Gladys Mensing took a generic medicine called “Metoclopramide” for four years to help fight diabetic gastroparesis. She alleges that taking the drug gave her a severe neurological movement disorder, tardive dyskinesia. The evidence shows that none of the generic drug's manufacturers and distributors made any effort to include warnings on the label.
She sued in state court in Minnesota, claiming that the drug manufacturer had a duty to warn her and others of all known risks in taking the drug. The generic drug's manufacturers and distributors asked for the lawsuit to be thrown out. They said that government regulations only require them to have the same label on metoclopramide as is on its brand-name equivalent, Reglan. (Reglan did not require a warning about tardive dyskinesia) They contend, that because they met the “minimum” regulations, then they cannot be held liable.
A federal judge agreed, saying the lawsuit was pre-empted by the federal regulations requiring the two labels to match. The case was dismissed. The victim’s attorneys appealed.
WASHINGTON — The Supreme Court seemed split on Wednesday on whether to allow generic drug makers to be sued in state court based upon common law duties to warn.
"I don't see how you can hold them liable, so long as they continued to give the warnings that they had to give," Justice Antonin Scalia said of the companies that make the generic drugs.
But Justice Sonia Sotomayor argued that it didn't seem likely that Congress wanted to completely immunize generic companies against these types of lawsuits. "Do you think Congress really intended to create a market in which consumers can only sue brand-named products?" she said. "Because if that's the case, why would anybody ever take a" generic?
PLIVA Inc. and other generic drug manufacturers argue that it's not their legal responsibility to request label changes, and lawsuits filed in state courts over the content of labels improperly infringe on the Food and Drug Administration's enforcement area.
"When a company doesn't make appropriate disclosures to the FDA, even if people are hurt by that, even if it causes people to be injured and states might otherwise want to compensate them for them, those disclosure obligations are up to the FDA with its discretion to enforce," said manufacturer lawyer Jay P. Lefkowitz.
But lawyers for victims say their lawsuits complement federal safety laws, instead of conflicting with them. They contend that the requirement for the dual label compliance is a minimum, not a maximum standard to be applied.
"This case is about the duty that the company owes to my clients and their doctors to provide them with adequate warnings," lawyer Louis M. Bograd said.
This is EXACTLY the job of an experienced Personal Injury Attorney: To stand up for the little guy.
The drug manufacturers make billions of dollars each year, and then, when is is discovered that their drugs cause serious side effects and permanent injuries, they hide behind the minimum regulations imposed by the FDA. This, indeed, is the old cigarette manufacturers defense.
Cigarettes are not bad for you; cigarettes do not cause cancer; there is no proof of this, and besides, we have done everything the FDA has told us to do ny putting that little warning on the pack that says “The surgeon General has determined that cigarette smoking may be hazardous to your health”. Case closed.
But is it really closed? Should it be?
If a drug manufacturer knows of a dangerous side effect of its product, and tells no one, and subsequently, there are victims of the side effects, should the drug manufacturer be able to defend and escape liability by merely saying “we put the warning label on there that the FDA said we had to”?
I don’t know about you, but this offends the senses. This, in fact, is scary. Is that really the standard? Say what you want, hide what you want, control the information flow and thus, the “labeling information” and then, hide behind it when people get hurt?
The United States is the land of opportunity, but is also is a land of laws. Our civil justice system gives each and every person the right to seek justice, no matter how big the opponent, for wrongdoing that occurs. We anticipate that the laws and the courts will provide justice, in an even-handed manner. We expect that the courts should not let big drug companies hide behind a little label, particularly one that that is lacking information that one would want to know before buying and ingesting the product.
A Personal Injury Attorney is often the last bastion of defense, in the fight by the powerless, against the powerful. Please keep that in mind.