[DK GreenRoots] Recap of Seattle & Puget Sound Kos meet up
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[Drug and Device Law] Breaking News - Reinforcement For Buckman
We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 14194231 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in Ouellette v. Mills, ___ F. Supp.3d ___, 2015 WL 751760 (D. Me. Feb. 23, 2015) (other aspects of Ouellette discussed here). Ouellette noted:
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Posted By Bexis to Drug and Device Law at 3/31/2015 02:45:00 PM --
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[Drug and Device Law] That One Particular Deposition
- Establish that the drug was an effective treatment (preferably for a number of medical conditions)
- Establish that the benefits outweighed the risks for most patients
- Establish that the prescriber weighed the risks/benefits for this patient AND concluded that the benefits outweighed the risks for this patient
- Establish either
- that the prescriber was aware of the very risk of which plaintiff suffered at the time he/she prescribed the drug OR
- that the prescriber continued to prescribe the drug to plaintiff after learning about the risk OR
- that the prescriber, now knowing about the risk, would still have prescribed it to plaintiff
- Establish that in general the prescriber continues to prescribe the drug
- Establish that other medications were not efficacious for this particular plaintiff
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Posted By Michelle Yeary to Drug and Device Law at 3/31/2015 10:44:00 AM --
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[Drug and Device Law] Limiting the Damage from One-Sided Ex Parte Interviews of Doctors
Plaintiffs' counsel may meet ex parte with treating physicians and ask them questions about the information obtained by an examination of their patients. Plaintiffs' counsel may then use the information learned from the ex parte contacts to tailor deposition questioning. As Defendants note, during deposition, Plaintiffs' counsel may show the treating physicians medical articles and documents [those which have been deemed confidential) and ask them whether they would have made prescribing decisions had they known certain facts at the relevant time.
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Posted By John J. Sullivan to Drug and Device Law at 3/30/2015 03:15:00 PM --
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[Drug and Device Law] Result-Driven Affirmance of Birth Defect Verdict
The crux of plaintiffs’ case was that the drug was Pregnancy Category C according to the FDA-approved label when the minor plaintiff’s mother took the drug. Category C is the middle category, but the required labeling language is fairly serious: “(Name of drug) has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species) when given in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of drug) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.” 21 CFR 201.80(f)(6)(i)(c) (the current version is quoted). The opinion does not quote the drug’s actual label, what exactly plaintiffs contended it should have said instead, or what new post-approval evidence allegedly required different labeling. It does say that FDA reclassified the drug up one category to Category D in 2011 without saying what evidence led to that change. Under the current regulation, Category D’s mandatory labeling template language is “(Name of drug ) can cause fetal harm when administered to a pregnant woman. (Describe the human data and any pertinent animal data.) If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.” The trial court had already determined that the defendant was unable to unilaterally change the Pregnancy Category or how the label described the risk of birth defects, but let the plaintiffs argue that the defendant could have requested a change. With this as their theory of liability, plaintiffs won an $11 million verdict and defendant appealed following the denial of its post-trial motions.
As noted above, the knowledge or decision making of the doctor who prescribed the pills that the minor plaintiff’s mother took while pregnant was not examined at all. The reasoning for ignoring these issues was as follows: “The fact that Haley obtained the Topamax for a few months using her mother’s prescription instead of her own because of the family’s financial difficulties does not permit Appellant to evade liability for Brayden’s injuries.” Id. at **24-25. We might have said it like “The fact that the drug used during pregnancy was illegally obtained when minor plaintiff’s mother did not have her own legal prescription creates an obvious break in the causal chain between defendant’s alleged negligence and the plaintiffs’ injuries.” We might have added something about the lack of evidence that the proposed labeling change would have meant the minor plaintiff’s grandmother would not have received a prescription. But nobody asked us. There is also an obvious gap in the evidence of proximate cause from the testimony of the physician who last prescribed the drug to the minor plaintiff’s mother several months before she became pregnant, with plaintiffs relying on:
Id. at *23. This testimony does not come close to indicating that the proposed labeling change would have come to the prescriber’s attention, let alone changed his decision to prescribe to the minor plaintiff’s mother.
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Posted By Eric Alexander to Drug and Device Law at 3/27/2015 04:59:00 PM --
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