Most Read Contributor in United States, March 2017
Just yesterday we made the following observation: a design
defect claim is often a make-weight claim. How should the design
have been improved? Not selling the product at all is hardly a
design improvement. An entirely different product is not a safer
alternative under the law of any enlightened state. Changing the
molecule or the device design cannot be done without FDA approval,
so preemption should apply (even if courts often miss this
And miss the point the court did in In re: Xarelto Prods.
Liab. Litig., 2017 U.S. Dist. LEXIS 56629 (E.D. La. Apr. 12,
2017). Plaintiffs in the Xarelto MDL allege that the
anti-coagulant drug caused serious bleeding events and that the
drug was unreasonably dangerous due to its defective design.
Id. at *3. As we noted yesterday, true design claims, as
opposed to failure to warn claims, aren't the crux of most
pharmaceutical drug cases. But the Xarelto plaintiffs went
that route and so defendants raised preemption as a defense.
Unfortunately, to no avail.
Xarelto is an anti-coagulant drug that is taken once a day and
all patients are given the same dosage without the need for routine
monitoring. Id. Plaintiffs argue that patients'
reactions to the drug vary causing some to experience bleeding
complications. Id. at *3-4. It is undisputed that both the
dosing and monitoring specifications were approved by the FDA.
Id. at *4. So, if the FDA approved the design, what do
plaintiffs say the manufacturer could have done differently?
Essentially, plaintiffs' position boils down to the
manufacturer should not have sold Xarelto but should have developed
and sought FDA approval of a different product. Wait. We've
been down this road before and the Supreme Court found such claims
preempted. Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466
Before we get to Bartlett, let's look at the
specific design defects plaintiffs alleged in this case. First, the
manufacturer should have designed an assay to allow doctors to
monitor the effects of the drug on each patient. Second, the
manufacturer should also have designed and marketed an antidote to
counteract a major bleeding event. Third, in the absence of the
first two, the manufacturer should have warned about the
availability of other tests to measure anticoagulation.
Id. Putting aside failure to warn, a claim that the
manufacturer should have submitted a different version of the drug
to the FDA for approval is the functional equivalent of the
"stop-selling" claim that the Court found preempted in
Now that we are back to Bartlett, we should point out
that the Xarelto court wrongly discounts defendants'
reliance on it, saying that it relates to generic drug
manufacturers, not name brand manufacturers. Id. at *7-8.
While it is true that that drug at issue in Bartlett was a
generic, the rulings are in Bartlett are not so limited,
and certainly not on the very issue germane to this case. The Court
in Bartlett went out of its way to state, "[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.'" 133 S. Ct. at 2471 (quoting 21 C.F.R.
§314.70(b)(2)(i)) (emphasis added). Instead the
Xarelto court, in its discussion of design defect, relies
more on Wyeth v. Levine, using that decision on failure to
warn claims to suggest that preemption is not as clear for brand
manufacturers. But the distinction between Bartlett and
Wyeth isn't that one involved a generic and one
involved a brand. It's that Bartlett dealt with design
defect and the court's failure to follow the preemptive logic
of Bartlett in this context is an error – at least
in our books.
The way the court appears to get around Bartlett is by
drawing an artificial distinction between "pre-approval"
and "post-approval" design defect claims. Id. at
*10. But, as noted above a pre-approval design defect claim is the
same thing as saying the manufacturer should stop selling the
current product – that it never should have been brought to
market. But it was. And only after the FDA reviewed and approved
it, including its dosage and monitoring specifications. A design
defect claim is about whether the product at issue – the one
that was sold and marketed and used by plaintiffs – was
defectively designed and whether there is a feasible alternative
design. By focusing on the "pre-approval" time period,
the court is basically inviting the jury to second guess the
FDA's approval of the drug — a question clearly not meant
for a jury. If the court had focused on the
"post-approval" product, the actual product at issue, the
design defect claims would fall squarely into Bartlett
But the court didn't and so we add this to the list of cases
that simply miss the point.
This article is presented for informational purposes only
and is not intended to constitute legal advice.
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