Novartis Prevails on Summary Judgment on Liability for Generic Products Manufactured by Others
May 12, 2014
The U.S. District Court for the District of Minnesota granted summary judgment in favor of Firm client Novartis Pharmaceuticals Corporation (“Novartis”) on all “generics liability” claims in the pharmaceutical products liability case, Kruszka v. Novartis Pharm. Corp., 28 F. Supp. 3d 920, No. 07-2793, 2014 WL 1878771 (D. Minn. May 12, 2014). The District Court held that Novartis had no liability for the effects of generic versions of the medication that plaintiff received after initially being treated with branded product.
Candice Kruszka alleged that she developed osteonecrosis of the jaw (“ONJ”) as a result of her infusions of Aredia, an FDA-approved medication prescribed to prevent or significantly delay the deep bony pain, pathologic bone fractures, and other bone damage that were complications of Ms. Kruszka’s multiple myeloma. In June of 2000, Ms. Kruszka was immediately placed on Aredia therapy after being diagnosed with multiple myeloma and presenting with severe bony complications, including a compression fracture in her spine and multiple areas of holes in her bones. She was maintained on generic pamidronate therapy until February 2005.
Novartis submitted evidence – including sales records of the sole supplier to the center where Ms. Kruszka received her pamidronate infusions, an affidavit from the center’s pharmacy manager, and a declaration showing that generic products dominated the pamidronate market beginning in 2002 – that Mrs. Kruszka stopped receiving branded Aredia® and started receiving generic pamidronate products no later than January 2002. The court rejected plaintiff’s contrary reliance on references in the medical records to branded product, finding that there was no genuine dispute of material fact regarding whether the plaintiff received generic product after January 2002. The court then ruled that Novartis was not liable for injuries caused by generic product manufactured by others.