Cowley v. Abbott Laboratories, Inc.

476 F. Supp. 2d 1053, 2007 U.S. Dist. LEXIS 14582, 2007 WL 663565
CourtDistrict Court, W.D. Wisconsin
DecidedFebruary 28, 2007
Docket06-C-532-S
StatusPublished
Cited by7 cases

This text of 476 F. Supp. 2d 1053 (Cowley v. Abbott Laboratories, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Wisconsin primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cowley v. Abbott Laboratories, Inc., 476 F. Supp. 2d 1053, 2007 U.S. Dist. LEXIS 14582, 2007 WL 663565 (W.D. Wis. 2007).

Opinion

MEMORANDUM AND ORDER

SHABAZ, District Judge.

Plaintiffs Danny E. Cowley and Glenda Cowley commenced this products liability action against defendants Abbott Laboratories, Inc. and Express Scripts, Inc. in Jackson County Circuit Court seeking monetary relief. Defendant Abbott Laboratories, Inc. removed this action pursuant to 28 U.S.C. § 1441(a) citing 28 U.S.C. § 1332(a) as grounds for removal. Defendant Express Scripts, Inc. consented to the removal. Jurisdiction is based on 28 U.S.C. § 1332(a)(1). The matter is presently before the Court on defendants’ motion for summary judgment. The following facts are either undisputed or those most favorable to plaintiffs. .

BACKGROUND

Plaintiffs Danny E. Cowley and Glenda Cowley are citizens of the State of Wisconsin residing in Hixton, Wisconsin. Defendant Abbott Laboratories, Inc. (hereinafter defendant Abbott) is a Delaware Corporation with its principal place of business in Abbott Park, Illinois. Defendant Abbott is engaged in the business of developing and manufacturing pharmaceutical drugs and medications. Defendant Express Scripts, Inc. (hereinafter defendant Express) is a Delaware corporation with its principal place of business in Maryland Heights, Missouri. Defendant Express is a pharmacy benefit manager.

On January 28, 2002 plaintiff Danny E. Cowley (hereinafter plaintiff Cowley) went to see Dr. Kimberly Carter Cerveny (hereinafter Dr. Cerveny) because he was experiencing pain and swelling in his wrist. Dr. Cerveny is licensed to practice medicine in the State of North Carolina and she practices in Elizabeth City, North Carolina. Additionally, she is a board certified rheumatologist. On April 16, 2002 Dr. Cerveny diagnosed plaintiff Cowley with rheumatoid arthritis.

Dr. Cerveny initially prescribed Prednisone to treat plaintiff Cowley’s rheumatoid arthritis (hereinafter RA) and Prednisone proved effective in alleviating his symptoms. However, Prednisone carries a high risk of side-effects such as weight gain, diabetes, coronary disease, cataracts, glaucoma, thinning of the skin, and infections. As such, Dr. Cerveny likewise prescribed Methotrexate in hopes that plaintiff Cowley could be weaned from Prednisone use. Additionally, on January 21, 2003 Dr. Cerveny began prescribing Plaquenil. On March 6, 2003 Dr. Cerveny removed Prednisone from plaintiff Cowley’s treatment regimen.

However, on July 1, 2003 Dr. Cerveny noted a recurrence of plaintiff Cowley’s pain and swelling. Plaintiff Cowley explained that he had stopped taking his Methotrexate and Plaquenil because he felt fatigued. According to Dr. Cerveny, fatigue is a common side-effect of these medications. As such, Dr. Cerveny determined that it might be appropriate for plaintiff Cowley to consider treatment with a TNF inhibitor. A TNF inhibitor is an anti-tumor necrosis factor anti-body.

Humira is one example of a TNF inhibitor. It is manufactured by defendant Abbott and is available only by prescription. . Humira is a biologic, disease-modifying anti-rheumatic drug indicated for: (1) reducing signs and symptoms, (2) inducing major clinical response, (3) inhibiting progression of structural damage; and (4) improving physical function in adults with moderate to severely active RA. Humira works by binding to tumor necrosis factor alpha and blocking its interaction with TNF receptors which neutralizes the human body’s inflammatory response and alleviates RA symptoms. Humira was ap *1055 proved by the Food and Drug Administration (hereinafter FDA) on December 31, 2002.

Additionally, on December 31, 2002 the FDA approved Humira’s product insert which references both Humira’s possible side-effects and adverse events identified in clinical trials. Humira’s product insert has been revised several times. However, each revision has warned about possible neurological side-effects including demyelinating disorders such as multiple sclerosis. 1 For example, Humira’s product insert contains a heading entitled “What important information do I need to know about side effects with HUMIRA?” Under this heading the insert provides in relevant part as follows:

Nervous system diseases: There have been rare cases of disorders that affect the nervous system of people taking HUMIRA or other TNF blockers. Signs that you could be experiencing a problem affecting your nervous system include: numbness or tingling, problems with your vision, weakness in your legs and dizziness.

Additionally, Humira’s product insert contains a section entitled “WARNINGS” which provides in relevant part as follows: Neurologic Events

Use of TNF blocking agents, including HUMIRA, has been associated with rare cases of exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with preexisting or recent-onset central nervous system demyelinating disorders.

Finally, every revision of Humira’s product insert contains a section entitled “Other Adverse Events” which provides the following relevant information:

Nervous System: Confusion, multiple sclerosis, paresthesia, subdural hematoma, tremor

Defendant Abbott conducted clinical trials for Humira use in RA patients during the development process. In the original clinical trials, defendant Abbott monitored 2,334 patients taking Humira 2 and these trials demonstrated that a number of patients experienced various side-effects while taking Humira. For example, approximately 5% of patients reported experiencing some neurological side-effects such as demyelinating disorders. Defendant Abbott reported all adverse events to the FDA in support of its application for approval.

Dr. Cerveny testified that she informed plaintiff Cowley about risks associated with TNF inhibitors (including Humira) during his July 1, 2003 visit. According to Dr. Cerveny, such risks include the inability to fight infections, reactivation of latent Tuberculosis, bone marrow abnormalities, and demyelinating disorders such as multiple sclerosis and optic neuritis. Dr. Cerveny testified that she described the meaning of demyelinating disorders to plaintiff Cowley specifically referencing multiple sclerosis. Further, Dr. Cerveny testified that she provided plaintiff Cowley with information concerning three TNF inhibitors: Humira, Enbrel, and Remicade including Humira’s product insert.

However, plaintiff Cowley testified that he cannot remember whether Dr. Cerveny *1056 discussed nervous disorders. Additionally, he testified that he does not know what demyelinating disorders are. Finally, plaintiff Cowley testified that Dr. Cerveny did not provide him with any written documentation or information concerning Humira.

Dr.

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Bluebook (online)
476 F. Supp. 2d 1053, 2007 U.S. Dist. LEXIS 14582, 2007 WL 663565, Counsel Stack Legal Research, https://law.counselstack.com/opinion/cowley-v-abbott-laboratories-inc-wiwd-2007.