In Re: Risperdal Litigation, MA.J.L. v. Janssen ( 2017 )

J-A27025-16
2017 PA Super 375IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
MA.J.L. AND M.L. :
:
Appellants :
:
:
v. :
: No. 577 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): August Term, 2013, No. 2596
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
A.H., JR. AND A.H. :
:
Appellants :
:
:
v. :
: No. 578 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
ABD JANSSEN REESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): April Term 2013, No. 1995
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
DANIEL BREWER :
:
J-A27025-16
Appellant :
:
:
v. :
: No. 579 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): March 2010 No. 296
October Term 2013, No. 3604
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
D.A. AND B.A. :
:
Appellants :
:
:
v. :
: No. 580 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): March 2010 No. 296
November Term 2013, No. 2990
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
K.S., AND SARAH LABADIE :
:
Appellants :
:
:
v. :
: No. 581 EDA 2015
-2-
J-A27025-16
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
JANSSEN RESEARCH AND :
DEVELOPMENT LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): March 2010, No. 296
September Term, 2013, No. 1341
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
MATTHEW LANTHIER :
:
Appellant :
:
:
v. :
: No. 582 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
JANSSEN RESEACH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): January Term 2014, No. 989
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
MITCHELL LINDBERG :
:
Appellant :
:
:
v. :
: No. 583 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
-3-
J-A27025-16
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): August Term 2013, No. 2624
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
MI.J.L. AND M.L. :
:
Appellants :
:
:
v. :
: No. 584 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEACH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): August Term 2013, No. 2611
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
ERIK RIGGS :
:
Appellant :
:
:
v. :
: No. 585 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): July Term 2013, No. 3223
March 2010 No. 296
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IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
SCOTT WISNIEWSKI :
:
Appellant :
:
:
v. :
: No. 586 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): August Term 2013, No. 473
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
NATHAN ZACHAR :
:
Appellant :
:
:
v. :
: No. 587 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): August Term 2013, No. 1909
March 2010 No. 296
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
DANNY WOODCOCK :
:
Appellant :
-5-
J-A27025-16
:
:
v. :
: No. 588 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): March 2010 No. 296
September Term 2013, No. 2986
IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
CORTEZ MULLEN :
:
Appellant :
:
:
v. :
: No. 589 EDA 2015
:
JANSSEN PHARMACEUTICALS, INC., :
JOHNSON & JOHNSON COMPANY, :
AND JANSSEN RESEARCH AND :
DEVELOPMENT, LLC.
Appeal from the Judgment Entered January 27, 2015
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): July Term 2013, No. 1440
March 2010 No. 296
BEFORE: PANELLA, J., RANSOM, J., and FITZGERALD, J.
OPINION BY PANELLA, J. FILED NOVEMBER 28, 2017
____________________________________________
 Former Justice specially assigned to the Superior Court.
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In these consolidated appeals, Appellants, Ma.J.L. and M.L., A.H., Jr.
and A.H., Daniel Brewer, D.A. and B.A., K.S. and Sarah LaBadie, Matthew
Lanthier, Mitchell Lindberg, Mi.J.L. and M.L., Erik Riggs, Scott Wisniewski,
Nathan Zachar, Danny Woodcock, and Cortez Mullen, appeal from the
judgments entered in the Philadelphia County Court of Common Pleas,
following the entry of summary judgment in favor of Appellees, Janssen
Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research
and Development, LLC.1 Appellants contend the trial court erred in
determining the Michigan Product Liability Act barred their claims. We affirm.
Appellees developed risperidone, an atypical antipsychotic, for the
treatment of schizophrenia in adult patients. The Food and Drug
Administration (“FDA”) approved risperidone for this use in December 1993.
Subsequently, in 1994, Appellees brought this product to market under the
brand name Risperdal. Risperdal was later approved for the short-term
treatment of manic episodes associated with bipolar disorder I in adults in
December 2003; for the treatment of irritability associated with autistic
disorder in children aged five to sixteen in October 2006; for the treatment
____________________________________________
1 The caption in the notice of appeal listed Johnson & Johnson
Pharmaceutical Research and Development, LLC, Excerpta Medica, Inc., and
Elsevier, Inc., as Appellees. See Notices of Appeal, 2/25/15. However,
Janssen Pharmaceuticals, Inc., Johnson & Johnson Company and Janssen
Research and Development, LLC appear to be the correct, and only,
Appellees to the instant appeal. See Appellants’ Brief; Appellees’ Brief;
Stipulation to Discontinue, 1/27/15. We have corrected the caption
accordingly.
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of schizophrenia in adolescents in August 2007; and for the treatment of
manic episodes associated with bipolar I disorder in children aged ten to
seventeen in August 2007.
Four years prior to Risperdal’s approval for use in juvenile populations,
Appellees began to study the safety and efficacy of Risperdal in children and
adolescents through clinical trials. The data from these trials indicated a
potential link between the ingestion of Risperdal and the development of
gynecomastia.2 In October 2006, when Risperdal was first approved for use
in juvenile patients, the Risperdal label was updated to include warnings of
this link.
Appellants in this mass action are young men3 who allege that they
suffered weight gain and developed gynecomastia as a direct result of the
ingestion of Risperdal. Appellants were residents of Michigan when they were
prescribed and ingested Risperdal. With the exception of Appellant K.S.,
Appellants were prescribed Risperdal prior to the FDA approval for the
treatment of their individual conditions.4
____________________________________________
2 Merriam-Webster’s online dictionary defines gynecomastia as “excessive
development of the breast in the male.” Available at http://merriam-
webster.com/dictionary/gynecomastia (last visited October 20, 2017).
3 In certain cases, where Appellant was under eighteen when suit was filed,
Appellant’s parent is also listed as an Appellant on behalf of his or her minor
child.
4See U.S. Food & Drug Administration, Understanding Unapproved Use of
Approved Drugs “Off Label,” available at
(Footnote Continued Next Page)
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Between April 12, 2013 and January 13, 2014, Appellants commenced
their actions by filing complaints. All thirteen complaints were filed in the
Philadelphia County Court of Common Pleas as part of the In re Risperdal
mass tort program, and incorporated allegations found in the master
complaint.5 Appellants contended that Appellees initially concealed, and
subsequently failed to warn, Appellants of the exact risk and prevalence of
developing gynecomastia. Based upon these allegations, Appellants raised
identical claims against Appellees of (I) negligence; (II) negligent design
defect; (III) fraud; (IV) strict liability failure to warn; (V) strict liability
design defect; (VI) breach of express warranty; (VII) breach of implied
warranty; (VIII) violation of Pennsylvania’s Unfair Trade Practices and
Consumer Protection Law (“UTPCPL”), 73 P.S. § 201, et. seq.; (IX) violation
of Michigan’s Consumer Protection Act (“MCPA”), Mich. Comp. Laws. §
445.901 et. seq. (IX) unfair and deceptive trade practices; (X) conspiracy;
(XI) punitive damages; and (XII) medical expenses incurred by parent.6
Appellees denied Appellants’ allegations and asserted all applicable defenses.
(Footnote Continued) _______________________
https://www.fda.gov/forpatients/other/offlabel/default.htm (last visited
August 24, 2017).
5 The In Re Risperdal® Litigation mass tort program was formed on May
26, 2010, as a depository for the filings of pleadings, motions, orders, and
other documents common to all Risperdal cases in the Philadelphia County
Court of Common Pleas. See Case Management Order 1, 5/26/10, In Re
Risperdal® Litigation, March Term 2010 No. 296.
6 Appellants A.H., Jr. and A.H. also raised a claim for loss of consortium.
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Appellees later filed a motion for partial summary judgment on the
master docket disputing the validity of the punitive damages claim. The trial
court granted Appellees’ motion and dismissed all plaintiffs’ claims for
punitive damages. The trial court then denied reconsideration.
On June 16, 2014, Appellees filed motions for summary judgment in
each of Appellants’ cases claiming immunity from suit. Appellees argued that
because Appellants were all residents of Michigan when they were prescribed
and ingested Risperdal, Michigan law governs the claims in Appellants’
complaints. See Appellees’ Motion for Summary Judgment, 6/16/14, at 3-6.
Therefore, because Appellees’ claims constituted product liability claims
under two provisions of Michigan’s Product Liability Act (“MPLA”) §§
600.2945 and 600.2946, and because Appellees had complied with the
conditions for protection under that law, Appellees asserted that they had
statutory immunity from Appellants’ common law claims. See id., at 6-13.
Appellants responded, asserting that Pennsylvania law, not Michigan
law, applied to Appellants’ claims. See Appellants’ Response to Motion for
Summary Judgment, 7/7/14, at 8-14. Further, even assuming that Michigan
substantive law governed their claims, Appellants contended that because
Appellees withheld or misrepresented evidence to the FDA, the MPLA’s
affirmative defense was not available to Appellees. See id., at 22-38.
Moreover, Appellants argued the MPLA’s protections should not be available
to Appellees, as Risperdal was prescribed to Appellants off-label. See id., at
14-22.
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Following oral argument on the motion, the trial court determined the
application of Michigan law, specifically §§ 600.2945 – 600.2949(b) of the
MPLA, barred Appellants’ common law claims against Appellees.7 See Trial
Court Order, 11/4/14. Further, the trial court found that Appellants’ UTPCPL
and MCPA claims failed as a matter of law. See id., at ¶¶ 2-3. Therefore, the
court granted Appellees’ motions in all thirteen cases.
The parties later stipulated to the dismissal of Appellants’ claims
against Excerpta Medica, Inc., and Elsevier, Inc.8 Appellants filed timely
____________________________________________
7 The trial court’s application of the law in its order granting summary
judgment differs from its application of the law in its Rule 1925(a) opinion.
In its November 2014 order granting summary judgment, the trial court
determined that Appellees’ common law claims fail as a matter of law due to
the application of the MPLA. See Trial Court Order, 11/4/14, at ¶ 1.
However, in its Rule 1925(a) opinion, following a conflict of law analysis, the
trial court determined that while the MPLA bars Appellants’ negligence,
negligent design defect, fraud, breach of express warranty, and unfair and
deceptive trade practices claims, Pennsylvania law bars Appellants’ strict
liability – failure to warn, strict liability – design defect, and breach of
implied warranty claims. See Trial Court Rule 1925(a) Opinion, 10/1/15 at
13-17.
While this lack of consistency is apparent, it does not impact our analysis.
In both the November 2014 order and the Rule 1925(a) opinion, the trial
court determined Michigan law applied after a choice of law analysis.
However, it appears the trial court dismissed the strict liability and breach of
implied warrant claims pursuant to Pennsylvania law in its Rule 1925(a)
opinion only after determining that both Pennsylvania and Michigan law
would bar the claims. Thus, because the trial court determined Michigan law
would bar all claims, we will restrict our analysis to the application of
Michigan law.
8 The parties filed praecipes, on each individual docket, to discontinue the
action against Excerpta Medica, Inc. and Elsevier, Inc. on January 27, 2015.
(Footnote Continued Next Page)
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notices of appeal as to the remaining parties. This Court consolidated all
thirteen cases.
On appeal, Appellants argue the trial court erred in granting Appellees’
summary judgment motions and dismissing Appellants’ claims based upon
the application of Michigan law.9 See Appellants’ Brief, at 3. While Appellants
do not dispute the trial court’s determination that Michigan substantive law
governs their claims, Appellants argue the MPLA does not apply to indemnify
Appellees in this specific case because Risperdal was not “approved” for
these Appellants at the time they ingested the medicine. See Appellants’
Brief, at 3 ¶ 1. Further, in the event the MPLA does govern the viability of
(Footnote Continued) _______________________
On February 13, 2015, the trial court entered individual judgments to that
effect, approving the stipulation to discontinue. However, in situations where
the praecipe to discontinue resolves all claims against the parties, the
praecipe itself constitutes a final judgment. See Levitt v. Patrick, 976 A.2d
581, 587-588 (Pa. Super. 2009). Therefore, final judgment was entered on
January 27, 2015. The trial court’s subsequent entry of judgment on
February 13, 2015 is a nullity.
9 In its November 4, 2014 order, the trial court dismissed a majority of
Appellants’ claims based upon the application of Michigan law and the MPLA.
See Trial Court Order, 11/4/14, at ¶ 1. However, the trial court separately
determined that Appellants’ statutory claims pursuant to the Pennsylvania
Unfair Trade Practices and Consumer Protection Law and the Michigan
Consumer Protection Act fail as a matter of law. See id., at ¶¶ 2-3.
Appellants do not appear to challenge this aspect of the trial court’s
summary judgment orders; in fact, Appellants focus their appellate brief
solely on the alleged error the trial court committed when it dismissed their
claims pursuant to the MPLA. See Appellants’ Brief, at 3. Therefore, we will
not address the trial court’s decision to dismiss Appellants’ claims of
violation of the UTPCPL and violation of the MCPA.
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Appellants’ claims, Appellants insist they presented substantial evidence that
the fraud exception to the MPLA defeated Appellees’ claimed immunity from
suit. See id., at 3 ¶ 2. Therefore, Appellants maintain the trial court usurped
a jury’s role by determining these genuine issues of material fact related to
the application of the exception to the MPLA.10 See id.
We review a challenge to the entry of summary judgment as follows:
[We] may disturb the order of the trial court only where it is
established that the court committed an error of law or abused
its discretion. As with all questions of law, our review is plenary.
In evaluating the trial court’s decision to enter summary
judgment, we focus on the legal standard articulated in the
____________________________________________
10 Through their respective notices of appeal, Appellants purport to appeal all
previously non-final orders that merged into and were made appealable by
the entry of the final judgment. See Notice of Appeal (Ma.J.L. and M.L),
2/23/15, at 2 (unpaginated); Notice of Appeal (A.H., Jr. and A.H.), 2/23/15,
at 2 (unpaginated); Notice of Appeal (Brewer), 2/23/15, at 2 (unpaginated);
Notice of Appeal (D.A. and B.A.), 2/23/15, at 2 (unpaginated); Notice of
Appeal (K.S. and Labadie), 2/23/15, at 2 (unpaginated); Notice of Appeal
(Lanthier), 2/23/15, at 2 (unpaginated); Notice of Appeal (Lindberg),
2/23/15, at 2 (unpaginated); Notice of Appeal (Mi.J.L. and M.L.), 2/23/15, at
2 (unpaginated); Notice of Appeal (Riggs), 2/23/15, at 2 (unpaginated);
Notice of Appeal (Wisniewski), 2/23/15, at 2 (unpaginated); Notice of Appeal
(Zachar), 2/23/15, at 2 (unpaginated); Notice of Appeal (Woodcock),
2/23/15, at 2 (unpaginated); Notice of Appeal (Mullen), 2/23/15, at 2
(unpaginated).
These orders include the order of May 2, 2014 entering partial summary
judgment for Appellees, the order entered July 18, 2014, denying Appellants’
motion for reconsideration, and the order entered November 4, 2014
entering summary judgment on the rest of Appellants’ claims. However,
through their appellate brief, Appellants only challenge the entry of
summary judgment on November 4, 2014. Thus, we restrict our review
accordingly.
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summary judgment rule. See Pa.R.C.P. Rule 1035.2. The rule
states that where there is no genuine issue of material fact and
the moving party is entitled to relief as a matter of law,
summary judgment may be entered. Where the nonmoving
party bears the burden of proof on an issue, he may not merely
rely on his pleadings or answers in order to survive summary
judgment. Failure of a non-moving party to adduce sufficient
evidence on an issue essential to his case and on which he bears
the burden of proof establishes the entitlement of the moving
party to judgment as a matter of law. Lastly, we review the
record in the light most favorable to the nonmoving party, and
all doubts as to the existence of a genuine issue of material fact
must be resolved against the moving party.
E.R. Linde Const. Corp. v. Goodwin, 68 A.3d 346, 349 (Pa. Super. 2013)
(citation omitted; brackets in original).
Here, the trial court granted summary judgment after determining
Appellants’ claims were barred due to the application of Michigan law,
specifically the MPLA. Unlike the law in Pennsylvania, Michigan has enacted a
statute which “limits the liability of drug manufacturers and sellers where the
drug at issue was approved for safety and efficacy by the United States Food
and Drug Administration and labeled in compliance with FDA standards.”
Taylor v. SmithKline Beecham Corp., 658 N.W.2d 127, 129-130 (Mich.
2003) (footnote omitted).
Specifically, MPLA provides:
(5) In a product liability action against a manufacturer or seller,
a product that is a drug is not defective or unreasonably
dangerous, and the manufacturer or seller is not liable, if the
drug was approved for safety and efficacy by the United States
food and drug administration, and the drug and its labeling were
in compliance with the United States food and drug
administration’s approval at the time the drug left the control of
the manufacturer or seller. However, this subsection does not
apply to a drug that is sold in the United States after the
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effective date of an order of the United States food and drug
administration to remove the drug from the market or to
withdraw its approval. This subsection does not apply if the
defendant at any time before the event that allegedly caused the
injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United
States food and drug administration information
concerning the drug that is required to be submitted under
the federal food, drug, cosmetic act, chapter 675, 52 Stat
1040, 21 USC 301 to 321, 331 to 343-2, 344 to 346a,
347, 348 to 353, 355 to 360, 360b to 376, and 378 to
395, and the drug would not have been approved, or the
United States food and drug administration would have
withdrawn approval for the drug if the information were
accurately submitted.
(b) Makes an illegal payment to an official or employee of the
United States food and drug administration for the purpose
of securing or maintaining approval of the drug.
Mich. Comp. Laws § 600.2946(5).
Further, the Michigan Legislature has defined a “product liability
action” as an “action based on a legal or equitable theory of liability brought
for the death of a person or for injury to a person or damage to property
caused by or resulting from the production of a product.” Mich. Comp. Laws
§ 600.2945(h). “Production” is defined as “manufacture, construction,
design, formulation, development of standards, preparation, processing,
assembly, inspection, testing, listing, certifying, warning, instructing,
marketing, selling, advertising, packaging, or labeling.” Mich. Comp. Laws §
600.2945(i).
Appellants do not dispute the trial court’s determination that their
claims constituted a product liability action or that the MPLA governs
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Michigan product liability actions. Instead, Appellants base both of their
claims of error on the trial court’s application of the MPLA to their specific
claims. See Appellants’ Brief, at 3.
Appellants first contend the trial court misconstrued the parameters of
the MPLA in granting summary judgment. See Appellants’ Brief, at 19-30.
Specifically, Appellants argue the MPLA does not apply to immunize
Appellees in this situation because Risperdal was prescribed to Appellants
“off-label” and thus not “approved” by the FDA relative to these specific
Appellants. See id., at 23-27. Conversely, Appellees argue that approval for
any population by the FDA implicates the MPLA, and bars Appellants’ suits.
See Appellees’ Brief, at 8-16.
Protection under the MPLA is broad. The Michigan Supreme Court has
explained that
[p]ursuant to this statute, unless the fraud exception in
subsection a or the bribery exception in subsection b applies ….,
a manufacturer or seller of a drug that has been approved by the
FDA has an absolute defense to a products liability claim if the
drug and its labeling were in compliance with the FDA’s approval
at the time the drug left the control of the manufacturer or
seller. Thus, the Legislature has determined that a drug
manufacturer or seller that has properly obtained FDA approval
of a drug product has acted sufficiently prudently so that no tort
liability may lie.
Taylor, 685 N.W.2d at 131.
Unfortunately, at this juncture, no Michigan state court has
encountered a claim that the MPLA does not provide protection for drug
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manufacturers when the FDA approval they received is for a different
population than those adversely affected by the drug.
However, Michigan federal courts have already dismissed several cases
based upon Appellants’ argument. For instance, in Griffus v. Novartis
Pharmaceuticals Corp., the plaintiff sued a drug manufacturer after
participating in a clinical trial testing the efficacy of a drug, Trileptal, for
treatment of pain associated with diabetic neuropathy. See 2006 WL
2583129, at *1 (E.D. Mich. 2006). Plaintiff claimed the MPLA did not apply
to bar her product liability claims against the drug manufacturer because
when she was prescribed the drug, it had only received FDA approval for the
treatment of seizures caused by epilepsy. See id. The district court rejected
plaintiff’s argument, reasoning the Michigan legislature was “certainly aware”
that a drug could be used for purposes other than what it received FDA
approval for, but that a clear reading of the statute provided the legislature
chose to offer blanket immunity to drug manufacturers once it received any
type of FDA approval. Id., at *2.
Additionally, in White v. SmithKline Beecham Corp., a plaintiff sued
a drug manufacturer for failing to warn of the associated risk between
adolescent use of Paxil and an increased risk of suicidality. See 538
F.Supp.2d 1023, 1025 (W.D. Mich. 2008). While the plaintiff admitted Paxil
had FDA approval for adults and was labeled in accordance with the FDA
requirements, plaintiff alleged that the fact the drug was prescribed “off-
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label” to the adolescent in question placed the case outside of the
parameters of the MPLA. Id., at 1029-1030.
However, the Michigan district court rejected this argument, finding
[t]he Michigan Legislature provided immunity for drug
manufacturers for products approved by the FDA, so long as the
product and its labeling meet the FDA standards. Through the
definition of “production,” the statute extends the protection
from suits broadly to a myriad of activities a manufacturer might
perform related to the product. The statute does not limit the
protection to situations when the drug is used for its approved
purposes. Should the Legislature wish to limit the protection
available to “off-label” uses of the drug, it may do so. Until such
an amendment is enacted, this [c]ourt must interpret the statute
as it is written. Under Michigan law, the actions of Defendant
GSK alleged in the complaint are protected from a lawsuit
because Defendant has complied with FDA regulations.
Id., at 1030.
Conversely, we were unable to find any state or federal cases
supporting Appellants’ reading of the statute.
After reviewing these cases within the context of the plain language of
the statute, we are inclined to agree with the federal courts’ determination
that the FDA “approval” required to trigger the application of immunity
under the MPLA does not need to be specific to the population utilizing the
approved drug.11 There is no language within the confines of the MPLA which
____________________________________________
11We recognize that with the exception of the United States Supreme Court,
we are not bound by a federal court decision. See NASDAQ OMX PHLX,
Inc. v. PennMont Secs., 52 A.3d 296, 303 (Pa. Super. 2012). However,
such decisions can be instructive in areas such as this where Pennsylvania
courts have not interpreted an out-of-state statute.
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suggests the Michigan legislature intended to limit this protection to drug
manufacturers when patients are prescribed the drug for its indicated uses.
Further, all of the Michigan case law that does refer to FDA approval
refers to the FDA approval of the drug, rather than FDA approval of a drug
for use in a specific population. See Taylor, 658 N.W.2d at 131 (“[A]
manufacturer or seller of a drug that has been approved by the FDA has an
absolute defense to a products liability claim….”) Thus, we conclude that as
long as a drug has received FDA approval, and its label is compliant with
FDA regulations, the MPLA applies to bar any product liability claim, despite
the drug’s indicated uses.
Through their complaints, Appellants concede Risperdal was initially
approved by the FDA in 1993. And, though Appellants dispute the accuracy
of Risperdal’s label, they do not dispute that the drug was labeled at all
times in compliance with the FDA regulations. Thus, Appellants’ contention
that the MPLA does not apply to their claims because Risperdal was not
“approved” for Appellants, fails.
Next, assuming the trial court correctly determined the MPLA applies
to these suits, Appellants maintain the trial court erred in granting summary
judgment due to genuine issues of material fact concerning the application
of the “fraud exception” to the MPLA’s blanket immunity for manufacturers.
Appellants’ Brief, at 30. Appellants assert the factual record contains issues
of material fact as to “(1) whether [Appellees] intentionally withheld or
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misrepresented information relating to the risk of gynecomastia associated
with Risperdal; and (2) whether the information was such that the drug
would not have been approved for pediatric use in October 2006.” Id., at
30-31.
Conversely, Appellees argue that because Appellants have not
presented evidence of an FDA finding of fraud, the “fraud-on-the-FDA”
exception to the MPLA has been preempted by federal law pursuant to the
Sixth Circuit’s decision in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d
961 (6th Cir. 2004). See Appellees’ Brief, at 17-22. In response to
Appellees’ claim, Appellants point, in their reply brief, to a conflicting case
from the Second Circuit, Desiano v. Warner-Lambert & Co., 467 F.3d 85(2d Cir. 2006), in which that court determined this particular exception is
not preempted by federal law. Appellees counter the Fifth Circuit in Lofton
v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 380
(5th Cir. 2012), found the Sixth’s Circuit’s preemption finding for the fraud
exception to the MPLA a more “faithful” reading of United States Supreme
Court precedent, while squarely rejecting the Second Circuit’s approach to
federal preemption in Desiano.
Once again, there is no guidance from the Michigan state courts
concerning the validity and application of this particular exception to the
MPLA. Further, we recognize the existence of a circuit split in relation to the
issue of federal preemption regarding this exception to the MPLA. However,
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we need not determine which circuit’s rationale and ultimate conclusion is in
line with Pennsylvania law because we agree with the trial court’s cogent
analysis on the application of the exception.
The trial court determined that
[f]or the purposes [] of this matter before th[e trial court], it is
immaterial whether Garcia or Desiano is applied, the result is the
same.[] Applying the law according to Garcia, the exception
contained within § 600.2946(5)(a) does not apply for two
reasons. First, there has not been a federal finding of fraud.[]
Second, even if there was a federal finding of fraud, [Appellants]
still have not produced any facts to satisfy their burden under §
600.2946(5)(a). Section 600.2946(5)(a) requires a plaintiff to
prove both intentional misrepresentation to the FDA and that
“the drug would not have been approved, or the [FDA] would
have withdrawn approval for the drug if the information were
accurately submitted.” Mich. Comp. Laws § 600.2946(5)(a).
[Appellants] have not produced any evidence to show the FDA
would not have approved Risperdal in 1993, or would have
withdrawn Risperdal from the market, if the information was
accurately submitted. Indeed, in response to a citizen’s petition,
the FDA recently declined to withdraw Risperdal from the
market, stating “based on review of clinical data submitted by
the sponsor, published literature, and postmarketing
surveillance, there is no evidence… that would warrant
revocation of the pediatric indication of [Risperdal].” FDA Citizen
Petition Docket No. FDA-2012-P-0857, Partial Petition Approval
and Denial Response Letter dated November 25, 2014 at p. 5. If
th[e trial court] applied the law according to Desiano, a federal
finding of fraud of the FDA is not required; however, [Appellants]
must still show that the FDA would not have approved, or would
have withdrawn approval for, Risperdal if the information was
accurately submitted. As discussed above, [Appellants] have not
provided any evidence to show Risperdal would not have been
approved in 1993, or the FDA would have withdrawn approval
for Risperdal, if the information was accurately submitted.
Trial Court Rule 1925(a) Opinion, 10/1/15, at 12-13.
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A review of the record reveals Appellants’ allegations of facts and
presentation of data to support their assertion that Appellees fraudulently
obtained FDA approval for Risperdal in relation to its approvals for
adolescents and children in 2006 and 2007. There is, however, an absence
in the record of any facts, or even argument, that Appellees fraudulently
obtained FDA approval for the first time in 1993.
As discussed previously, the MPLA indemnifies a drug manufacturer
once a drug had been approved by the FDA for any use, as long as the label
is compliant with FDA regulations. Thus, the proof of fraud a plaintiff is
required to present in order to receive the benefit of the fraud exception
must relate to the initial FDA approval. Further, as highlighted by the trial
court, Appellants cannot prove that the FDA, in receipt of the information
concerning the Risperdal/gynecomastia link, would have withdrawn it from
the market as the FDA had already explicitly declined to withdraw Risperdal
from the market for this reason.
Therefore, we cannot find any record support for Appellants’ assertion
there was a genuine issue of material fact relating to the application of this
exception.
Accordingly, the trial court did not abuse its discretion in determining
the fraud exception to the MPLA did not apply, leaving Appellees immune
from suit, and granting Appellees’ motion for summary judgment.
Appellants’ final issue merits no relief.
Judgments affirmed.
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Judgment Entered.
Joseph D. Seletyn, Esq.
Prothonotary
Date: 11/28/2017
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