How Quickly Should Generic Drug Makers Update Labels?

How Quickly Should Generic Drug Makers Update Labels?

Posted By The Maher Law Firm || 15-Sep-2014

dangerous drug lawsuits

If you use a generic drug, how do you know whether you are taking a medication that is known to be a potentially dangerous drug? Are you sure you have all of the information about it that is available?

A recent court case that may be taken up by the U.S. Supreme Court asks how fast a generic drug maker must act to update its label to match what is published about the equivalent brand-name medicine. The Wall Street Journal reports that "the fortunes of the generic drug industry may once again be in play."

The newspaper says "once again" because, three years ago, the Supreme Court held that generic drug makers cannot change their labels to add side effects until the brand-name maker of the drug has done so. The Court also held that generic drug makers should not be held accountable for a failure to warn against any risks

Lawsuit Involves Generic Version of Fosamax

According to the current lawsuit, a California woman was prescribed a generic version of Fosamax, a medicine sold by Merck & Co. that is used to treat osteoporosis. Merck updated the Fosamax label in 2010 and again in 2011 to warn about the risk of a femur fracture. The generic maker made comparable changes six weeks after each update, the Wall Street Journal reports, quoting court documents.

However, the woman's doctor claimed after the woman suffered a fracture that he was unaware of the side effect updates. The doctor said the generic drug makers failed to alert physicians with "Dear Doctor" letters, or a "standard notice about important product updates," according to the newspaper.

The generic drug makers claim that a "Dear Doctor" letter is considered labeling, so they were precluded from sending notices until Merck had done so.

Last year, a California appeals court ruled against the generic drug makers - Teva Pharmaceuticals and Caraco Pharmaceuticals, which is a unit of Sun Pharma, the newspaper reports.

Meanwhile, the U.S. Food and Drug Administration has proposed amending its rules to allow generic drug makers to update their labels as soon as information related to drug safety is known - regardless of what the primary manufacturer has done.

The FDA will make its final decision in December. However, the Supreme Court is likely to take until next fall to decide whether to hear the case. The future of the case may hinge on a technical issue regarding whether the State of California had jurisdiction to hear a lawsuit about federal regulations in the first place.

Patients Need to Ask Doctors about Drug Side Effects

The revised FDA rule would make the issue moot, the Wall Street Journal notes, but it would not affect this case or the injury suffered by the plaintiff.

Allowing generic drug makers to update labels when they deem it necessary will not guarantee it happens right away, either.

If anything, this case underscores the fact that patients need to ask their doctors about potential side effects of any drug they prescribe. When they ask, they should be sure to ask whether the doctor has seen "the latest information available" about the drug to be prescribed.

To be doubly safe, patients can make their own inquires through the FDA website, at

If you or a loved one has suffered an injury that you believe was caused by a dangerous drug or a failure to warn about its side effects, make sure to contact an attorney The Maher Law Firm to learn more about your rights.

Categories: Dangerous Drugs
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