Who’s liable when a consumer is injured by a defective drug?
The term “pharmaceutical liability” refers to the area of law that governs who (if anyone) is liable when a medicinal drug, because of a defect, causes harm.
Over the past 20 years, lawsuits against pharmaceutical companies have increased—particularly lawsuits involving contraceptives, vaccines, and drugs taken during pregnancy. What’s more, the circumstances under which courts hold pharmaceutical companies liable for injuries have broadened.
Let’s take a deeper look at pharmaceutical liability in the Hoosier State.
Types of pharmaceutical liability cases
A plaintiff in a pharmaceutical liability case must prove that the drug that caused their injury was defective. There are 3 types of defects recognized under Indiana law:
|Type of defect||Definition||Example|
|Manufacturing defect||A defectively manufactured drug is one that—though properly designed—left the manufacturer in a condition other than the one intended.||A teething syrup accidentally contaminated with diethylene glycol during the manufacturing process causes the syrup to become unsafe.|
|Design defect||A defectively designed drug is one that’s unreasonably dangerous to consumers even when used properly.||A drug intended to aid sleep causes 1 out of 20 people who take the drug to suffer a heart attack.|
|Marketing defect||A drug suffers from a marketing defect if the package doesn’t include the correct instructions or required warnings.||A drug increases the risk of miscarriage, but the manufacturer fails to provide a warning on the label indicating that the drug could be unsafe if taken while pregnant.|
NDMA is classified by the United States Environmental Protection Agency (EPA) as a probable human carcinogen, and studies show that exposure to the chemical can cause tumors in the liver, respiratory tract, kidneys, and blood vessels. The lawsuit, filed in 2020, is pending.
Common injuries caused by defective drugs
Injuries caused by defective drugs range from mild to fatal. Some of the most common injuries include:
- Increased blood pressure
- Organ failure
Potential defendants in a pharmaceutical liability lawsuit
Everyone in the distribution chain of a defective drug is potentially liable when someone is injured by the drug. Though your lawyer will investigate all potential defendants, you should know about some of the most common defendants:
- Manufacturers (including manufacturers of component parts). Drug manufacturers may be held liable for manufacturing defects, design defects, and marketing defects depending on the nature of the claim and the tasks performed by the manufacturer.
- Testing laboratories. Drugs are subject to several rounds of testing before reaching the marketplace. If one of these testing laboratories made a mistake or neglected to fully analyze the side effects of the drug being tested, the testing laboratory may be liable if the drug reaches the marketplace and causes harm to the public.
- Doctors. If a doctor provides inaccurate or insufficient information about a drug, the doctor may be liable for injuries that result.
- Pharmacists. If a pharmacist makes a mistake by misreading the prescription or grabbing the wrong drug from the shelf, the pharmacist may be liable for injuries that result.
What is the learned intermediary doctrine?
In Indiana, manufacturers can escape liability for failing to warn consumers about the potential risks of a drug if they provided adequate warning to the prescribing physician or pharmacist. This is referred to as the “learned intermediary doctrine.”
Let’s look at an example:
In this example, the manufacturer will likely avoid being held liable due to the learned intermediary doctrine (though you may be able to sue the prescribing physician).
Establishing a pharmaceutical liability case
To prove negligence, the plaintiff must establish that:
- The defendant owed the plaintiff a duty to exercise reasonable care (manufacturers owe a duty of care to all potential consumers),
- The defendant breached the duty of reasonable care, and
- The defendant’s breach was the proximate cause of the plaintiff’s injuries.
To prove strict liability, the plaintiff needs only to establish that:
- A drug was sold in an “unreasonably dangerous” condition (i.e., the risk of a drug’s use outweighs its utility),
- The unreasonably dangerous condition existed at the time the drug left the defendant’s control, and
- The dangerous condition was the proximate cause of the plaintiff’s injuries.
Though less common, a pharmaceutical liability case can also be based on a warranty claim. A warranty claim can be made against the seller of a drug if the seller expressly or implicitly made representations about the quality of the drug that were false or misleading (even if the seller believed them to be true).
Available damages in an Indiana pharmaceutical liability case
The vast majority of pharmaceutical liability cases are settled without the need for litigation.
According to research conducted by the United States Office of Technology Assessment, only 2% of product liability insurance claims are resolved through litigation. Of these, only 5% result in a trial verdict (the other claims are settled by the parties before trial).
In Indiana, plaintiffs in a pharmaceutical liability case can recover the following damages:
- Economic damages: the monetary damages that stem from the injury, including medical expenses and lost wages
- Noneconomic damages: the non-monetary damages that stem from the injury, including pain and suffering
Additionally, plaintiffs can recover punitive damages (damages intended to punish the defendant) if the defendant acted with malice, fraud, or gross negligence.
If a loved one died as a result of a defective drug, certain family members can recover the damages associated with the loss by filing a wrongful death lawsuit.
Steps to take if you’ve been injured by a defective drug
Your first step after learning that you may have been injured by a defective drug is to seek medical help. Not only should your health be your first priority, but establishing a medical record will help support your claim and prevent the insurance company or defendant from arguing that you failed to mitigate your damages.
Once you’ve taken care of your immediate health concerns, consider taking the following steps:
- Check the FDA website to see if the drug you took has been recalled
- Keep track of any medical bills that you accumulate due to your injury
- Keep track of how your injury impacts your day-to-day life
- Obtain the contact information of any witnesses who may have seen you ingest the drug or who may have witnessed your injury
- Locate an experienced pharmaceutical liability attorney