Small v. Amgen, Inc.

134 F. Supp. 3d 1358, 2015 U.S. Dist. LEXIS 129195, 2015 WL 5687668
CourtDistrict Court, M.D. Florida
DecidedSeptember 25, 2015
DocketCase No. 2:12-cv-476-FtM-29MRM
StatusPublished
Cited by9 cases

This text of 134 F. Supp. 3d 1358 (Small v. Amgen, Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Small v. Amgen, Inc., 134 F. Supp. 3d 1358, 2015 U.S. Dist. LEXIS 129195, 2015 WL 5687668 (M.D. Fla. 2015).

Opinion

OPINION AND ORDER

JOHN E. STEELE, Senior District Judge.

This matter comes before the Court on the defendants’ Motion for Summary Judgment (Doc. #82) filed on December 23, 2014. Plaintiffs filed a Response in Opposition (Doc. #89) on January 20, 2015. Defendants filed a Reply (Doc. # 92) on February 2, 2015, and plaintiffs filed a Sur-Reply (Doc. # 95) on February 10, 2015.

I.

Plaintiffs Rebecca and Lawrence Small filed this action against defendants Amgen, Inc., Wyeth, Inc., Pfizer, Inc., and Does 1-20 to recover damages for the injuries Ms. Small allegedly sustained as a result of her use of the prescription drug Enbrel. Plaintiffs allege that Ms. Small started using Enbrel in 2002 to treat her rheumatoid arthritis. Ms. Small continued her treatment with Enbrel 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 allegedly caused by her use of Enbrel. Plaintiffs allege that multiple surgeries were required to treat the infection.

In their Fourth Amended Complaint, filed on December 23, 2014, plaintiffs set forth the following five claims against Am-gen, Inc., Wyeth, Inc., and Pfizer, Inc.: (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.) On March 6, 2014, the Court entered an Opinion and Order dismissing Count IV to the extent plaintiffs asserted a claim for the negligent failure to test or inspect, and to the extent that plaintiffs asserted a claim of negligence per se. (Doc. # 66.) Defendants now move for summary judgment on the remaining claims, arguing that they are barred by Florida’s learned intermediary doctrine.

II.

Summary judgment is appropriate only when the Court is satisfied that “there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.” Fed. R.Civ.P. 56(a). “An issue of fact is ‘genuine’ if the record taken as a whole could lead a rational trier of fact to find for the nonmoving party.” Baby Buddies, Inc. v. Toys “R” Us, Inc., 611 F.3d 1308, 1314 (11th Cir.2010). A fact is “material” if it may affect the outcome of the suit under governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). “A court must decide ‘whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.’ ” Hickson Corp. v. N. Crossarm Co., Inc., 357 F.3d 1256, 1260 (11th Cir.2004) (citing Anderson, 477 U.S. at 251, 106 S.Ct. 2505).

In ruling on a motion for summary judgment, the Court views all evidence and draws all reasonable inferences in favor of the non-moving party. Scott v. Harris, 550 U.S. 372, 380, 127 S.Ct. 1769, 167 L.Ed.2d 686 (2007); Tana v. Dantanna’s, 611 F.3d 767, 772 (11th Cir.2010). Howev[1363]*1363er, “if reasonable minds might differ on the inferences arising from undisputed facts, then the court should deny summary judgment.” St. Charles Foods, Inc. v. America’s Favorite Chicken Co., 198 F.3d 815, 819 (11th Cir.1999) (quoting Warrior Tombigbee Transp. Co. v. M/V Nan Fung, 695 F.2d 1294, 1296-97 (11th Cir.1983) (finding summary judgment “may be inappropriate even where the parties agree on the basic facts, but disagree about the factual inferences that should be drawn from these facts”)). “If a reasonable fact finder evaluating the evidence could draw more than one inference from the facts, and if that inference introduces a genuine issue of material fact, then the court should not grant summary judgment.” Allen v. Bd. of Pub. Educ., 495 F.3d 1306, 1315 (11th Cir.2007).

III.

A. Rheumatoid Arthritis

Rheumatoid arthritis is an autoimmune disease that occurs when the body’s immune system mistakenly attacks joints, cells, tissues, and other organs of the body. (Doc. # 82-1, p. 10.) Rheumatoid arthritis typically causes inflammation in the body’s joints, but can also cause symptoms such as fatigue, joint stiffness, low grade fevers, rashes, ulcerations in the mouth, shortness of breath, and chest pains. (Id.) If left untreated, rheumatoid arthritis can lead to “[t]otal disability, and also a decrease in quality of life as well as a decrease in life expectancy.” (Id. at 11.) Early rheumatoid arthritis treatment options carried substantial risks, such as increased risk of lymphoma and nonmelanoma skin cancers, stomach ulcers, kidney disease, bone marrow depression, thinning of the skin, hypertension, and avascular necrosis. (Id. at 13-14.)

In 1998,- the Food and Drug Administration (“FDA”) approved the release of En-brel, a drug credited with revolutionizing the treatment options for those suffering from rheumatoid arthritis. (Doc. # 82, p. 3.) Enbrel is a “biologic” drug and is “alleged to be a recombinant human IcGI antibody that neutralizes and/or blocks the activity of TNFs [Tumor Necrosis Factor],” a naturally occurring substance in the human body. (Doc. # 54, ¶¶ 14-15.) Enbrel was developed by Amgen and, at all relevant times, the drug was marketed and sold by both Amgen and Wyeth. (Id. ¶¶ 16-17.) On October 15, 2009, Wyeth was acquired by Pfizer. (Id ¶ 18.)

B. Enbrel’s Warning Label and Medication Guide

Throughout the relevant time period, defendants distributed an FDA-approved package insert to physicians to inform them about how Enbrel should be used and what risks were associated with its use. (Doc. # 82-3.) The package insert issued in July 2001 identified infections as the primary risk of taking Enbrel. (Id.) Specifically, the warning, which was in capitalized and bold font, stated:

WARNINGS
INFECTIONS
IN POST-MARKETING REPORTS, SERIOUS INFECTIONS AND SEPSIS, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH THE USE OF ENBREL. MANY OF THE SERIOUS INFECTIONS HAVE OCCURRED IN PATIENTS ON CONCOMITANT IMMUNO IMMUNOSUP-PRESSIVE THERAPY THAT, IN ADDITION TO THEIR UNDERLYING DISEASE COULD PREDISPOSE THEM TO INFECTIONS. RARE [1364]*1364CASES OF TUBERCULOSIS (TB) HAVE BEEN OBSERVED IN PATIENTS TREATED WITH TNF ANTAGONISTS, INCLUDING ENBREL. PATIENTS WHO DEVELOP A NEW INFECTION WHILE UNDERGOING TREATMENT WITH ENBREL SHOULD BE MONITORED CLOSELY. ADMINISTRATION OF EN-BREL SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A SERIOUS INFECTION OR SEPSIS.

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134 F. Supp. 3d 1358, 2015 U.S. Dist. LEXIS 129195, 2015 WL 5687668, Counsel Stack Legal Research, https://law.counselstack.com/opinion/small-v-amgen-inc-flmd-2015.