Everyone’s heard of the FDA: it regulates food, drugs, and medical products. But not everyone knows how this federal agency works, or the statutory framework it operates under. The Food, Drug, & Cosmetic Act (FDCA) imposes a long list of requirements on drug and medical device manufacturers, and its general purpose is to protect the public from dangerous and untested products reaching the market. Many manufacturers comply with their duties to conduct testing and file reports on their products to the FDA, but unfortunately some manufacturers may see an incentive to withhold information to make their products seem safer or more effective than they actually are. This can have grave consequences, and can create criminal and civil liability for the manufacturer who decides to test the limits of this federal regulatory scheme.
While the FDA is designed to protect the public, and Congress has granted it the power to do so, sometimes consumers need the help of private litigators to help ensure that a manufacturer has complied with all of its requirements under the FDCA. If a manufacturer doesn’t investigate and report to the FDA when it should know that its products have caused harm, an individual may be able to sue that manufacturer for negligence. Alternatively, if a product presents an unseen or unknown danger when used as reasonably intended, an individual injured by that product may be able to hold the manufacturer and everyone in the stream of commerce liable for the injury.
The recent lawsuits relating to DePuy, Johnson & Johnson, and Stryker’s hip replacement systems serve as a prominent example of this type of lawsuit. The Plaintiffs alleged that these hip replacement systems, containing a metal ball and metal socket, wear away inside the patient, releasing metal ions and provoking an extremely dangerous biological reaction called metallosis. This reaction is highly debilitating and can be life-threatening, requiring multiple surgeries to correct. The attorneys who represented these patients relied on theories of negligence in failing to report the metallosis risk to the FDA and strict liability for failure to warn of the latent dangers and defects inherent in use of their hip replacement systems. Manufacturers of implantable pacemakers, spinal infusion pumps, and birth control devices, in addition to hip replacement systems, have been subject to such litigation. This type of lawsuit is an effective way for consumers to protect themselves and ensure the safety of medical products where manufacturers slip through the cracks in the FDA’s regulatory scheme, but requires an attorney who is familiar with the FDCA and and all of its regulatory framework.
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