Saturday, June 20, 2015

The End Draws Nigh, For Fosamax® Femur Fracture MDL Claims -- Materially Good News For Merck


We have expected this, for quite a while now. The femur claims (as distinguished from the ONJ ones) MDL is likely to come out as a complete win for Merck -- we have been following it since 2010.

I post yesterday's ruling so that the kind and gentle folks following the federal Propecia® MDL litigation will be able to see -- by analogy -- how important the label warnings have become, after the Supremes decided Wyeth v. Levine. From the full order, then (an 18 page PDF file):

. . . .On March 26, 2014, the Court entered judgment as a matter of law dismissing the claims of hundreds of Plaintiffs who allegedly suffered femur fractures prior to September 14, 2010 on preemption grounds. See In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., MDL 2243, 2014 WL 1266994 (D.N.J., Mar. 26, 2014) (the "Preemption Ruling"). The Preemption Ruling is now on appeal to the Third Circuit. . . .

On June 17, 2014, the Court granted summary judgment in favor of Merck in the Gaynor case and found that the 2011 Fosamax warning regarding atypical femur fractures is adequate as a matter of law because it "is accurate, clear, consistent and as a whole conveys a meaning that is unmistakable as it relates to AFFs." Gaynor v. Merck Sharp & Dohme Corp., Nos. 12-1492, 08-08, 2014 WL 2738224, at* 11 (D.N.J. June 17, 2014). The Gaynor Plaintiff has appealed this ruling to the Third Circuit. . . .

Following the dismissal of Gaynor, the PSC advised the Court by letter and during telephonic status conferences that to the best of their knowledge no Plaintiff is alleging that the 2011 Fosamax label was a proximate cause of his or her injuries and that the adequacy (or inadequacy) of that label has not been placed at issue by any Plaintiff. On November 5, 2014, the Court ordered those Plaintiffs whose cases had not previously been dismissed by the Preemption Ruling and who claim that the warning about AFFs in the January 2011 Fosamax label was inadequate and a proximate cause of their alleged injuries to show cause why their claims should not be dismissed in light of the prior rulings by the Court (the "November 5, 2014 Order")(Dkt. 3927). The November 5, 2014 Order further provided that if any Plaintiff did not make such a claim, then they would be forever barred, precluded, and estopped from claiming that the January 2011 Fosamax label was inadequate and a proximate cause of their alleged injury. . . .

[T]he Court has determined, after consultation with the PSC, that the claims of all remaining Plaintiffs in this litigation are based on the alleged inadequacy of the pre-2011 Fosamax label. Because the adequacy of the pre-2011 Fosamax label is the issue currently being decided [on appeal] by the Third Circuit, the decision on appeal will determine whether the claims of the remaining Plaintiffs in this litigation (identified in Appendix I hereto) remain viable or not. Consequently, IT IS on this 19th day of June, 2015, ORDERED that the claims of all Plaintiffs listed on Appendix I against Merck are hereby conditionally dismissed without prejudice pending the decision by the Third Circuit on the appeal of the March 26, 2014 Preemption Ruling. . . .


So it goes. So too -- on a cool, quiet Saturday -- we are actually quite melancholy -- about the lunacy of white domestic terrorists/supremecists our nation's NRA lobby refuses to address in any constructive way. But the mouthpieces for the NRA are first to the fore, when the terror threat is browner, or not born on our soil. Ironic -- and tragic. Will the NRA condemn these latest photos of Mr. Roof spitting on, and burning, the stars and stripes? I won't hold my breath. In fact, one NRA board member blamed the pastor of Mother Emanuel -- for the death of the other eight church-goers. That puts NRA Board member Charles Cotton on a par -- with the terrorist, himself -- in my view. I won't repeat the tortured reasoning by which Cotton justified his deplorable libel.

At least on Father's Day, please be better to one another than this. Please. . . .

13 comments:

Anonymous said...

Thanks for that. It is especially helpful for folks like me that haven't followed this stuff in the past.

So does it seem like in the Propecia case that the plaintiffs that took the drug further in the past (i.e., before the warning label was updated) will have stronger cases than those that took it more recently? - Mr. I

Anonymous said...

Mr. I beat me to the punch... that is exactly the question I was going to ask. I know the label update is going to be a huge part of the Propecia MDL so the question is how does it affect the plaintiffs? Does it weaken the cases of those who came after? Conversely, does it strengthen the cases of those that took Propecia before the label change? Will the plaintiffs argue that the label change was essentially an admission of guilt?

Mr. E

Anonymous said...

And again, while I don't really know what I'm talking about here...I would imagine that plaintiffs who took the drug after the label change might have a stronger case against their prescribing physician whereas a plaintiff before might have a stronger case against Merck. But that's just what makes sense to me; no real knowledge of the process. - Mr. I

Anonymous said...

As to the admission of guilt, that also makes sense to me, but perhaps Merck would argue that they were compelled by the FDA and still "don't believe there's a causal link" or something (i.e., they would not outright admit guilt). - Mr. I

Anonymous said...

True..... but wouldn't the FDA's opinion carry more weight than Merck's in a court of law in regards to the label change?

Mr. E

Anonymous said...

Of Nina_Simonee:

http://mobile.nytimes.com/2015/06/21/movies/nina-simones-time-is-now-again.html

Anonymous said...

"True..... but wouldn't the FDA's opinion carry more weight than Merck's in a court of law in regards to the label change?"

I would think so, but I don't really know. I mean...the label change to me seems enormously important and practically proof that something's up with all of this. If Merck used to not warn of side effects that they are now mandated to warn about, that seems like proof that there was a failure to warn. - Mr. I

Condor said...

Just a few thoughts, Messrs. I and E --

There is a policy in the common law, that any actor ought not be held more culpable for making a warning, unless that warning caused greater injury.

So, rarely will a warning be the basis of liability.

Doubly so, where a federal agency REQUIRES the exact verbiage in that warning -- FDA literally dictates how these warnings are to read. So Wyeth v. Levine, in part, is about protecting drugmakers -- when they follow the FDA's explicit commands.

NOW, if a plaintiff's injury was foreseeable BEFORE the warning -- no matter the source of the warning -- and s/he was in fact injured prior to the warning, or the warning was inadequate as a matter of law, AND can show that s/he would NOT have used the drug, if the warning had been given -- then, that plaintiff wins.

Finally, Propecia may be unlike Fosamax in that sexual dysfunction may appear slowly, over time -- in the femur Fosamax cases, an injury occurred all at once -- a sudden, inexplicable femur fracture. Easy to mark the date of manifested injury, and so easy to pinpoint the applicable warning.

All of which is to say, if plaintiffs can show declining sexual prowess, not primarily caused by simple advancing age, and show it during a period when Merck and or FDA ought to have known -- and warned -- that would be a winner.

All others will be much closer calls.

Just my musings -- from an unaided memory.

Namaste

Anonymous said...

As always, thanks for the info. Proving "declining sexual prowess" in a court of law could be difficult but if the plaintiff had blood work done showing their hormone levels were far below normal that could be significant. Also, proving they were healthy prior to taking Propecia could be tricky so it seems every case will be very different from the next.

Mr. E

Condor said...

Quite so, on all points, Mr. E.

I'd say that, if the good doctor's study notebooks show a marked decrease in sexual functioning, and well prior to a time when Merck undertook to revise the label -- with or without FDA input... That might make all claimants in that time frame winners.

But we shall have to wait and see -- about all of it.

Anonymous said...

So a really strong case might be someone that could show sudden and demonstrable sex drive collapse shortly after starting drug?

Anonymous said...

I would think so... something to the effect where there are doctor's records indicating a diagnosis of ED shortly after taking Propecia and prior to the label warning change. An even stronger case would be if that person started Propecia at a fairly young age and more bonus points if there is proof the plaintiff was healthy prior to taking Propecia.

Mr. E

Anonymous said...

I hope this is the case. I started Propecia in 2003. I was diagnosed with ED in 2006 and depression with cognitive issues in 2009, all prior to the label change. I was only 26 at the time I began taking it.

I first spoke with my counsel in late 2011, so we're almost at the 4 year mark for me. Obviously a lot has been going on, but from the outside, sometimes it just seems like 4 years of nothing. I think once the bellwether cases are selected, it will make it feel like the case has finally started moving.

Thanks for covering the case on here. I just found the blog and it is helpful to see case info here instead of having to look through PACER all the time.