Wednesday, December 31, 2008

Happy New Year on the Class Action Front

We posted earlier when the Second Circuit declared that class certification merits review was "in." Well, we're pleased to say that the Third Circuit just joined the party. In In re Hydrogen Peroxide Litigation, slip copy here, decided yesterday, the court "clarified" three areas of federal class action practice:
First, the decision to certify a class calls for findings by the court, not merely a “threshold showing” by a party, that each requirement of Rule 23 is met.... Second, the court must resolve all factual or legal disputes relevant to class certification, even if they overlap with the merits — including disputes touching on elements of the cause of action. Third, the court’s obligation to consider all relevant evidence and arguments extends to expert testimony, whether offered by a party seeking class certification or by a party opposing it.

Slip op. at 5. Class certification was reversed and remanded.


Tuesday, December 30, 2008

Top Ten Best And Worst Prescription Drug/Medical Device Decisions of 2008 - The Best

We’re back again with our manifestly unoriginal, but still interesting, idea of top ten lists for the best and worst decisions in our niche for 2008. It’s a way of recapping our second full calendar year in the blogosphere. Sure, there’s a little bit of time left in 2008, but that isn’t stopping anybody else, didn't stop us last year, so it won’t stop us this year, either.

Last week, we offered our choices for the ten worst drug and device product liability cases of 2008.

Today, it’s the other, happier side of the coin: Our choices for the best ten decisions of the year.
Drum roll, please:

1. Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). No surprise here. In baseball, they’d call it a “no doubt about it shot” - in other words, a home run. The Supreme Court, in an 8-1 opinion, recognizes extensive express preemption in product liability litigation involving PMA approved medical devices – ending years of litigation on the point with a clear-cut defense victory. It’s a game changer for manufacturers of PMA medical devices. Some of our posts on Riegel (there were a bunch) are here, here, here, and here.

2. Sinclair v. Merck & Co., 948 A.2d 587 (N.J. 2008). This ruling takes New Jersey, one of the biggest centers of pharmaceutical mass torts, just about out of the class action business in this area. Medical monitoring is out, because all product liability actions require a physical injury. Consumer fraud is also out, as those claims are subsumed by the New Jersey product liability statute. To boot, it’s one of Bexis’ cases. Our (well, Herrmann’s) posts on Sinclair are here and here.

3. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008). The Colacicco decision in the district court (and Bexis’ involvement) was a catalyst for the creation of this blog, and we’ve been following this case religiously ever since. The Third Circuit’s decision was worth the wait – the first appellate recognition of implied conflict preemption in a prescription drug product liability context. Colacicco held that SSRI suicide cases, at least in adults, were precluded by the FDA’s decade-long review of this issue and rejection of any causal language in product warnings. While factually narrow, it’s a conceptually broad decision. Beyond preemption, there’s an excellent discussion of judicial notice of FDA regulatory activity as a vehicle for bringing early dispositive motions. We blogged about the Colacicco decision here, here, and here.

4. In re St. Jude Medical, Inc., 522 F.3d 836 (8th Cir. 2008). Any class certification reversal is a big deal, and this is bigger than most. The core of the St. Jude decision – that, even though a consumer fraud statute eliminates reliance as an element of the action, class certification remains inappropriate because the defendant can defend by proving lack of reliance – has already been enshrined as an illustration in the ALI’s draft Principles of the Law of Aggregate Litigation. So St. Jude is relevant to consumer fraud class actions nationwide. We found St. Jude heavenly here and here.

5. Gourdine v. Crews, 955 A.2d 769 (Md. 2008). Maryland’s highest court rejects a novel “bystander” warning liability theory that potentially exposed drug manufacturers to liability to non-users – the plaintiff had been injured in an auto wreck allegedly caused by a user of the drug. The court held that a drug manufacturer had no duty at all to warn non-users. We discussed Gourdine here.

6. Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP, ___ F. Supp.2d ___, 2008 WL 4832659 (M.D. Fla. Nov. 4, 2008). This is the rejoinder to Judge Weinstein’s adoption of non-reliance RICO in Zyprexa (see worst ten list). In another MDL involving quite similar allegations, the court holds that, even if there’s no reliance element, RICO claims based on illegal promotion fail for lack of proximate cause due to the intervening conduct of the independent learned intermediary prescriber. Our post on the decision is here.

7. Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008). This is the best overall learned intermediary causation decision in a year where there were a lot of them (see here) – and a Herrmann (appellee)-Bexis (PLAC amicus) production to boot. The prescriber submitted an affidavit that the plaintiff’s proposed warning wouldn’t have changed anything he did. Summary judgment affirmed. The decision pretty much kills any heeding presumption in Texas pharma cases and will be useful elsewhere. We had to be careful what we could say, but we discussed Ackermann here and here.

8. In re: Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation,
MDL 08-1934 PSG (AGRx), slip op. (C.D. Cal. Dec. 17, 2008). Allegations that the defendant illegally promoted the off-label use of its drug aren't viable because they amount to a disguised attempt at private enforcement of FDA regulations, which the FDCA expressly prohibits. The master complaint is so shot through with prohibited allegations that the entire MDL was dismissed, with leave to replead. We blogged about Epogen here.

9. Ratliff v. Mentor Corp., 569 F.Supp.2d 926 (W.D. Mo. 2008). Even though Missouri has adopted medical monitoring, the court predicts that, for various jurisprudential and practical reasons, medical monitoring would be limited to environmental torts and not be extended to prescription drug product liability litigation. The court’s rationale is applicable to medical monitoring in any state. We discussed Ratliff here.

10. Perry v. Novartis Pharmaceuticals Corp., 564 F.Supp.2d 452 (E.D. Pa. 2008). This opinion wins the best-of-year prize in the Daubert category for drug/device cases. It offers excellent analysis of the flaws in a plaintiff’s expert's differential diagnosis, and a stellar discussion of why courts don’t let “early” cases go forward in the absence of clear scientific data. Our post on Perry is here.

Honorable Mentions: (11) Merck & Co. v. Ernst, ___ S.W.3d ___, 2008 WL 2201769 (Tex. App. May 29, 2008) (it's quite fact specific, or else it would have ranked higher; when a $250 million+ verdict ends up getting reversed outright for failure to prove the most basic thing of all – that the drug caused plaintiff’s injury – well, that’s a case that belongs on this list); (12) O’Neal v. Smithkline Beecham Corp., 551 F.Supp.2d 993 (E.D. Cal. 2008) (probably the best of quite a few good federal district court drug preemption decisions in 2008); (13) Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008) (best so far of post-Riegel PMA preemptions decisions; notably narrow construction of “parallel” violation exception); (14) Devore v. Pfizer Inc., 867 N.Y.S.2d 425 (N.Y.A.D. 2008) (state appellate holding that plaintiff’s home state controls on choice of law; similar to, but much better than, Desiano); (15) Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kan. 2008) (really good causation decision, both on medical (general and specific) and learned intermediary proximate cause; heeding presumption overcome; plaintiff’s treater's “might have monitored more” testimony did not create a triable causation issue); (16) Longs v. Wyeth, 536 F. Supp.2d 843 (N.D. Ohio 2008) (good on a couple of less common preemption points (black box & too dangerous to be sold); also adequacy as a matter of law under Ohio statute); (17) Bailey v. Wyeth, Inc., 2008 WL 5196846 (N.J. Super. Law Div. July 11, 2008) (it's only a state trial decision, but good on several issues: statutory presumption of adequacy, off-label use, CBE regulation limited to new information, ghostwriting, and exclusion of FDA experts); (18) Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314 (N.D. Fla. 2008) (double-barreled decision: one, no physical injury was established, and two, even if there were, the prescriber didn’t think the risk was worth warning about); (19) Mensing v. Wyeth, 562 F. Supp.2d 1056 (D. Minn. 2008) (well-reasoned published decision finding generic drug preemption; if you represent generics, you gotta love this case; we on the pioneer side, after Conte, have mixed feelings); (20 (tie)) In re Human Tissue Products Liability Litigation, ___ F. Supp.2d ___, 2008 WL 4665765 (D.N.J. Oct. 22, 2008) (excellent Daubert opinion excluding several experts for lack of scientific basis and bogus extrapolation; great ruling in high-profile case), and Mills v. Warner-Lambert Co., ___ F. Supp.2d ___, 2008 WL 4488308 (E.D. Tex. Sept. 30, 2008) (economic loss claims involving OTC drugs subject to preemption because they aren’t “product liability” actions; first reported case on this point outside of California).

We’re being optimists again. We only listed ten choices for our ten worst list, but as before we’ve included the ten (actually 11) honorable mentions for the ten best.

Looking ahead, we already know what the number one case of 2009 will be – Wyeth v. Levine. We just don’t know yet whether it’ll show up on the top ten best or top ten worst. Either way, though, you can bet we’ll have lots to say about it.

And another case we’re looking forward to, but that won’t make this list, is the California Supreme Court’s review of the challenge to the ability of governmental units to hire outside counsel on contingent fee in the Santa Clara lead paint case.

We hope that reading about all these wins will help our readers have a HAPPY NEW YEAR. Barring something cataclysmic, we’re off until next year.

Monday, December 29, 2008

Regulatory Preemption - Class II Devices and Special Controls

The Reed Smith Life Sciences Blog has an interesting post today about a proposed FDA regulation imposing special controls on a class II medical device (tissue expanders) that specifically states the Agency's intent that those controls have preemptive effect. That, the RS blogger notes, is a first.

Like RS we wonder whether it's necessary. Where there are device-specific special controls, even in non-Class III devices, the courts have already tended to find preemption. There is (as the RS post notes) the widely recognized preemptive effect of toxic shock warnings in tampons. And both a 1998 regulation applicable to latex gloves, and a 1997 regulation applicable to contact lens care products, have likewise been accorded preemptive effect due to their specificity. See Morgan v. Abco Dealers, Inc., 2007 WL 4358392 (S.D.N.Y. Dec. 11, 2007) (latex gloves); Tuttle v. Ciba Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007) (contact lens care products).

These controls should follow the same pattern.

So, since the tissue expander controls are of the same order of specificity, why bother with the explicit express preemption discussion? Without it, the FDA's controls are still analogous to tampons, gloves, and the rest. But if that language does not survive, it only complicates preemption argument down the road.

Polar Bears Nudge the MDL Panel In A Helpful Direction

What better way to celebrate winter than with polar bears? The following guest post, written by Pearson Bownas of Jones Day, discusses the recent Polar Bears decision by the MDL Panel. This work is entirely Pearson's; neither Beck nor Herrmann had anything to do with it:

The belief that polar bears cover their black noses with a paw to camouflage themselves in the snow and ice while hunting has been generally discredited. But did you know that polar bears may have helped to open the eyes of the Judicial Panel on Multidistrict Litigation? It’s true: polar bears may have helped the Panel to see an opportunity that it has historically overlooked to promote efficiencies other than those relating to discovery of defense-side facts bearing on core liability issues.

I explored this missed opportunity in an article co-authored with half of this blog’s dynamic duo, Mark Herrmann, titled “An Uncommon Focus on ‘Common Questions’: Two Problems with the Judicial Panel on Multidistrict Litigation’s Treatment of the ‘One or More Common Questions of Fact’ Requirement for Centralization,” published in the multidistrict litigation symposium issue of the Tulane Law Review, 82 Tulane L. Rev. 2297 (2008). There, we traced the origins of the MDL Panel back to the Coordinating Committee for Multiple Litigation of the United States District Courts (the “Coordinating Committee”). The Coordinating Committee was created in 1962 to deal with an explosion of over 1800 civil antitrust conspiracy and price fixing claims filed against manufacturers of electrical equipment in thirty-five district courts. The Coordinating Committee was charged with “considering discovery problems arising in multiple litigation with common witnesses and exhibits.” Philip C. Neal & Perry Goldberg, “The Electrical Equipment Antitrust Cases: Novel Judicial Administration,” 50 A.B.A. J. 621, 623 (1964) (quoting letter from Chief Justice Warren to the Honorable Edwin A. Robson (Jan. 26, 1962)). The Coordinating Committee’s efforts were, accordingly, aimed primarily at streamlining the discovery process by eliminating duplication. It did this by, for example, recommending that the district judges presiding over the cases vacate all previously served discovery, require the plaintiffs to serve one common set of discovery requests, and require the defendants to establish document repositories open to all plaintiffs.

While the MDL Panel was created as a direct result of the Coordinating Committee’s successful work, its statutory mandate seems much broader than mere discovery management. The MDL Panel may transfer actions pending in different districts that share “one or more common questions of fact” when transfer “will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions.” 28 U.S.C. § 1407(a). Nevertheless, many of the Panel’s decisions have appeared to focus largely on the same core liability discovery management issues that the Coordinating Committee was limited to.

For example, in In re Engle Progeny Tobacco Products Liability Litigation, the MDL Panel refused to centralize multiple smoking and health cases pending in federal courts that arose from the Florida Supreme Court’s decision to decertify a class of all Florida smokers at the end of the second phase of trial proceedings, but to permit all of the “Phase I” factual findings to have res judicata effect in future individual suits brought by former class members. These Phase I findings included that cigarettes cause certain diseases, that nicotine is addictive, that the defendants’ cigarettes were defective and unreasonably dangerous, and that the defendants made deliberate false or misleading statements to smokers. Engle v. Liggett Group, Inc., 945 So. 2d 1246, 1257 n.4 (Fla. 2006).

The tobacco manufacturer defendants asked the MDL Panel to centralize the Florida smokers’ individual cases so that uniform determinations could be made on common questions, such as the nature and factual extent of the effect, if any, of the preserved factual findings in the individual cases, the criteria that the individual plaintiffs must satisfy to prove membership in the former class to obtain the benefits of those findings, and the kind and quality of evidence needed to prove satisfaction of those criteria. While these were common questions, the uniform resolution of which by a single judge would have made the proceedings more “just and efficient,” the MDL Panel denied the manufacturers’ motion to centralize because “discovery on common factual issues [had already] occurred in the underlying state court action . . . .” In re Engle Tobacco Progeny Tobacco Prods. Liab. Litig., MDL No. 1887, 2007 U.S. Dist. Lexis 96327, at *2 (J.P.M.L. Dec. 12, 2007). Thus, notwithstanding the other potential benefits of centralization, the MDL Panel declined to centralize the cases because there was no common discovery to be coordinated.

So where do polar bears fit in all of this?

In its recent transfer order in In re Polar Bear Endangered Species Act Listing and § 4(d) Rule Litigation, MDL No. 1993 (link here), the Panel centralized four actions pending in two districts even though “[t]his group of cases [was] unlike many others that the Panel routinely encounters because the amount of pretrial discovery may be less onerous than in other litigations and because common legal issues may predominate the unresolved matters.” The Polar Bear cases challenge some or all aspects of the U.S. Fish and Wildlife Service’s listing of polar bear as threatened under the Endangered Species Act, and a related interim final rule promulgated under Section 4(d) of that Act. One of the parties moved to centralize the cases, arguing that “[i]f transfer is not granted and separate actions are maintained, there is great potential for conflicting adjudications regarding, inter alia, the scope and content of the administrative record, intervention, preliminary injunctive relief, the appropriateness of listing of the polar bear under the ESA, and the appropriateness of the Interim 4(d) Rule.” Motion For Transfer Of Actions To The U.S. District Court For The District of Columbia, filed in In re Polar Bear Endangered Species Act Listing and § 4(d) Litig., MDL No. 1993 (dated Aug. 29, 2008), at 4.

At the MDL Panel’s hearing on this motion (which I attended to argue a centralization motion in a case having nothing to do with polar bears), the Panel noted that, because the challenges raised by these lawsuits arose from an already-developed administrative record, there would be little, if any, discovery to be conducted in any centralized proceeding. The attorney representing the Government, which supported the motion to centralize, stressed the importance of avoiding conflicting rulings on the common questions posed in each case. What, she essentially asked the Panel, was the Fish and Wildlife Service to do if one court held that polar bears should be listed as threatened under the Endangered Species Act, and another court held that they should not be? Members of the Panel squarely framed the issue in their questions as whether the Panel could centralize cases simply to avoid conflicting rulings on common questions.

The Panel plainly decided that it could.

In its transfer order, the Panel explained that centralization “will eliminate duplicative discovery” – though it did not identify what discovery it had in mind – “and prevent inconsistent pretrial rulings, particularly those with respect to the identification of the underlying administrative record. Streamlining the pretrial resolution of such issues will avoid potentially conflicting obligations placed upon the federal defendants.”

This decision opens the door for parties in other cases to seek centralization to promote efficiencies other than those involved in plaintiffs taking discovery from defendants on common factual issues, which has been the historical focus of the Panel’s decisions. Defendants, for example, who would prefer a uniform ruling over conflicting ones on common issues arising from common facts, such as the application of a federal preemption or governmental contractor defense, could use the Polar Bear decision as authority to support a motion to centralize. And defendants faced with the risk that different courts in different cases will impose inconsistent obligations relating to common issues now have a stronger argument for centralization to avoid that result.

To be sure, the immediate effect of the Polar Bear decision should not be overstated. For one thing, the Panel may have felt a certain sympathy for the Government’s plight that it may not feel for all private litigants. And the rationale of the decision may be limited to cases that seek some form in injunctive or declaratory relief. Courts applying Fed. R. Civ. P. 23(b)(1)(A), which allows courts to certify a class when, among other things, “the prosecution of separate actions by . . . individual members of the class would create the risk of . . . inconsistent or varying adjudications . . . which would establish incompatible standards of conduct for the party opposing the class,” have held that this standard is not satisfied by the risk that a defendant may be found liable for damages in one case but not liable for damages in another case involving exactly the same issues. See, e.g., Corley v. Entergy Corp., 222 F.R.D. 316, 321 (E.D. Tex. 2004) (“If one plaintiff prevailed but another plaintiff lost, the defendant could act in a consistent manner” by paying the winning plaintiff and not paying the losing one.); Moore’s Fed. Prac. § 23.41[6][a] (“A defendant is not subjected to incompatible standards of conduct merely by exposure to the risk that the defendant might be liable to some plaintiffs and not to others.”) (citing many cases). Instead, courts have generally held that “[o]nly declaratory or injunctive relief will establish standards of conduct and only incompatible declaratory judgments or injunctions will establish inconsistent standards of conduct for the party opposing the class.” Moore’s Fed. Prac. § 23.41[6][a]. So cases involving damages alone may not threaten the type of incompatible results that convinced the MDL Panel to centralize the Polar Bear cases.

Nevertheless, the Polar Bear decision may represent an important first step in the development of the MDL process to accommodate all issues arising from one or more common questions of fact that would promote the “just and efficient conduct of . . . actions,” and not just those relating to the management of common discovery. And, for that, we have the polar bears to thank.

Tuesday, December 23, 2008

Supreme Court Conference 1/9/09

Materials have been distributed for the United States Supreme Court's January 9, 2009, conference. Among the certiorari petitions that the Court will consider whether to accept are Colacicco (our posts here and here) and Farm Raised Salmon (our posts here, here, and here). Expect orders, up or down, within a business day or so after the January 9 conference.

Off-Label Promotion MDL Dismissed under FDCA

As far back as the Bone Screw litigation, we've argued that many attempts to gin up litigation about alleged off-label promotion are really prohibited back-door attempts at private enforcement of FDCA violations. See Beck & Valentine, "Challenging The Viability Of FDCA-Based Causes Of Action In The Tort Context: The Orthopedic Bone Screw Experience," 55 Food & Drug L.J. 389, 413 & nn. 169-71 (2000). Among other places, we've blogged about the subject here ("first argument").

Well, that argument was just adopted, big time, in the Amgen MDL. Here's a copy of the opinion, which dismisses the entire MDL as little more than a disguised attempt to enforce the FDA's off-label promotion prohibitions. The bottom line:
In the present case, the Court finds that Plaintiffs’ suit is largely an attempt to bring a private cause of action for violations of the FDCA. Under FDA regulations, drug manufacturers are prohibited from promoting off-label uses of prescription drugs. Dissemination of an advertisement not in compliance with FDA regulations causes a drug to be “misbranded” in violation of the FDCA.... Although Plaintiffs have avoided explicit references to “misbranding” in their Complaint, their RICO and state law claims are primarily based on allegations that Defendants promoted [the drug] for off-label uses.... These allegations of off-label promotion are, in essence, misbranding claims that should be reviewed by the FDA.

Slip op. at 6-8 (extensive quotes from plaintiffs' complaint omitted).

The court didn't just dismiss this or that count of the plaintiffs' complaint. Rather, the forbidden attempt at private FDCA enforcement against purportedly illegal promotion was so thoroughly woven through the entire complaint, that for now anyway, the entire MDL is dismissed (albeit with leave to replead). Slip op. at 11-12.

Happy Holidays, indeed.

Top Ten Best And Worst Prescription Drug/Medical Device Decisions of 2008 - The Worst

We’re doing it again. We’ve prepared our top ten lists for 2008 – the top ten best, and the bottom ten worst drug and medical device product liability decisions of the year – our second full turn of the calendar in the blogosphere. You might think we’d start with the top ten, but that would mean closing out the year on a very sour note. So we’re working from the bottom up.

These are our choices for the ten worst drug and medical device product liability cases in 2008:

1. Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008). It’s only an intermediate appellate court decision, but the implications are staggering. The court held that the manufacturer of a pioneer (name-brand) drug can be liable for the inadequate warnings on a competing generic product. The mere label (“misrepresentation”) on the cause of action throws out 50 years of justifying product liability on the basis that the party profiting from the product should bear the burden of compensating product-related injuries. We posted on Conte here and here.

2. In re Zyprexa Products Liability Litigation, 253 F.R.D. 69 (E.D.N.Y. 2008). It’s Judge Weinstein. It’s a class action. That means that the result favors the plaintiffs, and the certification order is accompanied by a plausibly reasoned (if you think all class actions should be certified) opinion that goes on forever. Having had class certifications shot down by the appellate courts on market share, nuisance, and consumer fraud, this time Judge Weinstein tries non-reliance RICO. So it’s off to the Second Circuit again. Our post on this monster, here.

3. Hyman & Armstrong, P.S.C. v. Gunderson, ___ S.W.3d ___, 2008 WL 1849798 (Ky. April 24, 2008). In federal court, Parlodel stroke cases have almost always been thrown out on Daubert grounds - no scientific basis for causation. In Kentucky, they go to the jury and produce eight-figure verdicts – and they get affirmed by the Kentucky Supreme Court on the basis that you can prove causation with a dog and pony show featuring a bit of this and a bit of that, when none of the bits are valid science in and of themselves. We commiserated on Gunderson here.

4. Johnson v. GlaxoSmithKline, 83 Cal. Rptr.3d 607. (Cal. App. 2008). It's more class action shenanigans. The plaintiffs had sought class certification twice in federal court, first of a nationwide class and then of a California state class, both times using the same class definition, except for geographic scope. They lost both times. So the same lawyers, switching nominal plaintiffs, take a third bite at the apple in California state court. The trial court holds them to the result in their first chosen forum. The appellate court reverses, refuses to follow prior intermediate appellate authority in the state (something that’s allowed in California) and holds that plaintiffs can keep on looking until they find some judge (at least in California) that’s willing to certify their twice-rejected class. We blogged about Johnson here.

5. Smith v. Alza Corp., 948 A.2d 686 (N.J. Super. A.D. 2008). Just when things seemed to be improving in New Jersey, we get this awful choice of law decision. Essentially ignoring two New Jersey Supreme Court decisions (Rowe and Sinclair), the court applies New Jersey law to a case having nothing to do with the state (other than the defendant having shipped the product in question from New Jersey). The court goes on to hold that it would apply the New Jersey consumer fraud statute to an Alabama transaction because the New Jersey statute is “better” – meaning that it imposes more liability with looser standards. We discussed Smith here.

6. Rimbert v. Eli Lilly & Co., 577 F. Supp.2d 1174 (D.N.M. 2008). Ignoring several New Mexico appellate decisions, as well as settled Erie principles that diversity courts should not predict expansions of state-law liability, the court predicts that New Mexico would reject the learned intermediary rule – and it takes more than 100 excruciating pages to explain itself. We posted on Rimbert here.

7. Warner-Lambert v. Kent, 128 S. Ct. 1168 (2008). Yeah, we know, it’s only a non-precedential 4-4 affirmance, but frankly, we thought we’d win. Because we didn’t, and because Kent leaves something of a cloud over the unanimous holding in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), that fraud on the FDA claims are preempted, we’re putting it on the list. For another of our posts on Kent go here.

8. Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008), reconsideration denied, interlocutory appeal granted (E.D. Pa. Oct. 28, 2008). Strange things happen in preemption cases. One would have thought that Colacicco (see next week) killed SSRI suicide cases, at least in courts obligated to follow Third Circuit precedent. Knipe proves that any controlling precedent can be distinguished if the court is sufficiently determined. We discussed Knipe here, and here.

9. (jointly) American Home Products Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008), and Moreland v. Austin, ___ S.E.2d ___, 2008 WL 4762052 (Ga. Nov. 3, 2008). Strange things happen in tort preemption cases – especially in the Georgia Supreme Court. When a preemption ruling would aid the defense, in Ferrari, the court employs a presumption against preemption to adopt an extremely strained (we’re being polite) reading of legislative intent that would shock Congress, and is rejected by every other court to consider the Vaccine Act. When a preemption ruling would aid plaintiffs, the court finds in Moreland that state-law precedent allowing informal interviews by defense counsel is preempted by HIPAA, even though that statute expressly exempts litigation – with no presumption in sight. We blogged on Ferarri here.

10. Tucker v. SmithKline Beecham Corp., 2008 WL 2788505 (S.D. Ind. Sept. 19, 2008). On reconsideration, the court retracted a pro-preemption ruling in a SSRI suicide case. During the course of the opinion, the court engaged in some rather unusual analysis, with which we disagreed, here. Needless to say, we think the court got it right the first time.

That’s it for our rundown of the coals we found in our stockings this year. From here, there’s nowhere to go but up.

And to all our readers HAPPY HOLIDAYS! Drop by next week for the our review of the drug/medical device decisions we liked the best.

Monday, December 22, 2008

A Gripe With A Piece of Scientific Literature

J.C. McElveen, of Jones Day, wrote the following guest post, for which we thank him. As is always true of guest posts, the two of us had nothing to do with what follows; JC gets all the credit. (We alone, however, are to blame for not knowing how to create subscripts in blog posts. JC properly wrote the chemical name "V205" using subscripts for the numbers, and we're just too ignorant to create that format here.):

The other day, as I was perusing (as I'm sure many of you do) "Environmental Health Perspectives," “the peer-reviewed journal” of the National Institute of Environmental Health Sciences, I came across an article by Ehrlich, et al. titled “Inhalative Exposure to Vanadium Pentoxide Causes DNA Damage in Workers.” Environmental Health Perspectives; 116(12):1689-1693 (December 2008). Now, vanadium pentoxide (V205) is not one of those compounds that leaps trippingly off the tongue, but with a title like that, it was an almost irresistible read.

The study looked at peripheral white blood cells from vanadium production workers and controls and tested for several DNA damage endpoints: Micronuclei (MN), nucleoplasmic bridges (NPB), nuclear buds (Nbuds), oxidized purines and pyramidines (oxidized bases), and some others. The concluding paragraph of the article then made the following statement:

Overall, our results show that inhalative exposure to V205 increases the
levels of oxidized bases and of MN, NPB and Nbud frequencies in blood cells and
affects their DNA repair capacity . . . . Because the aforementioned parameters
are causally related to diseases including cancer, our findings strongly suggest
that more protective measures and periodical monitoring of the workers are
required. p.1692
I must admit that this is the first reference I have seen that says that these particular genetic changes are “causally related” to cancer, and my first reaction was “where is the footnote?” (I won’t talk about other diseases because the only other disease even mentioned in this article, and that only in passing, was cardiovascular disease). You would at least like a footnote for a statement like this one. There was no footnote, and, frankly, given what I had read in other parts of the paper, I was surprised that such an unequivocal statement would be made.

For example, earlier in the article, I saw this quote:

In this article we present the results of the first comprehensive study on the
impact of occupational exposure to airborne V205 on DNA stability. p.1691
Since replication of results is a commonly accepted criterion for causation, it would have been nice for the results to have been replicated before such a “causally related” statement was made. In fact, the paper admits that two earlier studies, looking at V205 and different DNA endpoints, were negative. p.1689

Also, when you think about a statement that says “because the aforementioned parameters are causally related to . . . cancer . . . .” You ask yourself: “What cancers?” “In what species?”

The article actually had something to say about those subjects that made its conclusion even more unusual. It pointed out that the National Toxicology Program found V205 inhalation caused a (presumably statistically significant) increase in adenomas and carcinomas in mice, but not in rats, and it noted that IARC, in 2006, based in part on these data, classified V205 as a “possible” human carcinogen (Group 2B).

So, thus far, all we know is that V205 is an animal carcinogen in mice, but where does the conclusion “the aforementioned [DNA damage] parameters are causally related to . . . cancer. . . .” come from?

One of the statements made early in the article is this one:

Because DNA damage and aneugenic processes are known to play a role in the onset
of human cancer (Duesberg, et al. 2005; Pitot, 1986), evidence of genetic damage
in exposed humans would support the assumption of increased cancer risks.
Well, there are references as support for, at least, the first part of that quote. One is to Dr. Henry Pitot, in 1986 and one is to Dr. Peter Duesberg, and others, in 2005. Since the Pitot piece is 22 years old, I thought I would look at the 2005 Duesberg article: “The Chromosomal Basis of Cancer,” Cellular Oncology 27(2005) 293-318. However, that article was published under the heading “Opinion” and the first sentence of the article says:

Despite over 100 years of cancer research, the cause of cancer is still a
matter of debate between theories postulating either mutation or chromosomal
alteration or epigenetic events as causes of cancer. p.293

That sentence is followed by cites to 29 footnotes, so there is no help there for the assertion in the V205 article, it would seem.

Later in the V205 paper, the authors say, with respect to the micronucleus test, that

. . . a prospective study showed that MNs in peripheral blood lymphocytes are a
valid biomarker for predicting an increased cancer risk in humans (Bonassi, et
al. 2007). pp.1691-1692

Well, that is a lead, and it is supported by a footnote, so, off to the literature. The cited article, by Bonassi, et al., was entitled “An Increased Micronucleus Frequency in Peripheral Blood Lymphocytes Predicts the Risk of Cancer in Humans.” Carcinogenesis 28(3); 625-631 (2007). However, the abstract of that article is a little more circumspect. It says:

The results from the present study provide preliminary evidence that MN
frequency in PBL (peripheral blood lymphocytes) is a predictive biomarker of
cancer risk within a population of healthy subjects. p.625

And, later in that article, the statement is made:

Nevertheless, we acknowledge that the number of cancers per organ site is
relatively small, and that the statistical estimates, which are suggestive
of an association with MN, are likely to become more stable as further
cancers accumulate with increasing age of the cohort. p.629

Well, maybe.

And later:

A feature of this study is the non-linearity of the dose-response
relationship between MN frequency and overall cancer incidence.

And later:

The international multi-centre nature of this study [43 sites in 23 countries –
the Human Micronucleus Project (HUMN)] may be considered among its strengths
[for the reasons cited]. . . . On the other hand, this approach has also
introduced a number of limitations. These include the large
inter-laboratory variability of MN frequency which is most likely due to
technical differences in slide preparation and scoring, the heterogeneous
quality of data in genotoxic exposures, such as cigarette smoking and
occupational carcinogens or the availability of a single measure of MN per
individual which may have resulted in misclassification among MN frequency
levels. A further potential source of bias is the heterogeneousity in the
cancer registration quality of the countries involved. p.630


I would go on, but for the one or two of you still reading, I will simply observe this: the micronucleus test (or any of the other ones mentioned at the beginning of the V205 article) may turn out to predict human cancer. They may even turn out to predict particular human cancers. However, I don’t think the evidence I saw supports the proposition that they do so now, and I think that any plaintiff who brought a V205 worker cancer case to court, on the basis of genetic evidence alone, would be hard-pressed to survive summary judgment.

Friday, December 19, 2008

Preemption and Investigational Devices after Riegel

One of the questions we've been asking - but not finding answers - is where exactly do investigational medical devices (IDE) fit in to the preemption rubric after Riegel. Investigational devices, after all, are PMA, only their applications haven't been approved yet. Since IDE devices are subject to the same regulations as PMA devices, only at an earlier stage of the process, it seems logical that IDE requirements would preempt tort requirements for the same reasons as in Riegel.

But no courts had considered the question - until now.

A tip of the cyberhat to Sean Saxon over at Wheeler, Trigg for passing along to us the first decisions (two identical rulings by the same judge) we've seen holding that, because IDE devices are subject to the same PMA regulatory scheme that was at issue in Riegel, product liability claims against such devices are subject to the same degree of preemption recognized in Riegel: The primary takeaway:

IDE approvals are within the express purview of the MDA, are a step on the way to potential Pre Marketing Approval, and the court is unable to differentiate the application of the preemption provisions of the MDA. The preemption provisions apply to IDE approvals.

Robinson v. Endovascular Technologies, Inc., No.: 1-03-CV-009655, slip op. at 3 (Cal. Super. Santa Clara Co. Dec. 17, 2008); Norks v. Endovascular Technologies, Inc., No.: 1-03-CV-010668, slip op. at 3 (Cal. Super. Santa Clara Co. Dec. 17, 2008). Nor could plaintiffs pursue claims alleging "fraudulent conduct of a defendant in approving an IDE," due to Buckman preemption. Id. at 3-4. This was not a case where the FDA had concluded that it was defrauded and ordered the device off the market. Id. at 4.

So there you have it - at least one court's answer: Manufacturers of investigational devices may rely upon the same extensive preemption that Riegel recognized with respect to devices that had completed the PMA process.

Bong Water Blues

The two of us have been slaving over this blog, regularly producing substantive posts about cutting edge legal issues, for more than two years now.

And what do we get called out for (by name) over at Above the Law this morning?

The "bong water" case.

We're speechless.

Thursday, December 18, 2008

Informal Physician Interviews - Where It's Kosher; Where It's Not

We’ve blogged before about the importance of both sides in personal injury litigation – and especially drug/medical device product liability litigation involving the learned intermediary rule – having equal rights to talk to treating/prescribing physicians. We’ve praised courts that have gotten this issue right – most significantly the New York Court of Appeals in the Arons case. We’ve debunked what we consider a spurious argument HIPAA (the Health Insurance Portability and Accountability Act) interferes with state law on this subject, since that statute specifically excludes civil litigation from its purview.

But we know, because we’re involved in litigation all over the country, that not every (probably not even most) state agrees with us. We also know that in federal MDLs, even though discovery procedure is a procedural issue (e.g., Williams v. Rene, 72 F.3d 1096, 1103 (3d Cir. 1995); Weiss v. Astellas Pharma, US., Inc., 2007 WL 2137782, at *3-4 (E.D. Ky. June 25, 2007), and the cases we cited here), in practice a lot of judges defer to state practice in this area. So it’s important for defense counsel to know – realistically, and regardless of our philosophical views on the matter – where we can talk to the docs informally, and where we’ll get in trouble just for doing what the other side is allowed to do.

Ten years ago, or even less, we’d have agitated for one of the ABA’s litigation committees to prepare a 50-state survey on the question – and there might even be one of those, but we don’t know of anything recent. We couldn’t find anything on the ABA’s website.

But one of the great things about being bloggers is we don’t have to go through all that. If we think something’s important, we can do it ourselves, and so we are.

Here’s what we know about – Okay, what we think we know about – the status of informal defense access to treating physicians in the fifty states.

Remember, you get what you pay for, so don’t even think about using us as the be all and end all on this (or any other) subject. If you do, please see our disclaimer. Consider what we’ve done here more of a jumping off point.

Also, if you think we didn’t get your state right, please let us know. We’ve been flamed before, so we don’t mind all that much.


From what we can tell, it’s okay to talk to a prescriber informally in the Heart of Dixie. Zaden v. Elkus, 881 So.2d 993 1012-13 (Ala. 2003). If a prescriber is willing, it’s okay to hire him/her as a defense expert. Romine v. Medicenters of America, Inc., 476 So.2d 51, 55 (Ala. 1985).


Likewise, it seems okay to meet with prescribers informally in the New Frontier, Christensen v. NCH Corp., 956 P.2d 468, 475 (Alaska 1998), although such meetings can’t be compelled against the doctor’s will. Langdon v. Champion, 745 P.2d 1371, 1373 (Alaska 1987). Not that we'd try to do that, anyway.


Don’t do it in the Grand Canyon state, though. Even though any privilege is waived, it’s only waived as to formal means of discovery. Don’t ask us why, but that’s what the court held in Duquette v. Superior Court, 778 P.2d 634, 637, 642 (Ariz. App. 1989). That was almost 20 years ago, but Arizona courts still follow the rule. See Styles v. Ceranski, 916 P.2d 1164, 1169 (Ariz. App. 1996). The federal courts have gone along. Benally v. United States, 216 F.R.D. 478, 480 (D. Ariz. 2003). Better safe than sorry.


Again, don’t do it. There’s a rule in the Diamond State that pretty clearly precludes defense counsel from having informal interviews without a plaintiff’s consent. Ark R. Evid. 503(d)(3)(B). The Arkansas Supreme Court enforced that rule in Kraemer v. Patterson, 29 S.W.3d 684, 690 (Ark. 2000), and the federal courts go along. Harlan v. Lewis, 982 F.2d 1255, 1264 (8th Cir. 1993).


The Golden State doesn't prohibit informal interviews with treating physicians. In Heller v. Norcal Mutual Insurance Co., 876 P.2d 999, 1005 (Cal. 1994), the Supreme Court rejected a blanket ban, explicitly disapproving Torres v. Superior Court, 270 Cal. Rptr. 401 (Cal. App. 1990). But Heller held that counsel have to comply with the state’s confidentiality of medical information act, Cal. Civ. Code §56, et seq., 876 P.2d at 1004-05, which is too complicated for us to get into here. Federal courts are split. In Crenshaw v. Mony Life Insurance Co., 318 F. Supp.2d 1015, 1024-25 (S.D. Cal. 2004), the court followed Torres, apparently without realizing the California Supreme Court had disapproved it. In Galarza v. United States, 179 F.R.D. 291, 294 (S.D. Cal. 1998) the court approved informal interviews. [see comment for pending legislation warning]


In the Centennial State, it’s okay to have informal interviews with physicians, and courts can grant orders authorizing them, as long as the plaintiff is given “reasonable notice” of proposed interviews, and the interviews are limited to medical matters waived by the plaintiff in the litigation. Samms v. District Court, 908 P.2d 520, 526 (Colo. 1995). Plaintiffs have no absolute right to attend such interviews. Reutter v. Weber, 179 P.3d 977, 978-79 (Colo. 2007).


There’s not much law in the Constitution State, but informal interviews seem to be allowed, only they can’t be required by court order. See Santaniello v. Sweet, 2007 WL 214605, at *3 (D. Conn. Jan. 25, 2007) (rejecting HIPAA preemption of informal interviews; documents must have HIPAA-compliant release); Valentino v. Gaylord Hospital, 1992 WL 43134, at *1-2 (Conn. Super. Feb. 19, 1992) (court refused to require interview).


Informal interviews are allowed in the First State, but only with prior consent or by court order. Green v. Bloodsworth, 501 A.2d 1257, 1259 (Del. 1985). In personal injury litigation, court orders will be routinely allowed if the plaintiff resists. Id. Any privilege is automatically waived by filing a personal injury action. Del. R. Evid. 503(3).

District of Columbia

Informal interviews are allowed in the District of Columbia. Street v. Hedgepath, 607 A.2d 1238, 1247 & n.8 (D.C. 1992) (adopting permissive rationale of Doe v. Eli Lilly & Co., 99 F.R.D. 126, 128 (D.D.C. 1983)). Federal courts after Street go along. Miller v. Hilton Hotels Corp., 1993 WL 210866, at *3, 995 F.2d 305 (D.C. Cir. 1993) (non-precedential).  The DC bar recently issued an ethics opinion that a plaintiff's attorney could request, but not instruct, a treater not to speak to opposing counsel.


There used to be a statute, Fla. Stat. §456.057(8), that courts in the Sunshine State had interpreted as forbidding informal physician interviews.  Acosta v. Richter, 671 So.2d 149, 152 (Fla. 1996).  That statute has been heavily amended, and if there's still a flat prohibition, it's now in subsection 7(a)
(“the medical condition of a patient may not be discussed”).  However §456.057(7)(a)(3) contains an exception for subpoenas in pending litigation, and may allow informal interviews if "discussions" are "such records" as used in that section.  No cases exist, so be careful.


While informal interviews were allowed by statute in the Peach State, Ga. Code. 9-11-9.2, the Georgia Supreme Court held that the statute was preempted by HIPAA.  Moreland v. Austin, 670 S.E.2d 68, 70-71 (Ga. 2008). All is not lost, however, since recently, in Baker v. Wellstar Health Systems, Inc., ___ S.E.2d ___, 2010 WL 2159372 (Ga. June 1, 2010), the court held that, although HIPAA applies, defendants may apply for a "qualified protective order" to allow informal interviews under HIPAA whether the plaintiff consents or not.  Id. at *2-3. 


The Aloha State hasn’t said “aloha” to this issue yet. We can’t say what Hawaii law is on informal defense interviews with treating/prescribing physicians. It’s a free country, which means things are allowed until the law prohibits them, so we’d would go ahead, but proceed cautiously. Be very careful to make sure a Hawaii doctor knows an interview is voluntary, do not get into irrelevant matters, etc. Dot your i’s and cross your t’s. You don't want to be the one remembered for making bad law.


There’s not a lot of law in Idaho, but in Morris v. Thomson, 937 P.2d 1212, 1217 (Idaho 1997), the court stated “the discovery rules do not limit defense counsel’s access to [the treating physician], and the defense is free to speak to the witness if she is willing.” That’s good enough for us to say it looks like the Gem State allows informal interviews.


The Land of Lincoln hasn’t emancipated defense counsel to have equal rights with plaintiffs for informal discussions with treating doctors. Burger v. Lutheran General Hospital, 759 N.E.2d 533, 554-55 (Ill. 2001). Far from it. In Illinois, it was even held unconstitutional for the legislature to permit informal interviews by statute. Best v. Taylor Machine Works, 689 N.E.2d 1057, 1100 (Ill. 1997). Don’t do it unless you enjoy being held in contempt of court. Petrillo v. Syntex Laboratories, 499 N.E.2d 952, 962 (Ill. App. 1986).


Defense informal interviews with treating physicians are barred in the Hoosier State as well. “[E]x parte interviews with a party-patient’s health-care providers by opponent’s counsel impermissibly compromise[] the physician-patient privilege.” Cua v. Morrison, 626 N.E.2d 581, 582 (Ind. App. 1993), adopted & incorporated, 636 N.E.2d 1248, 1249 (Ind. 1994). Federal courts, however, have been more liberal in allowing informal contacts under the Federal Rules. E.g., Martin v. CSX Transportation, Inc., 215 F.R.D. 554, 557 (S.D. Ind. 2003); Eve v. Sandoz Pharmaceuticals Corp., 2002 WL 32153352, at *1 (S.D. Ind. May 16, 2002).


While we can’t say it’s 100% foreclosed, we would be very leery of conducting informal treater interviews in the Hawkeye State in light of Roosevelt Hotel Ltd. Partnership v. Sweeney, 394 N.W.2d 353, 356-57 (Iowa 1986). Technically, Roosevelt Hotel held only that plaintiffs can’t be forced to consent to such interviews, but the opinion's language is definitely not helpful. A later case allowed workers compensation defendants to hold all the informal interviews they want. Morrison v. Century Engineering, 434 N.W.2d 874, 876-77 (Iowa 1989). So it's possible, if not likely, that there might be some flexibility here.


Federal courts in the Sunflower State routinely allow informal defense interviews with treaters. E.g., Harris v. Whittington, 2007 WL 164031, at *1 (D. Kan. Jan. 19, 2007) (describing practice as “well settled” and citing a bunch of cases). Kansas state courts don’t seem to have addressed the issue.


Go for it, guys. The Bluegrass State is amenable to informal defense interviews of treating physician. Roberts v. Estep, 845 S.W.2d 544, 547 (Ky. 1993); Davenport v. Ephraim Memorial Hospital, Inc., 769 S.W.2d 56, 62 (Ky. App. 1988); Weiss v. Astellas Pharma, US., Inc., 2007 WL 2137782, at *3 (E.D. Ky. June 25, 2007).  In Caldwell v. Chauvin, ___ S.W.3d ___, 2015 WL 3653447, at *7-8 (Ky. June 11, 2015), the court rejected a HIPAA-based challenge to the practice.


There’s a statute in the Pelican State that limits the litigation waiver of the physician/patient privilege to certain specified “discovery methods.” La. C. Evid. §510(E). This limitation has been held to prohibit defendant’s counsel from interviewing plaintiff’s treating or prescribing physicians informally. Coutee v. Global Marine Drilling Co., 895 So.2d 631, 641-42 (La. App. 2005), rev’d on other grounds, 924 So.2d 112 (La. 2006). Watch out in federal court, too. In In re Vioxx Products Liability Litigation, 230 F.R.D. 473, 476 (E.D. La. 2005), an MDL judge extended restrictive Louisiana law to actions filed anywhere in the country.


There’s no state court precedent, but a federal court in the Pine Tree State held that physician-patient privilege, even though waived, prohibited informal defense interviews with treaters. Neubeck v. Lundquist, 186 F.R.D. 249 (D. Me. 1999).


Informal defense interviews with treating physicians are just fine in the Old Line State. Butler-Tulio v. Scroggins, 774 A.2d 1209, 1224-25 (Md. Spec. App.), cert. denied, 783 A.2d 221 (Md. 2001). A federal district court, Law v. Zuckerman, 307 F. Supp.2d 705, 711 (D. Md. 2004), construed HIPAA as overriding state law, but as we’ve discussed elsewhere, that’s a weak argument.


In the Bay State, we’d hold off on interviewing physicians informally in light of Schwartz v. Goldstein, 508 N.E.2d 97, 99 (Mass. 1987), stating that “an opposing party should not be free to engage in clandestine, unauthorized conferences with a plaintiff's physician.” See Goldstein v. United States, 1995 WL 96959, at *1 (D. Mass. Feb. 6, 1995) (applying same rule in federal court).


Michigan has consistently allowed defense counsel to interview treaters informally. Domako v. Rowe, 475 N.W.2d 30, 36 (Mich. 1991); Davis v. Dow Corning Corp., 530 N.W.2d 178, 180 (Mich. App. 1995) (per curiam). While a non-precedential, unpublished opinion asserted that HIPAA preempted the litigation rules of the Great Lakes State, Belote v. Strange, 2005 WL 2758007 at *5 (Mich. App. Oct. 25, 2005), that opinion has not been followed.  See Thomas v. 1156729 Ontario Inc., 979 F. Supp.2d 780, 784 (E.D. Mich. 2013).


The North Star State’s gone back and forth. The current Minnesota physician/patient privilege would, if taken literally, forbid physicians even to give in-court testimony contrary to their patients. Minn. Stat. Ann. §595.02(1)(d). There’s an exception allowing a physician charged with malpractice to confer privately with his/her own counsel. Id. §595.02(5). We suppose this amendment was intended to overrule Blohm v. Minneapolis Urological Surgeons, P.A., 449 N.W.2d 168, 170 (Minn. 1989), which had allowed informal defense interviews under a prior iteration of the statute. The statute supported a blanket prohibition in In re Baycol Products Litigation, 219 F.R.D. 468, 473-74 (D. Minn. 2003). Baycol refused to follow Filz v. Mayo Foundation, 136 F.R.D. 165, 173 (D. Minn. 1991), which had allowed informal interviews as a matter of federal, rather than state, law.


In the Magnolia State, Mississippi Rule of Evidence 503(f) provides that a litigation waiver of the physician/patient privilege “does not authorize ex parte contact by the opposing party”). In Scott v. Flynt, 704 So.2d 998, 1006-07 (Miss. 1999), the court held that evidence obtained through an informal interview was inadmissible. We’d have thought that amounts to a prohibition, except that: (1) in Poole v. Avara, 908 So.2d 716, 725 (Miss. 2005), the court allowed the defendant to use a treater as an expert against a plaintiff/patient, and (2) in Griffin v. McKenney, the court dropped a footnote stating that Scott “in fact states that a defendant is not prohibited from speaking ex parte with a plaintiff’s physician,” but only that “information divulged by such communication is inadmissible.” 877 So.2d 425, 442 n.3 (Miss. App. 2003). This subsequent precedent leaves things sufficiently up in the air that we’d strongly recommend talking to a Mississippi lawyer about this before doing anything.


In Brandt v. Medical Defense Association, 856 S.W.2d 667, 673 (Mo. 1993), the court overruled prior precedent (State v. Ryan, 776 S.W.2d 389, 395 (Mo. 1989)), and allowed informal defense interviews with treating physicians. See also Brandt v. Pelican, 856 S.W.2d 658, 662 (Mo. 1993); State v. Dalton, 872 S.W.2d 888, 890 (Mo. App. 1994). Now, in the Show Me State, “[t]he decision of whether to engage in ex parte discussions with an attorney concerning medical information that is no longer subject to the physician-patient privilege belongs solely to the physician.” State v. Syler, 936 S.W.2d 805, 809 (Mo. 1997).  But watch out, an intermediate appellate court in State v. Messina, ___S.W.3d ___, 2009 WL 3735919 (Mo. App. Nov. 10, 2009), has held that Brandt didn't affirmatively decide anything, and that therefore HIPAA precludes informal interviews.  We think that Messina is both wrong about HIPAA and a usurpation of the Supreme Court, but know it's out there before you proceed.


It looks like informal interviews are allowed in the Treasure State. In Jaap v. District Court, 623 P.2d 1389, 1390 (Mont. 1981), the court held plaintiffs could not be ordered to consent to informal defense interviews, but didn’t seem to have any problem with the concept of informal interviews itself. Id. at 1392. Building on Jaap, the court in Ostermiller v. Alvord, affirmatively held that informal interviews were allowable. 720 P.2d 1198, 1200 (Mont. 1986) (“interview by defendant's counsel can better be described as a means of reviewing a witness’s testimony than as a means of discovery. . . . [I]t was not error to allow the interview to take place”). However, in Hampton v. Schimpff, 188 F.R.D. 589, 590 (D. Mont. 1999), without citing Ostermiller, the court held that informal interviews were not allowed under Jaap. So be careful.


In the Cornhusker State there’s very little law. Informal interviews were allowed in Scott v. Drivers Management, Inc., 714 N.W.2d 23. 36 (Neb. App. 2006), but that was under a special statute concerning worker’s compensation. Our “free country” comments under Hawaii apply.


There’s a statute in the Silver State that provides, “[t]here is no privilege . . . as to written medical or hospital records relevant to an issue of the condition of the patient in any proceeding in which the condition is an element of a claim or defense.” Nev. Rev. Stat. §49.245(3). Maybe that could be read to allow informal interviews, maybe not. Voluntary informal interviews were okay in Stewart v. Women in Community Service, Inc., 1998 WL 777997, at *3-5 (D. Nev. Oct. 7, 1998), but that decision was under federal, not state, law. Id. at *3. Informal interviews were allowed under the statute in Parker v. Upsher-Smith Laboratories, Inc., 2009 WL 418596 (D. Nev. Feb. 18, 2009), and plaintiff's counsel sanctioned for interfering with them.

New Hampshire

You can’t have informal interviews in the Granite State unless the other side agrees and opposing counsel is present. Nelson v. Lewis, 534 A.2d 720, 723 (N.H. 1987). Why bother?

New Jersey

The Garden State ostensibly allows informal defense interviews with treating physicians. Stempler v. Speidell, 495 A.2d 857, 864-65 (1985); In re Diet Drug Litigation, 895 A.2d 493, 504 (N.J. Super. 2005). However, parts of New Jersey have become “judicial hellholes,” and in some mass torts, New Jersey trial courts have systematically ignored Stempler, and refused to allow informal interviews at all. E.g., Smith v. American Home Products Corp., 855 A.2d 608, 625 (N.J. Super. 2003).

New Mexico

Informal interviews are a no go in the Land of Enchantment. Smith v. Ashby, 743 P.2d 114, 115-16 (N.M. 1987); Gomez v. Nielson’s Corp., 894 P.2d 1026, 1029 (N.M. App. 1995).

New York

As we’ve already discussed at some length, informal interviews with plaintiffs’ treaters are (subject to notice and filling out some forms) allowed, and indeed encouraged, in the Empire State. Arons v. Jutkowitz, 880 N.E.2d 831, 837 (N.Y. 2007); see id. at 842-43 (rejecting HIPAA preemption).

North Carolina

The Tar Heel State may be a favorable defense forum in other respects, but not when it comes to informal treater interviews. North Carolina law prohibits informal interviews unless the plaintiff gives his or her express consent. Crist v. Moffatt, 389 S.E.2d 41, 45-46 (N.C. 1990).

North Dakota

North Dakota state courts have not ruled on whether defendants may have informal interviews with treating physicians. But federal courts have not been receptive. In Weaver v. Mann, 90 F.R.D. 443, 445 (D.N.D. 1981), the court interpreted the Federal Rules as precluding informal discovery, even while conceding that any privilege had been waived. In Bohrer v. Merrill-Dow Pharmaceutical, Inc., 122 F.R.D. 217, 218-19 (D.N.D. 1987), the court refused to compel plaintiffs to authorize informal interviews. In the past twenty-plus years, nothing in the Peace Garden State.


The Buckeye State has surprisingly little law on this subject for such a large jurisdiction. Federal courts go both ways. In Bouchard v. American Home Products Corp., 213 F.Supp.2d 802, 805 (N.D. Ohio 2002), the court found insufficient Ohio precedent to preclude an informal meeting between defense counsel and a treating physician. More than thirty years earlier, another federal judge said such contacts were not allowed. Hammonds v. Aetna Casualty & Surety Co., 243 F. Supp. 793, 800 (N.D. Ohio 1965) (applying state law). The state courts are essentially silent, while in In re American President Lines, Ltd., 929 F.2d 226, 227 (6th Cir. 1991), the court had nothing against informal interviews except that they couldn’t be timely scheduled to fit within the trial court's discovery deadlines.


Defense counsel can have informal physician interviews in the Sooner State. Holmes v. Nightingale, 158 P.3d 1039, 1046 (Okla. 2007). There was no HIPAA preemption either. Id. at 1041.


There’s no case law on informal physician interviews in the Beaver State, but given the language of Oregon’s physician/patient privilege statute, Ore. Rev. Stat. §40.235(2), we doubt that informal discovery would be allowed, absent consent.


There’s no privilege, but under Pa. R. Civ. P. 4003.6, informal communication between defense counsel and a plaintiff’s treating physician is prohibited in the Keystone State.

Rhode Island

We can’t go informal in the Ocean State either. R.I. Gen. Laws §5-37.3-4 (“Disclosure by a health care provider of a patient’s health care information which is relevant to a civil action brought by the patient against any person or persons other than that health care provider may occur only under the discovery methods provided by the applicable rules of civil procedure . . . . This disclosure shall not be through ex parte contacts and not through informal ex parte contacts with the provider by persons other than the patient or his or her legal representative”).

South Carolina

We think the Palmetto State permits informal interviews. A federal court so held. Felder v. Wyman, 139 F.R.D. 85, 88 (D.S.C. 1991). Brown v. Bi-Lo, Inc., 581 S.E.2d 836, 838 (S.C. 2003), doesn’t appear to be contrary, as it involved a statute that expressly restricted means of communicating with treating physicians in workers compensation proceedings.

South Dakota

We’d be reluctant to have informal interviews in the Mount Rushmore State. While not directly on point, Schaffer v. Spicer, 215 N.W.2d 134, 137 (S.D. 1974), cited cases hostile to informal discussions. In DeNeui v. Wellman, 2008 WL 2330953, at *3-4 (D.S.D. June 5, 2008), the court allowed a treater to have informal contact with his own counsel (how generous), but “agreed” in dictum that defense counsel could not.


The Tennessee Supreme Court prohibited informal meetings with treaters in Alsip v. Johnson City Medical Center, 197 S.W.3d 722, 724 (Tenn. 2006).  The legislature in the Volunteer State has abrogated Alsip for medical malpractice actions, Tenn. C. Ann. §29-26-121(f), but that  statute leaves counsel for product liability defendants out in the cold.


Pursuant to statute, Tex, Civ. Prac. & Rem. C. §74.052, informal interviews between defense counsel and plaintiffs’ treaters are permitted in the Lone Star State.  Its application to informal interviews was confirmed in In re Collins, 286 S.W.3d 911, 919-20 (Tex. 2009). Furthermore, there's no HIPAA preemption either.  Id. at 920.  One more reason to like litigating in (most parts of) Texas.


We just lost the informal communication issue in the Beehive State. Sorensen v. Barbuto, 177 P.3d 614, 619-20 (Utah 2008).


There’s no law in the Green Mountain State on informal physician-opposing counsel meetings. See Hawaii. Vermont's a pretty tort-liberal state (see Wyeth v. Levine), so be careful.


We think that the clear implication of the Virginia Supreme Court’s decision in Maxey v. Hubble, 385 S.E.2d 593, 597 (Va. 1989) - reversing a verdict for “improper statements” that the defendant did something shady in having informal interviews with the plaintiff's treaters - is that the Old Dominion permits such interviews. Nonetheless, a federal court interpreted Virginia law to prohibit what the court in Maxey had no problem with. McCauley v. Purdue Pharma, L.P., 224 F.Supp.2d 1066, 1069-70 (W.D. Va. 2002). Thus, be careful what you do in Virginia.


We can’t have informal contact with treaters in the Evergreen State under Loudon v. Mhyre, 756 P.2d 138, 140 (Wash. 1988), unless we’re in workers compensation proceedings. Holbrook v. Weyerhaeuser Co., 822 P.2d 271, 274-75 (Wash. 1992). Do it, and you’re liable to have your evidence excluded. Rowe v. Vaagen Brothers Lumber, Inc., 996 P.2d 1103, 1110 (Wash. App. 2000).

West Virginia

West Virginia took the top spot in the 2008 hellhole jurisdiction sweepstakes. Why should the Mountain State's law on informal defense contact with treaters be any exception? It isn’t. State ex rel. Kitzmiller v. Henning, 437 S.E.2d 452, 455 (W. Va. 1993).


The Badger State frowns on informal interviews of treaters by defense counsel. Steinberg v. Jensen, 534 N.W.2d 361, 371 (Wis. 1995) (counsel “may not engage in ex parte ‘discovery’” with treaters, such as “a private question and answer session”). Informal questions must be in writing with a copy to opposing counsel. Id.

Wyoming law does not compel physicians to have informal interviews with defense counsel. Wardell v. McMillan, 844 P.2d 1052, 1065-67 (Wyo. 1992). Wardell pointed out that it was not addressing voluntary cooperation, however. Id. at 1067 n.15. On voluntary interviews, we’d like to think that the Equality State would follow its nickname. Our comment to Hawaii applies here.

Tuesday, December 16, 2008

Gunvalson v. PTC Therapeutics: Injunction Reversed

The Third Circuit just issued its opinion in Gunvalson v. PTC Therapeutics (link here), the case in which a trial court issued an injunction requiring a drug company, PTC Therapeutics, to provide an experimental drug to a patient outside of the context of a clinical trial. (One of our many earlier posts on the subject is here. Others have followed the case, among other places, here.)

The Third Circuit reversed the trial court opinion for two reasons. First, the Gunvalsons did not prove the existence of a "clear and definite promise" needed to support a promissory estoppel claim; second, the Gunvalsons did not "reasonably rely" on any promise that PTC may have made:

The promises the Gunvalsons assert that PTC and its officers made to them lack the requisite specificity and clarity required to succeed under the theory of promissory estoppel.
. . .

The district court erred in its analysis by failing to recognize the Gunvalsons did not enroll Jacob in the Phase 2a trial because Dr. Finkel, the principal investigator for the Philadelphia area clinical trial, ruled Jacob ineligible based on the medical records Mrs. Gunvalson provided him, and not because the Gunvalsons had been promised PTC 124 via some other means.
. . .

As we explained in open court following oral argument, we are sympathetic to the plight of Jacob and his family. Similarly, we are moved by the Gunvalsons' heroic efforts on behalf of their son and others afficted with this devastating disease. Nevertheless, we are constrained by the law to conclude that the Gunvalsons cannot demonstrate either a clear and definite promise or detrimental reliance, requirements for a promissory estoppel claim. Accordingly, because the Gunvalsons have not shown a reasonable probability of success on the merits, the district court abused its discretion in granting the preliminary junction. We will, therefore, vacate the order granting the preliminary injunction and remand for further proceedings.

New York, New York (reprise)

We posted last year about the NY Court of Appeals excellent decision in Arons v. Jutkowicz, on defense interviews with treating physicians.

We're doing it again. Here's a copy of the Court of Appeals (that's the state's highest court) recent decision in Adamo v. Brown & Williamson holding that, where a product's only function is satisfying the consumer, the plaintiff must show that the safer "alternative" "is as acceptable to consumers as the one the defendant sold." Slip op. at 4. This gives real teeth to the safer alternative design requirement in New York.

In short, a plaintiff can't just offer up some other product as a safer design. We've run into this a lot in medical device litigation, and even some in drugs. So it's a ruling we're happy to see. We also like to see courts reject arguments that amount to automatic liability:
But it is still lawful for people to buy and smoke regular cigarettes, and for cigarette companies to sell them. To hold, as plaintiffs ask, that every sale of regular cigarettes exposes the manufacturer to tort liability would amount to a judicial ban on the product. If regular cigarettes are to be banned, that should be done by legislative bodies, not by courts.

Slip op. at 5.

There's more we could say, but both of our firms represent tobacco companies - so we won't.

Amending FAS 5 -- An Update

The Financial Accounting Standards Advisory Council held a public meeting yesterday to discuss the proposed amendment to FAS 5, which deals with the disclosures that publicly traded companies must make about litigation. (We previously posted on that topic this summer.)

Here's a link to the agenda for that meeting.

We've heard through the grapevine that FASB is now considering an alternative to the original proposed amendment to FAS 5. Under the alternative, companies would have to disclose the nature of a claim, a qualitative description of the potential effect of a negative outcome on operations and liquidity, historical information on the outcome of similar claims, information about the proposed class period for class action securities litigation, and any information available from independent studies. The proposal will also have an exception saying that no prejudicial information need be disclosed.

FASB hopes to release the revised proposed amendment in the second quarter of 2009.

Blog Honors

We were pleased to see that USPharmD included us in its list of the "Top 50 Medical Ethics Blogs." Lord knows, we're not medical ethicists, but the list includes other topics, such as "medicine and the law" and "pharmaceuticals," so at least we're in the neighborhood. More importantly, you may find the other blogs on the list to be of interest.

While we're on the subject of "blog honors," please don't forget that the ABA Journal picked Drug and Device Law as one of the top 100 legal blogs on the web. And the ABA is now conducting a "reader's choice" poll to select the best of the best. We could use your support; vote here.

Given our comparatively small readership, we feel outgunned in this contest. So we're resorting to tactics suggested by one of our home state governors:

We know you won't give away your [bleeping] vote for free. We'll pay you for it! Vote for us; we'll send you a check. Remember: Beck and Herrmann -- Vote for us and nobody gets hurt.

(It felt like a privilege to live in Chicago on election night, just six weeks ago. How quickly times change.)

On Communicating By E-Mail

Herrmann's book, The Curmudgeon's Guide to Practicing Law, has a chapter about "couth" that discusses, among other things, communicating by e-mail.

He's now had two reactions to that chapter that he just has to share.

First, right after the book came out, an inside counsel offered this rant about lawyers communicating with clients by e-mail:

"Don't send me an e-mail transmitting a devastating loss that we just suffered in litigation and then head out to lunch for two hours! When I get that e-mail, the first thing I'm going to do is call to ask about the implications of the decision and how we should react to it. When I call, your secretary can't tell me, 'I'm sorry. He just left for lunch and won't be available until 2:30.'"

More recently, Herrmann gave his Curmudgeon "book talk" as the keynote address at St. John's Law School's "Practice Meets Pedagogy" conference. (Remarkably, here's an action shot of that talk.) Another speaker at the conference, Tracy McGaugh of the Touro College Jacob D. Fuchsberg Law Center, offered this tidbit about e-mail as a medium for transmitting a message:

Some things have to be communicated in the right way and with the right attitude. You simply can't send an e-mail with a "subject" line that says "Appeal Denied" transmitting this message:

Court denied your appeal. U will B executed Saturday. Thx. :)

With more examples like this, Herrmann may have to write a second edition of Curmudgeon some day.

Heaven help him.

Monday, December 15, 2008

What Does Good Say For Levine?

We hear you! We hear you!

We're slaving away at our day jobs, and you keep asking, "What does the Supreme Court's decision in Altria v. Good mean for the pending case of Wyeth v. Levine?"

For assorted reasons, we can't say much on this topic, but we offer these few words:

The bad in Good:

Five justices opposed preemption on some pretty preemption-friendly facts.

The good in Good:

The Solicitor General weighed in against implied preemption in Good, and the Court followed the SG's lead. (As you know, the SG weighed in favoring preemption in Levine, so deference to the SG would be helpful there.)

Altria v. Good Decided

By a five-to-four vote, the Supreme Court just ruled against preemption in the "light cigarette" case of Altria v. Good.

Here's a link to the opinion at the Supreme Court website.

A Look At Some Recent Scholarship

We've stumbled across a few law review articles recently.

We know and bemoan (as do many scholars and most practitioners) that practicing lawyers don't actually read the law reviews these days. We thought we'd share with you the gist of a few recent offerings, so that you could take a look if anything grabs your eye.

First, Gideon Parchomovsky and Alex Stein have posted their forthcoming article in the Michigan Law Review, "Torts and Innovation." The professors argue that tort liability for negligence, product liability, and medical malpractice is assessed by looking at custom. By looking backwards -- to custom and existing technologies -- to judge liability, the law discourages innovators and subsidizes replicators of existing technologies. To solve this problem, the professors propose, among other things, to deem industry customs to be irrelevant in product liability cases.

We have some qualms about that - because tort law is supposed to be "backward looking" - that's what "due care" is. And, as a practical matter, to the extent that industry custom is dictated by the government, we think compliance should be a defense, and certainly not irrelevant.

To calm people who, like us, are concerned about the strong-form of their proposal, Parchomovsky and Stein have an alternative. They suggest keeping the custom rules and creating special boards of industry experts to designate some innovations that have a privileged status equal to custom. We have mixed feelings about this. On the one hand, if we want the economy to remain vibrant and society to benefit from advances in science, we surely should not implement rules of tort law that discourage innovation. On the other hand, we always get nervous when people start proposing to use tort law as a vehicle for social change.

Second, Frank McClellan analyzes the Vioxx litigation in a recent issue of the Depaul Law Review. Here's a link to "The Vioxx Litigation: A Critical look at Trial Tactics, the Tort System, and the Roles of Lawyers in Mass Tort litigation." We're less impressed with this than we are with the Parchomovsky and Stein piece. McClellan argues that the mass tort litigation process is inefficient and expensive. (Film at 11!) But he then lays the blame for this on defendants, and suggests that the solution is to pass "a rule or statute that subjects defendants to a monetary penalty, such as treble damages" for insisting that they're going to try every case.

How many ways do we disagree with McClellan? Let us count the ways:

First, at the time McClellan's article went to press, the 14 Vioxx trials had "resulted in nine wins for Merck and five wins for plaintiffs." Article at 510. But two of those plaintiffs' verdicts were later reversed on appeal. Is it really unreasonable to refuse to settle cases that a defendant is overwhelmingly likely to win at trial?

Second, as Ted Frank has explained elsewhere, empirical analysis suggests the plaintiffs' Vioxx cases were weak. Why should the rules threaten only defendants, and not plaintiffs, with sanctions for taking aggressive settlement positions?

Third, as most observers of complex litigation agree, one real problem with the current system for adjudicating mass torts is that lawyers file claims on behalf of plaintiffs who never ingested the defendant's product, never suffered any injury, or have only the most implausible 'proof' of causation. (We're thinking of the caryrover paragraph between pages 3 and 4, but the whole letter is worth a read.) Wouldn't the system be improved by figuring out a way to separate the wheat from the chaff, rather than trying to coerce defendants to settle?

Fourth, McClellan ignores the overall strategic pressures that defendants face in mass torts. If defendants pay large settlements in early cases, they simply chum the waters, encouraging plaintiffs' counsel to file more lawsuits. If, instead, defendants defend the early cases aggressively, defendants may be able to discourage the filing of more cases, await the running of the statute of limitations, and then settle on reasonable terms. Do we really want to pass rules or statutes that prevent defendants from acting rationally?

We could go on in this vein, but we're getting apoplectic. We'll move on to a third, and last, recent law review article.

Lance McMillan has posted on SSRN "The Nuisance Settlement 'Problem': The Elusive Truth and A Clarifying Proposal." The piece of the abstract that we like is this:

"Ultimately, whether a particular plaintiff intends to abuse the legal system by filing a meritless claim comes down to this inquiry: what did the plaintiff know and when did the plaintiff know it? To aid in answering this question, this Article proposes a five-part test for determining nuisance intent. The test focuses the nuisance analysis on how a plaintiff acts to determine what that plaintiff actually believes. It is not enough to look at the face of a complaint and try to divine conclusions about the plaintiff's state of mind. Something more is needed. The test I propose aims to provide that something more. On the deterrence side, I then propose the Nuisance Litigation Sanctions Act, which combines the nuisance intent test with a number of small but important procedural changes designed to heighten the ability of defendants to seek relief against nuisance filings."

Now that's a breath of fresh air.

Thursday, December 11, 2008

DoJ/FDA Take Positions On §337(a), “Parallel” Requirements Litigation

We’ve been following the long migration of Farm Raised Salmon for some time now. Our prior posts on the California Supreme Court’s decision and on the Supreme Court’s request for the government’s views on the defendants’ certiorari petition are here, here, here, and here, respectively.

While Farm Raised Salmon is a food preemption case, it does involve some analogous issues. Our last post speculated on two such issues: (1) how much of a barrier to state-law litigation is 21 U.S.C. §337(a), granting exclusive FDCA enforcement authority to the federal government, and (2) assuming that the first issue is not dispositive, what kinds of “parallel” state-law claims are allowed by §337(a), and thus by implication, the Supreme Court’s decisions in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We described these as “sleeper” issues, and indicated that we would be very interested in what the government (the Department of Justice representing the FDA) was going to say about them in the amicus brief that the Supreme Court requested.

Well, the government filed its brief recently – and it seems that the issues are still sleeping. Nobody – not even (as far as we can tell) the Supreme Court junkies over at SCOTUSblog – has had anything to say about the government’s amicus brief in Albertson’s, Inc. v. Kanter, No. 07-1327 (filed Dec. 12, 2008), since it was filed last Friday. Heck, we didn’t even know it had been filed until this morning.

All this means is that, once again, we’ll be filling a much-needed gap in the blogosphere.

So what did the government have to say about these two issues we'd spotted? Briefly: (1) not much, and (2) really, really parallel.

Split decision.

Bottom line is that the DoJ/FDA thinks that the California Supreme Court's result in Farm Raised Salmon was correct, and that the U.S. Supreme Court should not grant an appeal. Amicus br. at 1.

The Government’s Position On §337(a)

As for §337(a), the government’s position is essentially, as long as the state-law claims actually are “parallel” (more to say about that in a bit) it’s open season for state litigants (including private state-law litigants) to bring actions that enforce standards “identical” to those set by the FDA. As a practical matter, that shouldn’t be all that surprising, we suppose. As we’ve discussed before, to make preemption work generally requires a strong administrative regime. And given some of the legitimate (we discount the self-interested bleatings of our litigation opponents) criticism the FDA has received recently, from an administrative perspective, it probably makes sense to enlist the help of states (and private attorneys general) that are willing to be of service – as long as the FDA ability to call the tune isn't jeopardized.

Still, we had hoped for better as to §337(a) itself – outside of the food area, where a subsequent amendment specifically authorizes a state role.

The DoJ/FDA amicus brief starts off (pp. 8-11), appropriately enough, with a discussion of 21 U.S.C. §341-1, the statutory savings clause for food, which effectively amended §337(a)’s exclusive jurisdiction language to provide for a limited degree of concurrent state enforcement in the food area. We’re not going to get into that because we’re drug and device guys and all we know about seafood – well, when we see food, we eat it.

Yeah, we know.... our humor smells like a dead fish, doesn't it?

What’s of more interest to us is the government’s position on §337(a) itself. The DoJ/FDA summarized that position:

Although 21 U.S.C. 337 precludes private actions to enforce the FDCA itself, Section 337 does not prohibit private actions to enforce parallel state requirements. A particular state-law suit might, in certain circumstances, impliedly conflict with provisions of the FDCA, implementing regulations, or a particular determination or enforcement action by FDA, but respondents’ suit poses no such conflict.

DoJ/FDA amicus br. at 8.

The government then addressed §337(a) itself – in the context of a defense argument that we suppose they had to make about the exclusivity purpose of this section effectively trumping the later addition of §343-1. The DoJ/FDA took the position that §337(a) is limited to prohibiting private actions directly under the FDCA, and does not restrict “identical” state-law cause of action:
Section 337 “applies only to proceedings to enforce the [FDCA. . .and] does not prohibit a State from enforcing an identical State law.” Similarly, Section 337 does not prohibit a State from authorizing private suits to enforce such a law.

DoJ/FDA amicus br. at 12 (quoting 58 Fed. Reg. at 2458 (1993)).

The government maintains a distinction between actions under the FDCA itself (prohibited §337(a)) and state law actions (not reached by §337(a)) even where those actions enforce “identical” standards. DoJ/FDA amicus br. at 12-13. Thus, the California statute (which “directly incorporate[d] regulations promulgated under the FDCA,” id. at 3) remained an action under "state" law even though all of the substantive standards were federal:

Actions to enforce state laws that impose requirements identical to those under the FDCA are not actions to enforce the FDCA itself. . . . Respondents’ suit can be resolved with reference to state law alone. . . . Although [the California] requirement mirrors the FDCA’s requirement. . .respondents can prove that petitioners violated the [California] Law requirement without even referring to the FDCA.
Id. at 12-13. It's pretty clear that the DoJ/FDA ain't buying what we once characterized as the “maximalist” preemption position with respect to “parallel requirements” litigation.

The government viewed the California claims as not preempted by §337(a) because they were the sort of “parallel requirements” claims discussed in Lohr: involving substantive federal standards to which non-substantive state-law elements (“such as damage or injury as a result of the violation”) were appended. DoJ/FDA amicus br. at 14 & n.2. Neither Lohr nor Riegel, the government argues, could have been decided the way they were had §337(a) “imposed a blanket prohibition on such claims.” Id. at 15.

As defense lawyers, we have some problems with this analysis, but those problems are primarily practical. We’ve simply seen enough purportedly “parallel” claims that aren't, that we tend to doubt that it’s even possible for private litigants to confine themselves to merely echoing the FDA’s dictates. Inevitably, they add (or subtract) something in the governing regulations. It’s such a pervasive phenomenon that it’s probably inherent in any situation where the government isn’t actually doing the enforcing.

We’d much prefer to cut off problems with non-parallel "parallel requirements" at the source, by reading §337(a) to preclude, in the first instance, anybody else from intruding upon what the Supreme Court described in Buckman as the FDA’s “exclusive” enforcement authority. 531 U.S. at 352.

But we can't help Lohr - because we didn't invent the §337(a) argument until what ultimately became Buckman.

Still, for the most part, those practical problems could also be addressed (if less efficiently) through strict adherence to the FDA’s definition of “parallel requirements,” which we will be discussing shortly (pain before pleasure).

But there’s one point where the government simply takes an ex cathedra position – one with no support whatever – that seems to us quite unwarranted. That occurs on pages 16-17 of the DoJ/FDA amicus brief, where the government states:

If Section 337(b)’s restrictions on a State’s direct enforcement of the FDCA itself do not preempt or otherwise restrict a State’s enforcement of its own parallel state requirements, then it follows that Section 337(a)’s restrictions on private enforcement of the FDCA likewise do not preempt a State from allowing private suits based on those parallel state requirements.
To us, one doesn’t follow the other. Congress often permits concurrent enforcement of federal law by the states themselves, and sometimes even mandates it. But opening things up to enforcement by an unending stream of difficult-to-control private entities – well, when Congress intends that (and it has on quite a number of occasions), it says so. Here, the government doesn’t cite anything authorizing private, non-state actors to sue, because there isn’t anything.

It’s not that the “interest in uniformity” is “unyielding. DoJ/FDA amicus br. at 17. Of course it can yield – it has here, as the government properly points out, with §343-1 (and with §337(b)). But that’s the way it should be done, through act of Congress. Otherwise, §337(a) really has no purpose except keeping cases out of federal court that probably (since they involve allegations that federal standards have been violated) should be there. Section 337(b) explicitly recognizes a state role. There's nothing in the FDCA recognizing a private enforcement role - and nothing in the legislative history of the act (because the government would have cited it) that Congress had any idea that any state would do what California has done and pass a statute generally allowing private suits under other statutes (such as California's little FDC ("Sherman") act).

The Government’s Position On “Parallel Requirements”

That's enough pain.

One thing we can say, if the government’s position on §337(a) were accepted, then defense counsel are going to have to become a lot more familiar with purely state-law grounds for restricting statutory violation claims, such as these:

  • Violation claims are improper where inconsistent with legislative intent – particularly the intent (identical to the undisputed intent of §337(a)) that statutes not include private causes of action.

  • Violation claims are improper where they would impose novel duties (like reporting adverse product experience to the government) not analogous to the common law.

  • Violation claims are improper where the alleged violation was of something lacking full force of law (such as an FDA guidance document).

  • Violation claims are improper where the enactment that was violated imposed only vague or imprecise standards (like the misbranding/adulteration sections of the FDCA).

  • Violation claims are improper where only a licensing requirement is involved (particularly important in off-label use cases).

  • Violation claims (in some states) are only permitted for violations of statutes, and not for violations of administrative regulations.
As a primer on these points we offer our prior post, “Defenses to FDCA-Based Negligence Per Se.”

Beyond that, we also recommend what the DoJ/FDA amicus brief has to say about what an unpreempted “parallel requirements” case really is – because if “parallel” isn’t really parallel, the government is quite clear that implied conflict preemption is proper:

[P]rivate suits under state law to enforce state food-labeling requirements that parallel FDCA requirements do not necessarily pose a conflict with the FDCA or its enforcement scheme. . .[but u]nless the state requirement is “identical” to the federal requirement, or the statute or FDA grants an exemption, the state-law suit will be preempted.
Id. at 17 (emphasis added).

Language like that leaves us pretty well satisfied with what DoJ/FDA have to say about the scope of “parallel requirement” litigation for purposes of preemption. The Government equates the statutory savings clause for food, 21 U.S.C. §341-1, with what the Supreme Court has called “parallel requirements” in preemption cases since Lohr. Substantively, a “parallel” action cannot do anything beyond enforcing what the FDA has already decided. These are:
private actions to enforce state requirements that mirror FDCA requirements [in] accord[ance] with this Court’s interpretation of similar preemption provisions. In Lohr, the Court construed 21 U.S.C. 360k. . . . The Court concluded that Section 360k does not preempt “State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the [FDCA].” 518 U.S. at 496-497 (emphasis added).
DoJ/FDA amicus br. at 10. The government goes on to cite discussions of state “parallel requirements” litigation in Riegel and Bates – particularly the Bates language describing such litigation as involving claims “equivalent to, and fully consistent with” pre-existing government standards. Id. at 11 (quoting Bates, 544 U.S. at 447).

Thus, the government takes a firm position that purportedly “parallel” claims that weren’t really parallel are subject to implied conflict preemption regardless of either §§343-1 or 337(a). DoJ/FDA amicus br. at 10 n.1 (citing government position in Wyeth v. Levine).

Thus, whenever a plaintiff bringing a supposedly “parallel requirements” action seeks to play fast and loose with how the FDA has interpreted a regulation, the claim should be preempted:

Even a suit to enforce an identical state requirement would be preempted if the particular suit actually conflicted with provisions of the FDCA, implementing regulations, or an administrative determination or enforcement action by FDA.
DoJ/FDA amicus br. at 18 (emphasis added).

Thus the DoJ/FDA effectively adopts our “third argument” in support of preemption of “parallel requirements” litigation – that purportedly “parallel” claims must be “genuinely” parallel (phrasing from Bates, 544 U.S. at 454) or else cannot escape preemption. Importantly, the government explicitly states that the requirement of actual parallelism applies to both formal and informal FDA decisions – not just the statute, not just FDA regulations – but also to FDA “administrative determinations” and “enforcement actions.” Id.

To us, it’s in the informal, day-to-day enforcement activity of the FDA that's where the rubber figuratively meets the road in “parallel requirements” cases. Plaintiffs routinely misconstrue the FDCA and FDA regulations (such as good manufacturing practices) to invent requirements that aren’t there or to twist those that are. Given what we’ve seen, so as long as preemption strictly enforces the FDA’s own reading of the regulatory scheme it administers, then we wouldn’t be surprised if 90% of all purportedly “parallel requirements” claims end up preempted. Medical device cases, where “parallel requirements” claims have been litigated the longest, provide support for this notion. See, e.g., McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (“[w]here a federal requirement permits a course of conduct and the state makes it obligatory,” the state requirement is no longer parallel and “is preempted”); Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2000) (supplemental premarket approval “d[id] not include” the requirement asserted by plaintiff; to permit liability for purported non-compliance with an incorrectly stated FDA requirement “would be to impose a requirement different from and in addition to those established by the FDA”); Parker v. Stryker Corp., ___ F. Supp.2d ___, 2008 WL 4716879, at *4 (D. Colo. Oct. 22, 2008) (state-law claims “not saved merely by being recast as violations of the federal adulteration and misbranding statutes”; dismissing vague violation claim for lack of “factual detail to substantiate that crucial allegation”); Clark v. Medtronic, Inc., 572 F.Supp.2d 1090, 1095 (D. Minn. 2008) (“[b]ecause plaintiff’s claims are not based on a breach of the [statute] as enforced by the FDA, the claims are not grounded in state laws that ‘parallel’ federal requirements”). Surviving claims would probably encompass little more than situations where the FDA had actually prosecuted a violation based upon its own reading of its regulations. Cf. Purcel v. Advanced Bionics Corp., 2008 WL 3874713, at *1 (N.D. Tex. Aug. 13, 2008) (parallel claim stated based upon FDA violation letters).

Beyond device cases, we’ve collected food, pesticide, and other precedent reaching similar conclusions, here.

And on this critical point, it turns out that the government even goes us one better. The DoJ/FDA demand for actual parallelism applies to matters of remedy as well. Thus, even where the FDA has itself found a violation, a plaintiff cannot allege that the product at issue should have been recalled where the FDA did not order a recall. DoJ/FDA amicus br. at 18 (private plaintiffs cannot demand recall where, due to “negligible” risk, FDA enforcement was limited to a prospective label change). See Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (“[a]ny claim. . .that Defendant. . .failed to recall a product” would “not parallel federal safety requirements” and was preempted).

We’ve made the same point ourselves in some of our prior discussions of “parallel requirements” claims, most thoroughly, here. We’re pleased indeed that the government essentially agrees with us that the “parallel” element of a “parallel requirements” claim must be strictly enforced, and that divergent claims unlike those in in Albertson’s (brought under a state statute that outright incorporated relevant FDA standards) would be preempted.

Thus the DoJ/FDA amicus brief both giveth and taketh away. It doesn’t go for the broad §337(a)-based preemption argument that we’ve advocated as a basis for eliminating altogether state-law actions that are functionally no different than private attempts to enforce the FDA. But the government does adopt the arguments we’ve made that “parallel requirements” claims must be “identical” and “genuinely” parallel in order to escape preemption. While we wouldn’t have made that swap (it’s cheaper to win on a motion to dismiss than on summary judgment), we’re not looking to jump out of any windows either.