Bartoli et al v. APP Pharmaceuticals, Inc. et al
Filing
27
ORDER granting (157) Motion to Dismiss for Failure to State a Claim in case 1:09-md-02120-KAM-SMG; granting (25) Motion to Dismiss for Failure to State a Claim in case 1:10-cv-01860-KAM-SMG. For the reasons stated in the attached Memorandum and Order, defendants' motion to dismiss the claims of all remaining plaintiffs is granted. The Clerk of Court is respectfully requested to enter judgment and close the case. Ordered by Judge Kiyo A. Matsumoto on 1/30/2012. Associated Cases: 1:09-md-02120-KAM-SMG, 1:10-cv-01860-KAM-SMG (Winterkorn, Margaret)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
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In re: PAMIDRONATE PRODUCTS
LIABILITY LITIGATION,
This Document Relates To:
NOT FOR PUBLICATION
MEMORANDUM AND ORDER
09-MD-2120(KAM)(SMG)
Case No.: 10-CV-1860(KAM)(SMG)
Bartoli et al. v. APP
Pharmaceuticals, Inc. et al.
----------------------------------X
MATSUMOTO, United States District Judge:
Presently before the court is a motion to dismiss
filed on January 6, 2012 by defendants APP Pharmaceuticals,
Inc., Ben Venue Laboratories, Inc. d/b/a Bedford Laboratories,
Hospira, Inc., Sandoz Inc., and Teva Parenteral Medicines, Inc.
(collectively, “defendants”).
Defendants’ motion seeks
dismissal of the claims of all remaining plaintiffs in this
consolidated multi-district proceeding — specifically, Jane
Clark (a/k/a Hazel Jane Clark), Marjorie McDonald, Christopher
Raso (o/b/o Susan Raso), Sylvia Rose, Karen Shareff, Betty Anne
Woodward, Carol Strong (successor: Stacy Strong), Skyla Whaley
(o/b/o Doris Whaley), and Cynthia Burke (o/b/o Ed Burke)
(collectively, “plaintiffs”) — in light of the Supreme Court’s
opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), reh’g
denied (“Mensing”).
(See ECF No. 157, Notice of Motion, filed
1/6/2012; ECF No. 158, Memorandum of Law in Support of
Defendants’ Motion to Dismiss All Remaining Plaintiffs’ Claims,
1
filed 1/6/2012 (“Def. Mem.”).) 1
Plaintiffs have not opposed the
motion and have indicated that they do not seek to do so. 2
For
the reasons that follow, defendants’ unopposed motion to dismiss
is granted.
BACKGROUND
On December 2, 2009, this multi-district litigation
(“MDL”) was transferred to this court by the United States
Judicial Panel on Multidistrict Litigation.
Transfer Order, filed 12/2/2009.)
(ECF No. 1-3, MDL
The MDL Transfer Order
described the cases as follows:
All actions share factual questions relating
to generic equivalents of Aredia 3, a brand
name prescription drug. Plaintiffs in all
actions challenge the safety of these
generic equivalents and allege that they
developed osteonecrosis of the jaw (ONJ) 4 or
have a higher risk for developing ONJ,
because of their infusion with those
pharmaceutical products.
1
Unless otherwise indicated, references to documents filed on the court’s
electronic case filing system (ECF) refer to docket number 09-md-2120.
2
By joint letters filed on November 23, 2011 and December 21, 2011,
plaintiffs’ counsel indicated that plaintiffs would not oppose the instant
motion. (See ECF No. 148, Joint Letter Regarding Status of Dismissal, dated
11/23/2011, at 2; ECF No. 154, Letter to the Honorable Kiyo A. Matsumoto
providing a joint status report, dated 12/21/2011, at 1.)
3
The generic equivalent of Aredia is called pamidronate. Pamidronate,
Drugs.com, http://www.drugs.com/mtm/pamidronate.html (last visited Jan. 30,
2012).
4
Osteonecrosis is bone death resulting from poor blood supply to an area of
bone. Definition of Osteonecrosis, Medterms.com,
http://www.medterms.com/script/main/art.asp?articlekey=4682 (last visited
Jan. 30, 2012).
2
(Id. at 1.)
Plaintiffs are all individuals or their decedents
who were given the generic drug pamidronate 5 and developed ONJ.
(See Case No. 10-CV-1860, ECF No. 10, Second Amended Complaint,
filed 1/6/2011 (“Compl.”) ¶ 6.)
On January 6, 2011, plaintiffs
filed a Second Amended Complaint (“Complaint”).
(See id.)
The
Complaint alleges that as a result of being infused with generic
pamidronate, plaintiffs developed ONJ and suffered injuries.
(Id. ¶¶ 31-32.)
Plaintiffs seek damages from defendants based
on theories of design defect, failure to warn, negligence,
breach of express warranty, and breach of implied warranty.
(Id. ¶¶ 33-60.)
On April 26, 2011, defendants served plaintiffs with a
motion to dismiss the Complaint, which plaintiffs opposed on
June 10, 2011.
Following the Supreme Court’s decision in
Mensing on June 23, 2011, this court stayed further briefing on
the pending motion to dismiss while the parties considered the
impact of that decision and/or whether plaintiffs’ claims
against defendants would be voluntarily dismissed.
(See ECF No.
128, Letter Request for Extension of Deadline to File Reply
Briefs by APP Pharmaceuticals, LLC, filed 6/27/2011; ECF No.
5
Pamidronate is in a group of medicines called bisphosphonates. It alters
the cycle of bone formation and breakdown in the body. It is used to treat,
inter alia, high levels of calcium in the blood related to cancer, Paget’s
disease of the bone, and bone damage caused by certain types of cancer, such
as breast cancer and bone marrow cancer. It does not treat cancer itself.
Pamidronate, Drugs.com, http://www.drugs.com/mtm/pamidronate.html (last
visited Jan. 30, 2012).
3
130, Letter re Status by APP Pharmaceuticals, LLC, filed
8/8/2011; ECF No. 131, Letter MOTION for Extension of Time to
File Response/Reply Brief in Support of Motion to Dismiss by APP
Pharmaceuticals, LLC, filed 8/8/2011.)
Of the 134 plaintiffs
included in the MDL, 125 plaintiffs voluntarily dismissed their
claims by December 28, 2011.
Pursuant to an Order dated
November 25, 2011 (Order dated 11/25/2011), on January 6, 2012,
defendants filed the instant motion to dismiss the remaining
nine plaintiffs’ claims (see ECF No. 157, Notice of Motion,
filed 1/6/2012; ECF No. 158, Def. Mem.).
DISCUSSION
I.
Standard of Review
A.
Motion To Dismiss
Defendants move to dismiss the Complaint pursuant to
Federal Rule of Civil Procedure 12(b)(6) for failure to state a
claim.
(See ECF No. 158, Def. Mem. at 1.)
In considering a
motion to dismiss pursuant to Rule 12(b)(6), the court construes
the complaint liberally, “accepting all factual allegations in
the complaint as true, and drawing all reasonable inferences in
the plaintiff’s favor.”
Chambers v. Time Warner, Inc., 282 F.3d
147, 152 (2d Cir. 2002) (citing Gregory v. Daly, 243 F.3d 687,
691 (2d Cir. 2001)).
In order to survive a motion to dismiss,
the complaint must set forth factual allegations sufficient “to
raise a right to relief above a speculative level.”
4
Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555 (2007).
The court need not
credit “legal conclusions” in the complaint or “threadbare
recitals of the elements of a cause of action, supported by mere
conclusory statements.”
Harris v. Mills, 572 F.3d 66, 72 (2d
Cir. 2009) (quoting Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949
(2009)) (internal quotation marks and alteration omitted).
A
motion to dismiss should be granted when, viewing the facts in
the light most favorable to the non-moving party, the complaint
fails to state a claim upon which relief may be granted.
B.
Law of Preemption
The Supremacy Clause of the United States Constitution
provides that federal law “shall be the supreme Law of the Land
. . . any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.”
U.S. Const. art. VI, cl. 2.
Implied
preemption, which is at issue here, occurs when it is
“impossible for a private party to comply with both state and
federal requirements.”
Freightliner Corp. v. Myrick, 514 U.S.
280, 287 (1995) (citation omitted); accord U.S. Smokeless
Tobacco Mfg. Co., LLC v. City of New York, 703 F. Supp. 2d 329,
334 (S.D.N.Y. 2010).
In other words, “[w]here state and federal
law ‘directly conflict,’ state law must give way.”
S. Ct. at 2577 (quoting
Mensing, 131
Wyeth v. Levine, 555 U.S. 555, 583
(2009) (Thomas, J., concurring in judgment)).
5
In PLIVA, Inc. v. Mensing, plaintiffs brought failure
to warn claims under state law against several generic
manufacturers of the drug metoclopramide.
at 2573.
Mensing, 131 S. Ct.
Plaintiffs alleged that the generic manufacturers
violated state tort laws by failing to change the labels for
metoclopramide to adequately warn of the risk of a severe
neurological disorder.
Id.
The applicable state tort laws
required manufacturers that are “or should be aware of [their]
product’s danger to label that product in a way that renders it
reasonably safe.”
Id.
The manufacturers, on the other hand,
argued that under federal regulations, the generic manufacturers
had a duty of “sameness” – that is, “the warning labels of a
brand-name drug and its generic copy must always be the same.”
Id. at 2574-75.
The Supreme Court held that the plaintiff’s
failure to warn claims under state law were preempted by federal
law because “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.”
II.
Id. at 2578.
Application
Defendants move to dismiss the Complaint, arguing that
plaintiffs’ state law tort claims are either preempted by
federal regulations applicable to generic drugs such as
pamidronate or are inadequately pled under federal pleading
6
standards.
(ECF No. 158, Def. Mem. at 1, 10.)
The court
agrees. 6
A.
Failure To Warn
Plaintiffs’ claims of failure to warn are squarely
preempted by Mensing.
Plaintiffs claim that defendants “knew or
should have known about the possible adverse side effects of
pamidronate” but nevertheless failed to satisfy their state law
duty to provide “proper warnings regarding possible adverse side
effects” of the drug.
¶¶ 42-43.)
(Case No. 10-CV-1860, ECF No. 10, Compl.
In essence, therefore, plaintiffs’ argument is that
defendants should have altered the labeling of pamidronate to
provide stronger warnings about the drug’s possible adverse side
effects.
However, federal drug regulations “demand[] that
generic drug labels be the same at all times as the
corresponding brand-name drug labels.”
2578.
Mensing, 131 S. Ct. at
If defendants “had independently changed their labels to
6
In dismissing plaintiffs’ claims, the court joins numerous other district
courts that have found claims against generic drug manufacturers to be
preempted by Mensing. See, e.g., In re Fosamax Prods. Liab. Litig. (No. II),
MDL No. 2243, Civ. No. 08-008, 2011 U.S. Dist. LEXIS 135006 (D.N.J. Nov. 21,
2011) (dismissing plaintiffs’ claims of defective manufacturing, design
defect, failure to warn, negligence, breach of implied warranty, and breach
of express warranty); Fullington v. PLIVA, Inc., No. 4:10-CV-236, 2011 U.S.
Dist. LEXIS 142931 (E.D. Ark. Dec. 12, 2011) (dismissing plaintiff’s claims
of strict liability, negligence, gross negligence, fraudulent
misrepresentation, negligent misrepresentation, fraudulent concealment, and
breach of the implied warranties of merchantability and fitness for a
particular purpose); Morris v. Wyeth, Inc., No. 3:09-CV-854, 2011 U.S. Dist.
LEXIS 121052 (W.D. La. Oct. 19, 2011) (dismissing plaintiff’s claims of
defective construction or composition, defective design, breach of express
warranty, and inadequate warning); Grinage v. Mylan Pharms., Inc., No. 11-cv1436, 2011 U.S. Dist. LEXIS 149667 (D. Md. Dec. 30, 2011) (dismissing
plaintiff’s claims of failure to warn, design defect, breach of implied
warranty, and fraud).
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satisfy their state-law duty, they would have violated federal
law.”
Id.
Thus, under the Supreme Court’s reasoning in
Mensing, plaintiff’s failure to warn claims are dismissed as
preempted.
B.
Design Defect
Plaintiffs’ claims alleging defective design are also
preempted by federal law.
In Mensing, the Supreme Court found
that a generic drug is “designed to be a copy of a reference
listed drug (typically a brand-name drug)” and it must be
“identical in active ingredients, safety, and efficacy.”
Mensing, 131 S. Ct. at 2574 n.2.
Thus, the “federal duty of
‘sameness,’” id. at 2575, also applies in the context of generic
drug design, and federal law preempts state laws imposing a duty
to change a drug’s design on generic drug manufacturers, see In
re Fosamax Prods. Liab. Litig. (No. II), MDL No. 2243, Civ. No.
08-008, 2011 U.S. Dist. LEXIS 135006, at *33-34 (D.N.J. Nov. 21,
2011) (finding state law design defect claims preempted pursuant
to Mensing); Stevens v. PLIVA, Inc., 6:10-0886, 2011 U.S. Dist.
LEXIS 147684, at *5-6 (W.D. La. Nov. 15, 2011) (same).
Accordingly, plaintiffs’ design defect claims are dismissed. 7
7
Plaintiffs’ allegations of design defect also fail because they are not
supported by factual allegations in the Complaint. Plaintiffs allege that
pamidronate was defectively designed because it was “unreasonably dangerous”
and “its foreseeable risks exceed the benefits associated with the design or
formulation.” (Case No. 10-CV-1860, ECF No. 10, Compl. ¶¶ 35-36.)
Plaintiffs do not describe the nature of the purported design defect or how
such defect caused plaintiffs’ injuries. Such “[t]hreadbare recitals of the
elements of a cause of action, supported by mere conclusory statements, do
8
C.
Negligence
Plaintiffs allege that defendants “failed to exercise
reasonable care in testing, manufacturing, labeling, marketing,
distributing and selling pamidronate . . . .”
1860, ECF No. 10, Compl. ¶ 48.)
(Case No. 10-CV-
First, allegations that the
labeling, marketing, distributing, and selling of pamidronate
failed to meet a certain standard of reasonable care are
preempted pursuant to Mensing because these allegations are in
essence failure to warn claims.
Second, plaintiffs’ allegations of negligence based on
the failure to exercise reasonable care in testing and
manufacturing pamidronate fail because the Complaint merely
makes a conclusory allegation of negligence, without any factual
support for this cause of action.
Indeed, the factual
allegations as to wrongdoing by defendants contained in
paragraphs 23 through 30 of the Complaint are all allegations
that defendants knew of the potential adverse effects of
pamidronate and provided inadequate information regarding the
harm that pamidronate may cause.
(See id. ¶¶ 23-30.)
Thus,
plaintiffs have provided no more than a “sheer possibility” that
defendants defectively tested and manufactured pamidronate.
not suffice” to state a claim. Iqbal, 129 S. Ct. at 1949; see also
Fullington, 2011 U.S. Dist. LEXIS 142931, at *15 (granting generic drug
manufacturers’ motion to dismiss where plaintiffs’ allegations of design
defect were conclusory).
9
Iqbal, 129 S. Ct. at 1949.
Plaintiffs’ “formulaic recitation of
the elements of a cause of action will not do.”
Twombly, 550 U.S. at 555).
Id. (citing
Thus, plaintiffs’ claims that
defendants were negligent are dismissed.
D.
Breach of Express Warranty
Plaintiffs’ claim based on breach of express warranty
is in essence a failure to warn claim, and thus is preempted
pursuant to Mensing.
Plaintiffs allege that defendants made
false statements or representations that pamidronate was “safe,
effective, and fit for its intended uses.”
1860, ECF No. 10, Compl. ¶ 52.)
(Case No. 10-CV-
Plaintiffs attack the accuracy
of these representations by alleging that pamidronate “caused
serious adverse side effects, including ONJ.”
(Id. ¶ 54.)
This
claim suggests that defendants should have changed or omitted
the allegedly inaccurate statements.
Federal law, however, forbids a generic drug
manufacturer from unilaterally changing, omitting, or
strengthening drug labeling.
See Mensing, 131 S. Ct. at 2578
(“[S]tate 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.”).
Here, defendants
could not unilaterally change their pamidronate labels pursuant
to state law and simultaneously comply with their federal law
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duty of sameness.
Accordingly, plaintiffs’ breach of express
warranty claims are preempted and dismissed.
E.
Breach of Implied Warranty
Plaintiffs’ breach of implied warranty claims are also
preempted.
Plaintiffs allege that defendants “impliedly
warranted to Plaintiffs and/or their decedents . . . and/or
their agents, that pamidronate was of merchantable quality and
was safe and fit for its intended uses,” but that the drug “was
not of merchantable quality or safe and fit for its intended
uses . . . .”
59.)
(Case No. 10-CV-1860, ECF No. 10, Compl. ¶¶ 57,
Because this cause of action is founded on the argument
that pamidronate should have been designed differently, it fails
for the same reasons previously explained in the court’s
analysis of the design defect claims.
Plaintiffs’ breach of
implied warranty claim necessarily alleges that defendants
should have changed the design of pamidronate to make it “safe
and fit for its intended uses.”
(Id. ¶ 59.)
Pursuant to
defendants’ “federal duty of ‘sameness,’” Mensing, 131 S. Ct. at
2575, however, defendants were prohibited by federal law from
changing the design of pamidronate.
Thus, plaintiffs’ breach of
implied warranty claims are preempted and dismissed.
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CONCLUSION
For the reasons stated above, defendants’ motion to
dismiss the claims of all remaining plaintiffs is granted.
The
Clerk of Court is respectfully requested to enter judgment and
close the case.
SO ORDERED.
DATED: Brooklyn, New York
January 30, 2012
/s/
________
Kiyo A. Matsumoto
United States District Judge
Eastern District of New York
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