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Page 500 DEFENSE COUNSEL JOURNAL–October 2012federal law duty to keep the labelthe same. 13In so finding, the Court explainedthat, “[w]hen the ‘ordinary meaning’ offederal law blocks a private party fromindependently accomplishing what statelaw requires, that party has establishedpre-emption[,]” rejecting an argumentthat the generic pharmaceuticalmanufacturers had the ability to workwith the FDA to have the brand-nameproduct’s (and thus the genericproduct’s) label changed. 14 Specific tothe situation of generic pharmaceuticalmanufacturers, the Court statedthat“[b]efore the [genericpharmaceutical m]anufacturers couldsatisfy the state law, the FDA – afederal agency – had to undertake aspecial effort permitting them to do so.To decide these cases, it is enough tohold that when a party cannot satisfy itsstate duties without the FederalGovernment’s special permission andassistance, which is dependent on theexercise of judgment by a federalagency, that party cannot independentlysatisfy those state duties for preemptionpurposes.” 15The Court recognized thedivergence between its decision inMensing and its 2009 holding in Wyethv. Levine that found no pre-emption forbrand-name pharmaceuticals. Inexpressly pointing out the differenttreatment accorded to what arechemically the same products, the Courtrecognized that its holding in Mensing13 Id. at 2578.14 Id. at 2580.15 Mensing, 131 S. Ct. at 2580-2581.may “make[] little sense” to Plaintiffs. 16The Court explained that the differentoutcomes were based on the differentregulatory treatment of the twocategories of pharmaceuticals, whichresulted from the legislative choice toregulate generic drugs differently to“bring[] more drugs more quickly andcheaply to the public.” 17 The SupremeCourt has not addressed pre-emptionand generic pharmaceuticals since.The application of Mensing bylower courts has not been consistent.Most notably, lower courts are dividedon whether Mensing strictly applies tofailure to warn claims or if it extends tocause the pre-emption of design defectclaims against manufacturers ofgenerics, and that split continues todevelop. For example, the First Circuitin Bartlett v. Mutual Pharmacy, foundthat design defect claims were notpreempted, reasoning that the genericpharmaceutical manufacturer had achoice not to make the product at all: “ageneric maker can avoid defectivewarning lawsuits as well as designdefect lawsuits by not making the drug;and while PLIVA is itself a limiteddeparture from a general rule of Wyeth,an extension of PLIVA to design defectclaims would comprise a general rulefor generics (although not one PLIVAexpressly adopted).” 18 In so finding,the court stated that only the SupremeCourt can decide whether the Mensing16 Id. at 2582.17 Id. at 2582.18 Bartlett v. Mutual Pharm. Co., Inc., 678F.3d 30, 38 (1st Cir. 2012). On July 31,2012, Mutual Pharmaceutical Companypetitioned the Supreme Court for a writ ofcertiorari.
Newsletters Page 501pre-emption exception for failure towarn claims extends to design defectclaims and noted the split amongcourts. 19 Other courts have echoed thatthis is an “open question of law” andexplained that design and warningdefect cases raise different questions forpre-emption purposes. 20 However,Bartlett’s reasoning was expresslyrejected by the United States DistrictCourt for the Eastern District ofKentucky in In re Darvocet, Darvon &Propoxyphene Products LiabilityLitigation, 21 when it dismissed allremaining claims against genericpharmaceutical defendants in thatMDL. 22 Similarly, the United StatesDistrict Court for the District ofVermont dismissed design defect claimsas pre-empted after finding that “[t]heGeneric Defendants’ ‘federal duty ofsameness,’ [] therefore applies to thedesign or composition of the drug aswell as to its labeling. Applying theMensing holding requires dismissal of19 Id. at 37-38.20 See, e.g., Halperin v. Merck Sharp &Dohme Corp., Docket No. No. 11 C 9076,2012 U.S. Dist. LEXIS 50549, *11-*12(N.D. Ill. Apr. 10, 2012) (“Illinois law doesnot base [the wholesale drug distributor’s]potential liability on any failure to complywith a state law duty, like the affirmativeduty to warn at issue in Mensing” and notingthat the wholesale drug distributor is beingsued for its place in the chain of commerce,not “for violating a state law duty to designsafe pharmaceuticals and, thus, no conflictarises”).21 MDL Docket No. 2226, 2012 U.S. Dist.LEXIS 89994 (E.D. Ky. June 22, 2012).22 Id. at *38-*39.the Lymans’ design claims as well.” 23The Lyman court is not alone in soholding; other courts have similarlyfound that “the ‘federal duty of‘sameness,’’ [] also applies in thecontext of generic drug design, andfederal law preempts state lawsimposing a duty to change a drug’sdesign on generic drugmanufacturers.” 24Courts are also addressing otherquestions raised by Mensing, includingwhat constitutes a generic manufacturerunder Mensing. As an example, afederal district court in New Jerseyfound that Mensing extends to barfailure to warn claims againstauthorized distributors of a brandedproduct due to the authorized distributorhaving no power to change thepharmaceutical’s labeling. 25In a departure from what isdeveloping into a rule of general23 Lyman v. Pfizer, Inc., No. 2:09-cv-262,2012 U.S. Dist. LEXIS 13185, *12 (D. Vt.Feb. 3, 2012) (citations omitted).24 In re Pamidronate Prods. Liab. Litig.,Docket No. 09-MD-2120, 2012 U.S. Dist.LEXIS 10901, *11 (E.D.N.Y. Jan. 30,2012); see also, e.g., In re Darvocet, Darvon& Propoxyphene Prods. Liab. Litig., MDLNo. 2226, 2012 U.S. Dist. LEXIS 30593,*106-*107 (D. Ky. Mar. 5, 2012)(dismissing “wrongful marketing” claims“based on strict liability design defect,negligent design, negligent marketing, andbreach of implied warranty” after reasoningthat they “are all based on the allegedlydefective design of the drug” and preemptedunder the reasoning of Mensing).25In re Fosamax (Alendronate Sodium)Prods. Liab. Litig., MDL No. 2243, DocketNo. 08-cv-0008, 2012 U.S. Dist. LEXIS5817, *26-*27 (D.N.J. Jan. 17, 2012).
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