Mandatory Drug Recall Under the Law
Once a drug has been approved by the FDA, the FDA or a court barely has any authority to force a recall. There are very limited situations when a mandatory recall is put in effect, none of which are drug related. The FDA is allowed to order a recall when the Agency:
- Finds there exists a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death.
- Determines that a batch, lot, or other quantity of biological product presents an imminent or substantial hazard to the public health.
- Determines that an adulterated or misbranded infant formula presents a risk to human health.
- Finds there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death.
- Determines there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
Lastly, the FDA has the right to force a mandatory recall when it finds that a human cell, tissue, or cellular and tissue-based product is a source of dangerous infection to humans, or does not provide enough protection against the risks of communicable disease transmission.
In situations other than those already stated above, recalls can be made as voluntary actions by a company expected to abide by FDA policy clearly stated in its regulations. An example of this would be the Hospira, Inc. (“Hospira”) litigation where the company had to end up voluntarily filing suit against the FDA following the approval of generic PRECEDEX.
At first swing at bat, Hospira was granted a Temporary Restraining Order (TRO). The court order telling the FDA to recall a drug product based on a Hatch-Waxman dispute was unprecedented.
Needless to say, the FDA states clearly in its Brief: “FDA cannot order recalls.” The FDA went on to argue that the recall ordered in the Hospira TRO could not be requested by the FDA since the grounds for the recall was a patent dispute and not about product safety. Hospira, Inc. then issued a voluntary nationwide recall on its product.
Outside of that example, it appears the only remedy for those injured by drugs is for the injured to sue the makers of a bad drug company in a civil court by attorneys who specialize in this type of litigation. Drug recalls occur after action by a governmental entity to remove a drug product off the market., but cannot be done by private companies or victims.
A great example of this happened last year when the injured plaintiffs were awarded $1.5 in compensatory damages and $9 billion in punitive damages in the first federal bellwether trial over the Type II diabetes drug known as Actos.
In short, if you have suffered injuries as a result of using a prescription drug, you should definitely speak to a personal injury attorney. You can also search online and the drug may already have a pending case. Product liability claims have a narrow time frame to actually use the claim against the drug manufacturers, so in some cases, if you don’t act soon, you may not be able to file the claim any longer.
Update 2/5/2015: Hospira has announced that it is being bought by pharmaceutical giant Pfizer for $15.23 billion. Pfizer is another company that has had their own bad drug litigation troubles with their hair loss drug Propecia.