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Bausch & Lomb Facing Multiple Lawsuits

Contact Lens Wearers Suffered Severe Eye Infections

By James R. Hood
ConsumerAffairs.com

May 5, 2006

• Another, Bigger "Complete MoisturePlus" Recall • "Complete MoisturePlus" Contact-Lens Solution Recalled • Texas Sues Contact Lens Dispensers • Studies Find Laser Surgery Safer than Contacts • CDC Confirms MoistureLoc-Eye Infection Link • Bausch & Lomb Recalls Contact Lens Solution • FDA Not Ready To Order Recall Of Bausch & Lomb ReNu • Bausch & Lomb Facing Multiple Lawsuits • Analyst Sees More Bausch & Lomb Recalls Ahead • Bausch & Lomb "Withdraws" ReNu Contact Lens Solution • Wal-Mart, Walgreens Stop Selling Bausch & Lomb ReNu • Serious Eye Infections Linked to Soft Contacts --- • Consumer complaints about AMO Complete MoisturePlus • Consumer complaints about Bausch & Lomb ReNu • Vision Care

Bausch & Lomb faces a growing number of lawsuits from users of its ReNu contact lens solution, which is now suspected in at least 186 cases of eye infections in 29 states. Without prompt treatment, the infection can scar the cornea and blind its victims. At least eight patients have required cornea transplants.

In Florida, Zoe Wade said she suffered an infection so severe that her left eye had to be removed to stop the infection from reaching her brain. Wade said she began using Renu MoistureLoc last July. By October, she was suffering from a severe case of Fusarium keratitis, a fungal infection.

"The pain is very traumatic ... It's like your head is going to come off," Wade said at a news conference.

Barbara Cavallaro, of Cranston, Rhode Island, said she is suing after she was forced to undergo a corneal transplant. Cavallaro's lawyer, Peter Wasylyk has filed a $5 million class action suit and an individual suit federal court in Providence.

Cavallaro said the trouble started in October. It took weeks before a Harvard Medical School expert finally diagnosed it as Fusarium keratitis. Cavallaro said it was all because of her contact lens solution, the Bausch & Lomb Renu with Moisture Loc.

Carvallaro said her sight is permanently damaged and she'll need two more surgeries. Because of the transplant, her eyes are now two different colors -- one is brown and the other is blue. She said her vision will never be the same.

Time Line

The company stopped sales of ReNu contact lenses with MoistureLoc solution last month after the product was linked to an apparent outbreak of Fusarium keratitis, a serious eye infection. Now, the company says it was alerted last fall to a rise in infections among lens wearers in Hong Kong.

Hong Kong officials said they had interviewed 62 patients, of whom 25 said they had used a ReNu solution. Seven of those 25 patients had the Fusarium keratitis infection, officials said.

The company also said earlier this week that Renu, which generated $45 million in U.S. sales last year, had been linked to a "handful" of eye infection cases in Europe but did not disclose the number of cases.

It's estimated that a third of the 30 million Americans who wear contacts use a Bausch & Lomb lens solution.

The Centers for Disease Control and Prevention said it is investigating 186 cases of the eye infection; 73 of those cases have been confirmed but the CDC isn't saying how many patients had used a ReNu solution.

Officials say that a high incidence of the affected patients interviewed had used ReNu with MoistureLoc, which was introduced in 2004.

The FDA and CDC say it could take a month or more to determine if MoistureLoc was indeed the cause of the infections. Inspectors have been examining the Greenville, S.C., plant where the solution is made for Far East and U.S. markets.

Symptoms of the infection can include blurry vision, pain or redness, excessive discharge and increased sensitivity to light.

Company Response

Although the company has stopped shipments of the product and asked retailers to remove it from their shelves, it has declined to call those actions a recall.

"Bausch & Lomb has not yet recalled ANY of its products. Rather, its ReNu MoistureLoc has been taken of the shelves. Who can I speak to about this inaccuracy?" said Grace Healy of the Hill and Knowlton public relations firm in an email to ConsumerAffairs.com.

Other pharmaceutical companies facing potential problems have taken much more aggressive measures to alert their customers of the possible dangers.

Ophthalmologists' Advice

"The wearing of contact lenses is generally very safe, but this outbreak of infections is certainly something to be concerned about," said H.Dunbar Hoskins, MD, executive vice president of the American Academy of Ophthalmology.

"Ophthalmologists across the country are sending in reports to help with the investigation, while at the same time making sure our patients who wear contact lenses are aware and informed."

The Academy recommends that consumers follow these precautions:
• Wash your hands with soap and water and dry them before handling lenses.
• Wear and replace your lenses according to the schedule prescribed by your doctor.
• Follow instructions from your doctor and your solution manufacturer for cleaning and storing your lenses.
• Make sure you always use fresh solution and replenish the solution daily.
• Keep your contact lens case clean and replace every three to six months.
• Remove the lenses and consult an ophthalmologist immediately if your eyes become red or irritated or your vision changes.

Regardless of what cleaning/disinfecting solution you use, consider performing a "rub and rinse" lens cleaning method rather than a "no-rub" method in order to minimize the number of germs to reduce the chances of infection.

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