SICH et al v. PFIZER PHARMACEUTICAL et al
OPINION. Signed by Judge Robert B. Kugler on 10/4/2017. (dmr)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
MICHAEL SICH and ELLEN
BITTERLICH, his wife,
PFIZER PHARMACEUTICAL, PFIZER
INCORPORATED, et al
KUGLER, United States District Judge:
This matter arises upon defendant Pfizer Incorporated’s (“Defendant”) motion to dismiss
plaintiffs Michael Sich and Ellen Bitterlich’s (“Plaintiffs”) suit for failure to state a claim upon
which relief can be granted. Fed. R. Civ. P. 12(b)(6). For the reasons set forth in the opinion
below, this motion is GRANTED WITHOUT PREJUDICE, and Plaintiffs are permitted to
submit an amended complaint as to only the claims arising under the New Jersey Products
Liability Act (“PLA”) within 14 days.
Plaintiffs allege that Defendant’s drug, Dep-Medrol, caused Mr. Sich severe physical
injuries. See Compl. at 1. In February 2015, Mr. Sich visited Reconstructive Orthopedics where a
physician’s assistant administered an injection of Dep-Medrol in his left knee. Id. Later that
month, Mr. Sich returned to Reconstructive Orthopedics for an appointment with Dr. Scott
Schoifet and received a second injection. Id. at 2. Within hours, Mr. Sich began experiencing
symptoms including elevated temperature, sensitivity, swelling, rashes, and hives. Id. Within a
week, Mr. Sich underwent open debridement and two operations, and required seventeen days of
inpatient treatment. Id. Plaintiffs then sued in New Jersey State Court, but Defendant removed
the case on diversity grounds. See Notice of Removal (Doc. No. 1). Mr. Sich alleges that the
“medication supplied by Defendant  was defective” and caused his injuries. Id.
Plaintiffs seek relief under a number of theories. See Compl. First, Plaintiffs allege a
design defect, a failure to warn, and manufacturing defects under the PLA. Id.; N.J.S.A. §
2A:58C. Second, Plaintiffs allege breach of actual and implied warranties, negligence, and “other
causes of action allowed by law.” Compl. at 4. Finally, Plaintiffs allege loss of consortium on
behalf of Ms. Bitterlich. Id. at 5.
Federal Rule of Civil Procedure 12(b)(6) allows a court to dismiss an action for failure to
state a claim upon which relief can be granted. When evaluating a motion to dismiss, “courts
accept all factual allegations as true, construe the complaint in the light most favorable to the
plaintiff, and determine whether, under any reasonable reading of the complaint, the plaintiff
may be entitled to relief.” Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009)
(quoting Phillips v. County of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)). In other words, a
complaint survives a motion to dismiss if it contains sufficient factual matter, accepted as true, to
“state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009);
Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007).
To make this determination, a court conducts a three-part analysis. Santiago v.
Warminster Twp., 629 F.3d 121, 130 (3d Cir. 2010). First, the court must “tak[e] note of the
elements a plaintiff must plead to state a claim.” Id. (quoting Iqbal, 556 U.S. at 675). Second,
the court should identify allegations that, “because they are no more than conclusions, are not
entitled to the assumption of truth.” Id. at 131 (quoting Iqbal, 556 U.S. at 680). Finally, “where
there are well-pleaded factual allegations, a court should assume their veracity and then
determine whether they plausibly give rise to an entitlement for relief.” Id. (quoting Iqbal, 556
U.S. at 680). This plausibility determination is a “context-specific task that requires the
reviewing court to draw on its judicial experience and common sense.” Iqbal, 556 U.S. at
679. A complaint cannot survive where a court can only infer that a claim is merely possible
rather than plausible. Id.
Plaintiffs’ Strict Products Liability, Negligence, Breach of Implied Warranty, and Loss of
Consortium Claims Are Subsumed by the PLA.
The PLA is “both expansive and inclusive, encompassing virtually all possible causes of
action relating to harms caused by consumer and other products.” In re Lead Paint Litigation,
924 A.2d 484, 436-37 (N.J. 2007) (citing N.J.S.A. § 2A:58C-1(b)(3) (defining “product liability
action”)). The statute’s reach includes “any claim or action brought by a claimant for harm
caused by a product, irrespective of the theory underlying the claim, except actions for harm
caused by breach of an express warranty.” N.J.S.A. § 2A:58C-1(b)(3).
Here, Plaintiffs allege injuries sustained as a result of Mr. Sich’s use of Depo-Medrol.
See Compl. The PLA, as a result, applies—this is a products liability case. But “negligence, strict
liability and implied warranty have been consolidated into a single product liability cause of
action” by the PLA. Clements v. Sanofi-Aventis, U.S. Inc., 111 F. Supp. 3d 586, 596
(D.N.J. 2015) (“New Jersey law no longer recognizes breach of implied warranty, negligence,
and strict liability as viable separate claims for harms deriving from a defective product.”); Fid.
& Guar. Ins. Underwriters, Inc. v. Omega Flex, Inc., 936 F. Supp. 2d 441, 446-51 (D.N.J. 2013);
Green v. Gen. Motors Corp., 709 A.2d 205, 209 (N.J. Super. 1998). Furthermore, the PLA
subsumes loss of consortium claims arising in products liability contexts. Chester v. Boston Sci.
Corp., No. CV 16-02421, 2017 WL 751424, at *4 (D.N.J. Feb. 27, 2017). Therefore, Plaintiffs’
strict products liability, negligence, breach of implied warranty, and loss of consortium claims
are subsumed by the PLA and must be dismissed as a matter of law.
Because the PLA subsumes these claims, it would be futile to include them in the
Plaintiffs PLA and Breach of Express Warranty Claims Fail to Meet The Fed. R. Civ. P. 12(b)(6)
Pleading Standard and Must be Dismissed Without Prejudice With Leave to Amend.
A. Design Defect
Under New Jersey law, the plaintiff must show that the “product was defective, that the
defect existed when the product left the defendant’s control, and that the defect caused injury to a
reasonably foreseeable user.” Feldman v. Lederle Labs., 97 N.J. 429, 449 (N.J. 1984); see
Donlon v. Gluck Grp., LLC, No. 09-5379, 2011 WL 6020574, at *3 (D.N.J. Dec. 2, 2011). The
plaintiff must demonstrate that the “product [was] manufactured as intended but the design
render[ed] the product unsafe.” Pollander v. Desimone BMW of Mt. Laurel, Ltd., No. A-320410T3, 2012 WL 127563, at *3 (N.J. Super. Ct. App. Div. Jan. 18, 2012). Plaintiffs must also
provide—pursuant to a risk-utility analysis—an alternative design that is both practical and
feasible. Lewis v. Am. Cyanamid Co., 155 N.J. 544, 560-61 (N.J. 1998); Schraeder v. Demilec
(USA) LLC, No. 12-6074, 2013 WL 5770970, at *2 (D.N.J. Oct. 22, 2013).
Plaintiffs have failed to reach this bar. Plaintiffs have alleged that as a result of a defect in
the product, “including its sterility and/or formulation, Plaintiff Michael Sich was injected with
toxic substances and injured.” Compl. at 3. That is not enough—Plaintiffs have failed to plead
facts that satisfy each of the necessary elements of a design defect claim, they have simply
B. Failure to Warn
A manufacturer is liable for harm caused by a failure to warn if the product does not
contain an adequate warning or instruction. N.J.S.A. § 2A:58C-4. A warning is adequate if it is
“one that a reasonably prudent person in the same or similar circumstances would have provided
with respect to the danger and that communicates adequate information on the dangers and safe
use of the product.” Id.; Banner v. Hoffman-La Roche Inc., 891 A.2d 1229, 1236 (N.J. Super.
App. Div. 2006) (cert. denied, 921 A.2d 447 (N.J. 2007)).
Plaintiffs’ allegations fail to meet this standard. Plaintiffs allege that “[a]s a direct and
proximate result of” Defendant’s failure to warn, “Plaintiff Michael Sich was injected with toxic
substances and was injured.” Compl. at 3. Plaintiffs offer nothing further, and thus do not reach
the requisite plausibility requirement.1 Iqbal, 556 U.S. at 680.
C. Manufacturing Defect
A manufacturing defect exists if a product “deviated from the design specification,
formulae, or performance standards of the manufacturer or from otherwise identical units
manufactured to the same manufacturing specifications or formulae.” N.J.S.A. § 2A:58C-2(a). A
plaintiff must prove “that the product was defective, that the defect existed when the product left
the manufacturer’s control, and that the defect proximately caused injuries to the plaintiff, [who
Because Plaintiffs have not alleged or pleaded any facts related to the warning label, this Court
does not reach the questions of (1) whether the learned intermediary doctrine applies and if Mr.
Sich’s healthcare provider was adequately warned of any relevant dangers; and (2) whether the
warning label is protected by the rebuttable presumption of adequacy afforded to FDA-approved
prescription medication under the PLA. N.J.S.A. § 2A:58C-4.
must be] a reasonably foreseeable or intended user.” McMahon v. Gen. Dynamics Corp., 933 F.
Supp. 2d 682, 695 (D.N.J. 2013) (citing Myrlak v. Port Authority of N.Y. and N.J., 723 A.2d 45,
52 (N.J. 1999)).
Plaintiffs have alleged that as a “direct and proximate result of . . . manufacturing defects
including its sterility and/or formulation, Plaintiff Michael Sich was injected with toxic
substance and was injured.” Compl. at 3. Plaintiffs have not, however, explained how the drug
differed from the requisite standard or how it was allegedly defective. This claim thus lacks the
factual support that it needs to reach the Twombly / Iqbal plausibility standards—conclusory
statements are not enough. 550 U.S. at 570; 556 U.S. at 680.
D. Breach of Express Warranty
An express warranty is an “affirmation of fact or promise made by the seller . . . which
relates to the goods and becomes part of the basis of the bargain.” N.J.S.A. § 12A:2-313(a).
Plaintiffs must allege: (1) that Defendant made an affirmation, promise, or description about the
product; (2) that this affirmation, promise, or description became part of the basis of the bargain
for the product; and (3) that the product ultimately did not conform to the affirmation, promise or
description. Mendez v. Shah, 28 F. Supp. 3d 282, 294 (D.N.J. 2014); Fid. & Guar. Ins.
Underwriters, Inc., 936 F. Supp. 2d at 451.
Plaintiffs have failed to present an affirmation, promise, or description about the product
made by Defendant. They have additionally failed to allege how this missing affirmation,
promise, or description became a part of the basis of the bargain for the product, nor how the
product ultimately did not conform to that affirmation, promise, or description. As such, the
breach of express warranty claim constitutes a categorical allegation and nothing more. Iqbal,
556 U.S. at 678.
Because the complaint as pleaded does not present facts, accepted as true, that give rise to
any plausible entitlement to relief, Defendant’s motion to dismiss is GRANTED WITHOUT
PREJUDICE and Plaintiffs are permitted 14 days to submit an amended complaint correcting
the deficiencies noted above.
_s/Robert B. Kugler_
ROBERT B. KUGLER
United States District Judge
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