August 1, 2012

We are continuing our discussion from last week of a medical device and its off-label use. The device is bone cement, which, when mixed with a particular chemical, the manufacturer believed would be effective in spinal surgery. The problem was that the Food and Drug Administration had approved the bone cement for use on arm bones, not vertebrae, and even then the mixture of the cement with the chemical had never been approved.

That “off-label” use of an adulterated product was responsible for a woman’s death during surgery in 2003, according to a wrongful death lawsuit filed by her daughter. Worse, the plaintiff says, the manufacturer deliberately flouted the law to promote the device for spinal surgery. (We should note here that all of this occurred far from Oregon.)

For a few years before the surgery, research proved that the device was dangerous when used in spinal surgery in animals. Scientists warned the manufacturer that the procedures could be fatal in humans. The FDA got wind of the research and requested that the manufacturer include a warning on the bone cement packaging that the device was not intended for the treatment of vertebral compression fractures.

The manufacturer agreed but failed to comply. Soon thereafter, the FDA cleared the bone cement and chemical mixture as a bone void filler under the “substantial equivalent” rule; that is, the mixture was not too different from the already approved bone cement, so, as long as the same restrictions regarding spinal surgeries were observed, the company could market the “new” product.

Under this substantial equivalent rule, however, the manufacturer can use different materials or different technology in the device as long as the new device has about the same safety and effectiveness as the device on which it is based. Aside from the restrictions on load-bearing conditions, the company was now free to take the product to market. Again, the warnings disappeared from the product literature.

All of this information has been boiled down to basics from the 49-page complaint. We aren’t quite finished with the story; in our next post, in fact, a handful of people will learn the hard way that it’s not nice to fool the FDA.


Courthouse News Service, “Woman Calls Drug Companies Unconscionable,” Reuben Kramer, July 31, 2012

Sloan v. Synthes, Inc., Complaint, U.S. District Court, E.D. Pennsylvania, filed July 27, 2012

Our firm handles similar situations to the one discussed in this post. If you would like to learn more about our practice, please visit our Portland wrongful death page.


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