Keeton and the FDA Conspiracy Concerning Pelvic Mesh
MND, August 3, 2015 ~ Lana Keeton seeks compensatory damages of $7 million and punitive damages of $21 million from J&J, the FDA, its lawyers and employees. This story is continued from Part One.
She’s a tough talking Texan given to accolades to the above, “This is God’s purpose for me. He perfectly prepared me for this,” who occasionally grows impatient with others (including your editor at times).
Lana Keeton, 68 years old, is from Bonham, Texas an hour north of Dallas. The daughter of a cattle farmer who owned a meat packing plant, she helped her father make his own brand of chili. In junior high, Lana would put labels on the bricks of chilled chili, answer the phone and write out invoices for her father’s business.
“He never ate bologna or vienna sausage because he knew what was in it,” she says today. Her father always wore a hat he put on top of the refrigerator every time he came home. The hat would return to his head when he’d leave the house in the morning. Fast forward to South Beach in Miami. Lana took what she learned from working in her Father’s business and turned it into a lucrative profession – brokering steel. Business was good. Keeton had a view of the Venetian Islands of Miami from her South Beach waterfront home. With a reliable supply of trucking companies and suppliers, and an ability to hold her own with steel manufacturers and the construction industry, Keeton looked forward to a rosy future.
Things changed drastically after Keeton received an Ethicon Gynecare TVT Prolene mesh implant in December 2001, she became deathly ill, complicated by an aggressive flesh-eating bacterial infection following a hysterectomy with bladder suspension surgery. Sometime later, Keeton would come to understand why the Ethicon mesh package warned that synthetic Prolene mesh “can potentiate an infection.”
“I didn’t even know I had mesh in me,” she says today.
Today she calls hers a “million dollar bladder” for what the $1,200 bladder surgery has cost her and American taxpayers in the 17 plus surgeries she’s endured to try and get the mesh out.
See MND background story in 2011.
The physical setbacks during recovery cost her financially. In 2003 Keeton filed for bankruptcy, first Chapter 7 and then Chapter 11. She lost her steel business and her home, and for a time was living with friends. She remade herself using her near death experience to broker a new future, learning everything she could about the medical device that had radically changed her life. In the process she created Truth in Medicine, a patient advocacy organization, set up a web site to educate others and became an avid patient advocate.
After years of trying to work cooperatively with the U.S. Food and Drug Administration (FDA) to lift the veil of ignorance from their eyes about the dangers of pelvic mesh, she decided the veil was there to hide what the agency knew. Last February 4, Keeton filed a RICO action asking for $7 million in compensatory and $21 million in punitive damages from J&J, the FDA, its employees, lawyers, Dr. Willy Davila and the Cleveland Clinic he works for, as well as two lawyers who have represented J&J in mesh litigation since 2005 and who currently represent J&J in the MDL in West Virginia.
RICO, the Racketeer Influenced and Corrupt Organizations Act, has been U.S. federal law since 1970. Originally it was applied to prosecute diverse groups such as the Hell’s Angels Motorcycle Club, Major League Baseball and the Gambino crime family, who, it was alleged, were part of a money making, criminal enterprise using mail or wire fraud, embezzlement, murder, kidnapping, bribery, or gambling, among other offenses.
In Keeton’s case, criminal charges are alleged in a civil lawsuit. J&J and the FDA, along with the Cleveland Clinic, conspired and abused the legal system to place misbranded and adulterated medical devices into the stream of commerce on an international level through medical professional societies harming her business and her property,” she says. Both the criminal and civil components allow the recovery of treble damages, or the tripling of the damage amount.
“If they didn’t harm my business or property I would not have a lawsuit. 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
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.”
Keeton points to the proposal to reclassify pelvic organ prolapse (POP) mesh to Class III. The comment period ended a year ago and today the proposal sits in limbo. See background story here. As it stands now, surgical mesh, whether for pelvic or hernia use, remains a Class II medical device and is cleared for sale after an exchange of paperwork between the manufacturer and the FDA with no clinical trials required. The whole process takes up to 90 days or less.
TALE OF THE TAPE
For years she tried to work within the FDA’s regulatory framework. Keeton says she and Bruce Rosenberg were naïve. Keeton with Truth in Medicine and Rosenberg with his Meshoma Foundation, a nonprofit concerned with hernia mesh injuries, thought employees of the Centers for Devices and Radiological Health (CDRH), the division that approves medical devices, didn’t know about “the tape.”
It turns out they were right.
During one meeting with the CDRH, Lana presented a scientific paper she had authored about nonylphenol, an endocrine disruptor that is in mesh. The Environmental Protection Agency and the European Union both ban nonylphenol and she wanted FDA regulators to know it.
Bruce told Dr. Shuren he wanted to come to the FDA to show them a videotape. Made by Ethicon and hosted by surgeon/consultant, Dr. B. Todd Heniford, the tape showed the doctor with a chunk of explanted hernia mesh. It had been removed from someone and was now hardened into the shape of a lamb chop. It was so hard, Dr. Heniford took it by its “handle” and slammed it into the metal table top.
The Ethicon promotional tape was singing the praises of a newer, softer, more user-friendly type of hernia mesh, ironically the very mesh implanted in Bruce. Hardly an improvement, and in ways it was worse than the old heavyweight mesh because it disintegrates into threads which are nearly impossible to remove.
Still today, the proprietary Prolene hernia mesh that Dr. Heniford hit on the table is used by Ethicon for its pelvic mesh implants.
A series of emails show that the FDA’s Dr. David Krause, whose job it was to authorize 510(k) clearances for medical devices including pelvic mesh, called the head of regulatory affairs for Ethicon, Peter Cecchini, to ask him about the video tape. Bruce had told Dr. Shuren what it showed.
Cecchini replied in an internal Ethicon October 20 email, “According to David K., it seems that Bruce Rosenberg claims to have a DVD that speaks to a mesh that falls apart after 1 year implantation. David would like the details of this and has requested a copy of the DVD. He did state that if this is true the product should be removed from the market and the 510(k) removed.”
Krause calls the consumer groups (Truth in Medicine and The Meshoma Foundation) “serious, irrational and nasty.”
“It was true and they still did nothing,” says Keeton. “That’s the whole point. Bruce and I didn’t know he contacted Cecchini back then. We are like little beavers, we are clueless people in the meeting. It’s been five years now and virtually all the hernia and pelvic mesh kits remain on the market. Nothing has happened.” Around the same time in October 2010, right after a Truth in Medicine conference she hosted in Washington DC, Keeton noted Jeff Shuren, the head of the CDRH, was hosting a Town Hall Meeting focusing on industry in San Francisco. She called him to protest the deference to industry over patients and to ask for a meeting.
Shuren called back to assure Keeton the FDA had provided many opportunities for consumer and patient groups to speak to the FDA.
“There is no special preference for industry,” he says in a voicemail she has today. “We have open sessions and people with issues are always welcome to come in the agency. Surgical mesh is an issue we continue to look into. We appreciate issues you’ve raised as well as Truth in Medicine.”
Shuren knew who Keeton was. He knew Keeton had testified at The Institute of Medicine (IOM) meetings on the 510(k) law in March and June of 2010. And she had had a meeting with others at the FDA on March 2, 2010, a day after the first IOM meeting.
During a meeting with the FDA on November 3, 2010, they met again. Dr. Shuren was sitting three feet away from Keeton as she addressed the FDA and said, “With all due respect, the FDA is a black hole for information.”
“I had the floor. They said nothing,” she says today.
In its March 5, Motion to Dismiss, defendant Johnson & Johnson calls Keeton “a serial product liability plaintiff,” and point to this as her third pro se product suit for damages against J&J and Ethicon. (See Doc 13) Johnson & Johnson’s spokesman, Matthew Johnson, (no relation) did not respond to a request for a comment to this story. J&J says her 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 she 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.) The claim 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.
Judge Goodwin ruled that 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 that the proper venue for her claim was in the Southern District of Florida, 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 because they are not lawyers but are entitled to their day in court equal to the rights of a represented person.
In it its Motion to Dismiss, the FDA makes the argument that there is no waiver of sovereign immunity and therefore Dr. Krause is protected by his qualified immunity. The RICO violations occurred after Keeton’s surgery in 2001, it says, therefore it’s impossible that any 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. The interaction between Dr. Krause and Peter Cecchini occurred in late 2010, nine years after her surgery. And the Plaintiff has not established an injury to her business or property.
Keeton believes the FDA’s attorneys are defending their client as if this is a personal injury claim, which it is not. Although not an attorney, Keeton argues the conspiracy began in 1997, not on the date of her surgery. She points to a signed contract with Dr. Ulf Ulmsten, the Ethicon consultant who invented the TVT and collected millions if his studies reached certain benchmarks. Not surprisingly, they did.
Keeton says that act alone caused every Gynecare TVT pelvic mesh kit to be misbranded and adulterated, a violation of the FDCA of 1938.
PATTERN OF CONSPIRACY
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 they had their first death, points out Keeton, then subsequent deaths continued, 12 in all from 1999-2007.
In 2005, the Prolift Pelvic Mesh Kit made it to market. Ethicon never sought FDA approval. The company just started selling the Prolift kit to treat pelvic organ prolapse (POP) along with its prepackaged stainless steel implanting arms known as trocars.
Keeton says within the FDA that between it, industry and doctors, there was an overall fraudulent scheme with an assortment of players that eventually led to the loss of her property and business.
“The law says if there is a corporation and Peter Cecchini is responsible for regulatory affairs, he knew about that videotape and he was in a position to change it and he didn’t, he becomes a responsible corporate officer who knew about the people dying. Krause told him. Krause was making decisions for government that were not in the interest of public health. Attorneys Leslie and Shapiro had a responsibility to give me the discovery and they did not.”
Ethicon had the Heniford tape, which she says was not provided to her in the discovery of her first case.
And while the video was being made at Ethicon, Krause supervised clearance of the Prolift M+, a newer version of Prolift in May 2008. At that time, the Prolift was discovered and cleared with no sanctions imposed by the CDRH. “Shapiro is representing Ethicon. Ethicon knows all this stuff and they say nothing.”
Dr. Willy Davila of the Cleveland Clinic was treating Keeton for mesh complications following the original implantation in 2001. In 2005 he was deposed. In 2009, he testified under oath at her medical negligence trial against the implanting doctor and again omitted the fact he ever was a paid consultant to Ethicon. He never ever told her of his association with Ethicon, she says.
“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.”
Meanwhile women continue dying and their reports are submitted to the FDA.
Keeton says nothing in life had educated her for this. She was not trained in the law, on how to be a pro se complainant, or an expert in this particular medical device. “I made the 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.” #