FDA Issues Warning Letter to Mesh Manufacturer ENDO for Federal Regulation Violations
Endo International PLC, a subsidiary of American Medical Systems, Inc. was recently issued a warning letter by the FDA for violating three federal regulations relating to how the Minnesota company facility manufactures its urological devices.
Click here to read the full article: Inspection Triggers FDA Warning for Mesh Manufacturer
While the warnings does not pertain directly to mesh, the circumstances shed light on the quality or lack thereof of Endo’s manufacturing processes. According to the FDA, Endo has not adequately validated manufacturing processes and test methods for the AMS 800 Urinary Sphincter and AMS 700 Inflatable Penile Prosthesis. The second violation relates to Endo’s failure to perform risk analysis for the AMS 800 and AMS 700. Finally, Endo failed to maintain procedures for taking corrective and preventive action when there is a quality issue in the manufacturing of a device. These violations go to essential manufacturing procedures and cast significant doubt on Endo’s overall quality of operation.
Vaginal Mesh Trial History
Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced. In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.
In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross had 18 surgeries. The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.
On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages. The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective. Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries. In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected. Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.
On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).
On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.
On September 29, 2014 the consolidated Boston Scientific mesh trial are scheduled to commence in the Southern District of Florida.
If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.
Endo International PLC and American Medical Scientific are registered trademarks. The use of these trademarks is solely for product identification and informational purposes. These trademarks are not affiliated with this website, and the trademarks have no affiliation with The Brandi Law Firm. Nothing on this site has been authorized or approved by the trademarks.