Prescription Drug Liability: Generic vs. Brand-Name

Prescription Drug Liability: Generic vs. Brand-Name

Defining Liability for Prescription Drug Injuries

We have written many blogs about the problems stemming from taking medications — negative side effects, worsening of symptoms, etc., and, coupled with reporting those problems, we have discussed litigation against the drug manufacturers who are responsible for the drugs they put out into the public. Well, this blog entry is a little different in that we are going to talk about something that very few people know about. First, let’s deal with a fact that most people aren’t aware of: generic drugs (drugs that are identical to the brand-name versions but often come at a fraction of the cost) now account for roughly 80% of all of the prescription drugs taken in the U.S.

Two years ago, the United States Supreme Court issued a ruling in the case of Pliva v. Mensing in which the Court sternly limited the circumstances under which people who consume generic drugs could sue the manufacturers of the drugs. The justification for the limitation, according to the Court, stemmed from the fact that generic drug companies didn’t have control over “what warning labels said and therefore could not be sued for not alerting patients to the risks of taking their drugs,” according to Katie Thomas of The New York Times on March 4th of this year. According to federal law, companies that manufacture generic drugs are not allowed to differ from the brand-name drug that they are copying.

Prescription Drug Liability - Aronberg LawSo, let’s look at a particular case: a woman took an anti-inflammatory drug called sulindac (manufactured by the generic drug company Mutual Pharmaceutical Company), a drug based on the ibuprofen-like Clinoril, produced by Merck. After taking the drug, the woman contracted the disease known as toxic epidermal necrolysis, a harsh form of the more well-recognized Steven Johnson’s Syndrome. Within weeks of taking the drug, the woman’s skin began to fall off until almost two-thirds of it was gone. Additionally, she spent two months in the medical burn unit, and spent even more months in a medical-induced coma. The reaction the woman had to the drug has permanently damaged her lungs as well as her esophagus—and it has left her blind.

Now, the federal law technically hinges on the fact that because generic companies can’t alter the labels, they can’t be held responsible for failing to warn customers of potential side effects. The woman who took sulindac, described above, is suing for something else, though. She isn’t claiming that the warning label was insufficient; she is claiming that the drug itself was flawed. The company responsible for the drug, though, is standing by the federal law and claiming that their defense is based on the law because the rationale remains the same in both cases. The Supreme Court will be hearing the case between the woman and the generic drug manufacturer, and its ruling will send legal reverberations throughout the country.

If the Supreme Court decides to strengthen current federal law by clarifying that generic drug-manufacturing companies cannot be held liable for defective products, victims of dangerous (generic) drugs will have even less recourse than they currently do.

If you have any questions about this contentious legal issue, or if you or anyone you know have been the victim of medical malpractice or injured due to dangerous prescription or over-the-counter drug, please contact us at the Law Offices of Aronberg & Aronberg for a free consultation by calling 561-266-9191 or emailing

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