Small v. Amgen, Inc.

• Decision Date: 25 September 2015
• Docket Number: Case No. 2:12–cv–476–FtM–29MRM.
• Citation: 134 F.Supp.3d 1358
• Parties: Rebecca A. SMALL and Lawrence W. Small, Plaintiffs, v. AMGEN, INC., Pfizer, Inc., and Wyeth, Inc., Defendants.
• Court: U.S. District Court — Middle District of Florida

134 F.Supp.3d 1358

Rebecca A. SMALL and Lawrence W. Small, Plaintiffs,

v.AMGEN, INC., Pfizer, Inc., and Wyeth, Inc., Defendants.

Case No. 2:12–cv–476–FtM–29MRM.

United States District Court, M.D. Florida, Fort Myers Division.

Signed Sept. 25, 2015.

Jordan L. Chaikin, Peter Cambs, Parker Waichman, LLP, Bonita Springs, FL, Keith Altman, Law Office of Keith Altman, Temecula, CA, for Plaintiffs.

Alvin F. Lindsay, Lauren S. Colton, Hogan Lovells US LLP, William P. Geraghty, Shook, Hardy & Bacon, LLP, Miami, FL, David S. Johnson, Shook, Hardy & Bacon, LLP, Tampa, FL, for Defendants.

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 Amgen, 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). However, "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 Enbrel

, 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 IMMUNOSUPPRESSIVE THERAPY THAT, IN ADDITION TO THEIR UNDERLYING DISEASE COULD PREDISPOSE THEM TO INFECTIONS. RARE

CASES 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 ENBREL SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A SERIOUS INFECTION OR SEPSIS. TREATMENT WITH ENBREL SHOULD NOT BE INITIATED IN PATIENTS WITH ACTIVE INFECTIONS INCLUDING CHRONIC OR LOCALIZED INFECTIONS. PHYSICIANS SHOULD EXERCISE CAUTION WHEN CONSIDERING THE USE OF ENBREL IN PATIENTS WITH A HISTORY OF RECURRING INFECTIONS OR WITH UNDERLYING CONDITIONS WHICH MAY PREDISPOSE PATIENTS TO INFECTIONS, SUCH AS ADVANCED OR POORLY CONTROLLED DIABETES (see PRECAUTIONS and ADVERSE REACTIONS, Infections).

(Doc. # 82–3, p. 12.) Defendants also distributed an FDA-approved medication guide that warned patients of various potential risks associated with Enbrel

, including the risk of serious infection. (Doc. # 82–8, p. 2.)

C. Ms. Small's Treatment with Enbrel

Ms. Small first visited her rheumatologist, Catherine Nina Kowal, M.D. (Dr. Kowal), on September 24, 2001.¹ (Doc. # 82–1, p. 37.) Dr. Kowal determined that Ms. Small's rheumatoid arthritis

was very active and tried to treat Ms. Small's condition with non-biologic medications such as Leflunomide and Methotrexate. (Id. at 37.) Ms. Small, however, continued to experience joint swelling and pain, predominantly in her hands, and was unable to really function. (Id. at 38.) Dr. Kowal then decided to treat Ms. Small with a biologic. Because Ms. Small could not afford Enbrel, Dr. Kowal asked her if she wanted to participate in a clinical study on Enbrel for which Dr. Kowal was a principal investigator. (Id. ) After a thorough discussion with Dr. Kowal, Ms. Small voluntarily decided to enroll in the Enbrel study. (Id. at 43–44.)

Before starting her treatment with Enbrel

, Ms. Small was given a Research Subject Information and Consent Form that contained information about the study, including the potential risks, hazards, and discomforts associated with Enbrel. (Id. ) As to the increased risk of infection, the consent form stated that:

It is possible that Enbrel

® may make infections worse or could lead to life-threatening infections. These infections may occur in any body system. In some patients[,] very low blood cell counts have been reported. If you develop signs and symptoms of a significant infection, or persistent fever, bruising, bleeding, or very pale skin, you should immediately contact your study doctor to determine whether you should stop taking Enbrel ®.

(Doc. # 82–4, p. 4.) Dr. Kowal talked to Ms. Small about the information in the Research Subject Information and Consent Form and explained that the serious conditions identified in the form are rare. (Doc. # 82–1, p. 44.) Ms. Small also reviewed the package insert and medication guide that accompanied Enbrel

before starting her treatment. (Doc. # 89–1, ¶ 2.)

Ms. Small treated her rheumatoid arthritis

with Enbrel from 2002 until August 29, 2008. Ms. Small's use of Enbrel, however, was not without interruption. In May 2003, Ms. Small took Dr. Kowal's recommendation and temporarily went off Enbrel before undergoing surgery on her thumb. (Doc. # 82–1, p. 48.) In October 2003, Dr. Kowal stopped Ms. Small's treatment with Enbrel and monitored her for infections because Ms. Small had...