Tuesday, June 30, 2009

Adverse Event Reports Go Unreported While Consumers Loose Eye Sight.

In a report by the Associate Press (June 20, 2009) the company – Advanced Medical Optics - chose to not report at least 9 Adverse Events cause by it’s product Complete MoisturePlus that showed a connection between its product and a serious eye infection caused by Acanthamoeba.

“Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP,three 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 cases of the infection in patients across the U.S.
Currently there are 257 Adverse Events listed in the Medical Device database (MAUDE).

When 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, according to the FDA documents.”

Apparently AMO chooses to not understand the requirements or purpose of Adverse Event Reporting. Suggesting that they are not required to report a problem that their label does not specifically address seems to indicate that the company feels that they are not obligated to be at all concerned about the consumer after they have taken payment for their product.

It is a given that AMO will play the FDA Preemption card in their liability defense. It is also likely that the case will be thrown out of court on those grounds.


  1. In the link Sidney Wolfe said, "If other companies notice that violations don't lead to any criminal investigation, that's a big problem."

    They do notice and it is a big dangerous problem for consumers.

  2. Right Dianne, and that is the root problem with the FDA and Preemption. Why would any corporate management (in the long run) continue to enforce ethical practices when everyone else in the industry allows more profitable, unethical practices? Eventually the managers that do enforce ethics will be replaced by those that are unethical but attain higher profit margins. We can't deny the truth.

    All the while, the FDA stands idly by. So the blind consumer asks a lawyer for help but the lawyer declines because the medical device industry is no longer responsible for the damages its product causes.

    The industry itself should be fully against Preemption because using the Preemption crutch sets it on the fast track to complete consumer distrust and eventually across-the-board reconstruction from the FDA up. (yes not down but up)

    We thought the auto industry scenario was bad.

    Here is a comment by Alison Bass concerning this travesty –

    “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.”

  3. This is actually bizarre. It would be like the fen-phensters claiming no liability because they didn't say their drug protected people against valvular heart disease (about 30% of women taking the drug showed some signs of valve problems).

    Now I know what defense lawyers are always trasning trial lawyers. As our lost Michael Jackson would have said, "The man in the mirror."

  4. It is interesting too that many of the Manufacturer Replies on the Adverse Event reports (see FDA MAUDE database)that I looked at say that the company would not investigate the incident because "no sample or lot report for the product was returned to the manufacturer."

    I’ve seen this excuse used elsewhere and continue to be amazed that the FDA allows it time after time after time. After almost 200 reports to the FDA you would hope that the company or the FDA would take it upon themselves to consider that maybe they have an issue with the product. Continuing to excuse investigation because the consumer forgot to keep a sample or write down a lot number for the product becomes an obvious case of negligence by both the company and the FDA. Add to that the fact that nobody really knows how many cases went unreported and you have a real problem.

    With this product it is likely that at the time the consumer experienced the infection they had no idea what was causing the problem. So as more and more people lost their eye sight and/or even their eyes, the system fails to engage due to the flimsiest of excuses.

    Obviously the current system is pathetic. The results for this and many other FDA supervised product failures is that patients or consumers will needlessly suffer major health issues, bodily harm and death.

    To take it a step further then – If it is the policy of the FDA to allow this kind of loophole for pharmaceutical companies - the FDA should also institute a requirement that for all products (even over the counter) the consumer must keep a sample or write down the lot number and register the date of its use. Can you imagine? But in the pharma bizzaro-world this is the logical thing to do!

  5. There is the FDA site AERS. These ADverse Events are reported by the doctors directly to the FDA and not through the drug companies. It is my understanding that these AE's should be also reported to the drug company.

    I would imagine that if any smart lawyer wanted to access the AERS data base on the FDA website which is available to the public as part of the freedom of access to information, then they would do so and use it as evidence that the company was aware of the problem.

    Isn't this what is supposed to be happening? Meaning the AE's are not reported to the FDA only from the companies themselves. Unless I have mis understood....

  6. Anonymous -
    According to the FDA - see here

    "Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident."

    In this case there are at least 9) such unreported reports.

    The following quote from the same FDA document may be the heart of the problem -

    "Although the requirements of the regulation can be enforced through legal sanctions authorized by the Federal Food Drug & Cosmetic (FFD&C) Act, FDA relies on the goodwill and cooperation of all affected groups to accomplish the objectives of the regulation."

    So the FDA really chooses not to enforce their own regulations and over time pharma has come to the point of thumbing their collective noses at the FDA. Even at this point of blatantly stating that they don't have to report Adverse Events just because they don't feel like they have to.

    Anonymous - to the point that you made -
    “I would imagine that if any smart lawyer wanted to access the AERS data base on the FDA website which is available to the public as part of the freedom of access to information, then they would do so and use it as evidence that the company was aware of the problem.”

    I would say yes it is obvious that this happens but that at least someone is paying attention to the 100's of thousands of reports made yearly by patients and consumers of medical devices and drugs. It is absolutely obvious that the manufacturers and the FDA do not give a whit about such reports.

    The only thing you can say for certain about AE reports is that there are far fewer reports than there are actual cases and that the groups the reports are meant to alert pay no attention to them.

    It appears that our FDA safety system is eroding into a catch as catch can, cat and mouse game leaving the individual consumer responsible for enforcing his/her own safety.

    Thus we fight against Preemption.

  7. Another note, Anonymous, about a lawyer using the AE system to press the point of negligence - in a word, it doesn't work. (I am not a lawyer so maybe if there are lawyers out there they can explain in detail)
    My understanding is that trying to get the court to accept a case involving medical device liability you can only use evidence of neglect if it directly relates to the harm done to the litigant. Therefore any reference to unrelated cases is not allowed. So if you said for example - there were 3 deaths and 15 injuries that occurred with your product and you did not report them to the FDA therefore you are negligent and it is likely that your product is harmful. - doesn't matter.

    Also finding out ust how many AE went unreported is only accomplished after the court accepts the case and discovery can proceed.

    Furthermore, even if in your own case the AE was not reported by the manufacturer, you still can't use that because the non-report came after the harm was done so it is also unrelated. I don't know the specific precedence on this but I do know it is a legal tactic that is used.

    But even all of this is of no consequence given preemption. Defense lawyers use a lot of verbiage when arguing back and forth that a case should not be taken up by the court but in reality they could save a lot of time and effort by just using a handy dandy rubber stamp that says - ALL CLAIMS PREEMPTED BY FDA APPROVAL Ultimately this is all they have to do.

  8. A more general point for the discussion--the ultimate fact is that companies will _always_ know more about their products, and sooner, than FDA--even with appropriate reporting. They knew the product from the beginning, have only a relative handful to oversee, and have all kinds of internal data and insider knowledge that contextualizes the AERs they do receive.

    Thus, my continuing argument that incentivizing responsibile self-regulation (and not incentivizing the opposite) is the key. Studies show that civil liability is probably the most effective external sanction to that end--much more important than either criminal sanctions (which almost never happen) or FDA regulatory action (which generally means squat).

    Beyond that, one good thing about our competitive system is that companies rat on each other. So if A thinks B is sitting on a pile of whit, A is likely to try to try to get it out there (unless they have some sort of "non-aggression pact")

  9. "companies will _always_ know more about their products", I disagree.
    One of the best selling drugs "Viagra" was discovered by accident.
    and historically discovering Penicillin's ability to fight infections/bacteria was an accident.
    (Accident "Fleming was convinced that penicillin could not last long enough in the human body to kill pathogenic bacteria" "Fleming praised Florey and Chain for transforming the laboratory curiosity into a practical drug."

  10. The total recovery time for a corneal transplant may be up to a year or longer. Initially, your vision will be blurry and the site of your corneal transplant may be swollen and slightly thicker than the rest of your cornea. As your vision is restored, you will gradually be able to return to your normal daily activities.


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