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When Can Patients Sue Drug Companies?

Written by Berkowitz


What is the difference between a medicine and a poison? Unfortunately, in thousands of cases every year, the answer is “very little.” In some cases, an error is made by a doctor or a pharmacist. In other cases, however, it is the drug itself that is the problem. Dangerous drugs remain on the market despite the fact that every drug must be approved by the U.S. Food and Drug Administration (FDA) after rigorous testing.

You might think that it would be impossible to sue a drug manufacturer for a defective drug once it has obtained FDA approval. In fact, however, this is not the case. In most cases, you can sue the drug manufacturer despite FDA approval of the drug in question. FDA standards are treated as minimum standards, and individual states are permitted to hold drug companies to higher standards. Connecticut allows you to sue a drug manufacturer under its Products Liability Act.

Products Liability vs. Medical Malpractice

If you are harmed by a prescription medication, you might have a products liability claim against the drug manufacturer. On the other hand, the problem might have arisen because your doctor prescribed you the wrong drug or because your pharmacist made an error when preparing your medication. If this happens, you should file a medical malpractice claim against the responsible party. A lawyer can help you identify the appropriate defendant.

Defective Drugs and Connecticut Products Liability Law

Connecticut products liability law allows you to sue a drug company for a drug that is defective and unreasonably dangerous. You can also sue anyone in the chain of distribution of the drug, including wholesalers and retailers, as long as they were in the business of regularly selling pharmaceuticals.

Types of Defects That Can Support a Defective Drug Claim

A product liability claim must identify one of the following three types of defects:

  • A design defect: Design defects are the most fundamental type of defect that a drug can have. The defect lies at the conceptual level (in the molecular structure of the compound, for example). Drug companies tend to resist design defect claims vigorously, because if they lose, they will have to take the drug off the market and redesign it.
  • A manufacturing defect: A manufacturing defect exists when the drug is not manufactured in the way it was designed, and when this difference caused the harm you are complaining of. A manufacturing defect might apply only to a single batch of the drug.
  • A label defect: A label defect, often referred to as a “warning defect,” is a defect in the product warnings that come with the packaging of the drug. It may neglect to mention, for example, that it should not be taken by pregnant women.

It is possible for a products liability claim to specify more than one of the foregoing types of defects (a design defect and a label defect, for example).

How Strict Products Liability Works in Defective Drug Claims

If you file your products liability claim under a strict liability theory, you can win without even directly proving that the drug manufacturer was negligent. Instead, you must prove the following:

  • The drug contained one of the three types of defects listed above, and the defect was “unreasonably dangerous.” A certain degree of risk is inherent in the use of any drug, and this risk doesn’t necessarily render the drug unreasonably dangerous even if you were injured by it. By the way, the precise application of the word “unreasonable” is where lawyers often fight.
  • The defect injured you as a user of the product.
  • The product was being used in a way that it was intended to be used when the injury occurred.
  • The product was not substantially changed, in terms of its performance, after it was originally sold.

Time Limitations

Connecticut products liability law requires you to comply with strict time limitations for filing a lawsuit. If you miss the deadline, you will sacrifice your claim; you probably won’t even be able to negotiate a private settlement..

The Statute of Limitations: The general statute of limitations deadline is three years after the date of the injury that you suffered. If you suffered a continuing injury (if you took the drug for several months, for example), the three-year clock starts ticking on the date of the last time you took the drug. This analysis can get tricky, so consult a lawyer if you are unsure.

The Discovery Rule: In many cases, you might not realize (and shouldn’t be expected to realize) that the symptoms you have been suffering from can be traced back to a defective drug. In other cases, the harm may not have produced symptoms immediately. In such cases, the statute of limitations clock does not begin running until the date that you knew or should have known that the defective drug was the cause of the harm you suffered.

The Statute of Repose: The statute of repose imposes a hard deadline on a products liability deadline. Regardless of whether the general statute of limitations deadline has expired, and regardless of any extension imposed by the discovery rule, no products liability lawsuit can be filed against a drug manufacturer more than 10 years from the date that the manufacturer last parted with possession of the product.

Comparative Fault

Under Connecticut’s comparative fault principles, you might still be able to seek compensation from a drug manufacturer even if you are partly at fault for your injury (you did not follow the doctor’s instructions on how to take the drug, for example). In such cases, your damages will be reduced in proportion to your fault.

Special Case: The National Vaccine Injury Compensation Program

In some cases people are injured by vaccines. A common injury, for example, is a severe allergic reaction. And in a few cases, a vaccine will cause the very disease that it was designed to protect against. The National Vaccine Injury Compensation Program (VICP) was created to help compensate people who were injured by the vaccines that are covered by the program. A claim under the VICP is an alternative to a lawsuit against a drug manufacturer.

To file a claim under the VICP, you must:

  • File a petition with the Court of Federal Claims.
  • The Department of Health and Human Services will review the petition and issue a recommendation.
  • The U.S. Department of Justice will review your claim and issue a recommendation to the Court of Federal Claims
  • A court-appointed special master will approve or dismiss the petition. He may convene an adversarial hearing before issuing his decision. The special master will also determine the amount of compensation.
  • If your claim is successful, the Court of Federal Claims will order the Department of Health and Human Services to pay the amount awarded by the special master.

Autism Claims

Neither Connecticut nor federal law recognizes the claim that cases of autism can be traced to vaccines. In fact, no jurisdiction in the United States recognizes this claim.

Special Case: Limitations on Claims against Generic Drug Companies over Label Defects

In 2013, the US Supreme Court imposed a significant limitation on an injured patient’s ability to sue a drug company. In the case, Mutual Pharmaceutical Co., Inc. v. Bartlett, the Court held that manufacturers of generic medications cannot be held liable under state “failure to warn” laws unless the brand name manufacturer had already changed its warnings, the FDA had approved the change, and the generic manufacturer failed to update its warnings accordingly.

Steps to Take to Enforce a Connecticut Product Liability Claim

Winning a product liability claim requires an intimate understanding of the technical issues involved, and it may require the advice and testimony of expert witnesses. The typical process involved in a defective drug products liability lawsuit is set out below:

  • Investigate the incident that led to the harm you suffered, and commission an expert to provide a technical review, if necessary.
  • Collect evidence such as your medical records, evidence of your injury and, of course, a sample of the drug itself.
  • Identify the appropriate defendant. There is likely to be more than one potential defendant, and you can sue all of them at the same time if you choose. The manufacturer, of course, is likely to have the deepest pockets, but it is also most likely to possess the financial resources necessary to put up a vigorous defense.
  • File a claim with the defendant and attempt to negotiate a settlement. You may have to actually initiate a lawsuit, however, to motivate the drug company to issue a serious settlement offer.
  • File a formal Complaint with the court.
  • Continue negotiating, if possible. Most products liability claims are settled out of court, and there is rarely any doubts as to whether a drug company is able to pay.
  • Go to trial, if necessary. You will need a lawyer to help you prepare legal filings, construct arguments, interview witnesses, and advocate for your interests.

Personal Injury Claims vs. Wrongful Death Claims

If your loved one was harmed by a drug, whether prescription or over-the-counter, a personal injury lawsuit based on products liability may be appropriate. If your loved one eventually dies from the condition caused by the defective drug, a wrongful death lawsuit against the drug manufacturer may be in order. But who is entitled to file such a lawsuit? In Connecticut, the personal representative (executor) of the deceased victim’s probate estate must file it.

The personal representative of the estate is either the person named in the last will and testament or another party named by the probate court, usually a close family member. Wrongful death damages can be substantial, and they go to the estate itself for eventual distribution to estate beneficiaries.

Call the Professionals Today

Products liability claims tend to be technically complex, requiring the expertise of an attorney with experience handling Connecticut medical malpractice lawsuits. We have that experience, and we will not charge you a dime unless we win your case. Contact Berkowitz Hanna today to schedule a no-obligation case evaluation. Call us now or contact us online to get started.