Company knew eyes were destroyed by its contact solution, but kept silent for a year or more.

Among the things that infuriate me are corporations that knowingly harm the consuming public.  My calm, logical demeanor is shattered even more quickly by government regulators who have the responsibility – backed by law – to protect the public from these economic giants and do nothing.

You may not have noticed an Associated Press report that a company which produced contact lens solution is allegedly responsible for blinding several people.

Here are the basic facts:

•    The Food and Drug Administration said that Advanced Medical Optics marketed a contact solution called Complete MoisturePlus.

•    The company pulled the solution off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious eye infection called Acanthamoeba keratitis.

•    The law firm for 70 or so plaintiffs suing the company says three of its clients had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage. By June 2007, the CDC had confirmed nearly 160 infected patients nationwide.

FDA logoSo if the eye-destroying solution is off the market, what’s the problem?

An investigation by FDA inspectors after the recall found the company had known that its solution has caused dramatic eye damage and did nothing for a year or more. Further, it allegedly violated FDA regulations that demand that reports of these adverse reactions be promptly reported to the agency.

Despite those violations, the FDA took no action against the company which some public health advocates insist is a vivid signal to other corporations that the safety laws can be flaunted.

The violations were made public after lawyers filed a Freedom of Information Act request with FDA for all reports and information obtained from the maker of the eye solution.

According to AP reporter Matthew Perrone, the documents showed the company said nothing to FDA after it received complaints from users of the product who were diagnosed with the Acanthamoeba infections.

AP’s story also said government documents reported that when the company was questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product’s labeling does not say it protects against Acanthamoeba.

Yep folks, that’s what the AP said the company told the feds.

“If I put bacteria in your food knowingly and you went blind I would go to jail,” says Dr. David Egilman, Clinical Associate Professor of Medicine at Brown University. “But a corporation can do this with impunity. They have immunity.”

Egilman, who for decades has investigated and written on corporate crime and government regulator’s unwillingness or inability to enforce the law, called the FDA’s lack of action in the Advanced Medical Optics episode “criminal” and “a level of negligence that cannot be tolerated.”

Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company “believed it was reporting customer complaints in compliance with FDA regulations.”

The FDA never pursued legal action against AMO.

“FDA felt that the company’s response to the (inspectors findings) in conjunction with the face-to-face meeting, were adequate,” FDA Spokesman Christopher Kelly told the AP.

Perhaps the ailment wasn’t serious enough to warrant FDA action.  Acanthamoeba is a microscopic organism typically found in water or soil that can cause devastating harm when it enters the eye, including blindness and, in rare cases, results in a deadly infection of the brain and spinal cord, Perrone wrote.

Here is a link to the AP story if you want all the details.


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Company knew eyes were destroyed by its contact solution, but kept silent for a year or more. — 1 Comment

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