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Legislation to Promote Generic Drug Safety

Written by Ankin Law Office

Democrats in Congress have introduced legislation that seeks to allow generic drug companies to update warning information on their drugs’ labels, thereby allowing patients to sue the drug companies for failures to warn about the risks associated with taking their drugs.

According to this article in the New York Times, the legislation was proposed in response to the Supreme Court’s decision last year in Pliva v. Mensing, which barred patients from suing generic drug companies based on the theory that the drug companies did not have control over the information on their labels and, accordingly, the generic drug companies could not be liable for failing to alert patients about the drugs’ risks.

Prior to the Mensing decision, an earlier Supreme Court decision had allowed patients to sue brand-name drug manufacturers for failure to warn of the risks associated with taking the brand-name drugs.

According to the New York Times article, the bill is backed by the consumer advocacy group Public Citizen, which has asked the U.S. Food and Drug Administration (FDA) to take a similar action.  The FDA has said that it needed more time to consider the issue.

Not surprisingly, the bill is opposed by generic drug companies.  They fear it could create a disorganized legal environment in which different drug companies could publish conflicting warning information about the same drugs. Under current law, only brand-name drug companies can update the drugs’ warning labels and generic drug manufacturers are then required to follow the direction of the brand-name manufacturers.

Proper marketing and warning labels are crucial for the safety of pharmaceutical drugs.  As we reported last year, Pfizer recently agreed to pay $14.5 million to settle a lawsuit alleging that it had illegally marketed the drugs Detrol and Detrol LA to men suffering from the signs and symptoms of benign prostate hyperplasia (BPH), which is commonly referred to as an enlarged prostate, despite the fact that Detrol treats muscle overactivity and does not have any therapeutic effect on males whose symptoms are caused by BPH.

The Chicago unsafe pharmaceutical drug attorneys at Ankin Law Offices, LLC represent clients throughout Illinois and the United States. We have significant experience handling class action lawsuits regarding unsafe pharmaceuticals and are familiar with the complex legal issues that these kinds of lawsuits generally involve. Contact us at (312) 600-0000 for more information on the improper marketing of Detrol or unsafe pharmaceuticals.

Categories: Medical Malpractice