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We don’t get to write much about the Federal Circuit.  It is unique in our federal court system in that it has nationwide jurisdiction over specialized subjects, most notably patent and trademark.  We are guessing the Federal Circuit sees a lot of drug and medical device cases as companies dispute intellectual property rights of one kind or another, and we picture the judges and clerks reading densely packed briefs written by engineers-turned-lawyers who are able to explain how one thing “teaches from” another, or how this thing “reads onto” that.  Patent lawyers and the judges they practice before have their own language, which makes us admire them all the more.

We are also guessing that the Federal Circuit does not see a lot of the FDCA.  A quick search of published Federal Circuit opinions found that the Federal Circuit cited the FDCA just once in all of 2013.  Did you think that we at the Drug and Device Law Blog would miss such a momentous event?  Certainly not, and we are doubly excited to report that the case at hand involved federal preemption of a state unfair competition statute, even though the opinion came out the wrong way.

The case is Allergan, Inc. v. Athena Cosmetics, Inc., No. 2013-1286, 2013 U.S. App. LEXIS 25746 (Fed. Cir. Dec. 30, 2013), which started unsurprisingly as a patent dispute.  The plaintiff Allergan sells a product called Latisse, a prostaglandin derivative and FDA-approved prescription drug indicated for eyelash growth.  Readers might recall the commercials for Latisse that ran a few years ago featuring Brooke Shields, the forty-something actress whose accomplishment-to-notoriety ratio is shockingly low.  But we digress.  The defendant Athena Cosmetics also sells a prostaglandin derivative for eyelash growth, but it does so without the FDA’s approval.  It seems the cosmetic manufacturer defendant considered the product to be the same as mascara and fingernail polish, which do not require approval through new drug applications (“NDAs”) if they affect only a person’s appearance.Continue Reading Federal Circuit Bats An Eye At FDCA Preemption

Do you recall last week when one of the smartest posters we have on this blog set out an impressive list of criteria to be used for selecting bloggable opinions: 1) the case must be useful or otherwise important for practitioners to understand;  (2) we would rather publicize good (pro-defense) results;  (3) powerful reasoning helps;

…

One hundred twelve years ago this Friday poor President McKinley was assassinated in Buffalo by an anarchist wannabe. It took the President a little more than a week to expire, and then Theodore Roosevelt (he hated being called “Teddy”) became the youngest (up to that point) man ever to become POTUS. We have been thinking about TR quite a bit lately, ruminating on the virtues of speaking quietly while carrying a big stick.  TR had a remarkable career in all kinds of ways. He’s right up there with Sam Houston and TR’s one-time buddy William Howard Taft in boasting all-time great resumes. Amidst all his accomplishments as a historian, naturalist, and politician, there is this: TR dropped out of Columbia Law School, deciding he would rather govern than litigate. He probably would not be a reader of this blog. He’d rather write something on his own, or run something, or kill something.

We, by contrast, are not going to charge up any hills, or win a Nobel prize, or put a water buffalo head on our library wall. We write about cases. Some of them are dramatic enough, at least for our taste.

Stop us if you’ve heard this one before. Actually, you pretty much have heard it before, or at least something very like it.  Last Friday we discussed an excellent Louisiana federal decision tossing a device case on preemption and TwIqbal grounds.  This week we have another Louisiana federal decision with a robust application of TwIqbal.  The case is Kennedy v. Pfizer, Inc., 2013 U.S. Dist. LEXIS  123292 (W.D. La. Aug. 28, 2013).  Kennedy was decided in the Western District of Louisiana, instead of the Eastern District, and it is a drug case instead of a device case.  Nevertheless, it is further proof of how the federal courts in Louisiana are starting to insist on pleadings that go beyond the boilerplate.  Maybe the courts there have simply seen enough meritless cases, and they have simply had enough.
Continue Reading East Side, West Side: Louisiana Federal Courts Continue to Wield Big Stick of TwIqbal

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

Back when Bexis was still at Dechert, we put up a cautionary post called “CAFA Not With Standing.”  In that post we cautioned against using constitutional standing as a defense to class actions with questionable and attenuated damages claims.  Remember CAFA, we pointed out.  The damages sought in state-court class actions need to support federal Article III standing, or else defendants won’t be able to keep the actions in federal court.
Well, yesterday the court in Bouldry v. C.R. Bard, Inc., No. 12-80951-CIV, slip op. (S.D. Fla. Dec. 18, 2012), addressed precisely the situation discussed in that post.  Fortunately, our side won, and the class action stayed in federal court, where there are plenty of other arguments against its validity.
First, we have to point out that Reed Smith was involved in the Bouldry case, so we can’t say as much as we’d like.  We’ll have to stick to the legal propositions.  As for the facts, all we can say is that the Bouldry opinion should be applicable to other attenuated injury class actions, regardless of the product or conduct involved.
Bouldry involved a state class action in Florida alleging that a medical device had a higher risk of failure than it should.  The class consisted of people who had not suffered any failure.  There are good arguments that this sort of at-risk damages are not recoverable under most states’ laws − see our no injury scorecard, and in particular the Shiley heart valve cases from the late 1980s and early 1990s, which addressed similar allegations.  Hint:  the defendant won almost all of them.Continue Reading At Risk Claims Sufficient To Support Federal CAFA Jurisdiction

Not exactly a catchy title.  And probably not enough to compete with all the other distractions of this time of year – wandering through a snow-covered field to chop down a Christmas tree, hand-dipping your own candles to give as gifts, delicately decorating gingerbread men baked from scratch.  No wait – we really meant setting up the artificial snowing Christmas tree (nothing says happy holidays like millions of tiny pieces of Styrofoam floating through your home), waiting to see if Amazon is going to get you the complete second season of Shameless on DVD before the 25th, and popping a Mrs. Smith’s frozen apple pie in the oven.  Whether your holidays are like the former, the latter or somewhere in between, you probably have something more pressing to attend to than reading this blog.  So, we thought we’d give you something to think about for the future – a proposed change to Federal Rule of Civil Procedure 37 regarding when sanctions can be imposed for failure to preserve evidence.  See Excerpt from Report of Civil Rules Advisory Committee here.
Honestly, we just happened upon this ourselves and haven’t had much time to fully digest all the implications.  As with any rule change, the real ramifications won’t be known until the courts start to apply it.  But since the proposed change looks to be slated for discussion early in the new year by the Civil Rules Advisory Committee, we thought we’d take a look.Continue Reading Proposed Changes to Federal Rules on Preservation of Evidence

We’ve discussed the so-called “Berrier question” – whether the Third Circuit’s prediction that Pennsylvania law would switch to the Third Restatement from the old Azzarello form of super-strict liability should continue to apply – before.  Our position is that stare decisis required application of Berrier, until the Pennsylvania Supreme Court said otherwise, and…

On Wednesday, we discussed the relevant parts of pending tort reform legislation.  Earlier in the month we updated our favorite federalist point, which is that federal courts should not issue expansive interpretations of state tort law when sitting in diversity jurisdiction.

OK, what do those two things have to do with one another.

Well,…

To our readers:
Sorry about that.  Blogger was down for almost 24 hours yesterday and this morning.  In almost five years, we’ve never experienced that during business hours.  Anyway, that combined with Bexis having to fly to the west coast for the ALI annual meeting, kept us from posting until now.
Here’s the post we…

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