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When is a Drug Defective?

Written by Berkowitz

prescription drugs

Pharmaceutical Malpractice Lawyers Serving those Injured by Defective Drugs throughout Connecticut

Pharmaceutical manufacturers make billions each year from their prescription medications and generics. The United States has reached an all-time high for prescription drug use.

In fact, nearly 70 percent of consumers are taking at least one prescription medication, and more than half of that number take two. The most commonly prescribed drugs are antibiotics, painkillers, and antidepressants.

While most medications on the market are safe, there are some that are dangerous and can cause fatal reactions when they are prescribed incorrectly, manufactured with defects, or when harmful side effects are not disclosed.

Today, we focus on the defective drug and what constitutes a defective medication.

The Unavoidably Safe Product Exception

Certain prescription medications are unavoidably unsafe. That means that these medicines cannot be 100 percent safe regardless of any alterations manufacturers would make to them. These drugs carry dangerous side effects, but the benefits of using these medicines outweigh the risks. Therefore, if the physician properly notifies their patient of the risks and benefits, and provides alternatives, using the drug cannot result in a lawsuit against the manufacturer.

However, the manufacturer must include proper warning labels and information to prescribers. If they do not, then their dangerous drug is open to lawsuits.

Drug Manufacturers Have a Duty to Warn

All manufacturers are required to disclose any side effects – including those that occur rarely. These warnings come in the informational sheets you receive with your prescription, labels on the bottles themselves, and they are given to prescribers so that everyone is equally informed.

Failure to Disclose Serious Side Effects

The manufacturer must disclose all side effects; therefore, when they skew information from clinical trials or outright avoid disclosure, they have violated their duty.

Drug manufacturers are experts in their field; therefore, the court is not forgiving when a manufacturer ignores their duty. Once a side effect becomes known, they are also required to update information and labels to ensure the public knows about new side effects.

What Is the Medication Guide Required by the FDA?

The FDA often requires a Medication Guide come with prescription medications. The guide is a paper handout given to patients and prescribers that addresses all potential side effects, symptoms, and concerns associated with that drug.

When Advertising Makes a Drug Dangerous

The FDA also imposes strict rules regarding advertisements for medications. If you have seen a drug commercial, you might have noticed that at the end of the commercial a long list of potential side effects and complications are shared. This is because the FDA requires any consumer advertisements include the risks of a medication – ensuring patients are not drawn in with flashy ads and unaware of the dangers.

The FDA’s Role in Prescription Drugs

The Food and Drug Administration (FDA) uses strict policies and standards to ensure that any medication released is safe. However, there is a surprising number of over-the-counter medicines still missing FDA approval.

The process for FDA approval is complicated and takes years – with certain medications not revealing their real dangers until years after they have been released.

When the FDA learns of adverse reactions, they respond by:

  • Writing reports regarding the potential hazards
  • Writing letters to prescribers informing them of the possible side effects
  • Demanding more trials from the manufacturer before further releases
  • Conducting in-depth reviews of the trial process and warning labels furnished by the manufacturer
  • Adding warnings to labels
  • Requesting that the manufacturer stop making the drug and remove it from the shelf

The Requirement of Clinical Trials

To receive FDA approval, drug manufacturers must conduct a series of clinical trials. These studies are then reviewed by the FDA to decide if the medication is safe. Some defective medications do not have side effects present in clinical trials – other times the manufacturer will outright skew data to hide these results.

Skewing any clinical trial results is a direct violation of FDA guidelines and the manufacturer opens the door to multiple lawsuits that might include punitive damages.

Common Types of Defective Drugs

Numerous types of medications could be considered defective, but specific classes of drugs are considered dangerous and face more defective drug lawsuits than others.

Diabetes Medications

Some diabetes medications were linked to cardiovascular conditions, including heart attacks and heart failure. Already multiple manufacturers have added warning labels and paid billions in lawsuits for failing to disclose the high risk of cardiovascular complications.

Antidepressant Medications

Antidepressants come in numerous forms, but those with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) tend to have multiple complications for users. These antidepressants have been linked to severe side effects. Common antidepressants in these categories include:

  • Prozac
  • Paxil
  • Zoloft
  • Effexor
  • Lexapro

Birth Control Pills

Birth control medications are linked to life-threatening complications, including blood clots, stroke, or death. Specific pill brands, like Ocella, Yaz, and Yasmin were linked to high risks of developing blood clots. Some conditions, like pulmonary embolisms and deep vein thrombosis (DVT), can happen too.

Acne Medications

Prescription acne medications can be a lifesaver for teens and adults facing severe, repetitive acne. However, they can also lead to catastrophic side effects. Drugs like Accutane, for example, have serious side effects that can increase suicidal thoughts in teenagers, congenital disabilities (if the patient is pregnant), and lead to Crohn’s disease.

Heart Disease Prescriptions and Anti-Stroke Medications

Blood-thinning medications, like Pradaxa, may cause fatal complications, including heart failure, liver damage, and uncontrollable bleeding. Stroke medications, such as Crestor, were associated with heart attacks, causing Type 2 diabetes, and even leading to rhabdomyolysis – which causes kidney failure and possibly death.

Osteoporosis Medications

As we age, our bone density decreases and for some patients, they are at high risk for bone fractures. Osteoporosis medications are supposed to decrease this complication. However, some drugs like Fosamax can increase the risk for bone fracture – the very thing they are meant to prevent.

These can also lead to osteoporosis of the jaw – Dead Jaw Syndrome. Eventually, this condition leads to a collapse of the jaw’s structure.


Antibiotics were initially introduced in the 1920s when the power of penicillin was first introduced. Today, antibiotics take many forms. Certain types are used for specific infections, but they are there to help treat dangerous infections before they turn life-threatening.

Z-Pack (Zithromax) is a powerful antibiotic still used today to treat bacterial infections. While effective, the FDA found that the drug can lead to fatal heart complications, especially if the patient already has a heart condition.

Dialysis Treatment

In some cases, a patient cannot live without weekly dialysis treatments. Drugs used for dialysis, such as GranuFlo, have been used to treat chronic kidney disease and renal failure. If these medications are administered in doses that are too high or inappropriately, they can lead to death. Also, medical conditions like metabolic alkalosis and heart failure have been linked to these medications.

Epilepsy Drugs and Antipsychotics

Drugs like Depakote which treats mood and seizure problems is linked to severe congenital disabilities when taken while pregnant. These drugs also seem to sometimes lead to liver failure and pancreatitis. Another medication, Topamax, treats epilepsy but can result in metabolic acidosis and birth defects.

What Constitutes a Defective Drug Lawsuit?

To prove that a medication classifies as a defective drug, you must determine four elements:

An Injury or Loss Was Suffered

First, you must establish there were injuries and losses due to the faulty medication. Your losses must be tangible and calculated so that your attorney can show a judge or jury the actual financial impact of the drug on your life and loved ones.

Evidence of a Defective Product

Next, your attorney must show how the medication is defective. In a product liability claim, there are three categories of defects, including inadequate warning labels, faulty manufacturing, or dangerous design (such as hazardous formulations).

This portion of the claim is the most complex, and your attorney will rely on study data, medical experts, and drug manufacturing experts to prove the medication is defective.

Using the Product as Intended

You cannot claim a medication is defective if you did not use it as it was intended. Therefore, abusing a drug, taking too much or too little, or sharing prescriptions with friends does not qualify.

If your physician prescribes the medication for off-label use – meaning a purpose it was not intended for – and the physician was not told to do so by the manufacturer, then you will likely not be able to sue the manufacturer. In this case you are more likely to file a malpractice claim against your doctor.


Lastly, your attorney must show that the defects in the drug caused your injury – despite you using the medication as intended.

Product Liability Claims in are Complex – Contact a CT Injury Attorney

Sadly, proving defective drugs is one of the harder product liability cases to file and win. When you work with a products liability attorney that has experience with defective drug lawsuits, however, you increase your chances substantially.

The CT personal injury lawyers at Berkowitz and Hanna, LLC understand your frustrations. You take a mediation to help you – not to feel worse. Let our injury attorneys file a claim against the manufacturer and hold them accountable for poor manufacturing, inadequate labels, or improper testing.

Contact Berkowitz and Hanna, LLC to schedule a no-obligation case evaluation. Call us or request your consultation online.