Here's the short version:
- Advanced Medical Optics, later acquired by Abbott, made a contact lens solution.
- The solution was pulled in 2007 after a CDC investigation linked it to cases of a rare, serious eye infection, Acanthamoeba keratitis, resulting in at least 70 claimed cases of blindness or permanent vision damage.
- The company had at least 9 complaints, that it failed to report to the FDA, during the year prior to the solution's removal from the market. When FDA inspectors showed up at the plant to investigate the product recall in June, 2007, they then discovered the complaint letters.
Here is the kicker. When asked why they had not sent reports of the complaints to the FDA as required by law, the company replied that as they had never claimed that the eye solution protected users against Acanthamoeba infection, they were under no legal obligation to report these complaints.
To which I offer two responses.
I'm not a lawyer but I play one on TV. (Actually I don't.) If I did, my lawyer-character would offer the opinion that U.S. law requires that drugs be both safe and effective. The law requiring that they be safe actually dates back to the original FDA act of 1906, while the requirement that they be effective only goes back to the 1962 amendments passed post-thalidomide. What you claim on the drug's label has a lot to do with the question of whether a drug is effective (for the indication claimed). It has nothing to do with whether a drug is safe. By contrast, a company's legal duty to report complaints of adverse reactions to the FDA is part of the FDA's duty to monitor a drug's safety. So to compare labeling with a duty to report adverse reactions is to compare apples and oranges.
My next response is more important. The Korean branch of a major drug company recent got a sort of skunk cabbage award within the business community when its CEO replied to a group of AIDS activists complaining about the high cost that made one of its HIV drugs unaffordable, that the drug company was not is business to save lives but to make money. This is something that most companies believe, and act like, but not something that most companies say. With Advanced Medical Optics, we now have another example of a firm that is so twisted in its thinking and behavior that it will say flat out that it has no business whatever assuring that people who put its solution into their eyes do not go blind as a result--so long as the money rolls in. Those who still believe that our salvation lies in the unfettered free market please raise your hands.