The federal right-to-try (“RTT”) adventure, which we chronicled here, and here, concluded not long ago with the final passage of S. 204, signed into law on May 30. The final bill is not materially different from the house draft we analyzed earlier. The final bill cleaned up some of the previous hastily-drafted
This post come from the non-Reed Smith part of the blog.
In Otis-Wisher v. Medtronic, Inc., 2015 U.S. App. LEXIS 9565 (2d Cir. June 9, 2015), an Infuse device decision, the Second Circuit offered its thoughts on the viability of parallel violation claims based on allegedly misleading off-label promotion. In short, they are not…
“We’ve seen this movie before.” That is something people say when they encounter something that seems simultaneously dreadful and predictable. That is how we felt upon reading the latest dismal opinion out of the Drake Botox litigation in Vermont federal court. We’ve blogged about this case several times before, bemoaning the blundering approach taken…
Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long decision of the court in Grocery Manufacturers Assoc. v. Sorrell, No. 5:14-cv-117, 2015 U.S. Dist. LEXIS 56147 (D. Vt. Apr. 27, 2015), has little to keep our DDL-centric attention—its discussion of preemption based on various federal statutes, including the FDCA. As the court forcefully rejected most preemption arguments raised by trade groups whose members were likely to be affected by Vermont’s labeling rules for foods derived in whole or in part from genetic engineering, we are reminded of another dynamic from the “Fight of the Century.” Watching live, with the volume up, a viewer might have been swayed by the cheering of the decidedly pro-Pacquiao crowd into thinking Pacquiao was doing damage during many of the too-infrequent exchanges of punches. However, almost invariably, the slow-motion replay between rounds showed Pacquiao’s blows had been deflected and followed by a Mayweather punch to the face, the latter almost too quick to see in real time. Similarly—or at least as similarly as pugilistic analogy allows—the court’s analysis of preemption relied on borrowing concepts from one type of preemption and applying them to another without saying what it was doing.
As our resident state historian cum travel brochure maker (and boxing aficionado) has noted here and here, Vermont has been known to do its own thing. That has included enacting peculiar statutes that unconstitutionally impinge on national commerce. Based upon its judgment that the various federal statutes and regulations—and the pendency of federal legislation—did not do enough to inform consumers of the existence of ingredients created through some degree of genetic engineering in products they might purchase, the Vermont legislature enacted Act 120. It contained two provisions challenged in the GMA case, one requiring packaging or site-of-sale displays disclosing the presence of ingredients derived from genetic engineering in products for sale and one prohibiting labeling or advertising describing the product as “natural” in one way or another. (We will skip the discussion of how much genetic engineering counts, given that humans have been eating “genetically engineered” food ever since our ancestors started selectively mating captured aurochs or zebu and have known that this was a manipulation of genetics at least since Gregor Mendel started playing with peas in his abbey.) The legislature could not say that foods with one or more genetically engineered ingredients were less safe than those without, but cared that polls showed Vermonters wanted to know about the presence of such ingredients so they can make “informed decisions” and not be “confus[ed] and dece[ived]” by claims of “natural” products. Before Act 120 even took effect, a multi-faceted constitutional challenge was brought. The decision we are discussing results from the Vermont AG’s motion to dismiss and the plaintiff’s motion for preliminary injunction. If you want to read about the Commerce Clause or First Amendment issues with Act 120, knock yourself out, but we will not discuss them here.
A week or so ago Grantland tv critic Andy Greenwald penned a “can we talk” letter to Sunday night, asking how it managed to fall so far from greatness. Just last Spring we could plop down on our couch at the end of the weekend to watch Game of Thrones, Mad Men, Veep, and Silicon Valley. Even if some time-shifting was required, it was worth it. Now with the departure of the criminally underrated Boardwalk Empire, Sunday evening has morphed into a drama wasteland. (Sunday Night Football certainly has not supplied any drama. Did you see the dumpster fire that calls itself the Chicago Bears?) The sheer craziness of Homeland has driven us away, with a lead character who calls in drone strikes as she boinks her way into fresh intel. And then we get the competing stories of The Affair, a show that hasn’t attained Rashomon heights of greatness (“Look, the guy from The Wire and the girl from Luther are remembering different wallpaper designs!” “Why is the cop telling them completely different stories about his home life?”).
Let’s pour out some hooch in honor of Boardwalk Empire and remember its well-drawn characters, some of them plucked from the pages of history, and their poetic recitations of despair. The show has one of those historical characters, the gambler/gangster Arnold Rothstein (some say he fixed the 1919 World Series), sharing this bit of wisdom: “All of man’s troubles come from his inability to sit in a quiet room by himself.” As we plunge toward dotage, that sentiment seems very true. Ex-federal agent Van Alden (played by the great Michael Shannon, the same actor who declaimed the insane sorority letter) realized, on the doorstep of his personal doom, that “[w]e haven’t thought this through.”
We are feeling a bit of despair this week after reading an opinion that we do not think was thought through. Last week we identified some things we liked and some things we did not like so much in the Daubert rulings in the Drake case pending in Vermont federal court, where the plaintiff claimed injuries from Botox injections. This week we will look at the summary judgment rulings in that same case. We harbor no mixed feelings at all about the opinion; it is a complete stinker. Drake v. Allergan, Inc., 2014 U.S. Dist. LEXIS 154979 (D. Vermont October 31, 2014). The opinion was appropriately issued on Halloween. It is scary bad. It mucks up the learned intermediary rule, whilst pretending to steer clear of saying anything about it.
In one courtroom scene in Boardwalk Empire, a judge says this to a prosecutor: “I sympathize with your desire to bring purpose to your life, however this courtroom is not the place to do it.” That is a hard-headed judge. We like that judge.
But now let’s go to Vermont. In Drake, the plaintiffs brought an action on behalf of their son, J.D., alleging that he was injured after receiving an “overdose” Botox injection for treatment of lower-limb spasticity. They brought claims of strict liability/failure to warn, negligence, and violations of the Vermont Consumer Fraud Act, all premised on an alleged failure to warn about proper dosages. Here is an additional wrinkle in this Botox case: because the FDA has not approved Botox as a treatment for pediatric spasticity, the administration at issue was off-label. Off label or not, the treating doctor testified that Botox has been one of the standards of care for treating pediatric spasticity for over 20 years.
If all Vermont had given us was fantastic cheese and Ben & Jerry’s ice cream, that would have been plenty. But the 14th state has also given us some interesting politicians (Calvin Coolidge, Howard Dean, Bernie Sanders), some riveting fictional characters (Simon LeGree, Pollyanna, Hawkeye Pierce), the setting for the sitcom that stuck the landing better than any other, Newhart, and, of course, perfect Autumn foliage. Vermont has been called home by one of our greatest playwrights, David Mamet, and one of our finest character actors, Luis Guzman (Out of Sight, Carlito’s Way, etc.). We hear that Guzman does ads for Cabot Creamery. We’d love to see those ads. Wait a minute – maybe through this internet thing we can do just that. Hold on a second. Okay, here you go. Please please please, do yourself a favor and see Out of Sight if you haven’t already. It might be Soderbergh’s and Clooney’s best movie. It is certainly J Lo’s best. It has a wonderful array of character actors: Ving Rhames, Steve Zahn, Dennis Farina, Don Cheadle, Albert Brooks, and the aforementioned Mr. Guzman. The romance scene between Clooney and J Lo is perfect, melding expectation and experience into a sensory now-now-now. See it! Now back to the law biz. By the way, the lawyer we most admire graduated from U. Vermont’s law school.
For the moment, let’s put aside the fact that Vermont gave us Wyeth v. Levine. (Sigh.)
The opinion we are cheddaring about today, Drake v. Allegan, Inc., 2014 U.S. Dist. LEXIS 151830 (D. Vermont October 23, 2014), comes from Vermont and it isn’t half bad. But it might be close to that. The plaintiff sued the defendant, alleging that its Botox product injured him. Both parties filed Daubert motions to exclude the other side’s experts. The court ended up entirely denying the plaintiff’s motion to exclude the defendant’s medical causation expert and partly granting the defendant’s motions to exclude the plaintiff’s regulatory and medical experts. If we were defense counsel in the Drake case, we’d call that a good day and reward ourselves with a dish of Vermont’s state pie (apple) drizzled with maple syrup, with a side of Vermont’s state beverage (milk, of course). And there would be fromage.