Sunday, September 30, 2007
We noted the grant of cert (and provided the cert petition, opposition brief, and reply) here, discussed the broader implications of the case here, and did a more thunderous analysis here.
In this post, we're searching the web and collecting links to what others have said about this case and its likely implications.
Point Of Law thinks Kent is a no-brainer: The Supreme Court took Kent to tell the Second Circuit that the unanimous decision in Buckman barring fraud-on-the-FDA claims meant what it said.
The Mass Tort Litigation Blog predicts that Kent will give Justice Scalia the chance to overrule Cipollone. (That post is a little cryptic for our taste, and we haven't gone back to re-read Cipollone. But, if the suggestion is that the Supreme Court will reject preemption in Kent -- thus reading narrowly (as in "into oblivion") the 9-0 decision in Buckman -- then we beg to differ.)
SCOTUS Blog describes the background of Kent and the arguments for and against granting certiorari, but adds nothing more to the mix. The FDA Law Blog does essentially the same, as does an Associated Press report that shows up on law.com, among other places.
The Fortune Legal Pad nicely describes the three most likely possible results in Kent and notes the implications of the case for the Vioxx Litigation. We agree with what's written there (which is not too surprising, since the post quotes us and links to this blog), but, given what we do for a living, we wouldn't limit our thinking to Vioxx. Although Vioxx is stealing the headlines as the pharmaceutical mass tort du jour, there are lawsuits involving an awful lot of other drugs, too. And, if a "fraud-on-the-FDA" exception allows those claims to proceed, then plaintiffs' counsel will plead fraud on the FDA in every case, as surely as night follows day. So don't think only about Vioxx. Think about every drug in the medicine chest -- from Accutane to Zyprexa -- as being effected by the outcome of this case.
There's the usual rant against preemption in Tort Deform. (Hey, we don't blame 'em for their point of view. We regularly rant in favor of preemption; fair is fair.) And there's a noteworthy post at Pharmalot, where Ed Silverman interviews Hank Greenspan, a social ethics lecturer at The University of Michigan Medical Center, who's been leading the charge against preemption in Michigan.
As far as we can tell, that's all of the non-redundant stuff about Kent in the blogosphere to date.
If you see anything else of interest, please let us know. In return, we'll do the same for you.
For individuals, "ego-surfing" is plugging your own name into Google and seeing how many times your name shows up on the web.
For law firms, ego-surfing is only slightly different.
A law firm's public relations folks will plug the firm's name into Google to see what people are saying on-line about the firm.
But it gets better. At many law firms, the ego-surfing is automatic: law firms set up "Google Alerts" to advise people automatically when the firm's name is used on-line. The Google Alerts send to lawyers' desktops a notice that the law firm was named on-line, a short snippet of the text surrounding the use of the firm's name (so the recipient of the Alert can make an informed decision whether to explore further), and a link to the website that contained the name.
This post is our own personal experiment in ego-surfing. We're about to post the names of four large law firms, surrounded by text that is likely to sound intriguing to lawyers at those firms. We'll then watch the results to see whether (1) we draw a surprising number of visitors from those firms over the next few days, and (2) whether any of those visitors are interested in pharmaceutical product liability defense and thus become regular readers. If the results are interesting, we'll let you know.
Here's the game:
1. DLA Piper has, seemingly out of nowhere, created one of the great mass tort defense practices in the world.
2. Kaye Scholer, which has long represented Pfizer, has achieved noteworthy victories in recent years.
3. Kirkland & Ellis, home to more than its share of superstar litigators, particularly in the fields of class action and mass tort defense . . . .
4. O'Melveny & Myers, one of the leading class action defense firms in the world . . . .
Well, let's not get carried away here.
The Drug and Device Law Blog extends a warm welcome to our new visitors from DLA Piper, Kaye Scholer, Kirkland, and O'Melveny. This blog contains its hosts personal views about the defense of pharmaceutical and medical device product liability cases (and, often, about the defense of complex litigation generally). The posts before and after this one are better examples than this one of the usual fare at this blog.
For the rest of you, we'll let you know what, if anything, we learn from this experiment in ego-surfing.
Thanks for bearing with us as we entertained ourselves. Back to drug and device law momentarily.
Thursday, September 27, 2007
Rather, the chief opportunity we see for defendants is that the Supreme Court might finally address how the “presumption against preemption” applies – if at all – in a situation involving implied conflict preemption.
To understand what’s at issue in Kent first requires review of what was decided in Buckman itself. The first thing that must be said about Buckman is that the Court was unanimous. Not a single justice thought that state courts could hear allegations of “fraud on the FDA.” In Buckman, the Court addressed charges that a defendant had “made fraudulent representations to [the FDA] in the course of obtaining approval” to market a medical device and that “such representations were at least a ‘but for’ cause” of the plaintiffs’ injuries. 531 U.S. at 343. The Court held that such state-law claims were preempted because states may not reexamine federal regulatory decisions. The claims that Buckman held preempted alleged that a medical device manufacturer – assisted by the defendant in the case (Pamela Buckman was an FDA regulatory consultant) – withheld from the FDA the actual indication for which the defendant intended to market a product. That allegedly constituted a misrepresentation of the product’s “intended use” on the approval application. Id. at 347.
All nine justices in Buckman said “no go.” What the plaintiffs claimed was that FDA approval was fraudulently obtained and thus state-law juries could ignore it. More broadly, state-law claims challenging the adequacy and veracity of submissions to the FDA failed the test of federal conflict (implied – not express) preemption for several reasons:
- “Policing fraud against federal agencies” is not a “traditional” state function. Id.
- Existing federal law “amply empowers the FDA to punish and deter fraud.” Id. at 348.
- State fraud-on-the-FDA claims would “skew” the Agency’s “balance of statutory objectives.” Id.
- Exposing applicants to “unpredictable civil liability” would “discourage” submission of “potentially beneficial” products. Id. at 350.
- Fraud-on-the-FDA claims would create “an incentive to submit a deluge of information that [FDA] neither wants nor needs, resulting in additional [administrative] burdens.” Id. at 351.
- “Congress intended that the [Act] be enforced exclusively by the Federal Government.” Id. at 352 (citing 21 U.S.C. §337(a)).
The first of the Court’s points – about states not having any “traditional” role in preventing federal agencies from being defrauded – was key to another part of the Buckman decision. For the same reason, the Court held that there could be no presumption against preemption in Buckman:
Id. at 347-48 (emphasis added). Note that it was the nature of the defendant’s alleged “dealings” with the federal agency – not the nature or elements of any cause of action being asserted – that caused the Court in Buckman to reject any presumption against preemption.
Policing fraud against federal agencies is hardly a field which the States have traditionally occupied, such as to warrant a presumption against finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character. . . . Here, petitioner’s dealings with the FDA were prompted by the MDA, and the very subject matter of petitioner’s statements were dictated by that statute’s provisions. Accordingly-and in contrast to situations implicating federalism concerns and the historic primacy of state regulation of matters of health and safety, no presumption against pre-emption obtains in this case.
Plaintiffs tried the same tack again on the merits, and once again the Court rejected all contentions that state-law-based allegations attacking the adequacy and honesty of FDA submissions were only “traditional,” unpreempted “violation” claims. 531 U.S. at 352-53. The court observed that, without the FDCA requiring submissions to the FDA, there could be no basis for any fraud claim at all. Id. Thus, “existence of these federal enactments is a critical element in [plaintiffs’] case,” and “this sort of litigation would exert an extraneous pull on the scheme established by Congress, and  is therefore pre-empted.” Id. at 353.
Again, the focus of the Court was not on how the fraud on the FDA claim was framed but on whether, substantively, the allegations of agency fraud were a “critical element” in the plaintiff’s “case.” The Supreme Court in Buckman looked at the substance of the claim, not its form.
Two justices in Buckman were willing to allow a little leeway for state tort law to prosecute fraud claims grounded in submissions to federal agencies – but only after the agency itself definitively concluded that it was defrauded and concluded that the fraud was serious enough to require a product recall:
This would be a different case if, prior to the instant litigation, the FDA had determined that petitioner had committed fraud. . .and had then taken the necessary steps to remove the harm-causing product from the market. Under those circumstances, respondent’s state-law fraud claim would not depend upon speculation as to the FDA’s behavior in a counterfactual situation. . .[and] a plaintiff would be able to establish causation without second-guessing the FDA’s decisionmaking or overburdening its personnel. . . . If the FDA determines both that fraud has occurred and that such fraud requires the removal of a product from the market, state damages remedies would not encroach upon, but rather would supplement and facilitate, the federal enforcement scheme.
531 U.S. at 354 (emphasis added). This was a two-justice concurrence. That means that the seven other justices were unwilling to sanction a state-court fraud-on-the-FDA action even where the FDA had found fraud and pulled the offending product from the market.
Given the Court’s unanimity and the breadth of its holding, for years Buckman was read to prohibit any state-law fraud allegations against any federal agency. E.g., Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-06 (9th Cir. 2002) (fraud on the EPA preempted). Agency fraud claims were held preempted even if “disguised” as something else. Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005); Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127, 138-39 (Tex. App. 2005) (“common-law cause of action for fraud” preempted as “essentially a ‘fraud-on-the-FDA’ claim”); Alfred v. Mentor Corp., 2007 WL 708631, at *7 (W.D. Ky. Mar. 5, 2007) (fraud claim “construed” as fraud on the FDA preempted). “[P]laintiffs cannot bootstrap their arguments regarding defendant’s failure to report and investigate adverse incidents to the FDA into a defective warning case.” Webster v. Pacesetter, Inc., 259 F. Supp.2d 27, 36 (D.D.C. 2003).
After Buckman, there was never any serious dispute that its rationale extended to prescription drugs as well as medical devices. Both, after all, are regulated by the FDA. E.g., Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 963-64 (6th Cir. 2004); Flynn v. American Home Products Corp., 627 N.W.2d 342, 349 (Minn. App. 2001); Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp.2d 666, 675 (E.D. Ky. 2006); Kobar v. Novartis Corp., 378 F. Supp.2d 1166, 1172-73 (D. Ariz. 2005); Dusek v. Pfizer, Inc., 2004 WL 2191804, *4 & n.4 (S.D. Tex. Feb. 20, 2004); Ledbetter v. Merck & Co., slip op. at 10, 2007 WL 1181991 (Tex. Dist. Harris Co. Apr. 20, 2007).
The real Buckman battleground turned out to be those states (about eight of them to date) that have product liability tort reform statutes concerning prescription medical products that include exceptions based upon fraud on the FDA. Indeed, plaintiffs’ counsel in Buckman told one of us, shortly after we’d won that case, that we “would be sorry” because plaintiffs would use Buckman to attack these state statutes. Two states, Michigan and (later) Texas, apply the exception to a presumption of non-defectiveness based upon FDA compliance. So does the federal Vaccine Act. The other states (Arizona, New Jersey, Ohio, Oregon, North Dakota, and Utah) use fraud on the FDA as an exception to compliance-based bars on punitive damages. We’ve discussed these before, here, and here.
Plaintiffs were as good as their word – but for a number of years they enjoyed little success. The first target was Michigan, whose tort reform statute was the most restrictive. In Garcia, 385 F.3d at 963-64, the Sixth Circuit analyzed Michigan’s fraud on the FDA exception to an otherwise conclusive presumption of non-defectiveness based upon FDA compliance. Id. at 964 (citing Mich. Comp. Laws §600.2946(5)(a) & (b)).
Garcia concluded that “Buckman teaches that state tort remedies requiring proof of fraud committed against the FDA are foreclosed since federal law preempts such claims.” 385 F.3d at 966. Since the practical effects of allowing state-law litigation of this exception were indistinguishable from Buckman, “[t]his difference, [between an exception and a cause of action] however, is immaterial in light of Buckman.” Garcia, 385 F.3d at 965-66. In either case, “a plaintiff asks a state court to find bribery or fraud on the FDA,” id. at 967, and plaintiff can only go forward “on the basis of state court findings of fraud on the FDA.” Id. at 966 (emphasis original). Since the mode of proof was identical, “[s]uch a state court proceeding would raise the same inter-branch-meddling concerns that animated Buckman.” Id. at 966.
Actually, the Sixth Circuit was conservative in its holding. Like the two concurring justices in Buckman, it recognized that “the same concerns do not arise when the FDA itself determines that a fraud has been committed” and thus, should the FDA find fraud, the state statutory exception would not be preempted. Garcia, 385 F.3d at 966 (emphasis original).
Just as the original threat by plaintiffs’ counsel in Buckman had indicated, the plaintiffs in Garcia were not interested in proving fraud, but rather sought to use Buckman to argue that the entire Michigan statute should be held unconstitutional as incapable of being severed from the plainly invalid fraud-on-the-FDA exception. In that, as well, they failed in Garcia. See 385 F.3d at 966-67 (finding statute severable, given purpose of legislature to reduce liability exposure of manufacturers of FDA-approved products). See also Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 136 (Mich. 2003) (also rejecting constitutional challenge – delegation – to Michigan statute).
To this day, other courts applying Michigan mostly find all fraud-on-the-FDA-related claims preempted. Duronio v. Merck & Co., 2006 WL 1628516, at *5 (Mich. App. June 13, 2006); Zammit v. Shire US, Inc., 415 F. Supp.2d 760 (E.D. Mich. 2006); Henderson v. Merck & Co., 2005 WL 2600220, at *7 (E.D. Pa. Oct. 11, 2005), reconsideration denied, 2005 WL 2864752 (E.D. Pa. Oct. 31, 2005). Other courts have adopted the same rationale with respect to other state fraud-on-the-FDA exceptions. In re Aredia & Zometa Products Liability Litigation, 2007 WL 649266, at *8-9 (M.D. Tenn. Feb. 27, 2007) (New Jersey punitive damages exception); Kobar, 378 F. Supp.2d at 1172-73 (Arizona punitive damages exception); Ledbetter, slip op. at 8, 2007 WL 1181991 (Texas presumption exception).
This was the state of play when the Court of Appeals in Desiano v. Warner-Lambert & Co., 467 F.3d 85, (2d Cir. 2006) – from which the Kent appeal was taken (Desiano involved identical claims brought by a group of Michigan plaintiffs in a coordinated MDL action; Kent is the name of another plaintiff in that group) – disagreed with Garcia. Desiano held that, because the Michigan statute “d[id] not create a new cause of action for misleading the FDA,” Buckman was inapplicable. 467 F.3d at 92, 98. According to Desiano, the Michigan exception merely preserved “traditional,” “pre-existing” tort causes of action. Because those preserved claims were not an “attempt to police fraud on the FDA,” id. at 94, the court concluded that Buckman did not mandate preemption. 467 F.3d at 94-97.
Desiano looked to the form of the cause of action of action in Buckman. It relied upon the Supreme Court’s factual statement that, in the case before it, the plaintiffs did not “rely on traditional state tort law which had predated the federal enactments in question,” but rather, “the existence of these federal enactments [was] a critical element in their case.” Buckman, 531 U.S. at 353. Desiano, 467 F.3d at 95-96. To support a narrow reading of Buckman, Desiano resorted to Buckman oral argument transcript, id. at 96, rather than rely upon the Buckman opinion itself, to hold that Buckman did not address fraud on the FDA in the context of a case where the plaintiff actually alleged that the product at issue was “defective” – and thus Buckman was not controlling in that situation (which encompasses the vast majority of tort claims. 467 F.3d at 96. Use of an oral argument transcript in this fashion is, shall we say, highly unusual.
Thus, what Desiano did was create a pleader’s exception to Buckman that would inevitably swallow the preemption rule that the Supreme Court laid down in that case. Desiano restricted Buckman preemption only to a cause of action denominated “fraud on the FDA” or something similar, that raised a “newly-concocted duty between a manufacturer and a federal agency.” 467 F.3d at 95. As long as allegations that the FDA was deceived are pleaded as part of some traditional cause of action or exception to a cause of action, then anything goes:
[T]he plaintiffs’ complaints allege a wide range of putative violations of common law duties long-recognized by Michigan’s tort regime. These pre-existing common law claims survive. . .because there is also evidence of fraud in FDA disclosures. But, unlike the claims in Buckman, they are anything but based solely on the wrong of defrauding the FDA. . . .Buckman cannot be read as precluding such preexisting common law liability based on other wrongs, even when such liability survives only because there was also evidence of fraud against the FDA.
467 F.3d at 95 (emphasis added). Further, because the fraud-on-the-FDA statutory exception is an affirmative defense, the defendant can “choose” not to raise it. Id. at 96. Since fraud on the FDA is thus not an “element” of the plaintiff’s claim (even though essential to the survival of the case) it is not preempted under Buckman. Id. The Desiano court’s view that it had merely “traditional” tort claims before it also gave it the excuse to apply the presumption against preemption to the entire case – including the fraud-on-the-FDA exception – in direct opposition to the unanimous Supreme Court’s determination (quoted and discussed above) in Buckman that no such presumption was appropriate where fraud on the FDA was concerned:
First, the presumption against federal preemption of state law obtains in the case before us. . . . In the case before us, instead, the cause of action. . .cannot reasonably be characterized as a state’s attempt to police fraud against the FDA. . . . [The Michigan statute] did not invent new causes of action premised on fraud against the FDA. The object of the legislative scheme was rather to regulate and restrict when victims could continue to recover under preexisting state products liability law.
467 F.3d at 94 (emphasis added).
None of this reasoning ever made much sense to us. Nine justices said that the presumption against preemption doesn’t apply to fraud on the FDA. No amount of sophisticated argument can hide the fact that the Second Circuit presumed just what the Supreme Court held it should not. The Supreme Court raised a litany of practical reasons why fraud on the FDA had to be preempted because of the adverse effects that such claims would have on the ability of the FDA to do its job. Desiano dismissed those practicalities almost contemptuously, claiming (without any empirical data) that fraud on the FDA allegations under the Michigan statute created “no greater. . .incentive” to “deluge” the FDA with superfluous material than the incentive that already “exists” in “any product liability suit brought against a drugmaker.” 467 F.3d at 97. Don't take our word for it - read what Desiano actually said:
So long as a court or jury is allowed to consider evidence of fraud against the FDA in an ordinary common law tort suit, and so long as juries are likely to react to such evidence, there will be substantial inducements on the pharmaceutical industry to provide the federal agency with just the kind of information that troubled the Buckman and Garcia Courts. Requiring such evidence when a plaintiff seeks to counter a statutory defense from liability would not significantly alter that incentive.
Id. (emphasis added). In other words, everything the FDA said in its amicus briefs in Buckman was wrong – and the unanimous Supreme Court was equally misguided and could not possibly have meant what it said. 467 F.3d at 97 (“[w]e do not believe Buckman meant to go anywhere near so far”).
We hope the Supreme Court will reaffirm that, when it stated that preemption was "inevitable" in this situation, 531 U.S. at 350, it meant it.
Equally fundamental, the practical effect of Desiano’s reasoning would have been to nullify Buckman by making preemption absurdly easy to avoid. Any pleader worth his salt can allege something more than “solely” fraud on the FDA – so any claim not denominated “fraud on the FDA” would survive Buckman preemption. That exalts form over substance – the same allegations, pleaded as a stand-alone cause of action, threaten to skew the “delicate balance of [the FDA’s] statutory objectives,” 531 U.S. at 348, whereas identical allegations, included in as part of some other “traditional” state-law count, would not. Desiano, 467 F.3d at 98 (preemption only when “the cause of action. . . assign[s] liability solely on the basis of fraud against the FDA”). Somehow, we don’t think a unanimous Supreme Court decision should be tossed aside so easily. Rather, we believe take the Buckman Court at its word that, however much a state might regulate a federally regulated company’s interactions with the public, no state can presume to regulate how such companies interact with their federal regulators – such as the FDA.
Nor do we think that the fundamental, inherent conflict between fraud-on-the-FDA allegations and FDA regulatory activity can be glossed over. Fraud-on-the-FDA allegations – however couched – are an invitation (express or implied) for state-law juries to ignore whatever FDA regulatory decisions (be they initial product approvals, labeling decisions, or anything else) they conclude were fraudulently obtained. At least where the FDA has not drawn a similar conclusion, there is an absolute and unavoidable conflict between an in-force FDA administrative action and a state-law-based jury conclusion that this same action was fraudulently induced (and thus can be ignored).
At bottom, the only function of fraud-on-the-FDA allegations, whether brought as a cause of action or something else, is to denigrate the FDA’s regulatory activity in a jury’s eyes. Thus, “[s]tate-law fraud-on-the-FDA claims inevitably conflict with the FDA’s responsibility to police fraud consistently with the Agency’s judgment and objectives.” Buckman, 531 U.S. at 350. Whatever their state-law trappings – as an exception or as a cause of action – the “inevitable” fate of fraud-on-the-FDA assertions should be preemption.
Because Desiano effectively ignored the express language of the statute it construed, conditioning survival of the suit on “intentional” “withhold[ing]” from or “misrepresent[ation]” to the “Food and Drug Administration,” its strained limitation upon Buckman had been criticized well before the Supreme Court granted certiorari.. Whether a particular fraud-on-the-FDA claim is a “cause of action” or an “exception,” it still has the same adverse effects on FDA’s regulatory process:
[We] respectfully disagree with the Second Circuit. . . . [T]he Michigan statute. . .provides drug manufacturers, not with an affirmative defense, but with absolutely immunity. . .absent a showing that the drug manufacturer secured FDA approval through fraud. For the reasons clearly outlined above. . .the FDA itself must make this finding of fraud.
Aredia & Zometa, 2007 WL 649266, at *9 n.17. Distinguishing between non-traditional fraud-on-the-FDA claims and “traditional” suits with a fraud-on-the-FDA predicate “is a distinction without a difference.” Ledbetter, 2007 WL 1181991, slip op. at 8.
So what’s at stake in the Warner Lambert v. Kent appeal? Well, at minimum, the Court is going to have to decide, once again, whether to let the fraud on the FDA genii out of the bottle. It decided unanimously not to allow that only a few years ago in Buckman, and we are skeptical that it’s going to let the same thing happen by means of a pleading subterfuge here. We expect to see the usual plaintiff criticism of the FDA as they attempt to overturn Buckman, but recent congressional action to strengthen the Agency should go a long way to deflating their argument that state tort law should be allowed to step in instead.
We think Kent goes beyond just a reaffirmation of Buckman, though. We hope the Court will react to how some lower courts have misused the presumption against preemption to try to nullify its preemption decisions. For instance, there’s nothing in Buckman, or any other Supreme Court case that we know of, that construes the presumption against preemption as turning on how a state’s intent in passing a statute (or allowing a common-law tort, for that matter) can be “characterized.” 467 F.3d at 94. As we discussed above, the Court in Buckman looked instead to the practical effects of allowing fraud-on-the-FDA causes of action to proliferate. To us anyway (we’re defense lawyers, after all, and proud of it), it seems like the Second Circuit applied its presumption in direct defiance of the Supreme Court. We hope that the Justices see things the same way.
Indeed, with the presumption against preemption on the table, we can allow ourselves to hope that the Court will also consider whether that presumption should apply at all in conflict case where preemption arises, not by virtue of statutory interpretation, but rather by direct operation of the Supremacy Clause. We’re not going to extend what’s rapidly becoming another of our overly long posts by getting up on that soapbox again. Rather, any reader who wants a detailed discussion of the paucity of Supreme Court precedent for applying the presumption against preemption in conflict preemption can read our inaugural post, here.
We’d also invite the Court to consider the effect of fraud on the FDA claims in the context of those state statutes that use it as an exception to a prohibition against punitive damages where the drug or medical device complies with FDA warnings, design requirements, etc. Punitive damages in a number of ways are even scarier than the compensatory claim at issue in Buckman. Punitive damages can be several times the amount of compensatory damages in a given case. Their only purpose is to punish and deter. Not only that, most jurisdictions prohibit insurance from covering punitive damages. For these reasons, all of the adverse incentives that the Buckman court cited in support of preemption are even more strongly present where claims of fraud on the FDA serve as the only avenue by which a manufacturer can be exposed to punitive damages.
Finally, for reasons we have yet to fathom, Desiano chose to drop a footnote that cast aspersions on the FDA’s 2006 Final Rule endorsing preemption. 467 F.3d at 97 n.9. The Second Circuit apparently received no briefing on that subject, id. (the Final Rule was adopted “[s]ince we heard oral argument in this case”), so that footnote was really a stretch. (For you laypeople, federal courts are not permitted to issue advisory opinions, but can only decide issues properly put before them by the parties). Be that as it may, the footnote exists. Interestingly, Desiano tied its skeptical view of administrative deference expressly to its position that “a presumption against federal preemption does apply.” Id. Perhaps the Supreme Court might view this this footnote as an engraved invite to say something nice about the Final Rule in connection with a favorable ruling overturning the Second Circuit’s expansive view of the presumption against preemption. Ordinarily, we’d expect the Supreme Court to stick to fraud on the FDA, but given that Desiano chose to reach out in this fashion..., well, we’re allowed to hope. Thus, we will be looking with interest at the upcoming briefs of the parties and their amici to see what they might be saying about the Final Rule.
Roger Parloff, of Fortune magazine, just posted this piece on the Fortune Legal Pad about the possible effect on the Vioxx litigation of a Supreme Court decision in Warner-Lambert v. Kent.
The post mentions our reaction to the case and links to your humble blog.
(We better be careful. If we keep getting publicity like this, we may not be so humble any more.)
Do something noble?
Think a brilliant thought?
Win a big case?
That's much too hard.
We did it the easy way: Moving.
Crain's Chicago Business Online profiled Herrmann this morning as a result of his recent move to Chicago. But, as part of the research for the article, Crain's contacted Beck for the inside scoop about his mobile sidekick.
Beck came through, concealing the warts and saying only nice stuff. Way to go Bexis! Your co-host will reciprocate some day. Here's a link.
Wednesday, September 26, 2007
The first problem is where to start. Because, as we’ve discussed recently, express medical device preemption is different from (and somewhat more established than) the kind of preemption available to prescription drug manufacturers, the January 2006 FDA Final Rule isn’t the kind of watershed event for medical device preemption cases that it is for our prescription drug defense.
We’re going to be practical and not go back to Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which was the last true watershed event for device preemption. (Back when Beck and Herrmann were toiling in the Bone Screw fields together, they collected every device preemption decision known to man. The original list appears in the footnotes of Mark Herrmann & Geoffrey J. Ritts, "Preemption and Medical Devices: A Response to Adler and Mann," 51 Food & Drug L.J. 1 (1996). Bexis’ book [we've decided that it's "Beck and Herrmann" in the aggregate, but "Bexis" in the singular] again gathers the pre-Lohr device preemption cases, along with the post-Lohr cases through late 2006.) So, in this post, we’ve decided to go back only as far as the beginning of 2007.
So here’s our 2007 scorecard on medical device preemption although there are a couple of earlier cases that even Bexis didn’t know about until recently:
- Teplitsky v. Gershman, 2005 WL 4926167 (Cal. Super. Nov. 4, 2005), finding broad preemption with respect to a Class III pre-market approved (“PMA”) device (“CoreTherm”) used to treat benign prostrate growths. To our knowledge, Teplitsky was never appealed.
- Weston v. Kim’s Dollar Store, 2006 WL 4911566 (S.C. C.P. Nov. 28, 2006), finding broad preemption with respect to a Class III pre-market supplement approved device (non-corrective contact lenses). Since a distributor was sued on an independent basis, this does not appear to be an appealable final judgment.
- Dreyfus v. Advanced Medical Optics, Inc., 2007 WL 148437 (E.D. La. Jan. 12, 2007), finding “likely” broad preemption with respect to a Class III pre-market approved (“PMA”) device (implantable ocular lens), with “only the claim of manufacturing defect viable” after preemption. Id. at *1. This is not a final judgment, as the manufacturing defect claim escaped summary judgment on non-preemption related grounds.
- Tuttle v. CIBA Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007), finding preemption specifically with respect to a warning defect claim involving a 510k-cleared device (contact lens disinfectant). After Lohr, 510k preemption is rare, but the court found preemption because the FDA had issued something device specific - “a comprehensive Guidance Document which governs the form, content and requirements for [that device’s] labels.” Id. at *2. It’s a final judgment, but there are alternative causation grounds for summary judgment. The Westlaw docket does not indicate an appeal, but doesn’t appear to be complete.
- Alfred v. Mentor Corp., 2007 WL 708631 (W.D. Ky. Mar. 5, 2007), finding broad preemption with respect to a Class III pre-market approved (“PMA”) device (breast implants). Claims for manufacturing defect, non-FDA-related fraud, and the Kentucky Consumer Fraud Act excaped preemption, although it does not appear that the defendant claimed preemption against the consumer fraud claim. All the unpreempted claims failed for other reasons, so this is a final judgment. We are not aware of any appeal, and it may not have been, given that the plaintiff’s expert was excluded in a prior ruling.
- Mattingly v. Medtronic Inc., 486 F. Supp.2d 964 (E.D. Mo. 2007), finding broad preemption with respect to a Class III PMA device (an implantable cardiac defibrillator) against a claim that it short circuited. The court allowed plaintiff to pursue an unpreempted claim of failure to comply with unspecified FDA regulations. As it stands, there is no final order, and thus no appeal.
- Rattay v. Medtronic, Inc., 482 F. Supp.2d 746 (N.D.W. Va. 2007), finding relatively broad preemption with respect to a Class III PMA supplement device (a catheter). A claim for implied warranty escaped preemption. Rattay is the first post-Lohr PMA preemption case in the Fourth Circuit. There is no final order, and thus no appeal.
- Brown v. DePuy Spine, Inc., 22 Mass. L. Rptr. 425, 2007 WL 1089337 (Mass. Super. Apr. 9, 2007), finding no preemption with respect to an investigational (“IDE”) device (an artificial spinal disc), against a plaintiff who was a participant in a clinical trial. The plaintiff did not, however, bring traditional product liability claims, which the court indicated would have been preempted. Id. at *11. Instead, he “advance[d] claims based on. . .alleged departures from the standards set forth in the. . .IDE and PMA application.” Id. Those claims were held to be unpreempted violation claims. Also as to these claims, the court rejected an implied preemption claim based upon Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
- Thornburg v. Stryker Corp., 2007 WL 1742172 (Mag. S.D. Ind. June 12, 2007), adopted, 2007 WL 1959117 (S.D. Ind. July 3, 2007), finding broad preemption with respect to a Class III PMA device (hip prosthesis). Plaintiff did not assert a noncompliance claim. This is a final judgment, and we don’t know if there’s been an appeal.
- In re Guidant Corp. Implantable Defibrillators Products Liability Litigation (Duron), 2007 WL 1725289 (D. Minn. June 12, 2007), finding no preemption with respect to a recalled Class III PMA supplement device (an implantable cardiac defibrillator) that had an increased risk of failure, but which was explanted before any failure. The court construed most of the plaintiff’s claims as unpreempted non-compliance claims, and also held that implied warranty claims were not preempted. Finally, the court rejected an implied preemption claim based upon Buckman. We suspect this case is part of the recent Guidant settlement.
- Von Essen v. C.R. Bard, Inc., 2007 WL 2086483 (D.N.J. June 18, 2007), is not really a preemption case, but involves “complete preemption” as a basis for “arising under” federal question jurisdiction (for any non-lawyers who are unaccountably still reading this, that’s a reason why the case could be heard by a federal, rather than a state, judge). In reaching its jurisdictional decision, the court took a narrow view of preemption under Buckman.
- Carson v. Depuy Spine, Inc., 2007 WL 1839324 (C.D. Cal. June 21, 2007), finding broad preemption with respect to a Class III PMA device (an artificial spinal disc). Plaintiffs did not assert a noncompliance claim. This was not a final judgment, there have been further developments post-Riegel. See our post-Riegel scorecard.
- Blunt v. Medtronic, Inc., 738 N.W.2d 143 (Wis. App. 2007), finding broad preemption with respect to a Class III PMA device (implantable cardiac defibrillator). We've blogged on this case before. There was a dissent, and we've been informed that the case is on appeal to the Wisconsin Supreme Court.
- Notmeyer v. Stryker Corp., 502 F. Supp. 2d 1051 (N.D. Cal. 2007), declining to find broad preemption with respect to a Class III PMA supplement device (hip prosthesis). It’s the first case in a while to following the post-Lohr minority view (Goodlin) that the PMA process is insufficiently “device specific” to be preemptive. Id. at *5-6. This is obviously not a final order, and after a petition for interlocutory appeal was denied the case settled.
- Cottengim v. Mentor Corp., 2007 WL 2782885 (E.D. Ky. Sep. 24, 2007), finding broad preemption with respect to a Class III PMA device (breast implant). Plaintifffs did not pursue a noncompliance claim. This is a final judgment, it might be on appeal, but there are non-preemption issues, such as exclusion of the plaintiff's expert, involved in the case.
- Herbert v. Mentor Corp., 2007 WL 2893387 (D.N.J. Sep. 28, 2007), finding broad preemption with respect to a Class III PMA device (breast implant). Plaintifffs did not pursue a noncompliance claim. This is a final judgment. An express warranty claim would not be preempted, but plaintiffs did not plead such a claim, and any amendment would be futile.
- Wawrzynek v. Statprobe, Inc., 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007), finding no preemption of a fraud on the FDA claim with respect to contract research organization, where the FDA had successfully prosecuted the manufacturer (which settled a separate suit in this case) for fraud in connection with the study that the CRO carried out. The product was a Class III PMA device (ADCON-L) used to prevent formation of scar tissue after spinal surgery.
- Ehrhart v. Synthes (USA), 2007 WL 4591276 (D.N.J. Dec 28, 2007), finding no preemption of a possible fraud on the FDA claim with respect to a medical device (radial plates). The class is not stated, but is probably Class II. The court refused to find preemption on a motion to dismiss.
- Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039; 70 Cal. Rptr. 3d 566 (Cal. App. 4th Dist. 2008), finding broad preemption with respect to a Class III PMA device (heart valve). Plaintifffs did not pursue a noncompliance claim. The case is subject to further appellate review. An implied warranty claim was barred on state-law grounds (privity) and preemption not reached as to that claim. Further appeal is possible.
- Mathis v. E.I. DuPont de Nemours & Co,, C.A. No. 06-0825 (W.D. La. Jan. 16, 2008), finding broad preemption with respect to a "transitional device" (injectable vocal cord paste) that was approved as a drug by the FDA prior to 1976 and deemed to be a Class III PMA device following enactment of the Medical Device Amendments. This is a final judgment subject to appeal.
- Jessen v. Mentor Corp., 2008 WL 142824 (Cal. App. Jan. 16, 2008), finding broad preemption with respect to a class III PMA supplement device (testicular prosthesis). There was no proof of noncompliance. Further appeal is possible.
- Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 324356 (Ark. Feb. 7, 2008), finding no preemption with respect to a class III PMA device (implantable hearing aid), following minority Goodlin reasoning. After Riegel, a motion to reconsider was granted, the decision was reversed, and preemption was affirmed. Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 1067202 (Ark. April 10, 2008).
- Riegel v. Medtronic, Inc., ___ S. Ct. ___, 2008 WL 440744 (U.S. Feb. 20, 2008), providing definitive answer - there is broad preemption with respect to class III PMA devices (in this case a balloon catheter). Strict liability, negligence, and warranty actions that challenge the safety or effectiveness of a PMA device are preempted. A noncompliance claim was dismissed in the lower courts on state-law grounds and was not before the court.
Tuesday, September 25, 2007
In a word, yes.
The Michigan law involved in Kent essentially bars product liability claims against manufacturers of prescription drugs -- unless a manufacturer defrauded the FDA. If the fraud-on-the-FDA exception is preempted, there can be no liability.
But Michigan is not alone.
Under Texas law, the warnings on presccription drugs are presumptively adequate, unless a manufacturer defrauded the FDA. If the fraud-on-the FDA exception is preempted, there can be no failure-to-warn claims.
And six states -- Arizona, New Jersey, North Dakota, Ohio, Oregon, and Utah -- bar claims for punitive damages, unless a manufacturer defrauded the FDA. If the fraud-on-the-FDA exceptions are preempted, there can be no punitive damages.
We've already discussed these statutes in more detail here.
Yes, now that you ask: We'll be watching this very closely.
The case comes out of the Second Circuit. In very general terms, Michigan state law protects drug manufacturers from liability in products cases unless the manufacturer defrauded the Food and Drug Administration. The question is whether Buckman preemption invalidates the fraud-on-the-FDA exception, leaving intact only the bar on liability.
In the Supreme Court, the case is called Warner-Lambert v. Kent (06-1498) . Here's the docket showing the grant of cert, the cert petition itself, the brief in opposition, and the reply brief.
Much more to come, obviously.
(We're luddites, too, and almost equally proud of that.)
As a result of having written The Curmudgeon's Guide to Practicing Law, however, Herrmann is now occasionaly asked to comment on things other than defending complex litigation -- such as, for example, legal writing.
But here's a new one. Many readers of this blog surely know about UC-Irvine's recent hiring, firing, and re-hiring of liberal legal scholar Erwin Chemerinsky to serve as dean of a new law school. The folks at the widely-read TaxProf Blog have asked a collection of folks who think about legal education to propose ideas to Dean Chemerinsky about how best to reform legal education. Since Herrmann wrote Curmudgeon, he was asked to contribute his 250 words of advice to the new dean.
Here's a link.
(Don't worry. Our next post will return to drug and device law.)
Over time, however, we've received a fair number of visits from the press. And several reporters have now asked us about the difference between the preemption defense in the context of drugs and devices. Why, reporters ask, are we talking about Riegel v. Medtronic as being a "device" preemption case that's in the Supreme Court, and Colacicco v. Apotex as a "drug" preemption case that's in the Third Circuit? When the Supreme Court decides Riegel, won't that resolve the whole enchilada, for both drug and device companies, at once?
In a word, no.
This post explains why.
Our regular readers, who know the difference between drug and device preemption in their sleep, should skip this post and come back in a couple of days. For everyone else, here's the story.
When there's federal law on a subject, it trumps state law on the same subject. Federal law is "supreme."
Why? Because the "Supremacy Clause" of the United States Constitution says so: "This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land . . . ." U.S. Const., Art. VI, cl. 2. The Supremacy Clause has been interpreted to mean that federal law trumps state law when (1) Congress expressly preempts state regulation; (2) Congress intends federal law to occupy the field; or (3) state law conflicts with federal law. Crosby v. National Foreign Trade Council, 530 U.S. 363, 372 (2000). For obvious reasons, the first category is generally known as "express" preemption; the second as "field" preemption; and the third as "conflict" preemption.
For medical devices, there's a law that expressly says that the FDA's regulation of medical devices displaces state law. Thus, for medical devices, the spat is about "express" preemption. The relevant statute, 21 U.S.C. § 360k(a), provides:
§ 360k. State and local requirements respecting devicesThat language leaves an awful lot for lawyers to quibble about. What does "different from, or in addition to" mean? What are "requirements"? What is "other matter included in a requirement"? And so on. But state laws -- such as jury verdicts -- that impose requirements different from, or in addition to, those imposed by the FDA are void. Thus, a jury verdict cannot compel a device manufacturer to give a warning that federal law does not require (or prohibits). For medical devices, that's the battle.
(a) General rule
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
For drugs, the legal sandbox is different.
Unlike the law governing medical devices, there is no statute that expressly says that FDA regulations displace state law. Thus, in the drug field, there's no issue about "express" preemption or quibbling about the meaning of words in a federal statute. The second type of preemption -- "field" preemption --- is a notoriously narrow doctrine, which applies to very few areas of law; pharmaceuticals is not one of them. So, for drugs, the battle ground is "conflict" preemption.
Conflict preemption occurs "where it is impossible for a private party to comply with both the state and federal law" or when "‘under the circumstances of [a] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’" Crosby v. National Foreign Trade Council, 530 U.S. 363, 372-73 (2000) (citation omitted); see also Geier v. American Honda Motor Co., 529 U.S. 861, 873 (2000).
Preemption is not limited to displacing state statutes. State-law tort obligations -- such as liability imposed by juries in product liability cases -- may be preempted when they are founded upon duties that conflict with federal law. See, e.g., Geier, 529 U.S. at 882 (state-law tort obligation to install automobile airbags preempted); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992) (state-law tort obligation to warn of health risks of cigarette smoking preempted). And it does not require a federal law (passed by Congress) to displace state law. Federal regulations, such as those enacted by the FDA, "have no less pre-emptive effect than federal statutes." Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982).
When drug companies raise the preemption defense, they are saying that FDA regulations compel the manufacturer to do certain things -- give certain warnings, manufacture a drug a certain way, and so on -- and juries cannot require the manufacturer to act differently. If juries required manufacturers to act in ways that federal law forbids, then it would be "impossible for [the manufacturer] to comply with both the state and federal law" -- the definition of "conflict" preemption.
In short, for medical devices, the question is "express" preemption: Does the governing federal statute displace state law?
But, for drugs, the question is "conflict" preemption: Could a jury verdict require a drug manufacturer to do something that federal law forbids?
Frankly, the more we're typing, the crazier this regulatory scheme seems. But don't blame us. Congress passed these laws; we just live with 'em.
We hope this explanation helps.
Sunday, September 23, 2007
Folks keep asking us for the drug preemption scorecard: Since the FDA promulgated its "Preemption Preamble" in January 2006, how many decisions have accepted the preemption defense, and how many have courts rejected it?
It's not quite that easy. There are cases that squarely accept the defense; cases that reject it; cases that say the defense may be available, but doesn't apply on the facts before it; cases that address vaccine preemption, which is a different, but sometimes related, issue; and cases that apply preemption in ways that may or may not affect drug cases. (And then there's medical device preemption. We view that as an entirely separate ball of wax. We'll have more to say about that shortly.)
In the meantime, here's the list of cases -- originally through Friday, September 21, 2007, but we now update it whenever we learn of more cases -- that appear on our drug preemption scorecard. But don't ask for a precise win/loss tally in the drug preemption wars. The issue has become slightly more complicated than that.
- Zammit v. Shire US, Inc., 415 F. Supp. 2d 760 (E.D. Mich. 2006), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Adderall/heart attack case. No mention of FDA preemption preamble. We do not believe this case was appealed.
- Militrano v. Lederle Laboratories, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006), app. denied, 857 N.E.2d 1137 (N.Y. 2006), finding express preemption in Tetramune/neurological injuries case under Vaccine Act while affirming pre-preemption-preamble preemption decision (769 N.Y.S.2d 839 (N.Y. Sup. 2003)). No mention of FDA preemption preamble.
- Abramowitz v. Cephalon, Inc., 2006 WL 560639 (N.J. Super. Law Div. March 3, 2006), finding implied conflict preemption and relying on FDA preemption preamble in Actiq/tooth decay case. We believe this case settled.
- Peters v. Astrazeneca, LP, 417 F. Supp.2d 1051 (W.D. Wis. 2006), rejecting field and implied conflict preemption in omeprazole/loss of taste case. No mention of FDA preemption preamble. The defendant won the case on other grounds and the preemption ruling was not appealed.
- Laisure-Radke v. Par Pharmaceutical, Inc., 2006 WL 901657 (W.D. Wash. March 29, 2006), reconsid. denied (May 3, 2006), rejecting implied conflict preemption and mentioning (but not discussing) FDA preemption preamble in fluoxetine (generic Prozac)/suicide case. The defendant won the case on other grounds and the preemption ruling was not appealed.
- In re Diet Drugs Products Liabilty Litigation (Mingus), 2006 WL 1071545 (E.D. Pa. Apr. 21, 2006), rejecting implied conflict preemption under Buckman against exclusively non-warning claims in diet drug/primary pulmonary hypertension case. No mention of FDA preemption preamble. There was no final order to appeal.
- Coutu v. Tracy, 2006 WL 1314261 (R.I. Super. May 11, 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Propofol/liver-kidney failure case. There was no final judgment to appeal.
- Gourdine v. Crews, 2006 WL 5277412 (Md. Cir. June 28, 2006), finding implied conflict preemption and relying on FDA preemption preamble in insulin/hypoglycemia case. The order was appealable and affirmed on other grounds (no duty, the plaintiff was not the drug user), 935 A.2d 1146 (Md. App. 2007). The Maryland Court of Appeals (Maryland's highest court affirmed dismissal on non-preemption grounds, 955 A.2d 769 (Md. Sept. 4, 2008).
- Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006), finding implied conflict preemption and relying on FDA preemption preamble in paroxetine (generic Paxil)/suicide case. The FDA filed amicus briefs supporting preemption in this case. Colacicco has extensive appellate history (see below), with the decision ultimately vacated and remanded.
- Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zoloft-Effexor/suicide case. There was no final judgment to appeal, and the case has settled.
- In re Bextra & Celebrex Marketing Sales Practices & Products Liability Litigation, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006), finding implied conflict preemption of failure to warn, but not false advertising, claims and relying on FDA preemption preamble in Bextra-Celebrex/cardiovascular risk MDL. There was no final judgment to appeal.
- Ackermann v. Wyeth Pharmaceuticals, 2006 WL 2591078 (Mag. E.D. Tex. Sept. 6, 2006), finding implied conflict preemption of failure to warn claims and relying on FDA preemption preamble in Effexor/suicide case. Opinion was withdrawn as moot in light of order granting complete summary judgment on other grounds, 2006 WL 3780913 (E.D. Tex. Dec. 20, 2006). The Fifth Circuit affirmed dismissal without reaching preemption. Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008).
- Conte v. Wyeth, Inc., 2006 WL 2692469 (Cal. Super. Sept. 14, 2006), and 2006 WL 3939262 (Cal. Super. Sept. 14, 2006), finding implied conflict preemption and relying on FDA preemption preamble in Metoclopramide/gastroesophageal reflux case). Affirmed in part and reversed on other (non-preemption) grounds, Conte v. Wyeth, Inc., 168 Cal. App.4th 89 (Cal. App. Nov. 7, 2008).
- McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zoloft/suicide case while denying reconsideration of, but certifying for interlocutory appeal, a pre-preemption-preamble preemption decision (2005 WL 3752269 (D.N.J. Dec. 29, 2005)). McNellis has extensive appellate history (see below, under Colacicco), with the decision ultimately vacated and remanded.
- Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (as amended Jan. 18, 2007) (2d Cir. Jan. 18, 2007), affirmed without opinion by equally divided court sub nom. Warner-Lambert Co. v. Kent, 128 S.Ct. 1168 (2008), reversing district court and rejecting implied conflict preemption of “fraud on the FDA” exception to state tort reform statute and rejecting FDA preemption preamble in Rezulin/diabetes case.
- Perry v. Novartis Pharmaceutical Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006), rejecting implied conflict preemption and distinguishing FDA preemption preamble in Elidel/lymphoma case. The FDA filed an amicus brief taking no position on preemption in this case. There was no final judgment to appeal. The defendant won the case on non-preemption grounds, Perry v. Novartis Pharmaceutical Corp., 564 F. Supp.2d 452 (E.D. Pa. July 9, 2008), and plaintiff did not appeal.
- Levine v. Wyeth, 944 A.2d 179 (Vt. Oct. 27, 2006) (affirming pre-preemption-preamble no preemption ruling, 2003 WL 25648135 (Vt. Super. Dec. 23, 2003)), cert. granted, No. 06-1249 (U.S. Jan. 18, 2008) (argued Nov. 3, 2008), rejecting implied conflict preemption and rejecting FDA preemption preamble in Phenergan/IV push case. Levine was affirmed by the Supreme Court, 129 S. Ct. 1187 (see last entry of this scorecard).
- Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp.2d 666 (E.D. Ky. 2006), rejecting implied conflict preemption, but relying on FDA preemption preamble in Elidel/lymphoma case. There was no final judgment to appeal.
- Brockert v. Wyeth Pharmaceuticals, 2007 WL 2077554 (Tex. Dist. Jan. 31, 2007), finding implied conflict preemption in Prempro/heart attack case). No mention of the FDA preemption preamble. Subsequent, post-Levine history is discussed in our new scorecard.
- In re Aredia & Zometa Products Liability Litigation, 2007 WL 649266 (M.D. Tenn. Feb. 27, 2007), rejecting "complete preemption," but suggesting that "ordinary" implied conflict preemption might apply and relying on FDA preemption preamble in Aredia-Zomenta/osteonecrosis case. Unappealable remand order.
- Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007), finding express preemption of design and warning claims, but not testing claims under Vaccine Act, and relying on FDA preemption preamble in Thimerosal/neurological injuries case. There was no final judgment to appeal. The remainder of the case was transferred to the Eastern District of Virgina (see separate entry).
- Kelly v. Wyeth, 2007 WL 1302589 (Mass. Super. April 12, 2007), cross-motions for reconsideration denied, 2007 WL 3407466 (Mass. Super. Oct. 23, 2007), rejecting implied conflict preemption and rejecting/distinguishing FDA preemption preamble in Reglan/generic metoclopramide/akathisia case. There was no final judgment to appeal.
- Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 U.S. Dist. Lexis 44718 (D. Ala. April 24, 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in cephalexin (generic Keflex)/Stevens-Johnson-Syndrome case. There was no final judgment to appeal.
- Ledbetter v. Merck & Co., 2007 WL 1181991 (Tex. Dist. April 20, 2007), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Vioxx/heart attack case. No mention of the FDA preemption preamble. The appeal has been dismissed at the plaintiff's request. See Ledbetter v. Merck & Co., 2008 WL 2066580 (Tex. App. May 15, 2008) (unpublished).
- Prohias v. Pfizer, Inc., 490 F. Supp.2d 1228 (S.D. Fla. 2007), finding implied conflict preemption of claims after July, 2004, but not before, and relying upon FDA preemption preamble in Lipitor/false advertising case. There was no final judgment to appeal.
- In re Zyprexa Products Liability Litigation, 489 F. Supp.2d 230 (E.D.N.Y. 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zyprexa/side effects (weight gain, hyperglycemia, and diabetes) MDL. There was no final judgment to appeal.
- Prohias v. AstraZeneca Pharmacerticals, L.P., 958 So.2d 1054 (Fla. App. 2007) (affirming, 2006 WL 4634292 (Fla. Cir. Oct. 2006)), finding implied conflict preemption in Nexium/false advertising case. A further appeal was denied by the Florida Supreme Court, 969 So.2d 1014.
- Giles v. Wyeth, Inc., 500 F. Supp.2d 1063 (S.D. Ill. 2007), rejecting implied conflict preemption in Effexor/suicide case. No mention of the FDA preemption preamble. The defendant won the case on other grounds and the preemption ruling was not appealed.
- Deutsch v. Wyeth, Inc., 2007 WL 2060072 (N.J. Super. Law Div. June 22, 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Prempro/breast cancer case. There was no final judgment to appeal.
- In re Vioxx Products Liability Litigation, 501 F. Supp.2d 776 (E.D. La. 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Vioxx/heart attack MDL. There was no final judgment to appeal, and the MDL has largely settled.
- In re Baycol Products Liability Litigation, 495 F. Supp.2d 977 (D. Minn. 2007), applying implied conflict preemption to exclude expert testimony offered to support allegations of “fraud on the FDA” in Baycol/muscle-kidney damage MDL. No mention of FDA preemption preamble. There was no final judgment to appeal.
- Price v. Cook, 2007 WL 2154766 (W. Va. Cir. July 9, 2007), finding implied conflict preemption and relying on prior FDA amicus briefs (but not mentioning FDA preemption preamble) in Zoloft/suicide attempt case. We believe this case has settled.
- Sarli v. Mylan Bertek Pharmaceuticals, Inc., 2007 WL 2111577 (M.D.N.C. July 19, 2007), rejecting implied conflict preemption but relying on FDA preemption preamble in Amnesteem/unspecified personal injury case. There was no final judgment to appeal, and the case has settled.
- Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 499 F.3d 239 (3d Cir. 2007), affirming district finding of implied conflict preemption in Nexium/false advertising case. No mention of FDA preemption preamble. A motion for panel rehearing and rehearing en banc was denied on September 19, 2007. After Wyeth v. Levine, the Supreme Court vacated the Third Circuit's opinion and remanded the case. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 129 S. Ct. 1578 (March 9, 2009). On May 5, 2009, the Third Circuit remanded the case to the District of Delaware.
- Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430 (E.D. Pa. 2007), finding express preemption under Vaccine Act in Tri-Immunol DPT vaccine/seizure-developmental delay case. No mention of FDA preemption preamble. There is a final judgment. The Third Circuit affirmed, 2009 WL 792468, see entry in our New Drug and Vaccine Preemption Scorecard.
- Strong v. American Cyanamid Co., 261 S.W.3d 493 (Mo. App. E.D. Aug. 28, 2007), rejecting express or implied conflict preemption in Orimune vaccine/polio case. No mention of FDA preemption preamble. Review ("transfer") was first rejected, then acceptef, and then rejected again by the Missouri Supreme Court, with the end result that the appellate decision was reinstated on Oct. 6, 2008.
- Dunson v. McNeil-PPC, Inc., 2007 WL 3052315 (Pa. C.P. Sept. 12, 2007), finding no implied conflict preemption and distinguishing FDA preemption preamble in over-the-counter Infant Tylernol/liver failure-death case. On appeal, j.n.o.v. was entered against plaintiffs on non-preemption grounds. Dunson v. McNeil-PPC, Inc., 2009 WL 1178651 (Pa. Super. April 24, 2009). Further appeal is possible.
- In re Seroquel Products Liability Litigation, 2007 WL 4117201 (M.D. Fla. Nov. 6, 2007), denying without prejudice implied conflict preemption motion for judgment on the pleadings until after discovery in Seroquel/diabetes cases. Merits not reached.
- [Intentionally omitted (Nov. 19, 2007). Another adverse, unpublished case. A federal trial court, in a one-page, three-sentence order, rejects a conflict preemption argument raised by a generic drug manufacturer. This one is too short to ever make the reporters, but we note here that it exists.]
- [Intentionally omitted (Nov. 29, 2007). This is another unpublished case that the reporters have not yet picked up, and we're not here to spread the word. A federal trial court rejected both an implied conflict preemption and a fraud-on-the-FDA statutory exception preemption argument raised by a generic drug manufacturer. If we see this reported somewhere, we'll provide the cite. Until then, just be aware that it exists.]
- Dobbs v. Wyeth Pharmaceuticals, 530 F. Supp.2d 1275 (W.D. Okla. 2008), finding implied conflict preemption and relying on FDA preemption preamble in Effexor/suicide case. While this is a partial summary ruling, a Rule 54(c) appeal has been taken. Post-Levine, the Tenth Circuit vacated and remanded, as discussed in our new scorecard.
O'Neal v. SmithKline Beecham Corp., 551 F. Supp.2d 993 (E.D. Cal. Jan. 30, 2008), finding implied conflict preemption in Paxil/pediatric suicide case. Summary judgment is granted against all claims, therefore the order is appealable. Reconsideration was denied. 2008 WL 1721891. The case has setttled.
- Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208 (E.D. Va. Feb. 12, 2008), finding implied conflict preemption of failure to warn claims and impliedly (the court does not use the word "preemption," but that's what the argument is) finding implied preemption of design defect claims in immune globulin case. The order denied a motion to amend and is not final judgment. No appeal was taken from entry of final judgment. This case is related to Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007), which is also on this list.
- Miller v. SmithKline Beecham Corp., 2008 WL 510449 (N.D. Okla. Feb. 15, 2008), finding implied conflict preemption in Paxil/suicide case. Summary judgment is granted against all claims. Post-Levine, the Tenth Circuit vacated and remanded, as discussed in our new scorecard.
- Longs v. Wyeth, 536 F.Supp. 2d 843 (N.D. Ohio Feb. 28, 2008), finding implied conflict preemption of some claims, those alleging that the drug should never have been approved or that no warning could be adequate, as well as fraud on the FDA, in a Redux/primary pulmonary hypertension case. Summary judgment was granded against all remaining claims on other grounds, therefore the order is appealable. Subsequent, post-Levine history is discussed in our new scorecard.
- White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023 (W.D. Mich. March 6, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in a Paxil pediatric suicide case. The case has settled.
- Collins v. Smithkline Beecham Corp., 2008 WL 744070 (Pa. C.P. March 11, 2008), finding no implied conflict preemption in Paxil/suicide case, refusing to judicially notice FDA final rule. There is no appealable order.
- Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768 (W.D.N.C. March 25, 2008), finding implied conflict preemption of some claims, including all warning-related claims, as well as fraud on the FDA, and relying on FDA preemption preamble in a Lotensin birth defect case. The order is not appealable. The case has been dismissed with prejudice.
- In re Aredia & Zometa Products Liability Litigation, 2008 WL 913087 (M.D. Tenn. Apr. 2, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Aredia/Zomenta MDL litigation. An appeal is pending in the Sixth Circuit (No. 08-5573, and others).
- Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008), finding broad implied conflict preemption and giving some deference to the FDA preemption preamble in two consolidated SSRI suicide cases (one, Colacicco, involving paroxetine (generic Paxil), and the other, McNellis, involving Zoloft. The FDA filed amicus briefs supporting preemption in this case. Rehearing has been denied. After Wyeth v. Levine, the Supreme Court vacated the Colacicco opinion and remanded the case to the Third Circuit. Colacicco v. Apotex, Inc., 129 S. Ct. 1578 (March 9, 2009). On April 22, 2009, the Third Circuit remanded both cases (Colacicco and McNellis) to the respective District Courts.
- Mason v. Smithkline Beecham Corp., 546 F. Supp.2d 618 (C.D. Ill. April 23, 2008), finding implied conflict preemption and relying on FDA preemption preamble in Paxil/suicide case. The Seventh Circuit reversed after Levine, as discussed in our new scorecard.
- McDarby v. Merck & Co., 949 A.2d 223 (N.J. Super. A.D. May 29, 2008), finding no implied conflict preemption in Vioxx/heart attack case; rejecting reliance on FDA preemption preamble; finding implied conflict preemption of “fraud on the FDA” exception for punitive damages in state tort reform statute. On May 7, 2009, the New Jersey Supreme Court dismissed an a pending appeal as improvidently granted. No. 62,856.
- Gaeta v. Perrigo Pharmaceuticals, Inc., 562 F. Supp.2d 1091 (N.D. Cal. June 13, 2008), finding preemption in the context of an over-the-counter, generic drug, and giving Chevron deference to the Preemption Preamble. The order is final, but there will be no appeal.
- Mensing v. Wyeth et al., 562 F. Supp.2d 1056 (D. Minn. June 17, 2008), finding conflict preemption of failure to warn claims in generic Reglan case. The Eighth Circuit reversed after Levine, as discussed in our new scorecard.
- Tucker v. SmithKline Beecham Corp., 596 F. Supp.2d 1225 (S.D. Ind. July 18, 2008) (S.D. Ind. Sept. 19, 2007), finding no implied conflict preemption and declining to rely on the FDA preemption preamble in a Paxil/suicide case. This is a reconsideration of an earlier opinion, at 2007 WL 2726259, that had recognized preemption. A second motion for reconsideration, or for interlocutory appeal, is pending.
- In re Celexa & Lexapro Products Liability Litigation, 2008 WL 2906713 (E.D. Mo. July 24, 2008), postponing decision of a motion seeking implied conflict preemption in generic SSRI/suicide case due to pendency of Levine. Obviously, there is no appealable order.
- In re Aredia & Zometa Products Liability Litigation, 2008 WL 2944910 (M.D. Tenn. July 25, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in several Aredia/Zometa cancer cases. No mention of the FDA preemption preamble. These orders were not appealed.
- In re Fosamax Products Liability Litigation, 2008 WL 2940560 (S.D.N.Y. July 29, 2008), finding no "impossibility" of a successful claim by reason of implied conflict preemption in fraudulent joinder context in Fosamax/osteonecrosis. No mention of the FDA preemption preamble. The case was remanded to state court.
- Depriest v. Astrazeneca Pharmaceuticals L.P., 2008 WL 3243562 (Ark. Cir. July 31, 2008), finding conflict preemption of all claims in economic loss consumer fraud claim involving promotion of Nexium. No mention of preamble. This is an appealable order.
- Masterson v. Apotex Corp., 2008 WL 3262690 (S.D. Fla. Aug. 7, 2008), finding conflict preemption of failure to warn claims in generic paxil (birth defects, not suicide) case. Manufacturing defect claims escaped preemption, so the order is not appealable.
- Valerio v. SmithKline Beecham Corp., 2008 WL 3286976 (S.D. Fla. Aug. 7, 2008) (companion case to Masterson -- same product, alleged injury, date of order, judge, holding, and reasoning, but different plaintiff).
- Bolin v. SmithKline Beecham Corp., 2008 WL 3286973 (S.D. Fla. Aug. 7, 2008) (another companion case to Masterson -- same product, alleged injury, date of order, judge, holding, and reasoning, but different plaintiff).
- Wright v. Aventis-Pasteur, Inc., 2008 WL 4144386 (Pa. C.P. Philadelphia Co. Aug. 27, 2008), finding express preemption under Vaccine Act in Thimerosal case against several vaccine manufacturers. No mention of FDA preemption preamble. An appeal (No. 336 EDA 2008) is pending in the Pennsylvania Superior Court.
- Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008), finding no conflict preemption of failure to warn claims in Paxil/teen suicide case. Giving FDA preamble some deference. An interlocutory appeal was granted by the District Court, 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008), but denied by the Third Circuit on December 30, 2008 (No. 08-8060).
- McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr. 3d 810 (Cal. App. 5th Dist. Sept. 25, 2008), finding no conflict preemption of failure to warn claims in generic Reglan (metoclopramide) tardive dyskinesia case, mentioning but neither following nor rejecting FDA preemption preamble. The California Supreme Court denied review on Jan. 14, 2009.
- Mills v. Warner-Lambert Co., 581 F. Supp.2d 772 (E.D. Tex. Sept. 30, 2008), finding express preemption of pure economic loss claims involving monograph (OTC) lice treatments. This is a final judgment, and there has been no appeal.
- American Home Products Corp. v. Ferrari, 668 S.E.2d 236 (Ga. Oct. 6, 2008), affirming intermediate appellate court ruling (650 S.E.2d 585) and rejecting express preemption under Vaccine Act in Thimerosal/neurological injury case. No mention of FDA preemption preamble. There is a certiorari petition (No. 08-1120) pending before the United States Supreme Court.
- Knipe v. SmithKline Beecham Corp., 2008 WL 4442635 (E.D. Pa. Sept. 30, 2008), no preemption of failure to warn claims as disguised fraud-on-the-FDA claims in Paxil/teen suicide case, but finding implied conflict preemption of “fraud on the FDA” exception for punitive damages in state tort reform statute. The preemption Preamble was not mentioned. There is no appealable order. The court has granted an interlocutory appeal concerning a related preemption issue, 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008), but denied by the Third Circuit on December 30, 2008 (No. 08-8060).
- Morris v. Wyeth, Inc., 582 F. Supp.2d 861 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 WL 424590 (W.D. Ky. Feb. 20, 2009), slip op. finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
- Smith v. Wyeth, Inc., 2008 WL 4696995 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 13250 (W.D. Ky. Feb. 20, 2009), finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
- Wilson v. Wyeth, Inc., 2008 WL 4697002 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 13273 (W.D. Ky. Feb. 20, 2009), finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
- Demahy v. Wyeth, Inc., 586 F. Supp.2d 642 (E.D. La. Oct. 27, 2008), finding no conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Fraud on the FDA claims are preempted. Mention preemption preamble only in a footnote, and gives it no deference, refuses to give deference to recent FDA statements regarding generic drugs. The District Court granted leave to take an interlocutory appeal, the Fifth Circuit accepted, and affirmed, as discussed in our new scorecard.
- Grange v. Mylan Laboratories, Inc., 2008 WL 4813311 (D. Utah Oct. 31, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute concerning punitive damages in fentamyl/wrongful death case. No mention of the FDA preemption preamble. There is no appealable order.
- In re Aredia and Zometa Prods. Liab. Litig., MDL No. 1760, 3:06-MD-1760 (M.D. Tenn. Nov. 25, 2008) (order is undated, but we believe it was entered on November 25), following earlier rulings in the Aredia and Zometa MDL and holding, in a two-page order, that the claims of Texas plaintiffs are barred by Tex. Civ. Prac. & Rem. Code Sec. 82.007(a) and, implicitly, that the fraud-on-the-FDA exception to that immunity is preempted under Buckman. "[P]laintiffs have reserved the right to seek appellate review of these rulings when they become appealable."
- Kunnemann v. Janssen Pharmaceutica Products, L.P., 2008 WL 5101116 (N.D. Ill. Dec. 2, 2008), finding no implied conflict preemption in duragesic patch/fentamyl case. Brief discussion is unclear whether drug or device preemption is claimed, we assume drug from the cited cases. No mention of FDA preemption preamble. There is no final order. The case has settled.
- Merck & Co. v. Garza, 277 S.W.3d 430 (Tex. App. Dec. 10, 2008), finding no implied conflict preemption and rejecting FDA preemption preamble in Vioxx/heart attack case. The court vacated the verdict in its entirety on other grounds, and a further appeal the the Texas Supreme Court is pending.
- Kellogg v. Wyeth, No. 07-82, 2008 WL 5272715 (D. Vt. Dec. 17, 2008), finding no conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Distinguishing FDA preemption preamble from generic drug preemption. There is no final order. Subsequent, post-Levine history is discussed in our new scorecard.
- Wyeth v. Levine, 129 S. Ct. 1187 (U.S. Mar. 4, 2009), finding no conflict preemption of failure to warn claims in Phenergan amputation case. Finding FDA preemption preamble entitled to no deference. The litigation is concluded as to preemption.
Friday, September 21, 2007
There's been a flurry of recent motion practice due to the death of the plaintiff - two and a half years ago - and the failure of plaintiff's counsel to file a suggestion of death or to raise and substitute an estate (for you non-lawyers, that's what we have to do in that situation because dead people can't sue) at any time during the intervening period.
The Supreme Court, not one to mess around with this kind of thing, requires substitutions within six months of death - or so we're informed.
We're not making this up. One of the biggest preemption cases (for the industries we defend anyway) could go down the tubes because the plaintiff's lawyer screwed up some relatively routine ministerial function. We hope they paid their malpractice premiums (well, maybe we don't).
Leaving an "i" undotted in this significant a case is so bizarre to us that the conspiracy theorist amongst us is awakened. Might Public Citizen (which is of record for plaintiffs) have decided that they didn't want this case heard by the Court right now? Specifically, might they not want to get a brief on the merits from the Solicitor General along the same lines as the brief that the government submitted on the petition for certiorari?
Maybe yes, maybe no.
If Riegel gets dismissed, then next in line (we thank Rick Samp over at WLF, who commented to the original version of this post, for this information) would be Baker v. St. Jude Medical, 178 S.W.3d 127 (Tex. App. 2005), rev. denied (Tex. Dec. 15 2006), pet. for cert. filed No. 06-1262. According to Rick, the justices are scheduled to review the Baker petition for certiorari at their September 24 conference - so stay tuned. We'd have to say, the profile of the Baker case may go up a bit. That's probably the only case with a chance for Supreme Court review before January 20, 2009, when a different administration will be inaugurated.
Beyond that, given the glacial speed with which the appellate wheels turn in litigation, there's virtually no chance for another case presenting the same issue of medical device preemption to get to the Supreme Court on the merits until after the change in administrations. We're aware of a number of cases where federal district courts recently granted preemption motions (Mattingly, Thornburg, Rattay), but only Thornburg appears to be a final judgment. The case that seems to be farthest along is Troutman v. Curtis, which the last time we looked (which wasn't recently) was pending in the Kansas Supreme Court. Even if that court handed down a decision next week, the timing would be really tough.
Apparently the suggestion of death was out of time before the appeal even got to the Supreme Court. The conspiracy theorists amongst us speculate (that's all it is) that maybe plaintiff's counsel were hoping for a free shot - if they liked the way the briefing was unfolding, keep it a secret, but if they didn't, torpedo the case by letting the (Schroedinger's) cat out of the proverbial bag.
Maybe we're just paranoid, but like we've said before, strange things seem to happen in tort preemption cases.
In any event, the likelihood of a definitive resolution of the preemption issue as it relates to pre-market approved medical devices has suddenly dropped precipitously.
Thursday, September 20, 2007
But today we’re confining ourselves to just one type of FDA-related evidence. It’s the gold standard. We’re talking about when the FDA feels strongly enough about something that it goes through the administrative gauntlet to publish something in the Federal Register. For all those out there who aren’t administrative law geeks, the Federal Register is the official government publication for all major decisions by regulatory agencies, not just the FDA. It comes out daily, and as you might expect runs through more pages each year than any one person could possibly hope to read.
There’s a lot of stuff in there, and some of it can be quite useful to our clients in the cases we have to try. Here’s an example. Compliance with FDA regulations is something we’ve discussed before in the context of presumptions and even adequacy as a matter of law. But more generally, even states that don’t give either conclusive or presumptive effect to our clients’ compliance with what the FDA tells them to do at least let us admit compliance into evidence. After all, doing what the FDA says is at least some evidence that our clients’ products aren’t defective. E.g., Carlin v. Superior Court, 920 P.2d 1347, 1353 (Cal. 1996); MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65, 70-71 (1985); Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867, 879 n.24 (E.D. Mich. 1985).
Thus, if “the trier of fact may assign FDA approval the weight it deserves,” Toner v. Lederle Laboratories, 732 P.2d 297, 311 n.12 (Idaho 1987), then just offering evidence of a client’s compliance isn’t going to be enough. We want to show the jury that compliance is, in fact, a big deal – that it should accord our client’s compliance a lot of “weight.” So we don’t want to stop just the (usually) incomprehensible language of the FDA regulation itself. That’s only the first step. We want to show the jury why the FDA thought the issue was important enough to write the regulation the way it did. That requires some examination, not just of the regulation itself, but of the FDA’s rationale for it.
We could go back in time to our Bone Screw days and draw on some examples there, because we did this a lot back in the day. But rather than offer something stale, let’s demonstrate what we mean with something a little more recent. We hear from plaintiffs’ counsel over and over how we should have added a warning about this, and we should have added a warning about that. “Here a warning, there a warning, everywhere a warning, warning....” We want to explain to the jury that there’s a reason why the FDA doesn’t require a warning about everything under the sun. Actually, we want the FDA to explain it for us. So we look in the Federal Register, and we find that the FDA has discussed this problem – the drawbacks of so-called “overwarning.”
Here’s what the FDA said on that score within the last couple of years.
Exaggeration of risk could discourage appropriate use of a beneficial drug. Liability concerns. . .creat[e]pressure on manufacturers to expand labeling warnings to include speculative risks and, thus, to limit physician appreciation of potentially far more significant contraindications and side effects. . . . [L]abeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance. Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health. . . . [A]dditional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved products or encouraging inappropriate use and undermining the objectives of the [FDCA].71 Fed. Reg. 3922, 3935 (FDA Jan. 24, 2006). We’d like the jury to hear all that, not just from our mouths but from the FDA - a disinterested and authoritative non-party. (Actually, we’d like there to be preemption, but for the purposes of this post, we assume there isn’t any.) So, what’s the quickest and easiest way to get something like this into evidence?
Again, so that non-lawyers aren’t left scratching their heads, “judicial notice” is when something is so definitively known (for any number of reasons) that it doesn’t have to be proven with first-hand testimony of that fact. Judicial notice is usually concerned with facts that aren’t really subject to dispute, such as did a particular date fall on a Tuesday, or is a town being located in a particular county or state. In such situations, it’s a waste of time to require evidence to prove that kind of fact. So the judge “notices” it – conclusively declaring it to be so.
But there are other ways that judicial notice can operate. One of them is by statute. The legislature can mandate judicial notice. That’s what’s happened with the Federal Register. Congress didn’t want people to have to jump through a bunch of hoops just to prove what federal administrative agencies have said. So it passed a law that requires all courts – state and federal – to admit anything that’s published in the Federal Register into evidence, as long as what’s been published passes the usual test of being relevant to what the case is about:
[F]iling of a document, required or authorized to be published [in the Federal Register], except in cases where notice by publication is insufficient in law, is sufficient to give notice of the contents of the document to a person subject to or affected by it. The publication in the Federal Register of a document creates a rebuttable presumption –44 U.S.C. §1507 (emphasis added). The relevant portion of §1507 is short, to the point, mandatory (“shall”) and does not make any exceptions. See Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 35 (1998) (“the mandatory ‘shall’. . .normally creates an obligation impervious to judicial discretion”). What part of “the contents of the Federal Register shall be judicially noticed” is it hard to understand?
(1) that it was duly issued, prescribed, or promulgated;
(2) that it was filed with the Office of the Federal Register and made available for public inspection at the day and hour stated in the printed notation;
(3) that the copy contained in the Federal Register is a true copy of the original; and
(4) that all requirements of this chapter and the regulations prescribed under it relative to the document have been complied with.
The contents of the Federal Register shall be judicially noticed and without prejudice to any other mode of citation, may be cited by volume and page number.
A bunch of courts have thus judicially noticed Federal Register statements under §1507. Here are a few appellate citations. E.g., Getty Petroleum Marketing, Inc. v. Capital Terminal Co., 391 F.3d 312, 325 n.19 (1st Cir. 2004); United States v. Woods, 335 F.3d 993, 1001 (9th Cir. 2003); Denius v. Dunlap, 330 F.3d 919, 926-27 (7th Cir. 2003); Mora v. Vasquez, 199 F.3d 1024, 1028 n.7 (9th Cir. 1999); United States v. Wolny, 133 F.3d 758, 764 (10th Cir. 1998); Powers v. United States, 996 F.2d 1121, 1125 n.3 (11th Cir. 1993); Crimm v. Missouri Pacific Railroad Co., 750 F.2d 703, 710 n.3 (8th Cir. 1984).
Under §1507, therefore, we’re entitled to get the FDA’s published views about “overwarning” into evidence simply by having the judge tell the jury that this is what the FDA has concluded – as long as it’s relevant. See Wolny, 133 F.3d at 765 (judicial notice not “mandatory, when a matter that appeared in the Federal Register is irrelevant”). Since juries are allowed to consider the “weight” to be afforded to FDA compliance, that pretty much by definition makes the FDA’s views about overwarning relevant any time that a plaintiff is arguing that, even though our client said everything the FDA wanted it to say, we should have said something more. See In re Ephedra Products Liability Litigation, 393 F. Supp.2d 181, 195-96 (S.D.N.Y. 2005) (agency statement in Federal Register admissible to bolster expert testimony by showing that “the FDA makes the same inferences from good but inconclusive science as the [party’s] experts”).
We think §1507’s pretty cool. Having the judge “notice” something is better than having the jury hear it from us or from paid or otherwise biased witnesses. We’ve found a number of cases, in which the courts have invoked mandatory judicial notice in the context of FDA publications in the Federal Register. In re Watson, 517 F.2d 465, 472 & n.2 (Cust. & Pat. App. 1975); County of Thuringer v. American Red Cross, 2006 WL 406353, at *3 (N.D. Iowa 2006); Santa Clara v. Astra USA, Inc., 401 F. Supp.2d 1022, 1024 (N.D. Cal. 2005); Elsroth v. Johnson & Johnson, 700 F. Supp. 151, 161 (S.D.N.Y. 1988); Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *7 n.53 (Tex. Dist. June 7, 1999).
As Baker indicates, judicial notice under §1507 is just as mandatory in state court as it is in federal court.
Texas courts must take judicial notice of the laws of the United States. . . . Administrative rules adopted by boards, departments, and commissions pursuant to federal statutes are also matters of judicial knowledge. When such regulations are published in the Federal Register a federal statute provides that their contents shall be judicially noticed.Ex parte Medellin, 223 S.W.3d 315, 359 n.2 (Tex. Crim. App. 2006). “Our research has not found any case in which a state appellate court ruled that a trial court is free to refuse to judicially notice the contents of the Federal Register.” O’Daniel v. PNB Corp., 1988 WL 94760, at*5 (Tenn. App. Sept. 14, 1988). “Federal laws and regulations are binding on state courts and are subject to their judicial notice.” Associated East Mortgage Co. v. Young, 394 A.2d 899, 902 (N.J. Super. 1978). Accord Schmidt v. Royer, 574 N.W.2d 618, 624 n.16 (S.D. 1998); Quinn v. Walters, 881 P.2d 795, 810 n.7 (Or. 1994); Yankee Atomic Electric Co. v. Secretary of the Commonwealth, 526 N.E.2d 1246, 1253 (Mass. 1988); Black v. Financial Freedom Senior Funding Corp., 112 Cal. Rptr.2d 445, 458 n.13 (Cal. App. 2001).
Now we’re not saying the judicial notice conclusively establishes anything (not in this post, anyway). We don’t ask (in this context) for judicial notice of the “truth” of the FDA’s position. See One Hour Cleaners v. Industrial Claim Appeals Office, 914 P.2d 501, 505 (Colo. App. 1995) (§1507 requires judicial notice “that a certain document exists” not “the truth of the statements contained”). That would be back-door preemption. As we’ve discussed above, as much as we like preemption, we’re assuming for present purposes that there isn’t any, for whatever reason. What §1507 does is admit into evidence of the position and reasoning of an expert agency. See Green Mountain Chrysler Plymouth Dodge Jeep v. Crombie, 2007 WL 1601518, *1 (D. Vt. June 4, 2007) (judicially noticing Federal Register excerpts to “set forth [the agency’s] position on various issues. . .not. . .as facts”). When we’re trying to persuade a jury that compliance matters, that’s precisely what we want the jury to hear.