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Invisalign maker gets FDA warning on side effects

The Food and Drug Administration (FDA) has issued a product warning to a company that manufactures a popular teeth straightener about its failure to report information about patient side effects. The popular teeth straightener, the Invisalign system, is made by Align Technology Inc., who acknowledged this week having received a November warning letter from the FDA after an inspection this summer. The letter accused the company of failing to comply with federal requirements to report serious product side effects associated with medical devices. The letter cited some patient complaints about allergic reactions to the Invisalign trays, including swollen lips and mouth ulcers. The company’s general counsel says that the company is working to resolve the issues.

Products liability is an area of personal injury law that focuses on dangerous and defective products. “Products” include a wide range of categories, like the Invisalign system above. The “products” also include items such as medical devices, machinery and tools, medicine and drugs, food and tobacco, toxic chemicals and substances, firearms, autos and other motor vehicles, automobile accessories, household products and appliances, toys and recreational equipment, and clothing and apparel.

Our Chicago injury attorneys at Levin & Perconti are very proud of our efforts to bring about change and ensure product safety. We have recovered substantial verdicts and settlements and have also helped to fight and make sure that the defective product was removed from the market and prevented from causing future personal injuries. For example, Levin & Perconti recovered a $3 million settlement against a car manufacturer of a vehicle that improperly designed the fuel delivery system of a vehicle, resulting in a fuel-fed fire after a head-on collision, which killed the occupants of the vehicle.

Read more about the product warning letter at The New York Times.