The U.S. Supreme Court has agreed to hear a landmark case on generic drug liability that could potentially impact the ability of consumers to bring product liability lawsuits against drug manufacturers if they are harmed by generic drugs.
The case – Mutual Pharmaceutical Co. v. Bartlett – involves an appeal by Takeda Phamaceutical Co.’s Mutual Pharmaceutical Co. division of a $21 million judgment awarded to a New Hampshire who alleged that she sustained injuries after taking a generic anti-inflammatory drug manufactured by the company. The plaintiff argues that the generic drug Sulindac did not contain adequate labeling because it was unreasonably dangerous.
In its appeal, the drug manufacturer argues that the claims, which are based on state law, should be preempted by federal drug regulations and that the company should be protected by the Supreme Court’s 2011 decision in in Pliva v. Mensing , in which it held that consumers cannot sue manufacturers of generic drugs based on allegations that the product was inadequately labeled.
The Wall Street Journal reports that Mutual and other generic-drug makers argued in briefs that were filed with the Supreme Court that they cannot change their product’s labeling or design because federal law requires that generic drugs be identical to their branded counterparts.
In recent years, the Supreme Court has chosen to treat manufacturers of generic drugs different than manufacturers of brand-name drugs when it comes to product liability. For instance, The Supreme Court’s decision in Pliva v. Mensing – upon which Mutual Pharmaceutical Co. bases its appeal – held that patients are barred 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. Conversely, plaintiffs are allowed to bring product liability lawsuits based on inadequate labeling against the makers of brand-name pharmaceuticals pursuant to a 2009 case against Pfizer’s Wyeth division.
After the Supreme Court’s 2011 decision in Pliva v. Mensing, democrats in Congress introduced legislation 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.
Oral arguments before the Supreme Court are expected to take place in March 2013, with a decision expected by the end of June 2013.
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.