Drugs & Medical Devices Law

Prescription Drug Lawsuits

When people are injured because of harmful prescription drugs they have taken, resulting lawsuits that may be filed on their behalf by their attorneys fall under the larger umbrella of products liability law. Products liability cases may be filed under three different categories: a defect in the design of a product, a defect in its manufacture or a defect in its marketing.

Design Defects

Drug manufacturers must go through a process for approval of a new drug with the Federal Drug Administration. In some instances, a medication that has been approved will have side effects that were not foreseen and that cause significant harm. For cases involving these types of claims, the medication was properly manufactured but the design of them caused dangerous and harmful side effects.

Marketing Defects and the Failure to Warn

The FDA also requires drug manufacturers to warn patients about drug interactions and side effects that can happen. In the case of medications that have been demonstrated to present a significant risk of harm to patients, the agency requires that the manufacturer include a black-box warning, the most serious warning available. Claims that fall under this category may be asserted due to the manufacturer’s failure to adequately warn about possible side effects. They may also involve claims against physicians and pharmacists if they failed to provide the warnings as well.

Manufacturing Defects

The third category of claims involves manufacturing defects. This can include problems that occurred in the manufacturing process that led to a medication being tainted. Other examples may include the wrong labels being placed on medications.


When harmful drugs cause injury multiple parties may be held liable in a product liability claim. These parties can be a component to any part of the product’s chain of distribution:

  • The manufacturer of the product
  • The manufacturer of a component of the product
  • The wholesaler
  • A retail store that distributed the product
  • Physicians or pharmacists if they failed to provide warnings about the products

The concept of market share liability states that, if the injured party cannot adequately identify which pharmaceutical company supplied the medication they took, each manufacturer who supplies the same medication can be held liable based on the number of sales they hold in the area.

Burdens of Proof

The burden of proof required for the plaintiff in a harmful drug lawsuit can vary. One rule is that of strict liability. In cases where strict liability is applicable, plaintiffs who have been harmed do not need to prove that anyone was negligent. They only need to prove that the medication was dangerously defective, that it was used in the way that it was intended to be used, and that it had not been substantially changed from the condition it was in when it was sold.

The doctrine of res ipsa loquitur, which translates to “the thing speaks for itself,” may be applicable in a case as well. In such a case, the burden of proof shifts from the plaintiff to the defendant. Rather than plaintiffs proving that the defendant was negligent, defendants must instead prove that they were not negligent.

Common Defenses to Product Liability Claims

Some of the defenses that are used in product liability claims in relation to defective drugs include that the injured party altered the drug in some way after it was sold. Another defense would be stating that the injured party misused the drug and that the misuse caused the injury.

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