Healthy Skepticism Library item: 17851

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Novartis Sanctioned For Withholding Info From Trial
Pharmalot 2010 May 28
http://www.pharmalot.com/2010/05/novartis-sanctioned-for-withholding-info-from-trial/

Full text:

In an unusual development, Novartis was sanctioned by a federal court judge for denying that it ran direct-to-consumer ads for its Zometa breast-cancer treatment and, then, failing to produce those ads – which were later discovered independenty by lawyers for a woman who claims the medication caused severe jaw damage. The drugmaker, which flip-flopped on the existence of the ads in different motions, was ordered to pay attorneys’ fees.
Here’s the background: Novartis faces hundreds of lawsuits in state and federal courts. Two years ago, Novartis argued that it didn’t run DTC ads, and later did some creative hair splitting by acknowledging that it ran only what it called direct-to-patient ads. Those ads, which Jane Bessmer’s lawyers had found by rummaging through a library, appeared in CURE magazine, which is distributed to cancer patients. Meanwhile, a Novartis employee denied the drugmaker had run any DTC ads in her deposition. Why does this matter?
The issue is important because Novartis had hoped to rely on the learned intermediary defense, which says a drugmaker only had a duty to warn doctors about any risks – through product labeling, for instance. But Bessmer saw a Zometa ad in CURE and so Novartis was now on the hook for what’s known as express warranty – she relied on the ad, in part, for deciding to take the drug. As a result, Novartis may have a hard time using the learned intermediary concept to defend itself when the next case goes to trial in New Jersey this fall (background story).
In his order, US District Court Judge Joe Brown called the distinction between DTC and DTP ads “misleading and outside the ordinary usage of such terms…There is no logical separation between consumers and patients in this context. The target market for these limited-use drugs is cancer patients and cancer patients are the consumers of Novartis products.” Brown also wrote that he was “troubled” Novartis failed to provide a complete list of Zometa ads or obtained such a list from its agencies.
One of Bessmer’s attorneys was, naturally, quite pleased. “For many years, we’ve trying to get this information and the court will now make sure we get it – and at Novartis’s expense,” says John Vecchione. “The question is why wasn’t it produced earlier?”