It didn’t take long for the plaintiff’s bar to seize on the June Spine Journal‘s Carragee Infuse study and find a patient to file a personal injury lawsuit against Medtronic, Inc.
On September 19, 2011, the San Francisco law firm of Lieff Cabraser Heimann & Bernstein, LLP, issued a press release announcing that a lawsuit (Jennifer English v Medtronic, Inc., Case No. 9:11-cv-81054) was filed in the U.S. District Court of the Southern District of Florida on September 16.
The suit states: “According to articles in the June 2011 issue of The Spine Journal (an international medical journal that publishes peer-reviewed research articles related to evidence-based spine care), earlier Medtronic-sponsored studies and articles inaccurately reported the safety of rhBMP-2 (the active fusion ingredient in Infuse) by underestimating its risks.”
“Biased and Corrupted Research”
Their press release stated that the Journal criticized research by Medtronic-funded physicians, “encouraging the widespread off-label use of Infuse as ‘biased and corrupted research.’ The articles in The Spine Journal charge that the prior studies in support of Infuse were authored by researchers with significant financial ties to Medtronic, and that this prior research vastly understated or failed to disclose Infuse’s side effects and risks.”
Medtronic chose not to publicly defend the studies, but asked Yale University to conduct an independent evaluation of all evidence and data collected about Infuse to date and make as unbiased and objective report as possible. The company has been able to avoid a direct clash with Eugene Carragee, M.D., but may now find itself having to address his allegations in a federal court.
Jennifer English’s Pain
The lawsuit was filed on behalf of Jennifer English, a physical therapist of Lake Worth, Florida. English received Medtronic’s Infuse Bone Graft (Infuse) as part of a posterior-approach lumbar spine surgery performed by Amos Dare, M.D., at the Wellington Regional Medical Center in Wellington, Florida, on August 8, 2007.
The surgery was conducted to address disk herniation and stenosis. During the surgery, according to the suit, Dr. Dare used Infuse in an off-label manner by implanting the product posteriorly into the lumbar region of English’s spine in order to attempt to fuse vertebrae S1 to L5. The FDA’s original approval for Infuse was for an anterior approach.
Infuse was approved by the FDA on July 2, 2002, for anterior use in the lower, or lumbar, region of the spine (at levels L4 through S1) to treat degenerative disc disease.
After the surgery, the suit says English experienced “increasingly severe pain and weakness on her left leg.”
Eight weeks after the surgery, English underwent an emergency revision surgery to remove ectopic bone growth that was compressing her nerve. During this surgery, according to the suit, her L5-S1 nerve was nicked and the dura sac surrounding her spinal cord was punctured, “creating a cerebral spinal fluid leak…which caused a four-centimeter-wide cyst to form.” The cyst caused additional sever pain.
In March 2010, English underwent a third surgery, this time to remove hardware such as pins and screws inserted in her first surgery. The suit says her surgeon noticed excess bone that required removal, but could not be removed at that time. English continued to experience significant pain, cramping and spasms going up her back, as well as weakness in her left leg.
An MRI done on August 4, 2011 showed, according to the suit, that English continued to experience ectopic bone growth in her lumbar region. “Comparing this region to a June 11, 2010 MRI study, the August 4, 2011 MRI study reported ‘more bony bridging posteriorly along the lateral margin of the interbody fusion.’ This bony bridging had lead to ‘more encroachment upon the left L5 nerve root, ‘” claims the suit.
Blaming Medtronic
English claims that Medtronic is responsible for her situation because the company “misrepresented the safety of Infuse to physicians and patients…and recklessly, willfully, or intentionally failed to alert English or her physicians of the extreme danger to patients of the off-label use of Infuse through a posterior approach.”
The suit says English would not have chosen to be treated with Infuse “had she known of or been informed by Defendants of the true risks of the off-label use of Infuse.”
Insufficient Warnings
Any warnings Medtronic may have issued concerning the dangers of off-label use of Infuse through a posterior approach were, according to the suit, “insufficient in light of Medtronic’s contradictory prior, contemporaneous and continuing promotional efforts and overpromotion of Infuse for off-label posterior-approach use in the lumbar spine.”
We called English’s lawyers and asked them why her surgeon chose to perform an off-label procedure and why their client wasn’t suing him?
They said that English’s physicians could not have discovered any defect in the Infuse product through the exercise of due care.
Dr. Amos Dare
Dr. Amos DareAt issue, no doubt, will be what Dr. Dare would have known about Infuse in August 2008, when English’s surgery took place.
According to Dr. Dare’s website dramosdare.com, he received his doctorate in Medicine from the Yale School of Medicine in 1997. He performed his internship in General Surgery at the New York University (Lennox Hill Hospital) in 1997 and was a neurosurgical resident at the State University of New York in Buffalo. From 2003 – 2004 he was a neurosurgical oncology Fellow at MD Anderson Cancer Center in Houston, Texas. Since 2004, he has served as President of Palm Beach Brain & Spine, PA in West Palm Beach, Florida.
In 2005 he became the Medical Director of Palm Beach Brain & Spine, LLC in Wellington, Florida and is currently the Director of Neurosurgery at Wellington Regional Medical Center.
He authored a book copyrighted in 2009 and titled: How to Take Care of the Pain in Your Back. He follows several case histories from diagnosis to treatment. “The book sheds light on several of the latest technologies available today for the management of back pain, ” states the promotional material for the book.
The lawyers told us, and claim in the suit that English’s physicians, “relied on Medtronic’s misrepresentations” regarding the safety and efficacy of Infuse in connection with their decisions to use Infuse off-label. They said English and her physicians did not know of the specific risks, and/or were “misled by Medtronic as to the nature and incidence of the true specific risks, and/or knew of the true risks and chose to not inform Plaintiff of those risks.” They claim Medtronic’s improper off-label promotion of Infuse cause her physicians to use the product off-label.
“The Evidence”
And this is where The Spine Journal and Carragee come in as part of a long list “evidence” that Medtronic promoted the off-label use of Infuse.
English’s lawyers argue that “these Medtronic-sponsored articles omitted mention of adverse effects seen in the earliest trials of Infuse. They also omitted mention of the risks of sterility and cancer associated with rhBMP-2 use, as reported in Food and Drug Administration documents and hearings. The actual rate of incidence of these serious side effects is much greater than the rate disclosed by Medtronic or these Medtronic-sponsored studies to physicians or to the public.”
They argue that Medtronic cultivated relationships with opinion leaders, paying them handsome consulting fees, travel expenses for seminars, and other perks, to encourage these physicians to promote the off-label use of Infuse.
“Medtronic…improperly paid doctors to promote, both directly and indirectly, the off-label use of Infuse through the posterior and lateral approaches in lumbar spine fusions, ” alleges the suit.
Kuklo
The lawsuit cites The Wall Street Journal’s reports of Timothy Kuklo, M.D.’s “fabricated claims of efficacy” and forging of signatures of co-authors for an article in a British medical journal while receiving “over $800, 000” as a paid consultant for Medtronic.
Poteet, Grassley and the DOJ
English’s lawyers also reached back to settled whistleblower cases involving a former employee named Jacqueline Poteet.
Those cases alleged that Medtronic paid illegal kickbacks to physicians to promoting the off-label use of Infuse in the spine, which resulted in the submission of false or fraudulent claims to federal health care programs.
In July 2006, Medtronic agreed to pay $40 million to the government and enter into a Corporate Integrity Agreement with Office of Inspector General to settle the lawsuits in July 2006.
Despite the 2006 settlement, English’s lawyers claim that Medtronic has continued to “improperly and illegally promote the off-label use of Infuse in non-FDA-approved spine surgeries.
U.S. Senate Investigations
The lawsuit cites letters and ongoing inquiries from U.S. Senators regarding payments to physicians related to Infuse.
U.S. District Court of the Southern District of FloridaThe Senators, led by Democrat Herb Kohl and Republican Charles Grassley, also note The Spine Journal articles to conclude that the Infuse trials and reports “suffered from idiosyncratic trial design, reporting bias, and peer-review/publication shortfalls.”
The lawsuit then quotes the Senators repeating Carragee’s assertion that each Medtronic sponsored study was funded in whole or in part by median payments between $12 million to $16 million by the company.
Medtronic’s Burden of Proof
Given all this evidence, English’s lawyers say the burden of proof should be on Medtronic to prove that the company did not cause the harms suffered by their client.
They say English demands a jury trial and will be entitled to damages in an amount to be determined at the trial.
There is no telling how the timing of this lawsuit plays out. But if it reaches a trial, Medtronic may well find itself staring over their defense table at Dr. Carragee on the witness stand. The government should sell seats for that.
