Can you recover damages after being injured by a defective or unreasonably dangerous drug?
Prescription and over-the-counter drugs are supposed to make you feel better or treat your health condition in a safe way. But every year drugs that are defective or unreasonably dangerous make their way into the marketplace. The people who take these unsafe drugs often suffer serious health complications that leave them or their families drowning in medical debt.
If you’re injured by a defective or unreasonably dangerous drug, you may be able to recover damages from the manufacturer or seller of the drug.
Let’s take a look at product liability claims involving pharmaceuticals in the Volunteer State.
Most drugs have known side effects. Just because you suffered harm after taking a drug, doesn’t mean you can sue the manufacturer or seller of the drug.
To establish a successful drug-related product liability claim, you need to prove that the drug you took was defective or unreasonably dangerous.
Lawsuits based on defective drugs
In order to recover damages for an injury caused by a defective drug, you need to prove that:
- The drug you took was in a “defective condition” at the time it left the control of the manufacturer or seller, and
- The defective condition caused your injury.
This begs the question:
What is a defective condition?
Under Tennessee Code 29-28-102, a “defective condition” is a condition that renders the drug “unsafe for normal or anticipatable handling and consumption.”
There are 3 common types of drug defects:
|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 intended.||A drug that became tainted with another drug during the manufacturing process.|
|Design defect||A defectively designed drug is one that failed to perform as safely as a reasonable person would expect, even when used as intended.||A common flu vaccine that causes an even more severe respiratory illness.|
|Marketing defect||A marketing defect exists if the drug does not contain proper warnings or instructions.||A drug increases the risk of a miscarriage, but the label doesn’t warn consumers that it’s unsafe for pregnant women.|
Though any drug can be defective, research suggests that 3 types of drugs are particularly vulnerable to defective-drug lawsuits:
- Drugs taken during pregnancy
The drug manufacturer Aurobindo Pharma was sued after a pharmacy found high levels of the known-carcinogen NDMA in specific lots of metformin (a common drug used to treat patients with type-2 diabetes). After an independent lab analyzed 38 batches of the drug, the lab detected unsafe levels of NDMA in 16 batches. Several batches contained over 10 times the safe daily limit.
The lawsuit alleges that the high levels of NDMA were a result of contamination during the manufacturing process. Aurobindo Pharma has a history of good manufacturing practice (GMP) violations. In 2018 alone, the United States Food and Drug Administration (FDA) found that:
- Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination
- Buildings used in the manufacture, processing, packing, or holding of drug products were not free of infestation by rodents, birds, insects, and other vermin
- Employees engaged in the manufacture, processing, packing, and holding of a drug product lacked the training required to perform their functions
Lawsuits based on unreasonably dangerous drugs
In order to recover damages in a drug-related product liability lawsuit based on an unreasonably dangerous drug, you must establish that:
- The drug was “unreasonably dangerous” at the time it left the control of the manufacturer or seller, and
- The unreasonably dangerous condition caused your injury.
Under Tennessee Code 29-28,102, a drug is “unreasonably dangerous” if it’s “dangerous to an extent beyond that which would be contemplated by the ordinary consumer.” To put it another way, a drug is unreasonably dangerous if its risks outweigh its utility.
Lawsuits based on unreasonably dangerous drugs are rare since the FDA requires most prescription drugs to be proven safe and effective for their intended use prior to marketing. However, the FDA allows unapproved prescription drugs to hit the market if:
- The drug is one of a few older drugs that are still being evaluated through an open drug efficacy study implementation (DESI) program,
- Health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition, or
- There is an insufficient supply of an FDA-approved drug.
What’s more, the dangers of a drug may not be understood or apparent until after the drug is approved by the FDA and hits the open market.
A recall is a voluntary action taken by a company to remove a defective drug from the market. Drug recalls are characterized as follows:
- Class I: A dangerous or defective drug that could cause serious health problems or death.
- Class II: A drug that might cause a temporary health problem, or pose a slight threat of a serious nature.
- Class III: A drug that is unlikely to cause any adverse health reaction, but that violates FDA labeling and manufacturing laws.
Whether or not a drug is recalled has no bearing on whether you can file a lawsuit. Evidence that a drug has been recalled may, however, help support your claim that the drug is defective or unreasonably dangerous.
The injuries that result from taking a defective or unreasonably dangerous drug range from minor to fatal. Some of the most common injuries include:
- Increased blood pressure
- Heart attacks
- Organ perforation
- Birth defects
- Mental health issues
What’s more, the investigation found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were higher for Actemra patients than for patients taking other competing drugs, even though Actemra failed to warn consumers about the dangerous side effects.
In Tennessee, the following parties may generally be held liable in a drug-related product liability lawsuit:
- Manufacturers. A manufacturer is an individual or entity that designs, fabricates, produces, compounds, processes, or assembles a drug or its component parts before the sale to a customer.
- Sellers. A seller is a person engaged in the business of selling a drug, whether it’s for resale or for use or consumption.
There are some conditions that need to be met for a seller to be held liable in Tennessee. Your lawyer can help you determine who best to sue.
Learned intermediary defense
One of the most common defenses raised in a drug-related product liability lawsuit is the “learned intermediary defense.”
Here’s how it works:
Manufacturers of certain medical products can rely on physicians to transmit their warnings and instructions. If the physician fails to warn the patient, the physician, rather than the manufacturer, is liable.
For example, if the manufacturer of Actemra fails to put a warning on its label stating that the drug may cause heart attacks, but tells physicians to warn their patients about the risk of heart attacks, then the manufacturer is off the hook if an unknowing patient takes the drug and suffers a heart attack. The patient can, however, sue the physician for their failure to warn.
Statute of limitations
Tennessee law limits the amount of time you have to file a drug-related product liability lawsuit. This time limitation is called the statute of limitations.
In most cases, you have 1 year from the date of your injury to file a defective drug lawsuit in Tennessee.
There are, however, a few situations in which you might have more time (for example, if you’re under 18). Under no circumstances, however, can you file your lawsuit more than 10 years after the drug was taken.
Damages available in a defective-drug lawsuit
In Tennessee you can recover the following damages:
- Economic damages include the monetary losses caused by your injury, including medical expenses and lost wages.
- Non-economic damages include the non-monetary losses caused by your injury, such as pain and suffering.
- Punitive damages are intended to punish the defendant and are only available in cases where the defendant acted intentionally or recklessly.
Like most states, Tennessee caps the amount of certain damages that you can recover. In Tennessee, the following damage caps apply to drug-related product liability lawsuits:
- Punitive damages are capped at $500,000—or twice the amount of compensatory damages (economic + non-economic damages) awarded, whichever is greater.
- Non-economic damages are capped at $750,000 unless the plaintiff suffered a catastrophic injury, in which case the cap is increased to $1 million.
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