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
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
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.