Midway Point for Heart Drug Plavix Statute of Limitations

May 20th, 2011. By AbiK

Plavix has started to appear in the news again. Word about Plavix lawsuits—as happens with many pharma tort cases—had died downed within a few weeks of the FDA’s announcement that it would place a black box warning on Plavix (clopidogrel bisulfate). That black box label change happened back in March, 2010—so for many, the statute of limitations for filing a Plavix lawsuit will be up as we approach April 2012—and that’s not as far away as it might seem.

Plavix, which is prescribed for patients at higher risk for heart attack or stroke, is an anti-platelet drug that works by helping to prevent blood from forming clots.

The issue with Plavix—and the reason for the black box warning—is that some patients are not able to metabolize the drug effectively once it’s in their system. The result is that the drug’s effectiveness is reduced. Which, for a person who may be prone to heart attack or stroke, could perhaps be life-threatening.

The patients identified as those at risk for lower metabolization of Plavix are those with an abnormal CYP2C19 genotype—those known as “poor metabolizers”; CYP2C19 is the drug-metabolizing enzyme that serves as the body’s catalyst to convert Plavix to its active (and effective) form.

Reports have indicated that potentially 2 to 14 percent of the population are “poor metabolizers”. Given that estimate, and given that a 30-ct bottle—about a month’s supply—of Plavix 75mg can run up to $200 (drugdepot.com), and that Bristol-Myers Squibb’s Plavix annual sales for 2010 were reportedly $6.7 billion, then 2-14% of that population could feasibly be about 55,000-390,000 individuals at risk. And I’m betting that’s a conservative range once you factor in that not everyone is paying full price, some are buying generic (which opens up a whole other can of worms that you can read about in our recent article on generic Reglan) and the fact that Plavix has been dubbed the “world’s second-best selling drug” (crainsnewyork.com).

There is a genetic test that doctors can authorize for patients who are being put on Plavix; the test identifies whether or not the patient is a “poor metabolizer”. The problem is that not all doctors have the test readily available to administer—which means sending the patient out to a lab for it and waiting on results—and, of course, there is the omnipresent question of whether or not insurance will cover the test. So knowing a test exists is one thing; having it easily administered is potentially another.

Added to the black box warning—though separate from it in terms of litigation—are allegations that the makers of Plavix heavily marketed the drug as a “super aspirin” when they in fact knew that the risks of taking Plavix far exceeded those of taking OTC aspirin. A complaint has been filed in Illinois on behalf of 11 plaintiffs who claim that Plavix is less effective than aspirin but has much more potentially serious side effects—at a much higher price.

Tags: antiplatelet, black box warning, blood clots, blood thinner, clopidogrel bisulfate, CYP2C19, FDA, heart attack, Plavix, plavix_heart_attack_stroke, stroke

This was posted on Friday, May 20th, 2011 at 2:07 pm and is filed under Drugs/Medical, Emerging Issues . Feel free to respond, or trackback. Read our comments policy.