Barnhill v. Teva Pharmaceuticals USA, Inc.

819 F. Supp. 2d 1254, 2011 U.S. Dist. LEXIS 51222, 2011 WL 1837816
CourtDistrict Court, S.D. Alabama
DecidedMay 10, 2011
DocketCivil Action No. 06-0282-CB-M
StatusPublished
Cited by8 cases

This text of 819 F. Supp. 2d 1254 (Barnhill v. Teva Pharmaceuticals USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Barnhill v. Teva Pharmaceuticals USA, Inc., 819 F. Supp. 2d 1254, 2011 U.S. Dist. LEXIS 51222, 2011 WL 1837816 (S.D. Ala. 2011).

Opinion

ORDER

CHARLES R. BUTLER, JR., Senior District Judge.

This matter is before the Court on a motion for summary judgment filed by Defendant Teva Pharmaceuticals USA, Inc. (Doc. 173.) Upon careful consideration of Defendant’s motion and supporting briefs, Plaintiffs’ briefs in opposition and all evidence relevant to the issues raised, the Court finds that Defendant is entitled to summary judgment for the reasons set forth below.1

[1256]*1256Findings of Fact

On January 27, 1998 Dr. Dina Jaalouk prescribed the antibiotic Keflex® to Plaintiff Ashley Barnhill for the treatment of streptococcal pharyngitis (strep throat). Plaintiffs mother filled the prescription2 for a cephalexin product with National Drug Code (NDC) number 0093-3147-01. This NDC number is associated with the Abbreviated New Drug Application (ANDA) No. 62-702 held by Teva USA, and with Teva USA’s 500 mg cephalexin capsules manufactured under this ANDA.3 Simply put, Plaintiffs Keflex® prescription was filled with cephalexin, a generic substitute. For the last four decades cephalexin has been one of the most widely prescribed antibiotics worldwide and is extremely beneficial in the treatment of bacterial infections.

Plaintiff began taking cephalexin on January 27, 1998 and continued to take it for seven days. Plaintiff stopped taking cephalexin on February 2, 1998, but she ingested additional cephalexin (left over from the January 27th prescription) during the first week of March. Keflex® had been prescribed for Plaintiff on three occasions prior to January 1998, although there is no evidence that those prescriptions were filled or that Plaintiff actually took Keflex® or cephalexin any time prior to January 27,1998. When Plaintiffs mother filled the prescription in January 1998, she did not receive any product literature, warnings or description of the drug’s side effects or symptoms.

On March 10, 1998, Plaintiff returned to Dr. Jaalouk with complaints of red eyes and a rash. After Plaintiffs symptoms worsened over the next day, she went to her primary care physician who referred her to the Atmore Community Hospital. That evening Plaintiff was transferred to the University of South Alabama Children’s and Women’s Hospital (USA) where Plaintiff was diagnosed with SJS. The diagnosis was confirmed with a biopsy on March 12, 1998. Plaintiff remained at USA for treatment until April 7, 1998. During her hospitalization, Plaintiff experienced a stormy course of SJS.

SJS can have multiple potential causes, including drugs and infections. If no cause is established, it is considered to be idiopathic. SJS can result from a hypersensitivity reaction to various drugs, including cephalexin. There is no diagnostic test to determine a predisposition to SJS from cephalexin or from any other drug. In its most severe form, SJS is sometimes referred to as toxic epidermal necrolysis (TEN).

The manufacture and sale of branded and generic prescription drug products in the United States is a highly regulated industry, under the jurisdiction of the United States Food and Drug Administration (FDA). The FDA draws its statutory authority as to the approval of such manufacture and sale of drugs primarily from its enabling statute, the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended by the Drug Price Competition and Patent Restoration Act of 1984 (the Hatch-Waxman Act) (collectively FDCA), and has promulgated regulations implementing such statutes, which may be found in pertinent part at 21 C.F.R. Part 314. The right to manufacture and market a branded drug in the United States is secured through the filing of a New Drug [1257]*1257Application (NDA). 21 U.S.C. § 355. To obtain approval of a NDA, the applicant must demonstrate the safety and efficacy of the drug for its intended indications to the satisfaction of FDA, typically through the conduct of extensive clinical trials in humans. The right to manufacture and market a generic drug in the United States is secured through the filing of an abbreviated NDA (ANDA), which process is governed by the Hatch-Waxman Amendments (codified at 21 U.S.C. § 355(j)). Under these regulations, an ANDA applicant need only certify that the generic manufacturer will produce a bio-equivalent of the branded drug and that the labeling and warnings of the generic drug are identical to that of the approved innovator drug. 21 U.S.C. § 355(j)(2)(A). An ANDA applicant is not required or expected to conduct clinical trials to establish the safety and efficacy of its generic drug (which trials must be conducted by the manufacturer of the branded drug). Rather, federal regulations limit the role and responsibility of an ANDA applicant to conducting so-called “bioequivalency” studies to establish that the dosage formulation of the generic product has the same pharmacological action in the human body as does the branded drug. 21 U.S.C. § 3550').

Under the FDCA, the FDA also controls the labeling of prescription drugs. It is the FDA’s role to review the proposed labeling submitted by the branded manufacturers and perform in-depth technical analysis and balancing of the benefits of the drug against he potential risks, to ultimately arrive at the final labeling. With respect to generic drugs, the labeling or “package insert” of the generic drug may not deviate in any material respect from that of its reference listed drug — all statements as to Warnings, Precautions, Contraindications, Adverse Reactions, etc. must adhere letter for letter to the language in the corresponding provisions of the labeling of the reference listed drug. 21 U.S.C. § 355(j). An ANDA holder does not have the right to enhance warnings on the label for its product through the mechanism of 21 C.F.R. § 314.70(c)(6)(iii)(A), the so-called “Changes Being Effected Amendment (CBE) provision, which provision is, in the context of prescription pharmaceuticals available only to NDA holders.

In 1987, Teva USA’s predecessor, Bio-craft Laboratories, Inc., first received approval of its ANDA for its 250 mg and 500 mg cephalexin capsules. In 1996, Teva USA became owner of this ANDA. Teva USA’ S 1996 and 1997 cephalexin package inserts, in effect at the time Plaintiff was prescribed cephalexin, state in pertinent part:

WARNINGS: BEFORE CEPHALEXIN THERAPY IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS AND PENICILLIN. CEPHALOSPORIN C DERIVATIVES SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS.
SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.

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Bluebook (online)
819 F. Supp. 2d 1254, 2011 U.S. Dist. LEXIS 51222, 2011 WL 1837816, Counsel Stack Legal Research, https://law.counselstack.com/opinion/barnhill-v-teva-pharmaceuticals-usa-inc-alsd-2011.