What Happened In The MassTorts World Last Week? 2019-Apr-22

An upcoming trial date against Monsanto over its Roundup weedkiller was vacated by U.S. District Judge Vince Chhabria as he ordered the parties to enter into confidential mediation to avoid the need for hundreds of individual cases to go before juries nationwide. As per the pre-trial court order no. 141, the decision was taken so that the resources of the parties and the court could be better spent on organizing the remaining cases in the MDL.  

A hearing is set for May 22, 2019, by Judge Chhabria, which would also serve as a case management conference to discuss next steps for management of the MDL proceeding and to discuss a new date for the vacated trial. The hearing would determine which cases must be dismissed or remanded to state court, and to prepare the remaining cases for transfer back to their home districts for federal court trials. The judge also ordered the parties to propose a mediator in their case management statement stating the court will appoint someone if they fail to agree. The third Roundup trial is already under its way in California, filed by a couple who were each diagnosed with non-Hodgkins lymphoma following exposure to Roundup.

Monsanto faces more than 11,000 cases over allegations that the company hid cancer risk linked to Roundup, ran a campaign of misinformation to convince government agencies, farmers, and the general public that the weedkiller was non-hazardous. Additionally, a number of state court trials are lined up throughout this year with a number of cases expected to face Missouri juries in summer and fall, as the vast majority of Roundup claims are currently pending in Missouri state court, as Monsanto’s U.S. headquarters were located.

On Tuesday, April 16, the U.S. Food and Drug Administration (FDA) ordered Boston Scientific and Coloplast to stop the sale of their pelvic mesh products in the U.S., typically used to treat pelvic organ prolapse (POP) and incontinence.

The agency had reclassified the devices as high-risk in 2016 when the manufacturers were required to submit premarket approval applications to keep their pelvic mesh product in the U.S. market. The order is applicable to Boston's Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System and Coloplast AS' Restorelle DirectFix Anterior Mesh. Both the manufacturers are given 10 days to submit a plan about the product withdrawal from the market. According to the agency, all other mesh products meant for repair pelvic organ prolapse were pulled out from the market in 2018 when their manufacturers failed to submit premarket approval applications. Talking about the market withdrawals, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said, in order to keep the devices on the market, evidence need to be added in the premarket applications that indicate them as a safer alternative to surgery. Boston Scientific & Coloplast are the only two remaining makers of the mesh devices, and they failed to prove the long-term safety and effectiveness of their devices. The FDA suggested that women who are planning to have transvaginal mesh repair of POP must discuss other treatment methods with their doctors.

On April 17,  a Philadelphia jury ruled in favor of a Johnson & Johnson unit, tossing claims made by a woman that the company's defectively designed pelvic mesh implant caused her severe pain and vaginal complications.

Though the jury agreed that J&J's subsidiary Ethicon Inc. was negligent in designing and marketing its TVT-Secur mesh implant, the jury determined that negligence was not the reason for the injuries the Philadelphia-area resident suffered from the device. The plaintiff was implanted with the TVT-Secur mesh in 2008 to treat her stress urinary incontinence. However, she experienced painful side-effects, and her condition seemed to worsen over the years. In her lawsuit, she asserted that Ethicon rushed the product to the market in 2006, without adequate clinical testing. The mesh implant was pulled from the market in 2012. Defendants argued that the woman's injuries were not linked to the mesh implant and that the product cannot be regarded as defective merely because it failed to cure her incontinence. The jury returned a defense verdict after about six hours of deliberation, ending the three-and-half-week trial.

Ethicon pelvic mesh lawsuits are consolidated as a part of a multidistrict litigation (MDL No. 2327; In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation) before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.

Tenneco Automotive Operating Company Inc. (Tenneco) was granted summary judgment by the Delaware Superior Court in an asbestos lung cancer lawsuit filed by a plaintiff as an administrator of the estate of a victim.

In the lawsuit filed against Tenneco, the plaintiff alleged that her deceased husband, who worked as an auto mechanic, developed lung cancer due to exposure to asbestos from Walker mufflers while he worked at two different automotive shops between 1963 and 1965. Prior to his death, the victim had testified that the lining of Walker mufflers contained a mesh-like material that left behind dust when replaced or removed. Tenneco argued that only some of its mufflers contained asbestos and that the plaintiff failed to prove that the company's asbestos-containing products caused the victim's lung cancer. The muffler manufacturer filed a motion for summary judgment on April 10.

The court found that Tenneco made mufflers that did and did not contain asbestos; however, the victim failed to identify the product other than to claim that he worked on them. The evidence presented by the plaintiff was found to be insufficient, and accordingly, Judge Vivian Medinilla ruled in favor of Tenneco.

A case management order issued on April 2, by Judge Robert B. Kugler, presiding over federal valsartan lawsuits, called for leadership counsel to send a notice to all plaintiffs' attorneys asking if they are willing to join the plaintiffs’ leadership committees. Responses are supposed to be submitted at the earliest by April 18, and the list of nominated members must be submitted by April 22. At the next status conference scheduled for April 24, Judge Kugler will consider the final submitted list of valsartan lawyers.

There are nearly 50 product liability lawsuits filed against generic valsartan drug manufacturers and distributors alleging that the hypertension drug, which was distributed all these years, was contaminated with cancer-causing chemicals including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The complaints filed claimed that these chemicals are linked to liver cancer, kidney cancer, colon cancer, stomach cancer, and other digestive tract cancers.

On Wednesday, April 17, The Environmental Protection Agency (EPA) announced to put a complete ban on the use of asbestos in product categories in the automobile industry and building materials.  

The rule will resolve loopholes in the decades-old partial ban on asbestos use, and the agency will review the limited instances where asbestos is still used for industrial purposes. The agency indicated that the intention behind the rule was to inspect any proposal to reintroduce asbestos into those products where it has already been removed. The new rule covers high-grade electrical paper, missile liner, pipeline wrap, and other materials. It will be taken into account in two months after its publication. Additionally, the EPA will also do a risk evaluation of the limited uses of asbestos that are still ongoing. The agency will impose a ban if required, after a thorough evaluation. The EPA rule is not an absolute ban. According to the rule, certain asbestos uses can continue and does not include a ban on importing raw asbestos.

Asbestos is still in use in some industries such as filtering chemicals and found in some vehicle brakes. However, the widespread use of the carcinogenic material in building products, including insulation was discontinued years ago. Asbestos exposure has been reported to cause mesothelioma, a rare form of cancer affecting the stomach, heart, and lungs.

On Thursday, April 18, Health and Human Services Secretary Alex Azar II sanctioned more than $350 million in a federal move aimed at bringing down opioid addiction deaths by 40% over the next three years.

The funds will be distributed as grant awards to a university or medical center in each state, including The University of Kentucky, Boston Medical Center, Columbia University in New York, and Ohio State University in Columbus. Ohio State and its partners will receive $65.9 million, of which the first installment amounts to $13 million. Ohio State University will lead a consortium of academic, state and community partners to reduce overdose deaths. The study will cover 19 Ohio counties, including Greene and Darke counties.  The University of Kentucky will receive $87 million, the largest grant it has ever been awarded, to combat the state's opioid epidemic. Boston Medical Center will get $89 million to take part in the nationwide project. The funds will allow the Center to better plan treatment options for specific communities. The Illinois Department of Human Services, IDHS, reported that the state will get $15 million, in addition to the 2016's $82 million federal funding, from the  U.S. Substance Abuse and Mental Health Services.

U.S. District Judge Dan Polster overlooks more than 600 opioid lawsuits filed by various government entities, all blaming the manufacturers and distributors for the national crisis.

U.S. District Judge David G. Campbell, presiding over all IVC Filter lawsuits filed against C.R. Bard, has allowed claims filed by a plaintiff to move forward to be heard before a jury next month.

The plaintiff received the Bard Recovery filter in 2005 to treat her deep vein thrombosis (DVT) and pulmonary embolism (PE). In 2013, the filter fractured, and small pieces entered into the right ventricle of her heart, due to which she suffered severe complications, including additional medical procedures and surgery to remove the broken pieces. However, some of the filter particles were found to be still inside her body, which couldn't be removed, putting her life at risk. The woman and her husband asserted failure to warn, design defect, misrepresentation, concealment, deceptive trade practices, and loss of consortium claims. C.R. Bard filed a motion for summary judgment to avoid the trial; however, Judge Campbell rejected the motion, indicating that there was enough evidence to allow the case to proceed. The bellwether trial for the plaintiff's claims has been scheduled to begin on May 13.

The plaintiff's lawsuit is one among the more than 7,000 product liability cases pending in the District of Arizona as part of a federal multidistrict litigation (MDL No. 2641; In Re: Bard IVC Filters Products Liability Litigation), covering allegations that the IVC filter sold by the manufacturer caused disastrous internal side-effects due to its faulty design.

Johnson & Johnson asked a federal judge to take over more than 2,400 talcum powder lawsuits, instead of allowing those cases to go before state court juries in the country.

The talcum giant is trying to take advantage of the legal protections granted to its talc supplier Imerys Talc America Inc. under Chapter 11 bankruptcy, which allowed them to temporarily halt lawsuits it faced. Since J&J has not filed for bankruptcy protection, it cannot demand to halt state-court litigation or the transfer of cases to a federal court. J&J said in court papers, "because the claims raise common questions of fact, law, and science, the current nationwide round of pre-trial information exchanges is duplicative, unpredictable, and wasteful.”

J&J has been facing 14,000 talcum powder lawsuits, each raising a common allegation that asbestos exposure from the company’s talc-based products causes ovarian cancer or mesothelioma. The company continues to vehemently deny carcinogen presence in its talc products.

On Friday, April 19, the Food and Drug Administration (FDA) granted final approval to the first generic version of naloxone hydrochloride nasal spray, also known as Narcan, to treat opioid overdoses.

The newly-approved spray is a Teva Pharmaceuticals product and had received tentative approval by the FDA in June 2018. Generic injectable naloxone products were available in the market for years; however, this was the first time a generic naloxone nasal spray was approved for use in a community where individuals using them to treat overdose, do not require any medical training. The drug can be sprayed into one nostril while the patient is lying on his or her back, and can be repeated if necessary. The agency also plans to take additional measures, to review new generic drug applications for treating opioid overdose, and to come up with a plan of action to help facilitate an over-the-counter naloxone product.

As per reports by the Centers for Disease Control and Prevention (CDC), almost 400,000 people died owing to opioid addiction and overdose between 1999 and 2017.