Dangerous Drug Lawsuits: How to Pursue Compensation for Side Effects

Serious drug side effects may entitle you to financial compensation. Here’s where we unpack what you need to know about bad drug claims and lawsuits.

More than 1.5 million people wind up in the hospital every year because of “adverse drug reactions,” meaning side effects from medications. As many as 100,000 patients die from drug side effects. ¹

Nearly half of all Americans outside of hospitals and nursing homes take at least one prescription medication. One out of ten people uses five or more prescription drugs. ²

We take medications to treat illnesses and prevent some diseases. We understand that medications might have some side effects. However, no one expects to suffer serious injuries or death from taking medicine.

If you or a loved one have been severely injured by a prescription or over-the-counter (OTC) medication, you have the right to expect compensation from the responsible parties.

Serious Drug Side Effects

Every medication has potential side effects. It’s up to each person and their medical providers to figure out when the benefits of using a particular medication are worth the risk of potential side effects.

Some side effects are annoying, but not life-threatening, like a dry mouth or drowsiness.

We can decide to take the medicine anyway and adjust to the expected side effect. For example, not “driving or operating machinery” after taking a drug that can make us sleepy.

Sometimes, serious side effects can take us by surprise. Severe injuries from dangerous drugs can include, but certainly aren’t limited to:

  • Anticholinergic Effects: Anticholinergic drugs are used to treat many types of diseases, including breathing disorders, Parkinson’s Disease, and overactive bladder. Side effects can include hallucinations, memory problems, confusion, and delirium. Some studies indicate an increased risk of dementia.
  • Anaphylactic Shock: A serious, life-threatening allergic reaction to a medication that can cause swelling of the face, tongue or throat; difficulty breathing; low blood pressure; vomiting; dizziness or fainting.
  • Birth Defects: Many types of medications can be harmful to a pre-born child if the drug is taken by the mother while pregnant. In 2017, a jury ordered drug manufacturer AbbVie, Inc. to pay $15 million to a boy born with a spinal defect blamed on the medication Depakote his mother took while pregnant.
  • Brain and Nervous System Disorders:  Some medications have side effects that can leave a person paralyzed, brain damaged, or with nerve damage in parts of the body. Bayer paid more than $8 million to settle a multi-state drug lawsuit over the cholesterol-reducing medication Baycol, alleging a failure to warn users against an increased risk of severe nerve and muscle disorders.
  • Cardiovascular Effects: Medications that result in heart attacks, fatal heart rhythms, heart failure, and strokes have led to billions of dollars in lawsuit settlements. For example, Merck pharmaceutical company paid $4.85 billion to settle 47,000 lawsuits filed by groups of people who alleged the pain-relieving drug Vioxx caused heart attacks and strokes.
  • Kidney Failure: Some patients can suffer serious kidney damage, including renal failure from their medications. Litigators are currently taking aim at drug companies that manufacture Prevacid, Prilosec, Nexium, and similar heartburn medications. Evidence is mounting to suggest that these heartburn medications are responsible for severe kidney damage.

Federal Drug Regulations and Compensation

The U.S. Food and Drug Administration (FDA) is the primary government agency responsible for:

“[P]rotecting the public health by regulating human and animal drugs, biologics (e.g., vaccines and cellular and gene therapies), medical devices, food and animal feed, cosmetics, and products that emit radiation.”

The FDA approves all new drugs and biologics. New drugs are approved only after the FDA has reviewed the result of all testing made by the manufacturer, and determined the manufacturer is capable of meeting FDA quality standards.

The FDA does not approve compounded drugs, meaning ingredients mixed by a doctor or pharmacist to meet the needs of individual patients.

Can I Sue the FDA for Approving Dangerous Drugs?

Government agencies, including the FDA, are protected by sovereign immunity.

Sovereign immunity is a legal rule that prevents the government or its subdivisions, departments, and agencies from being sued without its permission.

In non-drug cases, an individual can file an injury claim against the government under the rules of the Tort Claims Act for federal agencies. The Tort Claims Act comes into play if you are injured by an at-fault government employee, like a government worker who causes a car accident.

While a government worker who approves a medication that later turns out to be dangerous might be technically “at fault” the Tort Claims Act has specific exceptions to protect the FDA and its employees from alleged mistakes in the evaluation and approval of medications.

National Vaccine Injury Compensation Program

The National Childhood Vaccine Injury Act of 1968 has expanded to become the National Vaccine Injury Compensation Program. Funded by taxpayer dollars, this federal program is a no-fault way for individuals injured by severe vaccine side effects to receive compensation.

For the sake of public safety, the federal government wants to make sure there are enough vaccines to go around to prevent outbreaks of serious diseases.

If you give millions of people the same vaccine, there are bound to be occasional adverse reactions. If drug makers are hit with too many lawsuits, they won’t continue to make needed vaccines.

“[The fund] was created in the 1980s, after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates, which could have caused a resurgence of vaccine-preventable diseases.”

Anyone who believes they, or a family member, were injured from taking a covered vaccine may file a petition for compensation. Filing a petition is a legal action.

Most individuals hire a personal injury attorney to handle their claim. Your attorney’s fees and costs will be covered by the program and will not come out of your compensation award.

Case Summary: $11.6 Million Vaccine Injury Settlement

Sarah Behie was a nurse’s aide at a Pennsylvania hospital. She began having symptoms of pain and weakness about three weeks after receiving a flu shot at work.

Behie’s symptoms worsened until she was hospitalized, where she was diagnosed with Guillain-Barre syndrome, a rare neurological condition that left the 24-year old woman partially paralyzed and unable to care for herself.

Behie blamed the flu vaccine for causing her injuries.

Her attorney negotiated a settlement with the National Vaccine Injury Compensation Program that pays the disabled young woman over a million dollars for her medical expenses, lost wages, and pain and suffering.

The fund will also pay up to $11.6 million over Behie’s lifetime for her ongoing medical care.

When You Can Sue a Drug Manufacturer

If you’ve suffered a serious illness or injury from taking a dangerous drug, whether prescription or over-the-counter, your first instinct may be to blame the company that manufactured the drug.

Every type of medication has potential side effects. If you sue the manufacturer, you’ll have to prove you weren’t warned of the side effect you suffered.

If your medical provider or the manufacturer told you about a possible side effect, and you decided to take the medication anyway, you won’t be able to blame the drug company.

A legal action against a drug company is much the same as any other product liability lawsuit. You’ll need to show the medication had one or more defects:

  • Manufacturing defects in medications happen when the drug is made and can include problems like unsafe or tainted ingredients.
  • Dangerous side effects are adverse reactions to the medication that the drug maker knew about or should have known about through thorough testing.
  • Marketing defects (“Failure to Warn”) happens when the drug maker doesn’t provide the user or the prescribing doctor with enough information to determine if the risk of side effects are worth the benefits of using the medication.

Unfortunately, pursuing compensation from pharmaceutical companies became a lot more difficult in 2013, when the U.S. Supreme Court ruled that companies making generic medications can’t be held liable under state “failure to warn” laws.

Case Summary: Mutual Pharmaceutical Co., Inc. v. Bartlett

In 2004, Karen Bartlett was prescribed Clinoril for shoulder pain. The pharmacist filled her prescription with sulindac, the generic version of Clinoril made by Mutual Pharmaceutical.

Bartlett rapidly developed a severe skin reaction called toxic epidermal necrolysis that destroyed sixty percent of the skin covering her face and body.  After spending months in a medically-induced coma, Bartlett was left nearly blind and permanently disfigured.

At the time, the drug’s label didn’t specifically refer to toxic epidermal necrolysis but did warn of severe skin reactions. Toxic epidermal necrolysis was listed in the package insert.

Bartlett’s attorneys filed suit on her behalf in New Hampshire, blaming the drug company for “failure to warn” and “design defect” claims.

While the “failure to warn” claim was dismissed in District Court when Bartlett’s doctor admitted to not reading the package insert, the jury awarded Bartlett over $21 million for the design defect claim.

The District Court verdict was overturned by the U.S. Supreme Court.

The Supreme Court ruled that generic drug makers cannot be held liable under state laws for defects related to drug labels because the drug makers must comply with federal laws.

Under federal laws, generic drug manufacturers are prohibited from making any changes to the drug’s ingredients or the wording on the drug’s label from that which was approved by the FDA for the name-brand medication.

Don’t give up if a generic drug harmed you or a loved one. Talk to a personal injury attorney to discuss all your options for pursuing compensation.

How an Attorney Can Help You Win

While you may not be able to file a lawsuit against the FDA or a generic drug manufacturer, your attorney can help identify all the parties who may be liable for your injuries, expenses, and pain and suffering.

Class Actions Against Drug Manufacturers

A class action lawsuit is when a group of people injured by the same drug file a lawsuit against the drug manufacturer. The group of “similarly situated” victims are the class. The class is represented by one or more law firms.

You may have the right to “opt in” to a class action drug suit. As part of the class, you won’t have to pay any legal fees. All costs are paid in advance by the attorneys representing you and the other class members.

When your class action is settled or won at trial, the attorneys will be paid a percentage of the total amount, and the rest will be paid to the class members.

When the Doctor Shares Blame

There’s a difference between drug lawsuits and medical malpractice lawsuits. Malpractice can happen when your doctor was negligent in prescribing a drug that harmed you.

For example, the doctor may have prescribed a drug for “off-label use” meaning the drug was intended for a different condition than the one you’re being treated for. Or the doctor may have prescribed the wrong dosage, or failed to take into consideration your other medications or allergies.

When a patient is injured because the doctor deviated from standard medical practices, the doctor is negligent and liable for the resulting damages.

Pharmacists Can Be Held Liable

Pharmacists have a legal duty of care when giving out medications. They receive extensive training in pharmacology and should be familiar with every drug they dispense. This includes knowing about potentially harmful interactions between drugs when taken together.

It’s up to the pharmacist and doctor to work together to make sure a prescribed drug will not injure the patient. In today’s day and age however, communication between a doctor and pharmacist is often limited. The one who suffers most is the patient.

As a patient and customer, you have a right to rely on the expertise of your doctor, and the pharmacist who filled your prescription. When they fail to protect you from harm, and you suffer injuries, you have a right to seek compensation.

Why You Need an Attorney

Every pharmaceutical company is a huge corporation with an army of aggressive lawyers. Many are international companies, making litigation even more complicated.

Doctors and pharmacists rarely admit to fault and are often defended by large insurance companies with deep pockets.

Medical injury cases caused by bad drugs or malpractice are complicated, high-dollar claims. You’ll need a skilled attorney to get anywhere near a fair settlement for:

Experienced attorneys have the knowledge and money to handle complex medical liability cases. Most attorneys will represent injury victims on a contingency fee basis, meaning they won’t be paid any fees unless your case settles or you win a court verdict.

Don’t settle for less. It costs nothing to find out what a good attorney can do for you and your family.

Dangerous Drug Questions & Answers

Charles R. Gueli, Esq. is a personal injury attorney with over 20 years of legal experience. He’s admitted to the NY State Bar, and been named a Super Lawyer for the NY Metro area, an exclusive honor awarded to the top five percent of attorneys. Charles has worked extensively in the areas of auto accidents,... Read More >>