Fischer v. Bayer Healthcare Pharmaceuticals Inc.

          ORDER

          DAVID G. CAMPBELL SENIOR UNITED STATES DISTRICT JUDGE

         Plaintiff Susan Fischer has filed a motion for leave to file a second amended complaint. Doc. 43. Defendants oppose the motion. Doc. 47. The Court will grant the motion in part and deny it in part.

         I. Legal Standard.

         The Court “should freely give leave [to amend] when justice so requires.” Fed.R.Civ.P. 15(a)(2). This policy must not only be heeded, see Foman v. Davis, 371 U.S. 178, 182 (1962), it must be applied with extreme liberality, see Owens v. Kaiser Foundation Health Plan, Inc., 244 F.3d 708, 880 (9th Cir.2001). A court may deny leave when it would prejudice the opposing party, produce an undue delay in the litigation, or result in futility for lack of merit. See Foman, 371 U.S. at 182.

         II. Analysis.

         A. Undue Delay and Prejudice.

         The Court does not agree with Defendants' assertion that the motion to amend is untimely. The motion was filed within the time allowed in the Court's case management order, and relatively early in the discovery period. Nor does the Court agree that the motion is untimely because it is not based on recently discovered information. Defendants' reliance on Vicente v. City of Prescott, No. CV11-08204-PCT-DGC, 2014 WL 1346075, at *1 (D. Ariz. Apr. 3, 2014), is misplaced. Vicente concerned a motion to amend filed after the deadline set in the case management order and was governed by Rule 16(b)(4)'s good cause standard, not the liberal amendment standard of Rule 15. Id. at 1-2.

         The Court also disagrees with Defendants' claim that they will be prejudiced by the amendment. Ample time remains for discovery in this case, and the causation issue to be addressed by the Court on an expedited basis likely applies to each of Plaintiff's proposed new claims.

         B. Futility.

         Defendants argue that several of Plaintiff's proposed causes of action (referred to in this order as “counts”) are futile because they fail to state a claim for relief.

         1. Count 2 - Design Defect.

         Count 2 asserts a claim for strict liability based on design defect. Defendants assert that once a drug is approved by the FDA, the manufacturer is prohibited from making major changes to the drug. Defendants argue that Count 2 asserts that Defendants should have changed their drug after it was approved, and therefore is preempted by federal law. Defendants present a one-paragraph argument that relies on Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015). Doc. 47 at 13. Plaintiff provides an even shorter reply that does not address this preemption issue at all. Doc. 48 at 9.

         The Court notes that at least one case has declined to follow the holding in Yates that all design defect claims against drug manufacturers are preempted. See Guidry v. Janssen Pharm., Inc., 206 F.Supp.3d 1187, 1205 (E.D. La. 2016). Guidry agreed with Yates that design defect claims based on a failure to change a drug after FDA approval are preempted, but held that claims based on a defective design that occurred before FDA approval are not preempted. Id. at 1205-09. The Court finds this preemption issue far too complex to be decided on the basis of six sentences in Defendants' opposition and four sentences in Plaintiff's reply. See Doc. 47, 48. Given the liberal standard for amendments under Rule 15, the Court will permit Count 2 to proceed. Defendants can present a more detailed preemption argument (addressing Guidry and other relevant case law) at the summary judgment stage. If Defendants wish to brief the issue earlier, they may schedule a conference call with the Court to discuss whether earlier briefing is warranted.

         2. Count 4 - Breach of ...