PLIVA v. Mensing

I was once a big fan of generic medications, seeing them as a way by which to contain healthcare costs and loosen the deathgrip that Big Pharma exerted on the American economy and our individual wallets.

Then I worked briefly for a pharmaceutical contract research organization. And I went to law school.

I’m not so sure any longer.

With that in mind, you know it’s going to be a bad day for constitutional scholars when the high court says that its own ruling from only two years prior “makes little sense.” In this instance, SCOTUS was referring to PLIVA v. Mensing and that decision’s deleterious effect on some of those who have been harmed by prescription medications but now are left with few if any avenues for redress.

Two patients, Gladys Mensing and Julie Demahy, each saw their family physician and rec’d a prescription for Reglan, a medication used to treat nausea/ vomiting and other digestive problems. In both cases, local pharmacists substituted the generic version when filliing the prescriptions – dispensing metoclopramide and not branded Reglan. After each woman had taken the Rx as instructed for several years, both developed tardive dyskinesia (TD), an uncommon but serious and usually irreversible neurological condition more often seen in chronic psychiatric patients taking antipsychotic Rx.

The women filed state tort suits, later joined, claiming that the makers of the generic version of their Rx had failed to provide adequate label warning of this risk.

Metoclopramide was first isolated in the 1960s, when the risk of TD was not fully appreciated. Once approved in the U.S., branded Reglan became very popular, though its use was predictably later supplanted in the marketplace by newer agents. In 1982, Reglan went generic.

And there the story might have ended with Reglan eventually fading to obscurity. But it enjoyed a resurgence in use when one of the newer agents that replaced it was unexpectedly yanked from the market. So before long, millions of American were again taking Reglan (from Schwarz Pharma) and metoclopramide (from twenty-three different generic manufacturers).

Once enough Phase IV data suggested a possible problem, in 2004 a research team published a study that noted a definite TD-metoclopramide association, saying in pertinent part: “given [the Rx’s recent surge in usage], the incidence of TD may increase accordingly. Thus, TD risk factors relative to the intended benefit and duration of use should be considered in metoclopramide prescribing.”

And it was not until several years later that this warning was widely circulated in the medical community.

FDA regulations permit manufacturers of branded drugs to update their labels when new data comes to light, without having to petition first for FDA approval of the changes. However, FDA regulations do not allow makers of generic drugs to change labels on their own; those companies must use exactly the same labels that were originally approved for the branded drug when it was first marketed. Only under an FDA directive mandating such a change can the generic manufacturers update their labels.

Given the clinical findings, Reglan labels were accordingly updated by the brand name manufacturer. But the generic labels were not, as no such FDA directive was then issued.

Had Mensing and Demahy taken brand name Reglan, as their doctors prescribed, their injuries would have been potentially actionable under a failure-to-warn theory (depending on the wording of the added cautionary statement).

But the plaintiffs took generics. The generic labels had no mention of TD as a risk at all, because that informaton was not part of the original Reglan package insert. And the generic manufacturers couldn’t have updated their labels absent an FDA directive to do so.

Thus, held SCOTUS, state tort law was preempted in this instance by (very imperfect) federal generic drug regulations, and the lawsuit of Mensing and Demahy could not go forward.

Little consoluation, but the FDA has since ordered all manufacturers of Reglan/ metoclopramide to include a “black box” warning regarding TD on package inserts.

And as a postscript, I don’t know if the plaintiffs’ theory of failure-to-warn might extend to the pharmacists who substituted? I’ve not been able to ascertain if that’s an option or not.

Either way, the plaintiffs may just be SOL.

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