AstraZeneca Rep Is Sued By Nexium Patients
14 CommentsBy Ed Silverman // September 23rd, 2011 // 11:12 am
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.
Observer
To misquote the Bard:
“First hand all the reps!”
Observer
To more accurately misquote the Bard:
“First hang all the reps!”
Basel lair
I have news for many of you: very often the sales reps don’t know they are doing anything illegal or unethical in promotion of their drugs. How is that possible? Simple. Those who design promotional strategies, tactics and literature have become artists in blending the legal and illegal in such a way that only few can tell the difference between legal and illegal or ethical and unethical. This all under the guidence and approval by the management at all levels, for use of illegal and unethical practices is demanded by the management in order to enhance the returns beyond what using ONLY legal and ethical would bring in.The “smart” sales reps and other employees of these big pharma entities who can see this difference and collect the evidence have gone to DOJ and acted under the False Claim Act to bring some of them down. Look at Taxpayers agains fraud and you’ll see what has gone almost for ever within bigpharma in USA. In other countries we are not so lucky to have this powerful type of law so the bigpharma does all kinds of misconduct with complete impunity. Luckily things are changing and some other countries are waking up and acting against this serious internationally spread crime against the ill and healthy everywhere.
Justice in MI
Interesting case. Since reps are barred from promoting off-label uses, could it not be argued that they are also barred from discussing unlabled risks, even if there was evidence that they knew about them?
I’m not talk about ethics here, but about the law–often out of synch with each other.
Justice in MI
The converse occurs to me.
If the conservative think tankers and their sponsors have their way, and off-label promotion becomes essentially unregulated, would it not follow that failure to dislose unlabeled risks, for which there was at least as much data as unlabeled benefits, should open companies and their sales force to liability?
original industry insider
Don’t waste your time suing the reps. They are indemnified against these claims just as a CRA would be indemnified in the event that a clinical trial subject unexpectedly died in one of their studies, even though 1) the trial was for an as yet “unapproved” indication, which the CRA “promoted” by placing the study, and 2) even if death was not specified as an AE in the informed consent.
Chris
The reps wont get sued. I was a Pharma rep for 10 years and if the company did not provide info in the package insert on the side effect than the reps are safe.
Blaze
Happened to me over 150 times. In TEXAS… all in attempts to get the lawsuits kept in State Court rather than Federal court..
I have a box that is a foot and a half tall full of those lawsuits where they named the reps, too!
Ask the Redux reps… I know a bunch that were named… seems to be a Texas and Florida phenomenon. Cost the company a load of cash to get me taken off the cases as “illegally joining”. The whole point was that since I was an employee in the state of Texas I was responsible for my own tort. At least that was their argument to keep it in State Court, where they hunt and fish with the judges.
company insider
Basel Fair, you are correct for the most part. HOwever, reps don’t pay much attention tot he ruels becasue their management don’t think following the rules is important. THey fire you for not making your numbers and do nothing to most reps for breaking the rules especially as trained by their manager. Most of them now are marketing majors with no biology and probably could not critique a journal article if they had to. THe managers just make up the spin and then everyone spins the data. THey called it spinning the data at Pfizer to get the outcome they wanted and that is all that mattered. Their marketing was an incredilbe farce as effidenced by all their guilty pleas to the Justice department. Nice they REgional directors just laugh about all those guilty pleas and fire anyone who mentions a problem through harassment. If you work for a company like that don’t report internal, go straight to experienced false Claims act lawyers.
Becker's ASC
http://www.beckersasc.com/stark-act-and-fraud-abuse-issues/arkansas-to-bring-astrazeneca-to-trial-in-2012-for-alleged-off-label-marketing.html
Ex rep
I worked in pharma a long time. I worked for 3 different co’s over 28 years. AZ by far the worst. They only cared about the scripts and if you did not deliver the mgr had a long talk with you and said “What they hell is going On”? they would compare your results with the other reps in the dist. or region. It’s not about the pt. but about greedy profits. Then if you got caught doing anything even close to wrong they would fire you. A knife that cuts both ways. They do make some good products, but if you don’t deliver the goods you are forced out and the Pts. will suffer. Glad to be out this hell hole!
Justice in MI
Note that in Ed’s story, the people in question are a “district sales manager and “executive” sales rep.” I’m not sure what the latter means, but I assume they are not the average reps, but more like the folks Ex Rep describes above.
Former rep
An executive sales rep is just a promotion to put on your card, usually requires two years with the company. It has perks like getting your own room at a sales meeting. There are also Senior Executive sales reps and sometimes there might be a level I or level II. This means nothing. This is a field based sales person. Hospital reps and Specialty sales reps are a step up and even then, there is nothing special, just more experience and training. Titles and business cards can be deceiving. The newest rep business card might say “Territory Manager” on it. It’s a crazy business trying to keep sales reps happy with their titles while not giving them much in the way of a promotion.
Accountability
So, on the basis of this claim, can one sue a physician - who does not see reps and thus does not get detailed on a drug profile - for failure to know about and share all known and potential side effects with patients? Interesting precedent. If a rep can be sued for failure to share information in a 15 second over-the-counter detail where a physician asks “where do I sign?” then we have a BIG problem on our hands. The real problem here is sales goals attached to pharma reps. Instead of being paid a decent wage to ensure public safety, reps are given sales goals, and a canned marketing message, and trained to share product strengths vs. weaknesses; the weaknesses are shared in a “blurb” at the end of a detail. The only solution is to make the job of a rep truly consultative, non-sales, and if a medicine is good, and a company develops needed therapies, sales will be an organic result.