking of urine associated with an increase in intraabdominal pressure which may be caused by straining, physical activity, coughing or sneezing.

From 1992 until 2010, the FDA approved 168 vaginal mesh devices used for repair of POP or SUI.  These products were approved using
the 510(k) process and they did not undergo preclinical testing.  Most of these devices were approved between 2001 and 2010.  Serious complications associated with surgical mesh for vaginal repair of pelvic organ prolapsed and stress urinary incontinence have increased dramatically along with the flood of additional mesh devices onto the market. From 2008 until 2010, nearly 3,000 adverse events have been associated with surgical repair of POP and SUI using the transvaginal placement of mesh.  These adverse events include organ perforation, bleeding, urinary incontinence, fecal incontinence, pelvic pain, infection, discomfort during intercourse, and the need for corrective surgeries.

If you or someone you love has suffered from Transvaginal Mesh Products, contact Boyd B.Newton.  Boyd B. Newton is a prominent Atlanta Product Liability Attorney with the knowledge and experience to help.

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