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.


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.


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.”


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.


NPR Reports On Workplace Injuries Suffered By Nurses

NPR’s “All Things Considered”(2/4, 1.58M) examined the dangers nurses face at work, noting that the Department of Labor’s Bureau of Labor Statistics (BLS) found that more than 35,000 nursing employees suffer back and other injuries at work each year. According to the BLS, “nursing assistants are injured more than any other occupation, followed by warehouse workers, truckers, stock clerks and registered nurses.” The piece notes how some hospitals are trying to reduce the risk. However, “David Michaels, the assistant secretary of Labor who heads the U.S. Occupational Safety and Health Administration,” said Congress and the courts have severely restricted OSHA’s ability “to require hospitals to protect nursing employees.”


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.


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.”


The Deadline For Filing Claims Regarding GM Faulty Ignition Switches Passed On March 31, 2015

The AP (2/3, Krisher) is reporting that “the families of 51 people who died in crashes caused by faulty” GM ignition switches will receive money from the GM compensation fund, with another 77 to receive money for injuries, according to compensation expert Kenneth Feinberg. The deadline for filing claims was Saturday, March 31, 2015. As of Sunday there were “455 death claims and 3,447 for injuries.” Many are calling for GM to extend the deadline, “because victims do not know yet whether they can sue General Motors Co., the new company that emerged from bankruptcy protection in July 2009.”
According to The CBS Evening News (2/2, story 5, 2:30, Glor, 5.08M) Sens. Ed Markey (D-MA) and Richard Blumenthal (D-CT) are asking GM to reconsider the deadline, “as over a third of the vehicles are still not fixed.”
USA Today (2/2, Healey, 10.32M) reported that GM’s count of victims “only included people in the front seats who would have been protected, presumably,” if not for the defective switches, and only those driving or riding in models that were specifically recalled.


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.