By Steven DiJoseph
When pharmaceutical products are linked to adverse reactions, serious side-effects, or contamination, a manufacturerÃ¢â‚¬â„¢s immediate reaction to the problem is often the most critical factor in assessing whether the Ã¢â‚¬Å“crisisÃ¢â‚¬Â was managed correctly.
Many perceptions, inferences, and consequences are directly related to the effectiveness of the initial steps taken by any company once the safety of one of its products is brought into question.
The old adage Ã¢â‚¬Å“you only get one chance to make a first impressionÃ¢â‚¬Â applies with particular force to these situations for the following reason, among others:
*** <"http://www.yourlawyer.com/topics/overview/renu_contact_solution">Bausch & Lomb ReNu Linked to Serious Eye Infections***
- The companyÃ¢â‚¬â„¢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. A quick and decisive reaction will usually serve to boost confidence and trust in the company, while slow or evasive actions will only generate mistrust and second-guessing.
- Immediate steps to address the crisis will unquestionably save additional injuries or deaths. Thus, immediate voluntary recalls are always seen as responsible gestures. Such actions are expensive, but it is money well spent in terms of damage control. Forced recalls dictated by government agencies or court orders are extremely damaging to a companyÃ¢â‚¬â„¢s image.
- Any perceived delay or deception in dealing with a product-related crisis can do irreparable (or, at the very least, long-term) damage to a companyÃ¢â‚¬â„¢s reputation and sales. It may also have a spillover effect on the companyÃ¢â‚¬â„¢s other products even though they are not involved in the problem and remain perfectly safe.
- A companyÃ¢â‚¬â„¢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.
- Dealing with a crisis in an open and effective manner will avoid recriminations within the company and circumvent such internal problems as stockholdersÃ¢â‚¬â„¢ derivative lawsuits.
In the case of Bausch & Lomb, crisis management experts and business analysts have pointed out that, while the companyÃ¢â‚¬â„¢s actions have all been exemplary, the delay in their implementation was inexcusable and therefore highly damaging to the companyÃ¢â‚¬â„¢s overall image, stock value, and sales of other unrelated products.
As we have previously reported, <"http://www.yourlawyer.com/topics/overview/renu_contact_solution">Bausch & Lomb has always been regarded as a reputable consumer-product company specializing in eye health and perfecting vision.During its 153-year history, the Rochester, New York, the company has 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.
The companyÃ¢â‚¬â„¢s product line has changed over the years as eye care has advanced. Currently its core businesses include soft and rigid gas permeable contact lenses, lens care products, and ophthalmic surgical and pharmaceutical products.
Thus, it has come as somewhat of a shock to industry experts and consumer advocates that Bausch & Lomb has found itself in the middle of a rapidly-growing controversy concerning the safety of one of its widely used contact lens solutions, ReNu with MoistureLoc,
The difficulties have seriously affected Bausch & LombÃ¢â‚¬â„¢s stock value. Shares of the companyÃ¢â‚¬â„¢s stock dropped 17.3% on the day after it voluntarily suspended shipments of the affected product.
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 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 bombardment 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.
As we previously reported, the warnings issued by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) were serious and to the point:
Ã¢â‚¬Å“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.
Ã¢â‚¬Å“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.Ã¢â‚¬Â
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 & LombÃ¢â‚¬â„¢s ReNu or a generic version thereof also produced by the company. Most of those cases involved ReNu with MoistureLoc produced at the companyÃ¢â‚¬â„¢s Greenville, South Carolina, plant.
Nine patients reported wearing their lenses overnight, Ã¢â‚¬Å“a known risk factor for microbial keratitisÃ¢â‚¬Â, and eight required corneal transplantation.
The FDA is also advising soft contact lens wearers to follow all instructions and preventive hygiene practices carefully.
The Preliminary Public Health Notification issued by the FDA also contains the following additional information:
Ã¢â‚¬Å“CDC and FDA are investigating these case reports. Also, investigations by CDC, state and local health departments, FDA, and manufacturers of contact lens solutions are underway to define specific behaviors or products that place contact lens wearers at increased risk for Fusarium keratitis.
Ã¢â‚¬Å“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.
Ã¢â‚¬Å“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%.Ã¢â‚¬Â
A 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.
As the investigation continues with the companyÃ¢â‚¬â„¢s cooperation, the FDA offers the following recommendations for healthcare providers:
- If a patient presents with a microbial keratitis, consider that a fungal infection may be involved and obtain a specimen for laboratory analysis.
- Refer patients to an ophthalmologist for immediate treatment.
- Report cases of fungal keratitis in contact lens wearers to FDA as noted below.
For contact lens wearers, the agency recommends:
- Wash hands with soap and water, and dry (lint-free method) before handling lenses.
- Wear and replace lenses according to the schedule prescribed by the doctor.
- Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
- Keep the contact lens case clean and replace every 3-6 months.
- Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling.
In addition, Ã¢â‚¬Å“regardless of which cleaning/disinfecting solution used, wearers may want to consider performing a Ã¢â‚¬â„¢rub and rinseÃ¢â‚¬â„¢ lens cleaning method, rather than a no rub method, in order to minimize the number of germs and reduce the chances of infection.
Specific FDA Ã¢â‚¬Å“Advice to PatientsÃ¢â‚¬Â on this topic can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/041006-keratitis.html.
In an effort to gather as much information as possible relating to fungal keratitis in contact lens users the FDA and CDC Ã¢â‚¬Å“encourage you to report these infections to FDA. FDA will be sharing reported information with CDC.Ã¢â‚¬Â
Reports can be made directly to MedWatch, the FDAÃ¢â‚¬â„¢s voluntary reporting program by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
Those reporting information on fungal keratitis should include the following information if possible:
- Contact lens solutions trade names and lot numbers.
- Contact lens type, trade name and mode of wear (extended or daily wear).
- Patient non-compliance with contact lens regimen (e.g., overnight wear in daily wear lenses, not cleaning lenses).
- Results of all cultures taken (e.g., corneal, conjunctival, contact lens, care solutions, lens case).
- Special patient characteristics, including whether the patient was immunocompromised (e.g., used topical or systemic corticosteroids or had diabetes), or had any ocular trauma, surgery, or chronic eye problem.
- Topical ocular medications used to treat the patient (including trade names and lot number if available).
Yesterday, the FDA released a further Ã¢â‚¬Å“StatementÃ¢â‚¬Â that again notes Bausch & LombÃ¢â‚¬â„¢s full cooperation in the investigation as well as the companyÃ¢â‚¬â„¢s voluntary withdrawal of the product. That praise, however, cannot undo any harm that has been caused to Bausch & Lomb, its product-line, or people who continued to use Re-Nu with MoistureLoc before this weekÃ¢â‚¬â„¢s actions.
The newest release by the FDA states:
Ã¢â‚¬Å“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 MoistureLocÃ‚Â® contact lens solution from the market until the agencies have had a chance to conclude their investigation.
Ã¢â‚¬Å“FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, SC manufacturing plant and other facilities through next week. While the investigation continues, FDA will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.Ã¢â‚¬Â
For more information, please visit FDAÃ¢â‚¬â„¢s Contact Lens and Eye Infections page at: http://www.fda.gov/oc/opacom/hottopics/contacts.html.