Pawley et al v. Marie et al

MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM and Incorporated Memorandum of Law

N.D. Fla.February 27, 2017

1 243443 v3 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 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 Complaint because it fails to state a claim upon which relief can be granted. INTRODUCTION This is a product liability action in which pro se Plaintiff Cash Warren Pawley1 alleges he was injured as a result of being unlawfully ‘drugged’ with the 1 Mr. Pawley is no stranger to the federal court system. He currently has another case pending in the Southern District of Florida seeking a writ of habeas corpus. See Pawley v. The Attorney General of the State of Florida, et al., No. 4:17-cv- 10012-KMM (S.D. Fla. Jan. 18, 2017) (Moore, J.). And since his incarceration in 2013, Mr. Pawley has filed at least six other lawsuits in Florida federal courts, all of which have been dismissed as frivolous, malicious, or for failure to state a Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 1 of 14 2 243443 v3 prescription medication and controlled substance, zolpidem tartrate. Compl. at 2. On October 20, 2012, while visiting Ms. Janice Marie at her home in Key West, Florida, Plaintiff alleges Ms. Marie unlawfully gave him three doses of zolpidem tartrate, which had been prescribed to her by her physician. Id. at 2-3. Plaintiff alleges this “amounted to an extreme overdose” and caused him “to suffer an onslaught of side-effects,” culminating in a “minor skirmish” between Plaintiff and Janice Marie which left her with knife lacerations on the back and side of her neck. Id. Plaintiff was subsequently arrested and convicted of first degree attempted murder and aggravated assault with a deadly weapon and sentenced to forty (40) years in Florida state prison. Id. at 5-6. On July 11, 2016, Plaintiff initiated this action in the Second Judicial Circuit in and for Wakulla County, Florida. Plaintiff’s Complaint, which contains no enumerated counts or headings, appears to assert causes of action against Ms. claim. See Pawley v. Corizon Medical Services, et al., No. 4:16-cv-00479-RH- GRJ (N.D. Fla. Nov. 15, 2016) (Jones, J.) (dismissed pursuant to Plaintiff’s notice of voluntary dismissal and “abuse of the judicial process” under 28 U.S.C. § 1915(g)’s three-strikes bar); Pawley v. Broward County Sheriff’s Office, No. 0:14- cv-60293-RLR (S.D. Fla. Dec. 10, 2014) (dismissed for failure to exhaust administrative remedies); Pawley v. Nelson, No. 0:14-cv-60353-RNS (S.D. Fla. Aug. 26, 2014) (dismissed for failure to state a claim); Pawley v. Age, No. 4:14-cv- 10001-JEM (S.D. Fla. July 31, 2014) (dismissed for failure to state a claim); Pawley v. Doyle, No. 4:14-cv-10015, (S.D. Fla. June 19, 2014) (dismissed for failure to state a claim); Pawley v. State, No. 4:13-cv-10158-JEM (S.D. Fla. Apr. 28, 2014) (dismissed petition for writ of habeas corpus). Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 2 of 14 3 243443 v3 Janice Marie and Ms. Lisa M. Badini for perjury and violations of Plaintiff’s constitutional rights. Id. at 6-7. Plaintiff also alleges Ms. Marie’s homeowner’s insurance company is liable for Ms. Marie’s unlawful acts. Id. at 6. Finally, Plaintiff asserts what appear to be product liability - failure-to-warn allegations against Sanofi.2 None of Plaintiff’s alleged damages relate to any lingering adverse effects of zolpidem tartrate. Compl. at 8-9. Instead, all of Plaintiff’s harms relate to his criminal conviction and the financial and health consequences stemming therefrom. Plaintiff’s claims against Sanofi fail as a matter of law. First, Sanofi’s duty to warn of any potential side effects of a prescription medication runs only to prescribing physicians under Florida’s learned intermediary doctrine. Sanofi has no duty to warn a patient who is prescribed a drug in the course of seeking medical treatment or, as here, a third party like Plaintiff who is unlawfully given the drug outside of the physician-patient relationship. Second, federal case law and the doctrine of collateral estoppel bar Plaintiff from a bringing a civil tort claim which would re-litigate issues decided in his criminal case, such as his mental status and intent, and, thus, undermine his criminal conviction. Third, Plaintiff’s Complaint 2 Zolpidem tartrate, the medication at issue, is the generic name for Ambien®, a prescription drug manufactured by Defendant Sanofi. Several manufacturers produce generic versions of Ambien® which are sold under the name zolpidem tartrate. Plaintiff’s allegations are not clear as to whether he allegedly received Ambien® or a generic substitute from Janice Marie. Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 3 of 14 4 243443 v3 falls woefully short of pleading with sufficient particularity 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 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. Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 4 of 14 5 243443 v3 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 action, supported by mere conclusory statements, do not suffice.” Iqbal, 129 S. Ct. at 1949. II. ARGUMENT A. The Learned Intermediary Doctrine Bars Plaintiff’s Failure to Warn Claim. 1. Sanofi Had No Duty to Warn Plaintiff Directly; Under the Learned Intermediary Doctrine Sanofi’s Only Duty Is to Warn the Prescribing Physician. The Court should dismiss Plaintiff’s claim against Sanofi because it is barred by the learned intermediary doctrine. In cases involving prescription drugs, like the medication at issue here, a manufacturer has no duty to warn the patient directly of the risks that may be associated with the medication’s use. See, e.g. Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995); Buckner v. Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 5 of 14 6 243443 v3 Allergan Pharm., Inc., 400 So. 2d 820, 822 (Fla. 5th DCA 1981), rev. denied, 407 So. 2d 1102 (Fla. 1981). Rather, pursuant to the learned intermediary doctrine, a manufacturer of a prescription medication has a duty to warn only the prescribing physicians, i.e., the learned intermediaries, of potential risks associated with the medication’s use. Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990) (the “manufacturer’s duty to warn of the drug’s dangerous side effects is directed to the physician rather than the patient.”). The prescribing physician is responsible for communicating those risks to the patient during the course of medical treatment. Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1365-70 (S.D. Fla. June 15, 2007). Thus, because patients do not have access to prescription medications directly from the manufacturer or without the aid of a physician, “the manufacture[r] therefore has no duty to warn the patient him or herself.” Id. at 1368. Here, the sum and substance of Plaintiff’s allegations against Sanofi are as follows: Because defendant #3 (sanofi-aventis - U.S. LLC - A Sanofi Company and SANOFI) is the maker and/or supplier/distributor of “Ambien” (Zolpidem Tartrate), and the severe side effects of that narcotic were well known to the companies at the time of the incident, and the mg. (milligram) dosages at that time were twice what they should have been, they are culpable and liable as well. Compl. at 7. As set forth above, Sanofi’s duty to warn of any “severe side effects” runs to the prescribing physician, and the physician is then tasked with deciding which risks to pass along to patients. Beale, 492 F. Supp. 2d at 1370 Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 6 of 14 7 243443 v3 (“under Florida law, it does not matter whether the physician passes the information on to his patients.”); DiMieri v. Medicis Pharms. Corp., Case No. 2:14-cv-176-FtM-38DNF, 2014 U.S. Dist. LEXIS 95409, *8-9 (July 14, 2014) (Chappell, J.) (dismissing plaintiff’s failure to warn claim because “plaintiff only argues he had inadequate personal knowledge regarding [the drug’s] risks, but does not assert whether his physician’s knowledge of [the drug] was inadequate, which is the relevant question.”). Making Plaintiff’s allegation that Sanofi had a duty to warn him even more untenable is the fact that Plaintiff was not prescribed zolpidem and was not a “patient” in this scenario. No physician examined Plaintiff, diagnosed Plaintiff with a medical condition, considered possible treatment options, weighed the risks and benefits of zolpidem tartrate, or determined zolpidem tartrate was an appropriate treatment option and prescribed it to him. Instead, Plaintiff was unlawfully given the drug by Ms. Janice Marie3 and now seeks to benefit from this unlawful conduct and his criminal actions. Because Sanofi had no duty to warn Plaintiff directly about any potential adverse effects of Ambien®, Plaintiff’s claim fails as a matter of law. 3 Plaintiff concedes his ingestion of zolpidem tartrate was illegal throughout his Complaint. See Compl. at 2 (“Janice Marie . . .did unlawfully give, supply and/or administer to the plaintiff”); id. (“Not only was it against the law each of the ‘3’ times that she gave the drug to the plaintiff”); id. (“Selling or giving away Ambien may harm others, and is against the law, under both Federal and State (Florida) law.”) (underlining in original). Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 7 of 14 8 243443 v3 2. Plaintiff’s Illegal Consumption of Another’s Ambien Dooms His Failure-to-Warn Claims As He Cannot Establish Proximate Causation-i.e., That a Different Warning Would Have Changed His Physician’s Decision to Prescribe the Medication-Because He Did Not Obtain His Prescription From a Physician. To prevail on strict liability or negligent failure to warn claims under Florida law, a plaintiff must prove: “(1) that the warnings accompanying the item were inadequate; (2) that the inadequacy of the warnings proximately caused plaintiff’s injury; and (3) that plaintiff in fact suffered an injury by using the product.” Colville v. Pharmacia & Upjohn Co., LLC, 565 F. Supp. 2d 1314, 1320 (N.D. Fla. July 10, 2008); Baker v. Danek Med., 35 F. Supp. 2d 875, 881 (N.D. Fla. Sept. 1, 1998) (“[A] plaintiff must not only show that a manufacturer’s warning was inadequate, but that such inadequacy affected the prescribing physician’s use of the product and thereby injured the plaintiff.”). Here, Plaintiff was not prescribed zolpidem tartrate by a treating physician. Instead he unlawfully obtained the medication from Janice Marie. Compl. at 2.4 Without a prescribing physician, Plaintiff will be unable to provide testimony establishing a differently-worded warning would have resulted in Plaintiff not 4 Possessing and using a controlled substance like zolpidem tartrate that was not obtained from a medical practitioner pursuant to a valid prescription for the person in possession is unlawful under Florida law. See § 893.13(6)(a), Fla. Stat. (2016). Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 8 of 14 9 243443 v3 being prescribed the drug. See Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 76 (Fla. 1st DCA 2009) (finding plaintiff failed to prove causation because he presented no evidence that “a differently worded warning” would have affected his physician’s decision to prescribe the drug); Baker, 35 F. Supp. 2d at 882 (granting summary judgment for defendant manufacturer where there was no testimony that a different warning would have affected prescribing physician’s decision). B. 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. Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 9 of 14 10 243443 v3 Ct. 2013) (attached as Exhibit 1).5 To convict Plaintiff of this charge, the State had to prove beyond a reasonable doubt that Plaintiff (1) “did some act intended to 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. In his defense, Plaintiff entered an insanity plea. See Petition for Writ of Habeas Corpus (attached as Exhibit 2). To find here that Plaintiff’s unlawful use of zolpidem tartrate was the cause of his attempted murder of 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 by a Florida court, and have not been reversed, expunged, or declared invalid.6 To relitigate 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. 5 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). 6 Plaintiff’s petition for writ of habeas corpus pending in the Southern District of Florida 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 5 Filed 02/27/17 Page 10 of 14 11 243443 v3 Further, the doctrine of collateral estoppel bars Plaintiff from alleging zolpidem tartrate caused him to attack and attempt to murder Ms. Janice Marie. Dunkel, 2016 U.S. Dist. LEXIS 124093 at *34 (“Under federal law, collateral 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. Plaintiff’s mental status and intent in carrying out his crime were adjudicated in his criminal case, and Plaintiff cannot re-litigate those issues here. 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. C. Plaintiff’s Complaint is Insufficiently Pled The Court should dismiss Plaintiff’s Complaint because it does not contain sufficient facts to satisfy federal pleading standards. See Twombly, 550 U.S. at 555, 570. As set forth above, to prevail on a strict liability or negligent failure to warn claim a plaintiff must prove: “(1) that the warnings accompanying the item were inadequate; (2) that the inadequacy of the warnings proximately caused Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 11 of 14 12 243443 v3 plaintiff’s injury; and (3) that plaintiff in fact suffered an injury by using the product.” Colville, 565 F. Supp. 2d at 1320. And Sanofi’s duty to warn of the potential adverse effects of a prescription drug runs to the prescribing physician, not the patient. Upjohn, 562 So. 2d at 683. Plaintiff has failed to plead his failure-to-warn claim with the requisite specificity required under Twombly and Iqbal - failing to even set forth the bare elements of a viable claim, much less any factual basis for those elements. See Jackson v. BellSouth Telecomms., 372 F.3d 1250, 1263 (11th Cir. 2004). For example, Plaintiff does not provide any factual details as to the warnings directed to his prescribing physician, nor could he, because he did not receive Ambien from a physician. Indeed, Plaintiff alleges no facts regarding (1) which warnings his prescribing physician received, (2) how those warnings were inadequate, or (3) how the alleged inadequate warnings proximately caused his alleged injuries. See Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597, 608-09 (11th Cir. 2008) (allegations insufficient to state claim of strict-liability failure to warn, where complaint alleged in conclusory fashion that pharmaceutical company inadequately warned doctors, but did not present content of warning label or otherwise describe manner in which warning was inadequate). Accordingly, the Court should dismiss Plaintiff’s failure to warn claim. Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 12 of 14 13 243443 v3 III. CONCLUSION For all the foregoing reasons, Sanofi respectfully requests that this Honorable Court dismiss Plaintiff’s Complaint because it fails to state a claim upon which relief could be granted. LOCAL RULE 7.1(F) CERTIFICATION Pursuant to Local Rule 7.1(F), undersigned counsel certifies this motion and incorporated memorandum contains 3112 words. Dated: February 27, 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 Telephone: (813) 202-7100 Facsimile: (813) 221-8837 bguthrie@shb.com Attorney for sanofi-aventis U.S. LLC Case 4:17-cv-00095-MW-CAS Document 5 Filed 02/27/17 Page 13 of 14 14 243443 v3 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 27 th day of February 2017: Cash Wallace Pawley K09343 (pro se Plaintiff) Santa Rosa Correctional Institution Annex 5850 East Milton Road Milton, FL 32583 /s/ Brian T. 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