AstraZeneca Rep Is Sued By Nexium Patients

AstraZeneca Rep Is Sued By Nexium Patients

September 26th, 2011 // 12:04 pm @ jmpickett

In the pharmaceutical world, product-liability lawsuits are an everyday affair. Generally, a patient claims that a medicine caused them harm and a lawsuit accuses a drugmaker of failing to adequately warn of certain risks. Rarely, though, are individual sales reps also named as defendants.

Now, though, two people have filed a lawsuit in a Texas state court and they are pinning blame not only on AstraZeneca for bone deterioration and bone fractures allegedly attributed to the Nexium acid reflux pill, but they are also singling out a district sales manager and “executive” sales rep for improperly promoting the med to consumers and healthcare providers.

The specifics of the case appear rather straightforward: Mary Mai Nguyen and Tuoc Duong, both of Houston, claim AstraZeneca failed to properly disclose study results dating back to 2006 that showed bone fractures may occur. Meanwhile, FDA alerts were issued last year and labeling subsequently upgraded (see this).

Meanwihle, Nguyen and Duong both were prescribed Nexium, although the lawsuit fails to offer specifics. But they charge that Ghadeer Rafeedie, the sales rep, was complicit because he failed to “properly educate healthcare providers” about adverse events. He also allegedly failed to provide the appropriate “safety profile,” despite knowing the risks patients might face.

We asked a couple of product-liability attorneys, who regularly square off against drugmakers, whether reps are often named as defendants. Both replied that it is highly unusual. “Almost never,” says Stephen Sheller, a Philadelphia attorney who has filed such lawsuits over side-effect issues involving numerous medicines.

So why name a rep? Perhaps, the rep was engaged in particularly egregious conduct that would extend beyond the sort of liabilities usually attributed to the drugmaker. The lawsuit, however, does not specify anything of this sort. Or perhaps, in this case, the attorney for Nguyen and Duong named the rep, who is based in Houston, as a way to keep the lawsuit situated in state court. Generally, plaintiffs find these venues friendlier than federal courts (read the lawsuit here).

We asked Tammy Tran, the lawyer for the two plaintiffs, about her reasoning, but she declined to comment. [UPDATE: An Astra Zeneca writes us to say the drugmaker is “committed to supporting its employees and remains confident in the risk-benefit profile of Nexium. AstraZeneca believes that the available data does not demonstrate a cause and effect relationship between the use of PPIs and an increased risk of bone fracture and intends to vigorously defend this case.”]

Whether this trend catches on is unclear. If there were sufficient merit to this tactic, most likely other attorneys would have pursued more reps by now. Nonetheless, this may prove to be one more issue for the legal, marketing and sales teams to cautiously watch.

Source: Pharmalot