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Criminal Sanctions against Companies for Defrauding the Government and Selling Adulterated Foods and Drugs

Federal law prohibits a company, its officers or its management from making false statements to the federal government or defrauding the government. In addition, various laws allow federal agencies to ask the U.S. Attorney General to bring...

A Drug Manufacturer's Liability for Off-Label Use

Injuries Resulting from Off-Label Use

It is legal and common for physicians to make off-label uses of drugs and medical devices. Off-label use refers to the use of drugs and medical devices for purposes not...

Negligence

A defective product causes injury or harm because of a flaw or defect in the product. Maybe the product was defectively designed or maybe the manufacturer used a faulty part in the product. A product is also defective if the...

Medical Causation in Drug Products Liability Cases

What is a drug products liability case?

Drug products liability is an area of the law dealing with personal injury that results from using a drug or medical device.

What must the plaintiff prove...

FDA and the Recall Process

The U.S. Food and Drug Administration (FDA) is responsible for monitoring adverse product experiences. If a product is deemed defective by the FDA, the FDA is authorized to request that members of industries regulated by the...