On July 13, 2015, The FDA warned Bard that it has been illegally marketing the devices used to retrieve its IVC filters, which are known as the Recovery Cone Removal System, since 2003. Bard’s marketing of these devices is illegal as Bard has never sought clearance from the FDA to use these devices in humans. Thus, Bard has essentially been subjecting patients to an illegal research trial without the safeguards and oversight of an approved clinical trial or without the consent of patients. The July 13 letter from the FDA warned Bard to immediately cease commercial distribution and marketing of its Recovery Cone Removal devices for the retrieval of its IVC Filters.
The FDA regulates medical device manufacturers by requiring that all manufacturers must obtain FDA clearance prior to marketing a device for use in humans and by requiring that manufacturers voluntary adhere to minimum safety requirements in the manufacture and marketing of medical devices known as the Good Manufacturing Requirements.
The FDA also notified Bard that it had violated the numerous minimum safety provisions from the Good Manufacturing Requirements in the manner in which Bard manufactured and distributed its IVC filters. For example, Bard failed to establish and maintain procedures to ensure that device failures were adequately investigated, and repeatedly downplayed the severity of complications caused by its IVC filters, including death. Further, Bard failed to establish and maintain procedures to ensure that toxic acids and chemicals used in the manufacture of its IVC filters were reduced to acceptable levels prior to distribution.
The FDA has given Bard 15 days to explain “the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.”
For more than 30 years, the attorneys at the nationally-recognized plaintiffs’ law firm of Lopez McHugh have been obtaining justice for their clients and battling defendants who take advantage of consumers such as pharmaceutical giants, nursing homes and medical professionals, insurance companies, auto manufacturers, and the manufacturers of defective medical devices. To learn more about the extensive history of IVC filter lawsuits and how the products liability attorneys of Lopez McHugh can help you, contact us via our website or call (877) 737-8525 for a free attorney consultation.