Estate of Teri Cassel, et al. v. ALZA Corporation et al
ORDER denying 30 Motion to Amend/Correct order denying partial summary judgment on design defect as a matter of law; denying 15 Motion for Partial Summary Judgment. Signed by District Judge William M. Conley on 3/5/14. (krj)
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF WISCONSIN
ESTATE OF TERI CASSEL, TERRY
CASSEL, and RODNEY CASSELGEBHARD,
OPINION & ORDER
ALZA CORPORATION and JANSSEN
Teri Cassel passed away in 2009 while wearing two recently FDA-approved
Duragesic brand patches containing the drug fentanyl. Ms. Cassel’s estate and two of her
sons brought this lawsuit against defendants ALZA Corporation (“ALZA”) and Janssen
Pharmaceuticals, Inc. (“Janssen”), alleging that manufacturing, marketing and design defects
caused Ms. Cassel’s death by accidental fentanyl overdose. Defendants moved for partial
summary judgment on the design defect claims (dkt. #15), arguing that those claims are
barred by “impossibility preemption” as articulated in PLIVA, Inc. v. Mensing, 131 S. Ct.
2567 (2011); Wyeth v. Levine, 555 U.S. 555 (2009), and, most recently, Mut. Pharm. Co. v.
Bartlett, 133 S. Ct. 2466 (2013). In response, plaintiffs moved to stay summary judgment
briefing (dkt. #22) due to the fact-intensive nature of the preemption inquiry, a motion
which this court granted (dkt. #28).
The parties having now completed the necessary
discovery and briefing on defendants’ motion for partial summary judgment,1 the court will
deny defendants’ motion for the reasons stated below.
Defendants also moved the court to revise its order staying summary judgment briefing for further
factual development, pursuant to Rule 54(b), arguing that it is now clear that the design defect
Defendant corporations designed and manufactured the first transdermal fentanyl
patch drug for use in the United States under the brand name “Duragesic Reservoir Patch.”3
The Reservoir Patch contained the active ingredient fentanyl in a “form-fill-seal reservoir,”
within which the fentanyl was mixed in a gel with water and alcohol. There are four layers
in a Reservoir Patch: (1) a backing layer of polyester film; (2) a drug reservoir of fentanyl
and alcohol in a gel solution; (3) a rate-control membrane, which controls the rate of
fentanyl delivery to the skin surface; and (4) an adhesive lawyer. Before use, a protective
liner covering the adhesive layer is removed and discarded.
In 2009, the FDA approved a new fentanyl patch design that defendants submitted,
called the “Duragesic Matrix Patch,” which is the subject of this lawsuit.
Reservoir Patch, the Duragesic Matrix Patch contains no fentanyl gel. Rather, it contains
only two functional layers protected by the liner: a backing layer and an adhesive layer, in
which the fentanyl drug is contained.
Plaintiffs allege that the fentanyl patches that ALZA designed and manufactured and
that Janssen sold, supplied and distributed lacked a rate-control membrane or laminated
face adhesive layer, causing Teri Cassel’s death by fentanyl overdose. Due to these alleged
design defects, plaintiffs argue that the Duragesic Matrix Patch “fail[s] to provide adequate
claims can be resolved as a matter of law. (See dkt. #30.) That motion will be denied, both because
the court does not agree for the reasons articulated in this opinion and because the motion has been
rendered boot by the issuance of this opinion itself.
Defendants have proposed fourteen findings of fact in support of their motion for summary
judgment. (Dkt. #17.) Plaintiffs have not responded to those findings of fact in any way, and so
they will be deemed undisputed.
The Reservoir Patch sold between 1990 and 2009.
protection against uncontrolled fentanyl delivery” and can produce lethal levels of fentanyl
Summary judgment is appropriate if the moving party “shows that there is no
genuine dispute as to any material fact and the movant is entitled to judgment as a matter
of law.” Fed. R. Civ. P. 56(a). In ruling on a motion for summary judgment, the court views
all facts and draws all inferences in the light most favorable to the non-moving party.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). “Only disputes over facts that
might affect the outcome of the suit under the governing law will properly preclude
summary judgment.” Id. at 248.
The party moving for summary judgment bears the initial burden of informing the
district court of the basis for its motion. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).
Once the initial burden is met, for an issue on which the nonmoving party will bear the
burden of proof at trial, the nonmoving party must “go beyond the pleadings” and
“designate ‘specific facts showing that there is a genuine issue for trial.’” Id. at 324. It is
not sufficient to “simply show that there is some metaphysical doubt as to the material
facts.” Matsushita Elec. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). Rather, the
nonmoving party must produce “evidence . . . such that a reasonable jury could return a
verdict for the nonmoving party.” Anderson, 477 U.S. at 248. If he fails to do so, “[t]he
moving party is ‘entitled to a judgment as a matter of law.’” Id. at 323.
Here, defendants argue that they are entitled to judgment as a matter of law on
plaintiffs’ design defect claims based on the doctrine of conflict preemption. This doctrine
has its roots in the Supremacy Clause, which states that federal law “shall be the supreme
Law of the Land . . . anything in the constitution or laws of any State to the contrary
notwithstanding.” U.S. Const. art. VI, cl. 2. Thus, state law is preempted where (1) it is
impossible for a party to comply with both state and federal law, Fla. Lime & Avocado
Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963); or (2) the state law is an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress, Crosby v.
Nat’l Foreign Trade Council, 530 U.S. 363, 372-73 (2000).
The first species of conflict
preemption has come to be known as “impossibility preemption.”
In both Wyeth v. Levine and PLIVA, Inc. v. Mensing, the United States Supreme Court
discussed apparently incompatible duties under FDA regulations and state tort law.
Wyeth, the plaintiff was injured by an injection of the brand-name drug Phenergan. She
argued that the label violated Vermont tort law by failing to warn about the dangers of
Phenergan injection, even though it had been reviewed and approved by the FDA. The
Supreme Court agreed, rejecting the defendant’s preemption defense. Wyeth, 555 U.S. at
559-60. Specifically, the court held that the defendant could have complied with both state
tort law and FDA rules by unilaterally improving the warning label -- an option granted to it
by a “changes being effected” (CBE) regulation, which allowed a manufacturer to change a
label without waiting for FDA approval if the change was to “add or strengthen a
contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an
instruction about dosage and administration that is intended to increase the safe use of the
drug product.” Id. at 568 (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A), (C)). Although the
FDA retained the authority to reject such changes, the Court held that “absent clear
evidence that the FDA would not have approved a change to Phenergan’s label,”
impossibility preemption did not preclude the plaintiff’s claims. Id. at 571.
In Mensing, the plaintiffs were injured by generic metoclopramide and argued, as in
Wyeth, that the manufacturers were liable for violating their state law duty to provide
adequate warning labels. Despite the similarities to Wyeth, the Supreme Court disagreed,
holding that plaintiffs’ claims were barred by impossibility preemption. The Court found
that generic drug manufacturers face different duties than brand-name manufacturers, one
of which is the “duty of sameness”: generic drug labels must be the same at all times as the
corresponding brand-name labels.
Mensing, 131 S. Ct. at 2578; see also, e.g., 21 U.S.C.
§ 355(j)(2)(A)(v). Because of this “duty of sameness,” the Court explained, the generic
manufacturers sued in Mensing lacked the option to make unilateral changes to their drug’s
label. 131 S. Ct. at 2575. Accordingly, the Court found that FDA law preempted any state
law duty defendants had to ensure the label was adequate, since “it was not lawful under
federal law for the Manufacturers to do what state law required of them” -- changing the
generic metoclopramide’s label to reflect the risk of injury -- as doing so would differentiate
the generic label from the corresponding brand-name label. Id. at 2577.
Although the generic manufacturers in Mensing could have, at least theoretically,
requested FDA assistance to lobby the brand-name manufacturers to change their labeling,
the Court also found that doing so would not have satisfied state law requirements, since
state law demanded a safer label, not communication about the possibility of one. Id. at
2577-78. Thus, the Court held that “when a party cannot satisfy its state duties without
the Federal Government’s special permission and assistance, which is dependent on the
exercise of judgment by a federal agency, that party cannot independently satisfy those state
duties for pre-emption purposes.” Id. at 2580-81.
In granting plaintiffs’ motion to extend the time to respond to defendants’ summary
judgment motion, this court held that the Wyeth and Mensing decisions suggested a threepart test in analyzing impossibility preemption:
First, the court must identify the steps a defendant should have
taken to avoid liability under state tort law. Next, the court
must determine as a matter of law whether federal law expressly
prohibited the defendant from taking these steps. If the answer
to this second question is ‘No,’ the court must determine
whether the defendant has presented ‘clear evidence’ that the
regulatory agency would have stepped in and exercised its
discretionary authority to prohibit the defendant from taking
the necessary steps under state law.
(Opinion & Order (dkt. #28) 4-5.)
Applying that test, this court found that (1) plaintiffs were alleging a duty to design
the patches differently before FDA approval (rather than to change the design after the fact);
and (2) no federal laws or regulations appear to have prohibited them from doing so.
Accordingly, the court proceeded to step three, finding that the question of whether the
FDA would have prevented defendants from redesigning the patch was a factual one, and
granted plaintiffs’ motion to stay summary judgment briefing to allow for additional
discovery on this question. (Id. at 5-6.)
Since that decision, the Supreme Court has decided Mutual Pharmaceutical Co., Inc. v.
Bartlett, which applied the Wyeth and Mensing analyses to a design-defect case. In Bartlett,
the plaintiff was prescribed a generic form of an anti-inflammatory pain reliever known as
sulindac. As a result, she developed an acute case of toxic epidermal necrolysis. At the time
that she was prescribed sulindac, its label did not refer to the risks of toxic epidermal
necrolysis or the related condition Stevens-Johnson syndrome, though the label did warn
that the drug could cause “severe skin reactions” and “fatalities.” At trial, Bartlett prevailed
on a design-defect claim, and the court of appeals affirmed, finding that neither the FDCA
nor the FDA’s regulations preempted that claim. Specifically, the court of appeals found
that generic manufacturers facing design-defect claims could comply with both federal and
state law by choosing not to make the drug at all. Bartlett, 133 S. Ct. at 2472.
The Supreme Court reversed, holding that impossibility preemption barred Bartlett’s
claims. It found that New Hampshire state law imposed a duty “to ensure that the products
[manufacturers] design, manufacture, and sell are not ‘unreasonably dangerous.’”
2474. That duty could be satisfied “either by changing a drug’s design or by changing is
labeling.” Id. As for a redesign of the drug, the Court found that was not possible for two
reasons: (1) the FDCA requires generics to have the “same active ingredients, route of
administration, dosage form, strength, and labeling as the brand-name drug on which it is
based”; and (2) sulindac is “chemically incapable” of being redesigned. Id. at 2475.
Since redesign was not an option, the Court examined whether Mutual
Pharmaceutical Co. could have altered the drug’s labeling to render it not “unreasonably
dangerous,” but concluded, as in Mensing, that “federal law prevents generic drug
manufacturers from changing their labels.” Id. at 2476. Thus, the Court held that “federal
law prohibited Mutual from taking the remedial action required to avoid liability under
New Hampshire law.” Id. The Court also rejected the lower court’s conclusion that Mutual
could have complied with both state and federal law by simply exiting the market, holding
that, “if the option of ceasing to act defeated a claim of impossibility, impossibility preemption would be ‘all but meaningless.’” Id. at 2477 (quoting Mensing, 131 S. Ct. at 2579).
Defendants now argue that Bartlett stands for the proposition that “federal
preemption bars any state-law claim, including design-defect claims, premised on a
manufacturer’s failure to market a drug with a new design feature that would constitute a
‘major change’ or render it a new drug, either of which requires prior FDA approval.” (Mot.
to Revise Order (dkt. #30) 3.) They specifically rely on the sentence in Bartlett reading:
“once a drug – whether generic or brand-name – is approved, the manufacturer is prohibited
from making any major changes to the ‘qualitative or quantitative formulation of the drug
product, including active ingredients, or in the specifications provided in the approved
application.” Bartlett, 133 S. Ct. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)).4 Since
adding a rate-control membrane to the patch would have been by defendants’ lights just
such a “major change” requiring FDA approval, defendants were barred from the redesign
that state law allegedly required.
As an initial matter, the court does not read Bartlett so broadly. In Bartlett, the
Supreme Court found that designing sulindac differently was impossible for two specifically
enumerated reasons, neither of which is true in this case: (1) generic drugs must have the
same active ingredients, route of administration, dosage form, strength and labeling as their
brand-name counterparts; and (2) sulindac is chemically incapable of being designed
differently. Id. at 2475. Here, defendants are not subject to any such duty of sameness,
since their patches are brand-name, and their own proposed findings of fact demonstrate
that fentanyl patches are amenable to various designs. (See DPFOF (dkt. #17) ¶¶ 6-14.)
Thus, at a minimum, Bartlett is factually distinct from this case.
The court notes that this language is not, as defendants suggest, part of the Bartlett holding. It is in
fact a citation to the Code of Federal Regulations that appears in the Supreme Court’s overview of
the applicable statutory scheme and regulations.
mischaracterization of plaintiffs’ theory of the case. Defendants may well be right that
adding a rate-control membrane to their existing Duragesic Matrix Patch post-FDA approval
would have been a “major change” under 21 C.F.R. § 314.70(b) that they could not
undertake unilaterally. And certainly, the Bartlett Court held that federal law “does prevent
[drug companies] from taking certain remedial measures.” Bartlett, 133 S. Ct. at 2479. But
as this court noted in its previous order, that argument “would only matter if defendants’
tort lies solely in failing to redesign the patch after FDA approval.” (Opinion & Order (dkt.
#28) 6 (emphasis in original).) Plaintiff’s theory here is that defendants had a duty to
employ an alternative design – such as a design with a rate-control membrane, or a multilaminate design -- from the beginning, before FDA approval. (See Pl.’s Resp. (dkt. #32) 9.)
Thus, as this court noted in its previous order, defendants’ emphasis on altering their
patches after FDA approval is misplaced and does not entitle them to summary judgment.
Defendants do briefly address plaintiffs’ actual design defect theory in their Reply,
but those arguments are similarly unavailing.
Essentially, defendants contend that it is
irrelevant whether they could have initially created and submitted to the FDA a different
design -- such as a multi-laminate patch or a matrix patch with a rate-control membrane -when first seeking FDA approval in 2009. The reason, they argue, is because either of these
other designs would still have had to procure initial FDA approval before introducing them
into the market. In defendants’ view, the “need to ask the FDA for its approval before
marketing the new design . . . is dispositive of the preemption issue.” (See Defs.’ Reply (dkt.
#41) 2 (emphasis in original).)
The court finds this argument unconvincing. As an initial matter, to credit it would
effectively foreclose all design-defect claims against drug manufacturers, at least in systems
imposing affirmative duties on manufacturers.5 Under federal law, as defendants themselves
acknowledge, “[n]o person shall introduce or deliver for introduction into interstate
commerce any new drug, unless an approval of an application . . . is effective with respect to
such a drug.”
21 U.S.C. § 355(a) (emphasis added).
Since defendants would find
preemption wherever a manufacturer needs to ask for FDA approval before marketing, and
since all new drugs require FDA approval before marketing, no drug manufacturer could ever
be liable for a defectively designed product under defendants’ interpretation of the doctrine.
None of the impossibility preemption cases to date contemplates this wholesale preemption
of state product liability claims, at least in the drug context. To the contrary, the Supreme
Court in Bartlett specifically noted that “federal law establishes no safe-harbor for drug
companies.” 133 S. Ct. at 2479. To grant defendants’ motion for summary judgment on
this basis would credit a criticism in Justice Sotomayor’s dissent, which the Bartlett Court
expressly disavowed: it would “give pharmaceutical companies a right to sell a federally
approved drug free from common-law liability.”
Id. at 2478 (quoting id. at 2483
(Sotomayor, J., dissenting)).6
The Bartlett Court “save[d] for another day the question whether a true absolute-liability state-law
system could give rise to impossibility pre-emption.” Bartlett, 133 S.Ct. at 2474 n.1. It recognized
at the same time, however, that “most common-law causes of action for negligence and strict liability
do not exist merely to spread risk, but rather impose affirmative duties.” Id.
Indeed, the case factually closest to this one that the court has been able to find, Frazier v. Mylan
Inc., 911 F. Supp. 2d 1285 (N.D. Ga. 2012), rejected just such a preemption defense in the context
of design defect claims with respect to brand-name drugs, because the manufacturer “pointed to no
federal requirement mandating that Pfizer’s product be designed in a certain way or asserted that the
FDA requires a certain design.” Id. at 1295. Admittedly, this case was decided before Bartlett, but
there is no pronouncement in Bartlett that conflicts with the reasoning in Frazier.
Given the current state of the law as articulated by the Supreme Court, this court
holds to its original view of this case and the relevant test. Under plaintiffs’ theory, state
law required defendants to design their Duragesic Matrix Patches differently. See Wis. Stat.
§ 895.047(1)(a) (manufacturer liable for design defect if foreseeable risks of harm could
have been reduced or avoided by adoption of reasonable alternative design, omission of
which renders the product not reasonably safe). No federal law prohibited defendants from
submitting a different design (or at least, defendants have pointed to none). Similarly,
defendants have offered no evidence that the FDA would have exercised its authority to
prohibit defendants from creating and submitting such a design for approval. The court,
therefore, cannot say that defendants have met their burden to demonstrate as a matter of
law the “demanding defense” of impossibility preemption. See Wyeth, 555 U.S. at 573.
IT IS ORDERED that:
1) defendants ALZA Corporation and Janssen Pharmaceuticals, Inc.’s Motion for
Partial Summary Judgment (dkt. #15) is DENIED.
2) defendants’ Motion to Revise May 3, 2013 Order Denying Partial Summary
Judgment on Design Defect as a Matter of Law (dkt. #30) is DENIED.
Entered this 5th day of March, 2014.
BY THE COURT:
WILLIAM M. CONLEY
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