A Maryland federal judge last week put some tough limitations on plaintiffs’ expert in the Aredia/Zometa jaw injury case that was remanded back to Maryland from the MDL.
In Zimmerman v. Novartis Pharmaceuticals, plaintiffs brought a wrongful death lawsuit in the MDL. Plaintiff asserted strict liability and negligence claims against Novartis. Plaintiff was prescribed Aredia and Zometa, two bisphosphonate drugs that are administered intravenously to treat cancer patients for hypercalcemia, a potentially fatal elevation of calcium in the blood. Plaintiff developed osteonecrosis of the jaw which caused her death.
The case sat for years in the MDL in Tennessee but has since been remanded to Maryland to be tried before Judge Roger W. Titus. Novartis sought to exclude the testimony of a key plaintiff’s expert. The expert, a doctor, is a key witness for the plaintiff because she was, at one time, a medical officer with the FDA in the Office of Health Affairs. Defendants use the tacit backing of the FDA at every trial – WE WERE FDA APPROVED! – is a common theme banged over the heads of the juries. So having a doctor who worked for the FDA sometimes helps plaintiffs considerably.
Judge Titus will allow the expert to testify on the warnings issue, whether there is “reasonable evidence of an association of a serious hazard with a drug” as used in 21 C.F.R. § 201.57, but said that the expert may not offer an opinion on medical or causal causation, ghostwriting and undisclosed company funding of medical journals articles, industry standards and whether Novartis violated them, personal opinions or insinuation about the state of mind, motivation or intent of Novartis staff, and four other parts of her expert report.
This is a tough blow for plaintiffs but not entirely unexpected. There have been similar rulings in other jurisdictions on this expert.