tag:blogger.com,1999:blog-36762711.post1888493089315054201..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: New PhRMA Voluntary Guidelines – Will No Good Deed Go Unpunished?Rachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-36762711.post-91876890839655831162008-07-29T09:36:00.000-04:002008-07-29T09:36:00.000-04:00I didn't mean to set up a straw man; I think you'r...I didn't mean to set up a straw man; I think you're right on the law regarding retroactivity and negligence per se. I was just pointing a big issuethat was left unspoken -- indeed, I thought you had set up a straw man, I just didn't call it that!<BR/><BR/>I'm curious how frequently you see the retroactivity and per se arguments, and much more curious how frequently a court actually buys it. Seems to me the law is well-settled there, and thus no reason for concern.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-46715977758563888872008-07-26T20:34:00.000-04:002008-07-26T20:34:00.000-04:00"pablum" is spelled, well, "pablum.""pablum" is spelled, well, "pablum."Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-82687891153705369202008-07-25T13:20:00.000-04:002008-07-25T13:20:00.000-04:00As to the law, we're not in that much disagreement...As to the law, we're not in that much disagreement witn Max Kennerly. We're just addressing different questions.<BR/><BR/>Max has raised, and proceded to knock down, a straw man - that being whether currently applicable private codes can be used simply as evidence of an existing duty.<BR/><BR/>As long as they temporally applicable, most courts have considered private standards as relevant evidence of a standard of care. We generally like admitting such standards, since far more often than not, there's going to be compliance).<BR/><BR/>What we object to is using voluntary, nonretroactive codes in a manner for which they were never intended. That's why we addressed only the two questions we did, which were: (1) creation of a mandatory duty/standard of care that did not otherwise exist (a la negligence per se), and (2) trying to apply the PhRMA code retroactively.<BR/><BR/>Max either doesn't or can't disagree with either of the points we've made - thus his straw man approach.<BR/><BR/>We're certainly not going to say that, after 1/1/2009, the PhRMA code isn't going to be viewed as relevant to an existing marketing standard of care, provided state law has created such an animal.<BR/><BR/>As both violation and compliance with an applicable voluntary code are generally considered evidence of negligence/non-negligence, respectively, I am certain that, just as plaintiffs will attack instances of post-2009 non-compliance, defendants will equally strenuously assert their compliance. But the PhRMA code isn't a binding document, so it's not going to be conclusive either way.<BR/><BR/>As to the specifically Pennsylvania comment, we need to remind Max that strict liability is inapplicable in that state to product liabilty claims involving prescription medical products - as Bexis successfully argued to the Pennsylvania Supreme Court in the Hahn v. Richter case.<BR/><BR/>Finally, it's rather peculiar for Max to criticize the PhRMA code for not being mandatory. A private organization can't make anything mandatory - only a governmental body can do that. If Congress or the FDA is dissatisfied with the PhRMA code, they have the power to supersede it(within the constraints of the First Amendment).Beck/Herrmannhttps://www.blogger.com/profile/17150638020283243716noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-19080355345991136412008-07-25T11:07:00.000-04:002008-07-25T11:07:00.000-04:00I've blogged a reply, as linked in this commen...I've blogged a reply, as linked in this comment:<BR/><BR/>What about ordinary, post hoc negligence? Can voluntary industry codes be relevant to the standard of care?<BR/><BR/>Absolutely! For example, the Eastern District of Pennsylvania case they cited, Knarr v. Chapman Sch. of Seamanship, 2000 U.S. Dist. LEXIS 5351 (E.D.Pa. 2000)(interpreting Florida law), rejected the per se application of ANSI standards, but was happy to cite "Jackson v. H.L. Bouton Co., 630 So. 2d 1173, 1174-75 (Dist.Ct.App.Fl. 1994)(violation of ANSI standards is "merely evidence of negligence.)."<BR/><BR/>The same is true in Pennsylvania, where evidence of industry standards is clearly relevant to the reasonableness of a manufacturer's conduct, and is thus admissible, except in strict liability cases where reasonableness is irelevant. Lewis v. Coffing Hoist Div., Duff-Norton, 515 Pa. 334, 528 A.2d 590, 594 (Pa. 1987). As you'd expect, if the plaintiff brings in industry standards, so too can the defendant. Daddona v. Thind, 891 A.2d 786, 807 (Pa. Commw. Ct. 2006).<BR/><BR/>As for whether its plaintiffs or defendants are engaging in what D&D Law calls "foolishness," you can bet your bottom dollar that every PhRMA defendant from here on out will make their compliance with these new standards the centerpiece of future defenses, and that PhRMA took great pains to ensure these codes were easy to comply with and would play well in front of judges and juries.<BR/><BR/>Seriously, look at these codes and consider the state of the industry in 2008:<BR/><BR/> Promotional materials should:<BR/> (a) be accurate and not misleading;<BR/> (b) only make substantiated claims;<BR/> (c) reflect the balance between risks & benefits; and<BR/> (d) be consistent with all FDA requirements.<BR/><BR/> ...<BR/><BR/> Decisions regarding the selection or retention of [health care providers] as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area.<BR/><BR/> ...<BR/><BR/> Companies should not use consultant arrangements as inducements or rewards for prescribing a particular medicine or course of treatment.<BR/><BR/> ...<BR/><BR/> Train representatives to ensure general science and product-specific information so that representatives can provide accurate, up-to-date information, consistent with FDA requirements.<BR/><BR/>That's voluntary? It should be mandatory. No praise will come from these quarters, I don't consider it a "good deed" to encourage member companies follow FDA requirements. It's the law.<BR/><BR/>In 2008 we have to remind (it wasn't part of the old code!) pharmaceutical companies not to mislead people with promotional materials. What a shame.Anonymousnoreply@blogger.com