Court Misses Drug Preemption Call: Attorney

Attorney Michelle Yeary (Reed Smith) says a Louisiana federal judge erred in determining that Xarelto (rivoroxaban) multi-district litigation claiming that the drug was unreasonably dangerous due to a design defect was not preempted under the Supreme Court’s Bartlett decision. Writing in an online blog post, Yeary says that plaintiffs in the case said the manufacturer (Janssen) should have designed an assay to allow doctors to monitor the drug’s effects on individual patients, should also have designed and marketed an antidote to counteract a major bleeding event, and, in the absence of the first two, should have warned about the availability of other tests to measure anticoagulation.

“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,” the attorney writes. “We’ve been down that road before and the Supreme Court found such claims preempted” in Bartlett.

She says Janssen raised preemption as a defense but it was rejected by the judge. “We should point out that the Xarelto court wrongly discounts defendants’ reliance on it (Bartlett), saying that it relates to generic drug manufacturers, not name brand manufacturers. While it is true that the drug in Bartlett was a generic, the rulings … are not so limited, and certainly not on the very issue germane to this case.”

According to Yeary, the way the court appears to get around Bartlett is by drawing what she considers an artificial distinction between pre-approval and post-approval design defect claims. But, she says, a pre-approval design defect claim is the same thing as saying the manufacturer should stop selling the current product — that it should never have been brought to market.
“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,” she says. “By focusing on the pre-approval time period, the court is basically inviting the jury to second-guess 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 preemption.”