[Drug and Device Law] An Error-free Seventh Circuit Medical Device Case
Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers. Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what emerges is mostly correct and at least intermittently coherent. Some of us pretend to actually know Strunk & White by heart. Still, errors occasionally evade the dragnet of dorks. In honor of National Grammar Day, we have festooned today's post with enough errors to keep all of you grammar cops busy. We do this as a matter of principal.
But there are no errors in the case under review. We have a rare favorable medical device decision out of the Seventh Circuit. The case is called Kallal v. Ciba Vision Corporation Inc., 2015 U.S. App. LEXIS 2987 (7th Cir. Feb. 24, 2015). Mind you, the Seventh Circuit is one court we think the world of. Any court that is home to legal luminaries like Posner, Easterbrook, Wood, et al. must be fairy formidable. But the Seventh Circuit is also home to the hideous Bausch precedent. Perhaps you remember Bausch. Its hard to forget. The Seventh Circuit permitted a plaintiff to vaguely state a parallel claim which lacked substance under both federal and state law. TwIqbal pleading requirements impacted the case not at all. Irregardless of the Supreme Court's instruction that lame cases should be dismissed before subjecting defendants' to expensive discovery, the Bausch court elevated the plaintiff's desire for discovery into something sacramental.
But Kallal is much better than that is. The plaintiff claimed that defective contact lenses had hurt his eyes. The plaintiff did not have alot of evidence. The company had recalled some of it’s contact lenses. Courageously (after Bausch) the district court held that the plaintiff's claims were preempted nonetheless, and that the parallel claim could not save the case. The plaintiff argued that his suite fit inside of the Riegel exception because the company failed to list ion permeability as a “material characteristic” in its premarket approval list. The company responded that the FDA did not require them to meet any ion permeability threshold. The plaintiff did not offer any evidence to the contrary. In any jurisdiction but Bausch-land, that argument would win the preemption day for the defendant. And mirabile dictum, it managed to win for the defendant in Kallal. At least at the lower court’s level.
The Seventh Circuit upheld the dismissal, but they skirted the parallel claim exception - and not needing to grapple with Bausch's jabberings - by only holding that there was insufficient evidence of usage. The Kallal court called "classic dicta” the lower court's preemption analysis, that "can be sloughed off without damaging the analytical structure of the opinion.” You can often count on such poetry from the Court of Appeals seated in the City of Big Shoulders. Sweet home Chicago, named after a stinky onion, the cow butcher to the Republic, and shelterer of Carl (and Ryne) Sandburg, Buddy Guy, and all those "Yes-and"-ers at Second City. "The whole world’s watching." The place where Republicans, antitrust plaintiffs, and the Cubs lose with startling regularity. Surely Chicago, along with the City of Botherly Love, is one of the preeminent places to be a litigator - excuse us: trial lawyer. We like the Kallal opinion almost as much as we like deep dish pizza and Grant Achatz.
Here is the problem for the plaintiff in Kallal: the company's records did not show the recall including the lenses used by the plaintiff. None of the recalled lenses were in the plaintiffs' prescription strength. Against the company's records showing that plaintiff's lenses were not covered by the recall, the plaintiff mounted 2 responses: (1) the voluntary recall was so huge that the company could not possibly have known which lenses were defective (that is, the company got it wrong); and (2) some of the lenses the plaintiff wore were manufactured in an Indonesian plant that had manufactured also the recalled lenses. From that, the plaintiff inferred that every lens made in that factory must have been similarly flawed.
The plaintiffs’ claim resembled res itsa loquitur, but that didn't work because evidence suggested the plaintiff might have had an allergenic reaction. He had had problems with other companies' contact lenses as well. Oops. The district judge dismissed the plaintiff's evidence as a mere “wisp of circumstantial evidence” and the Seventh Circuit agreed. No design defect theory would establish the defendant's liability as against the plaintiff was simply being allergic to all contacts. And while its true that the plaintiff exhibited symptoms after wearing the defendant's contact lenses, the record needs to show more than post hoc, ipso propter hoc -- the mere fact that a person suffers pain when using a product does not, by itself, disprove that the product isn’t defective.
In any event, the plaintiff also could not defend a summary judgment motion just by attacking the credibility of the other side’s affirmative evidence that there was no claim. To quote another Latin aphorism - this one adorned the cafeteria door at our Catholic high school - fidem clam
The plaintiff also made an argument that has sadly some basis in Bausch: that the record was incomplete, because the district judge abused her discretion where she denied his request for more discovery. As an initial procedural hurdle, the plaintiff had failed to life a Rule 56(d) affidavit explaining why he needed additional discovery. Come to think of it, plaintiff's usually do not file affidavits like that. Which is nice. Further, it was clear that further discovery would be futile.
Thus spaketh the Seventh Circuit. We look upon its result and smile. But when we look upon the above paragraphs, with its many grotesque mistakes, we do not smile. In fact, what we wrote makes our eyes hurt.
--
Posted By Steve McConnell to Drug and Device Law at 3/04/2015 07:30:00 AM --
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.
No comments:
Post a Comment