Dangerous Drug Laws and Recalls

By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed September 11, 2024

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Modern medical research has produced a wealth of medications that help improve our health and extend the length and quality of our lives. A constant stream of new drugs hits the market each year. Unfortunately, some of these drugs are dangerous for consumers. These drugs hurt patients every day.

People harmed by these dangerous drugs have the option of suing the pharmaceutical companies for their injuries. It depends on whether they can show that the drug manufacturer did something to cause their injuries.

Here, we'll discuss what happens when people get hurt after taking a particular medication. We'll also briefly explain what to do if you're the victim of a dangerous prescription drug. If you want further information after reading this article, click the links below.

What Role Does the Food and Drug Administration Play?

The U.S. Food and Drug Administration (FDA) is the gatekeeper regarding dangerous medications and safety alerts. When a patient experiences an adverse event after using a defective drug, they notify their doctor or the FDA directly. The FDA then investigates the matter to determine if the drug poses a public health risk.

If the FDA confirms that the drug is dangerous, it can issue a recall. The recall process is complex and can take longer than most of us would like. However, as long as recalled products are off the shelves, that is the ultimate goal.

It's essential to point out that drug manufacturers also issue voluntary recalls when they learn their medications are dangerous or defective. There are many reasons why drugs get pulled from the market. For example, a new drug may have unpredicted side effects or become dangerous when combined with other medications.

What Dangers Does the FDA Look For?

Sometimes, the FDA receives so many complaints about a medication that it issues a recall immediately. Other times, the FDA will allow the drug to stay on the market but will require the drug company to add warning labels to their defective products.

Some of the common problems the FDA may identify in a drug product include:

  • Drugs causing unhealthy weight loss
  • Medications carrying a high risk of allergic reactions
  • Products containing an unconscionable disclaimer
  • Drugs causing bacterial infections
  • Prescription medications that increase a patient's risk of heart disease
  • Drug impurities
  • Label mix-ups
  • Unwarranted medical advice included in the drug's packaging
  • Medicines that increase or reduce a patient's blood pressure to dangerous levels

Once the FDA identifies a drug's danger or health risks, they may issue a drug recall. The agency classified these recalls as Class I, II, or III.

What Are the FDA Recall Classes?

As stated above, there are three classes of FDA recalls. Which class a drug falls into depends on the dangers it poses. For example, Class I medications are the most dangerous. Class I drugs carry a risk of serious injury, illness, or death.

The specific breakdown of the three FDA recall classes includes:

  • Class I: Products that pose a threat of serious injury/illness or death
  • Class II: Products that could cause a temporary injury or illness
  • Class III: Products that are generally safe but violate one of the FDA regulations

Whether your case is worth pursuing depends partly on which type of recall the FDA issues for the drug you took.

Life-Threatening Side Effects of Medication

All medications carry some degree of risk. Usually, these involve minor side effects. Sadly, some drugs cause severe injuries and even death. Drug manufacturers, pharmacies, and health care professionals must take steps to ensure drug safety and to identify and reduce severe risks like heart attacks, blood clots, etc.

The FDA issues a recall when a drug carries severe side effects, especially the risk of death. They may even order the drugmaker to take the medication off the market. It's also common for patients who took these dangerous drugs to sue the pharmaceutical company and any other responsible party.

Some of the drugs that have been the subject of legal action in recent years include:

  • Ozempic
  • Taxotere
  • Valsartan
  • Zantac
  • Singulair
  • Mounjaro
  • Tepezza
  • Tylenol

Of course, this list doesn't come close to naming all the dangerous drugs that have been the subject of recent product liability litigation. You'll find a more detailed list with accompanying links at the end of this section.

Over-the-Counter Drug Risks

Just because a medication is available without a prescription doesn't mean it's always safe. Over the years, there have been many lawsuits involving over-the-counter medications. Sometimes, the drug itself is said to be unsafe. Other times, a manufacturing defect makes the product dangerous.

One of the most noteworthy over-the-counter drug recalls involved Tylenol. In 1982, a 12-year-old girl died within hours of taking the medication. Many deaths followed. Within a month, the FDA identified more than 270 similar incidents.

All of the incidents involved Johnson & Johnson's Extra Strength Tylenol pills. The FBI and FDA learned that someone had tampered with the pills. They laced them with a myriad of poisons, including potassium cyanide.

The drug manufacturer spent millions of dollars to recall the product. The FDA and FBI confirmed that the deaths were unrelated to manufacturing defects. However, the incidents led to improved pharmaceutical industry security controls and prompted drugmakers to use tamper-proof packaging.

This example shows that, even when the danger is not the manufacturer's fault, the drug company still has a duty to protect consumers.

Market Withdrawal vs. Recall

Sometimes, a drug is so dangerous that the manufacturers decide to withdraw it from the market. These "market withdrawals" (also known as "product withdrawals") are not recalls. The manufacturer doesn't ask consumers to return the product.

Instead, the manufacturer stops distributing the drug. This gradually removes a drug from the market by cutting off its supply.

Market withdrawals tend to be business decisions. A manufacturer may claim that falling sales revenue makes selling a drug unprofitable. Or they may argue that a rise in product liability lawsuits has damaged the brand and hurt the company's public image. Ceasing to sell a drug can remove it from the market without attracting the attention of an actual recall.

How a Product Liability Attorney Can Help

If you or a loved one experienced dangerous symptoms or severe side effects while using a particular drug, contact a health care professional. You should also reach out to an experienced attorney to discuss your options.

An experienced product liability attorney can help guide you through the negotiation and settlement process. Your attorney can also help you determine your damages, secure evidence of your losses, and advise you on different settlement options.

To get started, have an experienced product liability lawyer specializing in drugs and medical devices evaluate your claim.

Click on any of the links below to learn more about laws and legal issues related to dangerous drugs.

Learn About Dangerous Drugs

  • Risperdal: An antipsychotic drug used to treat patients with mental health conditions. Its serious side effects and manufacturer Johnson & Johnson's sales practices have resulted in criminal fines and lawsuits.
  • Pradaxa: A blood-thinning drug prescribed to patients with irregular heartbeats. A high number of patients have reportedly suffered bleeding-related injuries after taking Pradaxa.
  • Yaz: Yaz is a birth control pill manufactured by Bayer. Women who took Yaz have suffered from blood clots as well as strokes, pulmonary embolisms, and heart attacks.
  • Depakote: An anticonvulsant drug for treating epilepsy, bipolar disorder, and migraines. Concerns over the drug's risk of congenital disabilities when taken by pregnant women have prompted FDA warnings and lawsuits.
  • Zoloft: An antidepressant drug manufactured by Pfizer. Experts have linked it to congenital disabilities, an increased risk of suicide among children and young adults, and a brain chemical imbalance called serotonin syndrome.
  • Lipitor: An anti-cholesterol drug manufactured by Pfizer. Researchers have linked this drug to an increased risk of patients developing Type 2 diabetes and liver damage.
  • Paxil: An antidepressant drug manufactured by GlaxoSmithKline. Reports have linked Paxil to an increased risk of congenital disabilities, an increased risk of suicide among children and young adults, and serotonin syndrome.
  • Viagra: One of the most popular drugs for erectile dysfunction on the market. However, the drug causes some pretty severe side effects, including sudden vision loss and priapism.
  • GranuFlo: A chemical solution used in kidney dialysis treatment. Manufactured and used by Fresenius, improper use of the drug can increase the risk of heart attack in patients.

Dangerous Drugs Articles

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