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A Manufacturer’s Liability for Drug-Related Injuries

Drugs are inherently dangerous products which can cause injuries even though precautions are taken to prevent such injuries. Pharmaceutical and medical device manufacturers have a duty to provide information about the effectiveness of a drug and to warn about a drug’s dangers.

Negligence Liability

A manufacturer might be sued if a patient suffers a drug-related injury. One theory of liability is based on negligence or a lack of due care. A manufacturer has a duty of reasonable care in the manufacture of a drug. Negligent manufacturing claims are usually alleged against manufacturers of medical devices, not drug manufacturers. To prove negligent manufacturing, an injured patient has to show that the device was defective because it did not meet design specifications or performance standards. The injured patient also has to show that the defect existed when the manufacturer delivered the device and that the defect was the proximate (immediate) cause of the patient’s injury.

The manufacturer also has a duty to provide adequate warnings about the drug and give instructions for its use. Generally, the manufacturer only has a duty to warn the physician. It is the physician’s responsibility to advise the patient of the dangers related to the use of drugs or medical devices. The adequacy of the warning is an issue that often arises in a negligence lawsuit against the manufacturer.

Finally, the manufacturer has a duty to discover or test for a drug’s adverse reactions. A manufacturer might be held liable for inadequate testing or for failing to discover adverse reactions. Also, if a manufacturer knew or should have known about a new adverse reaction, the courts might impose liability on the manufacturer if it failed to warn of the adverse reaction.

Liability for Breach of Warranty

Some courts recognize an implied warranty of fitness in the drug product field. A contaminated batch of a drug would be a manufacturing defect, and the drug would be considered unfit. Also, a drug could be defectively designed. If it was found that a drug was more dangerous than it was beneficial, the drug would be considered unfit. In either case, the manufacturer would be liable for breach of an implied warranty of fitness.

Express warranty claims are based on a manufacturer’s guarantee as to the safety of a drug or its freedom from side effects. If a manufacturer makes a statement or promise about a product which persuades the patient to buy the product, the manufacturer could be held liable for breach of warranty if the patient suffers injuries from using the product.

Strict Liability

A manufacturer can be held strictly liable for selling a drug in a defective condition if the drug is more dangerous than the consumer would expect. A court might also consider whether a prudent manufacturer, knowing all the risks, would have put the drug on the market. A manufacturer would be held strictly liable if the trier of fact (the jury in a jury trial or the judge in a bench trial) decides that the manufacturer acted imprudently in putting the product on the market.

Copyright 2011 LexisNexis, a division of Reed Elsevier Inc.