Justice Department subpoenas pharmaceutical company over generic antibiotic.

The Wall Street Journal (12/4, Dulaney, Subscription Publication, 6.23M) reports the Justice Department’s antitrust division subpoenaed the pharmaceutical company Mylan regarding how it prices and markets its generic antibiotic Doxycycline, the company said Friday.  Reuters (12/4, Humer, Grover) reports the Justice Department also requested information between the company and its competitors about the medication.

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NHTSA investigation of faulty Takata airbag inflators surveyed

The Legal Examiner (12/5, Cohn) surveys the history of the NHTSA investigation into Takata-made airbag inflators, noting that NHTSA claims Takata “was aware of problems with its air bags as far back as 2004.” NHTSA further states that “in round numbers, nearly 1 in 10 driver inflator ruptures has resulted in death.”

Bloomberg News (12/6, Hagiwara, Trudell, 3.4M) reports that Takata Corp. “has lost the confidence of one of its biggest former shareholders, which said the company cut off access to management and downplayed risks as its air bags spurred a record auto-safety recall.” Sawakami Asset Management, “whose $2.6 billion stock fund beat the benchmark Topix index 12 of the past 15 years, sold the last of its Takata shares in early October,” before the NHTSA’s unprecedented crackdown on the company, the article reports. “We could not help feeling the management is not trustworthy,” fund manager Takahiro Kusakari said in an interview. “We felt Takata had a ‘we are needed and our products are needed, so the business will come back and the situation won’t be that bad’ kind of attitude, downplaying the issue,” he added.

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FDA Bans Indian Pharmaceutical Firm From Exporting To US Because Of Quality Control Issues.

The Wall Street Journal (3/26, 5.67M) reported in its “Pharmalot” blog that the FDA banned the import of medicines from India-based pharmaceutical firm Aarti Drugs after it failed an FDA inspection last August. The agency’s inspection followed a warning letter the company received the previous year over several manufacturing standard violations at two Aarti facilities during a 2012 inspection. The plant is one of several from India that have faced similar bans.

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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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Transvaginal Mesh Litigation

Major activity is underway in the seven transvaginal mesh multidistrict litigations in the Southern District of West Virginia. While American Medical Systems (AMS) continues to settle claims involving its mesh products, C.R. Bard, Boston Scientific, Johnson & Johnson, and Cook Medical are gearing up for more bellwether trials this year. Here are some of the highlights:

C.R. Bard

Early last year Judge Goodwin selected 200 cases (Wave I and 2) for case specific discovery to include depositions of the Plaintiffs as well as treating physicians. In an effort to spur continued progression in these cases given the large number of pending claims, the Court later designated approximately 300 more cases (Wave 3) for discovery on cases involving only the Bard Avaulta mesh product used for pelvic organ prolapse repair.

Believing that it would be impossible to actually depose every treating physician responsible for the care and treatment of 300 Plaintiffs, the Court determined that depositions by written question would be the most efficient means of handling the deposition process; however, the process quickly became cumbersome and problematic for all the parties.

To address these concerns, the Court designated a Miniwave process, which reduced the number of Plaintiffs in the wave to 60. Once discovery is completed on these cases, they will be deemed trial ready, and will be either transferred to a federal district court of proper venue, or in the alternative, remanded to the federal district court from which the case was transferred to the MDL, if applicable.

Despite this movement, Bard continues to seek to delay trials and has even argued that trials should be delayed because comments by U.S. District Judge Joseph R. Goodwin served to prejudge Bard’s liability in these cases. Judge Goodwin rejected its argument and ruled that Bard had not demonstrated good cause to further delay trials. The next trial against Bard is scheduled to begin February 18.

Boston Scientific

Early 2014 resulted in the selection of approximately 200 cases (Wave 1 and 2) for case specific discovery. This litigation is currently in the Daubert motion phase and these cases will be deemed trial ready early this year. In September 2014, Boston Scientific lost its first trial in Texas state court when a jury awarded a $73.4 million verdict to a Plaintiff implanted with the company’s Obtryx midurethral sling. The jury found that there was a safer alternative design available than the Obtryx device and that it was unreasonably dangerous as marketed. The jury also found that Boston Scientific has acted with gross negligence. Trials against Boston Scientific are currently scheduled for February (Dallas, Texas), May (Delaware), and June 2015 (Texas and Massachusetts).

Johnson & Johnson

Cases against Johnson & Johnson and Ethicon have not been designated for case specific discovery through a wave process like in Bard and Boston Scientific. Instead, the Court chose six bellwether cases for trial designation, the last two of which are scheduled to be tried in March 2015 in West Virginia. These cases involve the Ethicon Prolift product for pelvic prolapse repair. The Prolift vaginal mesh system was associated with many negative side effects, prompting the company to voluntarily recall the product from the market.

Last September, a jury in West Virginia federal court awarded a $3.27 million verdict finding that Ethicon’s transvaginal sling was defectively designed. Prior to that, a jury in Texas state court found for the plaintiff and awarded a $1.2 million verdict. In addition to the federal trial in March, more trials are expected against Johnson & Johnson and Ethicon in state courts this year, with one scheduled for February 2015 in Austin, Texas and another scheduled for April in Dallas, Texas.

Cook Medical

Recently, the MDL court ordered four cases against Cook Medical to be tried as bellwether cases, with the first case to be ready to try on April 20, 2015. If that case is dismissed or otherwise not ready for trial, a back-up case will be tried in its place. The next trial is set for May 18, 2015, and if that case is dismissed or otherwise not ready for trial, another back-up case will take its place. The final trial date will be June 8, 2015.

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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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