AstraZeneca, Seroquel And Product Liability
11 CommentsBy Ed Silverman // April 28th, 2010 // 7:39 am
After agreeing to pay $520 million to settle civil charges for off-label marketing of its Seroquel antipsychotic, the drugmaker still faces an estimated 26,000 product liability lawsuits brought by individuals who claim that the risk of developing diabetes was hidden from patients and physicians.
But despite the deal - which includes a corporate integrity agreement but no criminal charges - it would seem unlikely, for now, that AstraZeneca will be motivated to reach a settlement with these plaintiffs. Why? The drugmaker has so far succeeded in fending off the initial rush of challenges, partly by arguing plaintiffs already suffer from health problems that can cause diabetes.
Earlier this month, a federal appeals court upheld a lower court ruling dismissing the first product liability lawsuit alleging Seroquel caused a patient’s diabetes. A three-judge federal panel ruled that the a federal court in Florida correctly dismissed a case brought by a woman because her doctor didn’t qualify as an expert under federal court rules (see here). And last month, a New Jersey state court jury decided against 61-year-old Vietnam War vet.
To cry uncle, “they would probably have to lose a few” lawsuits, says Stephen Sheller, an attorney who represented whistleblower James Wetta, a former AstraZeneca sales rep who will receive $45 million for exposing the drugmaker’s alleged fraud. (Wetta, by the way, was also a sales rep for Lilly and brought a separate suit that eventually resulted in a $1.4 billion fine). So before AstraZeneca forks over any money to plaintiffs, a smoking gun or some compelling testimony (perhaps from this fellow) may be required.
MsPiggy
http://online.wsj.com/article/BT-CO-20100427-719862.html?mod=WSJ_World_MIDDLEHeadlinesEurope
A former AstraZeneca PLC (AZN, AZN.LN) sales representative who helped the government to investigate allegations of illegal marketing practices at the drug maker is no stranger to blowing the whistle.
James Wetta’s 2004 whistleblower lawsuit against AstraZeneca triggered a U.S. probe of whether the U.K.-based company marketed the antipsychotic Seroquel for unapproved uses, the Justice Department said Tuesday. AstraZeneca and Justice officials confirmed Tuesday that the company has formally agreed to pay $520 million to settle the probe, though Astra denies the allegations.
Before he worked for AstraZeneca, Wetta, a resident of California, was a sales rep for Eli Lilly
Justice in MI
So, really, it comes down to this:
We know that AZ, like Lilly, Pfizer, et. al., promoted their product in ways that had the effect of killing or injuring X number of people.
It’s just difficult for any one of those people (or their survivors) to prove that they were one of the casualties.
Batman
Seems as though Astra Zeneca got what what they deserved.
SingSing
Death row?
Former SP
Unfortunately, the penalty is not harsh enough. It does not fit the “crime.” There is no accountability for the actions of the executives and the management team that allowed the off-lable promotion to take place just to push more drug use for more money in their pockets. Until the decision-makers are held responsible, face personal fines, face criminal charges and fines, these pharma practices will continue unabated. let’s see, I can make $10 billion, but I have to pat $520 million in fines and admit no wrongdoing. My net profit is $9.5 billion and this is good business. Nevermind that thousadns of people were harmed by my actions, I’m rich! besides, the sahareholders pay the fine and I laugh all the way to the bank. Educated crooks lead to a corrupt industry. Wall Street is a perfect example!
patrons99
An Alliance for Human Research Protection article titled “How to Stop Epidemic Antipsychotic Drug Prescribing”, on April 28, 2010, may be of general interest.
http://www.ahrp.org/cms/content/view/695/9/
AHRP Proposal:
Any FDA-approved drug, whose manufacturer has been found by a court of law or the Department of Justice–to have illegally marketed the drug by concealing risks or incidence of adverse effects, or making unsupported claims of clinical benefit–should be denied coverage by taxpayer funded insurance programs–including Medicaid, Medicare, VeteranstAffairs.
Justice in MI
Yeah, we’e batted this one around many times. I still believe it is not justice to punish innocent people in these programs–who rely on XYZ drug–in the name of justice.
There are other, better, more ethical ways.
patrons99
JiM -
“I still believe that it is not justice to punish innocent people in these programs…”
“other, better, more ethical ways”.
Well, yes, I’ve heard you make that argument before. However, I’m not so sure that the AHRP proposal does not have merit.
Isn’t there an equal protection argument in favor of denying coverage?
Alma, in another thread states,
“Horrifying to think that after all foster kids and “poor” kids go through, they should be exterminated by big business. The dollar has soylent green all over it.”
Evelyn, in another thread states,
“The doctor who prescribed the drugs to Gabriel Meyers, the Florida 7-year-old who hung himself about a year ago, received a warning letter from the FDA in February 2010 about violations in clinical trials.”
Were not Gabriel Meyers right to equal protection of law trampled on? Was he not “innocent” too?
patrons99
JiM - I know that we’ve covered this topic pretty thoroughly in various comments to posts of Ed’s. Yet, it’s an important topic covering an area that needs legislative reform, if not more aggressive investigation and enforcement of existing laws by state and federal regulators.
It occurs to me (a non-lawyer) that, generally speaking, there have been many violations of the False Claims Act and annual SoX (Sarbanes-Oxley) compliance statements, by pharma, which defrauds Medicare/Medicaid/Tricare, FDA, physicians, and patients. Perhaps product-liability class-actions would be more effective? Disgorgement of ill-gotten financial gains has been suggested in another thread.
One thing seems clear. Corporate Integrity Agreements and fines will not correct this problem. They’re not working. The crime spree hasn’t even slowed down.
Mike Wokasch
I just don’t understand why virtually everybody who looks at this can do the math and realize there is no deterrent in the fines and settlements being imposed and every incentive to continue to market pharmaceuticals to take advantage of much larger off-label market opportunities.
Worse than the skirting of the FDA approval process is the fact that patients unknowingly become experiments with the real potential for getting ineffective treatments and being unnecessarily exposed to potentially fatal adverse effects. As long as revenues and profits are more important than patient safety and regulations have no impact on deterring illegal activities, unfortunately these activities will continue.
http://www.pharmareform.com
J. latulippe
4 yrs ago my mental health nurse put me on Seraqual, (I NEVER EVEN SAW A SIDE AFFECT LIST FOR IT)It was G I V E N to mental health,who then put paitents like myself on it,as an anti-pchycotic,……Four 1/2 months after starting me on it , she called me in to say theres SOME bad side affects to this drug, n she was telling me NOW , because then I couldnt sue her,???????????????????Not only do I have diabetis/but gained 85 pds in 8 months while on it/ I quit taking it against nurses advise BECAUSE , with-in a 1/2 hr after taking my seraqual, I was getting BADDD CHEST PAIN , I had 2 EKG’S done while on this medication…BEWARE ITS DANGERIOUS TO UR HEALTH……