Grinage v. Mylan Pharmaceuticals, Inc. et al

Filing 33

MEMORANDUM. Signed by Judge Catherine C. Blake on 12/30/11. (mps, Deputy Clerk)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND

BEATRICE GRINAGE, as Personal
Representative of Aaron Grinage, Deceased
v.
MYLAN PHARMACEUTICALS, INC.

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Civil No. CCB-11-1436

MEMORANDUM
Beatrice Grinage (“Grinage” or “plaintiff”) brought this action against Mylan
Pharmaceuticals, Inc. and its parent company Mylan, Inc. (collectively, “Mylan” or
“defendants”) after her husband ingested Allopurinol, a Mylan-manufactured drug, and then
developed a skin disease that led to his death. Acting as her husband’s personal representative,
Grinage alleges Mylan is liable for both compensatory and punitive damages under state law
theories of negligence, strict products liability, fraud, and breach of implied warranty. Grinage
originally brought suit in Maryland state court, and Mylan removed to this court on the grounds
of diversity jurisdiction, as Grinage is a resident of Maryland, Mylan, Inc. is incorporated in
Pennsylvania, and Mylan Pharmaceuticals, Inc. has its principal place of business in West
Virginia. Grinage subsequently filed an amended complaint, and Mylan filed a Fed. R. Civ. P.
12(b)(6) motion to dismiss. The company argues that pursuant to Pliva, Inc. v. Mensing, 564
U.S. ----, 131 S. Ct. 2567 (2011), federal law and FDA regulations pre-empt the state law claims
raised. The issues have been fully briefed, and no hearing is necessary. See Local Rule 105.6.
For the reasons stated below, the defendant’s motion will be granted and this suit will be
dismissed.
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BACKGROUND
On January 21, 2008, Aaron Grinage received a prescription for Allopurinol tablets for
treatment of gout. (Am. Compl. ¶ 7, ECF No. 22.) The tablets were manufactured and marketed
by the defendant, Mylan. (Id. at ¶ 10.) Mr. Grinage took Allopurinol for approximately one
month before he was diagnosed with Stevens-Johnson Syndrome, a skin disease, and then with
Toxic Epidermal Necrolysis, a related but more severe skin reaction. (Id. at ¶¶ 22–26.) On
March 8, 2008, he suffered multi-system organ failure and died. (Id. at ¶ 28.)
Allopurinol is a generic version of Zyloprim, a brand-name drug the FDA approved in
1966. (Id. at ¶ 8.)1 Mylan alleges, and Grinage does not dispute, that the warning label for
Allopurinol “is and has always been substantially identical to the warning contained in the
labeling of . . . Zyloprim.” (Def.’s Mot. to Dismiss 5–6.) The labels for both products state that
the “most frequent adverse reaction to [the drug] is skin rash” and that “[s]kin reactions can be
severe and sometimes fatal.” (Def.’s Mot. to Dismiss, Exs. B, C.) Both labels report the skin
reactions of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis are “probably causally
related” to ingestion of the drug. (Id.) The labels cite one study that found that 3% of patients
had skin reactions, but they further note that “with current usage, skin reactions have been
observed less frequently than 1%.” (Id.)
In Grinage’s amended complaint she alleges that Mylan “knew or should have known
that the risk” of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis “was greater than
1% referenced in the label [sic].” (Am. Compl. ¶ 14.) The complaint further alleges that Mylan

1

The original Zyloprim patent-holder, Prometheus Labs, continues to manufacture and sell the drug. (Am. Compl.
¶¶ 10–13.)

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was “negligent in failing to report published articles and overwhelming scientific evidence of
increased risks” to the FDA, the brand name manufacturer, healthcare providers, and patients.
(Id. at ¶ 15.) As a result, Grinage concludes, the decedent consumed a product that “caused
unreasonably dangerous risks,” (id. at ¶ 43), and was “not safe or fit for its intended purpose.”
(Id. at ¶ 75.) In all, the complaint articulates independent claims of negligence, strict liability,
fraud, and breach of implied warranty.

Based on these claims, the complaint seeks

compensatory and exemplary damages for wrongful death. In response, Mylan has filed a
12(b)(6) motion to dismiss.

STANDARD OF REVIEW
“[T]he purpose of Rule 12(b)(6) is to test the sufficiency of a complaint and not to
resolve contests surrounding the facts, the merits of a claim, or the applicability of defenses.”
Presley v. City of Charlottesville, 464 F.3d 480, 483 (4th Cir. 2006) (internal quotation marks
and alterations omitted) (quoting Edwards v. City of Goldsboro, 178 F.3d 231, 243 (4th Cir.
1999)). When ruling on such a motion, the court must “accept the well-pled allegations of the
complaint as true,” and “construe the facts and reasonable inferences derived therefrom in the
light most favorable to the plaintiff.” Ibarra v. United States, 120 F.3d 472, 474 (4th Cir. 1997).
“Even though the requirements for pleading a proper complaint are substantially aimed at
assuring that the defendant be given adequate notice of the nature of a claim being made against
him, they also provide criteria for defining issues for trial and for early disposition of
inappropriate complaints.” Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009).
To survive a motion to dismiss, the factual allegations of a complaint “must be enough to

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raise a right to relief above the speculative level, . . . on the assumption that all the allegations in
the complaint are true (even if doubtful in fact).” Bell Atlantic Corp. v. Twombly, 550 U.S. 544,
555 (2007) (internal citations and alterations omitted). Thus, the plaintiff’s obligation is to set
forth sufficiently the “grounds of his entitlement to relief,” offering more than “labels and
conclusions.” Id. (internal quotation marks and alterations omitted). “[W]here the well-pleaded
facts do not permit the court to infer more than the mere possibility of misconduct, the complaint
has alleged - but it has not ‘show[n]’ - ‘that the pleader is entitled to relief.’” Ashcroft v. Iqbal, -U.S. --, 129 S. Ct. 1937, 1950 (2009) (quoting Fed. R. Civ. P. 8(a)(2)).

ANALYSIS
Mylan argues that Grinage’s claims are pre-empted by federal law and related FDA
regulations. The argument relies on the Supreme Court’s recent decision in Pliva, Inc. v.
Mensing, 564 U.S. ----, 131 S. Ct. 2567 (2011). The Mensing Court reviewed facts similar to
those at issue here, and the Court barred the plaintiffs’ state law tort claims under the preemption doctrine of impossibility. Id. at 2577. Impossibility, the Court explained, is a species of
conflict preemption. Id. (citing Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)).
“Where state and federal law directly conflict, state law must give way.” Mensing, 131 S. Ct. at
2577. Mylan contends that the Mensing decision is “dispositive” of all of Grinage’s claims.
(Def.’s Reply 2.)
In Mensing, the Court consolidated two cases where plaintiffs had sued generic drug
manufacturers using Louisiana and Minnesota state-law tort theories. 131 S. Ct. at 2573.
Plaintiffs pleaded that the drug manufacturers “knew or should have known of the high risk” of

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the neurological injuries at issue and “knew or should have known that their labels did not
adequately warn of that risk.” Id. at 2574. The Court concluded it was impossible for the
manufacturer–defendants to satisfy state products liability laws without violating FDA
regulations that require generic drugs to have the same labels as their brand-name counterparts.
Id. at 2577–78. The statutory language and regulations related to the Drug Price Competition
and Patent Term Restoration Act (“Hatch Waxman”) and the FDA’s interpretation of these rules
“require that the warning labels of a brand-name drug and its generic copy must always be the
same—thus, generic drug manufacturers have an ongoing federal duty of ‘sameness.’” Id. at
2574–75 (citing 57 Fed. Reg. 17961 (1992)); see also 21 U.S.C. §§ 355(j)(2)(A)(v),
355(j)(4)(G); 21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7). So even if a generic manufacturer had
new information about side effects, it could not change its label unless the brand-name
manufacturer did so first, or unless the FDA instructed all manufacturers to do so. As a result,
pursuant to impossibility pre-emption doctrine, federal law pre-empts any state law tort action
that creates liability for generic manufacturers who fail to take independent action to change their
labels. Mensing, 131 S. Ct. at 2577–81.
State products liability laws generally recognize three different types of actionable
product defects: “(1) design defects, (2) manufacturing defects, and (3) labeling defects (e.g.,
failure to warn).” Bruesewitz v. Wyeth LLC, 562 U.S. ----, 131 S. Ct. 1068, 1087 (2011)
(Sotomayor, J., dissenting). According to Grinage, Mensing stands only for the limited
proposition that a failure-to-warn claim is pre-empted when a plaintiff avers that a generic drug
manufacturer “was required to alter the content of FDA-approved labeling by seeking FDA
action.” (Pl.’s Resp. to Mot. to Dismiss 2.) Thus, Grinage argues, Mensing does not affect her

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negligence and strict liability claims based on failure to warn, at least to the extent that the failure
to warn arises from either (1) an independent “duty to effectively communicate warnings” or (2)
defendants’ alleged failure to convey warning inadequacies to Prometheus Labs, the brand-name
manufacturer of Zyloprim. (Id. at 4.) Likewise, she argues, her negligence claims also survive
pre-emption under a defective design theory, and her breach of implied warranty and fraud
claims are similarly unaffected.2 The court reviews each of these claims in turn.

A. Failure to Warn
The plaintiff’s alternative failure-to-warn theories fail either by preemption under
Mensing or for failure to state a claim under Iqbal and Twombly.
Grinage first argues that this court should, in determining whether a drug is defective
under a failure-to-warn theory, use a two-prong test considering both (1) the “substantive
adequacy” of warnings, and (2) the overall “efficacy of communication.” (Pl.’s Resp. to Mot. to
Dismiss 4–6.) Grinage suggests various methods Mylan could have employed for more effective
communication to healthcare providers and consumers, including through Dear Doctor letters,
training programs, or “prominent professional or public notifications.” (Id. at 9.)
Of these proposed alternative methods of communication, the Mensing Court directly
addresses only the use of Dear Doctor letters. Because these letters themselves qualify as
“labeling,” FDA regulations require any letter sent by a generic manufacturer to be “consistent
2

The complaint also alleges that Mensing does not apply to any claims arising after the enactment of the 2007 Food
and Drug Administration Amendments Act (FDAAA), 121 Stat. 823 et seq. (Am. Compl. ¶ 38.) In its motion to
dismiss, Mylan contends that “the FDAAA did not eliminate or amend any of the statutes or regulations relied upon
in Mensing and it therefore has no impact on the preemption analysis.” (Def.’s Mot. to Dismiss 16–18.) Grinage
failed to address this argument in her response, so the court will treat this claim as abandoned. See, e.g., Ferdinand
Davenport v. Children's Guild, 742 F. Supp. 2d 772, 777 (D. Md. 2010) (“By her failure to respond to [defendant's]
argument” in a motion to dismiss, “the plaintiff abandons [her] claim.”).

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with and not contrary to” the drug’s approved labeling. 131 S. Ct. at 2576 (citing 21 C.F.R. §
201.100(d)(1)). Grinage argues that the Mensing Court does not necessarily require pre-emption
of state law causes of action where the duty to warn can be satisfied with Dear Doctor letters, or
other methods of communication that may be more effective than labeling alone. Rather, such a
duty and cause of action are preempted only to the extent that the additional communications are
not consistent with the drug’s labeling and therefore are prohibited by federal law. See BrasleyThrash v. Teva Pharm. USA, Inc., 2011 WL 4025734 at *2–3 (S.D. Ala. Sept. 12, 2011) (finding
a failure to warn claim against a generic manufacturer not necessarily pre-empted where the
claim was supported by an alleged failure to use Dear Doctor letters to disseminate information
consistent with an updated brand-name label).3
The problem with Grinage’s argument, as applied here, is that she provides no method of
more effective communication that is “consistent with” the drug’s approved labeling. She
supports her failure-to-warn argument by suggesting that information about a 2007 Israeli study
of Allopurinol should have been communicated to medical providers through alternative
channels. (Pl.’s Resp. to Mot. to Dismiss 7.) Contrary to plaintiff’s contention, however, any
duty to send Dear Doctor letters that includes “substantial new warning information,” like the
Israeli study, is pre-empted by Mensing. 131 S. Ct. at 2576 (“A Dear Doctor letter that contained
substantial new warning information would not be consistent with the drug’s approved
labeling.”).4 Accordingly, Mylan cannot be held to have violated a state law duty to warn for
having failed to send a Dear Doctor letter about the Israeli study. Grinage suggests other

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An unpublished opinion is cited not for any precedential value but for the consistency of its reasoning on this issue.
The Court also reasoned that “if generic drug manufacturers, but not the brand-name manufacturer, sent such
letters, that would inaccurately imply a therapeutic difference between the brand name and generic drugs and thus
could be impermissibly ‘misleading.’” Id. (citing 21 C.F.R. § 314.150(b)(3)).
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alternative avenues of communication as well—through training for healthcare providers and
professional publications, for example. But she provides the court with no explanation why
these methods of communication should be evaluated any differently from Dear Doctor letters.
Grinage may also contend that the manufacturer could have met its duty by using the
various suggested alternative methods of communication without including substantial new
warning information like the Israeli study. But, to the extent that she does make this argument,
she has failed to sufficiently plead causation. Maryland courts recognize a presumption with
regard to causation, that plaintiffs “would have heeded a legally adequate warning had one been
given.” U.S. Gypsum Co. v. Mayor and City Council of Baltimore, 647 A.2d 405, 413 (Md.
1994). This presumption does not, however, relieve a plaintiff of the requirement that she
adequately allege causation in the first place. See Lowe v. Sporicidin Intern., 47 F.3d 124, 131
(4th Cir. 1995) (upholding dismissal of a failure-to-warn claim because plaintiff’s “sole
allegations as to causation were the very general assertions that ‘as a direct and proximate result
of the allegations set forth in’ the summarily pleaded counts”). Here, there is no allegation that
Mr. Grinage and his doctor did not see the labeling as it was approved and take into
consideration the information included therein about Stevens-Johnson Syndrome. Nor has
Grinage alleged any other facts sufficient to support a reasonable inference that further
communications consistent with the approved label would have affected the choices made by Mr.
Grinage or his doctor. Cf. Charleston Area Med. Ctr. v. Blue Cross & Blue Shield Mut. of Ohio,
Inc., 6 F.3d 243, 247 (4th Cir. 1993) (“Although issues of causation are to be decided by the jury,
whether the evidence is sufficient to create a jury issue is solely a question of law to be
determined by the court.”). Thus, while there may be a viable argument for a duty to “effectively

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communicate” that survives Mensing, Grinage has failed to articulate how actions required by
such a duty would have affected the outcome in this case.
Grinage also argues that her failure-to-warn claim survives pre-emption based on
defendants’ alleged failure to convey warning inadequacies to the brand-name manufacturer,
Prometheus Labs. This is identical to the argument, rejected in Mensing, that the plaintiff could
meet its duty to warn by reporting new warning information to the FDA and assuming that the
FDA would then approve new labeling for all manufacturers. The Mensing Court held that it is
not sufficient to “imagine that a third party or the Federal Government might do something that
makes it lawful for a private party to accomplish under federal law what state law requires of it.”
Mensing, 131 S. Ct. at 2579 (emphasis in original). Instead, in order to avoid impossibility preemption, the private party must be able to “independently” do under federal law what state law
requires of it. Id. Here, Prometheus is the third party referenced in Mensing. Grinage argues
that Prometheus, as the brand-name manufacturer, would have been required by FDA regulations
to make a labeling change upon receiving new information from Mylan. Then Mylan could have
updated its own label without violating the federal duty of sameness. But there is no guarantee
that Prometheus would change its own label after receiving communications of warning
inadequacies from Mylan. Thus, Mylan cannot independently remedy a state law violation for
inadequate labeling by communicating information to Prometheus. This second alternative
failure-to-warn theory is therefore squarely rejected by Mensing.

B. Defective Design
Plaintiff’s defective design claim must be dismissed. In Maryland, a manufacturer may

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be held strictly liable under a theory of defective design only if a court determines, as a threshold
matter, that the product is not “unavoidably unsafe.” See Miles Lab., Inc. Cutter Lab. Div. v.
Doe, 556 A.2d 1107, 1114–15, 1121 (Md. 1989) (“Miles Lab. I”). Defendant argues that all
prescription drugs are “unavoidably unsafe,” (Def.’s Mot. to Dismiss 13), but this conclusion
does not follow from relevant Maryland case law.5 In any event, the court need not determine
whether Allopurinol meets this threshold requirement. Even if it does, Grinage’s claim fails
because it cannot satisfy the pleading standards of Iqbal and Twombly.6
Maryland courts have not conclusively settled on the proper test for a defectively
designed prescription drug. Another judge in this District has applied a seven-factor test that
includes several traditional risk-utility factors. See Pease v. American Cynamid Co., 795 F.
Supp. 755, 759 (D. Md. 1992) (applying a defective design test in a vaccine product liability
case). The Maryland Court of Appeals discussed its approach to defective design claims in
Halliday v. Sturm, Ruger & Co., Inc., 792 A.2d 1145 (Md. 2001), involving a firearm. In
Halliday, the court held that the risk-utility test applies only when the product malfunctions in
some way. Id. at 1153.7 Otherwise, courts should apply a consumer expectation test. Id. at
1149–51, 1158. Applying a consumer expectation test, a product is “unreasonably dangerous,”

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The Maryland Court of Appeals has adopted Comment k of the Restatement (Second) of Torts § 402(A), which
defines and limits product liability actions against “unavoidably unsafe products.” See Miles Lab., Inc. Cutter Lab.
Div. v. Doe, 556 A.2d 1107, 1114–15, 1121 (Md. 1989) (“Miles Lab. I”). While Comment k states that unavoidably
unsafe products “are especially common in the field of drugs,” it does not suggest that all drugs are per se
unavoidably unsafe. Id. Rather, the determination of whether a product is unavoidably unsafe requires a weighing
of relevant risk/utility factors. See Doe v. Miles Lab., Inc. Cutter Lab. Div., 927 F.2d 187, 191 (4th Cir. 1991)
(“Miles Lab. II”).
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That plaintiff has styled her defective design claim as a negligence claim instead of a strict liability claim does not
affect this analysis. In defective design claims, the plaintiff’s “ultimate burden is the same whether her claim is
characterized as one for ‘strict liability,’ negligence or breach of warranty.” Pease v. American Cynamid Co., 795 F.
Supp. 755, 759 n.3 (D. Md. 1992). The same is true for failure-to-warn cases. Gourdine v. Crews, 955 A.2d 769,
782 (Md. 2008) (“[N]egligence concepts and those of strict liability have morphed together . . . in failure to warn
cases.”) (internal quotation marks and citations omitted).
7
Halliday involved a gun which functioned, as intended, to injure a human being.

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and therefore defective in design, if it is dangerous “to an extent beyond that which would be
contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common
to the community as to its characteristics.” Id. at 1150 (quoting Restatement (Second) of Torts §
402A cmt. i).
Whether this court applies a consumer expectations test or a risk-utility test, Grinage’s
defective design case fails. The consumer expectations test considers the same factors at issue in
a failure-to-warn claim, and so its application is barred by Mensing. An ordinary consumer
forms her expectations regarding the safety of drugs from her doctor or from the drug’s label.
Thus, if Allopurinol is dangerous beyond the expectations of the ordinary consumer, that can
only be a symptom of Mylan’s failure to update its label or communicate effectively with
doctors. For reasons articulated above, any state law defective design claim predicated on this
theory is pre-empted by FDA labeling regulations.
The pre-emption analysis may be different, however, for design defect claims where a
risk-utility test is appropriate.8 Regardless, Grinage has failed to state a claim based on a riskutility theory. The factual allegations included in the amended complaint are limited to
allegations regarding the defendants’ alleged failure to warn. The plaintiff alleges nothing with
regard to the utility of Allopurinol or availability of less dangerous alternatives. While she does
allege injury, a plaintiff’s right to recovery in a design defect case “may not rest on any
presumption from the happening of an accident.” Jensen v. American Motors Corp., Inc., 437
A.2d 242, 245 (Md. App. 1981). Here, no factual allegations are included that raise the right to
relief on a risk-utility design defect theory above the speculative level. See Twombly, 550 U.S. at

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The court expresses no opinion as to whether a properly pled defective design claim, based on a risk-utility theory,
would be pre-empted by Mensing.

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555. Thus, a claim based on the consumer expectations test is pre-empted, and a claim based on
a risk-utility test has not been sufficiently pled. The design defect claim therefore must be
dismissed.

C. Breach of Implied Warranty
Because Grinage can make out no viable design defect or failure-to-warn claim, her
breach of implied warranty claims must also fail. The complaint includes a claim for breach of
implied warranty of merchantability and a claim for breach of implied warranty of fitness for a
particular purpose. (Am. Compl. ¶¶ 70–77.) But, beyond those assertions supporting her failureto-warn and design defect claims, no further factual allegations are made in support of the
warranty claims. Without more, both warranty claims fail to meet the pleading standards of
Iqbal and Twombly.
A warranty of merchantability, warranting that the product sold is fit for the ordinary
purpose for which such products are used, is implied in the sale of any good, unless properly
waived or modified. Md. Code Ann., Com. Law § 2-314(2)(c) (2011); see Shreve v. Sears,
Roebuck & Co., 166 F. Supp. 2d 378, 421 (D. Md. 2001). To recover on a claim for breach of
implied warranty of merchantability, as with a strict liability or negligence claim, a plaintiff must
prove the existence of a defect at the time the product leaves the manufacturer. Ford Motor Co.
v. General Acc. Ins. Co., 779 A.2d 362, 369–70 (Md. 2001). Breach can be proved by showing
the existence of any of the three general types of defects: manufacturing defects, design defects,
or failure to warn. Id. at 370 n.13 (citation omitted). Here, Grinage has not alleged a
manufacturing defect, and, as discussed above, any design defect or failure-to-warn claim not

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pre-empted is too speculative to survive a motion to dismiss. If no claim of defect can survive a
motion to dismiss, neither can a claim for breach of implied warranty of merchantability.
Conversely, a claim for breach of implied warranty of fitness for a particular purpose
does not require proof of a defect. Id. at 376 (“[T]he warranty of fitness sharply contrasts with
the warranty of merchantability, which involves an inherent defect in the goods that existed
before they left the hands of the manufacturer.”). A warranty of fitness claim does, however,
require that the buyer have a “particular purpose” and that the seller have reason to know of that
particular purpose. Md. Code Ann., Com. Law § 2-315 (2011). A particular purpose “must be
peculiar to the buyer as distinguished from the ordinary or general use to which the goods would
be put by the ordinary buyer.” Ford Motor, 779 A.2d at 375 (citations omitted); see Bond v.
Nibco, Inc., 623 A.2d 731, 736 (Md. App. 1993) (holding that a complaint failed to state a claim
because plaintiff “nowhere alleged that he bought the [products] for a ‘particular purpose’ that in
any way differed from the ‘ordinary purpose’ for which these [products] might be used”).
Grinage does not aver that her husband had any particular purpose that differed from that of
other consumers of Allopurinol. Moreover, there is no indication that Mylan had any knowledge
of a particular purpose, if indeed her husband had one. As a result, this claim too must be
dismissed.

D. Fraud
Finally, Grinage’s fraud claim also fails. The basis of Grinage’s fraud claim is alleged
fraudulent representations made to the deceased, his prescribing physician, and to the FDA.
(Pl.’s Resp. to Mot. to Dismiss 20.) None of these allegedly fraudulent representations, however,

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can be the basis of a viable claim. Mylan made representations to the deceased and his
prescribing physician through the drug’s label. Any claim based on the errors in the label – or
omissions in labeling or communications with health providers – is pre-empted by the FDA
regulations for the same reason that failure-to-warn claims are pre-empted. See Fisher v.
Pelstring, --- F. Supp. 2d ---, 2011 WL 4552464 at *20 (D.S.C. Sept. 30, 2011) (finding fraud
claims pre-empted by Mensing because “the plaintiffs [had] not identified any mechanism by
which [the manufacturer] could have independently changed or omitted the allegedly false
representations on its label without first seeking the federal government's special permission and
assistance.”).
This leaves the allegations of fraudulent representations to the FDA to sustain a claim of
fraud. But, like her design defect claim, these allegations are too thinly-pled to survive a motion
to dismiss. Fraud claims are subject to the heightened pleading standards of Federal Rule of
Civil Procedure 9(b). Haley v. Corcoran, 659 F. Supp. 2d 714, 724 n.10 (D. Md. 2009). Rule
9(b) requires a plaintiff to plead “with particularity the circumstances constituting fraud.” Fed.
R. Civ. P. 9(b). These “circumstances” include “the time, place, and contents of . . . false
representations, as well as the identity of the person making the misrepresentation and what he
obtained thereby.” Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 (4th Cir.
1999) (quoting 5 Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure §
1297 (2d ed. 1990)). Grinage has not satisfied these heightened pleading standards. The
complaint contains no reference to any specific communication to the FDA that constituted a
misrepresentation, or to any specific studies or other information improperly omitted from filings
or other communications with the FDA. Fraud allegations that fail to comply with Rule 9(b)

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warrant dismissal under Rule 12(b)(6). Thus, Grinage’s fraud claims must be dismissed.9

E. Wrongful Death
Because Grinage has failed to state a claim for negligence, strict liability, breach of
warranty or fraud, she has also failed to state a claim for wrongful death. In Maryland, a
wrongful death action “may be maintained against a person whose wrongful act causes the death
of another.” Md. Code Ann., Cts. & Jud. Proc. § 3–902(a). Thus, a party can only bring a
wrongful death action if a “wrongful act” occurred. Georgia-Pacific Corp. v. Benjamin, 904
A.2d 511, 523 n.6 (Md. 2006). A wrongful act is “an act, neglect, or default including a felonious
act which would have entitled the party injured to maintain an action and recover damages if
death had not ensued.” Md. Code Ann., Cts. & Jud. Proc. § 3–901(e). Because Grinage cannot
maintain an action or recover damages for any of the independent product liability, warranty or
fraud claims she has articulated, she cannot maintain her claim for wrongful death. See Respess
v. Travelers Cas. & Sur. Co. of America, 770 F. Supp. 2d 751, 767–68 (D. Md. 2011) (granting a
12(b)(6) motion to dismiss a wrongful death claim where complaint failed to state a claim for
underlying wrongful conduct of gross negligence or intentional infliction of emotional distress).

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Furthermore, the Supreme Court has held that, at least as to medical devices, any claims of injury due to fraud
against the FDA are pre-empted by the federal statutory scheme that “amply empowers the FDA to punish and deter
fraud against the Administration, and . . . is used by the Administration to achieve a somewhat delicate balance of
statutory objectives.” Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 348 (2001); see also Cooper v.
Smith & Nephew, Inc., 259 F.3d 194, 203 n.3 (4th Cir. 2001) (rejecting a “fraud-on-the-FDA” claim where plaintiff
had argued that “but for” the fraud on the FDA, he never would have been injured). At least one federal circuit
court of appeals has held that the logic of Buckman applies to prescription drugs as well. See Garcia v. WyethAyerst Lab., 385 F.3d 961, 965–66 (6th Cir. 2004) (preempting a Michigan law that created an exception to tort
immunity for claims of fraud on the FDA). There are, however, other interpretations of Buckman. See Desiano v.
Warner-Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006) (limiting preemption to causes of action where liability is
based solely on the basis of fraud against the FDA). Determining the exact parameters of Buckman is not necessary
here, however, because Grinage’s claims fail to meet the 9(b) pleading standards. Cf. Henderson v. Sun Pharm.
Indus., --- F. Supp. 2d ---, 2011 WL 4015658 at *5 n.5 (N.D. Ga. Aug. 22, 2011) (declining, in a post-Mensing case,
to decide whether to extend Buckman).

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CONCLUSION
In sum, the plaintiff’s complaint is insufficient under the pleading standards of Iqbal,
Twombly, and Rule 9(b), to state any claim that is not otherwise pre-empted. While the Supreme
Court has not explicitly foreclosed all state law product liability claims against generic drug
manufacturers, Grinage has failed to plead factual allegations that raise a plausible right to relief
under her alternative theories.
This court acknowledges that, at least as to the plaintiff’s failure-to-warn claims, the
disposition of this motion to dismiss might have turned out differently had Mr. Grinage’s
prescription been filled with the brand-name Zyloprim instead of the generic Allopurinol. As
Justice Sotomayor noted in her dissent in Mensing,
[A] drug consumer's right to compensation for inadequate warnings now turns on the
happenstance of whether her pharmacist filled her prescription with a brand-name
drug or a generic. If a consumer takes a brand-name drug, she can sue the
manufacturer for inadequate warnings under our opinion in Wyeth [ v. Levine, 555
U.S. 555 (2009) ]. If, however, she takes a generic drug, as occurs 75 percent of the
time, she now has no right to sue.
131 S. Ct. at 2592. Precedent constrains this court. Unless and until the FDA modifies its
regulations, or Congress further amends the governing statute, there is no authority to allow
similar failure-to-warn claims to proceed against generic drug manufacturers like Mylan.
A separate order follows.

December 30, 2011
Date

/s/
Catherine C. Blake
United States District Judge

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