California Appeals Panel Revives Suits Over Diabetes Drugs

On Tuesday, November 4, a California appeals court revived claims that diabetes drug makers, including Merck & Co., failed to warn consumers about their drugs’ pancreatic cancer risks.

The revival of claims comes after the state appeals panel found that a lower court misinterpreted the U.S. Supreme Court’s ruling in Buckman Co. v. Plaintiffs’ Legal Committee, which bars state law tort claims that are based on alleged violations of the Food, Drug, and Cosmetic Act. The state appeals court also agreed with a Ninth Circuit decision that revived litigation in federal court over similar claims. Those claims proposed that the class of diabetes drugs, incretin-based drugs, also did not have warnings that they increase the risk of pancreatic cancer.

Why the Claims were Revived

The revival of claims comes after the panel found a lower court erred in not considering scientific evidence that the U.S. Food and Drug Administration hadn’t evaluated. As stated by the panel in an unpublished opinion, “the state judge and the California federal judge held joint hearings on the companies’ motions for summary judgment in the state and federal litigation. A week after, U.S. District Judge Anthony J. Battaglia dismissed the claims in the federal litigation while Judge William Highberger dismissed the roughly 300 claims in Los Angeles County Superior Court.”

Both the federal and state court suits were aimed at a class of Type 2 diabetes drugs, known as incretin mimetics. Since 2013, the drugs have been under scrutiny with the belief they may lead to an increased risk of pancreatitis and precancerous changes in the pancreas. Companies including Eli Lilly & Co., AstraZeneca’s now-defunct Amylin Pharmaceuticals unit and Novo Nordisk Inc., admitted that the Buckman ruling doesn’t apply to state law claims that a drugmaker failed to warn about its product’s risk, but argued that it didn’t take into account any evidence that manufacturers are alleged to have misreported or intentionally withheld from the FDA.

The panel, however, rejected their arguments stating that consumers did not allege that the companies played a part in withholding evidence, but rather claimed that if a drug manufacturer had included the new information in an application to change a drug’s labeling, it might have changed the FDA’s viewpoint on the risk of pancreatic cancer. A few of the drug companies undertrial, including Novo Nordisk, AstraZeneca, and Merck had their spokesperson give a comment regarding the revival of claims.

A spokesperson for AstraZeneca stated that the allegations made against them are without merit and all laws were followed while a spokesperson for Novo Nordisk stated how they are disappointed by the California Court of Appeal’s ruling. However, the plaintiffs’/patients’ counsel, Hunter J. Shkolnik of Napoli Shkolnik PLLC, approved of the Ninth Circuit’s reversal of Judge Battaglia’s order, stating “Both the federal court and state court rulings were improper, and now these families will be able to pursue their cases.” The case is Rotondo v. Amylin Pharmaceuticals et al., case number B275314, in the California Court of Appeals for the Second Appellate District, Division Seven.

The panel, however, rejected their arguments stating that consumers did not allege that the companies played a part in withholding evidence, but rather claimed that if a drug manufacturer had included the new information in an application to change a drug’s labeling, it might have changed the FDA’s viewpoint on the risk of pancreatic cancer. A few of the drug companies undertrial, including Novo Nordisk, AstraZeneca, and Merck had their spokesperson give a comment regarding the revival of claims.

A spokesperson for AstraZeneca stated that the allegations made against them are without merit and all laws were followed while a spokesperson for Novo Nordisk stated how they are disappointed by the California Court of Appeal’s ruling. However, the plaintiffs’/patients’ counsel, Hunter J. Shkolnik of Napoli Shkolnik PLLC, approved of the Ninth Circuit’s reversal of Judge Battaglia’s order, stating “Both the federal court and state court rulings were improper, and now these families will be able to pursue their cases.” The case is Rotondo v. Amylin Pharmaceuticals et al., case number B275314, in the California Court of Appeals for the Second Appellate District, Division Seven.

The panel, however, rejected their arguments stating that consumers did not allege that the companies played a part in withholding evidence, but rather claimed that if a drug manufacturer had included the new information in an application to change a drug’s labeling, it might have changed the FDA’s viewpoint on the risk of pancreatic cancer. A few of the drug companies under trial, including Novo Nordisk, AstraZeneca, and Merck had their spokesperson give a comment regarding the revival of claims.

A spokesperson for AstraZeneca stated that the allegations made against them are without merit and all laws were followed while a spokesperson for Novo Nordisk stated how they are disappointed by the California Court of Appeal’s ruling. However, the plaintiffs’/patients’ counsel, Hunter J. Shkolnik of Napoli Shkolnik PLLC, approved of the Ninth Circuit’s reversal of Judge Battaglia’s order, stating “Both the federal court and state court rulings were improper, and now these families will be able to pursue their cases.”

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