J&J’s Ethicon unit, which made Gynecare Prolift and TVT Retropubic meshes, lost or destroyed thousands of documents and computer files about the development of the devices from as far back as 2007, Cheryl Eifert, a U.S. magistrate judge in Charleston, West Virginia, concluded last week.
The TVM cases concerning the Prolift devices were consolidated into a multidistrict litigation (MDL) in West Virginia in 2012. It was recently revealed that Ethicon destroyed documents related to its transvaginal mesh products, including many that could have had significant impact on the MDL’s outcome. Knowing this, plaintiffs requested Ethicon be appropriately punished for its malicious disregard.
The judge, Cheryl Eifert, ordered Ethicon to pay a penalty for acting in bad faith and disadvantaging plaintiffs. The exact amount is yet to be decided. The judge further recommended that district judges decide whether or not to inform juries of Ethicon’s failure to preserve documents. For example, juries may need to be informed of the destruction if a testifying physician recounts information he received from an Ethicon sales person, whose call records have since been destroyed and therefore cannot be used in court.
The documents destroyed include emails and records belonging to more than 20 of Ethicon’s highest executives, including the former worldwide president. These emails could have been used to prove the company knew the TVM products were defective and unreasonably dangerous in women.
In 2012, Ethicon voluntarily recalled its TVM products, including the Gynecare TVT Secur, Prosima, Prolift, and Prolift+M Pelvic Floor Repair Systems. One TVM product was left on market, the Gynecare Gynemesh PS.
These products have caused severe, life-changing injuries in thousands of unsuspecting women throughout the U.S. Pelvic mesh devices were originally intended to treat urinary stress incontinence and pelvic organ prolapse (POP) in women. Over time, as more and more reports of severe injury from these products were reported, the FDA recommended that they be reclassified as Class III devices, which is the highest-risk category for all medical products.
The finding comes as J&J prepares to face its first trial February 10th in West Virginia regarding claims TVT Retropubic sling, used to support women’s internal organs, eroded and shrank over time, causing pain and injuries. J&J, based in New Brunswick, is facing more than 12,000 federal-court claims over the TVT Retropubic, as well as its other vaginal mesh inserts.
There are currently nine different companies that manufacture TVM devices and all are now facing extensive litigation from the defective, dangerous and harmful products. Between 2005 and 2010 there were more than 4,000 women who reported injuries to the U.S. Food and Drug Administration (FDA). This number is significantly less than the actual number of injuries, as neither patients nor physicians are required to report injuries to the FDA’s MedWatch program (though reporting is strongly encouraged by patient advocate groups).
Ethicon officials acknowledged their document retention system “failed miserably in certain instances” to properly preserve vaginal mesh files, Eifert said. She recommended that U.S. District Judge Joseph Goodwin, who is overseeing the consolidated cases, allow women suing over J&J to tell jurors about the loss of documents if they can show the destruction put them at a disadvantage.
Although Eifert stated in her report that there is no evidence Ethicon officials deliberately omitted some files from court, she still found they were negligent in their mishandling of the files and should be punished by allowing some juries to hear about the document destruction. The magistrate’s recommendations must be reviewed and approved by Judge Goodwin before they become final.
If you or someone you love was implanted with a TVM device and suffered serious side effects, we can help you get the compensation for medical bills, lost wages, and pain and suffering. Call one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).
