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What Is a Failure to Disclose Rare or Serious Side Effects?

Written by Berkowitz


Each year, patients are injured by prescription medications and over-the-counter drugs that are used to treat medical conditions. When an injury occurs from a prescription that did not disclose serious side effects, a victim may consider filing a lawsuit to collect compensation for any injuries and damages they sustained.

However, it is important as a victim to understand what qualifies for a lawsuit. Also, you must understand what it means for a manufacturer or physician to fail to disclose these side effects, and the chances of winning your case.

If you have suffered a serious injury from a prescription medication or over-the-counter drug with an undisclosed side effect, contact an injury attorney right away.

Filing a Dangerous Drug Lawsuit in Bridgeport, CT – Here’s What You Need to Know

After an injury from a medication, you may want to explore your legal rights. Some questions that you may have include:

  • Is my doctor liable or just the manufacturer?
  • Does the pharmacy share any responsibility for my injuries?
  • Can I sue the company that made the drug?

What Is a Failure to Disclose Dangerous Side Effects?

When you receive a medication from your physician, the pharmacy, or it is released by the manufacturer, all parties are required to disclose any harmful side effects that you may encounter. That is why when you receive a drug at the pharmacy you receive an information print out that discusses these effects. Sometimes side effects are minor and may include a cough or headache. Other times, side effects may be life-threatening, such as infection, brain bleed, liver damage, and more.

It is a manufacturer’s, physicians, and pharmacists job to prevent injury to consumers taking medications that they prescribe or supply. Therefore, when they fail to fulfill this duty, they may be held liable for damages.

The Role of the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is there to protect public health interests, regulate human and animal medications, and control all medical devices, food, and other products sold on the consumer market.

While you might think that the FDA approves all medications sold or prescribed, you would be incorrect. Not all medications are subject to FDA approval, such as compound medications. Other times, medications are not reviewed by the FDA until they are released and sold.

Even with FDA approval, dangerous drugs enter the market and may be prescribed and used by patients for years before their defects are discovered. Therefore, do not assume that any medication sold is approved, or that an approved medication is safe.

Also, if the FDA approves a dangerous drug, you may assume you can sue the FDA for failing to verify the medication’s safety – but you cannot. The FDA is a government agency. Therefore, they have sovereign immunity in personal injury lawsuits. The only time you could reasonably sue the FDA is if they allow it, which is rare.

How the FDA Approves Medications

Before a drug is legally released, the FDA typically approves that medication. The pharmaceutical manufacturer that wants to sell the drug must submit an application with the FDA. Then, they must supply clinical evidence that the medication brings the effect that they claim, and that it does so safely.

Clinical evidence comes from animal and human trials. These trials are conducted by the company releasing the medication, not the FDA. The clinical evidence is then given to the FDA, who will then decide if the benefits of the medication outweigh any risks or side effects noted in the trials.

It is not uncommon for the FDA to find out that a drug is dangerous months or even years after it was initially approved. Sometimes a medication must be taken on a large scale over longer periods of time before manufacturers realize that the medication has issues. If the FDA receives any reports of serious side effects, they could take action – such as requiring that the company include those warnings in information handed out, or completely remove the medication from the marketplace.

MedWatch’s Role

Physicians are required to keep up with MedWatch, which is operated by the FDA. MedWatch monitors any reports of side effects and deaths resulting from a medication. It also offers patients and healthcare professionals the opportunity to provide input to the FDA regarding any approved medications.

FDA Advertising Rules

The FDA has regulations on how medications are advertised. If you have seen a medication advertisement, you might note that at the end there are a list of potential side effects listed for those taking the medication. This is because the FDA requires any potential side effects are given, but also that manufacturers do not exaggerate or mislead patients about their drugs.

Manufacturer Liability for Serious Side Effects

Before 2013, a manufacturer of a dangerous medication could be sued if that medication led to injury, illness or death. In fact, these companies paids hundreds of millions to patients and their families.

However, in 2013, the United States Supreme Court in the case of Karen Bartlett vs. U.S. Merck and Co. and Mutual Pharmaceutical Company decided that if a drug receives FDA approval, then families and victims cannot sue the manufacturer even if the drug caused them harm.

Protections Only Go So Far

While the Supreme Court offers this protection to manufacturer’s, you must realize that this is for side effects that did not appear in testing. If it is determined that the manufacturer lied or failed to disclose these side effects, and they knew of their risk, then the court’s ruling would not apply.

Holding Doctors and Pharmacists Liable

While you cannot hold a manufacturer responsible for your injuries in some cases, you can still hold the pharmacy and physician liable for failing to disclose information, or when a prescription medication causes you harm. Deciding which parties apply to a lawsuit, however, should be left to an attorney. An attorney has handled countless cases just like yours, so they are experienced at identifying the responsible parties and seeking the highest possible compensation in your case.

When Is a Physician Liable?

Drug lawsuits and malpractice lawsuits are not the same. A lawsuit that is based on an injury or illness stemming from a physician’s negligence with prescribing medication still falls under malpractice.

A doctor is held to a higher standard of care in their community than the average person. When they fail to provide that standard of care and someone is injured, the physician is negligent and liable for those injuries.

If you can prove that your physician’s negligence was the cause of your injuries, you may receive compensation for those injuries.

When Is the Pharmacy Liable?

A pharmacist also has a duty of care when dispensing medications to patients. They receive training on medications and they must be familiar with every medication they dispense – including interactions with medications the patient is already taking.

It is up to the pharmacist to catch harmful side effects and interactions, and educate the patient before giving them the medication.

Potential Side Effects That Can Result in a Lawsuit

It is impossible to provide a full list of prescriptions and over-the-counter medication side effects that a patient may be able to sue for, but some of the potential side effects seen in past lawsuits include:

  • Physical Disability – A patient may suffer a physical disability, such as being unable to walk, joint pain, arthritis, ulcers, liver inflammation, sporadic muscle issues, birth defects, and more. If a physical disability results from the medication, especially a long-term or permanent one, then the patient may be able to sue for damages.
  • Liver Damage – A serious side effect of medications is liver damage, and when a patient is not warned about the potential for liver damage, the results could be catastrophic.
  • Suicidal Thoughts or Attempts – Some medications may increase the risk of a patient attempting suicide. Often medications prescribed to treat depression and suicidal tendencies can cause suicidal thoughts or increase a patient’s risk for attempting suicide.
  • Death – If the death occurs from a serious side effect, such as heart failure, stroke, or liver failure, the patient’s family may be able to file a lawsuit for the death.
  • Stroke – A common serious side effect that might not be disclosed is stroke. Strokes are frightening and can lead to long-term complications. Some medications that can increase the risk of blood clots or damage to arteries should have warnings for strokes and patients must be warned by physicians about the increased risk of a stroke.

What Role Does an Attorney Play in a Drug Lawsuit?

Whether you are suing your physician, the pharmacy or the manufacturer of the medication, it is important that you hire an attorney. Any type of drug lawsuit requires professional representation. A physician, pharmacy, and definitely a manufacturer would never admit fault, even if they know they are at-fault.

An experienced legal professional can help defend you from insurance companies and prove your case so that you can receive the compensation you need.

Contact Berkowitz and Hanna, LLC to schedule a no-obligation consultation. Call 866-479-7909 or contact us online to get started.