J-A27025-16

2017 PA Super 375

IN RE: RISPERDAL LITIGATION 

MA.J.L. AND M.L. 

Appellants

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 577 EDA 2015

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 

A.H., JR. AND A.H. 

Appellants

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

ABD JANSSEN REESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 578 EDA 2015

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 

DANIEL BREWER 

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA
J-A27025-16

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Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 No. 579 EDA 2015

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 

D.A. AND B.A. 

Appellants

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 580 EDA 2015

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 

K.S., AND SARAH LABADIE 

Appellants

v.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 581 EDA 2015
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JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

JANSSEN RESEARCH AND 

DEVELOPMENT LLC.

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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 

MATTHEW LANTHIER 

Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

JANSSEN RESEACH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 582 EDA 2015

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 

MITCHELL LINDBERG 

Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 583 EDA 2015
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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 

MI.J.L. AND M.L. 

Appellants

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY,

AND JANSSEN RESEACH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 584 EDA 2015

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 

ERIK RIGGS 

Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 585 EDA 2015

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 

SCOTT WISNIEWSKI 

Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 586 EDA 2015

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 

NATHAN ZACHAR 

Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 587 EDA 2015

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 

DANNY WOODCOCK 

Appellant

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA
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v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 No. 588 EDA 2015

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 

CORTEZ MULLEN 

Appellant

v.

JANSSEN PHARMACEUTICALS, INC., 

JOHNSON & JOHNSON COMPANY, 

AND JANSSEN RESEARCH AND 

DEVELOPMENT, LLC.

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 IN THE SUPERIOR COURT OF

 PENNSYLVANIA

 No. 589 EDA 2015

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

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 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 

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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.2In 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

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2 Merriam-Webster’s online dictionary defines gynecomastia as “excessive 

development of the breast in the male.” Available at http://merriamwebster.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. 

4 See 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 

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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. 

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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 

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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 

____________________________________________

11 We 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