Today, generic prescriptions represent between 55 and 80 percent of the drugs we consume in the U.S. Choosing a generic option generally saves patients hundreds and possibly thousands of dollars annually on drugs they need for treatment of certain conditions.
What’s problematic, however, is who is held liable when those generic drugs are defective and cause injury. Answer: generally no one. That’s because most claims regarding defective drug injuries are brought under a theory of negligence called “failure to warn.” That is, the company knew the drug was dangerous in some way, but failed to convey that to doctors or consumers. Because of the way generic drugs are regulated, though, their warning labels must mirror those of the brand name producers.
But here’s where it gets troublesome: Courts have generally held generic drugmakers can’t be liable for warning labels they didn’t create. However, neither can brand name drug manufacturers be held liable for illnesses or injuries caused by generic drugs they didn’t produce or sell.
According to court records, a patient suffered severe neurological side effects from metoclopramide, the generic version of acid-reflux drug Reglan. The brand name version of the drug was produced by defendant Wyeth, whom plaintiff argues failed to warn his doctor of the dangerous side effects, including a condition known as tardive dyskinesia, a disorder resulting in involuntary movements of the head, neck and face.
However, by the time plaintiff took the generic drug, Wyeth no longer controlled even the brand name product. The company was purchased by Pfizer.
The case first went to the Alabama Supreme Court last year, with the justices issuing a 6-3 decision in a 145-page opinion, finding brand name manufacturers could in fact be liable in these instances. Justices reasoned patients could only secure prescriptions legally through doctors, and doctors relied on warnings provided by brand-name manufacturers.
This concept is known in legal circles as “innovator liability.” It holds “innovators” liable for damages resulting from knock-off products.
Some are concerned this decision will bleed over into other types of consumer products. Whether that’s true remains to be seen.
What we do know is the court’s decision contradicts numerous rulings in both federal and state courts. Seven different federal courts of appeal – the Fourth, Fifth, Eighth, Nine, Tenth and Eleventh Circuits – have all ruled brand name manufacturers can’t be named as defendants in product liability cases regarding drugs they did not make or sell. In total, 98 courts applying the laws of 30 different states have rejected the “innovator liability” theory.
The Weeks case was recently before the Alabama Supreme Court for a second time after defendant sought reconsideration. The court reaffirmed its earlier decision.
Despite outcry from talking heads within big industry, one Alabama justice stated the issue was clear: Brand name manufacturers should be responsible for updating product labels and packet inserts and information when new dangers or side effects become evident – especially because generic drug companies aren’t allowed to make these changes on their own. Someone needs to be held responsible.
If you have been injured in Fort Myers, contact the Hollander Law Firm at (888) 751-7770 for a free and confidential consultation. There is no fee unless we win.
Wyeth v. Weeks, Aug. 15, 2014, Alabama Supreme Court
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