United States District Court, D. Arizona
G. CAMPBELL SENIOR UNITED STATES DISTRICT JUDGE
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
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.
Undue Delay and Prejudice.
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.
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.
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.
Count 2 - Design Defect.
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.
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.
Count 4 - Breach of ...