Jenna Reed and Rian Reed vs. Alcon Laboratories, Inc., Alcon Manufacturing, Ltd., and Alcon Refractive Horizons, Inc. United State District Court, District of Colorado.
Denver, CO (LASIK Newswire) August 24, 2008 — On August 20, 2008, plaintiffs, Jenna Reed and Rian Reed, filed their complaint in the United States District Court, District of Colorado, seeking damages against Alcon for strict liability, negligence, breach of warranty, misrepresentation, and violation of the Colorado Consumer Protection Act. Case Number 1:08-cv-01759-EWN Reed et al v. Alcon Laboratories, Inc. et al Complaint.
LASIK eye surgery is among the most prevalent forms of elective surgery performed in the United States. It is estimated that it is performed on approximately one million eyes per year. The LASIK industry generally, and defendants in particular, profess that the surgical laser systems used to perform the surgery are safe. However, on February 21, 2007, the United States Food and Drug Administration recalled defendants’ excimer surgical laser system, known as the LADAR6000 Excimer Laser (the ALADAR6000) due to reports that the LADAR6000’s CustomCornea Myopia and CustomCornea Myopia with Astigmatism algorithm procedures were causing Acentral islands in patients.
Unfortunately for the plaintiff Jenna Reed, a 33 year old wife and mother of two, who resides in Longmont, Colorado, the FDA Recall came too late. She was one of approximately 20 patients who were injured by the defective LADAR6000, which was used by her LASIK surgeon at Insight LASIK, in Layfayette, Colorado.
On September 22, 2006, Mrs. Reed’s doctor performed LASIK surgery on her, and programmed the LADAR6000 to perform CustomCornea Myopia with Astigmatism on Jenna Reed.
Predictably, Jenna Reed has developed Acentral islands, which are a laser created defect in her eyes caused by the laser’s uneven application of energy to her corneas. As a consequence of resultant peaks and valleys in her corneas, Jenna Reed is left with a permanent visual disability marked by problems with her vision, which include, without limitation, blurring, ghosting, double vision, photosensitivity, poor night vision, and ocular headaches.
Defendants have offered to send Jenna Reed, and numerous other patients injured by its defective LADAR6000, to Texas for purported corrective surgery. However, Jenna Reed’s eye care professionals at InSight (who are not the subject of this lawsuit) have advised her that there is no certainty that any further surgery can cure or correct her injuries.
The plaintiffs are represented by Carrie Frank of Klein | Frank, P.C., in Boulder, Colorado and Todd J. Krouner, from Chappaqua, New York. Mr. Krouner and Ms. Frank have also filed suit on behalf of another patient, Melanie Wheeler, of InSight who was also injured as a result of the defective LADAR6000. Klein | Frank, P.C. is a nationally recognized firm that handles cases involving defective products, personal injury and defective drugs throughout the United States.
###
Contact Information
Carrie Frank
Klein | Frank, P.C.
http://www.lawcolorado.net
303-448-8884
August 24th, 2008
This letter addresses my concern about the safety of LASIK surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on LASIK, I decided not to do the surgery. I believe LASIK surgery is not consistent with the ophthalmologist’s hypocritic oath of “first do no harm. ” Statistics on complications could easily be manipulated by surgeons and I don’t think their reporting of complications can be relied upon. I think a few points are more valid: it was reported in the last year in the literature that LASIK surgeons have an income creating the setting for significant bias. A highly significant fact that seems to be passed over without much comment is that the LASIK flap can be easily lifted for up to at least ten years exposing the pt to the risk of dislocating and/or losing the flap when subjected to injury. A recent article told of four such cases after ten yrs. When I have explained this fact to hundreds of patients who were considering LASIK, everyone stated that it is enough reason not to do the surgery. I explained to them that it’s as if you had a circular patch of skin incised and replaced and it could be easily lifted up ten years later. Everyone is overwhelmed with this fact and say they are convinced that they won’t do the surgery. When I have seen patients that have had LASIK surgery with other doctors, none of them were aware of this fact. We are playing Russian roulette with these patients, hoping statistically that they won’t be hit in the eye. We are also playing this Roulette game hoping beyond all hope that they don’t get infection, but we all know infections happen. I went to a meeting at the last conference in 2007 which was concerned with how commonly senior citizens eyes become irritated from dryness and the use of multiple preservatives over the years. I asked the panel at the meeting, many of whom are LASIK surgeons, why aren’t we more concerned about the damaging effects of LASIK which causes dry eye and damaged corneal nerves. They elected not to answer the question. I think we have a panel already in this country that is ideal to give you the answer to the problems with LASIK. The panel consists of the thousands of ophthalmologists who chose not to do this procedure knowing they could make a half million dollars more per year. I think you should send a questionnaire out to all the ophthalmologists, especially those who don’t do this surgery and ask them why they don’t do it. I have seen other examples of where the FDA allows higher risk manipulations of the eyes when it clearly is against the patients’ interest. Two of these examples are allowing all-in-one chemical solutions for contact lenses without advising the patient to rinse off the detergent and disinfectant with saline. These patients are soaking their eye all day in these two irritating chemicals. The three most commonly used solutions do not recommend rinsing. Another pandering to patients is the following of no-stitch cataract surgery, even though Medicare has shown the doubling of the incidence of infection in the eyes in the last ten years since no-stitch surgery has been initiated. This is not likely a coincidence. The three examples cited in the letter, i. e. , LASIK surgery, all -in-one contact lens solutions, and no-stitch cataract surgery are all examples of pandering to patients vulnerable instincts in an effort to promote a “wow” factor, rather than a healthier outcome. I have seen over the last thirty-five years in ophthalmology a steady trend within the profit side of medicine taking precedence over “first do not harm”.
Source: FDA Maude Database Report
August 9th, 2008
Ask any LASIK patient if he or she was given the FDA-mandated Patient Information Booklet prior to surgery. The answer is usually “no”.
Companies that manufacture lasers for use in LASIK surgery are required by the FDA to provide Patient Information Booklets to LASIK surgeons. In turn, LASIK surgeons are required to provide the booklets to prospective patients prior to surgery. Patient Infomation Booklets provide warnings and other information for patients to consider before consenting to undergo LASIK.
Below are two examples of the FDA mandate regarding Patient Information Booklets. The first example is found in an FDA Approval Order for the VISX laser, and the second is found in the VISX Physician Instruction Booklet.
Prospective patients, as soon as they express an interest in wavefront-guided LASIK for myopic astigmatism and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet (as described in your final submission to this PMA supplement). Link
All patients must be given the opportunity to read and understand the Patient Information Booklet and to have all their questions answered to their satisfaction before giving consent for Laser Assisted In Situ Keratomileusis (LASIK). Link
LASIK surgeons also fail to comply with mandatory reporting of complications and adverse events, as evidenced by researching the FDA’s Maude database. See related story.
Obviously, the LASIK industry has done a poor job of policing itself. And the FDA has done an equally poor job policing the use of LASIK devices. As a result, many patients have suffered serious injury and loss of quality of life.
July 27th, 2008
MIAMI, FLORIDA — A new study published in the July, 2008 edition of Archives of Ophthalmology demonstrates an elevated risk of suicide in people with visual impairment.
The psychosocial and health consequences of ocular conditions that lead to visual impairment (VI) are broad and include impaired activities of daily living, social isolation, cognitive impairment, impaired functional status and functional decline, increased dependency on others, increased risk of motor vehicle crashes, falls and fractures, poor self-rated health, and depression. Increased mortality risks also have been noted in adults with VI and disabling eye disease… Up to two-thirds of people who commit suicide have some type of physician contact in their last month, and physician education is effective in reducing suicide rates. Our results suggest older adults and those with nonocular health conditions, poor self-rated health, and reported VI are at increased suicide risk. Eye care professionals should be aware of the potential increased risk of suicide for patients with VI, especially those in poor health, and provide appropriate referrals for these patients… In summary, we observed that reported VI increased suicide risk, particularly indirectly via reported health status and health conditions.
Earlier this year in response to media reports of depression and suicide following LASIK, LASIK industry insiders denied any connection.
Dr. Richard Lindstrom, “The premise of your Feb. 3 article ‘Some link depression, failed LASIK’ was based upon incomplete, unpublished and anecdotal research and did a disservice to the millions of Americans who elect to undergo vision correction surgery each year. It is irresponsible to draw a conclusion between LASIK and suicide. There is simply no scientific basis to support a direct connection between a sub-optimal outcome from eye surgery and suicide.” Source
Dr. Steven C. Schallhorn, “There’s no cause and effect.” Source
These statements by LASIK industry leaders are perplexing, given the contradictory evidence published in the body of scientific literature. It is widely reported that visual impairment has an adverse effect on quality of life, which may lead to depression and thoughts of suicide.
At the April 25, 2008 FDA hearing on post-LASIK issues, several speakers gave compelling testimony of the link between bad outcomes from LASIK and depression and suicide. LASIK industry representatives in attendance appeared unmoved.
——————————————————
Byron L. Lam; Sharon L. Christ; David J. Lee; D. Diane Zheng; Kristopher L. Arheart. Reported Visual Impairment and Risk of Suicide: The 1986-1996 National Health Interview Surveys. Arch Ophthalmol. 2008;126(7):975-980.
July 19th, 2008
FOR IMMEDIATE RELEASE
July 15, 2008
Corneal ectasia; thousands of late onset complications of LASIK likely
LASIK surgeons fail to comply with FDA reporting requirement
After recklessly performing millions of LASIK surgeries over the past decade with little to no policing of its poor surgical practices and deceptive advertising, the LASIK industry is feeling the pinch. LASIK volumes have plummeted after a flurry of bad press and public outcry of widespread problems with LASIK. But this doesn’t help the patients who have been needlessly harmed by an unnecessary, irreversible surgery.
When a patient suffers a complication of LASIK, the surgeon is required to file a MedWatch report with the FDA. In a press release earlier this year, the LASIK industry stated that only 140 reports had been filed with the FDA “relating to LASIK dissatisfaction” between 1998 and 2006. In issuing this statement, the LASIK industry admitted that LASIK surgeons routinely fail to comply with FDA reporting requirements. In fact, it appears that most LASIK surgeons have never filed a single MedWatch report.
The LASIK industry received Food and Drug Administration (FDA) approval to perform a destructive surgery on healthy eyes based on sloppy science and insufficient, short followup data. LASIK causes chronic dry eyes and poor night vision in approximately 20% of patients, according to a review of FDA clinical trials. These “symptoms” were not disclosed to prospective patients, even though they can be permanent and life-altering.
But one complication of LASIK has the industry concerned because public awareness of the sight-threatening complication, corneal ectasia, could further tarnish the image of LASIK. Ectasia is a progressive forward bulging of the cornea, which requires corneal transplantation in most cases. Ectasia strikes when the cornea is too weak after LASIK to withstand the stress of the intraocular pressure of the eye. Medical studies show significant, permanent weakening of the cornea after LASIK in all eyes, which may lead to ectasia years after surgery.
The incidence of ectasia is estimated to be approximately 1 in 2,500 but this number could be an underestimate due to underreporting and lack of long-term followup after LASIK. Approximately 8 million people have undergone LASIK in the United States, likely resulting in thousands of unreported cases of post-LASIK ectasia.
Failure of the FDA to order long-term followup of LASIK patients (post-market surveillance) and enforce MedWatch reporting of LASIK complications is to blame for lack of public awareness of the potentially blinding complication of post-LASIK ectasia. But patient groups are watching, and they want the FDA to know that they will hold the Agency accountable.
July 15th, 2008
Previous Posts
