Pharmaceutical drugs are intended to help you feel better. But every once in a while, a drug makes its way into the marketplace that’s defective and makes you feel worse—sometimes even causing permanent damage or death. When this happens, your legal recourse takes the form of a product liability lawsuit.
Montana is no stranger to “bad drug” claims. The city of Anaconda recently joined a nationwide lawsuit alleging that nearly 20 pharmaceutical companies fraudulently marketed prescription opioids.
Pharmaceutical-based product liability claims are similar to other defective product claims, but there are some important differences. Let’s take a closer look at pharmaceutical liability in Montana.
Just like product liability claims in general, there are three categories of pharmaceutical liability cases:
Let’s take a look at each category.
A defectively manufactured pharmaceutical drug is a drug that—although properly designed—left the manufacturer in a condition other than the condition intended.
The most common example is when a drug becomes contaminated during the manufacturing process in such a way that the drug is no longer safe.
A drug is defectively designed if the drug is “unreasonably dangerous” to consumers even when used properly. For example, a blood-pressure medication that causes seizures in 50% of the people who take the drug would undoubtedly be “unreasonably dangerous.”
Claims based on defectively-designed drugs are rare because most unreasonably dangerous drugs aren’t approved by the U.S. Food & Drug Administration (FDA). Nevertheless, there are tools in place to allow certain drugs to be approved very quickly, and some side effects may not be realized until after the drugs are on the market.
When we think of drug “marketing,” we think of the colorful advertisements on television and in magazines. But, in the legal context, drug marketing also includes the warning labels affixed to drug packaging.
In order to establish that a drug was improperly marketed in Montana, you must prove that the manufacturer failed to warn you about a risk, and the risk made the product unreasonably dangerous.
For example, if a drug increases the risk of birth defects in pregnant women and the manufacturer failed to provide a warning indicating as much, a woman who gives birth to a child with an abnormality after taking the drug may be able to sue the manufacturer.
However, there’s one important caveat in Montana:
The manufacturer's duty to warn consumers is limited to providing an adequate warning to “the healthcare professional responsible for making decisions related to the patient’s care” who then assumes the duty to pass the necessary information on to the consumer. This is referred to as the learned intermediary doctrine.
In other words, if the manufacturer fails to affix a label warning you about the increased risk of birth defects, but instead informs your prescribing physician about the risks—and your prescribing physician fails to pass along the information—the manufacturer is off the hook (though you may be able to sue the prescribing physician for medical malpractice).
When it comes to bad drug cases, there are a number of potential defendants. These include:
A pharmaceutical liability case can be brought under a theory of negligence or strict liability (just like any other product liability case). Typically, a plaintiff will use the theory of strict liability because it’s easier to prove.
In a pharmaceutical liability case based on negligence, the plaintiff must prove that:
In a pharmaceutical liability case based on strict liability, the plaintiff doesn’t need to prove that the defendant breached any sort of duty. The plaintiff only needs to show that:
The “statute of limitations” is the legal term for the amount of time you have to file a lawsuit. In Montana, the statute of limitations is generally 3 years for a pharmaceutical liability claim. This means you must file your lawsuit within 3 years of being injured.
In Montana, a plaintiff in a pharmaceutical-based product liability lawsuit can recover both economic damages (like medical bills and lost wages) and non-economic damages (like pain and suffering).
Pharmaceutical-based product liability claims are unlike most other personal injury claims. When selecting an attorney, you’ll want to make sure the attorney has experience litigating pharmaceutical-based product liability claims.