Exposing the LASIK Scam

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 Post subject: FDA Fines Ophthalmologist $1.1 Million
PostPosted: Sun Jul 30, 2006 11:13 pm 
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http://www.fda.gov/ora/about/enf_story/ ... /cdrh1.htm

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00972.html

FDA Fines Ophthalmologist $1.1 Million for Clinical Study Violations

Clinical Investigator Used Unapproved LASIK Device Outside the Parameters of Clinical Protocol
A Lafayette, Louisiana ophthalmologist and the 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 reached with 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 on at least 175 occasions. LaHaye was also disqualified by FDA in June 2002, from conducting further clinical studies.

?This penalty sends a clear message to study sponsors: FDA will not tolerate misconduct of clinical studies. This puts participants at risk and is a serious violation of the law,? said FDA Commissioner Mark B. McClellan, M.D., Ph.D.

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.

Charges against Dr. LaHaye included:

Treating more subjects than allowed under the study plan that was approved by FDA;
Ignoring parameters of the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients;
Failing to submit complete, accurate and timely reports to the FDA about the ongoing studies; and
Misrepresenting to FDA that he was using an FDA-approved laser to treat patients when, in fact, the procedures were performed with an unapproved, experimental laser.
The settlement agreement was signed before an administrative law judge of the FDA.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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