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CERTIFIED FOR PUBLICATION
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
COUNTY, Respondent; OLGA PIKERIE, Real Party in Interest.
Original proceedings; petition for a writ of mandate/prohibition to
challenge an order of the Superior Court of Orange County, Steven L. Perk, Judge.
Horvitz & Levy, Jon B. Eisenberg; Goodwin Procter, Steven A. Ellis; and
Michael D. Shumsky for Petitioners Teva Pharmaceuticals USA, Inc., Barr
Pharmaceuticals LLC, and Barr Laboratories, Inc.
Shook, Hardy & Bacon, Michelle M. Fujimoto and Eva M. Weiler for
The Yocca Law Firm, Mark W. Yocca and Jared Glicksman for Petitioners
Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceutical Industries, Inc.
Lewis Brisbois Bisgaard & Smith and Pamela M. Ferguson for Petitioner
Robinson Calcagnie Robinson Shapiro Davis, Mark P. Robinson, Jr.,
Robert M. Partain, Karen B. Menzies; Skikos, Crawford, Skikos & Joseph,
Steven J. Skikos and Mark G. Crawford for Real Party in Interest.
Plaintiff suffered injuries, allegedly as a result of ingesting a brand-name
drug and its generic equivalents. She sued the manufacturers of both the brand-name
drug and its generic equivalents. Although plaintiff asserts 11 separate causes of action,
the gist of her claims against all defendants is the same—they failed to produce a safe
product, failed to adequately warn plaintiff of the safety issues regarding the products,
and failed to take other available steps within their control to warn plaintiff or protect her
The generic drug manufacturers demurred to plaintiff‟s complaint, arguing
that, under the United States Supreme Court‟s decision in PLIVA, Inc. v. Mensing
564 U.S. ___ [131 S.Ct. 2567] (Mensing
), all of plaintiff‟s claims were preempted by
federal law. The trial court overruled the demurrer. Defendants filed a petition for a writ
of mandate and/or prohibition. We issued an order to show cause, and now deny the
, the United States Supreme Court held that any claims that a
generic drug manufacturer should have included stronger warning labels than those
approved for use on the equivalent brand-name drug are preempted by federal law. The
court explained that under federal law, the generic drug‟s label must be equivalent to—
meaning it must match
—the brand-name drug‟s label. The court also held that a state
could not require a generic drug manufacturer to provide information on its label in
addition to information required on the brand-name drug‟s label, as that would make it
impossible for the generic drug manufacturer to comply with both its duty under federal
law to match the brand-name label and any claimed duty under state law to do more. As
a result of this impossibility, such a state requirement would be preempted by federal law.
In this case, in contrast, plaintiff alleged that the brand-name drug label was
updated, but the generic drug manufacturers failed to update their products‟ labels
accordingly. In other words, the generic drug labels did not match the brand-name drug
label. Consequently, we conclude, plaintiff‟s claims in this regard are not preempted by
federal law. Therefore, the trial court correctly overruled the demurrer.
STATEMENT OF FACTS AND PROCEDURAL HISTORY
Alendronate sodium is a generic version of the medication Fosamax, which
is manufactured and sold by Merck Sharp & Dohme Corp. and Merck & Co., Inc.
Merck‟s patent protection for Fosamax expired in 2008, at which time Teva
Pharmaceuticals USA, Inc. (Teva), Barr Pharmaceuticals LLC (Barr), Barr Laboratories,
Inc. (Barr Labs), Mylan Pharmaceuticals, Inc. (Mylan), Caraco Pharmaceutical
Laboratories, Ltd. (Caraco), Sun Pharmaceutical Industries, Inc. (Sun), and NorthStar Rx
LLC (NorthStar) (collectively, the Teva Defendants) began manufacturing and marketing
Fosamax and alendronate sodium belong to the class of drugs known as
bisphosphonates; they are indicated for the treatment and prevention of osteoporosis.
Olga Pikerie was prescribed and took Fosamax and/or alendronate sodium from 2006 to
2011. Pikerie‟s complaint alleged prolonged use of Fosamax and/or alendronate sodium
might cause fractures of the femur due to suppression of bone turnover. In April 2011,
allegedly as a result of using Fosamax and/or alendronate sodium, Pikerie suffered a left
In April 2011, lawsuits against the manufacturers of Fosamax and
alendronate sodium were coordinated before the Orange County Superior Court. By
agreement of the parties, a test case complaint was filed in January 2012, on behalf of
Pikerie, to raise and resolve the issue of federal preemption. Pikerie‟s complaint asserted
causes of action for strict liability, negligence, breach of express and implied warranties,
deceit by concealment, negligent misrepresentation, fraud, violation of Business and
Professions Code sections 17200 and 17500, and violation of Civil Code section 1750
Teva, Barr, and Barr Labs demurred to the complaint. Caraco, Sun, and
NorthStar joined in the demurrer.1 Following briefing and a hearing, the trial court
overruled the demurrer. The court concluded the allegations that the Teva Defendants
failed to make timely labeling changes and breached a duty to communicate to the public
and to health care professionals were sufficient to state causes of action, which would not
be preempted by the Supreme Court‟s opinion in Mensing
, 564 U.S. ___
[131 S.Ct. 2567]. The court granted the motions by Caraco, Sun, and NorthStar to join
the demurrer. The court also filed an order pursuant to Code of Civil Procedure
section 166.1, in which it certified and found: “In overruling the Demurrer, the Court
issued a ruling on a controlling question of law relating to federal preemption as to which
there are substantial grounds for difference of opinion; and [¶] . . . Appellate resolution of
the controlling question of law relating to federal preemption may materially advance the
1 Mylan is not named as a defendant in Pikerie‟s complaint. Mylan is a
manufacturer of alendronate sodium, and was one of the defendants who agreed with the plaintiffs‟ counsel in the coordinated litigation to test the issue of federal preemption of the plaintiffs‟ claims through a test case. No party disputes that Mylan is a proper petitioner in this case.
In ruling on a demurrer, the “allegations [of the complaint] must be
liberally construed, with a view to substantial justice between the parties.” (Code Civ.
Proc., § 452; Rickley v. Goodfriend
(2013) 212 Cal.App.4th 1136, 1141-1142 [court must
liberally construe complaint, and draw all reasonable inferences in favor of its
“„The standard of review for an order overruling a demurrer is de novo.
The reviewing court accepts as true all facts properly pleaded in the complaint in order to
determine whether the demurrer should be overruled. [Citation.]‟ [Citation.]” (Boy
Scouts of America National Foundation v. Superior Court
(2012) 206 Cal.App.4th 428,
FEDERAL LAWS AND REGULATIONS REGARDING DRUG LABELING
This case involves questions arising out of the Federal Food, Drug, and
Cosmetic Act (FDCA), 21 United States Code section 301 et seq. The United States
Food and Drug Administration (FDA) regulates the manufacture, sale, and labeling of
prescription drug products under the FDCA. (21 U.S.C. § 355(a).) Before marketing a
new drug, a drug manufacturer must obtain FDA approval, by proving the drug is safe
and effective, and that the proposed label for the drug is accurate and adequate.
(21 U.S.C. § 355(b)(1); see Mensing
, 564 U.S. at p. ___ [131 S.Ct. at p. 2574].) In
order to meet this burden, the manufacturer of a new, brand-name drug must perform
lengthy, expensive testing on its product. (21 U.S.C. § 355(b)(1); see Mensing
Manufacturers of generic drugs, however, may avoid the clinical testing
process and obtain FDA approval to market their products by filing an abbreviated new
drug application (ANDA), showing the generic drug is equivalent to the brand-name
drug, or reference listed drug (RLD), in active ingredients, safety, and efficacy (21 U.S.C.
§ 355(j)(2)(A)(ii) & (iv); 21 C.F.R. § 314.94 (2013)), and that the labeling for the generic
drug is the same as the labeling for the RLD (21 U.S.C. § 355(j)(2)(A)(v); 21 C.F.R.
§ 314.94(a)(8) (2013)). The 1984 legislation by which the United States Congress
authorized this simplified process for approval of generic drugs, the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub.L. No. 98-417 (Sept. 24,
1984) 98 Stat. 1585), is commonly referred to as the “Hatch-Waxman Amendments.”
The labeling on or within any prescription drug package must provide
sufficient information, including, but not limited to, “any relevant hazards,
contraindications, side effects, and precautions,” to allow physicians and pharmacists to
“use the drug safely and for the purposes for which it is intended.” (21 C.F.R.
§ 201.100(c)(1) (2013).) Specifically, the FDA requires that drug labels “describe
serious adverse reactions and potential safety hazards [and] limitations in use imposed by
them.” (21 C.F.R. § 201.80(e) (2013).)
Certain changes to an approved drug label require the drug manufacturer to
submit a prior approval supplement to the FDA. (21 C.F.R. § 314.70(b) (2013).) Other
changes may be made by the manufacturer without FDA approval, upon submission of a
“Changes Being Effected” (CBE) supplement. (21 C.F.R. § 314.70(c) (2013).) A CBE
supplement is permitted for “[c]hanges in the labeling to reflect newly acquired
information . . . to accomplish any of the following: [¶] (A) To add or strengthen a
contraindication, warning, precaution, or adverse reaction for which the evidence of a
causal association satisfies the standard for inclusion in the labeling under § 201.57(c) of
this chapter.” (21 C.F.R. § 314.70(c)(6)(iii)(A) (2013).)
The CBE process for changing labels is available only to manufacturers of
RLD‟s. As explained by the United States Supreme Court: “The FDA denies that the
[generic drug] Manufacturers could have used the CBE process to unilaterally strengthen
their warning labels. The agency interprets the CBE regulation to allow changes to
generic drug labels only when a generic drug manufacturer changes its label to match an
updated brand-name label or to follow the FDA‟s instructions. [Citations.] The FDA
argues that CBE changes unilaterally made to strengthen a generic drug‟s warning label
would violate the statutes and regulations requiring a generic drug‟s label to match its
brand-name counterpart‟s. [Citations.] [¶] We defer to the FDA‟s interpretation of its
CBE and generic labeling regulations.” (Mensing
, 564 U.S. at p. ___ [131 S.Ct.
Drug manufacturers may also be required to mail important information
about their products to physicians and other health care professionals. (21 C.F.R. § 200.5
(2013).) These mailings are commonly referred to as “Dear Doctor” letters. (See
generally Horn v. Thoratec Corp.
(3d Cir. 2004) 376 F.3d 163, 177, fn. 22.) Dear Doctor
letters are a form of product labeling (21 C.F.R. § 202.1(l
)(2) (2013)), and, therefore,
subject to the same requirement that they be “consistent with and not contrary to [the]
approved or permitted labeling” of the RLD (21 C.F.R. § 201.100(d)(1) (2013)). “[I]f
generic drug manufacturers, but not the brand-name manufacturer, sent [Dear Doctor]
letters, that would inaccurately imply a therapeutic difference between the brand and
generic drugs and thus could be impermissibly „misleading.‟ [Citations.]” (Mensing
, 564 U.S. at p. ___ [131 S.Ct. at p. 2576].)
The only issue raised by the parties in the demurrer to Pikerie‟s complaint
was whether all causes of action against the Teva Defendants were barred by the
impossibility preemption doctrine. The United States Congress has the power to preempt
state law concerning matters that lie within its authority. (Farm Raised Salmon Cases
(2008) 42 Cal.4th 1077, 1087.) Preemption of state law may be express or implied.
Implied preemption occurs “„(i) when it is clear that Congress intended, by
comprehensive legislation, to occupy the entire field of regulation, leaving no room for
the states to supplement federal law [citation]; (ii) when compliance with both federal
and state regulations is an impossibility
[citation]; or (iii) when state law “stands as an
obstacle to the accomplishment and execution of the full purposes and objectives of
, italics added.) The parties agree that in this case, we are concerned
only with implied preemption due to impossibility.
Not all state law claims are preempted by the FDCA. (See Wyeth v. Levine
(2009) 555 U.S. 555, 567 [the FDCA contains a savings clause, meaning state law is only
invalidated by a “„direct and positive conflict‟” with the FDCA; the FDCA does not
contain an express preemption provision regarding prescription drugs, although express
preemption provisions exist in the FDCA for other products, such as medical devices].)
Federal preemption applies when state and federal laws “directly conflict.”
(Wyeth v. Levine
, 555 U.S. at p. 583 (conc. opn. of Thomas, J.).) When it is
“„impossible for a private party to comply with both state and federal requirements,‟” a
direct conflict exists. (Freightliner Corp. v. Myrick
(1995) 514 U.S. 280, 287.) In
, 564 U.S. at page ___ [131 S.Ct. at page 2572], the United States
Supreme Court held certain state law tort claims against the manufacturers of a generic
drug were preempted under the impossibility preemption doctrine. The court concluded
that because the generic drug manufacturers could not comply with state law
requirements without violating federal drug labeling requirements, the impossibility
preemption doctrine barred the plaintiffs‟ state law claims. (Id.
at p. ___ [131 S.Ct. at
pp. 2577-2578].) “Taking [the plaintiffs‟] allegations as true, state law imposed on the
Manufacturers a duty to attach a safer label to their generic [drug]. Federal law, however,
demanded that generic drug labels be the same at all times as the corresponding
brand-name drug labels. [Citation.] Thus, it was impossible for the Manufacturers to
comply with both their state-law duty to change the label and their federal law duty to
keep the label the same.” (Id.
at p. ___
[131 S.Ct. at p. 2578].)
In their demurrer, the Teva Defendants did not raise specific arguments
regarding, or separately analyze, Pikerie‟s 11 causes of action. Further, the Teva
Defendants did not file a motion to strike specific allegations from Pikerie‟s complaint.
The parties agree there is a single issue before this court: Does the complaint allege
sufficient facts to state a cause of action, which is not preempted by federal law? Pikerie
bases all of her causes of action on the Teva Defendants‟ alleged failures to (1) update the
alendronate sodium labels to match the updated Fosamax label; (2) communicate the
updated safety information to physicians and other health care professionals; (3) stop
marketing alendronate sodium after learning about safety issues regarding the drug; and
(4) request the FDA to order a change to the Fosamax label, which would have enabled
the Teva Defendants to then update the alendronate sodium labels to match the Fosamax
The complaint alleged that on March 1, 2010, the manufacturer of Fosamax
changed the postmarketing experience subsection of the adverse reactions section on the
Fosamax label. The complaint further alleged that on January 25, 2011, language
regarding femoral fractures was added to the precautions section of the Fosamax package
“119. Per the provisions and procedures established under Subsections (a)
and (j) of FDCA §505, as amended by the Hatch-Waxman Amendments, an ANDA for a
generic version of Alendronate Sodium has been required to include proposed labeling
for the drug that is the same in all material respects to the labeling approved for the
so-called Reference Label Drug (RLD), which was Fosamax. [¶] . . . [¶]
“121. As holders of ANDAs for generic versions of the drug, generic
defendants are and have been required by federal law . . . to make timely revisions to the
labeling of the labels for their Alendronate Sodium products after revisions were made to
“125. Generic defendants failed to effectively and adequately communicate
the warnings in the label
to physicians and patients, to ensure that both were aware of the
risk of femoral fracture and to ensure that both were aware of the limitations regarding
the duration of use of the drug. The Defendants, as manufacturers and distributors and
sellers of Alendronate Sodium products, owed to Plaintiff and other patients, a duty to
provide to, and effectively communicate to them and to physicians adequate clinically
relevant information and data and warnings regarding the adverse health risks associated
with exposure to Alendronate Sodium products.
“126. Generic defendants failed to timely and properly correct
misstatements and misrepresentations in the label, failed to update the label
, failed to
ensure that the true risk[s] of femoral fracture were accurately stated in the label, and
failed to utilize FDA approved means to properly emphasize and reinforce the warnings
about the duration of use of the products.
“127. By failing to effectively communicate to Plaintiff . . . or [her]
physicians adequate clinically relevant information and data and warnings regarding the
adverse health risks associated with the ordinary, expected, and/or intended use of
Alendronate Sodium products, and failing to update the labeling of the products
, each of
the Defendants breached their duty to purchasers and consumers of its products.” (Italics
added & some capitalization omitted.)
From these allegations, we can reasonably infer that Pikerie alleged the
Teva Defendants failed to update the labels of their alendronate sodium products to
match the RLD label after the manufacturer of brand-name Fosamax updated its label.
These allegations are sufficient to state a cause of action based on the failure to update
the warning labels, and the causes of action based on the failure to update the generic
labels‟ warnings are not preempted. To the extent Pikerie alleged the Teva Defendants
failed to update the labels on the alendronate sodium products to say something more
than or different from the approved Fosamax label, Pikerie‟s claims would be preempted.
Fulgenzi v. PLIVA, Inc.
(6th Cir. 2013) 711 F.3d 578 supports our
conclusion. In that case, a brand-name drug manufacturer had updated its warning label
in July 2004 to include the risks of long-term use of the drug. (Id.
at p. 580.) The
plaintiff took the generic version of the drug for extended periods on two different
occasions—between September and November 2004, and then for over a year in 2006
and 2007. (Ibid.
) The generic drug manufacturer did not update its warning label to
match the label of the brand-name drug during the entire time the plaintiff was taking the
at pp. 580, 581-582.) The plaintiff developed serious complications due to her
use of the drug (id.
at p. 580), and she sued the generic drug manufacturer under Ohio tort
at pp. 581-582), claiming the generic drug manufacturer‟s failure to update its
warning label “„rendered its warnings inadequate under Ohio law‟” (id.
at p. 582).
The Sixth Circuit Court of Appeals concluded that the impossibility
preemption doctrine did not bar the plaintiff‟s claim, although the defendant‟s failure to
comply with its federal regulatory duties was the underlying cause of the plaintiff‟s claim
for relief. As the court explained: “Courts will find impossibility preemption where it is
„impossible for a private party to comply with both state and federal requirements.‟
[Citation.] This analysis can become difficult when applied to the regulatory context—
overlapping federal duties, ex-post and ex-ante agency approval, and ambiguous
regulations make the question of whether a party is acting in accord with federal policies
uncertain. In the wake of Wyeth
, 555 U.S. 555] and Mensing
564 U.S. ___ [131 S.Ct. 2567],] however, the application of impossibility preemption
principles has become clearer. Mensing
explains that the key question is „whether the
private party could independently‟ comply with its state duty—without relying on the
prior exercise of federal-agency discretion. [Citation.] Wyeth
, by contrast, holds that
there is no impossibility as long as the approval comes after
the independent action of the
private party (especially where denial is speculative and unlikely). [Citation.] In our
case, not only could PLIVA have independently updated its labeling to match that of the
branded manufacturer through the CBE process [citation], but it had a federal duty to do
so, 21 C.F.R. § 314.150(b)(10). As a result, compliance with federal and state duties was
not just possible; it was required. Impossibility preemption is inappropriate in such a
case. It is true that the FDA had the authority to reject PLIVA‟s labeling change after the
fact. But this is precisely the „possibility of impossibility‟ that Wyeth
to warrant preemption. Indeed, as PLIVA had a clear federal duty to update its label, it is
even less likely here that the FDA would have rejected the change. This case, therefore,
presents an even weaker case for impossibility preemption than Wyeth
.” (Fulgenzi v.
, 711 F.3d at p. 584.)
In this case, as in Fulgenzi v. PLIVA, Inc.
, it was possible for the Teva
Defendants to comply with both a federal duty to makes their labels match the Fosamax
label, and a state tort law duty to prevent harm to the consumers of alendronate sodium.
Therefore, the impossibility preemption doctrine does not bar Pikerie‟s claims.
Many other state and federal trial courts have reached the same conclusion,
based on comparable fact patterns. (See Phelps v. Wyeth, Inc.
(D.Or., Apr. 2, 2013, Civ.
No. 6:09-cv-06168 TC) 2013 U.S.Dist. Lexis 49422, p. *8 [“Unlike the failure to warn
claim in Mensing
, plaintiffs do not claim that Pliva was required to use a different or
stronger warning label; they merely claim that, under Oregon law, Pliva was negligent by
failing to update its label to match the name-brand label—a requirement that is consistent
with the FDCA. Thus, because plaintiffs‟ state-law claim does not make it impossible for
Pliva to comply with federal law, no conflict exists and preemption is not warranted”
(italics added)]; Johnson v. Teva Pharmaceuticals USA, Inc.
(W.D.La., May 21, 2012,
No. 2:10 CV 404) 2012 U.S.Dist. Lexis 71384, p. *10 [“impossibility preemption would
not apply to any requirement . . . that the Generic Defendants update their product labels
to reflect labeling changes made by the brand name manufacturer”]; Cooper v. Wyeth,
(M.D.La., Mar. 6, 2012, No. 09-929-JJB) 2012 U.S.Dist. Lexis 29209, pp. *11-*12
[“a generic drug manufacturer‟s failure to adhere to the brand-name label the generic
drug is tied to would plainly violate federal law and likely violate state law . . . . In the
latter scenario, the requirements of state law would coextend with, but would not exceed,
the requirements of federal law, rendering impossibility preemption inapplicable”];
Couick v. Wyeth, Inc.
(W.D.N.C., Jan. 11, 2012, No. 3:09-cv-210-RJC-DSC) 2012
U.S.Dist. Lexis 3699, p. *14 [“if Defendants‟ [product package inserts] did not match the
brand, there are at least some changes to their [product package inserts] that federal law
would allow, or even require, Defendants to make. A state law claim for failure to
include such warnings would not be preempted by federal law”]; Del Valle v. PLIVA, Inc.
(S.D.Tex., Dec. 21, 2011, Civ. A. No. B: 11-113) 2011 U.S.Dist. Lexis 153473, p. *14
[generic drug manufacturers‟ failure to update their labels, “after the brand named
manufacturers enhanced their warning labels in 2004, might preclude the application of
conflict pre-emption, but only as to the labeling information added by the brand named
manufacturers in 2004”]; In re Reglan Litigation
(Super. Ct. Atlantic County, N.J., 2012,
No. 289) 2012 WL 1613329 [“if labels belonging to generic manufacturers of tablets did
not match the brand-name manufacturers of tablets, then there are [at] least some changes
to their labels that federal law would allow, or even require, these defendants to make,
and state tort law in this situation does not conflict with federal law. Consequently, this
absence of „sameness‟ runs afoul of the preemption ruling in Mensing
, and the court finds
that to the extent that generic manufacturers of metoclopramide tablets failed to update
the labels to be the same as the brand-name label, they are excluded from preemption”];
Fisher v. Pelstring
(D.S.C. 2011) 817 F.Supp.2d 791, 805 [failure to update generic label
The Teva Defendants cite cases for the proposition that Pikerie‟s
failure-to-warn claims are preempted. To the extent those cases are based on facts
similar to those in Mensing
—i.e., that the generic drug manufacturer failed to update its
label or otherwise provide warnings to consumers, which update would have been
inconsistent with the RLD label—they are inapposite to the issues raised in the present
case. (See, e.g., Gross v. Pfizer, Inc.
(D.Md. 2011) 825 F.Supp.2d 654, 657-660; Beck v.
Teva Pharmaceutical Industries
(E.D.La., Sept. 13, 2011, Civ. A. No. 10-1901 Section I)
2011 U.S.Dist. Lexis 102951, pp. *9-*10 [“[n]or would defendants be able to satisfy their
state-law duties by asking the FDA to modify the labeling requirement for both
name-brand and generic drug manufacturers
” (italics added)]; see also Guarino v. Wyeth
(M.D.Fla. 2011) 823 F.Supp.2d 1289, 1291-1292 [opinion fails to describe the
The Teva Defendants argue that the demurrer should have been sustained
because, in essence, Pikerie‟s failure-to-warn claims are unavailing, given her additional
allegations that the 2010 and 2011 updates to the Fosamax label were insufficient.
California law permits Pikerie to plead inconsistent facts. (Adams v. Paul
Cal.4th 583, 593; Mendoza v. Continental Sales Co.
(2006) 140 Cal.App.4th 1395, 1402.)
Whether Pikerie may be able to establish she would have stopped using alendronate
2 We are, of course, not bound by the decisions of federal courts other than the
United States Supreme Court (People v. Gray
(2005) 37 Cal.4th 168, 226), although their interpretation of federal law may be persuasive (Spellman v. Securities, Annuities & Ins. Services, Inc.
(1992) 8 Cal.App.4th 452, 459). The same is true of decisions by the courts of our sister states. (In re Walton
(2002) 99 Cal.App.4th 934, 946.)
sodium and/or Fosamax if she and her physician had been aware of the safety risks
included in the 2010 and 2011 label changes is not before us. The likelihood that Pikerie
can do so is not a matter we may consider at this stage. Given the differences between
federal and California pleading standards, the federal cases the Teva Defendants cite for
this argument are of limited use to the analysis here.3
The Teva Defendants‟ additional argument that Pikerie‟s claims are
preempted by Buckman Co. v. Plaintiffs’ Legal Comm.
(2001) 531 U.S. 341 (Buckman
also fails. In Buckman
, the plaintiffs alleged the defendant made fraudulent
representations to the FDA, which led to the FDA‟s approval of medical devices that
caused injuries to the plaintiffs. (Id.
at p. 343.) The Supreme Court concluded, “the
plaintiffs‟ state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly
pre-empted by federal law. The conflict stems from the fact that the federal statutory
scheme amply empowers the FDA to punish and deter fraud against the Agency, and that
this authority is used by the Agency to achieve a somewhat delicate balance of statutory
objectives. The balance sought by the Agency can be skewed by allowing
fraud-on-the-FDA claims under state tort law.” (Id.
at p. 348, fn. omitted.)
3 See Morris v. Pliva, Inc.
(5th Cir. 2013) 713 F.3d 774, ___ [2013 U.S.App.
Lexis 3167, pages *7-*8] (claim that generic drug label not updated was not raised in the operative complaint; amendment would be futile because it was “logically incoherent” to also contend the brand-name label was inadequate); Del Valle v. PLIVA, Inc.
, 2011 U.S.Dist. Lexis 153473 at page *14 (“Even assuming that pre-emption does not apply to [the generic manufacturers‟] 2004 failure to update their labels, Del Valle has pled no facts to show that this failure caused her injuries. In fact, Del Valle asserts that the labeling by all of the manufacturers, brand name and generic alike, was defective up to 2009”); Morris v. Wyeth, Inc.
(W.D.La., Oct. 19, 2011, Civ. A. No. 3:09-CV-854) 2011 U.S.Dist. Lexis 121052, pages *7-*8 (amendment would be futile because the plaintiff alleged the RLD label was also inadequate); Coney v. Mylan Pharmaceuticals, Inc.
(S.D.Ga., Jan. 19, 2012, No. 6:11-cv-35) 2012 U.S.Dist. Lexis 6284, pages *9-*12 (the plaintiff could not survive summary judgment on the issue of preemption where the plaintiff argued failure to update generic label warnings to match RLD label warnings, though those claims had not been raised in the complaint).
Pikerie‟s claims are based on her contention that the alendronate sodium
labels were not complete and accurate, and did not match the warnings on the Fosamax
labels, not that the Teva Defendants committed a fraud on the FDA when submitting their
ANDA‟s. (See Fulgenzi v. PLIVA, Inc.
, 711 F.3d at pp. 586-587; Fisher v.
, 817 F.Supp.2d at p. 834.) We see a principled difference between a
federal agency acting in the face of someone trying to defraud it, on the one hand, and a
claim by a consumer that a label on a generic drug did not match the FDA-approved RLD
Our conclusion that Buckman
does not aid the Teva Defendants is bolstered
by the way Buckman
itself distinguished two other cases. First, Buckman
Silkwood v. Kerr-McGee Corp.
(1984) 464 U.S. 238, in which the Supreme Court had
found the plaintiff‟s private damage remedies were not impliedly preempted, although
they were allegedly in conflict with the federal regulatory scheme regarding the use and
development of atomic energy. The Buckman
court stated, “Silkwood‟s claim was not
based on any sort of fraud-on-the-agency theory, but on traditional state tort law
principles of the duty of care owed by the producer of plutonium fuel pins to an employee
working in its plant.” (Buckman
, 531 U.S. at p. 352, citing Silkwood v.
, at p. 241.) In the present case, Pikerie‟s claims are not based
on a fraud-on-the-FDA theory, but on state law tort principles of a drug manufacturer‟s
The Supreme Court in Buckman
also distinguished Medtronic, Inc. v. Lohr
(1996) 518 U.S. 470, in which the court concluded, “certain state-law causes of action
that parallel federal safety requirements” were permitted. (Buckman
, 531 U.S. at
p. 353.) The Buckman
court distinguished Medtronic, Inc. v. Lohr
because in the
case, “the fraud claims exist[ed] solely by virtue of the FDCA disclosure
, at pp. 352-353.) Pikerie‟s tort claims under California
law parallel the federal safety requirements arising under the FDCA, but do not exist
solely due to the Teva Defendants‟ alleged failure to comply with those requirements.
Although private rights of action “for the enforcement, or to restrain violations” of the
FDCA are barred (21 U.S.C. § 337(a)), Pikerie‟s claims are instead based on the alleged
failure to properly label alendronate sodium, not to enforce the FDCA or to prevent the
The Teva Defendants rely on a recent unpublished decision by the Court of
Appeals of Iowa, which concluded that a claim for failure of a generic drug manufacturer
to update a warning label to include changes to the brand-name drug‟s label would be
preempted as a private attempt to enforce the FDCA. (Huck v. Trimark Physicians
(Iowa Ct.App., Apr. 24, 2013, No. 3-129/12-0596) 2013 Iowa App. Lexis 435,
p. *9 (Huck
).)4 We respectfully decline to follow Huck
, based on the Supreme Court‟s
decision in Wyeth v. Levine
. In Wyeth v. Levine
, 555 U.S. at pages 568-572, the
Supreme Court concluded a claim under state tort law that a brand-name drug
manufacturer failed to warn patients of the risks of certain methods of administering the
drug was not preempted by the FDCA. Indeed, in Mensing
, the court reaffirmed its
holding in Wyeth v. Levine
is not to the contrary. In that case, as here, the
plaintiff contended that a drug manufacturer had breached a state tort-law duty to provide
an adequate warning label. [Citation.] The Court held that the lawsuit was not
pre-empted because it was possible for Wyeth, a brand-name drug manufacturer, to
comply with both state and federal law. [Citation.] Specifically, the CBE regulation,
21 CFR § 314.70(c)(6)(iii), permitted a brand-name drug manufacturer like Wyeth „to
unilaterally strengthen its warning‟ without prior FDA approval. [Citations.] Thus, the
federal regulations applicable to Wyeth allowed the company, of its own volition, to
4 The Huck
opinion does not rely on Buckman
to reach this holding. Indeed, it
does not rely on any state or federal authority, other than 21 United States Code section 337(a), which provides, “all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.”
strengthen its label in compliance with its state tort duty.” (Mensing
, 564 U.S. at
p. ___ [131 S.Ct. at p. 2581], fn. omitted.) The court in Huck
failed to address the
important point that Wyeth v. Levine
finds no implied preemption for claims in which
both state and federal law can be satisfied.
Failure to communicate with health care professionals
The same preemption analysis applies to Pikerie‟s claims that the Teva
Defendants failed to adequately communicate safety information about alendronate
sodium to health care professionals through Dear Doctor letters. In addition to the
portions of the complaint quoted ante
, the complaint alleged in this regard, as follows:
“123. The generic defendants breached their duty to effectively
communicate warnings to the medical community generally, Plaintiff‟[s] physicians,
Plaintiff, . . . and/or other foreseeable users of their products similarly situated, in that
they failed to: [¶] . . . [¶] i. Ensure that the actual warning language and other
information was effectively communicated to physicians and patients—both through
proper delivery of the existing RLD label, along with other means of communication that
did not require language different from the RLD label, and did not require permission or
assistance from the FDA, including but not limited to issuing Dear Doctor and Dear
Health Care Provider letters which do not contain additional or substantial new warning
information, but which are instead consistent with and not contrary to the approved
labeling, and which highlight and explain the warnings, the labeling and other
information . . . .” (Some capitalization omitted.)
It would not have been impossible for the Teva Defendants to send
Dear Doctor letters advising health care professionals of the risks identified in the 2010
and 2011 Fosamax label changes. Therefore, the impossibility preemption doctrine does
not bar such claims, and the trial court did not err in overruling the demurrer on this
ground. As with the failure-to-update claims, to the extent Pikerie‟s complaint alleged
the Teva Defendants failed to send Dear Doctor letters that were not the same as the
approved Fosamax label, the claims would be preempted.
The Teva Defendants cite numerous state and federal cases to support their
contention that “no state-law claim for failing to communicate product warnings survives
.” We respectfully disagree with the Teva Defendants‟ exaggerated statement.
Smith v. Wyeth, Inc.
(6th Cir. 2011) 657 F.3d 420, Gaeta v. Perrigo Pharmaceuticals Co.
(9th Cir. 2012) 469 Fed.Appx. 556, affirming (N.D.Cal. 2009) 672 F.Supp.2d 1017, and
Johnson v. Teva Pharmaceuticals USA, Inc.
, 2012 U.S.Dist. Lexis 71384 at
pages *7-*8, are factually indistinguishable from Mensing
, and therefore distinguishable
from the present case: they involved a generic drug manufacturer which could not send
out a Dear Doctor letter that would have been inconsistent with the approved RLD label.
Other cases cited by the Teva Defendants follow this same pattern, or did
not reach the issue before us at all. (See Bowman v. Wyeth, LLC
(D.Minn., Mar. 2, 2012,
Civ. No. 10-1946 (JNE/SER)) 2012 U.S.Dist. Lexis 27795, p. *19 [“The Court need not
address whether this type of claim [that the generic manufacturer failed to update its label
after the RLD label was updated] is preempted under Mensing
because Bowman does not
assert this claim in his Complaint”]; Moretti v. PLIVA, Inc.
(D.Nev., Feb. 27, 2012,
No. 2:08-CV-00396-JCM(CWH)) 2012 U.S.Dist. Lexis 24113 [no claim that generic
drug label was not updated to be equivalent to RLD label]; Kellogg v. Wyeth
Feb. 3, 2012, No. 2:07-cv-82) 2012 U.S.Dist. Lexis 13182, p. *4 [the plaintiff alleged she
stopped taking the generic drug before the RLD label was strengthened]; Moore v. Mylan
(N.D.Ga. 2012) 840 F.Supp.2d 1337, 1348-1349; Waguespack v. Pliva USA, Inc.
(E.D.La., Nov. 3, 2011, Civ. A. No. 10-692 Section “S” (3)) 2011 U.S.Dist. Lexis
135710, p. *8 [“Plaintiff does not allege that defendants failed to provide warnings to the
physicians that were identical to the brand name product‟s warnings. Instead, plaintiff
alleges that defendants did provide warnings to physicians, and that those warning[s]
were inadequate because they should have provided stronger warnings than those
provided on the brand name product‟s label”]; Morris v. Wyeth, Inc.
U.S.Dist. Lexis 121052 at pp. *7-*8 [claim that failure to send Dear Doctor letter
preempted; no allegation that RLD label provided stronger warnings]; Fullington v.
(E.D.Ark., Dec. 12, 2011, No. 4:10CV00236 JLH) 2011 U.S.Dist. Lexis
142931, pp. *16-*17 [the plaintiff did not allege generic drug manufacturer‟s failure to
send information to doctors after RLD label changed and before generic label changed,
nor that she ingested the generic drug during that time period].)
Metz v. Wyeth, LLC
(M.D.Fla. 2012) 872 F.Supp.2d 1335, 1340, on which
the Teva Defendants also rely, actually supports our conclusion on this point; there, the
court determined the claim against the generic drug manufacturer for failing to provide
doctors and consumers with safety information included in or recently added to the label
was not necessarily preempted: “In short, it would not be impossible for Actavis to
comply with its obligations under federal and state law to the extent state law is
determined to require Actavis to more effectively communicate the FDA approved label
to medical providers and/or consumers.” (Fn. omitted.)5
In one per curium opinion cited by the Teva Defendants, Morris v. Pliva,
, 713 F.3d at page ___ [2013 U.S.App. Lexis 3167 at pages *6-*7], the Fifth
Circuit Court of Appeals reached a contrary conclusion: “Appellants first contend that
did not dispense with claims concerning a failure to communicate approved
warnings. They allege the generic defendants are liable for failing to convey
FDA-approved information; information communicated by generic manufacturers that is
5 Although the plaintiffs‟ claim that the generic drug manufacturer failed “to more
effectively communicate the warnings contained in the FDA approved label” survived a motion to dismiss based on the impossibility preemption doctrine, the district court determined it could not survive a motion for summary judgment based on Florida‟s learned intermediary doctrine. (Metz v. Wyeth, LLC
, 872 F.Supp.2d at pp. 1343-1344.)
consistent with the brand-name labeling does not violate the duty of sameness. [¶] On the
forecloses such claims because failure to „communicate‟ extends
beyond just a label change. To avoid liability, the manufacturer must take affirmative
steps to alert consumers, doctors, or pharmacists of changes in the drug label. Because
the duty of sameness prohibits the generic manufacturers from taking such action
unilaterally, they are dependent on brand-names taking the lead. [Citation.] Under
federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not
whether the proposed warning to be disseminated contains substantially similar
information as the label. Because no brand-name manufacturer sent a warning based on
the 2004 label change, the generic manufacturers were not at liberty to do so. As
concluded, preemption is thus triggered since it would be impossible for PLIVA
to comply with both the state law duty to warn and the federal law duty of sameness.”
We respectfully believe Morris v. Pliva, Inc.
was incorrectly decided. The
Supreme Court in Mensing
, 564 U.S. at page ___ [131 S.Ct. at page 2576], held
that a generic drug manufacturer‟s Dear Doctor letter “contain[ing] substantial new
warning information would not be consistent with the drug‟s approved labeling,” and
would therefore violate the duty of sameness. Mensing
does not preempt a claim that a
generic drug manufacturer failed to send a Dear Doctor letter containing the same
information that is on the RLD‟s approved label. The contrary conclusion of Morris v.
is supported by neither the language nor the rationale of Mensing.
We have analyzed and followed the United States Supreme Court‟s
opinions in Mensing
, Wyeth v. Levine
, and Buckman
. We have surveyed and analyzed
the decisions of both state and federal courts applying the preemption analyses of those
Supreme Court cases. As we have discussed, many of the cases relied on by the Teva
Defendants did not address, much less resolve, the issue before us in this case, namely,
whether a state law tort claim can survive demurrer when it is based on an allegation that
a generic drug‟s label did not match the RLD label approved by the FDA.
Of the opinions that actually reached the issue before us, we believe the
2013 opinion of the Sixth Circuit Court of Appeals in Fulgenzi v. PLIVA, Inc.
711 F.3d 578, is the best reasoned and most soundly based on the law. As we have
explained in detail ante
, the analysis of the Fulgenzi
opinion comports with our analysis
of the relevant authorities. Many other opinions, cited ante
, also agree with the analysis
we employ here. We acknowledge a disagreement with our analysis in the opinions of
two other courts, one from the Fifth Circuit Court of Appeals and one from an
intermediate Iowa court of appeals. We respectfully disagree with those opinions for the
The trial court also overruled the Teva Defendants‟ demurrer on the
grounds the complaint alleged sufficient facts to state a cause of action based on the Teva
Defendants‟ alleged failure to stop marketing alendronate sodium after learning about
safety issues regarding the drug, and their alleged failure to request the FDA to order a
change in the Fosamax label. Because we have concluded the trial court correctly
overruled the demurrer based on the allegations that the Teva Defendants failed to update
the alendronate sodium labels and failed to send Dear Doctor letters as described, we
The petition is denied. Real party in interest shall recover costs in this writ
WE CONCUR: RYLAARSDAM, ACTING P. J. IKOLA, J.
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