Puricelli v. Genetech Inc
| Decision Date | 26 April 2011 |
| Docket Number | Case No. 4:10CV01793 JCH |
| Parties | LAURA PURICELLI, et al., Plaintiffs, v. GENETECH, INC. and BIOGEN IDEC, INC., Defendant. |
| Court | U.S. District Court — Eastern District of Missouri |
This matter is before the Court on Defendants' Motion for Judgment on the Pleadings Pursuant to Federal Rule of Civil Procedure 12(c) (Doc. No. 36). These matters are fully briefed and ready for disposition.
As a general rule, a Rule 12(c) motion for judgment on the pleadings is reviewed under the same standard as a 12(b)(6) motion to dismiss. Ginsburg v. InBev NV/SA, 623 F.3d 1229, 1233, n.3 (8th Cir. 2010); Clemons v. Crawford, 585 F.3d 1119, 1124 (8th Cir. 2009), cert. denied, 130 S. Ct. 3507, 177 L. Ed. 2d 1092 (2010); Ashley County v. Pfizer, 552 F.3d 659, 665 (8th Cir. 2009). That is, the Court must view the allegations in the Complaint liberally in the light most favorable to Plaintiff. Eckert v. Titan Tire Corp., 514 F.3d 801, 806 (8th Cir. 2008) (citing Luney v. SGS Auto Servs., 432 F.3d 866, 867 (8th Cir. 2005)). Additionally, the Court "must accept the allegations contained in the complaint as true and draw all reasonable inferences in favor of the nonmoving party." Coons v. Mineta, 410 F.3d 1036, 1039 (8th Cir. 2005) (citation omitted). A complaint must contain "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v.Twombly, 550 U.S. 544, 570 (2007) (). A plaintiff's obligation to provide the grounds of his entitlement to relief "requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555; Huang v. Gateway Hotel Holdings, 520 F. Supp. 2d 1137, 1140 (E.D. Mo. 2007).
When considering a motion for judgment on the pleadings, Porous Media Corp. v. Pall Corp., 186 F.3d 1077, 1079 (8th Cir. 1999).
When the Court exercises its power under diversity jurisdiction, it interprets the forum state's law. Gray v. AT&T Corp., 357 F.3d 763, 765 (8th Cir. 2004). Missouri law applies to this diversity case. Triton Corp. v. Hardrives, Inc., 85 F.3d 343, 345 (8th Cir. 1996). The Court attempts to predict how the highest court in Missouri would resolve these issues. Nordyne, Inc. v. Int'l Controls & Measurements Corp., 262 F.3d 843, 846 (8th Cir. 2001).
Defendants Genetech and Biogen are pharmaceutical companies that jointly developed, market and sell Rituxan. (Petition ("Pet."), Doc. No. 6, 1J1J12-16).1 The use of Rituxan has side effects. Patients who receive Rituxan can suffer profound immunosuppression, which can lead toserious and untreatable illnesses such as community viral infections or progressive multifocal leukoencephalopathy (PML). (Pet., ¶21).
Plaintiffs are the children of the decedent, Mary Merrick ("Merrick" or "the Decedent"). (Pet., ¶¶1-3). Merrick first was administered Rituxan in February 2009. (Pet., ¶18). On October 21, 2009, Merrick died as a result of PML. (Pet., ¶23).
Plaintiffs filed a Petition alleging causes of action for Wrongful Death-Strict Liability (Count I), Wrongful Death-Negligence (Count II), Wrongful Death & Negligent Misrepresentation (Count III), Punitive Damages (Count IV). The Petition was removed to this Court on September 24, 2010. (Doc. No. 1). On March 17, 2011, Defendants Genetech, Inc. and Biogen Idec, Inc. moved for judgment on the pleadings. (Doc. No. 36).
I. MOTION FOR JUDGMENT ON THE PLEADINGS
As stated, Plaintiffs allege causes of action for strict liability, negligence, and negligent misrepresentation, arising from the death of Merrick from PML, which Plaintiffs claim result from Merrick's use of Rituxan. Plaintiffs allege that their mother and her physician were not adequately warned about the dangers of Rituxan. (Plaintiff's [sic] Response to Defendants Motion for Judgment on the Pleadings ("Response"), Doc. No. 38, p. 2) ("Defendants placed an unreasonably dangerous product into the stream of commerce and failed to adequately warn the decedent and further misrepresented the dangers of the product to consumers and physicians.").
In Missouri, a products liability case can be based on strict liability, breach of warranty, or negligence. For products liability to be founded in negligence, the plaintiff must prove the existence of a duty, the defendant's breach thereof, and proximately caused damages. Morrison v. KubotaTractor Corp., 891 S.W.2d 422, 425 (Mo. Ct. App. 1994)(citing Commercial Distribution Ctr., Inc. v. St. Regis Paper Co., 689 S.W.2d 664, 671 (Mo. App. 1985)).
Defendants assert that they did not breach any duty because "Ms. Merrick's physician received a warning about the risks of PML and death and exercised independent medical judgment as to whether use of the medication was appropriate." (Defendants' Memorandum in Support of Their Motion for Judgment on the Pleadings ("Memorandum"), Doc. No. 37, p. 11). Defendants further state that "the warning at issue in this case is adequate as a matter of law." (Id.).
Defendants assert that the warning provided to Decedent's physician was adequate as a matter of law under the learned intermediary doctrine. (Id., pp. 7-12). The learned intermediary doctrine "assumes that it is reasonable for a manufacturer to rely on the prescribing physician to forward to the patient, who is the ultimate user of the drug products, any warnings regarding their possible side effects." Hill v. Searle Laboratories, Div. of Searle Pharmaceuticals, Inc., 884 F.2d 1064, 1070 (8th Cir. 1989).2 Defendants state that Merrick's physician received a copy of Rituxan's warning which stated in a bold-text black box: "JC virus infection resulting in PML and death can occur in patients receiving Rituxan." (Memorandum, pp. 1-3; Exhibit 37-2).3 Likewise, the warning was reprintedn the Physicians' Desk Reference. See Exhibit 37-3, 2010 Physicians' Desk Reference (64th ed.). In addition, the Rituxan label also warned that it should be prescribed only if other medications failed. See Memorandum, pp. 4-5. Finally, Defendants provided a Medication Guide to Rituxan users that warned about the risks of PML. See Memorandum, pp. 5-6. Plaintiffs admit that the Decedent received this Medication Guide. (Memorandum, p. 5; Pet., ¶25)(admitting Decedent received a "warning pamphlet").
In turn, Plaintiffs assert that the Defendants failed to provide the "proper warning" to the Decedent's physician. (Response, p. 2 (citing Madsen v. American Home Prod. Corp., 477 F.Supp.2d 1025 (E.D. Mo. 2007)). Plaintiffs assert that the Court must accept as true their allegation that the warning provided was not proper. (Response, p. 2).4
The cases cited by Defendants, save one case from New Jersey, were summary judgment decisions.5 In their Reply, Defendants primarily rely on Banner v. Hoffmann-La Roche Inc., 383 N.J. Super. 364, 382, 384 (App.Div. 2006), for the proposition that this Court can find Rituxan'swarnings to be adequate as a matter of law based solely on the pleadings. (See Defendants' Reply to Plaintiffs' Opposition to Defendants' Motion Pursuant to Federal Rule of Civil Procedure 12©, Doc. No. 40, pp. 1, 3).6 Banner, however, is not controlling authority for this Court. Furthermore, the Court does not have the same facts, as in Banner, that the Decedent and her physician were aware of the warnings and deliberately ignored them. In Banner, as part of the protocol for using Accutane, the patient had to participate in a pregnancy prevention program. Pursuant to that protocol, the patient had to complete a "Patient Information/Consent and Survey Enrollment Form" before she could receive a prescription for Accutane. 383 N.J. Super. at 369-70. Based upon the Accutane package insert, the Patient Information/Consent and Survey Enrollment Form and the other warnings provided to Ms. Banner and her physician, the court determined that the warnings given to Ms. Banner were "accurate, clear, and unambiguous," and were, therefore, adequate as a matter of law. Id. at 382. The court held that "Roche fulfilled its duty by advising of the risks associated withAccutane therapy and advising of the need for either effective contraception or abstinence." Id. at The unique factual situation in Banner, however, is not present here. Here, the Court has neither subjective nor objective information regarding whether the warning provided to the Decedent and her physician was sufficient. Plaintiffs do not allege that the Decedent or her physician filled out a consent form acknowledging the risks associated with Rituxan, including PML. Although Plaintiff admits that the Decedent received a "warning pamphlet" with her prescription (Pet., ¶ 25), there is no evidence that she or her physician read and understood this warning or that this warning was adequate under the circumstances. Cf Ziliak, 324 F.3d at 521 (); see also Jacobs, 693 F. Supp. at 1034 (). In fact, as the court in Banner acknowledged, "ordinarily, the question of whether a warning is adequate is one for a jury to...
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