A lot of things happened last week – so much that our usual wrap-up search last Friday took over three hours, which is more than twice as long as normal. Since there were too many cases of interest to blog about separately, we’re doing the next best thing, which is to give our readers a rundown of what’s left on the agenda.
Although the word “preemption” was never uttered in the opinion, the decision in Bennett v. Hoffmann-LaRoche Inc., 2013 WL 1191899 (E.D.N.C. March 22, 2013), occurred entirely within preemption’s shadow. The issue was product identification – specifically whether the drug that the decedent took was branded (unpreempted) or generic (preempted). Use of the drug took place in a military context: everyone in the decedent’s unit took an antimalarial drug before shipping to Afghanistan. The decedent then “committed suicide with his service-issued sidearm.” Id. at *3. Since the anti-malarial drug was detected by the autopsy, id., of course it must have caused the suicide.
But the service distributed both branded and generic, did so on a FIFO (first in, first out) basis, and didn’t keep records of who got what. Id. at *2, *4. Here’s what the plaintiff came up with to avoid preemption:
[Plaintiffs] . . . visited [decedent] at [his base]. While in [decedent’s] barracks room, he opened his closet and all sorts of stuff fell out, including an object with “silver foil” [not original packaging] and a small white rectangular box [consistent with either branded or generic]. . . . Beyond observing that the white box was about the same size as the silver object, [plaintiff mother] does not recall whether the box had been opened or any markings on the box.
[Plaintiff mother] asked [decedent] about the silver object that had fallen out. In response, he picked up the object, handed it to [plaintiff mother], and said, “It's Lariam”. . . . Before [plaintiff mother] responded to [decedent] handing her the blister pack, he also handed her a package insert. . . . To [plaintiff mother], who worked as a nurse, the paper appeared consistent with the type that normally comes in medication packs. . . . She unfolded the insert and noticed the word “Lariam,” as well as the hexagon logo for Roche. [Plaintiff mother] estimated that the entire sequence of events . . . occurred in a matter of seconds.
Bennett, 2013 WL 1191899, at *2 (deposition citations and quotation marks omitted). This testimony was, of course, rank hearsay – out-of-court events being admitted for the truth of the matter.
How convenient. We’ve blogged before about asbestos-style causation techniques finding their way into drug/device litigation where drugs are dispensed generically. Bennett – the prescription drug version of “I saw the defendant’s name/logo on the box” − is another example of how questionable litigation tactics spawned in asbestos actions are now trickling into our sandbox. Bennettlet the plaintiffs skate, holding that this testimony, since it took place in“seconds,” was a “present sense impression.” 2013 WL 1191899, at *5. We think that abuses the exception, since it’s not intended for particular purposes such as product identification:
A declarant who deliberates . . . or provides statements for a particular reason creates the possibility that the statements are not contemporaneous, and, more likely, are calculated interpretations of events.
Schindler v. Seiler, 474 F.3d 1008, 1011 (7th Cir. 2007). Product identification seems like a classic "particular reason" for rejecting use of the present sense impression. The abusive potential is obvious.
The “logo-on-the-box”-style identification was supposedly not hearsay at all. “[S]tatements that identify an object based on words or symbols that appear on the object are not hearsay merely because the means of identification is written.” Id. To that, we can only shake our heads. An unproduced writing is a classic out-of-court statement. The words – the supposed identification of the product – were useless if not admitted for their truth. There’s also a “best evidence rule” argument, but we’re not quarrelling with that. What we quarrel with is admitting asbestos-style rank hearsay for product identification purposes.
In a busy week, one can expect pain pump litigation to contribute its share, and it did. One decision, coincidentally also having to do with North Carolina (or at least what passes for North Carolina law in the District of Minnesota – those in the know can guess the judge), was really painful to read. In Block v. Woo Young Medical Co., 2013 U.S. Dist. Lexis 44106 (D. Minn. March 28, 2013), just about everything went wrong for the good guys – even though this defendant, unlike other pain pump cases, was never turned down for any FDA clearance (which shouldn’t make a difference anyway, but we digress). Id.at *3.
First, even though there’s next to no evidence that the prescriber had any contact with any “promotion” (on or off-label) by the defendant (he learned from colleagues, couldn’t remember brand of product, gave no defendant-specific testimony of sales rep contact, made no reliance on labeling, id.at *3-5), Block nonetheless denied summary judgment on warning causation grounds, adopting instead a weird, totally speculative causation-by-osmosis theory. Id. at *12-13 (“if [defendant] had warned individuals in the medical community about the orthopedic use of its pain pumps, [the prescriber] would have been likely to learn about the risks”).
Second, as for promotion, there’s no evidence that the defendant did anything, save signing a distribution contract with a third party. But that was enough (without any discussion of agency) to hold the defendant liable for everything the other party to the contract actually did. Id. at *10-11.
Third, to supply the otherwise missing element of “foreseeability,” Block – relying on Minnesota, rather than North Carolina law – invented a purported “duty to test” never before seen in North Carolina, see Couick v. Wyeth, Inc., 2012 WL 79670, at *7 (W.D.N.C. Jan. 11, 2012) (rejecting duty to test under NC law) − and actually beyond anything recognized in Minnesota, where testing is not an independent claim, but merely an element of a strict liability (which North Carolina bans by statute) duty to warn. Solo v. Trus Joist MacMillan, 2004 WL 524898, at *13 n.26 (D. Minn. March 15, 2004) (“duty to test . . . is not a separate cause of action under Minnesota law”); Kociemba v. G.D. Searle& Co., 707 F. Supp. 1517, 1527-28 (D. Minn. Feb. 16, 1989) (granting judgment n.o.v. against independent duty to test claim). Under Erie, federal courts are not supposed to invent new liability under their own state’s law; Block is even worse, inventing liability under the unfamiliar law of a different state.
Fourth, and finally, adding insult to injury, Block denied all of the defendant’s Daubert motions. We can’t tell from Block whether there was more to some of those motions than meets the eye, but letting an expert testify in direct contradiction to his own prior peer-reviewed scholarship, 2013 U.S. Dist. Lexis 44106, at *36-38, borders on bizarre. So much for the Supreme Court requiring that experts should be held to the same standards inside the courtroom as outside. Worst of all Block let the ubiquitous Dr. Parisian testify – even as to what the defendant “should have known” about the medical risk in question (chondrolysis), as to which she has no pretentions to expertise, either as a doctor or as a purported FDA expert. Id. at *42. Parisian’s infamous narrative testimony is permitted. Id. at *47-48. About the only good thing about Blockis its refusal to allow Parisian to testify directly that the defendant violated the FDCA, that being both an improper legal opinion and barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 2013 U.S. Dist. Lexis 44106, at *45. Even that was partially nullified by allowing equivalent opinions under an industry standards rationale. Id. at *45-46.
But we don’t want just to discuss yucky cases, so we’re bookending Block with another pain pump decision, Prather v. Abbott Laboratories, C.A. No. 3:09-CV-00573-H, slip op. (W.D. Ky. April 2, 2013), that granted summary judgment and dismissed the entire action. Prather comes courtesy of Lauren Tully atf Cozen, who won the case. Unlike North Carolina law in Block, Kentucky law recognizes strict liability. Slip op. at 5. In strict liability cases, Kentucky follows Restatement §402A, comment k – and applies it to medical devices. Slip op. at 6-7. Unlike Block the court in Pratherfound no foreseeability of injury as a matter of law – rejecting the same articles and the same expert (Dr. Parisian, once again), that snuck through in Block:
The Court concludes that these articles do not support the conclusion that in 2001, Defendant should have known of the risk of cartilage damage due to the intra-articular infusion of an anesthetic. . . . The additional articles [offered by plaintiff] suffer from the same deficiencies. . . . Specifically, these articles document the effects of exposure to solutions that are fundamentally different than the anesthetic medication used in the [plaintiff’s product]. The Court finds that the entirety of the articles presented by [plaintiff] are insufficient to create a factual issue of whether Defendant should have known of the risk of cartilage damage.
Prather, slip op. at 13 (footnotes omitted). So much for strict liability. Prather turned to negligence (the only claim at issue in Block). Predictably, plaintiff raised failure to test as a way to avoid the state of knowledge at the time. The question was the same as in Block – does Kentucky recognize an independent duty to test? Again unlike Block,Prather refused to invent a new legal theory of liability:
Though [plaintiff’s] expert Dr. Parisian suggests Defendant could have done additional testing, it is unclear whether such testing would have revealed a risk of chondrolysis. Defendant certainly had an obligation to conduct some amount of testing, defined by what risks the medical community identified or suspected the product to have, in order to ensure the general safety of the product. However, Defendant did not have an obligation to spearhead medical research by testing for every conceivable risks posed by use of the [device]. Imposing such an extraordinary, heightened duty of care would be inefficient; in most cases, additional testing would likely result in products that are marginally more safe, but unnecessarily more expensive.
Prather, slip op. at 17-18.
Plaintiff Prather also made a quasi-fraud on the FDA argument that “Defendant breached its duty of care by failing to submit sufficient information to the FDA.” Id.at 18. It didn’t work. First, the defendant was a contract manufacturer, not the application holder. Another company (now dissolved) was. So plaintiff had no evidence that this defendant was (or should have been) involved in the regulatory process. Id. Also, since the FDA cleared the device, and the device was used in the “precise way” it was cleared, plaintiff could not prevail in negligence. Id.
Warning causation also failed as a matter of law. None of that goofy causation-by-osmosis in Prather:
Here, the evidence indicates that [the prescriber’s] use and placement of the [device] were decisions entirely of his own. . . . [The prescriber], with his colleagues, adapted the [device] for use in the shoulder. . . . At no time did Defendant promote any particular use or placement of the [device]. In fact, the record strongly suggests that Defendant’s conduct did not have a meaningful effect on any of [the prescriber’s] medical decisions.
Slip op. at 19-20 (footnotes omitted). Finally, Prather briefly addressed (and threw out) warranty and fraud. Id.at 20-22.
When there’s a lot of activity, another likely source is Aredia/Zometa, and that was also true last week. We know of four new decisions. First, there’s a lengthy and well-reasoned decision evaluating choice of law, punitive damages, and preemption of the New Jersey fraud on the FDA exception. Guenther v. Novartis Pharmaceutical Corp., 2013 WL 1225391 (M.D. Fla. March 27, 2013). You know the drill by now. Guentherheld: (1) choice of law principles for punitive damages point to the manufacturer’s principal place of business, which in A/Z is New Jersey; (2) New Jersey prohibits punitive damages against FDA-approved products unless there’s fraud on the FDA; and (3) fraud on the FDA is preempted by Buckman. 2013 WL 1225391, at *2-4.
Contrast Guenther to the cruddy little one-paragraph order (there’s a second paragraph dealing with procedure) of another court in the same district that goes the other way (on preemption, at least). See Chiles v. Novartis Pharmaceuticals Corp., No. 3:06-cv-96-J-25 JBT, slip op. (M.D. Fla. Feb. 25, 2013). Unfortunately, since punitive damages have since been rejected by the jury at trial in Chiles it’s doubtful whether there’s anything left to appeal on that issue.
There’s also a Parisian motion in Guenther. Most of it is standard, governed by MDL rulings, and/or stipulated, but there’s one significant issue – so-called“regulatory causation.” We’ve posted beforeabout plaintiffs’ attempts (we called them sub rosa preemption) to try substitute the FDA’s regulatory labeling standard (“reasonable evidence of a causal association . . . a causal relationship need not have been definitely established”) for the common-law causation standard (but for causation/substantial factor in the result). Well, Dr. Parisian was up to that trick in Guenther, but the court didn’t allow it:
The Defendant argues that allowing Parisian to testify regarding [defendant’s] compliance with that regulation is effectively the same as allowing her to testify regarding medical causation. . . . Plaintiffs’ counsel responds that “causal association” is an FDA term, rather than a medical term, and that Parisian as an FDA compliance expert should be permitted to testify in regard to that term. Aside from its origin, however, Plaintiffs’ counsel offers nothing to meaningfully distinguish “causal association” from medical causation. . . . Parisian will not be permitted to offer opinions regarding any alleged “causal association” between ONJ and Zometa.
Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 1278089, at *3 (M.D. Fla. March 28, 2013). The FDA “causal association” standard, is just as Guenther stated – an “end run” around “medical causation.” Id.
Saving the best for last, the fourth A/Zdecision is McKay v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2013 WL 1278025 (W.D. Tex. March 28, 2013), granting complete summary judgment. It’s a Texas case, so the Texas presumption of adequacy (Tex. C.P.&R.C. §82.007) was in play – and had been in the MDL. Interestingly, McKayagreed that all of the plaintiff’s claims were, at bottom, predicated on warnings – no matter what the plaintiff called them. No exception to §82.007 applied. In particular, the exception for off-label promotion required not only promotion, but causation:
Plaintiffs must provide evidence that recommendations, promotions, or advertisements to use Aredia or Zometa for off-label purposes reached and were relied on by the prescribing physician. . . . Although Plaintiffs do provide evidence that [another doctor] “marketed” Aredia to [the prescriber] for an off-label use, they do not provide any evidence that [the other doctor] is a [defendant] agent or a key opinion leader who drove off-label marketing efforts for [defendant]. Accordingly, Plaintiffs have provided insufficient evidence to establish that any off-label promotion of Aredia or Zometa, by [defendant], actually reached and influenced . . . the prescribing physician.
McKay, 2013 WL 1278025, at *5-6. Always remember causation in this situation. The same prescriber non-reliance evidence that often wins learned intermediary cases on causation grounds should likewise win them under the off-label promotion exception to §82.007. McKay also rejected other, more technical, attempts to avoid §82.007. It held, first, that the effective date of the statute was the only date that mattered, not when the plaintiff used the product; and second, that the preempted part of the statute was severable. 2013 WL 1278025, at *6-7.
As to other supposed causes of action, the court made the following rulings: (1) Restatement §402A, comment k applies across the board in Texas, barring separate claims for design defect. 2013 WL 1278025, at *8-9; (2) the duty is to warn the prescriber, not every (unknowable to the manufacturer) doctor that might ever have seen a plaintiff, id. at *8; (3) there’s no direct-to-consumer exception to the learned intermediary rule, id. at *9; and (4) to the extent that plaintiff’s warranty claim otherwise survived, plaintiff failed to provide statutorily required notice. Id.at *10-11.
Guenther and McKay came to us by way of Hollingsworth, whom we also assume successfully sought F.Supp. publication of McKay (we’ve made similar requests many times, whether we won a decision or not). Other people sent us stuff this week as well:
Brendan Kenny of Blackwell Burke, who wrote the guest post some weeks ago about the Illinois Supreme Court’s in Fennell v. Illinois Central Railroad Co., ___ N.E.2d ___, 2012 WL 6725822 (Ill. Dec. 28, 2012), on forum non conveniens, has passed along a new decision (unfortunately unpublished) by the First District Appellate Court of Illinois, affirming transfer of a multi-plaintiff action out of Cook County under Fennell.
A source that wishes to remain anonymous sent me Flores v. Ethicon, Inc., C.A. No. 2:12-cv-01804, slip op. (S.D.W. Va. April 4, 2013), which is a favorable fraudulent joinder case from the transvaginal mesh MDL. First the court resolved an interesting procedural question of which law applied (the case had originally been filed in California district court), holding that on federal matters such as jurisdiction, the MDL/transferee court applied the law of its own circuit. Slip op. at 5. As a matter of substantive California law, the court held that the doctors and hospitals were fraudulently joined because: (1) no possibility of a strict liability or warranty cause of action existed against them from their use/supply of a medical device since they provided services, id. at 11-12, and (2) no negligent conduct of any kind was alleged. Id. at 8-11.
Finally, a plaintiff’s lawyer (whom we don’t know if he wants to be “outed” as a reader) sent along this certification order concerning the learned intermediary rule that a federal district court in a Humira case recently directed to the Tennessee Supreme Court. As of now, it hasn’t been accepted.
Now you’re as up to date as we are.