Photo of Bexis

Here’s today’s question: What do we think of McQuiston v. Boston Scientific Corp., No. 5:07-cv-01723-TS-MLH, slip op. (W.D. La. Nov. 19, 2009) (link here)?

Here’s today’s answer: We love it!

But not for the reasons you’d think.

Here’s the deal: On September 1, 2006, Dr. Thomas Brown performed an angioplasty and stent procedure on James McQuiston. Boston Scientific manufactured the stent. McQuiston said his condition deteriorated after the stent was placed, and he filed a typical product liability complaint against Boston Scientific. (There are actually two plaintiffs, because McQuiston’s spouse made a claim for loss of consortium.)

The stent was a Class III medical device that had been approved through the premarket approval process. Judge Stagg thus trots through the holding of Riegel v. Medtronic, 552 U.S. 312 (2008), and routinely applies that holding to find McQuiston’s claims of design defect, inadequate testing, failure to warn, breach of express and implied warranties, and manufacturing defect to be preempted. McQuiston, slip op. at 13-16.

What’s noteworthy there?

Not much. Although Riegel did not involve warranty claims, an earlier Fifth Circuit case did, so Judge Stagg found the warranty claims preempted. Id. at 15-16. Maybe that’s worth mentioning.

McQuiston also pleaded state law negligence and fraud claims. The court dismissed those because they were displaced by the Louisiana Product Liability Act, which provides the exclusive theories of liability against product manufacturers in Louisiana. Id. at 16-17.

But that’s still pretty routine. Where’s the good stuff?

Our reader who sent us the copy of McQuiston liked the fact that the court refused to allow McQuiston to raise at the eleventh hour a “parallel requirements” claim — a claim that preemption doesn’t apply because Boston Scientific had allegedly violated requirements imposed by the FDA. The court rejected that attempt because there were no corresponding allegations in the complaint and McQuiston had known for over a year that Boston Scientific intended to raise preemption as an affirmative defense. Id. at 18-19.

We like that, too, and we’re delighted that you shared the opinion with us. (Thanks!)

But we noticed two other things about this opinion that we liked even more:

At footnote 1 on page 4 of the opinion, the court recites the regulatory status of the Boston Scientific stent — and it’s not purely a Class III device. Rather, it’s a “combination device,” which involves both drug and device elements. (It was a paclitaxel-eluting stent.) For this stent, the Secretary of Health and Human Services decided that the “primary mode of action” of this combination product was to fulfill a “device function.”

We really like that. Cases involving combination devices are hard to come by, and we’re delighted to have another precedent to add to that relatively short list. (Riley v. Cordis Corp., ___ F. Supp. 2d ___, 2009 WL 1606650 (D. Minn. June 5, 2009), is another combination device case. It’s right there on our (New) Medical Device Preemption Scorecard.)

Also, at footnote 5 on page 17, the court notes that the state law fraud claim may include an imbedded claim of fraud on the FDA — the implication that Boston Scientific misled the FDA about some aspect of the device. The court properly finds that implied claim to be preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).

So we really like McQuiston, although for reasons that some might think obscure.