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Man Diagnosed with Fusarium Keratitis After Using ReNu with MoistureLoc Files Lawsuit Against Bausch & Lomb

Parker & Waichman, LLP Announces It Has Filed Suit on Behalf of Man Diagnosed With Fusarium Keratitis in Left Eye After Using ReNu With MoistureLoc Contact Lens Solution

Victim Underwent Cornea Transplant, Lensectomy, Capsulectomy, Iris Removal and Multiple Flush-Out Surgeries on Left Eye, Awaits FDA Approval for Iris Transplantp> Parker & Waichman, LLP announces that it has filed a suit against Bausch & Lomb, Inc. on behalf of a 53-year-old man who was diagnosed with Fusarium keratitis in his left eye after using ReNu with MoistureLoc. As a result of the infection, the injured man underwent a corneal transplant after several invasive surgical procedures to remove the infection failed. He is currently awaiting FDA approval for an iris transplant. The suit was filed yesterday in the Supreme Court of the State of New York in Onondaga County.

On April 10, 2006 the FDA and the CDC issued public health warnings concerning serious fungal infections associated with contact lens solution use. The CDC stated that it had interviewed 30 patients suspected of having fungal keratitis. Of these 30 patients, 28 wore soft contact lenses and 26 used a Bausch & Lomb ReNu contact lens solution in the month prior to the fungal infection diagnosis. On April 13, 2006 Bausch & Lomb, Inc. recommended that consumers switch to another lens care solution and asked all retailers to remove U.S.-manufactured ReNu with MoistureLoc from their shelves. On May 2, 2006 the CDC announced that the number of confirmed fungal infections rose to 88 cases. Just three days later, on May 5, 2006, the CDC revised the number of confirmed cases to 102.
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Health Canada Issues Warning of Serious Health Risks Posed By Nasutra, a Non-Prescription Sexual Enhancement Medication

Health Canada has issued a warning to consumers not to use the non-prescription product, Nasutra, because “it has been found to contain the undeclared ingredient sildenafil (chemical name for ViagraTM) that could lead to serious health risks, especially for patients with existing medical conditions such as heart problems, those who may be taking heart medications, or those who may be at risk for strokes.”

Although Nasutra is touted as an “all-natural traditional Chinese medicine for sexual enhancement,” it was found to contain sildenafil, “which should only be used under medical supervision.”
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European Commission Finds Sunscreen Labels Misleading and Potentially Dangerous

The European Commission is claiming precisely what pending lawsuits in California are alleging, namely, that sunscreen labels are not only misleading, but potentially dangerous in that they lead consumers to believe that the products protect tem from skin cancer or premature aging when, in fact, the benefit of the products is limited to sunburn protection.

The Commission is concerned with such labeling terms as “sunblocker” that could give consumers the mistaken impression that the products give total protection from the sun’s damaging rays. In fact, no sunscreen product provides complete protection from dangerous UV radiation.
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European Link to Eye Fungus Outbreak Puts Pressure on Investigators and Bausch & Lomb to Find Answers

By Steven DiJoseph

Although Bausch & Lomb and the FDA have not ordered a recall of any contact lens solutions other than ReNu With MoistureLoc, the continued spread of Fusarium keratitis cases around the globe raises serious questions as to the safety of these products in general.

Since the fungal infection at the center of the current problem is relatively rare, experts are troubled by spikes in its occurrence in Asia (Singapore and Hong Kong), the United States, and Europe all at the same time.
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Health Canada Issues Warning that Mislabeled Bottles of Sandoz Prednisolone 1% Ophthalmic Suspension Pose a Serious Risk of Eye Damage

Health Canada has issued a warning to consumers not to use Sandoz Prednisolone 1% USP ophthalmic suspension eye drops because of the possibility that the bottles may mistakenly contain Blue Collyrium another product that raises “potentially serious health risks.”

The problem was discovered when one bottle from one lot of Prednisolone 1% USP ophthalmic suspension eye drops was found to contain Blue Collyrium.
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FDA Announces Conviction of Two Executives for Fraudulently Selling Unapproved Sterilizing Devices that Led to Blindness in 18 Patients

The FDA is reporting that two executives of AbTox, a Mundelein, Illinois, company have been of “fraudulently selling uncleared surgical sterilizing devices that led to eye damage in eighteen patients, causing them to lose sight in one eye.”

Ross Caputo and Robert Riley were president and CEO and vice-president of regulatory affairs of AbTox when the company received permission “to market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without lumens (tubes) or hinges. The defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of non stainless-steel instruments.”
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CPSC Announces Recall of 104,500 Daisy Slingshots that Pose Risk of Blindness and Other Serious Eye and Facial Injuries

The Consumer Product Safety Commission and Daisy Manufacturing Co., of Rogers, Arkansas have announced the voluntary recall of about 104,500“ The Natural” Slingshots manufactured in Taiwan. Consumers should stop using the product immediately and contact the Daisy for refund or replacement.

If the slingshot band slips out of its frame during use, the ball at the end of the tubing can strike the user, resulting in serious facial injuries.
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Bausch & Lomb Reeling From CDC Report Now Linking Two of Its Leading Products to Additional Fungal Eye Infections

Bausch & Lomb’s problems just got significantly worse as the Centers for Disease Control and Prevention (CDC) has notified the company additional cases of Fusarium keratitis involving contact lens wearers have been linked to another of its leading products.

According to a press release, the CDC has found some 27% of the reported cases of the rare fungal infection in contact lens wearers occurred in people who had used ReNu MultiPlus, a contact lens storage solution that has approximately a 40% share of the
market.
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FTC Files Federal Action to Stop Web-Based Companies from Selling Consumers’ Confidential Telephone Records

By a vote of 5-0, the Federal Trade Commission (FTC) has announced that it has filed federal court complaints “charging five Web-based operations that have obtained and sold consumers’ confidential telephone records to third parties with violating federal law.” http://ftc.gov/opa/2006/05/phonerecords.htm.

According to the FTC, the named defendants in these cases are: 77 Investigations, Inc., and Reginald Kimbro, based in Upland, California, and using mailing addresses in Jacksonville, Florida, Broomfield, Colorado, and Nashville, Tennessee; AccuSearch, Inc., (more…)

Arizona Governor Vetoes Bill Making It More Difficult to Prove Malpractice Against Emergency Room Personnel

Arizona Governor Janet Napolitano, a Democrat, has vetoed a bill that would have raised the burden of proof in medical malpractice cases against emergency room personnel from a “preponderance of the evidence” (anything greater than 50%) to “clear and convincing proof,” which is the highest standard applied in civil cases (closely approaching the criminal standard of “beyond a reasonable doubt”).

Those who supported the law argued that it was needed to stop the exodus of doctors, who fear malpractice lawsuits, from emergency rooms in the state. Specialists, like neurosurgeons, are especially reluctant to serve in emergency rooms.
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