Pharmaceutical Liability Information Center

Pharmaceutical Liability - An Overview

“Pharmaceutical liability” is a term used to describe the legal consequences a manufacturer of drugs may face if its products injure people. Cases involving injuries caused by drugs, medical devices and other pharmaceuticals are a subset of products liability cases. Plaintiffs can bring claims against the manufacturer based on theories of strict liability, negligence or for failing to warn about potentially dangerous side effects. In some states, however, a statute creates a single claim for product injuries, which may combine aspects of the two. A lawyer at Dolan Law Firm in Miami who has experience in pharmaceutical liability law can advise you about your rights and help you decide whether you can pursue a claim.

Types of Defects

Prescription drugs, over-the-counter medicines, medical devices and herbal supplements may suffer from several different defects, which may lead to pharmaceutical liability claims. A design defect occurs when the manufacturer or producer fails to design the drug or medical device so that it is safe for its intended use. Typically, the manufacturer could have used a safer alternative design to avoid foreseeable risk.

A manufacturing defect occurs during the manufacturing process and has nothing to do with the design. Even if the design was perfect, poor manufacturing can undo proper safety measures. This can occur when a manufacturer uses the wrong materials or fails to use appropriate quality controls.

A marketing defect, such as the failure to warn of danger or instruct on proper use, is a different kind of defect. A product that is safe when the consumer knows how to use it can turn dangerous without the proper warnings. The manufacturer has a duty to warn users of potential side effects that can make the product dangerous. There can be a failure to warn if the manufacturer does not inform consumers about adverse drug interactions.

Elements of a Claim

Although the law varies from state to state, claims for injuries arising from the use of prescription drugs, over-the-counter medications, herbal or dietary supplements and medical devices generally may proceed under two legal theories: strict liability or negligence. Under the strict liability theory, the medicine is on trial and the jury will be asked to decide whether the medicine or its manufacturing process is defective. To prove the claim, you must show that the medicine has a defect that makes it unsafe, that the defect injured you and that the injuries caused you monetary damage.

For a negligence claim, you must show that the manufacturer owed you a duty of care, that the duty was breached, that the breach caused your injuries and that you were injured.

Another thing to consider is whether a claim ought to be pursued against the doctor who prescribed the medication to you or to the pharmacy that filled the prescription or helped you decide what medicine to buy. These claims are distinct from claims against the manufacturer and need to be considered separately.

The Role of Government Oversight in Pharmaceutical Liability Cases

Drug companies hoping to sell their products in the United States cannot do so until the Food and Drug Administration (FDA) reviews the medication and approves it for sale. The FDA does not guarantee drug safety. Once the FDA approves a drug for a particular use, patients who are injured by the drug — whether it is used for its approved purpose for some other reason (known as “off-label” use) — must look to the manufacturer for redress. Manufacturers will sometimes try to persuade a jury that, because the FDA approved the medication, the manufacturer should not have to answer for any injuries the medication caused.

What To Do If You Have Been Injured

When a person has an adverse reaction to a medication — whether the medication was obtained through a prescription or over the counter — it is important to seek legal advice as soon as possible. State laws impose time limits on when a lawsuit can be filed and if that deadline is missed, the case cannot proceed no matter how badly the person was injured. In some states, the time begins to run when you take the medicine. In other states, the time might not start to run until you learn that the medication may have caused your injuries. An attorney at Dolan Law Firm in Miami can advise you as to whether you still have time to file your case and prepare the papers to file with the court.

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DISCLAIMER: This site and any information contained herein are intended for informational purposes only and should not be construed as legal advice. Seek competent legal counsel for advice on any legal matter.

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