Can Drug Companies Be Liable for Adverse Side Effects?

Pharmaceutical companies have made remarkable advancements, but patients must always be aware of possible drug side effects for both prescription and over-the-counter medication. That does not, however, mean it’s the patient’s fault if they suffer harm because of a drug they’re taking. Like any other personal injury case, a victim can sue individuals and companies who had a duty of care, but failed to uphold that duty, resulting in measurable damages.

Adverse side effects can create new health concerns, worsen existing conditions, and even cause serious disabilities or death. The list of who is liable for drug side effects can include the manufacturer and others in the chain of distribution. 

What to Know About Drug Side Effects

We have all seen TV commercials that speed-talk through a long list of possible side effects. The same goes for the fine print in ads, packaging, and extra written material that comes with our prescriptions. They are all tools to alert consumers and shield drug makers from liability should something go wrong.

For all the good that medicines and medical devices can do, there are an alarming number of unintended consequences. This is especially true for vulnerable populations like those with existing health problems, infants, and the elderly. For example, AARP reports that for patients 65 and older, 96% of emergency room visits are due to reactions to therapeutic medications (as opposed to misuse of recreational drugs). The main culprits are diabetes medication and anticoagulants, both of which are common for this age group.

There is a wide array of drug side effects that may be experienced with ordinary medications. Effects can be mild, such as drowsiness, headache, or rash, or they may be serious and even life-threatening, including things like:

• Addiction
• Anaphylactic shock (allergic reaction)
• Birth defects
• Cardiovascular issues
• Stroke
• Kidney or liver damage
• Cancer risk
• Internal bleeding
• Brain or nervous system damage
• Violent or suicidal ideation

Even when potential consequences are rare, drug companies have a duty of care to warn consumers of what could happen. This is why they include those side effect lists and fine print with dosage recommendations and warnings about operating heavy machinery, alcohol consumption, and interactions with other drugs. 

Drugs and Consumer Safety—Do Pharmaceutical Companies Have to List Side Effects?

Drug manufacturers have a number of consumer safety requirements including listing potential drug side effects.

First, all medications go through lengthy, rigorous testing and clinical trials to get approval from the U.S. Food and Drug Administration (FDA). 

Through the testing process, the manufacturer may discover some possible dangers and side effects. They must disclose these issues to consumers and anyone else involved in marketing, selling, or prescribing the medicine. If they don’t warn people about known dangers, they can be held liable. 

Drug companies are usually not held liable for unknown dangers, for example, a side effect that only occurs in a handful of patients with a rare condition that was not considered during testing. However, if and when new drug side effects are discovered, the company must add the information to their warnings or risk liability.  

How Drug Companies May Breach Their Duty of Care

Unfortunately, makers of pharmaceuticals may not take adequate steps during the approval process or provide clear information about their medications. This may be a breach of their duty of care, opening themselves up to liability:

• Inadequate testing. While labs can’t test for every issue under the sun, they are expected to do reasonable and thorough testing for the most likely outcomes. Rules for this are outlined in the FDA’s Code of Federal Regulations Title 1.
• Defects and contamination. Things can go wrong during manufacturing to contaminate the ingredients of a drug or produce a defective medical device. 
• False claims. Advertising and marketing must not exaggerate what a drug can do, or downplay the chance of serious side effects.
• Failure to disclose dangers. As discussed in the previous section, any adverse effects discovered during testing—or after approval—must be made known to the end-user or anyone responsible for providing the drug.
• Unclear instructions and warnings. Drug makers may be held liable if the information they provide is vague or confusing. For example, if dosage amounts are hard to understand someone may be harmed by taking too much. 

These breaches can be due to a mistake, or because the company focused on profits over consumer safety. Regardless of their intention, they may be held liable if their actions resulted in someone being harmed due to an adverse side effect.

Proving Who Is Liable for Drug Side Effects

The type of breach that caused a victim harm can determine who is liable for drug side effects.

• Drug companies for releasing a product without FDA approval, failing to warn of dangers, or contamination.
• Labs for inadequate or flawed testing.
• Marketing companies and their sales reps for making false claims or failing to disclose side effects. 
• Doctors may be sued for personal injury or malpractice for prescribing the wrong drug, the wrong dosage, or for failing to check drug interactions. Giving off-label prescriptions, meaning prescribing drugs for purposes other than what was intended, can make doctors liable for side effects. An example is prescribing diabetes medications for weight loss before they were FDA-approved for that use.  
• Pharmacists may have the same liability as doctors and manufacturers if they do not inform patients of correct usage, drug interactions, and potential side effects.
• Medical facilities like hospitals and nursing homes share similar liability issues as pharmacists.

The FDA is the only party in the chain of distribution that can not be sued if there are adverse drug side effects. The agency is protected from liability by sovereign immunity. This is similar to restrictions one will face in suing a city for an accident with a city truck. The difference is that cities waive their immunity to give victims a chance to sue if the city was negligent. The FDA is fully protected.

Finding A Lawyer Who Can Win Against Big Pharma

To win a personal injury case, victims must be able to prove four things. This is also true for a case where the victim has suffered harm due to drug side effects. Those requirements are:

• The defendant (in this case the drug company or other related party) owed a duty of care.
• That duty of care was breached.
• The breach caused a personal injury.
• The victim suffered measurable damages as a result.

Proving these things can be challenging, especially when the party at fault is a huge pharmaceutical company. But if you have gotten sicker or have developed unrelated conditions due to a medication, you deserve compensation.

Unlike with a fender-bender or other minor accident, victims can’t just file a claim with their insurance company for these types of cases. You will need an attorney who can go up against the companies and medical professionals responsible.

If you have suffered side effects from a prescribed drug, an over-the-counter medication, or a medical device, contact Hipskind & McAninch. We are personal injury attorneys with experience in product liability and malpractice issues. We’ll review your case and fight to get you the compensation that you deserve.

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Product Liability

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