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Anyone who lives in the United States can file a complaint about a defective medication or product with the Food and Drug Administration (FDA). It's important to understand that the kinds of complaints the FDA considers are those that affect everyone who uses the product, defects that affect everyone, rather than a failure of the medication or product to work in your unique case. However, the FDA responds quickly to potential threats to life or causes of serious illness. File your complaint in writing at the link from the FDA's webpage for MedWatch: The FDA Safety Information and Adverse Event Reporting Program, or call your state's FDA consumer complaint coordinator for urgent cases.

The FDA acts to protect the public as a whole. It does not compensate or arrange treatment for individuals. In the United States, individual cases are adjudicated through the court system. When the injured party and the responding company are in different states, cases are heard in the federal court system, not the state court system, although sometimes state laws rather than federal laws apply.

A good example of just how the process works, or doesn't, is the large number of cases involving complaints about the Stryker CerviCore cervical disc implant. This was a metal device designed to replace a defective disk in the cervical (neck) portion of the spine without having to harvest bone from some other part of the body. In 2008, the company described the device as “composed of two opposing cobalt-chromium-molybdenum bearing surfaces backed with a titanium plasma spray coating to enhance osseous fixation. Two fins on each baseplate, each with three spikes, help achieve initial fixation. An anterior vertebral body stop decreases the chance of posterior placement or migration.”

Prior to 2008, however, a woman in California named Colleen Jaeger had been enrolled in a study to determine the effectiveness of the device. She claimed that she had developed "metallosis," or toxic metal poisoning, as a result of receiving the device, and that her consent forms only revealed that the device was made of titanium, failing to mention that its surfaces could release cobalt, chromium, molybdenum, titanium, or nickel. all of which are associated with metal allergies. Several years after receiving the disc, Jaeger had testing done that showed high levels of chromium in her bloodstream.

When Jaeger finally got her suit into court in 2014, the very first issue was whether she had filed it soon enough. In 2016, the federal judge threw out the case because California has a two-year statute of limitations for suits of this sort. That is, if you don't file a suit before two years have passed after your injury, you can't sue at all. The judge did allow Colleen Jaeger to refile her suit if her lawyers can make a compelling argument for ignoring the statute of limitations.

In Illinois, Carol McGrew and eight other CerviCore patients have faced a different set of legal challenges. Their legal team has uncovered problems with the manufacturing process for the disk in France and New Jersey (presumably leaving them at some point to need to sue in France). They claim that they have been stonewalled at every turn and denied information about the nature of the product that was put in their bodies, but they allege that the company "knew of multiple dangers with CerviCore, including that it might not implant properly, that its design caused excessive wear, that it was prone to breaking down prematurely, that it was prone to delaminating, that they manufactured it using improper processes, that they manufactured it in a facility prone to contamination, that it was made from cobalt, chromium, molybdenum, titanium, and nickel, and that it was likely to cause metallosis."

In this case, the patients suing the company haven't been able to establish which company's negligence caused them these problems.

What can you do if you want to sue for compensation for your injuries from a medical device?

  • First of all, don't wait. You may have as little as one year to file a claim in court.
  • Secondly, make sure you have all the facts, or that your complaint relies on you very simple, undisputed facts. When there are multiple companies or companies that have gone out of business (as there are with CerviCore), suing becomes much more difficult.
  • Thirdly, don't make plans for the money. A few people are awarded huge sums of money, but most get nothing. At least make sure your lawyer takes the case on contingency so don't have to pay the legal bills if you lose. Avoid having to pay the other side's legal bills by never trying to represent yourself in court.

 

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