Block on Trump's Asylum Ban Upheld by Supreme Court
Pharma can breathe a little easier knowing Sixth Circuit ruled against a 17-year-old girl injured by her birth control patch. It was the country's first ever appellate level expansion of the doctrine of " impossibility preemption."
If you're wondering what "impossibility preemption" is, we refer you back to the 2013 case of Mutual Pharmaceutical Co. v. Bartlett.
Yates, the plaintiff, was a 17 year old who had suffered sexual abuse and was currently suffering menstrual cramps. Jennifer Smith, a licensed physician, counseled Yates about several options for contraceptive interventions, going over the benefits and risks of each of the different options. The different options discussed included oral contraceptives, Depo-Provera, NuvaRing, and ORTHO EVRA.
Yates opted to try Depo-Provera which required regimental three month injections. A year later she opted to switch therapies to ORTHO EVRA because of weight gain. Again, Smith discussed the possible side effects.
Yates suffered a stroke after beginning ORTHO EVRA. She then sued the pharma companies on various state product liability theories including defective warning (despite the fact that she had actual notice of the risks). The issues of actual causation were not the main highlight of the case, but another legal issue dealing with the scope of preemption. Either way, the Sixth Circuit affirmed for the defendants on everything.
Follow the Law ...
By far the most important legal issue before the court was that of the often times murky relationship between federal and state law. The court relied on the 2009 case of Wyeth v. Levine, which stood for the rule that injured plaintiffs may bring state-law products liability cases against manufacturers so long as they don't run afoul of both state and federal laws in doing so.
The defense argument was that Yates's claim was preempted because defendants could not have followed state law without violating federal law, and vice versa. And because Yates had alleged design defects that took place pre-FDA approval and post-FDA approval, these main points were actually the main reason for the impossibility as dictated under Bartlett.
Yates argued that defendants could have lowered the dosage of the ORTHO EVRA to make it safer (a products liability theory). The applicable New York law codifies this common law theory. But under FDA regulations (21 C.F.R. § 314.70(b)(2)(i)), a manufacturer is prohibited from making from making any "major changes" to the quantity or formulation of a product once it is approved. And since lowering the dosage would be such a "major change," compliance with the federal law and New York law would be impossible -- hence impossibility preemption.
What About a Safer Drug?
Then there's part two. The circuit court addressed Yates's claim that the defendants could have made a safer version of the drug in the first place. But the Court didn't buy this argument and referred to the SCOTUS case of PLIVA, Inc. v. Mensing, which also dealt with preemption.
In that case, the Supreme Court rejected the bandied notion that defendants should halt all sales of their product pending approval and that do so would be nothing short of a "Mouse-Trap game." A chain of events of causation would be too attenuated and would allow the plaintiff to complain of a FDA approved product that, absurdly, never should have been put into the market in the first place. Thus, because of this absurdity, the court rejected Yates's pre-approval arguments as well.
Yates marks the first circuit case which sets precedent for expanding "impossibility preemption" to big pharma. It should be noted that many of the more controversial and influential pharmaceutical cases have been very recent.