Photo of Bexis

We’ve liked the Ortho Evra MDL.  We’re going to miss it.  It provided us with more than its share of good learned intermediary rule/warning causation decisions, since the risk of stroke associated with chemical contraceptives has been known about, and warned about, for years.  Thus, it was really
hard for plaintiffs making the contrary assertion to get around their prescribers’ testimony.  We reported on such wins here (Minnesota and Mississippi), here
(New York), here (Tennessee), here (Illinois), here (Missouri), and here (Tennessee).  So Ortho Evra improved the learned intermediary rule law of a half-dozen states (that we blogged about).

In the long run, however, the biggest contribution of the Ortho Evra MDL to prescription medical product jurisprudence is probably in the field of preemption.  Booker v. Johnson & Johnson, ___ F. Supp.3d ___, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014), which just made #7 on our top ten list of 2014 decisions, provided us with one of the first – and to date the most thoroughly reasoned – opinions applying preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to design defect claims involving non-generic prescription drugs.

But the MDL has come to an end.  The very last of the 1,518 cases in the Ortho Evra MDL was what was left of Yates v. Ortho-McNeil Pharmaceutical, Inc., No. 3:09 oe 40023, slip op. (N.D. Ohio Jan. 5, 2015).  The MDL judge had already dismissed the warning-related claims in a decision we discussed here.  What was left were design and manufacturing-related claims under various theories, and an express warranty claim.  Not any longer.

We liked the disposition of the design defect claims best – because Yates followed the same preemption rationale that the court had previously enunciated in Booker:

Regarding [plaintiff’s] defective design argument . . ., the courts of New York have previously ruled the argument preempted by federal law.  Amos v.
Biogen Idec Inc.
, 2014 WL 2882104, at *3 (W.D.N.Y. June 25, 2014).  Under New York law, an action based on an alleged defective design in strict liability or in negligence are “analyzed identically.”  Id.  In Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2477 (2013), the Supreme Court held that a state claim alleging a design defect is preempted with respect to FDA-approved drugs sold in interstate commerce.  See also Amos,2014 WL 2882104, at *3.

Although [plaintiff’s] attorneys assert that preemption is applicable to only generic drugs, the language in Bartlett and Amos is not so restrictive.  The Supreme Court specifically stated that “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.’ 21 C.F.R. § 314.70(b)(2)(I).”  Bartlett, 133 S. Ct. at 2471 (emphasis added). The Court held “that state-law design-defect claims . . . that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling.”  Id. at 2479.  This language establishes that the Supreme Court did not limit its holding in Bartlett to generic drugs, although the drug in question was generic.  Id. at 2471, 2480; see also Amos, 2014 WL 2882104, at *1 (drug in question was not generic).

Yates, slip op. at 9 (emphasis original).  Yates also hammered a poorly-reasoned contrary decision, Cassel v. ALZA Corp., 2014 WL 856023 (W.D. Wis. March 5, 2014), for “ignor[ing] the plain and explicit language of Bartlett.”  Yates, slip op. at 10.  As to design defect preemption, Yates also explained that Wyeth v. Levine, 555 U.S. 555 (2009), has no bearing because it wasn’t a design claim at all. “The issue in question does not concern the adequacy of Ortho Evra®’s labeling.  This is a design defect issue.  The Court’s discussion and holding in [Levine] concerning labeling simply does not apply to [plaintiff’s] design defect claim.”  Yatesslip op. at 11.

Yates also disposed of the plaintiff’s manufacturing defect claims, which didn’t seem to be all that strenuously advanced:

To establish a manufacturing defect claim, [plaintiff] must show that the Ortho Evra® patch which she used had a defect as compared to other samples of the drug.  There is no evidence that the Ortho Evra® patches which [plaintiff] received differed from either the manufacturing specifications for that product or from other identical units.  Therefore, the Defendants are entitled to summary judgment.

Id. at 8-9. Negligence and implied warranty claims failed for the same reasons as the corresponding product liability claims. Id. at 12.  Express warranty claims were dismissed for what were essentially learned intermediary reasons.  The plaintiff didn’t know about the product until her prescriber brought it to her attention, she was told about the risk, and reading the product warning wouldn’t have made a dime’s worth of difference in her decision to use it. Ergo, no reliance on any supposed warranty, as required by law.  Id. at 13-14.

And so that would be the conclusion of the last case left in the Ortho Evra MDL, except for one final post-mortem twitch.  At the last minute, literally – “thirty-nine minutes into the oral argument” of a motion that had been fully briefed for over three months, id. at 16 (giving detailed schedule of events) (emphasis added) – a motion to intervene was filed by former lead/liaison counsel for the MDL plaintiffs.  See also id. at 2 (identifying would-be intervenors).

What was responsible for this absurdly belated bit of gamesmanship?

Preemption. Why are we not surprised?  As we said in our Top Ten post, Booker was a big deal – a case we had been waiting for ever since we began discussing the Bartlett language that the Yates court highlighted above. Let’s see….  We first mentioned that on the same day that Bartlett was decided.  See our post here.  That was pretty quick.

The former Ortho Evra plaintiff-side honchos just couldn’t bear the thought that Bartlett’s chickens came home to roost in what once had been “their” MDL:

[T]hey chose to wait until the middle of oral argument on the motion for summary judgment to file their motion to intervene.  A reason for the motion to intervene is clear in [their] proposed amicus brief − the intervenors disagree with the Court’s decision in Booker [citation omitted], decided five days before oral argument.

Yates, slip op. at 16-17.  They didn’t like the Amos case either, but that, too, didn’t excuse springing an intervention motion during an oral argument.  The purported intervenors were on notice of that decision since defendants mentioned it in a filing they made on July 25, 2014.  Slip op. at 17.  (Or, if they had followed this blog, since we discussed the preemption-related aspects of Amos even earlier, on June 30).

The court told the 13th-hour intervenors to go away.  Yates, slip op. at 17-18.  They no longer represented anybody and had no legitimate interest. Their little stunt proved that they were no friends of that court.  Id.

Thus the Ortho Evra MDL endeth – except for possible appeals.