What is a statute of limitations?

A statute of limitations is a law that defines the time period during which legal action can be taken against a company or individual for an alleged wrong.

For most injury cases, the statute of limitations begins running at the time someone becomes injured (or becomes aware of their harm) and lasts for 2-6 years, depending on the state. But in pharmaceutical and medical device litigation, determining the statute of limitations can be less straightforward.

Purpose of Statutes of Limitations

Statutes of limitations are in place for reasons of procedural fairness. Proving fault in a lawsuit relies on evidence. The greater the amount of time that passes between (alleged) wrongdoing and a lawsuit, the greater the likelihood that evidence is no longer available, reliable, or easy to interpret. These factors can lead to inaccurate testimony that is unfair to the defendant.

At the same time, when a lawsuit is filed, the party being sued is put on notice to preserve relevant evidence. When this happens it’s harder for the defendant to argue that evidence was accidentally destroyed or lost. Especially when a defendant knows that they have done wrong, waiting too long to file a lawsuit provides the defendant an opportunity to get rid of evidence that can be used against them.

There’s also the argument that if someone can’t be bothered to file a lawsuit within the applicable statute of limitations, then the case isn’t that urgent, and since evidence fades over time, the case is not worth the attention of a court system with limited resources.

There are instances, however, where a plaintiff has legitimate reasons for not promptly filing a lawsuit. Fortunately, the law makes allowances for these circumstances in some cases.

The Statute of Limitations in Pharmaceutical Cases

Imagine that a pharmaceutical product causes some users to develop a medical condition. The link between the pharmaceutical product and the medical condition is well known to the public, but the symptoms of the condition don’t show up right way; they show up months to years after the drug regimen begins.

In this example, the statute of limitations does not begin to run when a patient starts taking the drug—it begins at the time that the symptoms of the medical conditions manifest.

But what happens when the symptoms have been occurring for many years, and the patient does not know—and has no way of knowing—that they are caused by a pharmaceutical product? This is where the statute of limitations can get tricky.

Here’s the same example, but with a twist: Although the pharmaceutical product has been available for years, there is initially no scientific evidence that links the drug with the patient’s medical condition. Only after the drug has been on the market for several years do studies begin to link it to adverse side effects.

In this scenario, the patient has no way of knowing that their condition was (potentially) caused by the drug. So even though it’s been many years since the patient first suffered harm related to their medical condition, and personal injury statutes of limitations have expired, a lawyer may be able to argue that the patient is eligible for a lawsuit because the link between their medical condition and the drug they were taking only recently became known.

For many drugs with previously undisclosed side effects, the statute of limitations begins running once the FDA warns about those side effects or issues a labeling change.

Due to the limited amount of time to file a lawsuit—and because of potential complications related to statutes of limitations—it’s critical that anyone considering legal action against a drug or device company get in touch with an attorney right away.