Articles Posted in Novartis

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Plaintiff’s only expert on causation in a Zometa jaw injury case was excluded last week when an Alabama court determined that an oral surgeon was unqualified to offer a causation opinion.

If you are not familiar with these cases, Plaintiff’s lawsuit reads like many of these tragic cases. Plaintiff alleges that she developed Avascular osteonecrosis of the jaw because of taking Zometa for post-cancer treatment of bone loss or osteoporosis. That’s the worst, right? You slay the beast that is cancer only to get another awful condition, arguably from the drug that was supposed to help you.

Plaintiff’s lawyers designated her treating oral surgeon as the plaintiff’s only expert on specific causation. Right off the bat, this sounds dangerous. Unless the treating surgeon just has the experience and expertise to speak to this issue, you are risking having an expert that lacks credibility with the jury or, worse, is not permitted to testify. Plaintiff’s lawyer later tried to add more experts after the deadline, but the court shot that effort down.

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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.

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Novartis got successive wins last week in jury trials in Kentucky and Missouri, in the Zometa lawsuits. Plaintiffs in both cases alleged that Zometa caused osteonecrosis of the jaw (ONJ), which is just an awful condition that can lead to chronic pain and disfigurement. It is also difficult to treat.

The battlefield in both of the lawsuits, as is often the case in drug cases, was the adequacy of the warning. Novartis apparently convinced these jurors it had properly warned about the osteonecrosis of the jaw side effect that has come for thousands with intravenous bisphosphonate medications like Zometa and Aredia.