Lauderdale v. Organon U.S., Inc.

• Decision Date: 26 August 2022
• Docket Number: 5:21-CV-5200
• Parties: ANGELA LAUDERDALE, Individually and as Representative of the Estate of Addison Cook, Deceased PLAINTIFF v. ORGANON USA, INC.; MERCK & CO. INC.; and MERCK SHARP & DOHME CORP. DEFENDANTS
• Court: U.S. District Court — Western District of Arkansas

ANGELA LAUDERDALE, Individually and as Representative of the Estate of Addison Cook, Deceased PLAINTIFF
v.
ORGANON USA, INC.; MERCK & CO. INC.; and MERCK SHARP & DOHME CORP. DEFENDANTS

No. 5:21-CV-5200

United States District Court, W.D. Arkansas, Fayetteville Division

August 26, 2022

MEMORANDUM OPINION AND ORDER

TIMOTHY L. BROOKS, UNITED STATES DISTRICT JUDGE.

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TABLE OF CONTENTS

I. INTRODUCTION

II. BACKGROUND

A. Nexplanon

B. Regulatory Regime

III. LEGAL STANDARD

A. Pleading

B. Matters Considered

IV. DISCUSSION

A. Preemption

1. Framework

2. Analysis

a. Scientific Studies Published After 2011

b. Implanon Clinical Trial Data

c. Other Clinical Study Data & Post-Market Adverse Events

B. Failure to State a Claim Upon Which Relief May Be Granted

1. Failure-to-Warn

a. Strict Liability

b. Negligence

2. Fraud a. Fraudulent Misrepresentation

b. Fraudulent Omission or Concealment

3. Gross Negligence

V. CONCLUSION

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I. INTRODUCTION

This is a personal injury suit. Plaintiff Angela Lauderdale sues Defendants Organon USA, Inc., Merck & Co. Inc, and Merck Sharp & Dohme Corp. (collectively, “Defendants”) in her personal capacity and as representative of the Estate of Addison Cook. See Doc. 2.

Ms. Lauderdale's daughter, Addison Cook, died at the age of 19 from a venous thromboembolism (“VTE”) allegedly caused by Nexplanon, a prescription contraceptive manufactured by Defendants. Ms. Lauderdale contends Defendants failed to properly label Nexplanon, leaving doctors in the dark about the risks associated with the drug.

Defendants' Motion to Dismiss (Doc. 25) is now before the Court. Defendants argue Ms. Lauderdale's claims fail as a matter of law. They contend federal law preempts Ms. Lauderdale's “failure-to-warn” claims, and she fails to state sufficient facts to plausibly allege strict liability, fraud, negligence, or gross negligence under Arkansas law.

After considering the parties' briefing and for the below reasons, Defendants' Motion is DENIED in part and GRANTED in part.^[1]

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II. BACKGROUND

In February 2019, 18-year-old Addison Cook attended a medical appointment at Parkhill Clinic for Women in Fayetteville, Arkansas. She expressed an interest in obtaining contraception and asked about Nexplanon, an implant manufactured by Defendants and approved by the Food & Drug Administration (“FDA”) to prevent pregnancy. In a follow-up visit a month later, Dr. Jason Hurt prescribed Nexplanon and implanted the small, flexible rod in Ms. Cook's arm the same day. See Doc. 2, pp. 6-7.

On December 6, 2019, Ms. Cook arrived at Washington Regional Medical Center's emergency room complaining of chest pain and shortness of breath. She was tachycardic and hypoxic. Lab results indicated a blood clot, and a CT scan showed a bilateral multiple pulmonary emboli with right lower lobe infarct and right ventricular strain. Doctors diagnosed Ms. Cook with a pulmonary embolism and infarction, acute cor pulmonale, and acute hypoxemic respiratory failure and admitted her for further treatment. She seemingly recovered and was discharged on December 10. Id. at p. 7.

Ms. Cook returned to Washington Regional on December 13-this time by ambulance. She was admitted to the ICU, where she died four days later from a fatal VTE. Id at pp. 7-8.^[2]

Ms. Lauderdale believes Nexplanon caused her daughter's death. Ms. Cook was a young African-American woman with a history of severe morbid obesity. According to the Complaint, Nexplanon has a synergistic effect on those individuals with other risk factors for VTE, and both obese women and African-American women experience VTE and other related cardiovascular events at higher rates. See id. at pp. 13-14.

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Ms. Lauderdale claims the Nexplanon label should have deployed stronger warnings about the risk of VTE-particularly with respect to obese and African-American women-and provided incidence data to allow prescribing physicians to place the increased risk of VTE in context when assessing Nexplanon's risk-benefit profile against safer contraceptive drugs. See id. at p. 4. If Defendants properly labeled Nexplanon, Ms. Lauderdale contends, Dr. Hurt would not have prescribed it to Ms. Cook. See id. at p. 29.

A. Nexplanon

Nexplanon is a small, flexible rod placed beneath the skin of a woman's inner-upper arm. See Doc. 27, p. 11. It is the newer, patent-protected version of Implanon. Because it is patent-protected, Nexplanon is considered a “brand-name” pharmaceutical product. (Doc. 2, p. 4). The FDA approved Implanon in 2006 and Nexplanon in 2011. See id. at pp. 11-12.

Implanon and Nexplanon are almost identical; they contain the same hormone, in the same quantity. See id. at pp. 4-5.^[3] Both drugs are progestin-only products (“POPs”) that release etonogestrel, a “progestin” or synthetic form of the female hormone progesterone.^[4]

Etonogestrel is a biologically active metabolite of desogestrel, a progestin developed by Organon. See Doc. 2, p. 15. In 1992, Organon received FDA approval for

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its first desogestrel-based contraceptive, Desogen. Organon has since introduced several other desogestrel-based products, including Mircette, NuvaRing, and, eventually, Implanon and Nexplanon. Id.

The Nexplanon label acknowledges the drug may increase the risk of VTE. The Prescribing Information cautions physicians that women with a “current or past history of thrombosis or thromboembolic disorders” should not use Nexplanon. See Doc. 26-5, p. 7. The “Warnings and Precautions” section also provides a more fulsome warning for doctors:

WARNINGS AND PRECAUTIONS

The following information is based on experience with the etonogestrel implants (IMPLANON and/or NEXPLANON), other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives.

...

5.4 Thrombotic and Other Vascular Events

The use of combination hormonal contraceptives (progestin plus estrogen) increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). NEXPLANON is a progestin-only contraceptive. It is unknown whether this increased risk is applicable to etonogestrel alone. It is recommended, however, that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed.

There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using the non-radiopaque etonogestrel implant. NEXPLANON should be removed in the event of a thrombosis.

Evaluate for retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

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Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

(Doc. 26-10, pp. 10-11 (emphasis in original)).

The Nexplanon Patient Information likewise discusses a risk of VTE associated with Nexplanon:

WARNINGS AND PRECAUTIONS

The following information is based on experience with the etonogestrel implants (IMPLANON and/or NEXPLANON), other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives. ...

5.4 Thrombotic and Other Vascular Events

The use of combination hormonal contraceptives (progestin plus estrogen) increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). NEXPLANON is a progestin-only contraceptive. It is unknown whether this increased risk is applicable to etonogestrel alone. It is recommended, however, that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed.

There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using the non-radiopaque etonogestrel implant. NEXPLANON should be removed in the event of a thrombosis.

Evaluate for retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

(Doc. 26-10, pp. 10-11 (emphasis in original)).

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The above reproduction derives from the first Nexplanon label, approved in 2011. According to Defendants, the FDA again approved the label in 2015 (Doc. 26-10) and in 2018 (Docs. 26-1 & 26-2). A review of the labels suggests neither the 2015 nor 2018 revision substantively changed the VTE-related warnings.^[5] In addition, all three iterations of the Nexplanon label largely resemble the label used for Implanon, Nexplanon's nearly identical predecessor drug.

B. Regulatory Regime

The Food, Drug, and Cosmetic Act (“FDCA”), ch. 675, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., empowers the FDA to regulate pharmaceutical products in the United States. The FDCA requires drug manufacturers to obtain FDA approval before marketing or distributing a new drug in interstate commerce. 21 U.S.C. § 355(a). Drug manufacturers may do so by submitting a new-drug application (“NDA”), or, in some circumstances, a supplemental new-drug application (“sNDA”). The same requirements govern both the NDA and the sNDA. See 21 C.F.R. § 314.1 et seq.

The NDA or sNDA must include “full reports of investigations which have been made to show...