Small et al v. Amgen, Inc. et al, No. 2:2012cv00476 - Document 66 (M.D. Fla. 2014)

Court Description: OPINION AND ORDER granting in part and denying in part 55 Defendants' Motion to Dismiss. Count IV is dismissed in part to the extent that plaintiffs assert a claim for the negligent failure to test or inspect, and to the extent that plaintiffs assert a claim of negligence per se. The motion is otherwise denied. See Opinion and Order for details. Signed by Judge John E. Steele on 3/6/2014. (MAB)

Download PDF

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA FORT MYERS DIVISION REBECCA A. SMALL LAWRENCE W. SMALL and Plaintiffs, v. Case No: 2:12-cv-476-FtM-29DNF AMGEN, INC., PFIZER, INC., and WYETH, INC., Defendants. OPINION AND ORDER This matter comes before the Court on review of defendants Motion to Dismiss (Doc. #55) filed on May 17, 2013. Plaintiffs filed a Response in Opposition (Doc. #59) on June 14, 2013. Defendants filed a Reply (Doc. #62) on June 28, 2013, and plaintiffs filed a Sur-Reply (Doc. #65) on July 5, 2013. I. Under Federal Rule of Civil Procedure 8(a)(2), a Complaint must contain a short and plain statement of the claim showing that the 8(a)(2). pleader This is entitled obligation to relief. requires more Fed. R. Civ. than labels P. and conclusions, and a formulaic recitation of the elements of a cause of action will not do. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)(citation omitted). To survive dismissal, the factual allegations must be plausible and must be enough to raise a right to relief above the speculative level. Id. at 555. See also Edwards v. Prime Inc., 602 F.3d 1276, 1291 (11th Cir. 2010). This requires more than an defendant-unlawfully-harmed-me accusation. unadorned, the- Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)(citations omitted). In deciding a Rule 12(b)(6) motion to dismiss, the Court must accept all factual allegations in a complaint as true and take them in the light most favorable to plaintiff, Erickson v. Pardus, 551 U.S. 89 (2007), but [l]egal conclusions without adequate factual truth, Mamani support v. are Berzain, 2011)(citations omitted). entitled 654 F.3d to 1148, no assumption 1153 (11th of Cir. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice. Iqbal, 556 U.S. at 678. Factual allegations that are merely consistent with a defendant s liability fall short of being facially plausible. Chaparro v. Carnival Corp., 693 F.3d 1333, 1337 (11th Cir. 2012) (internal quotation marks and citations omitted). Thus, the Court engages in a two-step approach: When there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief. 556 U.S. at 679. 2 Iqbal, II. On August 29, 2012, plaintiffs Rebecca and Lawrence Small filed a six count complaint against Amgen, Inc., Wyeth, Inc., Pfizer, Inc., and Does 1-20. 1 Plaintiffs amended their complaint on October 30, 2012, but it was subsequently dismissed as an impermissible shotgun pleading. (Doc. #53.) Plaintiffs are now relying on their Fourth Amended Complaint which sets forth the following five claims based on injuries allegedly caused by the prescription drug Enbrel: (I) strict liability based on a design defect; (II) strict liability based on a failure to warn; (III) breach of an express warranty; (IV) negligence; and (V) loss of consortium. (Doc. #54.) In support, plaintiffs allege the following: The prescription drug Enbrel is a biologic drug used to treat rheumatoid arthritis. 2 (Doc. #54, ¶¶ 15, 19.) Enbrel was originally developed by Amgen and, at all relevant times, the drug was marketed and sold by both Amgen and Wyeth. 17.) (Id. ¶¶ 16- On October 15, 2009, Wyeth was acquired by Pfizer. (Id ¶ 18.) 1Does 1-20, unknown defendants, are no longer parties to this action. 2A biologic drug is a medicine that has been constituted or reconstituted from natural substances in the body. (Doc. #54, ¶ 15.) 3 In 2002, Ms. Small began receiving two subcutaneous injections of Enbrel a week to treat her rheumatoid arthritis. (Id. ¶ 22.) Ms. Small continued the treatment until August 29, 2008, when she was admitted to the hospital on an emergency basis and was diagnosed with a perforated bowel from a diverticulitis infection that was caused by her use of Enbrel. Until a few days asymptomatic. infection. before her hospitalization, Ms. Small was Multiple surgeries were required to treat the (Id. ¶ 26.) Following her release from the hospital, Ms. Small visited her rheumatologist, Dr. Catherine Kowal. Dr. Kowal consulted with a sales representative regarding Enbrel and was ensured by the representative that it was appropriate to resume Ms. Small s treatment with Enbrel three months after the serious adverse effects occurred. round of (Id. ¶ 27.) complications Ms. Small experienced another associated with her requiring additional surgeries and treatment. use of Enbrel (Id. ¶ 28.) At no time prior to Ms. Small s injuries were doctors and patients warned infections. that Enbrel could cause asymptomatic serious The label accompanying Enbrel at the time of Ms. Small s injuries included the following boxed warning: Infections, including serious infection leading to hospitalization or death, have been observed in patients treated with ENBREL® (see WARNINGS and ADVERSE REACTIONS). Infections have included bacterial sepsis and tuberculosis. Patients should be 4 educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with ENBREL®. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, ENBREL® should be discontinued. (Id. ¶ 29.) information In sheet addition or to the medication boxed guide warning, accompanying a patient the drug contained the following instructions to patients: After starting ENBREL®, if you get an infection, any signs of an infection including a fever, cough, flulike symptoms, or have any open sores on your body, call your doctor right away. ENBREL® can make you more likely to get infections or make any infection that you may have worse. (Id. ¶ 30.) Although the warnings for Enbrel have mentioned infections since Administration at (FDA) least has 2002, required the that Food additional and Drug warnings covering histoplasmosis and other fungal infections be added to the label. (Id. ¶ 37.) III. Defendants assert in their Motion to Dismiss that the Fourth Amended Complaint still constitutes a shotgun pleading, plaintiffs were adequately effects of Enbrel, support their warned plaintiffs defective about failed design to claim, the allege potential any plaintiffs side facts to failed to identify an express warranty, and plaintiffs failed to identify 5 any negligent conduct. (Doc. #55.) The Court will address each argument in turn. A. Shotgun Pleading Defendants contend that the Fourth Amended Complaint still constitutes a shotgun pleading because plaintiffs simply removed the language incorporating the preceding paragraphs into each count and replaced it with a section titled Factual Allegations Relevant to All Causes of Action. In response, plaintiffs argue that the Fourth Amended Complaint does not constitute a shotgun pleading because the offending language was removed and the facts are relevant to all of their claims. A typical incorporate[s] each subsequent shotgun every claim pleading antecedent for is a allegation relief or by pleading that reference into affirmative defense. Wagner v. First Horizon Pharm. Corp., 464 F.3d 1273, 1279 (11th Cir. 2006). A complaint incorporating a long list of general allegations into each claim for relief will also constitute a shotgun pleading if it fails to specify which facts are relevant to each claim. Johnson Enters. of Jacksonville, Inc. v. FPL Group, Inc., 162 F.3d 1290, 1333 (11th Cir. 1998). The problem with a shotgun complaint is that most of the counts contain irrelevant factual allegations and legal conclusions. Strategic Income Fund, L.L.C. v. Spear, Leeds & Kellogg Corp., 305 F.3d 1293, 1295 (11th Cir. 2002); see also Anderson v. Dist. 6 Bd. of Trs. of Cent. Fla. Cmty. Coll., 77 F.3d 364, 366 (11th Cir. 1996) (The general problem with shotgun pleadings is that it is virtually impossible to know which allegations of fact are intended to support which claim(s) for relief. ) The Eleventh Circuit has routinely and explicitly condemned shotgun pleadings, Davis v. Coca-Cola Bottling Co. Consol., 516 F.3d 955, 979 n.54 (11th Cir. 2008), and has stated that neither the district courts nor the defendants are required to sift through the facts presented and decide for itself which were material to the particular cause of action asserted. Beckwith v. Bellsouth Telecomms. Inc., 146 F. App x 368, 372 (11th Cir. 2005) (quoting Strategic Income Fund, LLC v. Spear, Leeds & Kellogg Corp., 305 F.3d 1293, 1296 n.9 (11th Cir. 2002) (citations omitted)). The Fourth Amended Complaint is far from exemplary, but does not amount to an impermissible shotgun pleading. The problem with a shotgun pleading is that each subsequent count is replete with conclusions. general irrelevant factual allegations and legal Here, the complaint simply contains a section of factual allegations plaintiffs claims. that are relevant to all of The legal conclusions are not incorporated into each subsequent count. Given that all of the claims are based upon Ms. Small s use of Enbrel, the Court finds that the use of general factual allegation section is not problematic. 7 Therefore, defendants motion to dismiss the Fourth Amended Complaint as a shotgun pleading is denied. B. Count I: Strict Liability Defective Design In order to state a claim in Florida for strict products liability, a plaintiff must allege (1) the manufacturer s relationship to the product in question, (2) the unreasonably dangerous condition of the product, and (3) the existence of a proximate causal connection between such condition the user s injuries or damages. Bailey v. Janssen Pharmaceutica, Inc., 288 F. App x 597, 604 (11th Cir. 2008) (citing West v. Caterpillar Tractor Co., 336 So. 2d 80, 87 (Fla. 1976). Defendants contend that Count I should be dismissed because plaintiffs have failed allege a single fact in support of the products unreasonably dangerous condition. The Court disagrees. Plaintiffs allege that Enbrel® contained an unreasonably dangerous defect in design or formulation in that, when it left the hands of the Defendants, an average consumer could not reasonably anticipate the dangerous nature of Enbrel® nor fully appreciate Enbrel®. the attendant (Doc. #54, ¶ 46.) risk of injury associated with Plaintiffs further allege that Ms. Small experienced severe and significant infections due to the design defect. (Id. ¶¶ 23, 49-50.) The Eleventh Circuit has observed that [t]he very nature of a products liability actionwhere the cause or source of the defect is not obvious to the 8 consumer-would make it difficult for [a plaintiff] to pinpoint a specific source of defect against one entity along the chain of distribution prior to discovery. Although plaintiffs do not set Bailey, 288 F. App x at 605. forth the precise chemical, biological, or other process by which Enbrel causes asymptomatic infections, they do place defendants on notice of the type of harm allegedly caused by the design defect. the proceedings, the Court finds that At this stage of the allegations of an unreasonably dangerous defect are sufficient to plausibly state a strict liability claim based on a design defect. 288 F. App x at 608. See Bailey, Therefore, defendants motion to dismiss Count I of the Fourth Amended Complaint is denied. C. Count II: Strict Liability - Failure to Warn As a general rule, drug companies have the duty to warn of a drug s dangerous side effects; however, the duty to warn is directed to physicians rather than patients under the learned intermediary doctrine. Hoffmann-La Roche, Inc. v. Mason, 27 So. 3d 75, 77 (Fla. 5th DCA 2009) (citing Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102, 104 (Fla. 1989)). The duty to warn is satisfied if the drug manufacturer gives an adequate warning to the physician who prescribes the drug. Buckner v. Allegran Pharms, Inc., 400 So. 2d 820, 822 (Fla. 5th DCA 1981). In determining the adequacy of a warning, the critical inquiry is whether it was adequate to warn the physician of the possibility 9 that the drug may cause the injury alleged by the plaintiff. Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990). sufficiency and reasonableness of a warning is The generally a question of fact, but can become a question of law where the warning is accurate, clear, and unambiguous. Felix, 540 So. 2d at 105. Plaintiffs allege that defendants failed to adequately warn health care increased providers risk of that Enbrel complications was associated arising from with serious an and significant infection and failed to adequately instruct doctors and patients asymptomatic how to mitigate infections, (Doc. #54, ¶¶ 54, 56.) risks associated of infections, with the use including of Enbrel. Defendants contend that Packaging Insert accompanying Enbrel was adequate as a matter of law because it broadly and clearly warned Ms. Small s physician of the risk of infection. In support of their position, defendants rely on Salvio v. Amgen, Inc., No. 2:11-cv-00553, 2012 WL 517446 (W.D. Pa. Feb. 15, 2012). In Salvio, the court dismissed a failure to warn claim brought under Pennsylvania law because it determined that the adequately broad warned warning the of infection decedent s doctors accompanying of the occurred, a serious infection resulting in death. Enbrel injury that Id. at *5-6. Defendants requests that this Court follow the holding in Salvio by finding that the broad warning 10 of infection accompanying Enbrel adequately warned Ms. Small s physicians of the risk of a serious asymptomatic infection. A review of the warning label reveals that it not only provides a includes broad and warnings general warning regarding of specific infection, types of but also infections ( Infections have included bacterial sepsis and tuberculosis ). Because the warning asymptomatic label infections, does however, not specifically the Court finds warn of that a determination as to the adequacy of such a broad warning of infection is best left for a later stage of the proceedings. Plaintiffs have plausibly stated a cause of action. Accordingly, defendants motion to dismiss Count II is denied. D. Count III: Breach of Express Warranty Defendants assert that plaintiffs breach of express warranty claim should be dismissed because it is conclusory in nature. The Court disagrees. An express warranty is [a]ny affirmation of fact or promise made by the seller to the buyer which relates bargain[.] to Fla. the goods Stat. § and becomes 672.313(1)(a). a basis of the However, an affirmation merely of the value of the goods or a statement purporting to be merely the seller s opinion or commendation of the goods does not create a warranty. Fla. Stat. § 672.313(2). The existence of an express warranty is a factual issue for the 11 jury to decide. State Farm Ins. Co. v. Nu Prime Roll-A-Way of Miami, 557 So. 2d 107, 109 (Fla. 3d DCA 1990). Plaintiffs the package allege inserts, that the defendants expressly Physicians Desk warranted Reference, in other marketing literature, and documents provided to the FDA, that Enbrel was of merchantable quality, fit, safe, and otherwise not injurious to the health and well-being of Ms. Small. 3 ¶ 66.) (Doc. #54, Plaintiffs further allege that these representations were material to Ms. Small s decision to use Enbrel and that product did not conform to the representations. the product s nonconformity, she was injured. The Court plausibly finds state that a claim these for allegations breach of an As a result of (Id. ¶¶ 67-71.) are sufficient express to warranty. Therefore, defendants motion to dismiss Count III of the Fourth Amended Complaint is denied. E. Count IV: Negligence In order to state a claim for negligence under Florida law, the plaintiff must allege (1) a duty or obligation recognized by the law requiring the defendant 3In to protect others from response to defendants motion to dismiss, plaintiffs attempt to include the promises made by defendants sales representative in their breach of express warranty claim. Plaintiffs, however, have failed to include any allegations regarding the representative s promises in Count III. Accordingly, the Court declines to include them among the alleged warranties. 12 unreasonable risks; (2) a breach of that duty; (3) a reasonably close casual connection between the conduct and the resulting injury; and (4) actual loss or damages. So. 2d 1052, 1056 (Fla. 2007) (citing Williams v. Davis, 974 Clay Johnson, 873 So. 2d 1182, 1185 (Fla. 2003)). Elec. Corp. v. Here, plaintiffs allege that Defendants failed to exercise ordinary care in the design, formulation, manufacture, sale, testing, quality assurance, quality control, labeling, marketing, promotions and distribution of Enbrel® . . . . (Doc. #54, ¶ 74.) Defendants assert that there is not a single fact in the Fourth Amended Complaint to support the assertion that Enbrel was negligently designed or manufactured. 4 For the reasons set forth in Section 3.B above, the Court finds that plaintiffs have plausibly stated a claim for a design defect, and for the same reasons, the Court finds that the allegations are sufficient to support a claim of negligent manufacturing. See Hosler v. Alcon Labs., Inc., No. 12-60025-CIV, 2012 WL 4792983, at *6 (M.D. Fla. Oct. 9, 2012) (citing Bailey, 288 F. App x at 605). Defendants also assert that a claim for negligent testing is subsumed by plaintiffs claims for defective design and failure to warn. 4Defendants To this the also assert that the negligent failure to warn claim fails under the learned intermediary doctrine, but, as discussed above, the Court is unable to determine if the warning label is adequate as a matter of law. Therefore, plaintiffs may proceed on their negligent failure to warn claim. 13 Court agrees. testing or In Florida, no separate duty or claim exists for inspecting a product because it is part of the manufacturer s duty to design a product with reasonable care; thus, it is subsumed in claims for defective design and failure to warn. Hall v. Sunjoy Indus. Grp., Inc., 764 F. Supp. 2d 1297, 1302 (M.D. Fla. 2011) (citing Adams v. G.D. Searle & Co., Inc., 576 So. 2d 728, 730-31 (Fla. 2d DCA 1991)). plaintiffs claim for negligence cannot rest Accordingly, on defendants alleged failure to test or inspect. Plaintiffs also allege that defendants breached the duty of pharmacovigilance, which includes the duties to continually monitor, test, and analyze data regarding the safety, efficacy, and prescribing practices of Enbrel. (Doc. #59, ¶¶ 85-86.) In support of the alleged breach, plaintiffs assert that defendants learned through clinical trials and adverse event reports that there was a serious problem associated with Enbrel, but failed to adequately inform public of the risk. doctors, regulatory (Id. ¶ 86.) defendants failure to requirements of regulations FDA comply agencies, and the Plaintiffs further allege that with is the post evidence negligence and also constitutes negligence per se. of marketing defendants (Id. ¶ 91.) Defendants contend that plaintiffs cannot assert a claim of negligence per se for the failure to comply with FDA regulations because Florida law does not recognize a claim for negligence 14 per se for the alleged violation of the Federal Food, Drug, and Cosmetic Act (FDCA). District courts in this Circuit have consistently held that private actions based on the violation of FDA regulations are barred because Florida does not recognize such causes of action. Supp. 2d 1187, 1192 Kaiser v. Depuy Spine, Inc., 944 F. (M.D. Fla. 2013). See also Cook v. MillerCoors, LLC, 872 F. Supp. 2d 1346, 1351 (M.D. Fla. 2012). Thus, Count IV is dismissed to the extent that plaintiffs assert a negligence per se claim based on defendants alleged violations of FDA regulations. Accordingly, it is now ORDERED: Defendants Motion to Dismiss (Doc. #55) is GRANTED in part and DENIED in part. Count IV is dismissed in part to the extent that plaintiffs assert a claim for the negligent failure to test or inspect, and to the extent that plaintiffs assert a claim of negligence per se. The motion is otherwise denied. DONE AND ORDERED at Fort Myers, Florida, this of March, 2014. Copies: Counsel of record 15 6th day

Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.