Law

We’ve been advocating preemption of all product liability design defect claims against prescription drug manufacturers – “whether generic or brand name” – since we read that phrase in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2471 (2013), two years ago.  We’ve written on just about every case since Bartlett that has done so.  One of them was Yates v. Ortho-McNeil Pharmaceuticals, Inc., 76 F. Supp.3d 680 (N.D. Ohio 2015).

Today, Yates was affirmed by the Sixth Circuit, creating the first appellate authority recognizing impossibility preemption of design defect claims under the Bartlett rationale in a case not involving a generic drug.  Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 15-3104, slip op. (6th Cir. Dec. 11, 2015).  The court held both “post-approval” and “pre-approval” design claims were preempted.  A “post-approval design defect claim is clearly preempted” because both “major” and “moderate” changes required FDA preapproval.  Slip op. at 18.  While “minor” changes do not, a dosage change that would affect the product’s safety could not be considered “minor.”

We think it clear that changing the dosage level of the active ingredient of [the patch] constitutes a “major change,” such that prior FDA approval is necessary.  Therefore, to the extent [plaintiff] argues that defendants should have altered the formulation of [the patch] after the FDA had approved the patch, we find this claim clearly preempted.  Quite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.

Id. at 18-19.

A “pre-approval” claim – that the defendant should have submitted a different design to the FDA “in the first instance” – ultimately fared no better.

[Plaintiff’s] argument regarding defendants’ pre-approval duty is too attenuated.  To imagine such a pre-approval duty exists, we would have to speculate that had defendants designed [the patch] differently, the FDA would have approved the alternate design.  Next, we would have to assume that [plaintiff] would have selected this method of birth control.  Further, yet, we would have to suppose that this alternate design would not have caused [plaintiff] to suffer a stroke. This is several steps too far. . . .  Defendants could not have complied with whatever pre-approval duty might exist without ultimately seeking the FDA’s approval prior to marketing [the patch], and certainly prior to [plaintiff’s] use of the drug.

Id. at 19-20 (footnote omitted).  “[W]e are unable to conceive of any coherent pre-approval duty that defendants would have owed to [plaintiff] when it was developing [the patch].”  Id. at 20.

Not only that, the pre-approval claim plaintiff asserted was another form of the “stop selling” argument that was preempted in Bartlett. 

In contending that defendants’ pre-approval duty would have resulted in a birth control patch with a different formulation, [plaintiff] essentially argues that defendants should never have sold the FDA-approved formulation of [the patch] in the first place.  We reject this never-start selling rationale for the same reasons the Supreme Court in Bartlett rejected the stop-selling rationale of the First Circuit.

Yates, slip op. at 21.

Further, as to design defect preemption, the Sixth Circuit declined to apply prior adverse precedent, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), observing that Wimbush “predates the Supreme Court’s analyses in Mensing and Bartlett.” 

at 21.  Wimbush was distinguishable because that suit had been filed after that drug “was taken off the market.”  In Yates, “[plaintiff] used the patch in 2005, and today, medical providers continue to prescribe [it] as a manner of birth control.”  Id.  Wimbush therefore was not controlling.

There were other issues in Yates, but preemption of the design defect claim(s) was by far the most important.