Consider this an addendum to the “Adequate Warnings Should be Enough” post that Bexis wrote back in February. What makes a warning “adequate”? Insistence on truth and completeness is of little help. One does not have to be one of history’s all-time villains to ask what is truth, and it is just as legitimate to
Yesterday afternoon, only a few minutes after we saw the storm warning and cut short our walk with the Drug and Device Law Little Rescue Dogs, a brief but violent thunderstorm crashed through our neighborhood in the western suburbs of Philadelphia. (We note, parenthetically, that the adjective “violent” describes our weather with unprecedented and escalating
It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.
Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.
Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product
You’ll find plenty of decisions from the amiodarone litigation discussed on the blog. Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing. But there are cases involving exposure to the branded product as well. And earlier this
We love the unexpected. We loved standing up after what we thought was the finale of the fireworks show last night only to be left breathless by a stunning and unexpected encore. We loved walking in to a “quiet family dinner” for our recent advanced birthday to find the room filled with dear relatives and
When we were on a jury last month we were warned not to consult any outside sources. And we didn’t. When we were in high school last century and studied the works of Eliot, Lawrence, Joyce, Waugh, and (another) Eliot, we were instructed not to consider extraneous issues, such as biography or social conditions. Our
We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts). Last week, we saw the wonderful new musical Come From Away. It is a true story, and it begins
One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box
We’ve often thought that tort reform should be a major goal of those interested in preserving women’s reproductive choice. Every prescription medicine has risks, which is why the FDA requires a prescription in the first place, and prescription contraceptives are no exception. But ever since the very first birth control pills, back in the 1960s, the other side of the “v.” has consistently attacked every innovation in contraceptive technology and attempted to drive it off the market. It’s happened over and over again – with IUDs, Norplant, OrthoEvra, Yasmin, NuvaRing, Mirena, Essure. Except for the Dalkon Shield IUD forty years ago (and occasional idiosyncratic manufacturing errors), all these products were (or are being) ultimately vindicated, and the FDA continues to consider their designs to be both safe and effective. Unfortunately their users have had to pay a significant tort tax in order to continue exercising their personal choice of contraceptive method.
Niedner v. Ortho-McNeil Pharmaceutical, Inc., ___ N.E.3d ___, 2016 WL 5106479 (Mass. App. Sept. 21, 2016), is both an example of the plaintiff’s bar’s ongoing attempt to deprive women of reproductive choice and an exemplar of how to beat such efforts. Niedner involved a time-release contraceptive patch:
The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.
Id. at *1. The decedent decided to use this product in preference to both condoms and daily birth control pills. Id.
Risks.
It is a well-known scientific fact that any hormonal contraceptive places its user at an increased risk of stroke, myocardial infarction, and blood clots generally. This product was no exception:
[The prescribing physician] informed [the decedent minor and her mother] of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled by [the] pharmacy, the package included an insert prepared by . . . the manufacturer[], as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots.
Id. Unfortunately, after three months use the decedent suffered a fatal “massive bilateral pulmonary embolus.” Id.
Continue Reading Massachusetts Rebuffs Latest Plaintiff Attack on Reproductive Choice
Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016). With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date. The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.
Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury. Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury). The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue. Id. at 699.
[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.
Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).