Who protects consumers from negligently manufactured or dangerous drugs and medical devices? Is it the FDA? In part, yes and in part, no. The FDA, because of the way in which it was designed to operate, could be said to be analogous to the “fox guarding the hen house”.
In order to fund the operation of the FDA, half its budget comes from fees paid by manufacturers to facilitate a speeding up of the approval process for new drugs and medical devices. In fact, it is understandable that some of the scientists at the FDA see the pharmaceutical and medical device manufacturers as more “their clients”; than they do the consumer. This understandably creates a situation where FDA scientists feel like a part of the drug or device approval “team”, more than a part of the consumer’s police force.
The FDA review process for new drugs and medical devices has been described by some courts as “rigorous”. My experience is that the approval process can be rigorous, but is sometimes not discerning enough on the part of the FDA. Through the Pre-Market Approval process (PMA) manufacturers are supposed to submit detailed information and provide the FDA with “reasonable assurances” that the drug/device is effective and is safe for the consumer. The PMA process provides for differing levels of scrutiny on the part of the FDA. Devices, for example, are broken down into Class I, Class II, and Class II devices. Class I devices are supposed to be those that present the minimal potential for harm to the consumer and are often much more simple in design. Class II devices are similar to Class I, but are held to a higher level of assurance that they have a lower expectation of causing harm to the consumer; but they are subject to more regulation, often in terms of labeling, performance standards and post market surveillance. Class III devices require the most rigorous clinical and scientific documentation. The Class II review process requires the FDA to evaluate the “probable benefit from the use of the device against any probable risk of injury or illness from such use. 21 USC Sec. 360c (a) (2)(C).”
It is accepted that the FDA may grant approval to drugs and devices that they know may have some level of known complications associated with them, but the benefits of the drug/device make the potential complications acceptable. The problem often lies in product defects the manufacturer knows and fails to disclose to the FDA; or what the manufacturer should have clearly known but did not conduct analysis which was sufficient to discover.
The fact is that the FDA does not possess a sufficient budget to conduct its own, independent analysis of each drug or device submitted to it. The FDA, rather, relies on the sufficiency and veracity of the manufacturer’s research, clinical trial data, and complication rate.
Big Corporations are not primarily about producing quality products; they are about producing the maximum amount of profits. This is not meant to disparage Big Corporations unnecessarily. Corporate America does not set out to produce drugs or medical devices that will cause harm or death. The problem is that Big Corporations are not operated by the scientists or the physicians for the best interests of the consumers’ welfare. Understandably, Big Corporations are run by business people and when they run in to a “snag” in product development, often their reaction is to find a way to “engineer around it” or to ignore it.
So, why should the consumer be interested in the issue of preemption? Because preemption, in its most basics, protects Big Corporations from responsibility for injury or death caused by one of their products, as long as they have received FDA approval of their product, regardless of the negligence on the part of the manufacturer. This, on its face, seems fair to some consumers; if the FDA said it was ok, then why should the manufacturer get sued? Let’s try to phrase it a little differently, though:
If the manufacturing process chosen by the maker is proven to render the product defective, but the FDA approved the product, should the maker be shielded from liability of injuries or death caused by the defect?
Under a case decided by the US Supreme Court, the answer is yes (Riegel v Medtronic, Inc., 128 S. Ct. 999, 1003 ). Following the Riegel case, a new case has come out of the US District Court of Minnesota, “In re Medtronics Sprint Fidelis Leads Products Liability Litigation”. In this case, the court has dismissed the claims of thousands of injured victims; even though the Court conceded that: “the Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic…Plaintiffs assert claims for which the Court is simply without remedy.” The Court goes on to say, “though individuals are sometimes injured when using medical devices, Plaintiffs’ remedy… lies with the Congress, and not with this Court.”
The Court in the In Re Medtronics decision, by my reading, seems to be saying that, although it has sympathy for the plight of injured victims, as the result of protective legislation issued by Congress, the Court is prevented from allowing these injured people from having their day in court. The result of cases like these is to block a citizen’s right to the courthouse, as long as the FDA approved the product/device, even in situations where the manufacturer of a product is clearly negligent.
Consumers now find themselves in the position of being at the mercy of corporate responsibility and being denied the right to litigate cases under their own state laws in their own state courts. Instead, the federal government has decided that it, and not your state, is best able to decide who will be protected or sacrificed; the consumer or Big Corporations.