I am a compliance analyst in terms of manufacturing GMPs for drugs/dietary supplements and not law. I handle internal audits, supplier audits, and interface with the FDA when they come onsite for inspections.

And personally, I disagree with preemption.

Compiance Analyst,
In case your question was genuine (although it seems questionable since you are a compliance analyist and should probably know the answer), class 1 medical devices are unlikely to harm a user. They include tongue depressors, bedpans, and bandages. Class 2 medical devices are usually noninvasive and might require special labeling and postmarket surveillance. Examples of these are x-ray machines, powered wheelchairs and surgical needles. These two classes make up the majority of medical devices and are not preempted from lawsuits. They also are not nearly as likely to cause injury or death to their recipients. So, when you hear an advocate of medical device preemption state that most medical devices are not preempted from lawsuits, keep in mind that those devices are probably not likely to cause harm and, therefore, the chance of a lawsuit being brought against them is minimal.

According to the FDA, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.” Therefore, the FDA requires premarket approval of these medical devices and postmarket reporting. The problem with this system is that clinical trials and adverse event reporting is dependent upon the good will of the medical device manufacturer. It is they who conduct the clinical trials and report adverse events to the FDA. If their data is inaccurate, the FDA generally is unaware. If they report improperly, again, the FDA is generally unaware. And yet, the FDA’s knowledge of the safety and efficacy of a given device is dependent upon the medical device company’s reporting. And in most cases, I hope, that trust is not broken. But the naive belief that it can never be broken is incomprehensible. And if you believe that there is even one manufacturer out there who might by fudging data, under reporting adverse events or hiding results, then you have to believe that victims of this company’s medical device should be given the chance to state their case in court and somehow obtain justice. Unfortunately, this right has been absolutely taken away from any person who has been harmed by a medical device. Is that right? You tell me.

And again….I work for a non-sterile solid dosage and nonsolid dosage company. We used to have a medical device back in the day, but decided to stick to drugs (and I am familiar with 820).

JaT, not a problem, I apologize for reading your question incorrectly.

I did not simply ask why drug makers do not use metal detectors, as Compliance Analyst suggests. That would indeed be an assumption that they do not. My intent was this…

“Not so with drugs?”
(translation: do drug makers not use metal detectors as food producers do?)
“Why not?”
(translation: If they do not use metal detectors, why not?)

My intent holds no assumptions, but rather, was genuine curiosity. Curiosity based on metal being found in the Genzyme product and my small bit of knowledge of how food production avoids the same problem.

There is a difference, CA, which I hoped could be cleared up without having to write an essay. I definately could have formatted my questions in a better manner.

Sorry to have interrupted the conversation.

Rooster brought up the point that Genzyme also manufactures class 3 medical devices. These devices are totally immune from lawsuits because of the Supreme Court’s decision in Riegel v Medtronic. On the other hand, Wyeth v Levine maintained accountability through lawsuits for drug companies. Genzyme is a company that walks on both sides of this fence. If impurities were found in Genzyme’s Seprafilm. a class 3 medical device, and someone was harmed, I believe that there would be no chance that a lawsuit would be able to proceed. Conversely, if ultimately someone is harmed by one of the drugs mentioned in this story, Genzyme could face a lawsuit…What’s the difference, other than the fact that one is a medical device and the other is a drug? Also, does the threat of a lawsuit put Genzyme in a more defensive mode and encourage them to produce safer drugs? I believe that it does and it is a huge injustice that, just because someone is injured or killed be a medical device, they can’t seek redress in a court of law.