UPDATED Oct. 3, 2016, with news of Durrani’s whereabouts.
Medtronic (NYSE:MDT) yesterday escaped hundreds of lawsuits filed over the allegedly off-label use of its controversial bone-growth product, Infuse, by a Cincinnati doctor who has since fled to Pakistan.
Infuse consists of a collagen sponge that’s soaked in a bone-growth protein called recombinant human bone morphogenetic protein-2 and implanted in the spine within a metal device called the LT-Cage. The FDA approved Infuse in 2002 for use in single-level anterior lumbar interbody fusions (other dental and trauma indications followed).
The lawsuits, collected into an omnibus complaint, alleged that orthopedic surgeon Dr. Atiq Durrani used Infuse in a variety of off-label applications, including without the LT-Cage, using a posterior approach, in fusions of multiple levels and in the cervical and thoracic spine. The claims alleged included fraud; product liability for failure to warn, design defect, misrepresentation and negligence; and breach of warranty, according to court documents.
Medtronic moved to have the omnibus case dismissed, arguing that some of the claims were too vague and did not cite specific violations of federal law and that the rest were pre-empted by federal law. Judge Timothy Black of the U.S. District Court for Southern Ohio agreed, ruling that all but the fraud claims were pre-empted and that the fraud allegations were too vague.
“Ultimately, with the exception of plaintiffs’ fraud-based claims, all of the claims raised in the omnibus complaint represent an attempt to use state law to violate the regulatory monopoly on medical devices ,” Black wrote. “This court therefore finds, as have many of the other courts across the country that have considered these exact issues, that product liability claims of this nature cannot survive a motion to dismiss. Plaintiffs’ fraud claims independently fail for failing to meet the heightened pleading standard of Rule 9 of the Federal Rules of Civil Procedure.”
Durrani fled to Pakistan after his arrest in 2013 and was reportedly practicing as an orthopedic surgeon as recently as June 2015, although the hospital where he is said to practice does not list him on its website. As 1st reported over at Orthopedics This Week, he now appears to work at the Orthopedic & Spine Institute in Lahore. Durrani is named as 1 of the U.S. Health & Human Services Dept.’s “Most Wanted” by its inspector general’s office.
The hospital where he practiced in Cincinnati paid $4.1 million in October 2015 to settle allegations that the hospital violated the False Claims Act for billing Medicare and Medicaid for medically unnecessary spine surgeries.
The controversy over the Infuse product, which 1st erupted during the summer of 2011 when the Spine Journal dedicated its entire June issue to problems with the product, continued to make headlines as recently as last month, when the University of California agreed to pony up $8.5 million to settle a pair of lawsuits brought against a former UCLA spine surgeon.
And last spring the company and the FDA came under scrutiny for a 5-year delay in reporting results from a 2-year internal review of some 3,647 Infuse patients that turned up 1,000 adverse events that should have been reported to the FDA within 30 days. Medtronic, claiming that the results had been inadvertently misplaced, said it reported them to the FDA as soon as they were rediscovered; the federal safety watchdog later said that it took no action for the late filing because the data was consistent with earlier results on Infuse.
Medtronic agreed in May 2014 to pay $22 million to settle an estimated 950 lawsuits filed over Infuse, admitting to no wrongdoing in what it termed a “compromise” of disputed claims.
