Pawley et al v. Marie et al

MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

N.D. Fla.April 6, 2017

1 244927 v2 IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF FLORIDA TALLAHASSEE DIVISION CASH WARREN PAWLEY, SR. and HIS ESTATE AND HEIRS Plaintiffs, v. Case No. 4:17-cv-00095-MW-CAS JANICE MARIE, et al, Defendants. _____________________________/ DEFENDANT SANOFI-AVENTIS U.S. LLC’S MOTION TO DISMISS PLAINTIFF’S AMENDED COMPLAINT AND INCORPORATED MEMORANDUM OF LAW Defendant sanofi-aventis U.S. LLC (“Sanofi”), pursuant to Fed. R. Civ. P. 12(b)(6), respectfully moves to dismiss Plaintiff’s claims against it with prejudice because it fails to state a claim upon which relief can be granted and cannot be cured by amendment. INTRODUCTION Plaintiff’s Amended Complaint continues to try to re-litigate his mental state on the night he attempted to murder Defendant Janice Marie. Plaintiff’s mental state and intent were the focus of his criminal trial and have already been decided by a Florida jury, which found Plaintiff guilty beyond a reasonable doubt of first degree (premeditated) attempted murder. Federal law and the doctrine of collateral Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 1 of 16 2 244927 v2 estoppel bar Plaintiff from pursuing these civil claims which seek to undermine his criminal conviction. Looking past this initial bar to the merits of his pleading, Plaintiff’s claims also fail as a matter of law. The type of claim Plaintiff asserts here - that Sanofi should never have designed and sought FDA approval for Ambien® - has been explicitly rejected by the United States Supreme Court. Further, Plaintiff’s “violation of civil rights” claim has no basis against Sanofi when there are no facts to show it was acting under the color of state law. Even assuming these claims are cognizable, which they are not, Plaintiff’s Amended Complaint still warrants dismissal because it falls far short of alleging sufficient facts to satisfy federal pleading standards as required by Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955 (2007), Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 1949 (2009), and Fed. R. Civ. P. 8(a). Accordingly, the Court should dismiss all of Plaintiff’s claims against Sanofi pursuant to Fed. R. Civ. P 12(b)(6). MEMORANDUM OF LAW I. LEGAL STANDARD A complaint must set forth “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a). To survive a motion to dismiss under Fed. R. Civ. P. 12(b)(6), “[f]actual allegations must be enough to Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 2 of 16 3 244927 v2 raise a right to relief above the speculative level” and must state “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 555, 570 (emphasis added). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 129 S. Ct. at 1949 (quoting Twombly, 550 U.S. at 556). “Determining whether a complaint states a plausible claim for relief [is] a context- specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. at 1950. A complaint must contain “more than labels or conclusions” or “a formulaic recitation of the elements of a cause of action . . . .” Twombly, 550 U.S. at 555. The Court need not accept as true plaintiff’s conclusory allegations. Hall v. Bellmon, 935 F.2d 1106, 1110 (10th Cir. 1991). Indeed, while the Court must construe the allegations in the Complaint in the light most favorable to Plaintiff, “conclusory allegations, unwarranted factual deductions or legal conclusions masquerading as facts will not prevent dismissal.” Davila v. Delta Air Lines, Inc., 326 F.3d 1183, 1185 (11th Cir. 2003). “Where a complaint pleads facts that are ‘merely consistent with’ a defendant’s liability, it ‘stops short of the line between possibility and plausibility of ‘entitlement to relief.’” Id. at 1949 (quoting Twombly, 550 U.S. at 557). “Threadbare recitals of the elements of a cause of Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 3 of 16 4 244927 v2 action, supported by mere conclusory statements, do not suffice.” Iqbal, 129 S. Ct. at 1949. A. Plaintiff’s Criminal Conviction Bars His Civil Claims Under federal law, “to ensure finality and avoid inconsistent judgments, the United States Supreme Court has long enforced the principle that one cannot prevail in a civil tort action if doing so would undermine a final criminal judgment.” Dunkel v. Hedman, No. 3:15-cv-948-J-34PDB, 2016 U.S. Dist. LEXIS 124093, *33 (M.D. Fla. Aug. 17, 2016) (citing Heck v. Humphrey, 512 U.S. 477, 484-85, 114 S. Ct. 2364, 129 L. Ed. 2d 383 (1994)). Florida law also bars civil claims that would undermine criminal convictions. See Behm v. Campbell, 925 So. 2d 1070, 1072 (Fla. 5th DCA 2006) (barring plaintiff’s civil claims for battery, false arrest/imprisonment, and trespass which would undermine his criminal conviction). Here, Plaintiff was convicted of, among other charges, first degree attempted murder with a weapon. See Order of Probation, No. 12-CF-818-K (Fla. 16th Cir. Ct. 2013) (attached as Exhibit A).1 To convict Plaintiff of this charge, the State had to prove beyond a reasonable doubt that Plaintiff (1) “did some act intended to 1 Under Fed. R. Evid. 201(b), the Court may take judicial notice of a fact that cannot be reasonably disputed because it is either generally known or can be readily determined from reliable sources. See Dunkel, 2016 U.S. Dist. LEXIS 124093 at *25-26 (taking judicial notice of criminal conviction). Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 4 of 16 5 244927 v2 cause the death of [Ms. Janice Marie] that went beyond just thinking or talking about it;” (2) “acted with a premeditated design to kill [Ms. Janice Marie];” and (3) “the act would have resulted in the death of [Ms. Janice Marie] except that someone prevented [Plaintiff] from killing [Ms. Janice Marie] or he failed to do so.” Fla. Std. Jury Instr. (Crim.) 6.2. By filing this action Plaintiff is challenging the core finding of his criminal conviction - that he had formed the requisite intent and planned to kill Ms. Janice Marie. Plaintiff’s Amended Complaint makes clear he is attempting to challenge this exact jury finding here by repeatedly alleging Ambien® altered his thought process: This overdose amount of Ambien . . . caused the plaintiff to suffer an onslaught of side effects, including, but not limited to aggressive behavior, abnormal thoughts, confusion, agitation, homicidal actions and ideations, dizziness, a “drugged feeling,” violent behavior, mental/mood changes, depression, anxiety, difficulty breathing, and hallucinations. This reaction resulted in plaintiff’s incarceration. During the immediate time following the unlawful dosages of AMBIEN administered by the defendant (Marie), and for an extended period afterwards, the plaintiff was unable to formulate rational thought, and could not distinguish the difference between right and wrong, fantasy, or reality, or fact from fiction. . . . defendant Marie stabbed and cut the plaintiff at least four times, while he was so sedated by the Ambien she’d given him, that he was unable to defend himself. Pawley was not even coherent enough to comprehend what was going on . . . Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 5 of 16 6 244927 v2 Am. Compl. at 4-5 (emphasis added). Plaintiff made his intention to re-litigate his mental state equally clear in his response to Sanofi’s first motion to dismiss, where he stated that “the giving of the Ambien multiple times to plaintiff - caused [him] to become ‘involuntarily’ intoxicated (insane), and, under those laws, then, the actions of the plaintiff were not criminal.” Dkt. No. 19 at 7 (underlining in original). To find here that Plaintiff’s unlawful use of zolpidem tartrate caused him to become ‘involuntarily intoxicated’ and attempt to kill Ms. Janice Marie would undermine his criminal conviction. The issues of Plaintiff’s mental status and his intent in carrying out the attempted murder have been decided beyond a reasonable doubt by a Florida jury, where Plaintiff was presumed innocent, and have not been reversed, expunged, or declared invalid.2 To re-litigate these issues here would be contrary to federal and Florida state court precedent. See Dunkel, 2016 U.S. Dist. LEXIS 124093 at *36-37; Behm v. Campbell, 925 So. 2d at 1072. The doctrine of collateral estoppel further bars Plaintiff from alleging his use of zolpidem tartrate caused him to attack and attempt to murder Ms. Janice Marie. See Dunkel, 2016 U.S. Dist. LEXIS 124093 at *34 (“Under federal law, collateral 2 A pending petition for writ of habeas corpus does not affect his conviction for collateral estoppel purposes here. National Union Fire Ins. Co. v. Sun, No. 96- 9020, 1997 U.S. App. LEXIS 6174, *5 (2nd Cir. Apr. 2, 1997) (a “pending habeas corpus proceeding does not alter the preclusive effect of his prior conviction.”). Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 6 of 16 7 244927 v2 estoppel bars a person convicted of a crime from contesting that conviction in a later civil action if the issue is identical in both actions, the issue was litigated in the criminal trial, determining the issue was critical and necessary to the judgment in the criminal case, and the burden of persuasion is not significantly heavier in the later action.”). This principle applies whether challenging the conviction as a whole or to a single element of the crime. Id. The central issue in both Plaintiff’s criminal case and this case is Plaintiff’s mental status and intent on the night of October 19, 2012, when he tried to murder Ms. Marie. The jury in his criminal trial was required to make a specific finding that Plaintiff “acted with a premeditated design to kill” in order to convict him of first degree attempted murder. Fla. Std. Jury Instr. (Crim.) 6.2. Plaintiff’s mens rea was thus critical and necessary for his criminal conviction. And the jury reached that conclusion under the much heavier ‘beyond a reasonable doubt’ standard, as compared to the preponderance of the evidence standard applicable in this case. Plaintiff now asks this Court to ignore the jury’s findings and attribute his actions and resulting incarceration to his unlawful use of Ambien®. Because all of the factors set forth in Dunkel are satisfied, collateral estoppel bars Plaintiff from re-litigating those issues here. Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 7 of 16 8 244927 v2 Accordingly, the Court should dismiss Plaintiff’s Complaint on the principle that Plaintiff cannot prevail in a civil tort action if it would undermine a final criminal judgment and the doctrine of collateral estoppel. B. Plaintiff’s Negligence Claim Fails as a Matter of Law Plaintiff now alleges Sanofi should be held liable for designing Ambien and seeking and obtaining FDA approval to market the medication. Plaintiff’s Amended Complaint alleges: This is not a “failure to warn” claim, as the plaintiff (Pawley) was not a patient, did not ask for the “Ambien”; was given the drug surreptitiously under the guise it was an all-natural herbal supplement. It is a negligence claim for placing a product on the market that [Sanofi] knew had these severe side effects, when it never should have been, and . . . Am. Compl. at 11. Plaintiff’s new theory, that Sanofi should have “never sold” or should have “stopped selling” Ambien because it was allegedly too dangerous, has been explicitly rejected by the United States Supreme Court on the ground that it is preempted by federal law. See Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2477, 186 L. Ed. 2d 607 (2013). Bartlett involved a plaintiff who alleged injuries from taking the generic prescription medication sulindac. Id. at 2472. Plaintiff sued the manufacturer of the drug in New Hampshire state court alleging design defect and failure to warn claims. Id. After the manufacturer removed the case to federal court, the district court dismissed plaintiff’s failure to warn claims. Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 8 of 16 9 244927 v2 Id. At the conclusion of a two week trial, the jury found the manufacturer liable on the design defect claims and awarded damages to the plaintiff. Id. The First Circuit affirmed, finding the design defect claims were not preempted because “generic manufacturers facing design defect claims could simply choose not to make the drug at all.” Id. The Supreme Court rejected this “stop-selling” argument as incompatible with its preemption jurisprudence. Id. at 2477. The Court stated: Our pre-emption cases presume that an actor seeking to satisfy both his federal and state-law obligations is not required to cease acting altogether in order to avoid liability. *** Adopting the First Circuit’s stop-selling rationale would mean that not only PLIVA, but also the vast majority - if not all - of the cases in which the Court has found impossibility pre-emption, were wrongly decided. Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in PLIVA, so it is irrelevant to our analysis here. Id. at 2477-78. Accordingly, the Court reversed and entered judgment for the manufacturer finding the plaintiff’s design defect claims were preempted. The Sixth Circuit confronted “never-start selling” and “stop-selling” claims in Yates v. Ortho-McNeil-Janssen Pharm. Inc., 808 F.3d 281 (6th Cir. 2015). There, plaintiff alleged injuries after using the brand-name prescription medication Ortho Evra® and filed suit against the drug manufacturer. Id. at 286. The district court granted summary judgment on all five of plaintiff’s claims. Id. On appeal, Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 9 of 16 10 244927 v2 the Sixth Circuit framed the design defect issue as “whether defendants could have complied with their alleged duty under New York law to have designed a safer drug before submitting ORTHO EVRA® for approval to the FDA or to change its formulation post-approval, while simultaneously complying with federal law.” Id. at 294. The Sixth Circuit first held plaintiff’s post-approval design defect claim (i.e. “stop-selling”) was “clearly preempted by federal law.” Id. at 298. Once a drug is approved, FDA regulations prohibit the manufacturer from making “any major changes to the qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application.” Id. Thus, the court held plaintiff’s claim that defendants should have altered the formulation of ORTHO EVRA after FDA-approval was prohibited by federal law and preempted. Id. Next, the Sixth Circuit rejected plaintiff’s claim that there was no federal law that would have prevented defendants from designing a different drug in the first place (i.e. the “never start-selling” claim). Id. at 299. The court stated: To imagine such a pre-approval duty exists, we would have to speculate that had defendants designed ORTHO EVRA® differently, the FDA would have approved the alternate design. Next, we would have to assume that [plaintiff] would have selected this method of birth control. Further yet, we would have to suppose that this alternate design would not have caused [plaintiff’s injury]. Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 10 of 16 11 244927 v2 Id. The court found this was “several steps too far” because even if state law required defendants to produce a different design, the medication’s availability to plaintiff was contingent on whether the FDA would approve the alternate design in the first place. Id. The court was “unable to conceive of any coherent pre- approval duty that defendants would have owed to [plaintiff] when it was developing ORTHO EVRA®” and “reject[ed] this never start-selling rationale for the same reasons the Supreme Court in Bartlett rejected the stop-selling rationale of the First Circuit.” Id. at 300. The court then affirmed the district court’s order finding plaintiff’s pre-approval and post-approval design defect claims were preempted by federal law. Id.3 Plaintiff’s claims here warrant the same outcome. The crux of Plaintiff’s claim is that Sanofi should never have designed and sought FDA approval for Ambien®. Am. Compl. at 11 (alleging “it is a negligence claim for placing a product on the market that [Sanofi] knew had these severe side effects, when it never should have been, . . .”). However, Sanofi owed no pre-approval duty to Plaintiff or any other individual when it was developing Ambien®. Yates, 808 F.3d 3 See also Utts v. Bristol-Myers-Squibb, No. 16cv5668(DLC), 2016 U.S. Dist. LEXIS 178335 (S.D.N.Y Dec. 23, 2016) (rejecting plaintiff’s argument that “defendants had a pre-approval duty to submit a differently designed drug for FDA approval”); Barcal v. EMD Serano, Inc., No. 5:14-cv-01709-MHH, 2016 U.S. Dist. LEXIS 35765 (N.D. Ala. Mar. 21, 2016) (dismissing plaintiff’s claims premised on a deisgn defect theory because they are preempted by federal law). Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 11 of 16 12 244927 v2 at 300. This fact is even more true here than in Yates, which involved a patient who received the prescription medication from her physician, who would have weighed the risks and benefits of the drug based on the patient’s specific attributes and provided necessary counseling to minimize adverse events. Here, Plaintiff would not be considered a “patient” under any definition, as he did not receive Ambien® under the care of a physician and pursuant to a prescription, but rather received it and used it unlawfully. The Court should reject Plaintiff’s “never start- selling” claim as barred and preempted by federal law. See Bartlett, 133 S. Ct. at 2478; Yates, 808 F.3d at 300; Utts, 2016 U.S. Dist. LEXIS 178335 at *32-33; Barcal, 2016 U.S. Dist. LEXIS 35765 at *10-12. C. Plaintiff’s “Civil Rights” Claim Fails as a Matter of Law Plaintiff alleges his “civil rights were violated by each Defendant individually and jointly.” Am. Compl. at 17. To the extent this is an attempt to plead a violation of 42 U.S.C. § 1983, such a claim “requires a plaintiff to show he was deprived of a federal right by a person acting under color of state law.” Copeman v. Citifinancial Bank, et al., No. 1:10-cv-00228-SPM-GRJ, 2010 U.S. Dist. LEXIS 133644, *3 (N.D. Fla. Dec. 1, 2010). Section 1983 can apply to the actions of private actors if (1) the actor performed a function that is traditionally the exclusive prerogative of the state; (2) the state has coerced or significantly encouraged the action taken by the private party; or (3) the state has such a Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 12 of 16 13 244927 v2 relationship of interdependence with the private actor that it was a joint participant in the action. Jones v. Christ Town Ministries, No. 16-12834, 2016 U.S. App. LEXIS 19469, *1-2 (11th Cir. Oct. 28, 2016). Plaintiff has not and cannot allege facts to support a finding that Sanofi was acting under color of state law under any of these scenarios. Indeed, Sanofi has had no contact with Plaintiff or Plaintiff’s physician, who had the ability to prescribe Ambien® (because there is none), and Sanofi was not involved in Plaintiff’s criminal investigation, trial, or conviction by a Florida jury. Because there are no facts to show Sanofi was a state actor, the Court should dismiss Plaintiff’s violation of civil rights claim against Sanofi with prejudice. See Jones v. Christ Town Ministries, No. 4:16-cv-110-WS-CAS, 2016 U.S. Dist. LEXIS 64103 (N.D. Fla. May 6, 2016) (dismissing civil rights action without leave to amend because defendant was “not a state actor.”); Jones v. Robinson, No. 4:15-cv-620-RH-CAS, 2016 U.S. Dist. LEXIS 29388 (N.D. Fla. Mar. 7, 2016) (dismissing 42 U.S.C. § 1983 claims without leave to amend because plaintiff “has alleged no facts showing that he is entitled to relief.”). D. Plaintiff’s Amended Complaint is Insufficiently Pled Finally, the Court should dismiss Plaintiff’s Complaint on the additional basis that it fails to contain sufficient facts to satisfy federal pleading standards. See Twombly, 550 U.S. at 555, 570. “In the context of product liability, the basic Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 13 of 16 14 244927 v2 elements of a negligence cause of action apply: (1) duty of care toward the plaintiff; (2) breach of that duty (or negligence); (3) proximate cause.” Colville v. Pharmacia & Upjohn Co. LLC, 565 F. Supp. 2d 1314, 1320 (N.D. Fla. July 10, 2008). And to prevail under either a strict liability or negligence theory, “a plaintiff must demonstrate that the injuries complained of were caused by a defective product whose defect existed at the time of injury and at the time in which the product left the manufacturer’s control.” Id. Plaintiff’s Amended Complaint is woefully light on facts and full of conclusions. Plaintiff fails to allege a cognizable duty that Sanofi owed to him - a person who used a prescription medication unlawfully and without the care and warnings that a physician could have provided. Plaintiff simply claims Sanofi should be “liable for any adverse reactions ‘anyone’ could have.” Am. Compl. at 10. Plaintiff also fails to allege how Sanofi breached any duties it owed him or how these alleged breaches caused any of his claimed injuries. Accordingly, the Court should dismiss Plaintiff’s negligence claim. See Isberner v. Celebrity Cruises, Inc., Case No. 06-60447-CIV, 2006 WL 4005569, *4 (S.D. Fla. Dec. 21, 2006) (dismissing negligence claims when plaintiff “failed to allege facts sufficient to show that [d]efendant’s actions were negligent, and [] failed to specify how [d]efendant’s own actions proximately caused [p]laintiff’s injuries.”); Beale v. Biomet, Inc., Case No. 1:05-cv-22941-ASG, slip op. at 5 (S.D. Fla. Aug. 21, 2006) Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 14 of 16 15 244927 v2 (granting dismissal when pleading was “inexplicably vague in describing the conduct by [d]efendants that allegedly constitutes a breach of duty in the negligence context.”). Plaintiff’s violation of civil rights claim contains even less details. It consists of a single sentence in a catch-all attempt to cast liability: Violation of Civil Rights: Plaintiff’s civil rights were violated by each Defendant individually and jointly. Am. Compl. at 17. As explained above, Plaintiff fails to allege any facts showing Sanofi was a state actor. Accordingly, the Court should dismiss this claim for failure to state a cause of action. See Christ Town Ministries, 2016 U.S. Dist. LEXIS 64103; Robinson, 2016 U.S. Dist. LEXIS 29388. III. CONCLUSION For all the foregoing reasons, Sanofi respectfully requests that this Honorable Court dismiss Plaintiff’s Amended Complaint with prejudice. LOCAL RULE 7.1(F) CERTIFICATION Pursuant to Local Rule 7.1(F), undersigned counsel certifies this motion and incorporated memorandum contains 3618 words. Dated: April 6, 2017 Respectfully Submitted, /s/ Brian T. Guthrie Brian T. Guthrie FBN 0084232 SHOOK, HARDY & BACON L.L.P. 100 North Tampa Street, Suite 2900 Tampa, FL 33602-5810 Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 15 of 16 16 244927 v2 Telephone: (813) 202-7100 Facsimile: (813) 221-8837 bguthrie@shb.com Attorney for sanofi-aventis U.S. LLC CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been filed through the Court’s EC/CMF electronic case management system and furnished by U.S. Mail to the following parties on this 6th day of April 2017: Cash Wallace Pawley K09343 (pro se Plaintiff) Santa Rosa Correctional Institution Annex 5850 East Milton Road Milton, FL 32583 /s/ Brian T. Guthrie Attorney Case 4:17-cv-00095-MW-CAS Document 28 Filed 04/06/17 Page 16 of 16