CINCINNATI (CN) - A spinal surgeon did "criminal ... medically unnecessary, experimental spine surgeries" on 88 patients without informed consent, to sell Infuse Bone Graft for Medtronic, which paid him as a consultant, the 88 claim in court.
The 88 patients, three of them minors, sued Dr. Abubakar Atiq Durrani, the Center for Advanced Spine Technologies, West Chester Medical Center, UC Health Inc., Medtronic Sofamor Danek, and Children's Medical Center PSC, in Federal Court.
Many of the plaintiffs say they suffer unremitting pain from the unnecessary surgery.
Their attorney has filed 15 other complaints this calendar year against Durrani and the Center for Advanced Spine Technologies (CAST), according to the Courthouse News database.
"Unnecessary procedures are criminal acts," the new complaint states. "Defendants Durrani, CAST, West Chester, UC Health and Children's performed medically unnecessary, experimental spines surgeries on plaintiffs using falsely and improperly marketed Medtronic medical devices and drugs."
Durrani is a member of CAST, and "has a business relationship with Medtronics, the maker of BMP-2," a Medtronic drug, according to the complaint.
It adds: "Since over one hundred patients have contacted counsel and nearly one hundred have claims, it is believed there are hundreds and hundreds more who have suffered at the hands of Dr. Durrani."
The complaint adds: "According to the FDA and independent scientists and physicians, BMP-2 has been causally associated with ectopic bone growth, cancer, spinal stenosis, pain, retrograde ejaculation, throat and breathing constriction, swelling, and other complications.
"Defendant Durrani also received improper kickbacks, consulting fees, and other consideration from the manufacturer of BMP-2, Medtronic, Inc.
"BMP-2 is marketed by Medtronic as Infuse Bone Graft."
The plaintiffs claim that "during these unnecessary spine surgeries defendant Durrani implanted cervical and thoracic rods, screws and cages ['hardware'] into plaintiffs and used a drug called Infuse/BMP-2 ['BMP-2'].
"BMP-2 is manufactured, marketed, sold and distributed by defendant Medtronic under the trade name 'Infuse'. BMP-2 is not approved by the Food and Drug Administration for use on the cervical and thoracic spine. ... BMP-2 is not safe nor approved for use on children less than twenty-one (21) years of age." (Parentheses and brackets in complaint.)
The patients claim that "defendants Medtronic, Durrani and CAST knowingly and falsely marketed BMP-2 to plaintiffs as safe and approved for use in plaintiffs' cervical and thoracic spine surgeries. Defendants Durrani, CAST, West Chester, UC Health and Children's knowingly misled plaintiffs concerning BMP-2 used in plaintiffs' cervical and thoracic spine surgeries.
"Defendants Durrani, CAST, West Chester, UC Health and Children's knowingly and falsely misled the government by stating a) the surgeries on [plaintiffs] were medically necessary and b) that the defendants had obtained proper informed consent of the plaintiffs to use the hardware and BMP-2 on plaintiffs." (Brackets added; word apparently omitted in complaint.)
The complaint states: "Dr. Durrani has a business relationship with Medtronics, the maker of BMP-2. This business relationship includes financial compensation which is unknown.
"BMP-2 is a morphonegic [sic] protein.
"Dr. Durrani is a native of Pakistan, the place of his birth and childhood.
"Dr. Durrani travels to and from Pakistan, the place of his birth and childhood.
"Dr. Durrani has told some patients he's a prince in Pakistan.
"Dr. Durrani maintains his family owns an international textile business which makes him independently wealthy.
"Dr. Durrani claims ownership of a surgical tool business in Pakistan.
"Several state and federal agencies have opened investigations into Dr. Durrani's surgical practices and his billing practices.
"Tri-state orthopedic and neurosurgeon doctors support plaintiffs' medical malpractice, fraud and battery claims."
The complaint cites an FDA warning about BMP-2, that "the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use."
The plaintiffs claim Durrani ignored the warning and performed the surgeries anyway, without their consent, then falsified records to get paid.
"Defendants received payments and/or other consideration, directly or indirectly, from Medicare after submitting false claims for payment, including facts that the use of BMP-2 (bone morphogenetic protein) for this surgery was approved and proper, and that [the patient] was informed, and in fact, knowingly consented to the use of BMP-2 on this spinal surgery, which he did not," the complaint states.
The 88 patients seek compensatory and punitive damages for RICO charges, including mail fraud and wire fraud.
They are represented by Eric Deters of Independence, Ky., who has filed several other complaints against Durrani and CAST, in the Common Pleas Courts of Hamilton and Butler Counties, Ohio.