Jury Finds For Plaintiff In J&J Mesh Lawsuit

Bloomberg News (3/5, 2.94M) reported that a jury in California ordered Johnson & Johnson on Thursday “to pay $5.7 million to a woman who said one of the company’s Abbrevo vaginal-mesh implants eroded inside her, forcing her to have surgery, in the first verdict over that device.” In the first verdict “to find fault with the Abbrevo sling,” jurors determined that the product “was defectively designed and officials of J&J’s Ethicon unit failed to properly warn doctors and consumers about the device’s risks.”


NHTSA Reports That GM And Honda Recalls Are Biggest In History

According to the USA Today (3/3, Healey, 10.32M), “two of the biggest auto recalls in history took place last year” citing the NHTSA summary of recall activity, referencing GM’s 5.8 million vehicle recall for faulty ignition switches and Honda’s 5.39 million vehicle recall for defective airbags. Fifty-seven deaths are linked to the GM defect so far, and could rise as more claims are evaluated. The Honda defect is linked to five deaths. The GM recall “provoked federal fines, lawsuits, government investigations, an embarrassingly candid internal probe at the automaker, Senate and House subcommittee hearings and an overhaul of how GM regards safety concerns.” The AP (3/3) reported that the two recalls make up “more than half of the record 64 million vehicles recalled last year.”


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.


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.


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.


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.”


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.”


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.”


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.


DePuy’s Hip Recall


ASR XL Acetabular and ASR Resurfacing hip systems (ASR hips) were recalled in August 2010. DePuy Orthopedics and Johnson and Johnson manufacture these defective products. Following the recall, DePuy Orthopedics and Johnson & Johnson have aggressively defended the hip failure lawsuits that have been filed against them.  The ASR hips have an exceptionally high rate of revision surgeries within a short period of time following the first hip implant surgery.  The metal-on-metal design of the ASR hips leads to metal particles entering into the bloodstream of the person with the ASR hip. The metal particles in the bloodstream cause severe metal poisoning.  The metal poisoning and the general defective design of the ASR hips have also led to dislocation, hip mal-alignment issues and bone fractures. These issues were the main reason for the ASR hip recall.

DePuy and Johnson & Johnson immediately instituted a “medical bill reimbursement program” upon realizing the legal implications of the defective ASR hips.   This program allows DePuy to pay for medical bills associated with the follow-up care and treatment for defective ASR hip device, including any potential revision surgeries.  However, DePuy has required ASR hip users to obtain a claims number and sign a medical authorization release The medical authorization release violates many of the users’ rights.  This release authorizes DePuy to gain access and information about ASR users’ potential case that DePuy would not otherwise have.  For instance, the release allows DePuy, through the company that DePuy has hired to handle this program−Broadspire−to speak directly with the ASR user, his or her physicians, and obtain the ASR device if there is a need for revision surgery.  If DePuy takes physical possession of the ASR device, the potential client’s case will be severely compromised.

Through the efforts of the MDL Plaintiffs’ leadership committee (PSC), DePuy has recently agreed refrain from having clients sign the releases and has also agreed to pay for ASR users’ medical bills.  However, the ASR user should not communicate with DePuy or Broadspire directly.  Instead, potential clients should allow their products liability lawyer to handle any medical billing issues because DePuy and/or Broadspire can record any communications over the phone with the ASR user and use that information against the potential client. Therefore, if ASR hip users are interested in this reimbursement program, it would be in their best interest to hire a product liability lawyer to act on their behalf when dealing with DePuy or Broadspire regarding payment of their medical bills.