Reprinted with permission from www.fdaweb.com
As FDA Awaits LASIK Study, Lawsuit Hits Big Player
As FDA continues to await the results of a nationwide collaborative study on after-effects of LASIK eye surgery, due in 2012, injured patients have begun filing lawsuits based on their discontent with those after-effects — chronic and painful dry eyes, halos, starbursts, worsened vision, even suicide. At issue is whether these after-effects come to only 1% of patients as some LASIK surgery companies claim, or in excess of 20%, as injured patient activists claim. Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, on whose watch LASIK devices were approved, now says the agency “screwed up” in not setting a limit for adverse events from this elective cosmetic surgical procedure.
On 3/17, one of the nation’s largest chains of refractive eye surgery facilities, TLC LASIK Centers, was sued 3/17 in South Carolina federal court by attorneys for 181 injured patients alleging breach of contract, conspiracy, Racketeer Influenced and Corrupt Organization (RICO) violations. The company, whose parent corporation, TLC Vision Corp., is in Delaware Bankruptcy Court under Chapter 11, received five of 17 FDA Warning Letters sent to LASIK ambulatory surgical facilities 10/9/09 for failure to file required MDRs on adverse events. The new lawsuit is based on injuries it says TLC knew about and deliberately concealed.
As it announced those 17 Warning Letters, FDA also its extensive study of LASIK’s after-effects, in collaboration with the National Eye Institute and the Department of Defense. Expected not to report until 2012, the patient-experience parts of the study have not yet begun, but an agency statement 3/18 said the protocol for the phase involving the experience of military LASIK patients “has been developed by federal experts in clinical research and has been reviewed and approved by an independent committee comprised of patient representatives and experts in refractive surgery, clinical research, and questionnaire development. The protocol is ready for institutional review board submission.”
The concluding phase “will be a national, multi-center clinical study to determine the percentage of patients in a general LASIK population with significant symptoms and functional limitations after LASIK surgery, as well as explore possible contributing factors to poor outcomes. The protocol for Phase 3 is under development; therefore, enrollment into this study has not yet begun.”
Seeking a total $180 million in damages, the South Carolina class action complaint names as defendants 29 TLC LASIK surgical facilities in various states, 24 TLC clinical directors, 34 TLC LASIK surgeons and four corporate managers, including vice president for patient care John Potter. It alleges that they conspired to fraudulently extend post-operative, lifetime ocular health care until the injured patients’ statute of limitations right to sue ran out — usually two years.
“This enterprise which manifested itself in both the implementation of and contribution to an illegal, subverted database for a period of at least eight years, with both the enterprise and database being implemented through the use of mail and wire fraud, involving hundreds and potentially thousands of victims,” the complaint says. “The above scheme amounted to a pattern of racketeering activity and continues to pose a threat of continued criminal activity. A second prong of the scheme used to facilitate the concealment of the patient’s surgically created condition, was the marketing and implementation of the Lifetime Commitment Contract … [which] merely offered benefits to the extent it would prolong or prevent the patients from discovering the surgically created conditions.”
The complaint alleges that each of the defendants represented to patients “they had good ocular health, that new equipment and procedures were being approved in the immediate future which would resolve their condition and further concealed that the various visual disorders were surgically created.” These representations were allegedly intended to placate and deceive TLC’s injured patients and caused them to decide not to seek intervening medical treatment or legal remedies.
The plaintiffs are seeking lifetime ocular health care for all class members, payment for past and future medical expenses, waiver of statutes of limitation, disclosure of all medical records to plaintiffs, compensatory and punitive damages, attorney fees and statutorily trebled damages and costs.