Bergman v. Johnson & Johnson

U.S. District Court, District of Minnesota

Bergman v. Johnson & Johnson

Trial Court Opinion

                   UNITED STATES DISTRICT COURT                          
                      DISTRICT OF MINNESOTA                              


SARAH BERGMAN, KEN BERGMAN,                                              
PATRICIA BUDNIK, and ANTHONY          Civil No.  20-2693 (JRT/HB)        
BUDNIK,                                                                  



                       Plaintiffs,                                       


                                 MEMORANDUM OPINION AND ORDER            
v.                                                                       
                                 GRANTING DEFENDANTS’ MOTION FOR         

                                        PARTIAL DISMISSAL                
JOHNSON & JOHNSON and ETHICON,                                           

INC.,                                                                    

                      Defendants.                                        

    Andrew Feldman and Jacob A. Flint, FLINT LAW FIRM LLC, 222 East Park 
    Street,  Suite  500,  P.O.  Box  189,  Edwardsville,  IL  62034;  and  David  E. 
    Scouton, THIBODEAU JOHNSON & FERIANCEK PLLP, 302 West Superior       
    Street, Suite 800, Duluth, MN 55802, for plaintiffs.                 

    Tracy J. Van Steenburgh and Brandie  L.  Morgenroth,  NILAN JOHNSON  
    LEWIS  PA,  250  Marquette  Avenue  South,  Suite  800,  Minneapolis,  MN 
    55401, for defendants.                                               


    Plaintiffs  brought  a  products  liability  action  asserting  myriad  claims  against 
Defendants Johnson & Johnson and Ethicon for injuries allegedly caused by Defendants’ 
pelvic  mesh  products.    Defendants  have  moved  to  dismiss,  in  part,  Plaintiffs’  First 
Amended Complaint (“FAC”), arguing that all claims except those premised on failure to 
warn are either insufficiently pleaded or not cognizable.  Because Plaintiffs have failed to 
include  foundational  factual  allegations  and  because  most  of  their  claims  are  not 
recognized under Minnesota law, the Court will grant Defendants’ Motion for Partial 
Dismissal and dismiss all claims except for Plaintiffs’ failure to warn claims and the 

derivative claim for loss of consortium.                                  
                          BACKGROUND                                     

I.   FACTUAL BACKGROUND                                                   
    On November 17, 2003, Sarah Bergman had a procedure to implant pelvic mesh 
products.   (FAC ¶ 2,  Mar. 19, 2021,  Docket No. 18.)   She subsequently developed 
complications arising from the implanted pelvic mesh products, which required implant 

removal  and  allegedly  led  to  urinary  tract  infections,  pelvic  pressure  and  pain, 
dyspareunia, incomplete voiding, urgency, frequency, and nocturia.  (Id. ¶ 3.)   
    On May 7, 2008, Patricia Budnik had a procedure to implant a pelvic mesh product.  

(Id. ¶ 6.)  She subsequently developed complications arising from the pelvic mesh, which 
necessitated removal and allegedly led to complications, including pelvic pain, bleeding, 
urinary tract infections, and dyspareunia.  (Id. ¶ 7.)                    
    Defendant Ethicon, Inc. (“Ethicon”) is a wholly owned subsidiary of Defendant 

Johnson & Johnson (“J&J”).  (Id. ¶ 11.)  Ethicon is part of J&J’s Ethicon Franchise business 
unit, which was charged with the design, development, marketing, and distribution of 
pelvic mesh products.  (Id. ¶ 10.)  Surgical mesh has been used to treat pelvic organ 
prolapse (“POP”) and stress urinary incontinence (“SUI”) since the 1990s.  (Id. ¶ 26.)  

Defendants manufactured three pelvic mesh products—TVT, Gynemesh PS, and Prolift—
for women suffering from POP and SUI.  (Id. ¶ 28.)  Defendants’ pelvic mesh products are 
comprised of non-absorbable, synthetic, monofilament polypropylene mesh or collagen.  

(Id. ¶ 29.)  The FDA cleared the first pelvic mesh products for use in treatment of POP in 
2002, including Gynemesh PS and Prolift, and Defendants obtained FDA approval of their 
products at various times thereafter.  (Id. ¶ 37.)  However, the approval process did not 
require Defendants to prove the safety or efficacy of the products, so a safety review was 

never conducted.  (Id. ¶ 37.)                                             
    Defendants marketed the pelvic mesh products to the medical community and 
directly to patients as safe, effective, and minimally invasive, (id. ¶ 38), but Plaintiffs allege 

that, at all relevant times, Defendants were aware of or had actual knowledge that 
polypropylene mesh is biologically incompatible with human tissue and promotes an 
immune response that contributes to adverse reactions, (id. ¶¶ 31–32.)  Plaintiffs allege 
that Defendants withheld or misrepresented this information to Plaintiffs and withheld 

known information that collagen causes hyper-inflammatory responses, pain,  and a 
hardening of bodily tissue.  (Id. ¶¶ 31–34.)                              
    On October 20, 2008, the FDA issued a Public Health Notification describing more 
than  1000  complaints  or  adverse  events  related  to  TVT,  Gynemesh  PS,  and  Prolift 

products over the course of three years.  (Id. ¶ 43.)  The FDA issued a new warning and 
publication regarding serious complications on July 31, 2011, stating that complications 
associated with use of pelvic mesh for POP treatment are not rare and that benefits of 
using the products did not outweigh the risks.  (Id. ¶¶ 45–50.)  On April 16, 2019, the FDA 
ordered all POP device manufacturers to stop selling and distributing POP products.  (Id. 

¶ 57.)  Plaintiffs allege that the risks associated with SUI repair are the same as for POP 
repair even though the data is less developed.  (Id. ¶ 54.)               
    Plaintiffs allege that Defendants knew or should have known the pelvic mesh 
products unreasonably exposed patients to risk of serious harm while conferring no 

benefit over feasible alternatives, (id. ¶ 58), yet suppressed this information and failed to 
inform the FDA, health care providers, and patients, thus actively misleading the public, 
(id. ¶ 62.)  Plaintiffs also allege that Defendants failed to adequately test the products and 

failed to design a safe procedure for removal of the pelvic mesh products, and that an 
alternative design and procedures exist. (Id. ¶¶ 63–65.)                  

II.  PROCEDURAL HISTORY                                                   
    Plaintiffs initiated this action on December 30, 2020, (Compl., Dec. 30, 2020, 
Docket No. 1), and filed the operative First Amended Complaint on March 19, 2021.  
Plaintiffs justify the joinder of their claims pursuant to Federal Rule of Civil Procedure 20, 

on grounds that they were injured in the same transaction, occurrence, or series of 
transactions or occurrences because they were both implanted with the same pelvic mesh 
products.  (Id. ¶¶ 16–18.)  Plaintiffs also contend that the similarities of their claims and 
the  fact  that  general  discovery  has  concluded  in  the  related  multidistrict  litigation 

outweigh any case-specific differences between Plaintiffs.  (Id. ¶ 20.)   
    Plaintiffs assert fourteen claims: negligence (Count I); strict liability – design defect 
(Count II); strict liability – manufacturing defect (Count III); gross negligence (Count IV); 

negligent infliction of emotional distress (Count V); strict liability – failure to warn (Count 
VI); breach of warranty (Count VII); fraudulent concealment (Count VIII); constructive 
fraud (Count IX); common law fraud (Count X); negligent misrepresentation (Count XI); 
unjust enrichment (Count XII); loss of consortium (Count XIII); and punitive damages 

(Count XIV).  (Id. ¶¶ 83–291.)                                            
    On April 16, 2021, Defendants filed a Motion for Partial Dismissal, excluding the 
failure to warn claim (Count VI) and other claims that are premised on a failure to warn.1  

(Mot. Partial Dismiss, Apr. 16, 2021, Docket No. 22.)                     
                           DISCUSSION                                    

I.   STANDARD OF REVIEW                                                   
    In reviewing a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the 
Court considers all facts alleged in the complaint as true to determine if the complaint 
states a “claim to relief that is plausible on its face.”  Braden v. Wal-Mart Stores, Inc., 
588 F.3d 585, 594
 (8th Cir. 2009) (quoting Ashcroft v. Iqbal, 
556 U.S. 662, 678
 (2009)).  “A claim 
has facial plausibility when the plaintiff pleads factual content that allows the court to 



1 Earlier, Defendants filed a Motion to Dismiss in regard to the initial complaint.  (Mot. Dismiss, 
Mar. 12, 2021, Docket No. 13.)  As this Motion lost effect once Plaintiffs filed the FAC, the Court 
will deny it as moot.                                                     
draw the reasonable inference that the defendant is liable for the misconduct alleged.”  
Iqbal, 
556 U.S. at 678
.  Although the Court accepts the complaint’s factual allegations as 

true and construes the complaint in a light most favorable to the plaintiff, it is “not bound 
to accept as true a legal conclusion couched as a factual allegation.”  Papasan v. Allain, 
478 U.S. 265, 286
 (1986).  In other words, a complaint “does not need detailed factual 
allegations”  but  must  include  more  “than  labels  and  conclusions,  and  a  formulaic 

recitation of the elements” to meet the plausibility standard.  Bell Atl. Corp. v. Twombly, 
550 U.S. 544, 555
 (2007).                                                 

II.  ANALYSIS                                                             
    Defendants have moved to dismiss all counts except those claims predicated on a 
failure to warn theory.  Failure to warn allegations are included in Counts I and VI, for 

negligence and strict liability, respectively.  Count VI, for strict liability failure to warn, 
survives the Motion in full.  Count I for negligence survives the Motion only insofar as 
Plaintiffs  have  alleged  a  negligent  failure  to  warn;  the  other  types  of  negligence 
encompassed in that claim—design defect and manufacturing defect—will be dismissed.  

Because Defendants have not moved to dismiss the failure to warn claims, the claim for 
loss of consortium will also survive the Motion, as it is related to the failure to warn claims.  
See Kaplan v. Mayo Clinic, 
947 F. Supp. 2d 1001, 1011
 (D. Minn. 2013).  The Court will 
dismiss the remaining claims for failure to state a claim pursuant to Rule 12(b)(6), as 

explained below.                                                          
    A.   Strict Liability – Design Defect                                
    To prevail on a strict liability design defect claim under Minnesota law, a plaintiff 

must prove (1) the products were in a defective condition unreasonably dangerous for 
their intended use; (2) the defect existed when the product left the manufacturer’s 
control; and (3) the defect was the proximate cause of the injury sustained.  Green Plains 
Otter Tail, LLC v. Pro-Envtl., Inc., 
953 F. 3d 541
, 545–46 (8th Cir. 2020).  The parties dispute 

whether Plaintiffs have sufficiently alleged the third element in regard to both causation 
and injury.                                                               
    The FAC lacks basic details about Plaintiffs’ alleged injuries, such as when their 

injuries  were  discovered,  or  locations  or  dates  about  the  revision  procedures  that 
Plaintiffs allegedly underwent to address the injuries.  Plaintiffs have alleged numerous 
design defects, but those defect allegations are not accompanied by allegations regarding 
how any of the defects caused the alleged injuries.  As such, the allegations in the FAC are 

insufficiently sparse because the FAC lacks factual allegations specific to Plaintiffs and 
their alleged injuries.  Accord Dolan v. Boston Sci. Corp., No. 20-1827, 
2021 WL 698777
, 
at *2 (D. Minn. Feb. 23, 2021).                                           
    Plaintiffs contend that their claims could proceed under a theory of res ipsa 

loquitor, which permits plaintiffs to prove products liability claims based on circumstantial 
evidence when it can be inferred that a plaintiff would not have been injured absent a 
defect in the product.  See Holkestad v. Coca-Cola Bottling Co. of Minn., Inc., 
180 N.W.2d 860
, 865–66 (Minn. 1970).  However, the FAC deficiencies are not limited to allegations 
about the product defects, but rather lack detail even regarding Plaintiffs’ injuries—

information that Plaintiffs should have access to themselves.  The FAC merely rattles off 
a number of conditions the Plaintiffs developed at unspecified times and of unspecified 
severity, without any details about the treatment sought or any other facts that support 
an inference that Plaintiffs were injured because of Defendant’s pelvic mesh products.  As 

such, the Court finds that res ipsa loquitor cannot salvage Plaintiffs’ design defect claim 
and will grant Defendants’ Motion as to Count II.                         

    B.   Strict Liability – Manufacturing Defect                         
    A manufacturing defect claim comprises the same three elements as a design 
defect claim, but the defect arises from a discrepancy between the design and the actual 

manufactured product, whereas in design defect cases the product is in the condition 
intended by the manufacturer but the chosen design is defective.  See, e.g., Bilotta v. 
Kelley Co., Inc., 
346 N.W.2d 616, 622
 (Minn. 1984).  Plaintiffs have not alleged how the 
products they received deviated from a correctly-manufactured version of Defendants’ 

pelvic mesh products—or even that they deviated at all.  Manufacturing defect claims 
depend on a “manufacturing flaw—some deviation from a flawless product—that renders 
a product unreasonably dangerous.” Kapps v. Biosense Webster, Inc., 
813 F. Supp. 2d 1128, 1147
 (D. Minn. 2011).  Plaintiffs have alleged that the product was unreasonably 

dangerous, but have not alleged a deviation from a flawless version.  Thus, they fail to 
state a claim for manufacturing defect, and the Court will grant Defendants’ Motion as to 
Count III.                                                                

    C.   Negligence Claims                                               
    As stated at the outset, the failure to warn aspect of Count I for negligence is not 

subject to Defendants’ Motion and will not be dismissed.  However, Count I also includes 
negligence-based design defect and manufacturing defect theories.  Under Minnesota 
law,  “the  distinction  between  theories  of  strict  liability  and  negligence  is  typically 
insignificant.”  
Id. at 1146
.  Although strict liability imposes liability without proof of 

negligence, “in many  cases proof  of a defect may simply be a  substitute  word for 
negligence.”  Lee v. Crookston Coca-Cola Bottling Co., 
188 N.W.2d 426, 432
 (1971).  
Because Plaintiffs have failed to sufficiently allege causation and injury for strict liability 

design defect, their negligent design defect claim likewise fails to state a claim.  Further, 
their failure to allege a manufacturing flaw for the strict liability manufacturing defect 
claim is equally fatal to the negligent manufacturing defect claim.  The Court will therefore 
grant Defendants’ Motion as to Count I insofar as it is premised on negligent design and 

manufacturing defect theories.                                            
    Plaintiffs have pleaded several other negligence-based claims, none of which are 
sufficient to state a claim on which relief can be granted.  First, Count IV for gross 
negligence will be dismissed because under Minnesota law, “a claim for gross negligence 

is not recognized as a distinct cause of action, separate from a cause of action from 
ordinary negligence.”  See Doub v. Life Time Fitness, Inc., No. A17-0322, 
2017 WL 4341814
, 
at *4 (Minn. Ct. App. Oct. 2, 2017); see also Peet v. Roth Hotel Co., 
253 N.W. 546, 548
 

(Minn. 1934) (“The doctrine that there are three degrees of negligence—slight, ordinary, 
and gross—does not prevail in this state.”).                              
    Second, Plaintiffs’ claim for negligent infliction of emotional distress (“NIED”) 
requires proving negligence plus three elements: that a plaintiff “(1) was within the zone 

of danger of physical impact created by the defendant’s negligence; (2) reasonably feared 
for  their  own  safety;  and  (3)  consequently  suffered  severe  emotional  distress  with 
attendant physical manifestations.”  Engler v. Illinois Farmers Ins. Co., 
706 N.W. 2d 764, 767
 (Minn. 2005) (cleaned up).  Under Minnesota law, the zone of danger test for NIED 
requires that a plaintiff was clearly in grave personal peril for some defined period of time, 
a standard which products liability cases such as this one are hard-pressed to satisfy.  See 
Masepohl v. Am. Tobacco Co., 
974 F. Supp. 1245, 1252
 (D. Minn. 1997).  Plaintiffs have 

not pleaded factual allegations supporting an inference that they were in a zone of danger 
related to the pelvic mesh products.  Additionally, emotional distress must meet a high 
standard to qualify as severe under the NIED elements.  See, e.g., Hubbard v. United Press 
Int’l Inc., 
330 N.W.2d 428, 440
 (Minn. 1983).  Plaintiffs’ allegations about their emotional 

distress lack specificity and are conclusory and merely consistent with liability for NIED.  
The Court therefore finds that Plaintiffs have failed to state a claim for NIED and will grant 
Defendants’ Motion as to Count V.                                         
    Third, Plaintiffs have alleged liability for negligent misrepresentation.  Negligent 
misrepresentation claims are subject to the pleading standard of Rule 9(b), which requires 

a plaintiff to plead “such facts as the time, place, and content of the defendant’s false 
representations, as well as the details of the defendant’s fraudulent acts, including when 
the acts occurred, who engaged in them, and what was obtained as a result.”  United 
States ex rel. Joshi v. St. Luke’s Hosp., Inc., 
441 F.3d 552, 556
 (8th Cir. 2006).  The FAC is 

devoid of nearly any specifics about the “who, what, where, why, and how” of the alleged 
misrepresentation and it therefore falls short of the heightened pleading requirements 
under Rule 9(b).  See id.; see also BJC Health Sys. v. Columbia Cas. Co., 
478 F.3d 908, 917
 
(8th Cir. 2007) (“Conclusory allegations that a defendant’s conduct was fraudulent and 

deceptive are not sufficient to satisfy the rule.”).  Moreover, Minnesota courts have not 
recognized negligent misrepresentation as a viable theory of recovery for physical harm, 
instead suggesting that negligent misrepresentation is limited to commercial or business 

transactions resulting in pecuniary damages.  See Forslund, 
2010 WL 3905854
, at *6.  As 
such,  the  Court  finds  that  Plaintiffs  have  not  stated  a  claim  for  negligent 
misrepresentation under Minnesota law and will therefore grant Defendants’ Motion as 
to Count XI.                                                              

    D.   Fraud                                                           
    Plaintiffs assert three other fraud-based claims—fraudulent concealment (Count 

VIII), constructive fraud (Count IX), common law fraud (Count X)—all of which also must 
be pleaded with particularity.  See Tuttle v. Lorillard Tobacco Co., 
118 F. Supp. 2d 954, 963
 
(D. Minn. 2000) (stating that heightened pleading requirements under Rule 9(b) apply 

when the gravamen of the complaint is fraud).  However, in some cases, the standard 
might be relaxed: “[w]hen the facts constituting the fraud are peculiarly within the 
opposing party’s knowledge . . . such allegations may be pleaded on information and 
belief.  Claims pleaded on information and belief are sufficient under Rule 9(b) if they are 

accompanied by a statement of the facts on which the belief is based.”  Select Comfort 
Corp. V. Sleep Better Store, LLC, 
796 F. Supp. 2d 981, 985
 (D. Minn. June 17, 2011) 
(quotation and citations omitted).                                        

    Plaintiffs assert that a relaxed standard should be applied in this case because 
information about the alleged fraud was within Defendants’ exclusive control, it occurred 
over an extended period of time, and it consisted of numerous acts.  Yet, Plaintiffs admit 
that they “have substantial prediscovery evidence—much of which was obtained from 

the discovery already concluded in the underlying [multidistrict litigation].”  (Mem. Opp. 
Mot. Partial Dismissal at 13, Apr. 28, 2021, Docket No.26.)  Even if there are some details 
about the nature of the fraud that Plaintiffs should not be expected to know at this point, 
the FAC lacks specifics about the “who, what, where, why, and how” of the Defendants’ 

alleged fraud as it relates to the Plaintiffs injuries, despite Plaintiffs admittedly being privy 
to pre-discovery evidence, and Plaintiffs’ allegations that the misrepresentations were 
made to them, their physicians, and the public at large.  Thus, it cannot plausibly be said 
that the facts are “peculiarly within the opposing party’s knowledge,” and Plaintiffs have 
not sufficiently pleaded their fraud claims in light of the circumstances.  The Court will 

therefore grant Defendants’ Motion as to Counts VIII–X.                   
    E.   Breach of Warranty                                              

    Plaintiffs represent that their warranty claim is based on breach of both express 
and implied warranties.  Under Minnesota law, however, claims for breach of implied 
warranty are preempted by strict liability claims where personal injuries are at issue.  
Masepohl, 
974 F. Supp. at 1253
.  The Court therefore only decides whether Plaintiffs have 

adequately pleaded their claim for breach of express warranty.            
    To establish such a claim, “the plaintiff ordinarily must establish that the seller 
made an express, affirmative promise about the qualities of the product.”  Leedahl v. 

Rayco Mfg., Inc., No. 06-310, 
2006 WL 1662959
, at *4 (D. Minn. May 15, 2006) (citations 
omitted).  Additionally, Minnesota statute provides that a breach of warranty claim must 
be brought within four years of when the action has accrued.  
Minn. Stat. § 336.2-725
(1).  
“A breach of warranty occurs when tender of delivery is made, except that where a 

warranty explicitly extends to future performance of the goods and discovery of the 
breach must await the time of such performance the cause of action accrues when the 
breach is or should have been discovered.”  
Id.
 § 336.2-725(2).           
    Plaintiffs had the pelvic mesh implanted more than four years before initiation of 

this action: Bergman underwent her procedure in 2003 and Budnik in 2008, and the action 
is deemed initiated as of February 23, 2017.2  Plaintiffs argue that Defendants warranted 
future performance such that the statute of limitations should be tolled.  However, 

Plaintiffs have not alleged any specifics about Defendants’ express warranties such as the 
format, timing, or language used.  Without more specific allegations of what Defendants 
warranted to Plaintiffs, the Court cannot toll the statute of limitations or conclude that 
Plaintiffs have pleaded factual allegations above a conclusory level.  The Court therefore 

finds that Plaintiffs have failed to state a claim for breach of express warranty and will 
grant Defendants’ Motion as to Count VII.                                 

    F.   Unjust Enrichment                                               
    Plaintiffs assert a claim of unjust enrichment in the alternative to legal remedies 
sought.  In Minnesota, courts allow simultaneous pleading of legal claims and unjust 

enrichment claims under Rule 8(d), see, e.g., Daigle v. Ford Motor Co., 
713 F. Supp. 2d 822, 828
 (D. Minn. 2010), but unjust enrichment is limited to claims premised on “an 
implied or quasi-contract in which the defendant received a benefit of value that unjustly 
enriched the defendant in a manner that is illegal or unlawful,” Caldas v. Affordable 

Granite & Stone, Inc., 
820 N.W.2d 826, 838
 (Minn. 2012).  Plaintiffs have not pleaded 




2 The action was initiated on December 30, 2020, but Defendants state that “pursuant to a private 
agreement between the parties, their suit is deemed filed as of February 23, 2017.”  (Mem. Supp. 
Mot. Partial Dismiss at 12, Apr. 16, 2021, Docket No. 23.)                
allegations that sound in quasi-contract, but only in tort.  As such, the Court will deny the 
claim for unjust enrichment and will grant Defendants’ Motion as to Count XII.   

    G.   Punitive Damages                                                
    Minnesota law provides that punitive damages are available “upon clear and 

convincing evidence that the acts of the defendant show deliberate disregard for the 
rights or safety of others.”  
Minn. Stat. § 549.20
, subd. 1(a).  Punitive damages are a 
derivative claim like loss of consortium, see Hern v. Bankers Life Cas. Co., 
133 F. Supp. 2d 1130, 1139
 (D. Minn. 2001), but Defendants seek dismissal of the punitive damages claim 

in full because Plaintiffs have violated the procedural requirements to seek punitive 
damages under Minnesota law.                                              
    Minnesota Statutes § 549.191 provides that a complaint must not seek punitive 

damages; instead, a party must later move to amend the pleadings to claim punitive 
damages, which a court shall grant if it finds prima facie evidence in support of the 
motion.  
Minn. Stat. § 549.191
.  The relationship between § 549.191 and Federal Rule of 
Civil Procedure 15, which provides that a court should freely give leave to amend when 

proposed  claims  are  plausible,  has  recently  evolved  in  the  District  of  Minnesota, 
specifically as to whether § 549.191’s prima facie standard or Rule 15’s plausibility 
standard applies.  See, e.g., Shank v. Carleton Coll., 
329 F.R.D. 610
, 612 (D. Minn. 2019).  
As there is no motion to amend or proposed amended complaint at issue in the present 

matter, the issue of which standard the Court would apply to determine whether a 
plaintiff may seek punitive damages is irrelevant.  Plaintiffs have never filed a motion to 
amend; they have improperly included punitive damages from the outset.  See Clancy v. 

Vacationaire Ests., Inc., No. 18-2249, 
2019 WL 955113
, at *11 (D. Minn. Feb. 27, 2019).  
The Court therefore grants Defendants’ Motion with respect to punitive damages at this 
time.  Should Plaintiffs later file a motion for leave to amend to add a punitive damages 
claim, the Court will examine the sufficiency of the allegations and support for punitive 

damages then.                                                             

ORDER

    Based on the foregoing, and all the files, records, and proceedings herein, IT IS 
HEREBY ORDERED that:                                                      
    1.  Defendants’ Motion to Dismiss [Docket No. 13] is DENIED as moot;  

    2.  Defendants’ Motion for Partial Dismissal [Docket No. 22] is GRANTED, in part, 
      as follows:                                                        
         a.  Count I Negligence is DISMISSED without prejudice with respect to 
           design  defect  and  manufacturing  defect,  but  NOT  DISMISSED  with 

           respect to failure to warn;                                   
         b.  Count II Strict Liability – Design Defect is DISMISSED without prejudice;  
         c.  Count III Strict Liability – Manufacturing Defect is DISMISSED without 
           prejudice;                                                    

         d.  Count IV Gross Negligence is DISMISSED without prejudice;   
     e.  Count V Negligent Infliction of Emotional Distress is DISMISSED without 
        prejudice; 
     f.   Count VI Strict Liability — Failure to Warn is NOT DISMISSED; 
     g.  Count VII Breach of Warranty is DISMISSED without prejudice; 
     h.  Count VIII Fraudulent Concealment is DISMISSED without prejudice; 
     i.   Count IX Constructive Fraud is DISMISSED without prejudice; 
    j.   Count X Common Law Fraud is DISMISSED without prejudice; 
     k.  Count XI Negligent Misrepresentation is DISMISSED without prejudice; 
     |.   Count XII Unjust Enrichment is DISMISSED without prejudice; 
     m.  Count XIII Loss of Consortium is NOT DISMISSED; and 

     n.  Count XIV Punitive Damages is DISMISSED without prejudice. 

DATED:  August 13, 2021                     Toa   (ashen 
at Minneapolis, Minnesota.                   JOHN R. TUNHEIM 
                                             Chief Judge 
                                      United States District Court 

                              -17- 

Trial Court Opinion

                   UNITED STATES DISTRICT COURT                          
                      DISTRICT OF MINNESOTA                              


SARAH BERGMAN, KEN BERGMAN,                                              
PATRICIA BUDNIK, and ANTHONY          Civil No.  20-2693 (JRT/HB)        
BUDNIK,                                                                  



                       Plaintiffs,                                       


                                 MEMORANDUM OPINION AND ORDER            
v.                                                                       
                                 GRANTING DEFENDANTS’ MOTION FOR         

                                        PARTIAL DISMISSAL                
JOHNSON & JOHNSON and ETHICON,                                           

INC.,                                                                    

                      Defendants.                                        

    Andrew Feldman and Jacob A. Flint, FLINT LAW FIRM LLC, 222 East Park 
    Street,  Suite  500,  P.O.  Box  189,  Edwardsville,  IL  62034;  and  David  E. 
    Scouton, THIBODEAU JOHNSON & FERIANCEK PLLP, 302 West Superior       
    Street, Suite 800, Duluth, MN 55802, for plaintiffs.                 

    Tracy J. Van Steenburgh and Brandie  L.  Morgenroth,  NILAN JOHNSON  
    LEWIS  PA,  250  Marquette  Avenue  South,  Suite  800,  Minneapolis,  MN 
    55401, for defendants.                                               


    Plaintiffs  brought  a  products  liability  action  asserting  myriad  claims  against 
Defendants Johnson & Johnson and Ethicon for injuries allegedly caused by Defendants’ 
pelvic  mesh  products.    Defendants  have  moved  to  dismiss,  in  part,  Plaintiffs’  First 
Amended Complaint (“FAC”), arguing that all claims except those premised on failure to 
warn are either insufficiently pleaded or not cognizable.  Because Plaintiffs have failed to 
include  foundational  factual  allegations  and  because  most  of  their  claims  are  not 
recognized under Minnesota law, the Court will grant Defendants’ Motion for Partial 
Dismissal and dismiss all claims except for Plaintiffs’ failure to warn claims and the 

derivative claim for loss of consortium.                                  
                          BACKGROUND                                     

I.   FACTUAL BACKGROUND                                                   
    On November 17, 2003, Sarah Bergman had a procedure to implant pelvic mesh 
products.   (FAC ¶ 2,  Mar. 19, 2021,  Docket No. 18.)   She subsequently developed 
complications arising from the implanted pelvic mesh products, which required implant 

removal  and  allegedly  led  to  urinary  tract  infections,  pelvic  pressure  and  pain, 
dyspareunia, incomplete voiding, urgency, frequency, and nocturia.  (Id. ¶ 3.)   
    On May 7, 2008, Patricia Budnik had a procedure to implant a pelvic mesh product.  

(Id. ¶ 6.)  She subsequently developed complications arising from the pelvic mesh, which 
necessitated removal and allegedly led to complications, including pelvic pain, bleeding, 
urinary tract infections, and dyspareunia.  (Id. ¶ 7.)                    
    Defendant Ethicon, Inc. (“Ethicon”) is a wholly owned subsidiary of Defendant 

Johnson & Johnson (“J&J”).  (Id. ¶ 11.)  Ethicon is part of J&J’s Ethicon Franchise business 
unit, which was charged with the design, development, marketing, and distribution of 
pelvic mesh products.  (Id. ¶ 10.)  Surgical mesh has been used to treat pelvic organ 
prolapse (“POP”) and stress urinary incontinence (“SUI”) since the 1990s.  (Id. ¶ 26.)  

Defendants manufactured three pelvic mesh products—TVT, Gynemesh PS, and Prolift—
for women suffering from POP and SUI.  (Id. ¶ 28.)  Defendants’ pelvic mesh products are 
comprised of non-absorbable, synthetic, monofilament polypropylene mesh or collagen.  

(Id. ¶ 29.)  The FDA cleared the first pelvic mesh products for use in treatment of POP in 
2002, including Gynemesh PS and Prolift, and Defendants obtained FDA approval of their 
products at various times thereafter.  (Id. ¶ 37.)  However, the approval process did not 
require Defendants to prove the safety or efficacy of the products, so a safety review was 

never conducted.  (Id. ¶ 37.)                                             
    Defendants marketed the pelvic mesh products to the medical community and 
directly to patients as safe, effective, and minimally invasive, (id. ¶ 38), but Plaintiffs allege 

that, at all relevant times, Defendants were aware of or had actual knowledge that 
polypropylene mesh is biologically incompatible with human tissue and promotes an 
immune response that contributes to adverse reactions, (id. ¶¶ 31–32.)  Plaintiffs allege 
that Defendants withheld or misrepresented this information to Plaintiffs and withheld 

known information that collagen causes hyper-inflammatory responses, pain,  and a 
hardening of bodily tissue.  (Id. ¶¶ 31–34.)                              
    On October 20, 2008, the FDA issued a Public Health Notification describing more 
than  1000  complaints  or  adverse  events  related  to  TVT,  Gynemesh  PS,  and  Prolift 

products over the course of three years.  (Id. ¶ 43.)  The FDA issued a new warning and 
publication regarding serious complications on July 31, 2011, stating that complications 
associated with use of pelvic mesh for POP treatment are not rare and that benefits of 
using the products did not outweigh the risks.  (Id. ¶¶ 45–50.)  On April 16, 2019, the FDA 
ordered all POP device manufacturers to stop selling and distributing POP products.  (Id. 

¶ 57.)  Plaintiffs allege that the risks associated with SUI repair are the same as for POP 
repair even though the data is less developed.  (Id. ¶ 54.)               
    Plaintiffs allege that Defendants knew or should have known the pelvic mesh 
products unreasonably exposed patients to risk of serious harm while conferring no 

benefit over feasible alternatives, (id. ¶ 58), yet suppressed this information and failed to 
inform the FDA, health care providers, and patients, thus actively misleading the public, 
(id. ¶ 62.)  Plaintiffs also allege that Defendants failed to adequately test the products and 

failed to design a safe procedure for removal of the pelvic mesh products, and that an 
alternative design and procedures exist. (Id. ¶¶ 63–65.)                  

II.  PROCEDURAL HISTORY                                                   
    Plaintiffs initiated this action on December 30, 2020, (Compl., Dec. 30, 2020, 
Docket No. 1), and filed the operative First Amended Complaint on March 19, 2021.  
Plaintiffs justify the joinder of their claims pursuant to Federal Rule of Civil Procedure 20, 

on grounds that they were injured in the same transaction, occurrence, or series of 
transactions or occurrences because they were both implanted with the same pelvic mesh 
products.  (Id. ¶¶ 16–18.)  Plaintiffs also contend that the similarities of their claims and 
the  fact  that  general  discovery  has  concluded  in  the  related  multidistrict  litigation 

outweigh any case-specific differences between Plaintiffs.  (Id. ¶ 20.)   
    Plaintiffs assert fourteen claims: negligence (Count I); strict liability – design defect 
(Count II); strict liability – manufacturing defect (Count III); gross negligence (Count IV); 

negligent infliction of emotional distress (Count V); strict liability – failure to warn (Count 
VI); breach of warranty (Count VII); fraudulent concealment (Count VIII); constructive 
fraud (Count IX); common law fraud (Count X); negligent misrepresentation (Count XI); 
unjust enrichment (Count XII); loss of consortium (Count XIII); and punitive damages 

(Count XIV).  (Id. ¶¶ 83–291.)                                            
    On April 16, 2021, Defendants filed a Motion for Partial Dismissal, excluding the 
failure to warn claim (Count VI) and other claims that are premised on a failure to warn.1  

(Mot. Partial Dismiss, Apr. 16, 2021, Docket No. 22.)                     
                           DISCUSSION                                    

I.   STANDARD OF REVIEW                                                   
    In reviewing a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the 
Court considers all facts alleged in the complaint as true to determine if the complaint 
states a “claim to relief that is plausible on its face.”  Braden v. Wal-Mart Stores, Inc., 
588 F.3d 585, 594
 (8th Cir. 2009) (quoting Ashcroft v. Iqbal, 
556 U.S. 662, 678
 (2009)).  “A claim 
has facial plausibility when the plaintiff pleads factual content that allows the court to 



1 Earlier, Defendants filed a Motion to Dismiss in regard to the initial complaint.  (Mot. Dismiss, 
Mar. 12, 2021, Docket No. 13.)  As this Motion lost effect once Plaintiffs filed the FAC, the Court 
will deny it as moot.                                                     
draw the reasonable inference that the defendant is liable for the misconduct alleged.”  
Iqbal, 
556 U.S. at 678
.  Although the Court accepts the complaint’s factual allegations as 

true and construes the complaint in a light most favorable to the plaintiff, it is “not bound 
to accept as true a legal conclusion couched as a factual allegation.”  Papasan v. Allain, 
478 U.S. 265, 286
 (1986).  In other words, a complaint “does not need detailed factual 
allegations”  but  must  include  more  “than  labels  and  conclusions,  and  a  formulaic 

recitation of the elements” to meet the plausibility standard.  Bell Atl. Corp. v. Twombly, 
550 U.S. 544, 555
 (2007).                                                 

II.  ANALYSIS                                                             
    Defendants have moved to dismiss all counts except those claims predicated on a 
failure to warn theory.  Failure to warn allegations are included in Counts I and VI, for 

negligence and strict liability, respectively.  Count VI, for strict liability failure to warn, 
survives the Motion in full.  Count I for negligence survives the Motion only insofar as 
Plaintiffs  have  alleged  a  negligent  failure  to  warn;  the  other  types  of  negligence 
encompassed in that claim—design defect and manufacturing defect—will be dismissed.  

Because Defendants have not moved to dismiss the failure to warn claims, the claim for 
loss of consortium will also survive the Motion, as it is related to the failure to warn claims.  
See Kaplan v. Mayo Clinic, 
947 F. Supp. 2d 1001, 1011
 (D. Minn. 2013).  The Court will 
dismiss the remaining claims for failure to state a claim pursuant to Rule 12(b)(6), as 

explained below.                                                          
    A.   Strict Liability – Design Defect                                
    To prevail on a strict liability design defect claim under Minnesota law, a plaintiff 

must prove (1) the products were in a defective condition unreasonably dangerous for 
their intended use; (2) the defect existed when the product left the manufacturer’s 
control; and (3) the defect was the proximate cause of the injury sustained.  Green Plains 
Otter Tail, LLC v. Pro-Envtl., Inc., 
953 F. 3d 541
, 545–46 (8th Cir. 2020).  The parties dispute 

whether Plaintiffs have sufficiently alleged the third element in regard to both causation 
and injury.                                                               
    The FAC lacks basic details about Plaintiffs’ alleged injuries, such as when their 

injuries  were  discovered,  or  locations  or  dates  about  the  revision  procedures  that 
Plaintiffs allegedly underwent to address the injuries.  Plaintiffs have alleged numerous 
design defects, but those defect allegations are not accompanied by allegations regarding 
how any of the defects caused the alleged injuries.  As such, the allegations in the FAC are 

insufficiently sparse because the FAC lacks factual allegations specific to Plaintiffs and 
their alleged injuries.  Accord Dolan v. Boston Sci. Corp., No. 20-1827, 
2021 WL 698777
, 
at *2 (D. Minn. Feb. 23, 2021).                                           
    Plaintiffs contend that their claims could proceed under a theory of res ipsa 

loquitor, which permits plaintiffs to prove products liability claims based on circumstantial 
evidence when it can be inferred that a plaintiff would not have been injured absent a 
defect in the product.  See Holkestad v. Coca-Cola Bottling Co. of Minn., Inc., 
180 N.W.2d 860
, 865–66 (Minn. 1970).  However, the FAC deficiencies are not limited to allegations 
about the product defects, but rather lack detail even regarding Plaintiffs’ injuries—

information that Plaintiffs should have access to themselves.  The FAC merely rattles off 
a number of conditions the Plaintiffs developed at unspecified times and of unspecified 
severity, without any details about the treatment sought or any other facts that support 
an inference that Plaintiffs were injured because of Defendant’s pelvic mesh products.  As 

such, the Court finds that res ipsa loquitor cannot salvage Plaintiffs’ design defect claim 
and will grant Defendants’ Motion as to Count II.                         

    B.   Strict Liability – Manufacturing Defect                         
    A manufacturing defect claim comprises the same three elements as a design 
defect claim, but the defect arises from a discrepancy between the design and the actual 

manufactured product, whereas in design defect cases the product is in the condition 
intended by the manufacturer but the chosen design is defective.  See, e.g., Bilotta v. 
Kelley Co., Inc., 
346 N.W.2d 616, 622
 (Minn. 1984).  Plaintiffs have not alleged how the 
products they received deviated from a correctly-manufactured version of Defendants’ 

pelvic mesh products—or even that they deviated at all.  Manufacturing defect claims 
depend on a “manufacturing flaw—some deviation from a flawless product—that renders 
a product unreasonably dangerous.” Kapps v. Biosense Webster, Inc., 
813 F. Supp. 2d 1128, 1147
 (D. Minn. 2011).  Plaintiffs have alleged that the product was unreasonably 

dangerous, but have not alleged a deviation from a flawless version.  Thus, they fail to 
state a claim for manufacturing defect, and the Court will grant Defendants’ Motion as to 
Count III.                                                                

    C.   Negligence Claims                                               
    As stated at the outset, the failure to warn aspect of Count I for negligence is not 

subject to Defendants’ Motion and will not be dismissed.  However, Count I also includes 
negligence-based design defect and manufacturing defect theories.  Under Minnesota 
law,  “the  distinction  between  theories  of  strict  liability  and  negligence  is  typically 
insignificant.”  
Id. at 1146
.  Although strict liability imposes liability without proof of 

negligence, “in many  cases proof  of a defect may simply be a  substitute  word for 
negligence.”  Lee v. Crookston Coca-Cola Bottling Co., 
188 N.W.2d 426, 432
 (1971).  
Because Plaintiffs have failed to sufficiently allege causation and injury for strict liability 

design defect, their negligent design defect claim likewise fails to state a claim.  Further, 
their failure to allege a manufacturing flaw for the strict liability manufacturing defect 
claim is equally fatal to the negligent manufacturing defect claim.  The Court will therefore 
grant Defendants’ Motion as to Count I insofar as it is premised on negligent design and 

manufacturing defect theories.                                            
    Plaintiffs have pleaded several other negligence-based claims, none of which are 
sufficient to state a claim on which relief can be granted.  First, Count IV for gross 
negligence will be dismissed because under Minnesota law, “a claim for gross negligence 

is not recognized as a distinct cause of action, separate from a cause of action from 
ordinary negligence.”  See Doub v. Life Time Fitness, Inc., No. A17-0322, 
2017 WL 4341814
, 
at *4 (Minn. Ct. App. Oct. 2, 2017); see also Peet v. Roth Hotel Co., 
253 N.W. 546, 548
 

(Minn. 1934) (“The doctrine that there are three degrees of negligence—slight, ordinary, 
and gross—does not prevail in this state.”).                              
    Second, Plaintiffs’ claim for negligent infliction of emotional distress (“NIED”) 
requires proving negligence plus three elements: that a plaintiff “(1) was within the zone 

of danger of physical impact created by the defendant’s negligence; (2) reasonably feared 
for  their  own  safety;  and  (3)  consequently  suffered  severe  emotional  distress  with 
attendant physical manifestations.”  Engler v. Illinois Farmers Ins. Co., 
706 N.W. 2d 764, 767
 (Minn. 2005) (cleaned up).  Under Minnesota law, the zone of danger test for NIED 
requires that a plaintiff was clearly in grave personal peril for some defined period of time, 
a standard which products liability cases such as this one are hard-pressed to satisfy.  See 
Masepohl v. Am. Tobacco Co., 
974 F. Supp. 1245, 1252
 (D. Minn. 1997).  Plaintiffs have 

not pleaded factual allegations supporting an inference that they were in a zone of danger 
related to the pelvic mesh products.  Additionally, emotional distress must meet a high 
standard to qualify as severe under the NIED elements.  See, e.g., Hubbard v. United Press 
Int’l Inc., 
330 N.W.2d 428, 440
 (Minn. 1983).  Plaintiffs’ allegations about their emotional 

distress lack specificity and are conclusory and merely consistent with liability for NIED.  
The Court therefore finds that Plaintiffs have failed to state a claim for NIED and will grant 
Defendants’ Motion as to Count V.                                         
    Third, Plaintiffs have alleged liability for negligent misrepresentation.  Negligent 
misrepresentation claims are subject to the pleading standard of Rule 9(b), which requires 

a plaintiff to plead “such facts as the time, place, and content of the defendant’s false 
representations, as well as the details of the defendant’s fraudulent acts, including when 
the acts occurred, who engaged in them, and what was obtained as a result.”  United 
States ex rel. Joshi v. St. Luke’s Hosp., Inc., 
441 F.3d 552, 556
 (8th Cir. 2006).  The FAC is 

devoid of nearly any specifics about the “who, what, where, why, and how” of the alleged 
misrepresentation and it therefore falls short of the heightened pleading requirements 
under Rule 9(b).  See id.; see also BJC Health Sys. v. Columbia Cas. Co., 
478 F.3d 908, 917
 
(8th Cir. 2007) (“Conclusory allegations that a defendant’s conduct was fraudulent and 

deceptive are not sufficient to satisfy the rule.”).  Moreover, Minnesota courts have not 
recognized negligent misrepresentation as a viable theory of recovery for physical harm, 
instead suggesting that negligent misrepresentation is limited to commercial or business 

transactions resulting in pecuniary damages.  See Forslund, 
2010 WL 3905854
, at *6.  As 
such,  the  Court  finds  that  Plaintiffs  have  not  stated  a  claim  for  negligent 
misrepresentation under Minnesota law and will therefore grant Defendants’ Motion as 
to Count XI.                                                              

    D.   Fraud                                                           
    Plaintiffs assert three other fraud-based claims—fraudulent concealment (Count 

VIII), constructive fraud (Count IX), common law fraud (Count X)—all of which also must 
be pleaded with particularity.  See Tuttle v. Lorillard Tobacco Co., 
118 F. Supp. 2d 954, 963
 
(D. Minn. 2000) (stating that heightened pleading requirements under Rule 9(b) apply 

when the gravamen of the complaint is fraud).  However, in some cases, the standard 
might be relaxed: “[w]hen the facts constituting the fraud are peculiarly within the 
opposing party’s knowledge . . . such allegations may be pleaded on information and 
belief.  Claims pleaded on information and belief are sufficient under Rule 9(b) if they are 

accompanied by a statement of the facts on which the belief is based.”  Select Comfort 
Corp. V. Sleep Better Store, LLC, 
796 F. Supp. 2d 981, 985
 (D. Minn. June 17, 2011) 
(quotation and citations omitted).                                        

    Plaintiffs assert that a relaxed standard should be applied in this case because 
information about the alleged fraud was within Defendants’ exclusive control, it occurred 
over an extended period of time, and it consisted of numerous acts.  Yet, Plaintiffs admit 
that they “have substantial prediscovery evidence—much of which was obtained from 

the discovery already concluded in the underlying [multidistrict litigation].”  (Mem. Opp. 
Mot. Partial Dismissal at 13, Apr. 28, 2021, Docket No.26.)  Even if there are some details 
about the nature of the fraud that Plaintiffs should not be expected to know at this point, 
the FAC lacks specifics about the “who, what, where, why, and how” of the Defendants’ 

alleged fraud as it relates to the Plaintiffs injuries, despite Plaintiffs admittedly being privy 
to pre-discovery evidence, and Plaintiffs’ allegations that the misrepresentations were 
made to them, their physicians, and the public at large.  Thus, it cannot plausibly be said 
that the facts are “peculiarly within the opposing party’s knowledge,” and Plaintiffs have 
not sufficiently pleaded their fraud claims in light of the circumstances.  The Court will 

therefore grant Defendants’ Motion as to Counts VIII–X.                   
    E.   Breach of Warranty                                              

    Plaintiffs represent that their warranty claim is based on breach of both express 
and implied warranties.  Under Minnesota law, however, claims for breach of implied 
warranty are preempted by strict liability claims where personal injuries are at issue.  
Masepohl, 
974 F. Supp. at 1253
.  The Court therefore only decides whether Plaintiffs have 

adequately pleaded their claim for breach of express warranty.            
    To establish such a claim, “the plaintiff ordinarily must establish that the seller 
made an express, affirmative promise about the qualities of the product.”  Leedahl v. 

Rayco Mfg., Inc., No. 06-310, 
2006 WL 1662959
, at *4 (D. Minn. May 15, 2006) (citations 
omitted).  Additionally, Minnesota statute provides that a breach of warranty claim must 
be brought within four years of when the action has accrued.  
Minn. Stat. § 336.2-725
(1).  
“A breach of warranty occurs when tender of delivery is made, except that where a 

warranty explicitly extends to future performance of the goods and discovery of the 
breach must await the time of such performance the cause of action accrues when the 
breach is or should have been discovered.”  
Id.
 § 336.2-725(2).           
    Plaintiffs had the pelvic mesh implanted more than four years before initiation of 

this action: Bergman underwent her procedure in 2003 and Budnik in 2008, and the action 
is deemed initiated as of February 23, 2017.2  Plaintiffs argue that Defendants warranted 
future performance such that the statute of limitations should be tolled.  However, 

Plaintiffs have not alleged any specifics about Defendants’ express warranties such as the 
format, timing, or language used.  Without more specific allegations of what Defendants 
warranted to Plaintiffs, the Court cannot toll the statute of limitations or conclude that 
Plaintiffs have pleaded factual allegations above a conclusory level.  The Court therefore 

finds that Plaintiffs have failed to state a claim for breach of express warranty and will 
grant Defendants’ Motion as to Count VII.                                 

    F.   Unjust Enrichment                                               
    Plaintiffs assert a claim of unjust enrichment in the alternative to legal remedies 
sought.  In Minnesota, courts allow simultaneous pleading of legal claims and unjust 

enrichment claims under Rule 8(d), see, e.g., Daigle v. Ford Motor Co., 
713 F. Supp. 2d 822, 828
 (D. Minn. 2010), but unjust enrichment is limited to claims premised on “an 
implied or quasi-contract in which the defendant received a benefit of value that unjustly 
enriched the defendant in a manner that is illegal or unlawful,” Caldas v. Affordable 

Granite & Stone, Inc., 
820 N.W.2d 826, 838
 (Minn. 2012).  Plaintiffs have not pleaded 




2 The action was initiated on December 30, 2020, but Defendants state that “pursuant to a private 
agreement between the parties, their suit is deemed filed as of February 23, 2017.”  (Mem. Supp. 
Mot. Partial Dismiss at 12, Apr. 16, 2021, Docket No. 23.)                
allegations that sound in quasi-contract, but only in tort.  As such, the Court will deny the 
claim for unjust enrichment and will grant Defendants’ Motion as to Count XII.   

    G.   Punitive Damages                                                
    Minnesota law provides that punitive damages are available “upon clear and 

convincing evidence that the acts of the defendant show deliberate disregard for the 
rights or safety of others.”  
Minn. Stat. § 549.20
, subd. 1(a).  Punitive damages are a 
derivative claim like loss of consortium, see Hern v. Bankers Life Cas. Co., 
133 F. Supp. 2d 1130, 1139
 (D. Minn. 2001), but Defendants seek dismissal of the punitive damages claim 

in full because Plaintiffs have violated the procedural requirements to seek punitive 
damages under Minnesota law.                                              
    Minnesota Statutes § 549.191 provides that a complaint must not seek punitive 

damages; instead, a party must later move to amend the pleadings to claim punitive 
damages, which a court shall grant if it finds prima facie evidence in support of the 
motion.  
Minn. Stat. § 549.191
.  The relationship between § 549.191 and Federal Rule of 
Civil Procedure 15, which provides that a court should freely give leave to amend when 

proposed  claims  are  plausible,  has  recently  evolved  in  the  District  of  Minnesota, 
specifically as to whether § 549.191’s prima facie standard or Rule 15’s plausibility 
standard applies.  See, e.g., Shank v. Carleton Coll., 
329 F.R.D. 610
, 612 (D. Minn. 2019).  
As there is no motion to amend or proposed amended complaint at issue in the present 

matter, the issue of which standard the Court would apply to determine whether a 
plaintiff may seek punitive damages is irrelevant.  Plaintiffs have never filed a motion to 
amend; they have improperly included punitive damages from the outset.  See Clancy v. 

Vacationaire Ests., Inc., No. 18-2249, 
2019 WL 955113
, at *11 (D. Minn. Feb. 27, 2019).  
The Court therefore grants Defendants’ Motion with respect to punitive damages at this 
time.  Should Plaintiffs later file a motion for leave to amend to add a punitive damages 
claim, the Court will examine the sufficiency of the allegations and support for punitive 

damages then.                                                             

ORDER

    Based on the foregoing, and all the files, records, and proceedings herein, IT IS 
HEREBY ORDERED that:                                                      
    1.  Defendants’ Motion to Dismiss [Docket No. 13] is DENIED as moot;  

    2.  Defendants’ Motion for Partial Dismissal [Docket No. 22] is GRANTED, in part, 
      as follows:                                                        
         a.  Count I Negligence is DISMISSED without prejudice with respect to 
           design  defect  and  manufacturing  defect,  but  NOT  DISMISSED  with 

           respect to failure to warn;                                   
         b.  Count II Strict Liability – Design Defect is DISMISSED without prejudice;  
         c.  Count III Strict Liability – Manufacturing Defect is DISMISSED without 
           prejudice;                                                    

         d.  Count IV Gross Negligence is DISMISSED without prejudice;   
     e.  Count V Negligent Infliction of Emotional Distress is DISMISSED without 
        prejudice; 
     f.   Count VI Strict Liability — Failure to Warn is NOT DISMISSED; 
     g.  Count VII Breach of Warranty is DISMISSED without prejudice; 
     h.  Count VIII Fraudulent Concealment is DISMISSED without prejudice; 
     i.   Count IX Constructive Fraud is DISMISSED without prejudice; 
    j.   Count X Common Law Fraud is DISMISSED without prejudice; 
     k.  Count XI Negligent Misrepresentation is DISMISSED without prejudice; 
     |.   Count XII Unjust Enrichment is DISMISSED without prejudice; 
     m.  Count XIII Loss of Consortium is NOT DISMISSED; and 

     n.  Count XIV Punitive Damages is DISMISSED without prejudice. 

DATED:  August 13, 2021                     Toa   (ashen 
at Minneapolis, Minnesota.                   JOHN R. TUNHEIM 
                                             Chief Judge 
                                      United States District Court 

                              -17- 

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