Marvin, Judy et al v. Wyeth-Ayerst Laboratories, Inc. et al

Filing 71

ORDER denying 22 Motion to Dismiss First Amended Complaint with respect to the statute of limitations. The ruling on defendant's motion with respect to plaintiffs' medication guide claims is RESERVED. Plaintiffs shall have until May 10, 2016 to provide additional legal argument on whether the limitation on enforcement actions in 21 U.S.C. § 337 prohibits plaintiffs from basing a negligence per se claim on defendant's alleged violation of the federal medication guide provisions in 21 C.F.R. § 208.24(b). Defendant shall have until May 17, 2016 to respond. Signed by District Judge Barbara B. Crabb on 4/28/2016. (kwf)

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF WISCONSIN
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - JUDY MARVIN, BEVERLY SCHULTZ,
PATRICIA COLLINS, ROBERT ELICK
and SANDRA CONLEY, individually and
as next friend of the ESTATE OF SHIRLEY JOHNS,
ORDER
Plaintiffs,
v.

15-cv-749-bbc

ZYDUS PHARMACEUTICALS (USA) INC. and
WYETH PHARMACEUTICALS, INC.,
Defendants.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Plaintiffs in this civil action are suing defendants Zydus Pharmaceuticals (USA) Inc.
and Wyeth Pharmaceuticals, Inc. for the wrongful death of Shirley Johns, who died allegedly
from injuries incurred when she took a drug commonly known as Amiodarone. Before the
court is defendant Zydus Pharmaceuticals (USA) Inc.’s motion to dismiss the complaint
against it on the following grounds: (1) plaintiffs’ claims are barred by Wisconsin’s threeyear statute of limitations, Wis. Stat. § 893.54; and (2) plaintiffs do not have a private right
of action with respect to their negligence per se claim that defendant Zydus failed to provide
a medication guide for the Amiodrone sold to Johns because the Food, Drug and Cosmetic
Act, 21 U.S.C. § 337, limits enforcement of its provisions to actions brought by the United
States. Dkt. #22.
I am denying defendant Zyfus’s motion to dismiss with respect to timeliness because

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it is not clear from the complaint that plaintiffs’ claims are barred by the statute of
limitations. I am reserving ruling on its motion with respect to plaintiffs’ negligence per se
claim because further briefing from the parties is needed to determine whether such a claim
is preempted by § 337 of the Food, Drug and Cosmetic Act.

ALLEGATIONS OF FACT
In resolving a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), the court must
accept as true all well-pleaded factual allegations in the complaint, Adams v. City of
Indianapolis, 742 F.3d 720, 728 (7th Cir. 2014), and view them in the light most favorable
to the non-movant, Santiago v. Walls, 599 F.3d 749, 756 (7th Cir. 2010) (quoting
Zimmerman v. Tribble, 226 F.3d 568, 571 (7th Cir. 2000)). “Threadbare recitals of the
elements of a cause of action, supported by mere conclusory statements, do not suffice.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atlantic Corp. v. Twombly, 550
U.S. 544, 555 (2007)). For purposes of the present motion, I will accept as true the
following allegations of fact from plaintiffs’ first amended complaint. Dkt. #16.
Shirley Johns was a 77-year-old resident of Crandon, Wisconsin who had a diagnosis
of atrial fibrillation. She died on November 19, 2012, allegedly from Amiodarone-induced
lung disease.

(Amiodarone has many side effects, the most serious being pulmonary

toxicity-lung disease.) Plaintiffs Judy Marvin, Beverly Schultz, Patricia Collins, Robert Elick
and Sandra Conley are the children of Shirley Johns; all of them reside in Crandon,
Wisconsin. Plaintiff Conley is the next friend of the estate of Shirley Johns.

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Defendants Wyeth Pharmaceuticals, Inc. and Zydus Pharmaceuticals (USA) Inc. are
New Jersey corporations involved in the distribution, marketing, promotion, sale, labeling
and design of amiodarone hydrochloride (or Amiodarone).

Wyeth was the initial

manufacturer and distributor of Amiodarone in the United States. In 1985, it received
approval from the Food and Drug Administration to market and sell Cordarone (its named
brand of Amiodarone) as a drug of last resort for patients suffering from recurrent
life-threatening ventricular fibrillation and ventricular tachycardia when those conditions
would not respond to other available anti-arrhythmic drugs and therapies. On September
16, 2008, Zydus received approval from the Food and Drug Administration to manufacture,
market, sell and distribute a generic formulation of Amiodarone. As it does with all generic
drug approvals, the Food and Drug Administration required Zydus to provide patients
prescribed the drug with approved labels, warnings and medication guides containing the
exact same information required of Wyeth as the brand formulation manufacturer.
A medication guide is a “plain English” description of the dangers of a drug. The
Food and Drug Administration requires drug manufacturers to issue medication guides with
certain prescribed drugs and biological products when the agency determines the information
is necessary to prevent serious adverse effects. In that case, patients are to be informed
about a known serious side effect or patient adherence to directions for the use of a product
are essential to its effectiveness. The agency requires manufacturers of Amiodarone to
provide medication guides in lieu of “package inserts” or any other means by which the
manufacturers may attempt to warn consumers of the effects of Amiodarone. Regulations

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promulgated by the Food and Drug Administration require each manufacturer who ships a
container of Amiodarone to provide a sufficient number of medication guides to authorized
distributors, packers and dispensers so that every consumer receives a guide with each
Amiodarone prescription. 21 C.F.R. § 208.24(b).
After receiving approval from the Food and Drug Administration, Wyeth, Zydus and
other companies sought to increase sales of Amiodarone for the “off-label” use as a “first-line
anti-arrhythmic medication,” or a drug of first choice in treating non-life threatening heart
ailments.

(“Off label” uses are those not yet approved by the Food and Drug

Administration.) Although pharmaceutical companies may disseminate certain information
about off-label uses, they must adhere to strict requirements. For instance, a manufacturer
must submit an application to the Food and Drug Administration seeking approval of the
drug for off-label use, provide its marketing materials to the Food and Drug Administration
prior to dissemination, distribute the materials in unabridged form and include disclosures
that the materials pertain to an unapproved use of the drug and, if the Food and Drug
Administration deems it appropriate, provide “additional objective and scientifically sound
information . . . necessary to provide objectivity and balance.” 21 U.S.C. § 360aaa. A drug
manufacturer’s dissemination of information in violation of any of these provisions qualifies
as a violation of the Federal Food, Drug and Cosmetic Act and regulations promulgated
under it. Zydus did not adhere to these requirements.
Dr. Richard A. Reinhart prescribed Shirley Johns a 90-day course of 200mg
Amiodarone tablets for treatment of atrial fibrillation, an off-label use of the drug. Shirley

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Johns filled the prescription at a pharmacy and ingested the Amiodarone according to
instructions. In the spring of 2012, Johns began to experience shortness of breath, wheezing,
trouble breathing, coughing, tiredness, weakness, nervousness, irritability, restlessness,
decreased concentration, depression, impaired vision and stomach, leg and chest pain. Johns
asked Dr. Reinhart about the effects of Amiodarone and underwent tests for pulmonary
toxicity, but Dr. Reinhart told her that her lungs looked perfect. Later it was determined
that a mistake had been made in reading those tests. Johns died on November 19, 2012.
The bottles of Amiodarone that Shirley Johns received were each marked with
“MANUFACTURER ZYDUS PHARM,” identifying the bottles as manufactured, marketed
and distributed by defendant Zydus. Defendant failed to provide up-to-date warning labels
or the medication guides required by the Food and Drug Administration to any of the
pharmacies from which Johns obtained Amiodarone.
Plaintiffs filed their complaint in this action on November 20, 2015.

OPINION
A. Statute of Limitations
Defendant Zydus has moved to dismiss the wrongful death claims against it on statute
of limitations grounds. “[B]ecause the period of limitations is an affirmative defense,” the
Court of Appeals for the Seventh Circuit has held that “it is rarely a good reason to dismiss
under [Fed. R. Civ. P.] 12(b)(6).” Reiser v. Residential Funding Corp., 380 F.3d 1027, 1030
(7th Cir. 2004). See also Clark v. City of Braidwood, 318 F.3d 764, 767 (7th Cir. 2003)

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(plaintiff is not required to allege facts that negate affirmative defenses in his complaint).
However, dismissal under Rule 12(b)(6) on statute of limitations grounds is “appropriate
where ‘the allegations of the complaint itself set forth everything necessary to satisfy the
affirmative defense, such as when a complaint plainly reveals that an action is untimely
under the governing statute of limitations.’” Andonissamy v. Hewlett–Packard Co., 547
F.3d 841, 847 (7th Cir. 2008).
In Wisconsin, actions to “recover damages for death caused by the wrongful act,
neglect or default of another” must be commenced within three years of the date of death
or “on the date the injury is discovered or with reasonable diligence should be discovered by
the wrongful death beneficiary, whichever occurs first.” Wis. Stat. § 893.54; Christ v. Exxon
Mobil Corp., 2015 WI 58, ¶ 47, 362 Wis. 2d 668, 691, 866 N.W.2d 602, 613 (internal
quotations omitted) (holding that discovery rule permits survival and wrongful death claims
to accrue after date of decedent’s death). In Christ, the Wisconsin Supreme Court explained
that
In the absence of a legislatively created rule to the contrary, these claims
accrue when there is a “claim capable of present enforcement, a suable party
against whom it may be enforced, and a party who has a present right to
enforce it.” Employers Insurance of Wausau, 154 Wis. 2d 199, 231, 453
N.W.2d 856, 869 (1990) (citation omitted). These criteria are not met “until
the plaintiff discovers, or in the exercise of reasonable diligence should have
discovered, not only the fact of injury but also that the injury was probably
caused by the defendant’s conduct or product.” Borello v. U.S. Oil Company,
130 Wis. 2d 397, 411, 388 N.W.2d 140, 146 (1986).
Christ, 2015 WI 58, ¶ 75.
Defendant argues that plaintiffs’ claims are barred by the statute of limitations

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because they filed their complaint three years and one day after the date of Shirley Johns’s
death. It contends that plaintiffs’ claims accrued no later than the date of Johns’s death
because it is clear from the facts of the complaint that Johns had reason to believe before she
died that Amiodarone was causing her adverse effects.

In support of its contention,

defendant cites plaintiffs’ allegations that Johns asked her doctor about the side effects of
Amiodarone and was tested for lung toxicity. However, as plaintiffs argue, it is not when
Johns discovered the cause of her injuries that matters for the purposes of the statute of
limitations. According to Christ, plaintiffs’ claims accrue on the date that they (the wrongful
death beneficiaries) discovered or with reasonable diligence should have discovered the cause
of Johns’s injuries.
The first amended complaint alleges no information about when plaintiffs discovered
the cause of Johns’ death. Defendant points out that plaintiffs allege that Johns’s symptoms
were serious enough to elicit worry [in] those around her” and forced her to depend “on the
charity of others,” dkt. #16 at ¶¶ 18-23 and 102, and argues that the most plausible scenario
is that Johns’s children were the ones to worry and about and tend to Johns’s needs.
However, this is only speculation. Further, even if plaintiffs were the ones worrying about
Johns’s symptoms and tending to her needs, they did not necessarily have reason to know
the cause of her symptoms. Because it is impossible to determine at this stage of the
proceedings when plaintiffs’ claims accrued under the statute of limitations, defendant’s
motion to dismiss will be denied.

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B. Medication Guides
Defendant argues that plaintiffs’ claims that it failed to provide medication guides for
the Amiodarone it manufactured must be dismissed because the duty to provide medication
guides to pharmacies arises under federal law, 21C.F.R. § 208.24(b), and the Food, Drug and
Cosmetics Act does not allow private litigants to enforce its provisions. 21 U.S.C. § 337(a)
(enforcement proceedings “shall be by and in the name of the United States”). See also
Buckman Co. v. Plaintiff's’ Legal Committee, 531 U.S. 341, 349 n.4 (2001) (“The FDCA
leaves no doubt that it is the Federal Government rather than private litigants who [is]
authorized to file suit for noncompliance with [its] provisions.”). However, as plaintiffs
contend, they are not attempting to enforce federal regulations; they are relying on them to
establish the standard of care for their claim that defendant was negligent per se in failing
to provide medication guides for Amiodarone. Schmitz v. Canadian Pacific Railroad Co.,
454 F.3d 678, 682 (7th Cir. 2006) (citing Restatement (Second) of Torts § 286) (“In a
typical negligence per se case, a violation of a statute can be a basis for liability when the
statute is intended to protect against the specific type of harm sustained by the plaintiff.”);
Kurer v. Parke, Davis & Co., 2004 WI App 74, ¶ 20, 272 Wis. 2d 390, 405, 679 N.W.2d
867, 874 (“In Wisconsin, violations of FDA regulations may constitute negligence per se.”).

In Kurer, the Wisconsin court of appeals considered whether a drug manufacturer
could be found negligent for failure to warn of a rare medication side effect; the plaintiffs’
claims included negligence per se and common law negligence. 2004 WI App 74, ¶¶ 1-2.

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The specific question in Kurer was whether the failure to include additional warnings was
a cause of the patient’s injury when she disregarded specific statements in the warning
directing her to seek medical attention for the symptoms she exhibited. Michaels v. Mr.
Heater, Inc., 411 F. Supp. 2d 992, 1006 (W.D. Wis. 2006) (finding same). The court noted
that Food and Drug Administration regulations concerning prescription drug labeling
standards could establish the standard of care for negligence per se in Wisconsin and
explained that compliance with the regulations generally would foreclose a claim of
negligence per se. Kurer, 2004 WI app 74, at ¶¶ 19-24 (citing Lukaszewicz v. Ortho
Pharmaceuticals Corp., 510 F. Supp. 961, 964 (E.D. Wis. 1981), amended, 532 F. Supp.
211 (E.D. Wis. 1981)). In addition, the court held that “it is a ‘well-established rule that
the enactment of safety statutes or legislation giving a commission jurisdiction over a certain
activity does not abolish the duty arising under common-law negligence.’” Id. at ¶ 20. It
explained the Wisconsin Supreme Court has found that “a safety statute merely establishes
a minimum standard of care and the conduct, even though sanctioned or in conformity with
the statute, is not thereby necessarily relieved of conforming to the common-law
requirements of ordinary care.” Id. (quoting Hoffmann v. Wisconsin Electric Power Co.,
2003 WI 64, ¶ 12, 262 Wis.2d 264, 664 N.W.2d 55).
In its reply brief, defendant discounts Kurer as a non-binding state appellate opinion
“of dubious validity” after the decision in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), in
which the U.S. Supreme Court held that the Food, Drug and Cosmetic Act preempted a
state law requiring generic drug companies to update and improve a warning label that had

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been approved previously by the Food and Drug Administration. In PLIVA, the Supreme
Court reasoned that “[i]f the Manufacturers had independently changed their labels to
satisfy their state-law duty, they would have violated federal law” requiring that generic drug
labels exactly match those of their brand-name counterparts. Id. at 618. The Court was
concerned primarily with the fact that state law imposed a greater duty on drug
manufacturers than that required under federal law. Id. Although PLIVA seems to cast
doubt on the continuing validity of Kurer’s holding with respect to common law negligence,
it is not clear that the Court’s ruling with respect to preemption has any effect on whether
a regulation promulgated under the Food, Drug and Cosmetic Act may supply the standard
of care for a state law negligence per se claim. Unlike in PLIVA, plaintiffs are not attempting
to subject defendant to additional state law requirements that conflict with the requirements
of the Food, Drug and Cosmetic Act; they merely seek to hold defendant liable for negligence
under state law for the same conduct that violated the federal regulations.
Defendant contends that this court has rejected plaintiffs’ argument concerning
negligence per se in an earlier decision. In Cali v. Danek Medicine, Inc., 24 F. Supp. 2d 941,
953-54 (W.D. Wis. 1998), Judge Shabaz held that basing a claim of negligence per se on the
violation of an Food, Drug and Cosmetic Act regulation is not actionable under Wisconsin
law. Judge Shabaz found that “[f]or the violation of a safety statute to constitute negligence
per se [in Wisconsin], a plaintiff must show: (1) the harm inflicted was the type the statute
was designed to prevent; (2) the person injured was within the class of persons sought to be
protected; and (3) there is some expression of legislative intent that the statute become a

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basis for the imposition for civil liability.” Id. (quoting Tatur v. Solsrud, 174 Wis. 2d 735,
743, 498 N.W.2d 232 (Wis. 1993)). Judge Shabaz concluded that the third element was
absent because “[t]here is no explicit private right of action and no suggestion that the act
creates an implied private right of action.” Id. at 954 (citing limitation in 21 U.S.C. § 337
that only United States may bring enforcement proceedings under Act).
Plaintiffs have not had an opportunity to respond to defendant’s arguments with
respect to Kurer or Cali. A review of relevant case law shows that courts have reached
different conclusions about whether negligence per se claims based on violations of the Food,
Drug and Cosmetic Act should be permitted. Howard v. Zimmer, Inc., 2013 OK 17, ¶¶ 2431, 299 P.3d 463, 470-73 (summarizing cases). At least a few courts in the Seventh Circuit
who have addressed the issue have not found the reasoning in Cali to be persuasive and have
allowed negligence per se claims to proceed in certain cases. Valente v. Sofamor, S.N.C., 48
F. Supp. 2d 862, 875-76 (E.D. Wis. 1999) (relying on Medtronic v. Lohr, 518 U.S. 470,
495 (1996), for view that nothing in preemption provision of Medical Device Amendments
Act, 21 U.S.C. § 360(k), prohibits states from providing damages remedy for violations of
common-law duties when those duties parallel federal requirements); Menges v. Depuy
Motech, Inc., 61 F. Supp. 2d 817, 829 (N.D. Ind. 1999) (plaintiff could assert negligence
per se claim based on alleged violations of Act). The Supreme Court and the Court of
Appeals for the Seventh Circuit also have discussed whether the Food, Drug and Cosmetic
Act preempted state law claims in certain circumstances. E.g., Riegel v. Medtronic, Inc., 552
U.S. 312 (2008); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.1997). However, many

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of these cases address the effect of the preemption provision in the Medical Device
Amendments to the Act, 21 U.S.C. § 360(k), and not the enforcement limitation in § 337.
(Congress declined to enact a preemption provision for prescription drugs. Wyeth v. Levine,
555 U.S. 555, 567 (2009).) Because the parties have not had the opportunity to fully brief
this issue and there appears to be some disagreement among courts, I am asking the parties
for supplemental briefing.
Plaintiffs shall have until May 10, 2016 to provide additional legal argument on
whether the limitation on enforcement actions in 21 U.S.C. § 337 prohibits them from
basing a negligence per se claim on defendant’s alleged violation of the federal medication
guide provisions in 21 C.F.R. § 208.24(b). Defendant shall have until May 17, 2016 to
respond.

ORDER
IT IS ORDERED that defendant Zydus Pharmaceuticals (USA), Inc.’s motion to
dismiss the first amended complaint, dkt. #22, is DENIED with respect to the statute of
limitations. The ruling on defendant’s motion with respect to plaintiffs’ medication guide
claims is RESERVED. Plaintiffs shall have until May 10, 2016 to provide additional legal
argument on whether the limitation on enforcement actions in 21 U.S.C. § 337 prohibits
plaintiffs from basing a negligence per se claim on defendant’s alleged violation of the federal

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medication guide provisions in 21 C.F.R. § 208.24(b). Defendant shall have until May 17,
2016 to respond.
Entered this 28th day of April, 2016.
BY THE COURT:
/s/
_________________________
BARBARA B. CRABB
District Judge

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