Product Liability Claims Involving Prescription Drugs

When you're harmed by a prescription drug, what are your legal options, and what should you expect?

Updated by , J.D. University of San Francisco School of Law
Updated 9/26/2023

If you've been injured by a pharmaceutical drug, you might have a valid legal claim against the manufacturer, or against some other link in the "chain of distribution." In this article, we'll cover:

  • what kinds of situations might justify a lawsuit over the safety of a product like prescription drugs or other medications
  • what injured patients should consider in trying to decide whether a lawsuit is the right move
  • how to figure out who might be on the legal hook for harm caused by a pharmaceutical drug, and
  • when it might be time to talk with an experienced legal professional about your options.

How Pharmaceutical Drug Product Liability Works

Most lawsuits over harm caused by a prescription medication or other pharmaceutical drug are governed by an area of law known as "product liability." Drug-related product liability claims usually come in three basic varieties:

  • claims based on defectively manufactured pharmaceutical drugs
  • pharmaceutical drugs with dangerous side effects (even though properly manufactured), and
  • improperly marketed pharmaceutical drugs.

These parallel the three categories of defective product claims in general (learn more about the different types of defective product claims). Let's take a closer look at each of them.

Defectively-Manufactured Pharmaceutical Drugs

This category of claims involves injuries caused by pharmaceutical drugs that have been improperly manufactured or have somehow become tainted. This may be the result of:

  • an error at the manufacturing facility or the pharmacy where the drug was made or bottled
  • a problem that occurs during shipping
  • an error in labeling, or
  • any mistake made at any point between manufacture and the point when the patient receives the drug.

Prescription Drugs With Dangerous/Unknown Effects

This category of claims involves pharmaceutical drugs that, although properly manufactured, have side effects that result in injury. These cases sometimes involve drugs that have been on the market for a long time before it's discovered that they increase the risk of a certain type of injury, such as heart attack, stroke, or cancer.

Improperly-Marketed Prescription Drugs

The "marketing" of a pharmaceutical drug refers to the warnings, instructions, or recommendations concerning the use of that drug.

This category often involves injuries caused by:

  • a failure to provide adequate or accurate warnings regarding a dangerous side effect, or
  • a failure to provide adequate instructions regarding the safe and appropriate use of the drug.

The "failures" listed above may have come from the manufacturer, a doctor, a pharmacist, or some other medical provider. We'll talk more later about who might be sued in these kinds of cases.

You Don't Need to Rely on One Theory of Liability

A defective product lawsuit may include a combination of claims. For example, a claim based on a drug with a dangerous side effect may be coupled with a claim based on the failure to warn of that side effect. Each different type of claim may also net a different subset of defendants (for instance, the manufacturer and the pharmacist; more on this below).

Learn more about the different theories of liability in cases involving dangerous or defective products.

Should I File a Product Liability Claim Over a Prescription Drug?

There's no easy answer to this question, as it's a personal one. In general though, it's good to assess whether going to the trouble of filing a lawsuit over a pharmaceutical product is really going to be worth it. Specifically, it might make sense to ask:

  • Did you take the medication according to a prescription, following the dosage guidelines?
  • Did you suffer some kind of measurable harm ("damages" in the language of the law) as a result of taking the drug?
  • Did you require additional medical treatment or even receive a diagnosis of an additional health problem brought on by your use of the drug?

If your answer to all of these question is "yes," it might make sense to at least discuss your situation with an experienced legal professional.

How to File a Prescription Drug Liability Lawsuit

Once you've decided to file a lawsuit over harm caused by a pharmaceutical drug, actually getting the lawsuit started is fairly straightforward. While suing a pharmaceutical drug company or health care provider is obviously different from suing over car accident injuries, the court-based procedure is quite similar for any injury-related lawsuit. Get the basics on filing a personal injury lawsuit.

Two of the biggest issues at the outset are:

  • figuring out who the proper defendant(s) might be (who you should sue, in other words), and
  • making sure you get the lawsuit filed in time under the "statute of limitations"

Who Would I Sue for Harm Caused By a Prescription Drug?

To make sure you include all the potential defendants in your lawsuits, consider everyone in the "chain of distribution" of a drug—that is, the path the drug takes from the manufacturer to the consumer.

Manufacturer. Pharmaceutical manufacturers are typically large companies, due to the huge market for pharmaceutical drugs and the technical challenges involved in developing new drugs. This is generally good news if you're seeking compensation for your injuries, although it is also true that these companies inevitably retain teams of high-priced lawyers to defend such cases.

Testing laboratory. The drug that injured you may have worked its way through an elaborate series of tests on its way to the market, and you should include any of these testing laboratories as defendants in your complaint, especially if they are independent of the manufacturer.

Pharmaceutical sales representative. Drug companies often make use of pharmaceutical "sales reps" who meet with doctors and other members of the medical community to tout the latest drug and make recommendations regarding its uses. Such representatives may be liable if they recommended the drug that injured you.

Doctor. The doctors who prescribed the drug that injured you may be liable for your injuries, because they're part of the drug's chain of distribution. The doctors may also be liable based on their failure to warn you about potential side effects, or to provide adequate instructions regarding the proper use of the drug. This is where there may be some overlap between product liability and medical malpractice.

Hospital or clinic. Any company, including a hospital or a clinic, that was part of the chain of distribution of the drug may be liable for your injuries.

Pharmacy. Your pharmacy is often the final point in the chain of distribution of a drug from the manufacturer to you. The pharmacist's counseling regarding use of the drug that injured you may constitute an additional basis for the pharmacy's liability.

Learn more about who to sue in a defective product liability case.

What's the Statute of Limitations for Filing a Product Liability Lawsuit?

Any time you're thinking about filing a lawsuit over harm caused by a pharmaceutical drug (or any kind of product), it's crucial to understand the statute of limitations that will apply to your case.

A statute of limitations is a law that sets a strictly-enforced time limit on the right to file a lawsuit. For lawsuits over harm caused by pharmaceutical drugs, the statute-of-limitations deadline may be the same as the one that applies to most personal injury lawsuits. But many states have a separate statute of limitations for product liability cases.

Whichever deadline applies, you'll need to comply with it and get your lawsuit filed in time, otherwise the court is almost certain to toss your case out. If that happens, you'll have lost your right to get fair compensation for your harm. Learn more about the statute of limitations in product liability cases.

Do I Need to Hire a Lawyer for a Prescription Drug Liability Case?

Unlike certain kinds of injury cases—like those stemming from a minor car accident, for example —when you decide to take on a big drug company or any other link in the "chain of distribution" of a pharmaceutical drug, you need an experienced legal professional on your side.

Putting together your best product liability case, and coming away with a fair result, often requires:

  • careful investigation and thorough analysis of complex evidence and documents
  • preparation of a convincing case for liability and damages, often involving a network of experts and consultants, and
  • the ability and skills to stand up to high-powered defendants and their legal teams, and fight for a favorable outcome.

There's simply no substitute for a lawyer's experience in building the best product liability case, and their willingness to battle it out. Along those same lines, if you discuss your potential drug liability case with a number of different lawyers and they all turn down the chance to represent you, now may be a good time to rethink your strategy.

Learn more about finding and working with an injury attorney.

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