Back in September, we reported on Flagg v. Stryker Corp., 801 F.3d 456 (5th Cir. 2015), which reversed a nearly ten-year trend in Louisiana product liability litigation recognizing diversity jurisdiction where plaintiffs improperly sued in-state medical malpractice defendants in violation of Louisiana’s medical review board pre-submission requirement.
Literally hundreds of cases have been removed
A couple of years ago the one–two punch was all the rage in prescription drug cases. “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the threat of generic drug preemption, by also suing branded drug manufacturers on innovator liability theories alleging that innovators’ purportedly inadequate labeling could make them liable to people who never used their products. The new one-two held the generic drug claims preempted while at the same time ruling that the state in question (see our 50-state compilation) did not recognize inadequate warning claims against companies that neither sold nor profited from the sale of the drug that purportedly injured the plaintiff. A one-two punch decision required us to update both our generic preemption and our innovator liability scorecards.
More recently, these cases sort of tailed off. We assumed this was due to a litigation version of chronic traumatic encephalopathy − the plaintiffs had grown weary (and financially wary) of losing, and had stopped suing these defendants on theories that had been so widely rejected in the courts. Apparently, though, the plaintiff in Tsavaris v. Pfizer, Inc., ___ F. Supp.3d ___, 2016 WL 80221 (S.D. Fla. Jan. 7, 2016), didn’t get the memo. The result is another excellent one-two punch decision.Continue Reading The New One-Two Is Back
The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In that post we asked, “Has anybody else seen the United States government make such a statement in a filed court document before?” Friend
We spent the past weekend in Cleveland, visiting a dear law school friend of whom we see much too little. Cleveland deserves more press as a travel destination. It boasts beautiful architecture, (including spectacular bridges, like the Detroit-Superior Bridge over the Cuyahoga River), reasonable prices, and the Cleveland Clinic. It is also home to the world-class Cleveland Symphony and the renowned Cleveland Museum of Art. But (not surprisingly, for regular readers of our posts) our most memorable afternoon was spent in that mecca of popular culture, the Rock and Roll Hall of Fame. We had to be dragged away from the continuous loop of induction ceremony highlights. We gleefully donned headphones and entered a simulated recording booth, where we “laid down the harmony track” over a melody line sung by a popular artist. We stared at Elvis’s army uniform and the sheet of paper on which Neil Young first jotted the lyrics for “Heart of Gold.” But we were most captivated by a room-size exhibit devoted to one of our personal idols, Graham Nash, a two-time Hall inductee (with the Hollies and with Crosby, Stills and Nash), onetime Joni Mitchell cohabitant, and author of a song in serious contention to be our all-time favorite, the folk-y classic “Teach Your Children.” (In a minute, we will find a way to tie this, however tenuously, to something legal. We make no such attempt with this link to a lovely moment from the 2007 American Idol finale, on which Nash sat on a stool with an acoustic guitar and performed this song with an Idol finalist.)
Nash is an intelligent, socially-conscious man of diverse talents that include painting and photography. Among the tidbits revealed in the headphone-accessible interview clips interspersed throughout the exhibit was the fact that he is also a serious collector of memorabilia. He seeks to acquire items that capture the seminal moments of significant political and musical events. (For example, his collection includes a piece of the fence that rings the grassy knoll in Dallas.) In today’s case (see – we told you!), a minor cautionary tale from the Mississippi Supreme Court, the seminal moment in the demise of the plaintiff’s case occurred 120 days after she filed her First Amended Complaint. While rock-and-rollers can often flout the rules, it’s always a good idea for lawyers to follow them, as this case demonstrates.
In Meeks v. Hologic, Inc., 2015 Miss. LEXIS 610 (Dec. 17, 2015), plaintiff initially sued a physician and a medical center for injuries she had allegedly sustained two years earlier during outpatient gynecologic surgery. Both defendants answered the Complaint. Two years and 363 days after she discovered her injuries (this becomes important, because Mississippi has a three-year statute of limitations), with leave of court pursuant to the Mississippi rules, plaintiff filed her First Amended Complaint (“FAC”) adding Hologic, manufacturer of a device used in her surgery, as a defendant, and adding warranty claims against all defendants. Plaintiff served the doctor and the medical center with the FAC, but never served the FAC upon Hologic. Neither the doctor nor the medical center answered the FAC. (This was also important in the plaintiff’s mind, but it wasn’t really.)Continue Reading Mississippi Plaintiff Defeated By Improper Construction of “Amend As A Matter Of Course” Rule
This post is not from the Reed Smith side of the blog. Here is a link to today’s opinion in Cisson v. C.R. Bard, Inc., No. 15-1102 (4th Cir. Jan. 14, 2016). The plaintiff’s verdict in Cisson was affirmed.
As we mentioned before Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label use/promotion. Just about all our readers know that Bexis has been a long-time First Amendment advocate with respect to truthful off-label speech, since the beginning of this blog, and before.
We’re not going to rehash any of that. There are, however, a couple of new First Amendment developments that we learned about at the conference that we want to pass along. The first is that the Ninth Circuit (or at least a panel of that notably fractious court) has fallen into line behind Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), and recognized that Sorrell strengthened First Amendment protections for commercial speech – at least where it’s truthful, which is the assumed cornerstone of our position on off-label promotion in the first place.
The new case is Retail Digital Network, LLC v. Appelsmith, ___ F.3d ___, 2016 U.S. App. Lexis 140, slip op. (9th Cir. Jan. 7, 2016). It’s not about drugs, devices, or the FDCA, but rather about alcoholic beverage advertising. At issue was another absolute ban on commercial speech that failed to take truth or falsity into consideration. The state of California, in order to prevent kickbacks and other preferential treatment (taking the state’s professed interest at face value), flatly prohibits manufacturers of alcoholic beverages from any paid advertising at retail establishments. Id. at *2-3 (citing Cal. Bus. & Prof. C. §25503(f)-(h)). Almost 30 years ago the Ninth Circuit held this provision constitutional under the pre-Sorrell commercial speech test established in Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557 (1980). See Actmedia, Inc. v. Stroh, 830 F.2d 957 (9th Cir. 1986). Retail Digital, however, held that Sorrell toughened First Amendment protections. The Actmedia decision was “clearly irreconcilable” with Sorrell, because “Sorrell requires heightened judicial scrutiny of content-based restrictions on non-misleading commercial speech regarding lawful products, rather than the intermediate scrutiny” of Central Hudson. Retail Digital, 2016 U.S. App. Lexis 140, at *3.Continue Reading Latest First Amendment Off-Label Notes – Has DoJ Finally Come Around?
This post is from the non-Reed Smith side of the blog.
Occasionally, a qui tam action grabs our attention. Usually because it would seek to penalize off-label use. Anything that shuts that down deserves a mention here.
Qui tam plaintiffs seek damages under the False Claims Act based on allegations that a defendant caused the
Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards. As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).
The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a). Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.” 361 P.3d at 871 (citations omitted). See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).
So why are we telling you this? We’re not the food blog, after all. Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.Continue Reading California Supreme Court – Presumption Against Preemption Still Around
We have been meaning for a while to write about LabMD’s epic data privacy fight against the FTC. We’re sure you have read about the action, and particularly about the administrative order dismissing the government’s Administrative Complaint in November 2015. The noteworthy part of the order is its holding that the government has to prove actual injury to consumers, not merely a theoretical “risk” of future harm, in data privacy enforcement actions. We like the sound of that. It reminds us of the old days of medical monitoring class actions, otherwise known as “money for nothing,” where uninjured plaintiffs would claim compensation for future medical surveillance, even though they had never experienced any actual complication. We don’t see those much anymore, but a similar battle has gone on in the context of data privacy. The vast majority of data security breaches result in no tangible harm to anyone, but plaintiffs still sue, and they still want money for the theoretical risk that someone, someday might use their private information to cause them harm—fraud, identity theft, and the
like.
But back to LabMD. The FTC has gone after many companies for allegedly lax data security practices, and in almost every case, the target comes to a negotiated resolution, usually involving a fine and a consent decree requiring certain measures to better protect private information. What makes LabMD different is that, once it found itself in the FTC’s crosshairs, it fought back. That decision was bad for business—the company announced in 2014 that the government’s action essentially closed it down—but it resulted in a complete win at the administrative level and a landmark order pinning back the government’s ears. The action has been going on for years, but here is what you really need to know:
Why do we care? The issue is data privacy and security, and the drug and device industry holds reams of private information—employee data, customer data, consumer data, patient data, etc. The FTC remains the biggest bully in the schoolyard when it comes to data privacy, and the LabMD order is a landmark in delimiting the FTC’s usually unchallenged regulatory prerogative.Continue Reading All You Need to Know About LabMD’s Big Win in/over the FTC
Some of your bloggers are speaking at upcoming events – events that are either free or offered at reduced price to our readers.
Coming up in a couple of weeks – specifically on January 19 between 1:00 and 2:30 p.m. (EST) – will be a “Thumbs Up and Thumbs Down” webinar presenting the best and