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Potential Law Change Could Benefit Those Harmed By Generic Drugs

Current rules greatly restrict an injured consumer's right to recover damages when a generic drug causes injury. Federal law requires generic drug labels to match the warnings of the name-brand drug, even if the generic manufacturer believes the label fails to sufficiently warn consumers about a risk.

Because these rules prevent generic drug manufacturers from warning patients of risks that aren't disclosed on the name-brand drug label, the U.S. Supreme Court has ruled that generic manufacturers cannot be held liable for failing to warn consumers about undisclosed risks. The federal law and Supreme Court decision combine to create a disastrous situation for consumers: Those taking generic drugs may suffer side effects or injury from them that weren't disclosed on the warning label, and they won't even be able to recover damages from the drugmaker in a lawsuit.

The U.S. Food and Drug Administration (FDA) is considering a desperately-needed change that would afford generic drug manufacturers flexibility to add their own warnings to the medications they produce. This would presumably also make generic manufacturers liable for undisclosed risks that harm patients, since they would have the power to notify consumers about potential side effects as they saw necessary.

Even if the law change occurs, the FDA is notorious for being agonizingly slow to create and implement new rules. In the meantime, people will continue to suffer unnecessary harm from undisclosed drug side effects, with no right to legal recourse.

It's important to understand that there still are situations where someone injured by a generic drug may still be able to recover damages. For example: If a doctor or pharmacist makes a medication error, such as providing inappropriate dosages, there is still an opportunity to file a lawsuit and recover compensation.

McKeen & Associates, PC, is a Detroit law firm that represents medical malpractice patients throughout the country. The firm's staff of adept litigators and attention to detail has resulted in a long track record of impressive damage awards for injured clients.

Source:, "Generic Drug Label Rules May Be Changed, Eliminating Preemption," Irvin Jackson, Feb. 13, 2013

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