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The other day, we did a quickie post on the state court Sprint Fidelis win for Medtronic here, as soon as we got it. If you’re a subscriber then that’s where you probably learned about the case, since we were first on the Internet with it.

Today, we’re going to look at certain aspects of the decision (now also available at 2009 WL 3417867). Specifically, we want to go over the non-preemption aspects of the decision.

Why? you ask. Aren’t we supposed to be “all preemption, all the time”?

Well – no. For one thing, as we mentioned in the quickie post, the state court Sprint Fidelis preemption analysis largely tracked the earlier federal court decision on the same subject. In re Medtronic Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009). We already analyzed that preemption analysis at quite some length, here, shortly after the federal decision came down. Except for citing some newer precedent, most notably Covert v. Stryker Corp., ___ F. Supp.2d ___, 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) (which we told you about here), it’s not so much different on preemption to warrant a new long post on that subject.

Second, since the Supreme Court has decided the basic preemption framework for both drugs and devices, there’ve been other things in the drug/device universe than the FDA and preemption.

Like Twombly/Iqbal, for instance?

Yeah, that’s a good start. Maybe we’ll become all pleading all the time.

Anyway, one of the more interesting things that we noticed in what we’ll call “state Sprint Fidelis” or SSF for short, is footnote 9 (slip op. pp. 16-17). It’s not even about anything the court decides.

So what’s up?

Footnote 9 contains news we didn’t know – specifically that the Minnesota Supreme Court has a pending appeal in which it will consider whether to interpret the Minnesota state version of Fed. R. Civ. P. 8 in accordance with Bell Atlantic v. Twombly, 550 U.S. 544 (2007). We don’t know how that Minnesota appeal (having nothing to do with drugs/devices) will turn out, but just the fact that it exists points to an important issue:

A lot of states’ rules of civil procedure mirror the federal rules. Thus, these states could – although they don’t have to – apply the Supreme Court’s improved pleading standards to their own state court litigation. As good as Twombly/Iqbal is, our clients face at least as many (and often more) suits in state court as in federal court. We’d like for Twombly/Iqbal to apply in state court, too.

Being the compulsive types we are, we decided to see if there were any states where any appellate court had adopted Twombly/Iqbal. We’re in luck. There are some.

In addition to the Minnesota intermediate appellate court decision now under review, Bahr v. Capella University, 765 N.W.2d 428, 437 (Minn. App. 2009), Twombly/Iqbal has made inroads in several other states.

Most notably, the Supreme Judicial Court in Massachusetts specifically “t[oo]k[] the opportunity to adopt the refinement” to the pleading standards that Twombly enunciated:

We agree with the Supreme Court’s analysis of the Conley language. . ., and we follow the Court’s lead in retiring its use. The clarified standard for rule 12(b)(6) motions adopted here will apply to any amended complaint that the plaintiffs may file.

Iannacchino v. Ford Motor Co., 888 N.E.2d 879, 890 (2008). That’s one.

The South Dakota Supreme Court has also followed Twombly/Iqbal. See Gruhlke v. Sioux Empire Federal Credit Union, Inc., 756 N.W.2d 399, 409 (S.D. 2008); Sisney v. State, 754 N.W.2d 639, 643 (S.D. 2008); Sisney v. Best, 754 N.W.2d 804, 80809 (S.D. 2008) (“adopt[ing] the Supreme Court’s new standards”). That’s two.

The Maine Supreme Court, noting that the state’s relevant rule was “practically identical” to Fed. R. Civ. P. 8, followed Twombly in Bean v. Cummings, 939 A.2d 676, 680 ¶ 10 (Me. 2008). That’s three.

And, perhaps reflecting its federal roots, the highest court in the District of Columbia has applied Twombly/Iqbal pleading standards several times, in Murray v. Motorola, Inc., ___ A.2d ___, 2009 WL 3459991, at *_ & n. 32(D.C. Oct. 29, 2009) (that’s today folks – presumably why there’s no page number); Grayson v. AT & T Corp., ___ A.2d ___, 2009 WL 2957812, at *4 nn.16-21 (D.C. 2009), and Clampitt v. American University, 957 A.2d 23, 29 (D.C. 2008). That’s four.

The Georgia Supreme Court cited Twombly with approval in Charles H. Wesley Education Foundation, Inc. v. State Election Board, 654 S.E.2d 127, 132 n.7 (Ga. 2007). That may be five, but we haven’t seen anything since out of the Peach State on this subject, so we’re reluctant to call that one on the basis of a single footnote.

Intermediate appellate courts in some other states also have followed Twombly/Iqbal. In Tennessee, the Middle Division of the state’s intermediate appellate court found Twombly “consistent with” state law, and therefore followed it, in Hermosa Holdings, Inc. v. Mid Tennessee Bone and Joint Clinic, P.C., 2009 WL 711125, at *3 (Tenn. App. Mar. 16, 2009). It’s kept it up ever since: Western Express, Inc. v. Brentwood Services, Inc., 2009 WL 3448747, at *9-10 (Tenn. App. Oct. 26, 2009); Deja Vu, Inc. v. Metropolitan Government, 2009 WL 3270195, at *5 (Tenn. App. Oct. 12, 2009). A Louisiana appellate court adopted Twombly in a state antitrust action in Tuban Petroleum, L.L.C. v. SIARC, Inc., 11 So.3d 519, 523 (La. App. 2009). Ohio joined the parade in Gallo v. Westfield National Insurance Co., 2009 WL 625522, at *2 ¶9 (Ohio App. Mar. 12, 2009), applying several aspects of the Twombly pleading standards.

All in all, we’re pleasantly surprised by the degree of acceptance of Twombly/Iqbal by state courts. On the merits, significantly more states have adopted it than have declined. Indeed, almost all of the state courts not following the new federal standard have done so only because they were intermediate courts, and the existing standard were set by their supreme court’s interpretation of the state’s equivalent to Rule 8 (usually following Conley), which they were obliged to follow.

Anyway, that’s one interesting non-preemption point raised in SSF. There are others relating to violation claims that bear discussion.

On page 40 of the SSF slip opinion, the court addressed a claim that, supposedly, the defendant violated some FDA regulation that required it to submit a supplemental PMA application for each and every modification to the device, no matter how trivial. After holding that there was no such regulation, the court said something else of interest: “claims predicated upon the alleged failure to submit PMA Supplements do not seek to enforce any common-law duty.” Id.; see also id. at 42 n.28.

That’s important not only as a statement of a preemption principle (that a claim isn’t “parallel” if there’s no analogous state law claim), but also as an interpretation of the common law itself. The common-law principle is that mere lack of a government-mandated license does not create a common-law “violation” claim for all injuries suffered by anyone as a result of the defendant’s unlicensed activities. This comes up most often where unlicensed auto drivers are sued. Failure to have a license does not make non-negligent driving into a tort.

Before most of our readers had ever heard of us, we discussed this proposition at more length in one of our earlier posts on “Defenses to FDCA-Based Negligence Per Se.” We’re glad (but not surprised) to see that Medtronic recognized and raised the licensing point as an alternative, non-preemption based way of disposing of this sort of allegation. It’s an argument we’ve been trying to popularize ever since we more or less invented it (in the FDCA context) in the Bone Screw litigation.

For a complete discussion of why failure to obtain FDA approval – the equivalent of an FDA license to market a particular product – isn’t a valid claim under state law, we invite you to take a look at that earlier post. Another good post to review is here, where we discuss Iacangelo v. Georgetown University, 595 F. Supp.2d 87 (D.D.C. 2009), which holds quite explicitly that:

As a result, it is no more logical to infer a causal connection between [the drugs’] unapproved status and [plaintiff’s] injuries than it is to infer a causal connection between a driver’s lack of a drivers license and injuries he causes while driving.

Id. at 93.

Additional (non-drug/device) cases for the proposition that mere failure to have a government license does not establish negligence per se as to injuries suffered as a result of the unlicensed activity include: Cousin v. Enterprise Leasing Company-South Central, Inc., 948 So.2d 1287, 1290 (Miss. 2007) (driver’s license); State v. LaFlam, 965 A.2d 519, 522-23 (Vt. 2008) (commercial driver’s license); Mousseau v. Schwartz, 756 N.W.2d 345, 352-53 (S.D. 2008) (medical license); Florida Marine Transporters, Inc. v. Sanford, 255 Fed. Appx. 885, 888 (5th Cir. 2007) (admiralty law) (shipmaster’s license); State v. Smith, 771 N.W.2d 151, 155 (Neb. App. 2009) (child care facility license); West v. Levee Lift, Inc., 2009 WL 2192746, at *5 (Ky. App. July 24, 2009) (driver’s license); Vanalkemade v. Hitsman, 2009 WL 1864055, at *4 (Ohio App. June 30, 2009) (commercial driver’s license); Bell v. American Traffic Solutions, Inc., 633 F. Supp.2d 305, 314-15 (N.D. Tex. 2009) (investigator’s license); Garrett v. Land West Ventures, Inc., 2007 WL 2071615, at *3-4 (D. Colo. July 19, 2007);. All of these cases have been decided since our January, 2007 post on this subject.

So the second point that defense counsel should draw from SSF is that you don’t need preemption to beat a negligence per se/violation claim where the claim is based on an allegation that the product did not have the necessary FDA approval. That kind of claim fails for separate, independent reasons of state law: a defendant doesn’t commit a tort just because it doesn’t have a license required by the government – including the FDA.

Our third interesting non-preemption point gleaned from SSF is on page 42 of the slip opinion, where the court states: “Where a statute expressly precludes a private right of action to enforce its provisions, litigants cannot avoid these limits by crafting negligence per se claims for violation of the statutory scheme.” This is yet another way to defeat negligence per se claims without preemption. Many states – not all, but a lot – do not permit negligence per se claims where doing so would be contrary to the intent of the legislature. Since Congress specifically stated, in the FDCA (21 U.S.C. §337(a)), that only the government could enforce it, negligence per se claims cannot lie due to their conflict with congressional intent. E.g., Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226, 1231 (D. Nev. 2009).

Again we’re proselytizers on this, since it’s something else we invented in Bone Screw. Legislative intent is another of the state law defenses to negligence per se that we discussed at length in the early 2007 post. SSF is important as another case recognizing this defense specifically in the FDCA context.

As the previous post explains in great detail, conflict with legislative intent is a defense to negligence per se that isn’t found in the black letter law of the Second Restatement of Torts. It’s out there, though, in the law of most states. Here are some more cases that have been decided on this point since our January, 2007 post: Lombard v. Colorado Outdoor Education Center, Inc., 187 P.3d 565, 574 (Colo. 2008) (premises liability statute); P.S. v. San Bernardino City Unified School District, 94 Cal.Rptr.3d 788, 793 (Cal. App. 2009) (child abuse reporting statute); Young v. Carran, 289 S.W.3d 586, 589 (Ky. App. 2008) (HIPAA); In re Carter, 653 S.E.2d 860, 866-67 (Ga. App. 2007) (sickle cell anemia reporting statute); Chilcutt v. Ford Motor Co., ___ F. Supp.2d ___, 2009 WL 3259418, at *6 (S.D. Ohio Oct. 7, 2009) (OSHA); Deacon v. Metro North Railroad Co., 2009 WL 3059128, at *4-5 (D. Conn. Sept. 22, 2009) (OSHA); Mazzeo v. Gibbons, ___ F. Supp.2d ___, 2009 WL 1872978, at *14-15 (D. Nev. June 29, 2009) (various statutes criminalizing assault); Lee v. K&P Brothers, Inc., 2008 WL 839791, at *1-2 (N.D. Ohio March 27, 2008) (false imprisonment statute); Innis Arden Golf Club v. Pitney Bowes, Inc., 514 F. Supp.2d 328, 335-36 (D. Conn. 2007) (state water pollution statute); Garrett v. Land West Ventures, Inc., 2007 WL 2071615, at *3 (D. Colo. July 19, 2007) (federal firearms statute). Every one of these cases holds, with respect to whatever statute is at issue, that because the legislature didn’t intend for there to be private claims, negligence per se is precluded as a matter of law.

SSF demonstrates that the legislative intent argument can be a winner with or without preemption. SSF also demonstrates that savvy defense counsel raise this argument when they’re dealing with FDCA-based negligence per se claims. All readers should make sure to have this arrow in their quivers the next time they confront one of these. In other words, don’t be like the defense lawyers, here.