Wednesday, February 04, 2009

One Two Medical Device Punch

A tip of the cyberhat to Tom Stayton at Baker & Daniels for passing along this little gem. In Feusting v. Zimmer, No. 02-2251, 2009 WL 174163 (C.D. Ill. Jan. 26, 2009), a case involving a prosthetic knee joint, the court granted summary judgment, after concluding under a Daubert analysis that the plaintiff's expert wasn't up to snuff. The plaintiff alleged that a common sterilization process for medical devices - gamma ray irradiation - damaged the device itself and caused it to fail. The implanted device lasted nine years before failure.

The plaintiff's expert was Dr. Robert Rose, a name familiar to just about anybody who's defended prosthesis manufacturers over the last decade or more. Getting him excluded is a pretty big deal. The basic problem with Dr. Rose's opinion is that it had no basis. There was nothing to show that this kind of sterilization was any worse, in terms of deterioration (oxidation) after implantation than any other method - and even Dr. Rose conceded that devices have to be sterilized somehow. Slip op. at 7.

Not only that, before Dr. Rose got his hands on the device, it had been steamed sterilized and then left lying around for six years after being removed from the plaintiff's body. But he didn't even try to account for the oxidation that necessarily occurred during this period:
[Plaintiff's] prosthesis had been sterilized with GIA at least sixteen years earlier, and was stored in air for at least six years after explantation and before testing. That in vivo oxidation accounts for most of the oxidation in [plaintiff's] implant is not supported by citation to any reference nor does Dr. Rose explain this conclusion.

Slip op. at 8. Oops. There was also nothing in the opinion that could convert Dr. Rose's "related to" opinion to an actual statement that the deterioration caused the actual failure of the device. Id. So the opinion was not only insufficiently supported, but insufficiently definite as well.

That's all well and good - and if that was all the opinion was about, we might have told Tom "thanks but no thanks."

But there is more. As astute readers have no doubt already figured out, a lot of time passed after this case was filed (it has a 2002 docket number) and Dr. Rose getting involved (six years between explantation and testing is a really long time).

That's right. There's a great deal of discussion in the opinion about a previous trial and appeal in the case. The previous appeal generated two opinions: Fuesting v. Zimmer, 448 F.3d 936 (7th Cir. 2006), and Fuesting v. Zimmer, 421 F.3d 528 (7th Cir. 2005). Deja vu all over again - that earlier appeal was also mostly about Daubert, and the Court of Appeals held that the plaintiff's first expert's opinions also failed to pass muster. The district court, having been reversed once already, made sure to discuss the outcome of that prior appeal at some length:
The Seventh Circuit rejected Dr. Pugh's testimony on causation because he "did not conduct any scientific tests or experiments to bolster his theory relating polyethylene delamination to gamma irradiation in air, nor did he produce or rely on any studies to verify his conclusions." Moreover, Dr. Pugh "did not bridge the analytical gap between [the] basic principles [which Zimmer did not dispute] and his complex conclusions." The court had not been presented with evidence that Dr. Pugh's delamination theory had been published or subjected to peer review, or had gained acceptance in the scientific community - specifically, that "his untested and unpublished theory that polyethylene delamination from oxidation triggered by gamma irradiation results in an appearance distinctive from delamination from other causes - leaving a readily identifiable `signature' or `hallmark'- has not received any, let alone general, scientific acceptance." That Dr. Pugh developed his opinion expressly for this case also supported a finding that "Pugh's testimony on causation stacks up quite poorly against most all indicia of reliability[.]"

Slip op. at 4-5 (all quotations from Fuesting, 421 F.3d 528).

The "Pugh" mentioned in the opinion was Dr. James Pugh, who if anything has been even more frequently employed by plaintiffs in this type of case than Dr. Rose.

And it means that in the same case Zimmer succeeded in getting both Pugh and Rose thrown out on Daubert grounds - and that's a one-two punch worth blogging about. Keep up the good work.



1 comment:

Anonymous said...

As a former medical device representative for total joint implants, it never ceases to amaze me the number of times companies are sued for what is oftentimes poor surgical technique. 9 years is not bad, although I worked with some docs that were getting 12-15 or more years out of a knee. Additionally, the poly wears and has to replaced at some point. Glad to see that Pugh and Rose received a nice smack down.