What laws and regulations apply to defective drug injury claims?

In California, defective drug injury claims are subject to two primary sets of laws and regulations: the U.S. Food and Drug Administration (FDA) and state tort law. The FDA regulates the safety and efficacy of drugs and medical devices, meaning any product that can help diagnose, monitor, or treat a medical condition. If a lawsuit is filed against a drug or medical device manufacturer, the FDA can be called upon as an expert witness to testify regarding the safety and efficacy of the product in question. At the state level, California has also enacted laws and regulations that apply to defective drug injury claims. In California, a defective drug injury claim must meet certain criteria in order to be successful, such as proving the product was unreasonably dangerous or did not provide sufficient warning of possible side effects. Additionally, the claimant must prove that the product caused the injury and that the defendant was liable for the injury. In addition to state law, defective drug injury claims may also be subject to federal statutes and regulations such as the Uniform Commercial Code (UCC) and federal preemption. Under the UCC, drug manufacturers may be subject to stricter liability standards than other types of manufacturers, and the UCC may also give the injured party additional remedies. Federal preemption, on the other hand, may prevent state courts from hearing certain types of claims if those claims are already governed by federal law. Overall, defective drug injury claims in California are subject to multiple layers of complex laws and regulations, and legal representation is highly recommended for anyone considering filing a claim. An attorney will be able to explain all of the applicable laws and regulations and guide the claimant through the process of filing a claim.

What laws and regulations apply to defective drug injury claims?

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