Pharmaceuticals and Medical Devices



Carlton Fields has extensive experience litigating drug and medical device matters on behalf of industry-leading national and international clients. We defend our clients in individual, mass tort, class action, and other complex litigation matters in state and federal courts, from inception through appeal.

Our pharmaceutical work puts us at the forefront of cutting-edge issues, including preemption of medical device and prescription drug claims, the learned intermediary doctrine, comment k, market share liability, and brand name liability for generic use. We routinely take on Daubert and Frye expert challenges and summary judgments on medical causation. Our experience encompasses all types of pharmaceutical products and medical devices.


Seminal Representative Matters

Our dedicated pharmaceutical and medical device team has handled the following decisions establishing drug and medical device law:

  • Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (Eleventh Circuit first applies Riegel preemption to require specific allegations of parallel claims).
  • Colville v. Pharmacia & Upjohn Co., 565 F. Supp. 2d 1314 (N.D. Fla. 2008) (learned intermediary doctrine applies when prescriber independently assesses risk and decides not to warn plaintiff).
  • Beale v. Biomet, Inc., 492 F. Supp. 2d 1360 (S.D. Fla. 2007) (learned intermediary doctrine applies to medical devices and FDUTPA claims, no Florida court recognizes direct-to-consumer or overpromotion exceptions).
  • Alexander v. Danek Med., Inc., 37 F. Supp. 2d 1346 (M.D. Fla. 1999), and Savage v. Danek Med., Inc., 31 F. Supp. 2d 980 (M.D. Fla. 1999) (a plaintiff must prove a defect with expert proof).
  • Adams v. G.D. Searle & Co., 576 So. 2d 728 (Fla. 2d DCA 1991) (comment k applies as Florida law).
  • Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102 (Fla. 1989) (learned intermediary doctrine adopted as Florida law).

​Additional Published Opinions

  • Grubbs v. DePuy Synthes, No. 8:15-cv-00443, 2016 WL 360610 (M.D. Fla. Jan. 19, 2016) (granting summary judgment because the plaintiff failed to allege the violation of any federal requirement in the PMA device components that he received).
  • Marshick v. Johnson & Johnson, No. 5:14-cv-00498, 2015 WL 9266955 (M.D. Fla. Dec. 11, 2015) (granting summary judgment when the plaintiff lacked expert proof of general and specific causation).
  • Teva Pharm. Indus., Ltd. v. Ruiz, 181 So. 3d 513 (Fla. 2d DCA 2015) (reversing denial of motion to dismiss for lack of personal jurisdiction where general jurisdiction was lacking and the plaintiff failed to establish specific jurisdiction and sufficient minimum contacts to satisfy due process).
  • Marmol v. St. Jude Med., 132 F. Supp. 3d 1359 (M.D. Fla. 2015) (dismissing claims against PMA medical device under implied preemption and lack of a remedy to enforce FDA regulations or requirements).
  • Ocasio v. C.R. Bard, Inc., No. 8:13-cv-01962, 2015 WL 3496062 (M.D. Fla. June 3, 2015) (granting summary judgment on warnings claim for lack of an expert on inadequacy and rejecting any inference of a manufacturing defect).
  • Homaday v. Smith & Nephew, Inc., 994 F. Supp. 2d 1264 (M.D. Fla. 2014) (wrongful death claim in third amended complaint related back to original filing for purposes of the statute of limitations). 
  • Brown v. DePuy Orthopaedics, Inc., 978 F. Supp. 2d 1266 (M.D. Fla. 2013) (claims against PMA medical device preempted). 
  • Kaiser v. DePuy Spine, Inc., 944 F. Supp. 2d 1187 (M.D. Fla.  2013) (dismissing claims with prejudice, before discovery, under Riegel preemption and Wolicki-Gables for failing to specify a parallel claim or allege noncompliance with a formal performance standard established by the FDA).
  • Layton v. SmithKline Beecham Corp., No. 05-CA-007440, 2012 WL 4983778 (Fla. Cir. Ct.  Oct. 16, 2012) (an evidentiary hearing is not required to determine entitlement to attorneys’ fees and costs based upon a proposal for settlement).
  • Chapman v. DePuy Orthopaedics, Inc., 760 F. Supp. 2d 1310 (M.D. Fla. 2011) (granting summary judgment for medical device manufacturer based upon choice of law analysis and Virginia’s statute of limitations).
  • Gomez v. Pfizer, Inc., No. 1:09-cv-22700, 2010 WL 4102922 (S.D. Fla. Oct. 18, 2010) (plaintiff alleging failure to warn claims regarding over-the-counter product must respond to discovery and provide specific warning language that allegedly should have accompanied product).
  • Howe v. Wyeth Inc., No. 8:09-cv-00610, 2010 WL 1708857 (M.D. Fla. Apr. 26, 2010) (granting summary judgment for brand-name manufacturers when plaintiff used only generic product).
  • Levine v. Wyeth Inc., 684 F. Supp. 2d 1338 (M.D. Fla. 2010) (granting summary judgment for brand-name manufacturers when plaintiff used only generic product).
  • Doriand v. Centocor Inc., No. 1:09-cv-00078, 2010 WL 325742 (N.D. Fla. Jan. 26, 2010) (rejecting plaintiff’s attempt to add a “sharing” provision to a protective order).
  • Gomez v. Pfizer, Inc., 675 F. Supp. 2d 1159 (S.D. Fla. 2009) (granting motion to dismiss claims of negligence and strict liability under Iqbal and Twombly).
  • Dietrich v. Wyeth, Inc., No. 50-2009-CA-021586, 2009 WL 4924722 (Fla. Cir. Ct. Dec. 21, 2009) (granting summary judgment for brand-name manufacturers when plaintiff used only generic product).
  • Devore v. Howmedica Osteonics Corp., 658 F. Supp. 2d 1372 (M.D. Fla. 2009) (defendant properly removed based upon plaintiff’s discovery responses and fraudulent joinder of alleged product distributor).
  • Wolicki-Gables v. Arrow Int’l, Inc., 641 F. Supp. 2d 1270 (M.D. Fla. 2009) (granting summary judgment of claims against alleged manufacturer, distributor, and manufacturer’s representative under Riegel preemption, learned intermediary doctrine, and failure to present expert proof).
  • Wolicki-Gables v. Arrow Int’l, Inc., No. 8:08-cv-00151, 2008 WL 2773721 (M.D. Fla. June 17, 2008) (granting motion to dismiss claims of strict liability and negligence under Twombly).
  • Chase v. Novartis Pharm. Corp., 740 F. Supp. 2d 1295 (M.D. Fla. 2006) (granting summary judgment under learned intermediary doctrine).
  • Sharp v. Leichus, No. 2004-CA-0643, 2006 WL 515532 (Fla. Cir. Ct. Feb. 17, 2006) (granting summary judgment for brand-name manufacturers when plaintiff used only generic product), aff’d per curiam, 952 So. 2d 555 (Fla. 1st DCA 2007).

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