WRONGFUL DEATH: PATIENT WAS TEST SUBJECT FOR OFF-LABEL USE OF DEVICE

August 1, 2012

This is not the first claim we’ve heard about a company located in or outside of Oregon using humans as unwitting clinical trial participants, nor, unfortunately, will it be the last. In this case, the company that manufactured a type of bone cement for one purpose and proceeded to sell it for another has already paid for its actions, at least in part: Four executives were sentenced to prison in a federal criminal trial.

For the plaintiff in a recent suit, though, that isn’t enough. She says the company was responsible for her mother’s death, and she is suing for wrongful death, fraud and fraudulent concealment, negligence and gross negligence, failure to warn, reckless misconduct, conspiracy and loss of consortium. She is asking for both compensatory and punitive damages.

Bone cement is commonly used to anchor artificial joints or to strengthen spongy bone. In 2003, when these events occurred, the Food and Drug Administration had only approved the product for broken wrists (distal radius fractures, to be exact). The manufacturer, the plaintiff says, was determined to sell that product to treat vertebral compression fractures as well.

Vertebral compression fractures can be caused by trauma and, in some cases, osteoporosis. The bone cement would be injected directly into the damaged vertebrae to reinforce the bone and to protect any adjacent bones. The cement relieves pressure on the bone by restoring the bone’s height.

Scientific American wrote about the promise of this therapy — in 2009, a full six years after the plaintiff’s mother died. In 2003, the manufacturer believed that mixing the FDA-approved product with barium sulfate would produce a cement that could work in spinal surgeries. Ignoring multiple warnings and results of tests on animals that showed how dangerous the cement was, the company set out to make their case.

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.

Sources:

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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