Jane Akre at Mesh Medical Device News Desk reports that a Texas woman is suing the FDA and Johnson & Johnson for $7 million, with punitive damages of $21 million.
Lana Keeton, 68, a Texas native from Bonham (an hour north of Dallas), was a successful trucking company supplier living in the tony South Beach section of Miami, when she was implanted with J&J’s Ethicon Gynecare TVT Prolene mesh. Her health and life went downhill in a hurry after the implant.
In December 2001, she nearly died from a flesh-eating bacterial infection that followed a hysterectomy with bladder suspension surgery. She found out firsthand why the Ethicon mesh package warned synthetic Prolene mesh “can potentiate an infection.” At the time, she didn’t even know she’d been implanted with mesh.
17 Surgeries to remove Plastic Mesh
She has endured 17 plus surgeries since to try and get the mesh out.
In 2003 Keeton filed for bankruptcy, Chapter 7 and later Chapter 11, after her physical problems overwhelmed her. She lost her business and home, lived for a time with friends. She began to claw her way back to life by learning all she could about the mesh that had derailed her life. She created Truth in Medicine to advocate for patients, set up a web site to educate others, became a patient advocate herself.
FDA, J&J targeted in Lawsuit
After years of attempting to work with FDA to show the dangers of pelvic mesh, Keeton decided the agency was willfully blind. On February 4, 2015, she filed a RICO action for $7 million in compensatory damages, $21 million in punitives from J&J, FDA, agency employees, lawyers, Dr. Willy Davila (a J&J consultant who failed to disclose his ties) and the Cleveland Clinic which employs him. She also filed against two lawyers who have represented J&J in mesh litigation since 2005, who currently represent J&J in the MDL in West Virginia.
RICO – an acronym for Racketeer Influenced and Corrupt Organizations Act – has been U.S. federal law since 1970. It was initially applied to prosecute such diverse groups such as the Hell’s Angels Motorcycle Club, Major League Baseball, the Gambino crime family, who were part of a money-making, criminal enterprise that used mail or wire fraud, embezzlement, murder, kidnapping, bribery, gambling, prostitution and other offenses.
Keeton alleges criminal charges in her civil suit. She says J&J and FDA, along with Cleveland Clinic, conspired and abused the legal system to place mis-branded and adulterated medical devices into the stream of commerce on an international level through medical professional societies, harming her business and her property. Both the criminal and civil components allow the recovery of treble damages, or the tripling of the damage amount.
Keeton said she has a RICO suit because they harmed her business and property: “I was the target of their conspiracy, but they knowingly and intentionally also harmed the U.S. Bankruptcy Court and Medicare, two other federal agencies. The case is not based on physical injuries from the mesh.”
TRUTH IN MEDICINE
Jane Akre reports, “In the years since, Keeton has taken directly to Washington her fight to have polypropylene mesh removed from the market. She has addressed an FDA expert panel on pelvic mesh, has had sit-down meetings with members of the FDA, hand delivered letters to members of Congress calling for a Congressional hearing. She’s spoken to the Institute of Medicine three times about the dangerous 510(k) loophole that allows medical devices onto the market with a wink and a nod. In June 2008 she formed the patient advocacy group Truth in Medicine and set up a website to raise awareness of the dangers of PP mesh. Implanted women flock to her for advice and she’d been crediting with saving many women’s lives by providing the right doctor in their time of need.
“‘Washington is not a results-oriented culture,’ she says. There are so many special interests that it’s muddled, there are no clear goals or clear answers. I’m very results oriented. FDA is like a black hole; things go in and never come out.”
DEFENDANTS STRIKE BACK
In its March 5, Motion to Dismiss, Johnson & Johnson calls Keeton “a serial product liability plaintiff.” It points to this action as her third pro se product suit for damages against J&J and Ethicon. Johnson & Johnson’s spokesman, Matthew Johnson, (no relation) did not respond to a request from Jane Akre for a comment to her story. J&J claims Keeton’s complaint should be dismissed because the judgments and orders in her prior suits bar her complaint and she lacks standing to assert a RICO claim and fails to state one. In her first lawsuit filed pro se, she alleged design defect, a failure to warn, and negligent manufacturing claims Keeton v. Gynecare Worldwide, et al., No. 1:06-cv-21116-UU (S.D. Fla.), which was dismissed by the Eleventh Circuit Court. Keeton then filed a product liability lawsuit in the MDL in West Virginia adding fraudulent concealment. 2:13-cv-24276, MDL 2327.
In West Virginia, Judge Goodwin ruled Keeton’s first judgment barred her second suit, but he did not prevent her from moving forward. Instead he dismissed her claim in the MDL without prejudice and advised her the proper venue for her claim was in the Southern District of Florida (where she had lived), based on Fraud by Omission claims she made on her short form complaint in the MDL.
Pro se plaintiffs are supposed to be given wide latitude by judges because they are not lawyers but are entitled to their day in court equal to the rights of a represented person.
FDA Motion to Dismiss
In its own Motion to Dismiss, FDA argues there is no waiver of sovereign immunity; therefore its employee Dr. Krause is protected by his qualified immunity. The RICO violations occurred after Keeton’s surgery in 2001, FDA says; therefore no RICO claims could have caused her injuries. Instead, the FDA says the Federal Tort Claims Act (FTCA) is the statute that provides jurisdiction over tort claims against the government.
12 Mesh Deaths in 8 Years
The TVT, transvaginal tape, used to treat stress urinary incontinence (SUI) was cleared by the FDA for use in the U.S. in 1998. By March of the following year, Keeton points out they had their first death. Subsequent deaths continued, 12 in all from 1999-2007.
Doctor fails to disclose Ties to Ethicon
Keeton is also suing because Dr. Willy Davila of the Cleveland Clinic, her treatment doctor for mesh complications following the original 2001 implant, failed to disclose his paid consultant arrangement with J&J and Ethicon. Davila was deposed on her case in 2005, and he testified again in 2009 at her medical negligence trial against the implanting doctor. On both occasions, Davila failed to disclose his clear conflict of interest.
Keeton told Jane Akre, “I still didn’t know until last year Willy Davila had worked for them since 2001. Twelve years later. He had been examining me, cutting on me, lying in a deposition and at trial. I was completely violated. It was not on the Cleveland Clinic website anywhere. No one at Cleveland Clinic can do this unless signed off by the Cleveland Clinic. His CV had nothing about his consulting.”
Ugly Stuff, and a Crime
Keeton said she has made a choice “to be better not bitter. I feel much better when I take action rather than waiting for someone else to do something because it’s not happening. This is ugly stuff and it’s a crime.”