Weekly Mass Torts Bulletin 2024-May-13

NJ Pharma Settles: Cash, Narcan for Delaware

Amneal Pharmaceuticals, a New Jersey-based drug manufacturer, has reached a settlement agreement with Delaware and other states over its involvement in the opioid crisis, as announced by the Delaware Department of Justice.

The settlement, exceeding $270 million, stems from allegations that Amneal, a producer of nearly 9 billion generic opioid pills from 2006 to 2019, negligently failed to monitor and report suspicious orders by its customers, leading to the overprescription of opioids.

This agreement comes amid a surge in overdoses in Kent and Sussex counties, prompting state police to issue multiple safety advisories following 125 suspected overdoses reported in a single week. Analysis by the Delaware National Guard revealed that many of the drugs involved contained both xylazine, a veterinary sedative also known as "tranq," and the synthetic opioid fentanyl.

As part of the settlement, Amneal will provide $92.5 million in cash to the participating states over the next decade. Delaware's share will be directed to the Prescription Opioid Settlement Distribution Fund, which supports organizations dedicated to addressing addiction.

The remaining settlement funds will be allocated to states in the form of naloxone nasal spray, commonly known as Narcan. Amneal's generic version of Narcan received FDA approval for over-the-counter sales on April 24, according to the company.

Although Amneal did not issue a formal statement regarding the settlement, the company's co-chief executive officers expressed pride in assisting with the public health emergency in a press release coinciding with the launch of their generic Narcan.

Delaware's Attorney General emphasized the state's commitment to holding pharmaceutical companies accountable for their role in the opioid crisis, stating, "While no amount of money can undo the harm that has been done, we will continue to stand for it no more."

3 Roundup Suits Cleared for Massachusetts Remand

The U.S. District Judge overseeing coordinated pretrial proceedings for Roundup non-Hodgkin’s lymphoma lawsuits across the federal court system has denied a motion to dismiss three cases originally filed in the District of Massachusetts.

This decision paves the way for the cases to proceed to trial in about two weeks if settlements are not reached. Bayer and its Monsanto subsidiary have grappled with over 167,000 lawsuits nationwide, alleging inadequate warnings about the cancer risk associated with Roundup. The litigation surged in 2015 after the World Health Organization's International Agency for Research on Cancer labeled glyphosate in Roundup a probable carcinogen. Despite paying over $10 billion in settlements, Bayer and Monsanto face ongoing jury trials and new claims.

The judge's pretrial order rebuffed Monsanto's attempt to exclude plaintiffs' expert witnesses' testimony in the Massachusetts lawsuits. This move was pivotal, as it could have left the cases without evidence linking Roundup's exposure to the plaintiffs' illnesses, potentially leading to dismissal. However, the judge deemed Monsanto's arguments against the expert witnesses scientifically unfounded.

The ruling impacts lawsuits filed in June 2019 and January 2020. The first plaintiff developed B-cell type non-Hodgkin’s lymphoma after Roundup use, while the second was diagnosed with positive B-cell lymphoma consistent with chronic lymphocytic leukemia. The third plaintiff was diagnosed with mantle cell lymphoma, all allegedly due to Roundup exposure.

Each plaintiff plans to rely on expert medical testimony to establish the causal link between Roundup and lymphoma. With the motion to exclude testimony denied, the judge plans to issue a suggestion of remand for the cases to return to the District of Massachusetts if settlements are not reached.

Hundreds of Roundup claims are consolidated before a federal judge in California, with many primed for remand to different federal district courts. Additionally, numerous cases are pending in state courts nationwide, including Missouri, Pennsylvania, New Jersey, and California, where non-Hodgkin’s lymphoma lawsuits are slated for trial in the near future.

In summary, the denial of Monsanto's motion to dismiss signals the progression of Roundup litigation, with affected plaintiffs poised to pursue their claims in court if settlements are not achieved.

J&J to Settle $6.5B Talc Cancer Suits

Johnson & Johnson (J&J) subsidiary proposes $6.5B talc ovarian cancer lawsuit settlement.

J&J subsidiary plans to pay $6.475B over 25 years to resolve most pending lawsuits alleging its talc-based baby powder caused ovarian cancer. The settlement aims to resolve 99.75% of the pending lawsuits against J&J and its affiliates.

J&J announced its decision to stop selling talc-based baby powder in 2023 amid ongoing legal battles over the product. J&J's worldwide VP of litigation described the plan as the culmination of their consensual resolution strategy announced in October. The company has worked with counsel representing the majority of talc claimants to bring the litigation to a close.

The reorganization plan for J&J, revealed Wednesday, differs slightly from previous proposals by its subsidiary, LLT Management. Under the new strategy, claimants have a three-month solicitation period to vote on the proposal. If 75% of ovarian cancer claimants approve, the subsidiary may file for a consensual "prepackaged" Chapter 11 bankruptcy for confirmation.

According to J&J, this approach prioritizes the vote of claimants over the conflicting financial incentives of a small minority of plaintiff lawyers who stand to gain excessive legal fees outside of a reorganization. J&J clarified that remaining personal injury lawsuits related to mesothelioma will be addressed separately from the new proposal. The company reaffirmed its support for its talc-based products.

J&J's VP of litigation emphasized the impact of talc claims on U.S. businesses, citing meritless litigation, extreme judgments, forum shopping, distortion of scientific literature, and unregulated financing by financial institutions.

Overall, the proposed settlement represents a significant step towards resolving the talc ovarian cancer lawsuits against J&J, aligning with the company's efforts to address legal challenges and uphold its commitment to consumer safety.