Whose Fault Are Drug Recalls?

May 23, 2014
by Adler Markoff & Associates

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    Whose Fault Are Drug Recalls?

    Even with numerous clinical trial requirements, safety protocol and federal regulations established by the Food and Drug Administration (FDA), pharmaceutical drugs are subjected to recalls every year, many of which have the potential to cause serious consumer injury or death. Most recently, significant attention has been paid to the potential blood clot risk associated with Bayer’s Yaz and Yasmin birth control pills, and the possible risk of birth defects connected to SSRI antidepressants like GlaxoSmithKline’s Paxil. It’s easy to place blame on the drug firm for manufacturing the medication, on the FDA for approving the potentially dangerous drug, and on doctors for prescribing it to patients, but the question is: Who is really at fault for drug recalls? If you have suffered injuries caused by a dangerous drug, contact our drug injury lawyers at AMA Law to discuss your legal options.


    Pharmaceutical companies are required to maintain rigorous standards of cleanliness in their manufacturing facilities, and are subject to FDA inspections and fines if violations are found by the federal agency. While these safety practices may work to curb consumer injury caused by factors like tainted drugs and packaging errors, what is really being done to prevent injuries and fatalities caused by medications that are dangerous in their design? In most cases, it isn’t until a large group of consumers suffer the same injury or die of a drug side effect that the safety of a medication is called into question. At this point, even if the drug is eventually removed from the market, there is little that drug companies can do to reverse the effects of their dangerous medication on injured users, except to pay damages.


    Although drug recalls cost pharmaceutical companies a lot of money,drug firms stand to make a whole lot more by getting their medication on the market, in which case the profit likely outweighs the penalty. The millions or billions of dollars drug companies are forced to pay in drug recalls, side effect lawsuits and criminal penalties barely even scrapes the surface of the firm’s profits. In 2009 for example, yet another Pfizer subsidiary agreed to plead guilty to charges involving the illegal promotion of a medication for unapproved uses. Turns out, executives at Pharmacia & Upjohn had been promoting its Bextra drug for the treatment of all kinds of acute pain, despite the fact that the medication was only FDA-approved for the relief of arthritis and menstrual discomfort. For the felony offense, Pfizer paid $1.19 billion – the largest criminal fine in U.S. history – a penalty just under the $1.4 billion in sales Bextra brought in for Pfizer each year.


    Bextra was subjected to a recall in the United States and Europe in 2005 when the FDA found that the risk of potentially-fatal side effects linked to the drug was found to outweigh any possible benefits of the medication. Unfortunately, some drug companies are already aware of the side effect risks associated with their medications before they become available to consumers, but deceptively choose to conceal this information from the public in an attempt to avoid adverse consequences, like a drug recall. A drug company is required by the FDA to alert the agency as soon as it becomes aware of a danger linked to its medication. Unfortunately, when drug companies withhold important sid effect information from consumers and healthcare providers, the patients are the ones who pay the price. If you have suffered from a serious injury caused by an allegedly defective medication, contact our drug injury attorneys at AMA Law for legal help.

    Request a free consultation

    (405) 607-8757