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Appeals court says expert witness should have been admitted in Novartis case


A federal appeals court has reversed the dismissal of a case against Novartis Pharmaceuticals Corp., in connection with a drug that allegedly causes bone deterioration in the jaw, stating the lower court improperly excluded expert testimony in the case.

Linda Messick was diagnosed with breast cancer in August, 2000, according to Friday's ruling by the 9th U.S. Circuit Court of Appeals in San Francisco in Linda Messick v. Novartis Pharmaceuticals Corp.

Between May 2002 and November 2002, she was treated with Zometa, a Food & Drug Administration-approved bisphosphonate drug manufactured by East Hanover, N.J.-based Novartis that is used to treat multiple myeloma, a malignant tumor of the bone marrow, according to the ruling.

In 2005, oral specialists discovered she suffered from osteonecrosis of the jaw, which is the death of bone cells because of decreased blood flow, near three of her teeth.

Ms. Messick and her husband blamed Zometa and filed suit against Novartis for strict products liability, negligent manufacture, negligent failure to warn, and breach of express and implied warranty and loss of consortium.

To support her claims, Ms. Messick offered testimony by Dr. Richard Jackson, an oral surgeon who is a specialist in osteonecrosis of the jaw.

The federal district court in Seattle agreed to Novartis' motion to exclude Dr. Jackson's testimony and then granted Novartis summary judgment dismissing the case. Ms. Messick appealed.

The district court set too high a standard in determining the relevance of Dr. Jackson's testimony, said a three-judge panel, in unanimously reinstating the case.


“The relevancy bar is low, demanding only that the evidence 'logically advances a material aspect of the proposing party's case,'” said the court, in quoting one of its earlier rulings.

“The district court excluded Dr. Jackson's testimony as irrelevant because of its view that his 'differential diagnosis only determines that Ms. Messick's (osteonecrosis) is related to her bisphosphonate use and he admits that a diagnosis of (bisphosphonate-related osteonecrosis of the jaw) does not mean that bisphosphonates caused her (osteonecrosis),'” said the court in quoting the lower court ruling

“The district court applied too high a relevancy bar without reference to California law,” said the appeals court ruling. “While Dr. Jackson never explicitly stated that Mesick's bisphosphonate use caused her (osteonecrosis), he did say it was at least a substantial factor in her development” of the disease.

Because of the inherent uncertain in establishing a connection between a medical cause and effect, said the ruling, “we do not require that an expert be able to identify the sole cause of a medical condition in order for his or her testimony to be reliable. … Dr. Jackson's testimony should be admitted as relevant and reliable,” said the appeals court, in remanding the case for further proceedings.

Earlier this year, a federal appeals court upheld a $225,000 jury verdict against Novartis, in a different case in which it was accused of warning about the dangers of Zometa and another of its drugs, Acedia.