After plate in leg breaks again, military vet brings lawsuit against device company



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Posted on December 19, 2013 at 11:27 PM

Meet Sgt. Don Gustafson; a dad, grandpa, and former prison sergeant for the State of Texas.

"Sgt. Gus" went from training officers on defense tactics, to now walking with a cane.

A 2007 motorcycle accident broke both bones in his lower leg.

“I did 10 years in the Marine Corps and seven in the Navy Reserve, military police for both of them. When you look up and you're in a wheelchair, then from wheelchair, you go from walker, to this. You're able to finally stand up. These people don't understand the half of what they've done to me,” Gustafson said.

'Those people' are with Zimmer Inc., a medical device company selling everything from knee to hip devices, with worldwide earnings around $4 billion per year.

Gustafson said it was a Zimmer plate doctors used to stabilize his fractures. But it didn't work. The plate broke.

He called Zimmer to make them aware.

“All they could tell me is there was nothing wrong with their product,” he said.

And he believed it, enough to head back into the operating room to get an identical plate screwed into his bones. But about a year later, his pain led to an X-ray.

According to a lawsuit filed by Sgt. Gustafson, the plate broke again.

“I can see something happening with one plate, but two plates?” he said.

So Gustafson said he started asking questions, from Zimmer to the FDA.

“You have no idea what they're putting in you," he said. "You trust your surgeon, you trust the manufacturer that makes the plate, and that they actually done some type of testing to ensure that this plate going into a human body is safe."

Turns out the FDA was questioning Zimmer, too.

It sent a letter to Zimmer see if they had "received similar complaints on this device?" Zimmer replied no.

But how could that be? Five months prior, a Zimmer employee was in the operating room to take a picture of Sgt. Gustafson's broken plate. But according to records from the lawsuit, it wasn’t reported within the 30 days required by the FDA.

Gustafson's lawyer, Chris Hamilton, argues Zimmer should have reported this earlier.

“When Sgt. Gus reported the second device failure, Zimmer - knowing the FDA was hot on their trail at that point - didn't report to the FDA until after the lawsuit was followed,” Hamilton said.

With two product failures on file, Gustafson's plate made the list of top trauma implant complaints at the time.

Deposition documents show a corporate representative from Zimmer, who trains sales associates, doesn't believe it's Zimmer policy to report all adverse events to the FDA. He admitted to seeing products fail, and then not telling the FDA, with one exception.

Lawyer Chris Hamilton: "So your understanding from Zimmer is that unless a physician tells you, you don't have any obligation to report an adverse event involving a product failure or product breaking."

Corporate Zimmer Representative: "That's correct."

“Zimmer has a practice of not properly reporting adverse events or product failures to the FDA," Hamilton said. "So the long and short of it is, because Zimmer doesn't follow the rules and hasn't followed the rules on reporting these devices to the FDA that don't work, there is no way to know."

But Sgt. Gustafson knows. He asked that his plate be returned as proof of his problem.

“Well, when you contact the FDA and you ask them if they're having problems with this product. Of course they're not, if doctors are throwing them away," he said. "The people don't have the plates to turn in.”

Gustafson said Zimmer also questions the plates thickness, its strength, and testing.

Internal and confidential Zimmer documents show "concern" about its product; worries that "the plate construct was not being tested." Doctors on their team "vote for added thickness..." and "...preference to adding strength."

But Zimmer, knowing its "plate is 20 percent weaker" than others, decided to go with "how the current models are already finished."

Zimmer told News 8 it "denies that the plates are either defective or unreasonably dangerous," saying the plates went through "rigorous design and development process that involved extensive testing and analysis" and that "no product implanted into the human body can ever be guaranteed for any period of time, and it is common knowledge that implants can fail for a variety of reasons unrelated to product defect."

"We reiterate that the FDA cleared these plates for use over eight years ago, and the plates continue to be used successfully by surgeons today," Zimmer said in a statement.

Sgt. Gustafson understands things can fail, but doesn't get why Zimmer would keep putting these plates in people's bodies, knowing what they know.

It was so bad before his third surgery doctors discussed amputation with him.

“So when I was put under that last time, I didn't know if I would have a leg when I came out,” Gustafson said.

But he did. With a rod in it.

After three surgeries, Gustafson leads a life with major limits, something he says the truth could have prevented.

The trial for this case is set for January in Collin County.