TRACY WIN KLER HAMILTON COUNTY CLERK OF COURTS COMMON PLEAS DIVISION ELECTRONICALLY FILED August 28, 2013 03:16 PM TRACY WINKLER Clerk of Courts Hamilton County, Ohio CONFIRMATION 27 647 8 VS. CINCINNATI CHILDRENS HOSPITAL MEDICAL CENTER FILING TYPE: INITIAL FILING (IN COUNTY) WITH JURY DEMAND PAGES FILED: 26 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 IN THE COURT OF COMMON PLEAS HAMILTON COUNTY, OHIO CIVIL DIVISION FRIEDA AARON KATRINA ALLEN SHERRI LYNN ALLEN REBECCA APPLEGATE GEORGE ARNOLD NICOLE BAKER JENNIFER BALLINGER CINDY BARTLETT LAURA BATSCHE NANCY BEGLEY Case No. LEONA BEYER PATRICIA BOONE DEENA BORCHERS GERALD BOTNER Judge: ARLETTA SUE BOWLING NANCY BOWMAN RANDALL BREWER JAMES BROWN ANDREW CARR SHERRI CINQUINA JESSICA COCHRAN COMPLAINT AND JURY DEMAND ELIZABETH COMPO CLASS ACTION GARY COOTS WILLIAM DABNEY NELLIE DAVIS DAMON DECK SANDRA DENNIS ROBERT DENSLER KRISTINE DOYAL DORITY CAROLYN DOTSON DAWN DUNKLIN OANN FRAZIER GLORIA GREENE JENNY GRIMM DOROTHEA HAMILTON JESSICA HASTINGS KELLY HENNESSY JENNIFER HICKEY CELESTE HOFFMAN HOWELL TAMMY HUGHES ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 SARAH UERGENS CHARLOTTE KING AMANDA KOCH VALARIE KOPP SHEILA KRABACHER SHIRLEY MAINS TIMOTHY MARSHALL JULIE MARTIN DEREK MAYFIELD TONY MCCLENDON LAURA KRANBUHL MCKEE TERESA MCMILLEN MARK MCMURREN RANDALL METCALF DEBBIE MOORE OETTA NAFE TONY NEAL MARJORIE NEWMAN TERESA NICHOLS CLARENCE PHILLIPS SANDRA RADEKE TODD RAY KENT REYNOLDS LISA REYNOLDS JOHN RICHARDSON JASON RILEY JASON ROMER DOROTHY ROSE CAROL ROSS RUEVE ROBERT RUNTZ MIKE SAND JOSEPH SCHIMMEL STEVEN ANDREW SCHULTZ TIMOTHY SCHULZE RONALD SCHUSTER DAVID SCOTT RHONDA SCOTT DANA SETTERS DONNA SMALLWOOD DAVID SMITH DAVID SNIDER LINDA KALLMEYER WARD LONNIE WHEELER TROY WILDER CAROL WILSON ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 ROBERT WILSON VICKY WILSON BILLY WOLSING LEAH RAY WRIGHT BRENDA SHELL DONNA GOOD KELLY HENNESSY TAMMY JONES MARY RAVENSCRAFT DONNA RISTER DANIEL WEBBER THE ESTATE OF WILLIAM HAYES JEFF POTTS BARBARA HENSLEY PIERCE STEPHANIE HERRIN-THREM BRANDON WEBSTER KAREN FELTNER CATHY BEIL DORIS BOTNER REBECCA BREITENSTEIN TAMMY MANN CHRIS CLARK PATRICIA LEGENDRE SIERRA STRATMAN NEIDIG BOBBIE DOUGLAS EDYTHE BISHOP KATHERINE CURLEY VICKI BUSHUR FRANCINE FORD RAHMAN NISBET MIDDENDORF ANTOINE POWELL PATRICK STEPHENSON MELISSA VANDEGEER Plaintiffs, v. CINCINNATI HOSPITAL MEDICAL CENTER 333 Burnette Ave. Cincinnati, Ohio 45229 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 SERVE: Frank Woodside, 1900 Chemed Center 255 E. Fifth Street Cincinnati, Ohio 45202 (Serve via Certified mail) Defendants. PARTIES. JURISDICTION AND VENUE Comes now, Plaintiff by and through counsel, and for this Complaint states as follows: 1. The incidents giving rise to this action and the subject matter of the Complaint arise out of acts, omissions, and conduct that occurred in Hamilton County and Butler County, Ohio. 2. At all times relevant, Plaintiffs were residents of the United States and had surgery performed in Hamilton County or Butler County, Ohio. 3. At all times relevant, Cincinnati Children's Hospital Medical Center ["Children's"] was a corporation authorized to transact business and perform medical services in the State of Ohio. 4. At all times relevant, UC Health was a holding, billing, administrative, support and/or profit seeking business entity that was licensed to and did in fact perform medical, billing, logistic, administrative, support, and ancillary services in the State of Ohio and was a corporation authorized to transact business in Ohio. UC Health also owned and operated West Chester Medical Center with West Chester Hospital, LLC. ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 5. Children's and UC Health share common financial funding, interests, goals, information, credentialing, staff, physicians, offices, resources, business interests, research, grants, and other common financial and structural components and ownership. 6. The amount in controversy exceeds the jurisdictional threshold of this Court. 7. This action is filed on behalf of Plaintiffs and the class to recover treble damages, civil penalties, dis gorgement of gross receipts or profits, the imposition of a constructive trust, attomeys' fees, expenses, exemplary damages and all other applicable remedies. 8. The Defendant engaged in a common scheme with UC Health and Dr. Durrani involving civil conspiracy, fraud, material misrepresentation, deceit, and extreme and outrageous conduct intentionally directed at each of the patients. In furtherance of their scheme to defraud, the Defendant has violated and/ or caused others to violate several statutes, regulations, and other state and Federal legal requirements including but not limited to: a. Ohio Product Liability Act, RC. 2307.7l--2307.80; b. 42 C.F.R. ?482.l3, codifying the Patient's Right to Informed Consent; c. 42 C.F.R. ?482.5l, covering the informed consent of surgical patients; d. 45 C.F.R. Part 46, et seq., specifically 45 C.F.R. ?46.l22, covering the conducting of medical research on human subjects with the support of federal funds, known as the "Common Rule"; e. l8 U.S.C. ?l035, covering the criminal act of making "False Statements Relating to Health Care Matters" involving any health care benefit program, public or private; f. l8 U.S.C. ?l347 of the Criminal Code covering "Health Care Fraud" involving ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 any health care benefit program, public or private; g. 18 U.S.C. 1341, 1343, 1956, 1957, and 2314 covering "Mail Fraud", "Wire Fraud", "Money Laundering", "Use of Dirty Money", and "Travel to Effect the Scheme", to effectuate the fraudulent scheme; and h. The violation of the warning letter from the FDA dated June 23, 2011 Warning against promoting and marketing PureGen without FDA approval; and for violating the Food Drug and Cosmetic Act, 21 U.S.C. 351, et seq., by marketing a device Without premarket approval, 510k clearance, meeting the humanitarian device exception, exemption from the Act, or other qualification to market the device; for violating the Public Health Service Act 42 U.S.C. ?201, et seq., specifically 262(a) and and related federal regulations, specifically 21 C.F.R. 1271. for violating the Food Drug and Cosmetic Act 21 U.S.C. ?351, et seq., specifically 355(a) and and 21 C.F.R. 312; and the Public Health Service Act 42 U.S.C. 262, specifically 262(a) and 9. This cause of action is brought by class members pursuant to Ohio Civil Rule 23 and other applicable rules and law. 10. Plaintiff Class Members are citizens and residents of the United States who had surgery performed on them by Dr. Durrani in Ohio without the benefit of truthful and accurate information regarding settlements claiming Durrani was negligent; reportable changes in Durrani's privile gel admitting status; and/ or reportable events pursuant to the laws and regulations explained herein; Defendant's failure in their duty under state and federal law and their bylaws and regulations to properly discipline, de--credential and revoke the privileges of Dr. Durrani; failure to properly report to the National Practioner Data Bank; 6 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 ll. 12. 13. 14. 15. 16. All class members had surgery at West Chester Medical Center and they would not have had surgery with Dr. Durrani had Children's Hospital not breached their duties under the law as described herein. Defendant not only breached their duties, they intentionally breached these duties to protect both Dr. Durrani and themselves. Under Ohio Civil Rule 23, this class of Plaintiffs is so numerous that joinder of all members is impracticable; there are questions of law or fact common to the class; the claims or defenses of the representative parties are typical of the claims or defenses of the class; the representative parties will fairly and adequately protect the interests of the class; Common questions predominate over questions effecting only individual members; and, that a class action is superior to other available methods of resolving the claims. BACKGROUND Plaintiffs incorporate by reference each and every allegation in the paragraphs above. While an employee of Children's Hospital from 2003-2008, Durrani performed medically unnecessary, negligent, reckless and improper surgeries on children and adult patients. Cincinnati Children's Hospital and UC Health are financially intermingled, and share common marketing and ownership interests. UC Health's moniker, copyright, trademark, and marketing symbols can be found on Cincinnati Children's Hospital medical and billing records, and vice versa, during the relevant times. Durrani was an employee, agent, and representative of UC Health from 2003-2013, through his business, research, and faculty relationships. 7 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 17. 18. 19. 20. 21. 22. 23. Durrani was an employee, agent, and representative of Cincinnati Children's Hospital from approximately 2003-2008. UC Health and Cincinnati Children's Hospital have parallel corporate and financial plans, which included collaboration among and between physician staff spine surgeons. UC Health had actual knowledge, through direct and indirect sources, that Children's terminated the admitting privileges of Durrani from Children's Hospital in 2008. Despite this knowledge, Durrani was recruited, accepted, hired and placed into admitting privileges at the newly acquired West Chester Medical Center, which is owned and managed by UC Health. While an employee of Children's Hospital from 2003-2008, Dr. Durrani was also a paid consultant for medical device Medtronic and AlphaTec and its subsidiaries with the full knowledge of Children's Hospital. While an employee of Children's Hospital from 2003-2008 and thereafter, Children's Hospital received numerous complaints, claims and lawsuits concemin professional negligence and improper medical treatment by Dr. Durrani both from patients and other medical staff from Children's. Children's Hospital had a statutory and common law duty to inform patients of Dr. Durrani that Children's Hospital had suspended, terminated, and/or revoked the privileges of Dr. Durrani and/or accepted his resignation in lieu of termination. To this day, Dr. Durrani denies under oath ever having this happen to him at a single hospital. ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 24. 25. 26. 27. 28. If Defendant and other hospitals don't act to protect the public, the public is not protected. Children's Hospital had a statutory duty to report to the National Practitioner Data Bank that Children's Hospital had suspended, terminated, and/ or revoked the privileges of Dr. Durrani and! or accepted his resignation in lieu of termination pursuant to 42 USC 11151, et seq., and regulations promulgated thereunder. Children's Hospital had a statutory duty to report to the National Practitioner Data Bank that Children's Hospital settled medical and related negligence claims involving the professional medical acts and omissions of Dr. Durrani pursuant to 42 USC 11151 et seq. Children's Hospital had a common law duty to report Dr. Durrani's termination of privileges under these circumstances to Durrani's current and future patients, the public, other hospitals, insurance companies, Medicaid, Medicare, the medical licensing authorities, and otherwise foreseeable and/or potential patients of Dr. Durrani. Plaintiffs began treating with Dr. Durrani after his employment and admitting privileges terminated at Children's Hospital. Defendants did not report to the medical licensing and state and federal regulatory authorities and/ or inform Plaintiffs, inter alia, that: a) legal malpractice claims had been settled involving allegations of his professional negligence while Durrani had been an employee at Children's Hospital. Claims would be settled in a manner to protect Dr. Durrani and Children's including 9 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 but not limited to confidentiality agreements, sealed agreements, dismissal of Dr. Durrani prior to settlement by agreement and other means meant to conceal a settlement of a claim. b) Children's Hospital had terminated and/ or restricted Durrani's privileges and] or accepted his resignation in lieu of termination. c) Children's Hospital had settled cases involving allegations of medical negligence of Dr. Durrani; d) Durrani left Children's Hospital after an intemal investigation revealed his incompetence, negligence and ineptitude; e) Durrani left Children's Hospital on "good terms;" f) Durrani's privileges had not been revoked, suspended or affected by acts and omissions while an employee at Children's Hospital; g) by failing to adhere to Defendant's own bylaws, regulations, policies and procedures concerning the hiring, retention, revocation, suspension, supervision, and termination of Durrani while at their facilities; h) Durrani left West Chester Medical Center in May 2013 after an internal investigation revealed his incompetence, negligence and ineptitude. 29. Dr. Durrani completed an application for privileges at West Chester Medical Center prior to his obtaining those privileges. Had Children's not breached their duty, West Chester Medical Center would have had to reject Dr. Durrani, not because they didn't already know about Dr. Durrani, but because they couldn't have hidden their knowledge. 10 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 30. It's the position of Plaintiff that West Chester Medical Center knew about Dr. Durrani's problems, regardless of Children's. The game West Chester played was to conceal, knowingly together with Children's and Durrani, but be able to claim they had no reason not to grant him privileges. They needed the money baby! 31. As early as 2007, Children's Hospital knew or had reason to know that Dr. Durrani performed medically unnecessary, negligent, reckless and improper surgeries, and knew or had reason to know of Durrani's medical and ethical improprieties, but Children's Hospital continued to allow Durrani to be an employee and to enjoy full admitting and surgical privileges at Children's Hospital through December 2008, and limited admitting, clinical, and surgical privileges thereafter into at least February 2009 and possibly after. 32. Ranus v. Durrani was a claim that originally named Dr. Durrani as a Defendant. This case resulted in a confidential settlement and Dr. Durrani was dismissed from the case. The facts and circumstances surrounding the claim, including the substantial cash settlement, were not reported to any regulatory or licensing authority, or made known to the public. Plaintiff and counsel received this information from Ramus out of the blue and unsolicited. Plaintiffs and counsel are not bound by any of the confidentiality terms of Ranus v. Durrani. 33. Children's Hospital represented the interests of Durrani in the case of Ranus v. Children's Hospital. Children's Hospital used legal techniques to permit Durrani to be dismissed from the case. Counsel for Children's claims to Plaintiffs counsel that Dr. Durrani was dismissed in Ramus because it was nursing error, not Dr. Durrani. They ll ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 34. 35. 36. 37. 38. 39. 40. produced no proof. However, we are not in a position based upon past misrepresentations. Upon information and belief, Children's Hospital and/ or its insurer funded, in whole or in part, the legal defense of Dr. Durrani in Ranus V. Durrani. Upon information and belief, there are numerous other lawsuits involving Durrani and Children's Hospital that have been settled for substantial confidential amounts. A search of the NPDB reveals that Children's Hospital has not reported these settlements or any adverse employment actions it took concerning Durrani. As recently as July 2013, Children's, Dr. Durrani and his representatives and attorney continue to mislead the public during news interviews that no settlements have even been paid on Durrani's behalf and/ or that Durrani has never committed an act or omission that resulted in a legal or insurance claim that resulted in the payment of money to a patient. They are lying. Dr. Durrani and the hospitals like Defendant who protected him are "Exhibit in a failed healthcare system which under the cloak of secrecy, manipulation and lies, fails to warn the public about a doctor who deserves a warning "tag." In addition, the Kentucky and Ohio Medical Boards were not provided information from Defendant necessary for them to properly discipline Dr. Durrani and protect the public. The mother of Alexander Ranus has stated that at Children's Hospital, Durrani performed a medically unnecessary and improper surgery on Mr. Ranus who is a 12 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 41. 42. 43. 44. 45. 46. 47. quadriplegic. According to family of Mr. Ranus, during the surgery, Durrani and/or Children's Hospital Nursing Staff under the direct supervision of Dr. Durrani allegedly breached the standard of care causing harm to Mr. Ranus. According to family of Mr. Ranus, the surgery performed on Mr. Ranus was also experimental, and done Without proper informed consent. At the time of the surgery, Mr. Ranus was also mentally, physically and totally disabled and could not make decisions for himself. After the surgery by Durrani, Mr. Ranus' mother hired an attorney who made a legal claim against Children's Hospital and] or Dr. Durrani. Children's Hospital did not report the Ramus out of court settlement, Durrani's negligence, and/ or the adverse event surrounding the claim to the National Practitioner Data Bank in violation of 42 USC and other applicable law, regulations and duties. Children's Hospital did not report the Ramus claim, the settlement, and/ or the adverse event surroundin the events to the Ohio Medical Board. Children's Hospital did not report the Ramus out of court settlement to insurance companies. Upon information and belief, there have been several other substantial out of court settlements by Children's Hospital that were also not reported to the NPDB, in violation of federal and state law. 13 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 48. Children's Hospital also did not inform Plaintiffs that it had terminated the privileges of Dr. Durrani and] or that Durrani was asked to resign in lieu of termination. 49. Thereafter, and in reliance, inter alia, upon the lack of information, lack of report to the National Practitioner Databank by Children's Hospital, and lack of public information about the improprieties of Dr. Durrani, Plaintiffs treated with Dr. Durrani and he performed negligent and] or medically unnecessary surgeries on Plaintiffs at UC Health facilities such as West Chester Hospital or Journey Lite. 50. As a result of the protection and concealment of Defendant of Dr. Durrani, when Plaintiffs goo gled, researched, checked references and investigated Dr. Durrani prior to their surgery(s) and treatment with Dr. Durrani, they found nothing critical of Dr. Durrani so as to be warned about his real record never reported. As proof of this reality, since February 2013 when more information through the date of this filing came to light, the public has been warned so patients avoided surgeries planned by Dr. Durrani. 51. Defendant negligently, recklessly and/ or fraudulently made misleading and false statements and created misleading documents concerning Durrani's tenure at Children's Hospital. 52. Plaintiffs and their insurers were falsely induced into undergoing and paying for medical treatment by Durrani that was unnecessary and improper. 53. West Chester Medical Center/UC Health and Journey Lite, submitted false insurance claims, and scheduled medically improper and unnecessary surgeries upon Plaintiffs. l4 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 54. As a direct and proximate result of the conduct of the Defendant, Plaintiff suffered anxiety, physical pain and discomfort, lost wages, lost economic opportunities, out of pocket expenses, and miscellaneous other financial damages, and will continue to suffer permanent anxiety, distrust, fear, and economic loss in the future. 55. As a direct and proximate result of the conduct of the Defendant, Plaintiff have lost economic potential. 56. As a direct and proximate result of the conduct of the Defendant, Plaintiff and their insurers and third parties have incurred unnecessary medical expenses. 57. As a direct and proximate result of the conduct of the Defendant, Plaintiff lost time off work, lost opportunities, increased insurance rates, adverse credit reporting events resulting in lower credit and miscellaneous and other expenses to be proven at trial. COUNT I: NEGLIGENCE 58. Plaintiff incorporates by reference each and every allegation in the paragraphs above. 59. Defendant owed Plaintiff the duty to exercise the degree of skill, care, and diligence of an ordinary prudent health care provider would have exercised under like or similar circumstances, inter alia, in covering up, failing to report, failing to terminate, failing to suspend, misreporting, misinformation, hiring, credentialing, privileging, marketing, and similar acts and omissions as described in this Complaint. 60. Defendant breached their duties, causing damages, by failing to exercise the duty of an ordinary prudent health care provider would have exercised under same or similar circumstances. 15 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 61direct and proximate result of the aforementioned acts and omissions by the Defendant, Plaintiff sustained the damages as outlined in this Complaint COUNT II: NEGLIGENT HIRING, RETENTION. CREDENTIALING SUPERVISION Plaintiff incorporates by reference each and every allegation in the paragraphs above. Defendant was responsible for the hiring, credentialing, screening, supervision, oversight, and acts and omissions of Dr. Durrani. Children's Hospital had a duty to report settlement(s) of malpractice claims of Dr. Durrani, Durrani's negligence, hardware implant failures, off label use of drugs and biologics, off label marketing of drugs and biologics, and/or adverse medical and ethical events pertaining to Dr. Durrani to the National Practitioner Data Bank, the relevant state medical licensing boards, state and federal government, the public, insurance companies, and the Plaintiffs. Children's Hospital failed to inform and report to the relevant regulatory and licensing entities that Children's Hospital had terminated Dr. Durrani's privileges. Children's Hospital failed to inform and report to these entities that Dr. Durrani had resigned in lieu of termination. Children's Hospital violated the HCQIA, 42 USC by failing to report the termination and] or resignation in lieu of termination to the National Practitioner Databank. 16 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 68. Children's Hospital violated the Safe Medical Device Act, Public Law as a.rnend.e.d., by failing to report that Durrani's hardware implants failed, required removal, revision surgeries, corrective surgeries, broke, fractured, broke through the skin, dislodged, and! or caused serious bodily injury and harm to Durrani patients. 69. Defendant had a duty to reasonably supervise, control, monitor, report, inform, and oversee the conduct and consequences of Dr. Durrani, as well as the accurate reporting of information about his malfeasance, in order for Plaintiffs to make an informed choice and consent to future medical care. 70. Defendant breached their duties to Plaintiffs as described herein. 7l. Defendant provided Dr. Durrani inter alia, direct and indirect financial support, control, medical facilities, logistics, billing and insurance payment support, staff support, medicines, drugs, biologics, equipment, and tangible items for use on patients in medically unnecessary diagnostic procedures, surgeries and medical care, including the diagnosis and treatment of Plaintiffs. 72. Defendant misled Plaintiffs about Durrani's character, reputation in the medical community, his malfeasance, his potential for harm, and the risks associated with continuing care with Dr. Durrani. 73. Defendant knew that Dr. Durrani had his privileges terminated and/ or refused at Christ Hospital, Good Samaritan Hospital, Deaconess Hospital, and St. Elizabeth Hospital. 17 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 74. 75. 76. 77. 78. 79. 80. Defendant did not properly inform Plaintiffs that Dr. Durrani had his privileges terminated and/or refused at Christ Hospital, Children's Hospital, Good Samaritan Hospital, Deaconess Hospital and St. Elizabeth Hospital. On information and belief, as part of the agreement of Dr. Durrani's departure from Children's, Children's agreed to purge Dr. Durrani's complete file and they did so. Children's Hospital failed to inform the appropriate authorities that Durrani had resigned in lieu of termination and] or had his privileges terminated so these authorities could protect the public. Children's Hospital failed to inform these authorities that Durrani was performing unnecessary surgeries, implanting unnecessary hardware, settlements, resignation in lieu of termination, termination of privileges, hardware failures, and/or negligently diagnosing patients EDS. Children's Hospital failed to inform authorities that it had terminated Durrani's privileges to treat patients at Children's Hospital facilities. Children's Hospital violated the HCQIA, 42 USC by failing to report the termination and] or resignation in lieu of termination to the National Practitioner Databank. Children's Hospital violated the SMDA by not reporting the instances of implant hardware's causing serious injury related to Durrani's negligence. 18 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 81. 82. Defendant breached their duty to Plaintiffs, inter alia, by not properly supervising and controlling the actions of Dr. Durrani, other doctors, nurses, staff, and those with privileges, during the medical treatment of Plaintiffs. As a direct and proximate result of the acts and omissions described herein, Plaintiffs sustained damages as alleged in this Complaint. COUNT EXCEPTION TO QUALITY ASSURANCE 83. 84. 85. 86. PEER REVIEW Plaintiffs incorporate by reference each and every allegation in the paragraphs above. A crime/fraud exception must apply when "peer review" or "quality assurance" activities are improperly and illegally used to assist in the cover up and/ or misinformation to licensing and regulatory authorities. When crimes and fraud are employed, no privilege should be available to protect Defendant from discovery or civil liability for negligent credentialing, negligent supervision, and/ or failures to report as explained herein. Defendant violated federal and state law in failing to report the failed medical devices, the privilege and credentialing changes, the settlements, the resignation(s) in lieu of termination(s), the medically unnecessary surgeries, the health care fraud, by making material false representations to licensing authorities and regulatory authorities, and to Plaintiffs and their insurers and third parties related to Plaintiffs care and treatment, as outlined in this Complaint. 19 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 87. Because of these violations of law, Plaintiffs underwent surgery with Durrani without the benefit of truthful information pertaining to Durrani's incompetence and intentional misconduct. 88. Such false representations include, inter alia: the medical billing and coding; the billing statements; stating that the surgery was medically necessary to the patient and the insurer(s) before surgery, and during the approval and/ or precertification process; that Dr. Durrani "could fix" Plaintiffs; that further conservative treatment was futile; by marketing and making Plaintiffs believe the surgeries would be simple and "minimally invasive"; that the procedures and surgery billing to the insurance companies was accurate and medically indicated; by exaggerating diagnoses; that instrumented spine fusion was medically necessary; by using scare tactics, including that Plaintiff's "head would fall off" if they didn't have surgery or that they "would be paralyzed" if they did not have surgery; that Durrani had left Children's Hospital on good terms; that Durrani had begun his own practice; by failing to inform Plaintiffs that Durrani's privileges at Children's had been terminated after an intemal investigation by Children's Hospital; by permitting Durrani to continue to perform medically unnecessary surgeries after obtaining knowledge of substantial malfeasance, negligence, frauds, and similar unethical and improper acts and omissions. 89. Defendant knew or should have known such representations and false reports were false, and/or made the misrepresentations and misinformation with such utter disregard and recklessness as to whether they were true or false that knowledge of their falsity may be inferred. 20 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 90. 91. 92. 93. 94. 95. 96. 97. Defendant made the misrepresentations and failed to make the reports both before and after the surgeries with the intent of misleading Plaintiff and third parties into relying upon them. Plaintiff and the insurers justifiably relied upon the material misrepresentations of Defendant when making the decision to undergo and pay for unnecessary medical treatment, and the physical and manifestations of facing surgery. On July 25, 2013 Durrani was arrested and charged with Health Care Fraud and Making False Statements relating to Health Care. In August 2013, a grand jury indicted Dr. Durrani for same. A federal investigation remains ongoing into Dr. Durrani and the culpability of employers and business partners of Durrani, including Children's Hospital. A state criminal and licensing investigation remains ongoing in Ohio. A licensing investigation remains ongoing in Kentucky. COUNT IV -- NEGLIGENCE PER SE Plaintiffs incorporate, adopts and re--alleges as if fully restated herein, those allegations contained in the above paragraphs. Defendant is liable for the results of violating statutes that apply to them. Defendant violated 42 USC 11151 by failing to report to the National Practitioner Databank that Dr. Durrani's privileges were terminated from Children's Hospital. 21 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 98. 99. 100. 101. 102. 103. 104. 105. Defendant is obligated and have a duty to obey Section 361 of the Public Health Service Act, codified at 42 U.S.C. 264 [the Act"] and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 and other applicable statutes. Defendant had a duty to prevent illegal, off label, and improper marketing of bone graft and spine surgery implant hardware at their facilities. Defendant had a duty pursuant to the Safe Medical Device Act Public Law 101-629, as amended, and regulations proniulgated. thereunder, to report failed hardware implants that caused serious harm and death, but failed to make such reports. These reporting requirements can be found at: fda. Defendant breached the aforementioned statutory duties. Defendant violated these statutes, causing harm to Plaintiffs. As a direct and proximate result of the statutory violations as described in this Complaint, Plaintiffs sustained damages as outlined in this Complaint. COUNT - CLASS ACTION CAUSE OF ACTION Plaintiff Class Members are citizens and residents of the United States who had surgery performed by Dr. Durrani in Ohio without the benefit of truthful and accurate information regarding settlements involving Durrani; without the benefit of truthful and accurate information regarding reportable changes in Durrani's privilegel admitting status; and/ or without the benefit of truthful and accurate information regarding reportable events pursuant to the laws and regulations explained herein; 106. All class members had surgery without the benefit of this information that should 22 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 have been reported, but was instead covered up, by the Defendant. 107. All of the following Sections of Ohio Civil Rules apply: Prerequisites to a class action. One or more members of a class may sue or be sued as representative parties on behalf of all members only if: (1) the class is so numerous that joinder of all members is impracticable; (2) there are questions of law or fact common to the class; (3) the claims or defenses of the representative parties are typical of the claims or defenses of the class; and (4) the representative parties will fairly and adequately protect the interests of the class. TYPES OF CLASS ACTIONS. A class action may be maintained if Rule 23(a) is satisfied and if: (1) prosecuting separate actions by or against individual class members would create a risk of: (A) inconsistent or varying adjudications with respect to individual class members that would establish incompatible standards of conduct for the party opposing the class; or (B) adjudications with respect to individual class members that, as a practical matter, would be dispositive of the interests of the other members not parties to the individual adjudications or would substantially impair or impede their ability to protect their interests; 23 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 (2) the party opposing the class has acted or refused to act on grounds that apply generally to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole; or (3) the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy. The matters pertinent to these findings include: (A) the class members' interests in individually controlling the prosecution or defense of separate actions; (B) the extent and nature of any litigation concerning the controversy already begun by or against class members; (C) the desirability or undesirability of concentrating the litigation of the claims in the particular forum; and (D) the likely difficulties in managing a class action. 108. All of these elements are met by the Plaintiffs herein. 109. It is judicially more economic to adjudicate these claims en masse, as opposed to individual lawsuits, since all claims involve the same allegations, the application of the same law, and the same Defendants, based on events and misinformation that affected all Plaintiffs in substantially the same way. llO. Plaintiffs all justifiably relied upon the lack of reported information when deciding to undergo surgery with Durrani at another facility after his privilege relationship terminated at Children's Hospital. 24 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 111. Plaintiffs all justifiably relied upon the lack of reported information when deciding to undergo surgery with Durrani at West Chester Hospital which is owned by UC Health. 112. UC Health and Children's Hospital knew that Plaintiffs did not have the benefit of truthful and accurate information about Durrani's incompetence, but failed to accurately and truthfully convey this information to 113. Plaintiffs are asking the Court to certify a class action under Ohio state law. PRAYER FOR RELIEF WHEREFORE, Plaintiff demands judgment against Defendants on all claims. Plaintiffs further request: 1. Past medical bills; 2. Future medical bills; 3. Lost income and benefits; 4. Lost future income and benefits; 5. Loss of ability to earn income; 6. Past pain and suffering; 7. Future pain and suffering; 8. Plaintiff seeks a finding that their injuries are catastrophic under Ohio Rev. Code ?23 15. 18; 9. All incidental costs and expenses incurred as a result of their injuries; 10. The damages to her credit as a result of their injuries; 11. Loss of consortium; 12. Punitive damages; 25 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478 13. Costs; 14. Attorneys' fees; 15. Interest; 16. All property loss; 17. All other relief to which she is entitled to. Based upon this itemization of damages, the damages sought exceed the minimal jurisdictional amount of this court. Respectfully submitted, \s\Eric C. Deters Eric C. Deters (38050) ERIC. C. DETERS PARTNERS, PSC 5247 Madison Pike Independence, KY 41051 Phone: (859) 363-1900 Fax: (859) 363-1444 erieffie' eriedeters.coin JURY DEMAND Plaintiff hereby respectfully request trial by jury on all issues. \s\Eric C. Deters Eric C. Deters (0038050) 26 ELECTRONICALLY FILED IFIJ A1305864 CONFIRMATION NUMBER276478