CDC and FDA Investigating Additional Eye Infections as Inspection of Bausch & Lomb’s South Carolina Plant Continues

By Steven DiJoseph

From every indication, the current outbreak of serious fungal eye infections is going to get worse before it gets better and that is not good news for the public and certainly not an encouraging sign for Bausch & Lomb.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are anxiously searching for the source of the problem while the number of reported cases of the normally rare infection continues to increase dramatically.

Both the CDC and the FDA are continuing their examination of data from their inspection of Bausch & Lomb’s Greenville, South Carolina plant where ReNu With MoistureLoc contact lens solution if manufactured. Those agencies have stated that their analysis could take another month, however.

The present inability of either agency to pinpoint the exact source of the problem is troubling since, without that information, any preventive action will not be fully effective.

In the meantime, the number of <"">cases of <"">Fusarium keratitis, which can cause blindness and other serious eye problems, continues to grow. The CDC is reporting that it is investigating some 67 additional cases of the infection that now involves 29 states.

Although no definitive link has been announced between the outbreak and Bausch & Lomb’s product (or any other particular product or source), the company’s <"">ReNu With MoistureLoc solution has been found to have been used by an extremely high percentage of the people who have contracted the fungal infection in the past 10 months.

The outbreak has caused Bausch & Lomb some serious financial, legal, and image problems as it has found itself both at the center of the crisis and widely criticized for its indecisive reaction to the outbreak.

The 153-year-old company based in Rochester, New York, had gradually become a highly visible and respected healthcare brand worldwide with annual revenues of over $2 billion from sales in over 100 countries where it employs some 13,700 people. Currently its core businesses include soft and rigid gas permeable contact lenses, lens care products, and ophthalmic surgical and pharmaceutical products.

Now, however, Bausch & Lomb is faced with class-action lawsuits, individual personal injury claims, falling stock value, an expensive product recall, a plant closure, two very concerned federal agencies, and an enormous amount of negative publicity.

Reports have also been released as to FDA inspections in May and June 2002 at Bausch & Lomb’s Greenville, South Carolina, plant that found paint chips in rooms where containers of eye care products were filled.

In a warning letter from July 17, 2002, the FDA cited the company for its failure to adequately investigate the cause of the paint chips “which directly related to product quality.” The warning also expressed concern over the company’s ability to test for the appropriate amount of preservative/disinfectant “used in the majority of your eye care products.”

The company maintains that the problem was cleared up and that no eye care product’s quality or sterility was ever in question.

The current problem, however, is far more serious and several crisis management experts have expressed amazement that the company has mismanaged the situation to the extent that it has thereby causing itself financial harm and potential loss of business with respect to its other products.

In the case of Bausch & Lomb, analysts have pointed out that, while the company’s actions have all been exemplary, the delay in their implementation was inexcusable and therefore highly damaging to the company’s overall image, stock value, and sales of other unrelated products. (Bausch & Lomb’s stock value dropped 17.3% on the day after it voluntarily suspended shipments.)

Although the infection issue is serious enough in terms of finding out why it has occurred, the perceived failure by Bausch & Lomb to take immediate corrective action in terms of a recall or warning blitz has become a problem for the company that is not going away.

While the company maintains that it reacted quickly and decisively in the matter, the perception is that it did not.

Bausch & Lomb claims it contacted the Centers for Disease Control as soon as it learned the infection had appeared in Singapore, and suspended sales of ReNu With MoistureLoc in Singapore and Hong Kong in February.

The company also notes that on March 31, it issued a press release advising of the testing it was doing to ensure that quality had not been compromised at its South Carolina plant.

Crisis management consultants, however, see the facts a bit differently. They believe Bausch & Lomb would have been well-served by recalling the product immediately upon release of the CDC warning.

While some retailers followed that path, the manufacturer did not. The hesitation allowed the product to remain on the market for a considerable length of time when it should have been already on its way back to the company. Additional cases of the fungal infection could have occurred during this critical delay.

The delay in launching an all-out media blitz containing warnings and safe eye-care procedures has also been seen as a problem for the company. While government agencies reacted to protect the public as soon as they could, Bausch & Lomb could have done so much sooner given its immediate knowledge of the Asian cluster of what is normally a very rare infection.

The warnings issued by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) were released faster and with more emphasis than anything done to that point by the company. For example, the FDA stated:

“This is to inform you of a recent increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

“Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating this situation. At this time, Bausch and Lomb has agreed to stop shipping the ReNu MoistureLoc brand contact lens solution. This Notification will be updated as more information becomes available.”

Before the announcement of the additional cases being investigated, 109 cases of the infection had been reported to the CDC from 17 states in the U.S. Of 30 cases already investigated, 28 involved soft contact lens wearers and 26 of those patients had used Bausch & Lomb’s ReNu or a generic version thereof also produced by the company. Most of those cases involved ReNu with MoistureLoc produced at the company’s Greenville, South Carolina, plant.

Nine patients reported wearing their lenses overnight, “a known risk factor for microbial keratitis”, and eight required corneal transplantation.

“Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February 2006. At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong, pending their investigations, after multiple reports of Fusarium keratitis among contact lens users there.

“Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use. There are an estimated 30 million soft contact lens users in the United States; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on overnight lens use. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1% in New York. The proportion of fungal keratitis due to Fusarium spp. also varies by region, from 25-62%.”

One newly filed class-action alleges Bausch & Lomb failed to disclose the possible link between ReNu with MoistureLoc and Fusarium keratitis once it learned of the problem among its users in Asia. Singapore health officials noticed an increase in reports of infection in January of this year. An investigation revealed 39 cases involving contact lens users from 2005 to February 2006. Cases of the infection have also been reported in Malaysia and Hong Kong.

The newest release by the FDA states: “FDA is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb’s decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.”

A second class-action lawsuit has now been filed in United States District Court for the Eastern District of New York, on behalf of all users of the affected lens solution seeks compensatory and punitive damages from Bausch & Lomb to Cover medical screening and medical monitoring.

Attorneys close to the litigation and familiar with pharmaceutical cases in general have reported to that calls are “pouring into” personal injury law firms concerning possible cases against Bausch & Lomb.

One firm, Parker & Waichman, which filed the federal class action in New York, also reported that “it has been retained by a 53-year-old man who was diagnosed with Fusarium keratitis after using ReNu with MoistureLoc Solution. Due to the infection, the victim underwent numerous lengthy and invasive surgeries including: cornea transplant, lensectomy, capsulectomy, removal of iris, removal of vitreous fluid and the removal of the fungal infection. The victim is left with only 15% vision in his left eye and is currently awaiting FDA approval for an iris transplant.”

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