Millions of Americans depend on medications each and every day. Medications must be safe for consumers by being free from manufacturing defects, design defects, and inadequate warnings. When a manufacturer later discovers that medication is not sufficiently safe, it may have obligations to make the product safer through additional warnings or even a full recall of the drug. Below is an overview of what factors go into the determination that additional warnings or a recall are appropriate, as well as a discussion of legal remedies an injured consumer has when injured by this medication.
Government Required Drug Recalls
A manufacturer of drugs is required to do sufficient testing of the drug prior to releasing it to the general public. Prior to 2017, this always meant at least one clinical trial and study that produced results within the Food and Drug Administration’s (“FDA”) acceptable risk levels. However, Congress passed the 21st Century Cures Act in December 2016. This bill was a decision by Congress that it was better to have cutting-edge prescriptions drugs even if they are riskier than current medications. To achieve this new balance, the Act no longer requires every drug to go through a clinical trial process. Instead, other forms of evidence are acceptable to show sufficient safety for release. A natural outgrowth of this law is that more risks will slip through and reach the public. As a result, drugs are more likely to be recalled today than ever before.
After a drug has been released, the manufacturer may discover alarming side effects or even contamination of a batch of the drug. If the dangers posed by this drug are too serious, the FDA will issue a warning about the drug. In even more serious situations, the manufacturer may have to recall the drug under orders of the FDA. The FDA has three classes of recalls. Class I recalls are the most dangerous and are used when a drug has a serious, irreversible health effect up to and including death. Class II recalls are less severe. They are used when the drug poses an adverse but reversible and treatable effect on health. Class III recalls are also known as “administrative recalls.” These are used when no adverse health effect is currently present, but the drug has violated some other FDA regulation, such as a misbranded drug (generic labelled as brand-name.).
What does a FDA recall mean for an individual injured by the recalled drug? Unfortunately, the answer is not much. In Buckman Co. v. Plaintiff’s Legal Committee, the United States Supreme Court stated that violations of FDA regulations could not form the basis of state law negligence per se claims. Thus, even though most laws that are violated give rise to a private right of action through a negligence per se claim, federal drugs are treated differently. This doesn’t mean injured plaintiffs are left high and dry, though. An injured party can still bring a product liability claim against the drug manufacturer. As a federal district court noted in re Multi-Piece Rims Products Liability Litigation, the fact that a product was subjected to a mandatory federal recall is admissible to show that the medication was defective. Thus, bringing suit after a FDA recall allows a plaintiff to present extremely damning evidence of a defect to the jury.
Voluntary Drug Recalls and Additional Warnings
A manufacturer may discover potential adverse effects with medications or may suspect a batch of medications has been contaminated, though tests as to both are inconclusive. In these scenarios, the FDA will not impose a mandatory recall for these drugs: the evidence of adverse health effects or contamination isn’t strong enough to justify the recall. The manufacturer then has a decision to make. It may choose to issue a warning about potential side effect or even recall the medications voluntarily. These are in-house decisions and each manufacturer will make such decisions on its own terms, looking at what it considers important. When an individual is harmed by a medication that has been voluntarily recalled, the individual can bring a product liability claim. However, unlike an involuntary recall, evidence of the voluntary recall may not be admissible to show the drug is defective. For example, Kansas Rule of Evidence 451 doesn’t allow any evidence of a subsequent remedial conduct—actions taken to make a product safer, such as a recall or additional warning—to prove a medication is defective. Thus, if the recall is conducted after the plaintiff’s injury, no evidence of the recall is admissible. This is not the case when the FDA forces the recall because that manufacturer did not take the remedial conduct itself.
Class Action Lawsuits
When a voluntary or involuntary recall occurs, a class action lawsuit is likely to follow. Television and radio ads are commonplace for these types of lawsuits. A class action lawsuit is a single suit that attempts to join as many plaintiffs as possible that have suffered common injuries from a common source, such as using the same defective medication. However, because of the nature of class action lawsuits, each individual plaintiff won’t be able to present evidence of how they were injured. It is important to note that an individual can always opt out of a class action lawsuit and bring his or her own claim individually. In doing so, a jury will get to hear how that individual suffered and how that individual’s life has been changed by the manufacturer’s wrong. Thus, though it may be tempting to take the “no cost, no work” route of a class action lawsuit, all a class member can get from this type of lawsuit is “generalized” damages. Only when a private, personal attorney is retained can an individual get his or her specific story heard and his or her specific injuries and suffering redressed.
Defective medications can be extremely dangerous. When a medication is recalled, the effect on legal redress can be quite different. To make things even more complicated, a class action lawsuit may be filed and attempts made to get you to opt in. However, it is imperative that you contact an attorney before opting in and giving away your private right to a jury. This is the only way to ensure full and fair redress is achieved.