Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations
A Lafayette, La., ophthalmologist and eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil money penalties for violating federal laws related to the conduct of clinical studies. The violations involved studies of a laser system built by the ophthalmologist for LASIK treatment of nearsightedness.
In a settlement agreement signed today with the Food and Drug Administration (FDA), Leon C. LaHaye, M.D., will pay $150,000 and his LaHaye Center for Advanced Eye Care of Lafayette will pay $950,000 for clinical study violations that occurred on at least 175 occasions. In June 2002, FDA disqualified LaHaye from conducting further clinical studies.
“This penalty sends a clear message that FDA will not tolerate conduct that can put patients at risk and erode the trust between research subjects and the medical research community,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D.
To protect patients and to help ensure that tests of unapproved products will yield useful data, FDA regulations establish strict conditions under which clinical studies of medical devices may occur. For example, studies of high risk devices such as ophthalmic lasers must be conducted according to an investigational plan reviewed and approved by FDA and an investigator must obtain informed consent from each participant. In addition, the device cannot be used on patients before the study begins.
The civil money penalties complaint filed by FDA alleged that Dr. LaHaye and his center:
Used an unapproved laser on patients before the study began;
Treated more subjects than allowed under the study plan that was approved by FDA;
Ignored parameters of the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients;
Failed to submit complete, accurate, and timely reports to FDA about the ongoing study; and
Misrepresented to FDA that Dr. LaHaye was using an FDA-approved laser to treat patients when, in fact, the procedures were performed with an unapproved, experimental laser.
The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act give FDA the authority to impose civil money penalties. The payments do not go to FDA, however, but to the U.S. Treasury.
Today the parties filed the signed settlement agreement. This agreement will not take effect until it is approved by the Administrative Law Judge.
The above was obtained from the FDA's website.