This post is from the non-Reed Smith side of the blog.
Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping,
Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following:
In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited. St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky.
Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires
This post originates from the non-Reed Smith side of the blog.
A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex
What follows is a guest post by Cara DeCataldo, a Reed Smith associate, who gamely stepped up to the plate to research one of a number of blogging topics that have been hanging fire for some time now. This topic is a type of “no good deed goes unpunished” liability – whether a defendant whose internal policies aspire to a degree of care that exceeds legal requirements can be sued solely because it allegedly failed to live up to those high aspirations. The two most common theories that purportedly support such a result are negligence per se and negligent undertaking. Thankfully, Cara’s research indicates that such liability is not recognized.
As always, our guest posters are entitled to all of the credit, and any blame, for their efforts.
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Clearly articulated company policies imposing heightened safety standards on a company and its employees can’t be a bad thing, right? But what happens when a Plaintiff attempts to use a company’s alleged failure to comply with its own corporate aspirations as the basis for a lawsuit? There is an inherent tension between a company’s desire to set high standards for employee conduct and/or its products, and the fear of liability if those standards are not met. With this in mind, we thought it would be a worthwhile to take an in-depth look at whether internal company policies that exceed what the law requires, can also pose the risk of creating a legal duty.
For those companies seeking to hold employees and/or products to ambitious standards of care, the news is largely good. Most courts to address the issue support these endeavors and recognize the value of encouraging companies to maintain high voluntary standards. They also recognize the potential negative impact if those goals were misused to create legal duties to the public. Negligence per se claims consistently fail when citing various official pronouncements that encourage, but do not mandate, conduct, such as company credos, internal agency manuals, protocols, policy statements, and the like, as relevant evidence of the alleged negligence. Many states take matters a step further and bar the admission of company policies even as evidence of negligence. The most frequently applied rationale barring the admission of internal policies is that to the extent internal rules and regulations exceed the standard of care, then they are not admissible.Continue Reading Guest Post – Tis Better to Try and Fail, Then to Have Never Tried At All: Internal Corporate Policies Do Not Create a Heightened Legal Duty
A federal judge in Wisconsin issued an order a few weeks ago that covers two topics on which we often write—negligence per se and implied preemption. The two concepts are not unrelated. We most commonly see negligence per se when plaintiffs try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim. State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman. That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that.
It seems pretty straightforward to us, but some courts still resist. That is what happened in Marvin v. Zydus Pharmaceuticals (USA) Inc., No. 15-cv-749, 2016 U.S. Dist. Lexis 112047 (W.D. Wis. Aug. 23, 2016), where the plaintiffs based their negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions. The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at **2-3 (citing 21 C.F.R. §§ 208.1, 208.24(b)).
The defendants allegedly did not provide medication guides to the decedent’s pharmacy, but do the decedent’s heirs have a private right of action? The defendants justifiably did not think so, and they moved to dismiss on the basis that the plaintiffs’ claims were impliedly preempted. Along the way, the district court ordered supplemental briefing on whether Wisconsin law would recognize a claim of negligence per se in the first place.
We are fond of Wisconsin. We once drove from a deposition in Marquette, Michigan, to visit family in Minneapolis. As students of the geography of the Upper Midwest will tell you, that took us across the entire width of Wisconsin. One day we will return to partake of “fresh cheese curd,” which we saw advertised at multiple roadside markets along the way. We have more recently learned that it is commonly deep fried and served at carnivals and county fairs across the region.
But for now, we will respectfully state that the district court in Marvin came to the wrong result. The district court held first that federal law did not impliedly preempt the negligence per se claim, and in reaching that result, it cited and quoted extensively from the Seventh Circuit’s abominable Bausch opinion. Faithful readers will be familiar with the disdain we have heaped on Bausch for, among other things, its recognition of a “parallel claim” based on even the most general FDA regulations and its blithe rejection of implied preemption without citing or even acknowledging section 337(a). The posts are too numerous to list, but you can get the gist here and here.Continue Reading Wisconsin Preemption Ruling Makes Our Cheese Curdle
This post is not from the Dechert side of the blog.
The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”). So have federal courts of appeals.
If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.
Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims
Happy Birthday, Eric Clapton. (Today is also the birthday of painters Goya and Van Gogh. Is there something about March 30 that breeds people who turn their blues into art?) Clapton has been around so long it is easy to take him for granted. He has built up a formidable body of musicianship. He is the only three-time inductee in the Rock and Roll Hall of Fame, for his solo work as well as his stints with the Yardbirds and Cream. We remember how, in the late 1960s, one of our sisters would scribble on her school notebooks that “Clapton is God.” That sister later married a very nice, very hip guy, who was also a Clapton fan. A couple of years ago Clapton’s autobiography came out. Our brother-in-law summarized the book thusly: “I made a lot of music, took a lot of drugs, caused a lot of damage to relationships and health, but in the end, everything was pretty cool.” Just so.
In the early 1990s, we were working at a law firm representing the Robert Stigwood Organization (RSO). You might remember RSO as the force behind the soundtracks for Grease and Saturday Night Fever. RSO also managed the careers of the Bee Gees, Andy Gibb, Yvonne Elliman, and Clapton. In our case, RSO, along with Eric Clapton, was being sued by Jim Gordon, the drummer in the short-lived rock group Derek and the Dominos. Gordon claimed he had been denied writing credit and money for the long piano coda in the all-time great song, “Layla.” By the time he filed the lawsuit, Gordon was a resident of the Atascadero Prison for the criminally insane. Somewhere along the way, Gordon had started hearing a voice. That voice told him to kill his mother. With a hammer and butcher knife. He obeyed that voice. Needless to say, the deposition of Gordon behind prison walls was odd. Earlier in the case, our firm sent a representative to London to meet with our co-defendant, Mr. Clapton. That assignment went to another associate – one who didn’t even like Clapton’s music that much – certainly not as much as we did. Our bitterness and envy were complete. We insisted that the lucky associate (a close friend of ours, but his musical tastes ran more toward c&w and happy pop than toward guitar gods) relay a message to Clapton that, of all the versions of “After Midnight,” the best was the slow one that ran on the Michelob beer commercials. Imagine our delight when we were told that after Clapton listened to that opinion, he paused thoughtfully, nodded, and gently assented: “Yes. That one is the most soulful.”
It would be hard to list all of the great songs that Clapton worked on, but here is a start:
[The founder of this blog wants us to include “Wonderful Tonight” on our list of Clapton favorites. Who are we to refuse? But who knew there was a softer side of Bexis?]
Another one of Clapton’s hits was “Cocaine.” And thus we have an introduction to today’s case, Tersigni v. Wyeth, 2016 U.S. App. LEXIS 5393 (1st Cir. March 23, 2016). Tersigni was a diet drug case, and the alleged injury was Primary Pulmonary Hypertension (PPH). PPH is a very bad disease. The claims were brought under Massachusetts law for negligent design and negligent failure to warn. The trial court dismissed the negligent design claim. The negligent failure to warn claim went to the jury, which returned a defense verdict. On appeal, the plaintiff raised these issues:
Continue Reading First Circuit Upholds Defense Verdict in Diet Drug Case
The Middle District of Florida in Gallant v. Ortho-McNeil-Jannsen Pharmaceuticals, Inc., 2014 U.S. Dist. LEXIS 131769 (M.D. Fla. Sept. 29, 2014), recently addressed a plaintiff’s negligence per se and fraud claims in the Risperdal litigation. It dismissed the negligence per se claim, a claim that is a bit unusual for a drug case. While
This post is from the non-Reed Smith side of the blog.
We’re going to be right up front with you today. It’s a work day. It’s the World Cup. The US is playing Belgium in the Round of 16 at 4:00 EDT. We don’t want to miss it. And soccer — unlike sports like football and baseball — has no time-outs, no 7th inning stretch. There aren’t even any commercials. You look away for a minute to answer an e-mail, you could miss the only goal of the game. So, we’ll get right to the point.
Medtronic scored another InFuse victory in Dunbar v. Medtronic, No. 2:14-cv-01529-RGK-AJW, slip op. (C.D. Cal. Jun. 25, 2014). The allegations in this complaint, like all of the others we’ve previously discussed, focus almost exclusively on off-label use of the Class III, PMA spinal fusion device. Seeing Class III and PMA in the description of the medical device should almost certainly guarantee a defense win on preemption as most courts have acknowledged that there is only a “narrow gap” between Riegel preemption and Buckman preemption in which plaintiffs can state a claim. And that is why the InFuse plaintiffs have tried, with only limited success, to get courts to recognize a preemption exception when a PMA device is used off-label.Continue Reading Latest InFuse Win – Good on Negligence Per Se