Weekly Mass Torts Bulletin 2021-Apr-19

U.S. Budget To Include $132B To Fight COVID & Opioid Crisis

On Friday President Biden's administration released a plan, which called for a nearly 25 percent increase in discretionary funding to fight against the COVID-19 pandemic and the opioid crisis in the U.S.

The administration released a $131.7 billion budget request for the fiscal year 2022 for the U.S. Department of Health and Human Services (HHS), which is the center of the federal government’s pandemic response. The plan proposes $905 million for HHS to provide the strategic national stockpile of medical supplies and for restructuring efforts that began amid the pandemic. 

The plan includes a request for a $10.7 billion investment for the opioid crisis, which is considered historic and is $4 billion more than the 2021 enacted level. The money will be directed to states and Native American tribes and towards federal research for opioid addiction and treatment.

Opioids are on the market for ages and have been used basically for pain relief for post-surgical pain, cancer-related pain, chronic or persistent pain. Opioids when used in proper dosage and along with a combination of other pain treatments, work in relieving pain successfully, unless there is a misuse or abuse of the drug.

The manufacturers are alleged of convincing the medical community that the medications were not addictive and were purely beneficial. This belief led to a rise in the number of prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an opioid crisis.

In February, the U.S. Centers for Disease Control and Prevention’s (CDC) released a Morbidity and Mortality Weekly Report (MMWR), which indicated that the rate of deaths from 2013 to 2019 related to fentanyl, and other synthetic versions of the addictive opioid pain killers increased by 1,040%. The report shows that opioid dependence is worsening in the nation.

The budget plan request is $25 billion more as compared to the fiscal year 2021 with an $8.7 billion investment in CDC. It is the highest budget increase in the last 20 years for the agency and the money will also be directed towards cancer research and other public health crises along with the pandemic.

Additionally, $6.5 billion will be directed towards the Advanced Research Projects Agency, a new federal body that would focus on research on cancer and other chronic diseases like diabetes and Alzheimers. This proposal is a part of a $51 billion request for the National Institutes of Health.

Roundup MDL Will Include National Black Farmers' Lawsuit

On April 1, an order was filed by the U.S. Judicial Panel on Multidistrict Litigation (JPML) in which the panel rejected the Bayer AG unit's motion over reconsideration of a decision to transfer a Roundup lawsuit brought by the National Black Farmers Association (NBFA) in the California multidistrict litigation docket (MDL).

According to the order, the panel rejected the company's effort stating that the lawsuit involves many of the same issues of causation, background science, and regulatory history similar to the claims already pending in the national coordinated docket.

The lawsuit was filed by the association in August 2020 in the Missouri federal court, alleging that the company's aggressive business practices forced the members of the association to use the controversial weedkiller. The association is trying to have the manufacturer stop the sales of Roundup, which contains glyphosate and is linked to causing cancer and other ailments.

A motion was granted in February by the panel, allowing the consolidation of the lawsuit in the MDL, which is formed in the Northern District of California under MDL No. 2741 and is presided by U.S. District Judge Vince Chhabria.

The manufacturer opposed the consolidation and requested JPML to reconsider the decision, asserting that the lawsuit is not limited to non-Hodgkin's lymphoma (NHL) or other hematopoietic cancers, and hence should not be a part of the ongoing docket.

Additionally, the company also argued that the lawsuit would not fit easily within the current pretrial structure and should be placed on its own litigation track.

However, the panel in its recent decision noted that all the arguments were previously considered during the initial decision and further added that the judge has the discretion to use separate tracks or other pretrial management techniques within the MDL as an appropriate measure to address the lawsuit.

A Lawsuit Over 3T Heater-Cooler System Revived

Last Friday, a three-judge panel from the Third Circuit restored a lawsuit filed by a Louisiana man who alleged LivaNova’s 3T Heater-Cooler System for contracting bacterial infections during open-heart surgery.

The federal appellate panel reinstated the previously dismissed lawsuit by the Pennsylvania federal court ruling that it should not be dismissed on the basis that the plaintiff did not respond timely to a multidistrict litigation (MDL) court’s Lone Pine order.

In 2017, the plaintiff underwent heart surgery in Louisiana using a 3T device, following which he was infected and the doctors believed that it was an NTM infection. Patients who had a similar surgery using the device in the same hospital were reported to have caught the infection.

The lawsuit filed against LivaNova Holding USA Inc., earlier known as Sorin Group USA, was dismissed last year by the lower court stating that the plaintiff had no proof that he suffered from nontuberculous mycobacterium (NTM) infection, which is required as part of a case management order in the MDL.

According to the April 9 precedential opinion, the appellate panel said that the claims might be viable under the Louisiana Products Liability Act. and hence the MDL court should have allowed the transferor court to hear the case.

The panel termed the dismissal an abuse of discretion and further added that the lower court deprived the plaintiff of the opportunity to litigate his suit in any venue without consideration of how it might fare outside the MDL context.

The opinion also noted that the plaintiff might be able to make a case in Louisiana, where the lawsuit was filed initially, and the panel asked the lower court to suggest to the Judicial Panel on Multidistrict Litigation (JPML) to send the case to Eastern Louisiana federal court.

Federal Judge Drops Argon Medical From An IVC Filter Case

On Monday, an order was filed in which U.S. District Judge Gershwin A. Drain released Argon Medical Devices Inc. from an inferior vena cava (IVC) filter lawsuit filed by a woman who allegedly suffered from injuries following implantation.

According to the April 12 order, the Michigan federal judge ruled that plaintiff failed to plausibly allege that the seller failed to exercise reasonable care and breached an express warranty as to the device. Two of the four claims made against Rex Medical Inc., another defendant in the lawsuit, were also dismissed and the company will now only face negligence and breach of implied warranty claims.

In 2014, the plaintiff underwent surgery for the Option filter, which is manufactured by Rex and marketed by Argon. In 2017, the woman underwent another surgery to retrieve the filter. The filter was found broken and a fractured strut on the implant had moved and injured her.

The woman filed a lawsuit against both the companies alleging negligence, breach of implied and express warranty, and negligent misrepresentation.

In the recent opinion, Judge Drain noted that Argon is a non-manufacturer seller and so carries different standards for claims as compared to the manufacturer, which requires the plaintiff to allege that the company breached a duty to care. The judge further added that plaintiff's complaint is devoid of facts as to when, how, and by whom the express warranty was made, which she alleged as breached.

The plaintiff's claims against Rex survived as the judge found enough specific facts for the claims to withstand complete dismissal. However, the negligent misrepresentation claims against Rex were dropped as the judge believed that the plaintiff failed to specify what misrepresentations the company made to her in its advertising.

JPML Asked To Centralize Belviq Cancer Lawsuits

On Monday, a petition was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting consolidation of Belviq cancer claims filed by the former users of the weight loss drug.

According to the April 12 petition, the plaintiff stated that currently there are at least 13 Belviq cancer lawsuits pending in 12 different U.S. District Courts nationwide. The petition also noted that the number of cases filed across the country is likely to grow in the coming months.

Lorcaserin, marketed under the brand name Belviq, is a prescription weight loss drug developed to treat obesity. The diet drug was developed by Arena Pharmaceuticals, and the rights were sold to the Japanese drugmaker, Eisai Inc., in 2017.

In February, Eisai Inc. voluntarily announced a Belviq recall after receiving safety communication from the Food and Drug Administration (FDA). The recall was based on a clinical study that showed an increase in the occurrence of certain cancers among Belviq users.

The former users of the drug are filing complaints to seek reimbursements for the premium price paid for the recalled diet drug, as well as funding for medical monitoring that they would require to detect cancer that might surface months or even years after last exposure.

A group of plaintiffs joined together and filed the motion to transfer for the centralization of all the nationwide pending cases in the Eastern District of Louisiana for discovery and pretrial proceedings.

The plaintiffs have noted that the consolidation of all the lawsuits would help avoid duplicative discovery, prevent contradictory rulings from different judges, and serve the convenience of the parties, witnesses, and the courts.

A hearing will be scheduled this summer to hear oral arguments on the motion, including any response filed by the drugmaker to determine whether centralization is feasible at this early stage of the litigation and to find the most appropriate forum for the pretrial proceedings.