Barnhill v. Teva Pharmaceuticals, USA, Inc. et al

Filing 203

ORDER with findings of fact denying 160 Motion to Strike ; granting 173 Motion for Summary Judgment; denying 190 Motion for Oral Argument. Signed by Senior Judge Charles R. Butler, Jr on 5/9/2011. (adk)

IN THE UNITED STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION
ASHLEY BARNHILL,

)
Plaintiff

)

v.

)

TEVA PHARMACEUTICALS USA, INC.
and TEVA PHARMACEUTICAL
INDUSTRIES, LTD.,

)

Defendants.

CIVIL ACTION NO. 06-0282-CB-M

)
)
ORDER

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
FINDINGS 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). Plaintiff’s mother
filled the prescription2 for a cephalexin product with National Drug Code (NDC) number 00933147-01. 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

1

Plaintiff’s motion to strike Defendant’s designation of expert witnesses (doc. 160) and
Defendant’s motion for oral argument (doc. 190) are denied.
2

Plaintiff was twelve years old at the time.

1

under this ANDA.3 Simply put, Plaintiff’s 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 Plaintiff’s 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 Plaintiff’s 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.

3

These are the facts proffered by the Defendant and agreed to by the Plaintiff. In simple
language, Dr. Jaalouk prescribed Keflex® to treat Plaintiff’s strep throat. The prescription was
filled with the generic equivalent—cephalexin—which was manufactured by Teva. In this order,
the Court will, at times, use cephalexin to refer to refer to both Keflex® and its generic
equivalent.

2

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.. § 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 Application (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

3

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. § 355(j).
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, Biocraft 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.
4

There is some clinical and laboratory evidence of partial cross-allergenicity of the
penicillins and the cephalosporins. Patients have been reported to have had
severe reactions (including anaphylaxis) to both drugs.
Any patient who had demonstrated some form of allergy, particularly to drugs,
should receive antibiotics cautiously. No exception should be made with regard
to Cephalexin.
...
PRECAUTIONS: General—Patients should be followed carefully so that any
side effects or unusual manifestations of drug idiosyncrasy may be detected. If an
allergic reaction to Cephalexin occurs, the drug should be discontinued and the
patient treated with the usual agents (e.g., epinephrine or other pressor amines,
antihistamines, or corticosteroids).
...
ADVERSE REACTIONS
...
Hypersensitivity—Allergic reactions in the form of rash, urticari, angioedema, and
rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal
necrolysis have been observed.
These reactions usually subsided upon
discontinuation of the drug. In some of these reactions, supportive therapy may
be necessary.
The 1997 and 1998 volumes of the Physician Desk Reference (PDR) contain virtually identical
language for the branded drug Keflex®, with the exception of permitted differences relating to
the fact of a different manufacturer.
In her deposition testimony, Dr. Jaalouk could not pinpoint precisely when she became
aware that Keflex® could cause SJS, although she believed it was during her medical residency.
She also testified that is was possible, though less likely, that she became aware of that fact
sometime after 1998. “If it’s written in the books and I study from that book, I should have
known.” Jaalouk Dep. 116, ECF No 175-18. Dr. Jaalouk also testified that, as a physician, she
expects a drug manufacturer to inform doctors of the side effects of a medication. If a potential

5

side effect is critical, she would want it both in the warnings and the adverse reaction section of
the label.
PROCEDURAL BACKGROUND
Plaintiff initially filed this diversity action against Teva USA, Teva Pharmaceutical
Industries, Ltd. and Eli Lilly & Company asserting, under Alabama law, various claims based on
strict liability, misrepresentation negligence, breach of express warranty and breach of implied
warranty of merchantability. Plaintiff’s claims against Eli Lilly & Company, the manufacturer
of Keflex®, were dismissed prior to commencement of discovery. (Doc. 61.) Plaintiff has
agreed to the dismissal of her claims against Teva Pharmaceutical Industries, Ltd. Early in this
litigation, Teva USA filed a motion to dismiss the complaint for failure to state a claim, which
was partially successful. Plaintiff’s claims based on strict liability and misrepresentation were
dismissed. However, the Court rejected Defendant’s argument that all state law claims were
preempted by FDA regulations. Teva has nonetheless held steadfastly to its position, as similar
preemption claims worked their way through the federal appellate system. During the pendency
of this case, the United States Supreme Court decided two preemption cases, Wyeth v. Levine,
555 U.S. 555 (2009), and Altria Group, Inc. v. Good, 555 U.S. 70 (2008), and the parties
provided additional briefs in light of those cases.
ISSUES PRESENTED
Of the many claims asserted in the complaint, only three remain: (1) negligent failure to
warn; (2) negligent failure to conduct post-marketing surveillance; and (3) breach of the implied

6

warranty of merchantability.4 As noted, Defendant continues to assert that all state law claims
are preempted by FDA regulations promulgated pursuant to the FDCA. Defendant also argues
that it is entitled to summary judgment because Plaintiff cannot meet her burden of proof on any
of the three claims. Plaintiff argues that there is no FDA preemption of state law claims. With
regard to the specific claims, Plaintiff contends that the evidence, viewed in the light most
favorable to her, is sufficient to support a verdict in her favor.
LEGAL ANALYSIS
Summary Judgment Framework
Summary judgment should be granted only if "there is no genuine dispute as to any
material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a).
The party seeking summary judgment bears "the initial burden to show the district court, by
reference to materials on file, that there are no genuine issues of material fact that should be
decided at trial." Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir. 1991). Once the
moving party has satisfied his responsibility, the burden shifts to the nonmoving party to show
the existence of a genuine issue of material fact. Id. "If the nonmoving party fails to make 'a
sufficient showing on an essential element of her case with respect to which she has the burden
of proof,' the moving party is entitled to summary judgment." United States v. Four Parcels of
Real Property, 941 F.2d 1428, 1437 (11th Cir. 1991) (quoting Celotex Corp. v. Catrett, 477 U.S.
317 (1986)) (footnote omitted). "In reviewing whether the nonmoving party has met its burden,
the court must stop short of weighing the evidence and making credibility determinations of the
truth of the matter. Instead, the evidence of the non-movant is to be believed, and all justifiable
4

In her response brief, Plaintiff has conceded four claims: Failure to use reasonable care
in formulating and manufacturing cephalexin, inadequate pre-clinical and clinical testing, breach
of express warranty and the claim for punitive damages. Pl.’s Summ. J. Rsp. 23, ECF No. 184.

7

inferences are to be drawn in his favor.” Tipton v. Bergrohr GMBH-Siegen, 965 F.2d 994, 999
(11th Cir. 1992) (internal citations and quotations omitted).
The factual disputes raised by the nonmoving party must be both material and genuine.
“As to materiality, the substantive law will identify which facts are material. Only disputes over
facts that might affect the outcome of the suit under the governing law will properly preclude the
entry of summary judgment. Factual disputes that are irrelevant or unnecessary will not be
counted.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). “Genuine disputes are
those in which the evidence is such that a reasonable jury could return a verdict for the nonmovant. For factual issues to be considered genuine, they must have a real basis in the record.”
Mize v. Jefferson City Bd. of Educ., 93 F.3d 739, 742 (11th Cir. 1996) (quoting Hairston v.
Gainesville Sun Publishing Co., 9 F.3d 913, 918 (11th Cir. 1993)).
FDA Preemption
Defendant’s preemption argument is a purely legal issue, and one that has already been
decided in favor of the Plaintiff. Nevertheless, Defendant relies on Levine, an intervening United
States Supreme Court decision, in its attempt to demonstrate that this Court erred in rejecting
Defendant’s preemption argument. In Levine, the Supreme Court held that state law failure-towarn claims against the holder of a NDA (i.e., the brand name manufacturer) are not preempted.
In so doing, the Court addressed (and rejected) many of the same preemption arguments
Defendant has raised here. Nevertheless, this case is slightly different from Levine in that the
Defendant is the holder of an ANDA (i.e., the generic manufacturer), which brings different
FDA regulations into play. Nothing in Levine affects the Court’s prior decision, which
addressed the differences in regulations applicable to name brand and generic manufacturers.
Recently, three courts of appeal have applied Levine in identical situations, and all three have

8

reached the same conclusion as this Court—FDA regulations do not preempt state law failure-towarn claims against generic manufacturers. Gaeta v. Perrigo Pharma. Co., 630 F.3d 1225 (9th
Cir. 2011); Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir.), cert. granted, 131 S. Ct. 817 (2010);
Mensing v. Wyeth, 588 F.3d 603 (2009), cert. granted sub nom PLIVA, Inc. v. Mensing, 131 S.
Ct. 817 (2010).5 Consequently, this Court declines to reverse its decision on the preemption
issue.
Negligent Failure to Warn
Plaintiff contends that Defendant is liable for negligence due to its failure to provide an
adequate warning of the risk of developing SJS associated with cephalexin. The elements of a
cause of action are well-settled. Plaintiff must prove that Defendant had a duty to warn, that
Defendant breached that duty, that she was injured and that Defendant’s breach of duty was the
proximate cause of her injury. Prill v. Marrone, 23 So. 3d 1, 7 (Ala. 2009). In this case,
Defendant contests Plaintiff’s ability to prove that it breached its duty or, if it did, that the breach
was a proximate cause of her injury. Before considering issues of duty and proximate cause, the
Court must determine the extent of a drug manufacturer’s duty to warn under Alabama’s learned
intermediary doctrine.
Duty to Warn: Alabama’s Learned Intermediary Doctrine
A properly prepared prescription drug is an “unavoidably unsafe” product which must be
accompanied by an adequate warning. Alabama law does not require a direct warning to
prescription drug users but adheres instead to the learned intermediary doctrine.
[W]here prescription drugs are concerned, the manufacturer's duty to warn is
limited to an obligation to advise the prescribing physician of any potential
dangers that may result from the drug's use. . . .Pharmaceutical companies then,
5

The issue is currently under review by the Supreme Court in Gaeta and Demahy.

9

who must warn ultimate purchasers of dangers inherent in patent drugs sold over
the counter, in selling prescription drugs are required to warn only the prescribing
physician, who acts as a “learned intermediary” between manufacturer and
consumer.
Stone v. Smith, Kline & French Lab., 447 So. 2d 1301, 1304 (Ala. 1994) (quoting Reyes v. Wyeth
Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974)). Hence, Defendant had a duty to warn
Plaintiff’s physician of the potential dangers associated with cephalexin, including the risk of
developing SJS. The package insert and PDR entry in this case listed SJS as a potential adverse
reaction, but Plaintiff challenges the adequacy of that that warning.
Adequacy of Warning
Defendant contends that its warning labels and inserts were sufficient to satisfy its duty to
warn Plaintiff’s physician. Plaintiff addresses the adequacy of the cephalexin warranty only in
broad, vague terms. Unfortunately, Plaintiff dedicates little discussion to the adequacy of the
warning as a separate element of proof and leaves it to the Court to decipher her theory of
inadequacy. First, she argues, without citing any evidentiary support, that there are jury issues
regarding the existence, reasonableness, placement and adequacy of any warning. The existence
of the warning cannot be questioned, despite Plaintiff’s argument to the contrary. Moreover,
there is no evidence that warning information provided regarding the relationship between
cephalexin and SJS was inaccurate. Plaintiff does cite evidentiary support for her theory that the
warning was inadequate due to its placement--the testimony of her treating physician, Dr.
Jaalouk. Dr. Jaalouk testified at deposition that, in general, she relies on the manufacturers to tell
her the side effects of a drug. She also testified that, in general, information in the warnings
section of a label or package insert carries more weight than information listed in the adverse
reaction section. Further, Dr. Jaalouk testified that she would expect information about any
relationship between SJS and the use of a drug to be in the warnings section. Based upon this
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evidence, the Court will presume, only for purposes of this motion, that the warning was
inadequate because the information about SJS was listed as an “Adverse Reaction” rather than
under “Warnings”.
Proximate Cause
Plaintiff must establish that the placement of the SJS information under “Adverse
Reactions” rather than “Warnings” proximately caused Plaintiff’s injuries. To prevail on a
failure-to-warn claim under Alabama law, a plaintiff “must demonstrate a causal link between
the allegedly inadequate warning and the injury. In cases such as these [involving prescription
drugs and the learned intermediary doctrine], that means that the plaintiff[ ] must demonstrate
that, had the defendant given an adequate warning, it would have been read and heeded by the
prescribing physician[ ].” Brasher v. Sandoz Pharma. Corp., 2001 U.S. Dist. Lexis 18364 (M.D.
Ala. Sept. 21, 2001); see also Bodie v. Purdue Pharma. Co., 236 Fed. Appx. 511, 516 (11th Cir.
2007) (applying Alabama law). Defendant argues that “Plaintiff cannot establish proximate
causation because Plaintiff has put forth no evidence that Dr. Jaalouk would not have prescribed
cephalexin for Plaintiff if the drug contained a different or stronger warning.” Def.’s Summ. J.
Brf. 21, ECF No. 174. Plaintiff counters that her proximate cause evidence is adequate to
withstand summary judgment for two reasons. First, she contends that Dr. Jaalouk’s testimony is
sufficient because it demonstrates that the physician relied on prescription drug warning labels
and inserts. Alternatively, Plaintiff argues that she has no burden to present evidence of
proximate cause.
Theoretically, proof of proximate cause could take one of two forms: (1) evidence that
Dr. Jaalouk would not have prescribed cephalexin at all if the warning had been stronger or (2)
evidence that, though she still would have prescribed cephalexin, Dr. Jaalouk would have

11

changed her behavior or treatment in some way that would have resulted in a different outcome
for the Plaintiff. As to the latter argument, the record is devoid of any evidence that the outcome
would have been better or different come if the cephalexin had been prescribed or administered
in a different manner.6 Nor is there any evidence that Dr. Jaalouk would not have prescribed
cephalexin if the warning had been different. In fact, at the time of her deposition--ten years
after firsthand experience with Plaintiff’s SJS--Dr. Jaalouk continued to prescribe cephalexin for
the treatment of strep throat, the very same illness for which she treated Plaintiff.7 The evidence
cited by Plaintiff is much too vague and generalized to serve as proof of proximate cause. The
critical issue is not the amount or type of attention Dr. Jaalouk would have given to the
information on the label if the warning about SJS had been more prominently displayed. The
issue is whether, and in what way, that information would have affected her decision to treat
Plaintiff with cephalexin at that time.
Despite the lack of evidence, Plaintiff argues that “[c]learly a fact question remains as . .
. to what degree a better warning would have altered Dr. Jaalouk’s prescribing of Cephalexin.”
Pl.’s Summ. J. Rsp. 9, ECF No. 184. Relying on a Tenth Circuit case, Thom v. Bristol Myers
Squibb Co., 353 F.3d 848 (10th Cir. 2003), Plaintiff asserts that the mere existence of an
inadequate warning creates a rebuttable presumption that the warning would have been heeded.
Plaintiff’s argument fails for two reasons. First, Alabama courts have not recognized such a
6

For example, there is no reason to believe that Plaintiff’s SJS would have been
diagnosed earlier or treated differently if Dr. Jaalouk had taken different precautions when she
prescribed the drug, such as warning Plaintiff or her mother of the potential for SJS.
7

Because there is no way of determining whether a patient will develop a reaction to
cephalexin, there is no way to minimize risk. A physician has only two choices—to prescribe
cephalexin or not to prescribe it at all. Dr. Jaalouk’s continued use of cephalexin to treat strep
throat serves as evidence that she would have made the same decision to prescribe cephalexin to
Plaintiff, no matter how the warning had been given.

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presumption. In Deere & Co. v. Grose, 586 So. 2d 196 (Ala. 1991), the Alabama Supreme Court
stated that “as concerns proximate cause, a negligent-failure-to-warn-adequately case should not
be submitted to the jury unless there is substantial evidence that an adequate warning would have
been read and heeded and would have prevented the accident.” Id. at 198 (citing Gurley v.
American Honda Motor Co., 505 So. 2d 358, 361 (Ala. 1987)).
Even if a “read and heed” presumption existed, that presumption alone would not
establish proximate cause. In Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806 (5th Cir. 1992),
the Fifth Circuit rejected a plaintiff’s contention that “causation is presumed, given an inadequate
warning, in the context of an unavoidable risk.” Id. at 814.8 The court did, however, assume that
that failure to provide an adequate warning entitles a plaintiff to a “rebuttable presumption that
the learned intermediary would have read and heeded a proper warning.” Id. That presumption
falls far short of establishing proximate cause.
But “heed” in this context means only that the learned intermediary would have
incorporated the “additional” risk into his decisional calculus. The burden
remains on the plaintiff to demonstrate that the additional non-disclosed risk was
sufficiently high that it would have changed the treating physician’s decision to
prescribe the product for the plaintiff.
Id. at 814. Any presumption that the prescribing physician would have “heeded” a proper
warning holds even less sway in the instant case. Plaintiff has pointed to no substantive
information that was omitted from the warning. At best, Plaintiff’s evidence is that the manner

8

As the court explained, such a presumption is logical only in the context of avoidable
risk. Id. at 813-14. When the risk is avoidable, i.e., a choice between safe and unsafe use of a
product, then it is reasonable to presume that a consumer would have minimized his risk by
using the product safely. In other words, the consumer would have heeded a proper warning if
one had been given. However, when the risk is unavoidable, as with a prescription drug, the
same reasoning does not apply. Id. If the consumer acts in a way to minimize risk, then his
decision to use an unavoidably unsafe product will be the same, irrespective of any warnings,
unless the risk of using the product is greater than the risk of not using it.

13

of disclosing the risk of SJS was not commensurate with the gravity of the potential harm.
Stated differently, the warning label was not wrong, it simply was not forceful enough. Because
there is no evidence that a more forceful warning would have changed Dr. Jaalouk’s decision to
prescribe cephalexin, Plaintiff has failed to establish proximate cause.
Negligent Failure to Conduct Post-Marketing Surveillance
The Defendant can be held liable for negligent failure to conduct post-marketing
surveillance only if it had a legal duty to do so. Plaintiff has failed to establish the existence of
such a duty, at least one that was unfulfilled. It is axiomatic that a cause of action for negligence
does not arise unless the defendant owed the plaintiff a duty of care. Smitherman v. McCafferty,
622 So. 2d 322, 324 (Ala. 1993). Whether a duty exists depends on “on a number of factors,
including public policy, social considerations, and foreseeability [of harm]. The ultimate test of
the existence of a duty to use due care is found in the foreseeability that harm may result if care
is not exercised.” Armstrong Business Serv., Inc. v. AmSouth Bank, 817 So. 2d 665, 679 (Ala.
2001) (internal citations and quotations omitted).
Identifying the duty has been slightly problematic in this case. In its summary judgment
motion, Defendant presumed that Plaintiff’s claim was based on a legal duty, created by FDA
regulations, requiring a generic drug manufacturer to report adverse events related to its product.
21 C.F.R. § 314.80, 314.81(b)(2)(8). Defendant submitted evidence that it had complied with
this requirement and thus satisfied its duty. In response, Plaintiff states that she “is not claiming
that Teva failed to report events to the FDA[ ] but that Teva was negligent in monitoring other
adverse events relating to Cephalexin.” Pl.’s Summ. J. Brf. 38, ECF No. 174. The only
evidence Plaintiff points to involves Defendant’s acknowledgement that it did not track the
adverse event experience of other cephalexin manufacturers. Absent a legal duty to track such

14

information—and Plaintiff has failed to identify the source of any purported duty--Defendant’s
failure to act does not amount to negligence.9
Breach of Implied Warranty of Merchantability
In general, Alabama law does not recognize a cause of action for breach of implied
warranty of merchantability for inherently dangerous products. As the Eleventh Circuit has
noted “courts applying Alabama law have seen fit to subsume U.C.C.-based breach of implied
warranty claims into tort and product liability claims, where the product is fit for its intended use
and there is no evidence of ‘non-merchantability’ other than a general allegation that the product
contains inherent dangers.” Bodie, 236 Fed. Appx. at 524. Plaintiff argues that her breach of
warranty claim survives because there is evidence of “non-merchantability.” Plaintiff relies on
Griggs v. Combe, 456 So. 2d 790 (Ala. 1984), a case involving a question certified to the
Alabama Supreme Court by the Eleventh Circuit. The plaintiff in Griggs had an allergic reaction
to a topical analgesic and asserted, inter alia, a claim for breach of implied warranty of
merchantability against the manufacturer. The question involved whether such a cause of action
was available to the plaintiff against a drug manufacturer. The supreme court answered the
question in the negative, explaining:
For all that appears in the question before us, Griggs is the only person who has
suffered this kind of injury in the long history of the use of the drug in question.
We agree with the above authorities that a product must adversely affect at least
some significant number of persons before a question of “merchantabilty” arises.
Therefore, Griggs cannot recover under this theory, either.

9

The Court cannot conceive of any foreseeable harm from the mere failure to track
adverse events experienced by other companies.

15

Id. 793. Thus, Griggs left the door slightly ajar to the possibility of a breach-of-impliedwarranty claim against a drug manufacturer, if the product adversely affected a “significant
number of persons”.
Plaintiff tries to slip through that narrow opening, arguing that cephalexin has adversely
affected a significant number of people. To support her claim, Plaintiff relies on the report of
Defendant’s expert, Dr. Steven Lamm. Plaintiff points out that “Dr. Lamm [ ] cited an article by
Jick and Derby published in 1995 which recorded the risk of SJS and or TEN following
Cephalexin to be 1 case per 100,00 patients or 1 case for every 160,000 prescriptions.” Pl.’s
Summ. J. Brf. 28. Extrapolating from those figures (based on the number of Cephalexin
prescriptions per year) Plaintiff arrives at the preposterous assertion that “75 people a year on
average suffer from SJS or TEN after taking Cephalexin.” Pl.’s Summ. J. Brf. 28. Dr. Lamm’s
report contains no such conclusion. Quite the opposite, Dr. Lamm found only 2 cases reported in
the United States between 1992 and 2008. Dr. Lamm noted the unreliability of the Jick and
Derby study, which was based on only 2 patients whose case histories are not described and
therefore may have been exposed to other drugs associated with SJS and TEN. If the Jick and
Derby figures were correct, Dr. Lamm points out, “then with annual cephalexin sales in the U.S.
of over 12 million prescriptions per year one would predict an observed incidence of
approximately 80 cases per year. Not one such case has been reported in the published
literature, and TEVA has informed me they are aware of only two alleged cases (including Ms.
Barnhill) since they began selling cephalexin in the United States in 1992.” Lamm Rpt.10, Pl.’s
Ex. D, ECF No. 175-4. Dr. Lamm concluded that the risk of developing SJS or TEN from
cephalexin exposure is “low, i.e., in the less than one per 10 million range.” Id.

16

As an inherently dangerous product, cephalexin is presumed to be merchantable, i.e., fit
for its intended use. Plaintiff relies on non-existent evidence to support her claim that it is not fit.
Because Plaintiff’s evidence fails, so does her claim for breach of implied warranty of
merchantability.
CONCLUSION
This Court remains unpersuaded by Defendant’s argument that FDA regulations preempt
all state law claims against a prescription drug manufacturer. Nevertheless, Plaintiff’s state law
claims cannot survive summary judgment. Plaintiff has conceded that she is unable to prove
many of the claims asserted in the complaint. As to the remaining claims—negligent failure to
warn, negligent failure to conduct post-marketing surveillance and breach of implied warranty of
merchantability—the evidence is insufficient to create a genuine dispute of material fact.
Accordingly, the motion for summary judgment filed by Defendant Teva Pharmaceuticals USA,
Inc. is hereby GRANTED.
DONE and ORDERED this the 9th day of May, 2011.

s/Charles R. Butler, Jr.
Senior United States District Judge

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