Problems Continue to Mount for Bausch & Lomb over Fungal Infections Linked to Its Contact Lens Solution, ReNu with MoistureLoc
Apr 20, 2006 NewsInferno.com News Staff
In less than two weeks, Bausch & Lomb has taken quite a tumble from one of the most respected companies specializing in consumer eye-care products to one that has been rocked by a major embarrassment and potential liability for injuries involving its popular contact lens solution, ReNu With MoistureLoc.
Bausch & Lomb is facing several ReNu Contact Lens Solution lawsuits, an enormous amount of negative publicity, and a Food & Drug Administration (FDA) investigation into just went wrong with its product.
The latest revelation that has further tainted the company’s formerly pristine image is the report that FDA inspections in May and June 2002 at Bausch & Lomb's Greenville, South Carolina, plant 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 cases of adverse reactions, serious side-effects, or contamination, a manufacturer’s immediate reaction to the problem is often the most critical factor in assessing whether the “crisis” was managed correctly.
A company’s perceived concern (or lack thereof) for the safety of the public in general, and its own customers in particular, will be largely defined by the speed and scope of its reaction to the crisis.
Quick and decisive reactions usually serve to boost confidence and trust in a company, while slow or evasive actions only generate mistrust and second-guessing.
Immediate steps to address the crisis will also unquestionably save additional injuries or deaths.
Prompt voluntary recalls, although costly, are always seen as responsible gestures, while forced recalls dictated by government agencies or court orders are extremely damaging to a company’s image.
Any perceived delay or deception in dealing with a product-related crisis can seriously damage a company’s reputation and sales and have a spillover effect on the company’s other products even though they are not involved and remain perfectly safe.
A company’s initial reaction to a crisis will unquestionably find its way into any subsequent litigation related to it. Quick, decisive, and thoughtful actions will serve as strong defensive statements, while a slow, evasive, and self-serving approach will provide the plaintiffs with a powerful weapon against the company involved.
Unless there has been some illegal or otherwise improper conduct, an immediate response that effectively addresses the problem will usually stave off monetary penalties and punitive measures by regulatory authorities.
In the case of Bausch & Lomb, crisis management experts and business 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 percent 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 is becoming even more of a problem for the company. 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 (CDC) 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.
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.
So far, 109 cases of the infection have 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.
One of the ReNu Contact Lens Solution lawsuits alleged the company failed to warn consumers about a link between the contact lens solution and fungal infections once it knew the problem existed among some users in Asia. An investigation revealed that between 2005 and 2006, there were nearly 40 cases involving contact lens users 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 filed this week 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.
For more information, please visit FDA’s Contact Lens and Eye Infections page at: http://www.fda.gov/oc/opacom/hottopics/contacts.html
To learn more about ReNu lawsuits, call 1 (855) 722-2552.