McBride v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 96438 (W.D. La. July 10, 2013), is an opinion in a medical device case, and it is a joy for two reasons, one substantive and the other entirely stylistic. As to substance, it doesn’t allow plaintiffs to muse into existence a state law claim on which to base their parallel violation claims. As to style, the opinion, written by Judge Trimble, is a smooth and enjoyable read because it doesn’t jam its paragraphs chock full of citations, italics, underlining, parentheticals and other distractions that are best placed elsewhere.
We’ll take the last point first. Lawyers somehow pride themselves on being the only group of writers and readers who identify their sources in the text. Most professions, industries and for that matter schoolchildren know that a written piece with many sources should identify those sources in footnotes, not the text. Rather than turn paragraphs into a game of visual hopscotch, let the text be the text and identify citations at the bottom of the page where readers can easily find them when they want to. A written piece – particularly one intended to persuade – should be a clean, crisp trip down the highway. Not with lawyers. With them, it’s a herky-jerky ride down Rt. 1 in New Jersey. There’s a light at every intersection. You’re forced to constantly be on the look-out for cars entering the road from every direction. And you’ve got a congestion headache. Lawyers seem to take pride in the pain they cause themselves, as if developing the skill to quickly read a page-long paragraph that has two actual sentences is something to be proud of. Law students starting out on law journals seem to understand that this is not the way to do it. They put citations in footnotes at the bottom of the page. Then they graduate and become lawyers . . .
Well, Judge Trimble understands how to do it. His citations are in footnotes. The opinion has 42 of them, its text is clean and crisp, and it’s a joy to read.
The read is even better because of the substance. The case involved a Class III medical device that was approved under the FDA’s PMA process. That means that plaintiffs’ claims are preempted unless they can properly allege state-law parallel violation claims. As we’ve discussed many times before, parallel violation claims are an ill-defined set of claims that arose from dicta and are often misunderstood.
A lot of things have to happen for a plaintiff to state a parallel violation claim. They must allege facts about the violation. Generalities won’t do under Twombly. They must allege a violation of an FDA requirement or an established state-law requirement that is parallel to an FDA requirement. That violation must have played a role in the plaintiff’s injury. And there must be an actual state law that enforces the requirement. Plaintiffs can’t simply make up that state law, or take one that doesn’t enforce requirements parallel to FDA requirements and act as if it does. Manufacturing a state-law claim to enforce FDA requirements is too much like trying to directly enforce FDA requirements, which civil litigants are not authorized to do. Only the federal government can do that.
The court in McBride understood all of this. Most impressive was its understanding that the plaintiff couldn’t just invent state-law to suit their purposes. In Louisiana, all of plaintiffs’ product liability claims were subsumed under Louisiana’s Product Liability Act (“LPLA”). In other words, plaintiffs could bring claims only under the LPLA. And, as we mentioned, preemption means that their claims must enforce requirements parallel to FDA requirements. But, as the court held, no such claims exist under the LPLA:
[T]he LPLA does not recognize a claim for violation of FDA regulations and, thus, even if plaintiffs' complaint had alleged a claim for negligence based on the violation of federal regulations, such claim would not be cognizable under Louisiana law. 41
41. 2013 U.S. Dist. LEXIS 6166, [WL] at *6 (internal citations omitted); King v. Bayer Pharmaceuticals Corp., 2009 U.S. Dist. LEXIS 125802, 2009 WL 2135223 (W.D. La. 2009).
Id. at *12-13 (note the footnote!). In other words, plaintiffs couldn’t simply fabricate a new LPLA claim that has never existed to facilitate the parallel violation claim that they wanted to bring. And so their negligence claim was dismissed. Id.
The court also dismissed plaintiffs’ failure to warn claim. “[B]y their very nature, they ask the fact finder to conclude that the warnings approved by the FDA were insufficient.” Id. at *13. Plaintiffs’ manufacturing defect claim was also deficient. Plaintiffs’ claimed that the defendant violated its own manufacturing standards. That’s different from a claim that the defendant violated FDA standards. With preemption, different is bad. This claim was dismissed. Id. at *10. Not only were plaintiffs’ claims dismissed. They were dismissed with prejudice. Plaintiffs didn’t properly file a motion to amend their complaint. Id. at *8-9, 14.