As reported in Law360, Morrison Mahoney partners Arthur Liederman and Nicole Battisti recently secured a win for their client, Zydus Pharmaceuticals, in a duty-to-warn case.

Zydus had been sued by 209 people who alleged that they or their loved ones were harmed by the marketing of a generic heart medication, amiodarone, but a New Jersey district court dismissed the case with prejudice.

The court rejected the plaintiffs’ claim that it was the company’s duty to warn prescribing physicians about the drug’s potential dangers relying on the learned intermediary doctrine. Jankowski v. Zydus Pharmaceuticals, 3:20-cv-02458 (D.N.J. May 28, 2021.

Among the plaintiffs’ claims in this third version of the lawsuit (which had previously been dismissed without prejudice) were that generic manufacturers of the drug promoted off label use of the product. In addition, the plaintiffs argued that the company should be liable because the physicians never saw the warning label on the prescription bottle received by patients. Previously the plaintiffs had argued that they had failed to receive a medication guide at the point of sale from the dispenser. The court had rejected the argument that the federal regulations made the manufacturer the insurer of the dispenser’s acts or omission.

The court ruled that in this third iteration of the complaint and motion to dismiss the court need only address whether Zydus failed to provide physicians with a U.S. Food and Drug Administration warning about amiodarone—which, in these cases, had been prescribed provided in the package insert. The court rejected the additional argument that the company was obligated to correct allegedly misleading statements found in certain online third party databases.

As Law360 notes, the judge wrote in his ruling that “New Jersey state law says a drug maker cannot be held accountable for failing to warn if it provided doctors information about a drug and did not market it directly to patients.”

Arthur and Nicole have represented Zydus in a series of lawsuits across the United States involving the same drug and similar issues as in this case. This included actions in Texas, California, South Carolina, Louisiana and New York. Along with various dismissals they obtained a 4th and 2nd Circuit affirmance of lower court dismissals.


This decision was also covered in Harris Martin. Read more here [subscription]: Learned Intermediary Doctrine Defeats Multi-Plaintiff N.J. Amiodarone Lawsuit”