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Articles Posted in Pfizer

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Five plaintiffs last week sought an MDL for federal lawsuits against Pfizer’s Lipitor.  The allegations are the same in all cases: the cholesterol drug caused them to develop diabetes.

The gist of plaintiffs claims is that the drug increased serum glucose levels causing diabetes.  Pfizer never properly let patients or doctors know of this risk so they could make a different choice, or perhaps avoid this class of drugs altogether. Accordingly, the suits allege that Lipitor is defective and unreasonably dangerous and was sold with a warning that did not properly alert patients and doctors of the risk.

Not for nothing, Pfizer has been making money hand over fist with Pfizer.  If you have help Pfizer stock in the last few years, you have gotten pretty rich in no small part due to Lipitor.

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Almost all prescription drugs carry the potential for side effects.  Some of these are minor, others significant.  Recent data suggests that Lipitor, the popular cholesterol drug, is strongly correlated with increased rates of Type 2 diabetes.

Lipitor (atorvastatin calcium), made by Pfizer, is a statin.  Statins reduce cholesterol by blocking specific liver enzymes.  By blocking these cholesterol-producing enzymes, the body begins to use cholesterol already in the blood.  This process lowers overall cholesterol levels and the risk of heart disease and heart attacks.

One problematic and newly discovered side effect of Lipitor is the increased potential for developing Type 2 diabetes.  Just last year the FDA mandated a change to Lipitor’s warning label.  The new label specifically tells users of the threat of diabetes.  Other statins, like Zocor and Crestor, were also required to make similar label changes.

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Pfizer and Endo Pharmaceuticals settled with the State of Texas to pay $50 million to settle a lawsuit accusing these drug companies of falsifying drug prices to bleed Texas’ Medicaid program.

As often happens, the case stemmed from a whistleblower lawsuit, this one by Ven-A-Care, who has a history of filing these claims against pharmaceutical companies.

Ven-A-Care is basically four guys who have become professional witness blowers that have made hundreds of millions of dollars for their companies. These guys lie low: they don’t talk to the media and have not spoken publicly since 2004.

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Pfizer’s lawyers took their best shot at winning these cases with the only strategy that will work: keep the cases away from a jury that will weigh the evidence.

This strategy took a hit on Tuesday when the MDL judge overseeing the 2,500 Chantix lawsuits in federal court shot down Pfizer’s motion to exclude the general causation and liability opinions of five plaintiff experts.

Judge Inge Prytz Johnson ruled that while Pfizer has interesting arguments, they are jury arguments not “the expert should be excluded” arguments. I’m not sure a jury will be too impressed with hypertechnical attacks on these experts’ methodology as long as they swallow the big picture: these drugs put users at risk for homicidal and suicidal behavior that they would not have committed if there were not on the drugs. It is that simple.

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Zoloft can allegedly cause serious birth defects to developing fetuses when ingested during pregnancy. These defects include pulmonary atresia,  deformed limbs, patent ductus arteriosus, ventricular and septal defects, hypoplastic heart syndrome, aortic and ventricular outflow tract obstruction defects, craniosynostosis, omphalocele, gastroschisis, spina bifida, and cleft palate. The lawsuits filed throughout the country allege that Pfizer failed to adequately warn patients and healthcare professionals of these risks. Pfizer denies the association.

Lawsuits alleging birth defects caused by the antidepressant Zoloft/sertraline were consolidated on Tuesday before Judge Cynthia M. Rufe in the U.S. District Court for the Eastern District of Pennsylvania. About 92 federal lawsuits – and counting – will be included in this MDL.

What does this mean for Zoloft birth injury plaintiffs? The cases are technically not a class action, but the cases are merged together for discovery on issues common to all the Zoloft birth defect lawsuits. The upside for individual Zoloft birth defect lawyers is the efficiency of pulling together resources to really discover what Pfizer knew about the harmful effects their drugs had on unborn children whose moms were on Zoloft.

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You and Dawson, you both live in the same dreamworld! It doesn’t matter what I believe. It only matters what I can prove! So don’t tell me what I know, or don’t know! I know the LAW!

Lt. Daniel Kaffee, that crazy kid, was on to something here. You can apply Kaffee’s logic to Chantix. Chantix is always on the FDA adverse event reports leaderboard, both in terms of breadth and quantity. Where there is smoke, there is usually fire. Not always. But usually.

There is certainly enough of a connection between the smoke in Chantix suicide cases. If someone takes Chantix and kills themselves, it will not be difficult to explain to a jury the relationship. It is not a leap to say that if someone has been going through life without killing themselves (obviously), takes Chantix, and then kills themselves, it will be more likely than not that Chantix was a contributing cause. Not definitively connected beyond all reasonable doubt – suicide is too complex of an event for that – but certainly more likely than not to be a contributor.

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MassTortDefense Blog posted about the U.S. Supreme Court decision to not hear a punitive damages case, Wyeth v. Scroggin.

In the first trial, bifurcated on liability and damages, the jury held the drug company responsible to the tune of $2.7 million in compensatory damages, and then $19.4 million in punitive damages. Appeals predictably followed, and the U.S. Court of Appeals for the Eighth Circuit overturned the punitive damages award based on some evidence that should not have been permitted. That court then ordered a new trial on punitive damages, only.

The issue that some wanted the Supreme Court to decide was whether a new trial on punitive damages alone was okay, or whether the entire trial had to be redone.

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The Supreme Court rejected Pfizer’s appeal in the Scroggins, where a jury rendered a compensatory damages verdict of $2.75 million. Pfizer wanted the Supreme Court to order a new trial on the entire case—compensatory and punitive damages, as well as causation. The trial jury decided on $27 million for punitive damages, and Pfizer will get a new trial on that.

Wyeth has lost seven out of eleven cases (at the trial level) since 2006.
For more on the hormone therapy backstory, see our prior Drug Recall Lawyer Blog posts.

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Mylotarg-06-22-10.jpgMylotarg, Pfizer’s leukemia drug that was approved by the FDA in 2000 under an accelerated approval program (early approval for drugs that show particular promise) will be pulled from the market. A continuing study revealed that patients are more likely to die while taking Mylotarg and chemotherapy than those who undergo chemotherapy, alone. That study was prematurely stopped last August (ten months ago? What’s the deal with the delay between the study results and pulling the drug from the market?)

One physician from the Cleveland Clinic noted that the drug did cause disease remission; unfortunately, it also caused increased toxicity which was oftentimes fatal.

If you are taking this drug, be sure to consult with your physician about whether you should continue to take it.

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Here are this week’s stories:

  • Blood Products: The FDA hit the Red Cross with $16.2 million in fines for blood safety violations. Maybe I should take my donations to the local hospital, instead…
  • Hormone Therapy: Pfizer needs to get ready to try its hormone therapy cases all over the country, now that cases have been sent from Arkansas to their home states (with more awaiting transfer). Some think the upcoming cost will be an incentive for settlement. (HT: Bloomberg).
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