Monday, January 7, 2019

Finally! It Is FINALLY Oral Argument Day -- On Fosamax® Femur Fracture "Pre-Emption", At The Supremes...


We've been covering this narrative arc pretty steadily for eleven years -- both as "Wyeth-style" pre-emption, as enunciated by the Supremes almost a decade ago, and in the Fosamax® femur fracture cases -- more generally. [Those links are but three examples -- of hundreds of posts here, just search Fosamax.]

So it is with some relief -- that we have reached argument Monday, at the SCOTUS, this morning. The Supremes are to decide whether Merck may be sued for failure to warn -- in the femur cases. [Merck will this morning tell the Supremes that Wyeth style preemption dismissals require only "clear" evidence that the label change/warning would not have been accepted -- not the tougher standard of "clear and convincing" evidence.]

In plain(er) English, then -- Merck suggests the FDA's instructions to it at the time made it impossible for Kenilworth to provide a warning. Here's a very cogent (third party) bit on it, from a recent entry at the fine SCOTUS Law Blog:

. . . .When state law and federal law conflict, the Constitution’s supremacy clause provides that federal law displaces, or pre-empts, state law. Pre-emption issues permeate prescription-drug safety litigation because the Food and Drug Administration regulates the safety and efficacy of prescription drugs under federal law, while state tort law provides the remedy for patients injured by the use of FDA-approved drugs. Prescription drug manufacturers frequently raise “impossibility pre-emption” as a defense in drug-injury cases, arguing that federal regulation would have prohibited the additional warnings plaintiffs allege state tort law required.

The Supreme Court has decided numerous pre-emption cases involving FDA regulations, bringing “impossibility pre-emption” into sharper focus over the past decade, starting with its 2009 opinion in Wyeth v. Levine. In Wyeth, a patient brought state tort claims against the manufacturer of an FDA-approved drug for injuries resulting from its failure to warn about the risks associated with intravenous administration. The manufacturer argued that the FDA’s extensive regulatory authority over its labeling made simultaneous compliance with state-law duties to warn impossible, thereby pre-empting the state tort claims. The Supreme Court held 5-4 that defendants asserting impossibility pre-emption had to produce “clear evidence” that the FDA would have prohibited an additional warning, and that Wyeth had not done so. . . .


I'll offer some live audio links, to the back and forth -- and questions from the bench -- as they become available, right here. Should be fascinating. Onward on a warm, if rainy, Monday.

नमस्ते

3 comments:

Kevin Caraher said...

Any movement on the Propecia MDL case yet ? It seems like all communications and information on that MDL has come to an abrupt halt.

condor said...

Hey Kevin — the case is fully settled; here was my latest — as of December 4, 2018:

https://shearlingsplowed.blogspot.com/2018/12/federal-propeciaproscar-mdl-in-brooklyn.html

As of August 2018, all but a few of the 670 or so cases were in the process of being paid out:

“...Thus far, the Parties can report the following with respect to the MDL proceedings, which currently has a total of 436 active cases:

 405 Plaintiffs have submitted executed Releases;

 2 Plaintiffs have been granted an extension (as provided in the Master Settlement Agreement) to submit a release on or before August 21, 2018;

 1 Plaintiff is expected to be dismissed on or before September 5, 2018;

 3 Plaintiffs have been excluded from the Master Settlement Agreement;

 19 Plaintiffs are not participating in the Master Settlement Agreement: i.e., they have either determined they would not participate or have not executed a release (please see discussion, below, regarding these 19 Plaintiffs); and

 6 cases involve pro se Plaintiffs and are not subject to the Master Settlement Agreement.
. . .”

Hope this helps!

Namaste....

condor said...

To be clear — the 405 people named above should already have their money — they’ve signed releases.

Contact your lawyer if you haven’t been paid yet...

That’s the learning here.

All the best, in 2019.