About a year ago, we discussed precedent establishing that off-label use can be, and often is, the medical standard of care.  Conversely, that means that it could be considered medical malpractice not to prescribe certain off-label therapies.  All of a sudden, that issue has popped up again, with two cases in the last week, both dealing with the off-label use of drugs in the abortion context.

We stay away from politics on this blog – whether it’s the merits of Obamacare or the merits of  legal restrictions on medical abortion. But where legal questions associated with this sort of controversial issue impact matters relevant to drug/device defense, we will cautiously venture into such territory, as we did here (ACA could render medical monitoring cause of action unnecessary) and here (FDCA preemption in abortion litigation context).  This time, it’s off-label use.
We’ll polish off the lesser of the two off-label use decisions quickly.  In Planned Parenthood of Greater Texas Surgical Health Services v. Abbott, ___ F. Supp.2d ___, 2013 WL 5781583 (W.D. Tex. Oct. 28, 2013) (“Abbott”), stay granted in part on other grounds, ___ F.3d ___, 2013 WL 5857853 (5th Cir. Oct.  31, 2013), an “off-label protocol” for terminating pregnancy using drugs rather than surgery was, as with the other off-label uses we discussed in our earlier post, determined to be the medical standard of care, and conversely, the FDA-approved intended use of the same key drug (mifepristone, also known as RU-486) was obsolete.  As the court stated:

Abortion-performing physicians have since developed a medication-abortion protocol using mifepristone that, although varying significantly from the FDA protocol, has become the de facto standard of care in Texas.  This protocol, or one substantially identical, accounts for the vast majority of medication abortions performed nationwide since 2007.  The new protocol [is] endorsed by the American College of Obstetricians and Gynecologists.

Id. at *7 (footnote omitted).  We omitted a footnote.  We now add it back in, because it is more relevant to our product liability defense-related concerns than most of the opinion:


Continue Reading A New Off-Label Use Hot Spot

Back in 2009, we posted that a recently enacted Oklahoma tort reform statute included a provision to eliminate most class action litigation under the notorious outlier case Ysbrand v. DaimlerChrysler Corp., 81 P.3d 618 (Okla. 2003), by forbidding nationwide classes to be brought under Oklahoma law.  It seems to have worked.  We haven’t heard of any Ysbrand shenanigans since then.

Well, the Oklahoma Supreme Court was plainly out of control in Ysbrand, and unfortunately it remains out of control to this day.  Recently, in Douglas v. Cox Retirement Properties, Inc., ___ P.3d ___, 2013 WL 2407169 (Okla. June 4, 2013), the same court invalidated the entire tort reform statute, under the obscure (and rightly so) “single subject” rule for legislation.  Funny how we never seem to see that invoked except when tort reform is at issue….

Douglas thus resurrects (at least potentially) the anything goes class action practice that existed under Ysbrand – as well as the raft of other litigation abuses that the Oklahoma legislature thought it had addressed in 2009.  That’s bad news.

The silver lining is that, since practically the day Douglas was decided, legislators in Oklahoma, who passed the original bill by a substantial margins, have been quoted as saying that they would break up the original legislation into separate bills.  Moreover, with Douglas reviving tort reform as an issue, additional “measures − to limit liability for gun manufacturers, adopt federal guidelines for expert witnesses and protect restaurants [from] obesity-related lawsuits” may also be on the agenda.

Umm … guys….


Continue Reading Umm . . . While You’re At It

We were planning to write about the Bartlett oral argument today (we still might) when we learned about Howard v. Zimmer, Inc., ___ P.3d ___, 2013 WL 1130759 (Okla. March 19, 2013), in which the Supreme Court of one of the reddest states in the country, overruling prior precedent, held that, in general, violations of federal regulations suffice as a basis for negligence per se under Oklahoma law.  Contrary to a stiff dissent, the court reached this result notwithstanding 21 U.S.C. §337(a) in which Congress expressed its intent that claimed violations of the FDCA only be enforced by the federal government.  Id. at *6-7.

Prior Oklahoma precedent (rather like the law of Kentucky that we discussed earlier) had declined to permit state-law negligence per se to be brought on the basis of claimed violations of purely federal regulations.  E.g., Claborn v. Plains Cotton Co-op. Ass’n, 211 P.3d 915 (Okla. App. 2009) (no negligence per se for claimed OSHA violations); Christian v. First Capital Bank, 147 P.3d 908 (Okla. App. 2006) (same; federal usury regulations on agricultural loans); Rosson v. Coburn, 876 P.2d 731 (Okla. App. 1994) (same; Medicaid abortion regulations).

Howard was, of course, a case where federal preemption had wiped out the usual product liability claims plaintiffs would normally bring against the defendant.  A couple of years ago, in the same peripatetic case, the Sixth Circuit, in a non-precedential decision, allowed a “parallel claim” to escape preemption.  Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. 2010) (“Howard I”).  Howard I, of course, did not purport to decide that such a parallel claim existed under state law.  Id. at 442 (not reaching “whether Oklahoma law recognizes a negligence per se action based on violations of FDA
regulations”).

That was the Oklahoma Supreme Court’s job.  Procedurally, at least, we think that the Tenth Circuit chose a better path in certifying the issue to that court.

Under Erie, certification was a proper avenue, although we have to wonder why the plaintiff didn’t do this during the prior appeal in the Sixth Circuit.  Unlike Fulgenzi v. PLIVA, Inc., ___ F.3d ___, 2013 WL 949096 (6th Cir. March 13, 2013), at least, the Tenth Circuit respected the limited authority of federal courts in diversity actions and certified the negligence per se question rather than making up novel state law claims out of whole cloth.  And “whole cloth” is the right description − there was nothing in prior Oklahoma law that remotely suggested what the happened next.

Make something up is exactly what Oklahoma Supreme Court did.  Not only did it overrule all prior precedent barring federally based negligence per se as a general matter, it decided not to follow its own prior precedents precluding private allegations of alleged violations where a particular piece of legislation “indicate[es that] . . . the law-making body concerned itself specifically with the problem of who should be able to bring an action . . .and it then resolved not to confer a remedy on private individuals.”  Holbert v. Echeverria, 744 P.2d 960, 965 (Okla. 1987); see also State ex rel. Oklahoma Bar Ass’n v. Mothershed, 264 P.3d 1197, 1227 (Okla. 2011) (where a statute “clearly places enforcement in the hands of governmental authorities the right of action is exclusively vested in such governmental authority”); Walls v. American Tobacco Co., 11 P.3d 626, 631 (Okla. 2000) (failure to make private cause of action retroactive was legislative intent not to permit earlier claims amounting to private enforcement).


Continue Reading Oklahoma Supreme Court OKs Federal Takeover of State Tort Law

Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff’s on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs

Some lawyers in the East Coast and West Coast – you know who you are – tend to be dismissive of decisions from the middle of the country, referred to with disdain as “flyover country.” In our experience, the assumptions of the superiority of the coastal courts and the inferiority of landlocked courts are unwarranted.

Not too long ago, the Sixth Circuit – in an unpublished opinion in a below-the-radar case – held that a PMA medical device plaintiff had successfully threaded the preemption needle in Howard v. Sulzer Orthopedics, Inc., ___ Fed. Appx. ___, 2010 U.S. App. Lexis 12290, slip op. (6th Cir. June 16, 2010) (it’s also in our device preemption scorecard).  The one claim that the court held survived summary judgment was a negligence per se claim in the nature of a manufacturing defect claim based upon an FDA Good Manufacturing Practices regulation that the court admitted could be read two different ways.  Slip op. at 8 (“The provision, as we say and as the dissent illustrates, can reasonably be read either way”).  Based on some language it found in FDA “comments” and guidance documents, the court concluded that the plaintiff was interpreting the regulation in a way consistent with the FDA’s reading, and thus held that the regulatory-based claim survived preemption.  Id. at 7-8.

We don’t know enough about either the device or the regulatory history of the particular section that the plaintiff in Howard hung his hat on to say anything particularly useful.

What we’re interested in is where a defendant goes from here.  We were all set to pummel the defendant for ignoring the state-law based defenses to negligence per se that we’ve pontificated about at length when we noticed this in the Sixth Circuit’s opinion:

We also leave it to the district court to consider [the defendant’s] alternative ground for summary judgment: namely, whether Oklahoma law recognizes a negligence per se action based on violations of FDA regulations. All that we decide today, rather, is that [plaintiff’s] negligence per se claim for GMP violations is not preempted.

Slip op. at 9.  So it wasn’t the defendant’s fault.  If it was anyone’s, blame the court for reaching a constitutional issue when there were non-constitutional grounds available.


Continue Reading PMA and Negligence Per Se Post Preemption – Then What?

When you see a reference to West Virginia in this blog, it’s usually followed by biting criticism, regret, and a citation to the latest Judicial Hellhole listing. But not everything out of the Wild and Wonderful state makes us grimace. Heck, we’re huge fans of Chuck Yeager, Jerry West, and Don Knotts. John Denver sang a pretty nice song about the place — sort of. (The Shenandoah River and Blue Ridge Mountains are associated more with Virginia.)

And, mirabile dictu, last week saw a nice West Virginia opinion on state safe harbor law. Arnett v. Mylan, Inc., 2010 U.S. Dist. LEXIS 50460 (S.D. W. Va. May 20, 2010). It’s not exactly preemption, but it’s kind of a kissing cousin to it (we are resisting the usual West Virginia jokes, honest), and it’ll do.

The case was a wrongful death action, claiming plaintiff’s decedent died from wearing a fentanyl pain patch. The decedent was an Oklahoma resident, and the defendants are corporate residents of West Virginia. Because West Virginia uses the lex loci delicti (place of the injury) test, Oklahoma law applied to the case. That in itself is a good ruling. Then the court discusses the Twombly standard. By this point, we’re practically shooting off fireworks, and it’s not just because of the Holiday. (More on that later.)

Count Three of the Complaint asserts a claim under the Oklahoma Consumer Protection Act (OCPA). The OCPA provides a safe harbor for defendants by providing that nothing in the act applies to “[a]ctions or transactions regulated under laws administered by … any … regulatory body or officer acting under statutory authority of this state or the United States.” 15 Okla. Stat. section 754(2). The pain patch was subject to the Food Drug and Cosmetic Act, so the OCPA action is history, right? Yes. Yes it is. But not without a fight.


Continue Reading A Safe Harbor Opinion that is Almost Heaven

It’s already been reported elsewhere that significant tort reform was recently passed in Oklahoma, along with some of the details. But when someone mentions Oklahoma to us in the context of litigation – we free associate “Ysbrand,” as in Ysbrand v. DaimlerChrysler Corp., 81 P.3d 618 (Okla. 2003), which is the leading (and nearly