Title: Dunn v. Genzyme Corp.
Citation: N/A
Docket Number: SJC-12904
State: Massachusetts
Issuer: Massachusetts Supreme Court
Date: January 29, 2021

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SJC-12904 
 
PATRICIA M. DUNN  vs.  GENZYME CORPORATION. 
 
 
 
Norfolk.     September 11, 2020. - January 29, 2021. 
 
Present:  Lenk, Gaziano, Lowy, Budd, Cypher, & Kafker, JJ.1 
 
 
Federal Preemption.  Negligence, Defective product.  Practice, 
Civil, Motion to dismiss, Complaint. 
 
 
 
 
Civil action commenced in the Superior Court Department on 
June 1, 2018. 
 
 
A motion to dismiss was heard by Elaine M. Buckley, J. 
 
 
Leave to prosecute an interlocutory appeal was allowed in 
the Appeals Court by John C. Englander, J.  The Supreme Judicial 
Court on its own initiative transferred the case from the 
Appeals Court. 
 
 
 
John C. Dougherty for the defendant. 
 
Matthew J. Dunn for the plaintiff. 
 
The following submitted briefs for amici curiae: 
 
Lawrence G. Cetrulo, Kyle E. Bjornlund, & Jesse G. Ainlay 
for Massachusetts Defense Lawyers Association. 
 
Jaime A. Santos, Sarah K. Frederick, & Edwina B. Clarke for 
Chamber of Commerce of the United States of America & another. 
 
David R. Geiger, Michael Hoven, & Stephen Stich for 
Washington Legal Foundation. 
                                                          
 
 
1 Justice Lenk participated in the deliberation on this case 
prior to her retirement. 
2 
 
 
 
 
 
 
GAZIANO, J.  We are asked in this case involving claims of 
personal injury and product liability against the manufacturer 
of a medical device to decide whether Federal law preempts the 
plaintiff's State law claims because the device is regulated 
under the Medical Device Amendments (MDA), 21 U.S.C. §§ 360c et 
seq., of the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et 
seq.  State law claims survive preemption under the MDA so long 
as these claims parallel, rather than supplement, Federal 
requirements.  See Riegel v. Medtronic, Inc., 552 U.S. 312, 330 
(2008).  Under this standard, plaintiffs need not specify the 
precise defect in the medical device nor the specific Federal 
regulatory requirement allegedly violated in order to survive a 
motion to dismiss.  No heightened pleading standard is required.  
Rather, we conclude that plaintiffs asserting parallel State law 
claims may do so with no greater degree of specificity than 
otherwise required under Iannacchino v. Ford Motor Co., 451 
Mass. 623, 636 (2008). 
 
While all of the plaintiff's State law claims here properly 
parallel the Federal requirements, none of them is sufficiently 
pleaded under Iannacchino, supra, to survive the manufacturer's 
motion to dismiss.  Accordingly, the Superior Court judge's 
decision denying the manufacturer's motion to dismiss must be 
reversed. 
3 
 
 
 
 
1.  Statutory background.  Congress adopted the MDA in 
1976, in response to the perceived failure of the various States 
to provide for the adequate regulation of new medical devices.  
See generally Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-477 
(1996) (Lohr).  In an effort to establish regulatory uniformity 
and enhance consumer protection, the MDA thus "swept back some 
state obligations and imposed a regime of detailed federal 
oversight."  Riegel, 552 U.S. at 316. 
 
The MDA establishes three classes of medical devices, and 
corresponding levels of oversight, depending on the risks they 
present to the public.  Class III devices -- those "purported or 
represented to be for a use in supporting or sustaining human 
life or for a use which is of substantial importance in 
preventing impairment of human health," as well as those that 
"present[] a potential unreasonable risk of illness or injury" -
- are subject to the most stringent oversight.  21 U.S.C. 
§ 360c(a)(1)(C)(ii)(I), (II).  Such devices generally are 
subject to a "rigorous" premarket approval process by the Food 
and Drug Administration (FDA).  See Lohr, 518 U.S. at 477.  This 
process includes, among other precautions, a review of the 
device's proposed labeling to evaluate the safety and 
effectiveness of using the device under the conditions set forth 
on the label, 21 U.S.C. § 360c(a)(2)(B), and to ensure that the 
4 
 
 
 
proposed labeling is neither false nor misleading, 21 U.S.C. 
§ 360e(d)(1)(A). 
 
Once a medical device has been approved, manufacturers of 
Class III devices also have continuing duties to comply with 
regulations and reporting requirements.  See generally 21 U.S.C. 
§§ 360 et seq.  The MDA, for example, prohibits the manufacturer 
from making changes in design specifications, manufacturing 
processes, labeling, or any other attribute, that would affect 
safety or effectiveness without FDA permission.  See 21 U.S.C. 
§ 360e(d)(5)(A)(i).  More generally, the FDA's good 
manufacturing practice regulations impose comprehensive 
requirements concerning the device-manufacturing process, 
including a manufacturer's personnel qualifications,2 buildings,3 
equipment,4 production and process controls,5 packaging and 
labeling,6 distribution,7 and recordkeeping.8  Additionally, 
manufacturers are required to inform the FDA of new clinical 
                                                          
 
 
2 See 21 C.F.R. § 211.25. 
 
 
3 See, e.g., 21 C.F.R. § 211.42. 
 
 
4 See, e.g., 21 C.F.R. § 211.63. 
 
 
5 See, e.g., 21 C.F.R. § 211.110. 
 
 
6 See, e.g., 21 C.F.R. § 211.122. 
 
 
7 See 21 C.F.R. § 211.150. 
 
 
8 See, e.g., 21 C.F.R. § 211.180. 
5 
 
 
 
investigations or scientific studies concerning the device that 
the manufacturer is aware of or reasonably should be aware of, 
see 21 C.F.R. § 814.84(b)(2), and to report incidents in which 
the device may have caused or contributed to death or serious 
bodily injury, or malfunctioned in a manner that likely would 
cause or contribute to death or serious bodily injury if it 
recurred, see 21 C.F.R. § 803.50(a).  The FDA "shall" withdraw 
approval if it determines that a device is unsafe or ineffective 
under the conditions of its labeling.   21 U.S.C. § 360h(e).  To 
facilitate this Federal regulatory scheme, the MDA expressly 
preempts certain State regulation of approved medical devices.  
Under its preemption clause, 
"Except as provided in subsection (b), no State or 
political subdivision of a State may establish or continue 
in effect with respect to a device intended for human use 
any requirement -- 
 
"(1) which is different from, or in addition to, any 
requirement applicable under this chapter to the device, 
and 
 
"(2) which relates to the safety or effectiveness of the 
device or to any other matter included in a requirement 
applicable to the device under this chapter." 
 
21 U.S.C. § 360k(a).  An exception in subsection 21 U.S.C. 
§ 360k(b), not relevant here, permits the FDA to exempt some 
State and local requirements. 
 
2.  Factual background.  In an attempt to alleviate the 
symptoms of osteoarthritis in her knees, according to her 
6 
 
 
 
complaint, the plaintiff, Patricia Dunn, received two injections 
of Synvisc-One on June 8, 2015, one in each knee.  Synvisc-One 
is manufactured by Genzyme Corporation (Genzyme) and is a Class 
III medical device subject to premarket approval under the MDA.  
Synvisc-One was approved by the FDA in 2009 for the treatment of 
pain associated with osteoarthritis of the knee in patients who 
have failed to respond to other treatments. 
 
Immediately after receiving the injections, Dunn 
experienced severe side effects, including "pain and swelling in 
her knees, difficulty walking, hip bursitis and systemic 
pseudoseptic acute arthritis."  These side effects caused her to 
fall several times and ultimately resulted in serious injuries, 
including a tear to her meniscus and breaking her neck.  As a 
result of these injuries, Dunn asserts that she "experienced 
significant physical pain and suffering, under[went] surgeries, 
and endured prolonged hospitalization and physical 
rehabilitation." 
 
In June 2018, Dunn commenced an action against Genzyme in 
the Superior Court, asserting that Synvisc-One was "negligently 
manufactured, designed, distributed, and sold by [Genzyme], 
and . . . failed to contain appropriate and significant warnings 
related to its use."  Specifically, Dunn sought monetary damages 
based upon four State law claims: (1) failure to warn; 
(2) breach of warranty; (3) negligence; and (4) products 
7 
 
 
 
liability.  In a joint stipulation filed on June 22, 2018, and 
subsequently approved by the judge, both parties agreed to 
extend the time within which Dunn could file an amended pleading 
until August 17, 2018.  Dunn, however, failed to meet this 
deadline.  She filed an amended complaint on September 11, 2018, 
three days before the parties had stipulated that Genzyme was to 
file its response.  In her amended complaint, Dunn added a fifth 
claim under the Massachusetts consumer protection act, G. L. 
c. 93A, asserting that Genzyme "undertook certain unfair and 
deceptive acts or practices." 
 
In response to the amended complaint, Genzyme filed a 
motion to dismiss pursuant to Mass. R. Civ. P. 12 (b) (6), 365 
Mass. 754 (1974), on the grounds that the allegations of both 
the original complaint and the amended complaint were preempted 
by Federal regulation and failed to meet the applicable State 
law pleading standards. 
 
Following a nonevidentiary hearing, the judge denied 
Genzyme's motion to dismiss, concluding that Dunn had supplied 
sufficient factual allegations in her complaint to "state a 
plausible claim for relief" and survive preemption under the 
MDA.  The judge noted that courts, both nationally and in the 
Commonwealth, have disagreed about the required level of 
specificity with which a plaintiff must allege a violation of 
FDA regulations to properly plead State law claims; neither the 
8 
 
 
 
United States Supreme Court nor the United States Court of 
Appeals for the First Circuit has addressed the issue 
explicitly.  Pointing to the decision of the United States Court 
of Appeals for the Seventh Circuit in Bausch v. Stryker Corp., 
630 F.3d 546, 560-561 (7th Cir. 2010), cert. denied 565 U.S. 976 
(2011), the judge emphasized the informational disparities 
between individual plaintiffs and medical device manufacturers 
that often limit the information available to plaintiffs prior 
to discovery.  The judge also noted that "there [was] nothing to 
indicate that Dunn had access to any publicly available 
information which would have permitted her to plead with greater 
specificity" and, accordingly, determined that the complaint was 
sufficient, "given the amount of information to which she had 
access." 
 
Genzyme appealed, and a single justice of the Appeals Court 
granted Genzyme's application for interlocutory review on the 
question of the sufficiency of Dunn's complaint.  We transferred 
the matter to this court on our own motion. 
 
3.  Standard of review.  We review the denial of a motion 
to dismiss under Mass. R. Civ. P. 12 (b) (6) de novo.  See 
Rafferty v. Merck & Co., 479 Mass. 141, 147 (2018); Curtis v. 
Herb Chambers I-95, Inc., 458 Mass. 674, 676 (2011).  Accepting 
the facts asserted in the complaint as true and drawing all 
reasonable inferences in the plaintiff's favor, we must 
9 
 
 
 
determine "whether the factual allegations in the complaint are 
sufficient, as a matter of law, to state a recognized cause of 
action or claim, and whether such allegations plausibly suggest 
an entitlement to relief."  See Dartmouth v. Greater New Bedford 
Regional Vocational Tech. High Sch. Dist., 461 Mass. 366, 374 
(2012).  See also A.L. Prime Energy Consultant, Inc. v. 
Massachusetts Bay Transp. Auth., 479 Mass. 419, 424 (2018); 
Edwards v. Commonwealth, 477 Mass. 254, 260 (2017). 
 
4.  Discussion.  In assessing the sufficiency of Dunn's 
complaint, we turn first to the issue of Federal preemption.  
The relative specificity of the pleadings under State law is 
irrelevant if constitutional principles preclude the assertion 
of State law claims in light of existing Federal regulation.  
See, e.g., Gade v. National Solid Wastes Mgt. Ass'n, 505 U.S. 
88, 108 (1992) ("under the Supremacy Clause, from which our pre-
emption doctrine is derived, any [S]tate law, however clearly 
within a State's acknowledged power, which interferes with or is 
contrary to [F]ederal law, must yield" [quotations omitted]).  
We then evaluate whether any of Dunn's claims that survive a 
preemption analysis also satisfy the Massachusetts pleading 
requirements, as set forth in Iannacchino, 451 Mass. at 636.  In 
order for this court to affirm the judge's denial of the motion 
to dismiss, Dunn's claims must satisfy both requirements. 
10 
 
 
 
 
a.  Preemption.  Analysis under the supremacy clause begins 
"with the assumption that the historic police powers of the 
States [are] not to be superseded by . . . Federal Act unless 
that [is] the clear and manifest purpose of Congress."  
Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992), 
quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 
(1947).  A congressional intent to preempt State law may be 
stated explicitly in statutory language, or implicitly within 
the structure and purpose of a statute.  See Cipollone, supra, 
quoting Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977).  
The MDA, under which Synvisc-One is regulated, includes such 
language, and preempts State requirements "different from, or in 
addition to, any requirement applicable . . . to the device" 
under Federal law.  21 U.S.C. § 360k(a)(1). 
 
In Riegel, 552 U.S. at 321-325, the United States Supreme 
Court set forth a two-part analysis for determining whether a 
plaintiff's State law claims are preempted under the MDA.  
First, the reviewing court must determine whether the FDA has 
imposed requirements applicable to the medical device at issue.  
See id. at 321.  Second, the court must decide whether the 
particular State law claims are preempted because they are 
"different from, or in addition to, any requirement 
applicable . . . to the device" under Federal law.  21 U.S.C. 
§ 360k(a)(1) (2020).  See Riegel, supra at 323.  The court has 
11 
 
 
 
said that the language of the MDA "does not prevent a State from 
providing a damages remedy for claims premised on a violation of 
FDA regulations; the [S]tate duties in such cases 'parallel,' 
rather than add to, [F]ederal requirements."  Id. at 330.  Thus, 
plaintiffs may bring so-called "parallel" State claims, i.e., 
tort and other claims that are based on, or coextensive with, 
violations of Federal statutes and regulations.  See Lohr, 518 
U.S. at 495.  See also Hughes v. Boston Scientific Corp., 631 
F.3d 762, 770 (5th Cir. 2011) ("claims for negligent failure to 
warn or negligent manufacturing of a device are not preempted, 
provided that such claims are premised entirely on violation of 
the applicable federal requirements"); Bausch, 630 F.3d at 552 
("section 360k protects a medical device manufacturer from 
liability to the extent that it has complied with [F]ederal law, 
but it does not extend protection from liability where the 
[State tort] claim is based on a violation of [F]ederal law").  
Common-law duties are among the State law claims that may 
survive preemption.  Riegel, supra at 323-324. 
 
Turning to Dunn's complaint, we conclude that all of her 
claims satisfy the preemption standard. 
 
The first question, as to whether the FDA has imposed 
requirements applicable to the device at issue, undoubtedly can 
be answered in the affirmative.  As in Riegel, 552 U.S. at 321-
323, the record establishes that Synvisc-One is a stringently 
12 
 
 
 
regulated Class III medical device under the MDA.  The premarket 
approval process thus imposes Federal requirements under 21 
U.S.C. § 360k. 
 
With respect to the second part of the analysis, the 
complaint describes each of Dunn's five claims in very limited 
detail, but the assertions contained therein are consistent with 
claims under Massachusetts law that "parallel" violations of 
Federal statutes and regulations.  The claims -- negligent 
failure to warn, breach of warranty, negligent manufacture, 
products liability, and violations of G. L. c. 93A -- all can be 
interpreted as coextensive with the comprehensive Federal 
requirements imposed on Genzyme under the MDA, such as, for 
example, those regulating production and process controls, see, 
e.g., 21 C.F.R. § 211.110, and packaging and labeling, see, 
e.g., 21 C.F.R. § 211.122.  In other words, enforcing these 
State law obligations "'parallel[s],' rather than add[s] to, 
[F]ederal requirements."  Riegel, 552 U.S. at 330. 
 
We will not require plaintiffs who are asserting parallel 
State law claims to plead specific facts, such as the precise 
Federal regulations purportedly violated or the precise 
relationship between State and Federal requirements, to meet our 
ordinary, notice-pleading standard.  "Although the complaint 
would be stronger with such detail, we do not believe the 
absence of those details shows a failure to comply" with the 
13 
 
 
 
requirements.  Bausch, 630 F.3d at 560.  See Rosbeck v. Corin 
Group, PLC, 140 F. Supp. 3d 197, 210 (D. Mass. 2015).  "Nothing 
in § 360k denies [Massachusetts] the right to provide a 
traditional damages remedy for violations of common-law duties 
when those duties parallel [F]ederal requirements."  Lohr, 518 
U.S. at 495.  Thus, Dunn's claims fit within the "narrow gap 
through which a plaintiff's [S]tate-law claim must fit if it is 
to escape express or implied preemption" under the MDA.  Riley 
v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009). 
 
b.  Sufficiency of State law pleadings.  As the judge 
indicated, there is a wide disparity in views among the few 
Federal circuit courts that have examined the level of 
specificity necessary to plead State law claims in order to 
survive preemption under the MDA.  Compare Wolicki-Gables v. 
Arrow Int'l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) ("A 
plaintiff must allege that the defendant violated a particular 
[F]ederal specification referring to the device at issue" 
[quotation and citation omitted]), with Bausch, 630 F.3d at 560 
(declining to require that plaintiffs "specify the precise 
defect or specific [F]ederal regulatory requirements that were 
allegedly violated").  See Otis-Wisher v. Medtronic, Inc., 616 
Fed. Appx. 433, 434 (2d Cir. 2015) (applying traditional 
pleading standard in assessing State law claims purportedly 
preempted under MDA).  While no appellate courts in the 
14 
 
 
 
Commonwealth appear to have addressed this issue, a few Superior 
Court judges have; this disparity is evident as well among those 
judges.  Compare Morris vs. Rotolo, Mass. Super. Ct., No. 12-
04046 (Middlesex County Jan. 15, 2014) (requiring plaintiffs to 
plead in detail Federal requirement purportedly violated), with 
Phillips vs. Medtronic, Inc., Mass. Super. Ct., No. SUCV2009-
05286-A (Suffolk County July 10, 2012) (concluding that 
"plaintiffs need not plead a parallel claim with any degree of 
heightened specificity"). 
 
Under Mass. R. Civ. P. 8 (a) (1), 365 Mass. 749 (1974), a 
complaint must include only "a short and plain statement of the 
claim showing that the pleader is entitled to relief."  Thus, 
"[t]o survive a motion to dismiss, the facts alleged and the 
reasonable inferences drawn therefrom must plausibly 
suggest . . . an entitlement to relief" (quotation and citation 
omitted).  Coghlin Elec. Contrs., Inc. v. Gilbane Bldg. Co., 472 
Mass. 549, 554 (2015).  While a complaint need not include 
"detailed factual allegations[,] a plaintiff's obligation to 
provide the grounds of his [or her] entitle[ment] to relief 
requires more than labels and conclusions."  Iannacchino, 451 
Mass. at 636, quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 
555 (2007) (Twombly).  Such factual allegations "must be enough 
to raise a right to relief above the speculative level . . . 
[based] on the assumption that all the allegations in the 
15 
 
 
 
complaint are true (even if doubtful in fact)."  Iannacchino, 
supra, quoting Twombly, supra.  See Galiastro v. Mortgage Elec. 
Registration Sys., Inc., 467 Mass. 160, 165 (2014); Lopez v. 
Commonwealth, 463 Mass. 696, 700-701 (2012). 
 
Although Genzyme asserts that it is not asking that a 
heightened pleading standard be applied to Dunn's complaint, its 
interpretation of Iannacchino effectively requires such a 
standard for plaintiffs asserting parallel, State-law claims 
regarding MDA-regulated medical devices.  For example, Genzyme 
contends that Dunn's complaint is insufficient because it "never 
states which [premarket approval] requirements Genzyme 
purportedly violated, nor describes how Genzyme allegedly 
violated them."  Mandating that plaintiffs provide such details 
at the pleading stage extends well beyond Iannacchino's notice-
pleading standard, see Iannacchino, 451 Mass. at 636, and 
essentially mirrors the level of specificity required to plead 
fraud.  See Mass. R. Civ. P. 9 (b), 365 Mass. 751 (1974).  See, 
e.g., Equipment & Sys. for Indus., Inc. v. Northmeadows Constr. 
Co., 59 Mass. App. Ct. 931, 931–932 (2003) ("At a minimum, a 
plaintiff alleging fraud must particularize the identity of the 
person[s] making the representation, the contents of the 
misrepresentation, and where and when it took place.  In 
addition, the plaintiff should specify the materiality of the 
misrepresentation, its reliance thereon, and resulting harm"). 
16 
 
 
 
 
We decline to require that plaintiffs asserting State 
common-law claims regarding MDA-regulated medical devices plead 
these parallel claims in greater specificity than otherwise 
would be required under the plausibility standard set forth in 
Iannacchino, 451 Mass. at 636.  Cf. Bass v. Stryker Corp., 669 
F.3d 501, 509 (5th Cir. 2012); In re Medtronic, Inc., 623 F.3d 
1200, 1212 (8th Cir. 2010) (Melloy, J., concurring).  Rule 9 (b) 
of the Rules of Civil Procedure does not impose any special 
requirement that such a claim be pleaded with particularity, as 
it does for other types of claims, such as for fraud, see, e.g., 
Tetrault v. Mahoney, Hawkes & Goldings, 425 Mass. 456, 463 n.7 
(1997), and we discern no reason to do so.  Otherwise put, 
plaintiffs asserting parallel State-law claims based upon a 
violation of FDA regulations must articulate only "factual 
allegations plausibly suggesting (not merely consistent with) an 
entitlement to relief" (quotation and citation omitted), 
Iannacchino, 451 Mass. at 636, in order to satisfy the 
Commonwealth's pleading standard; plaintiffs need not point to 
conclusive or specific evidence of such violations, as would be 
required under a heightened pleading standard, see id. 
 
None of Dunn's claims meets this standard.  Dunn asserts 
that the "reasonably foreseeable use of Synvisc-One involved 
significant dangers not readily obvious to the ordinary user of 
the product"; Synvisc-One had "dangerous propensities that were 
17 
 
 
 
known or reasonably knowable to [Genzyme] at the time of its 
manufacture and distribution of Synvisc-One"; Synvisc-One posed 
"known or reasonably knowable dangers"; or, alternatively, that 
the "Synvisc-One that was ultimately injected into [Dunn] was 
adulterated and defectively manufactured, distributed, marketed, 
and sold" by Genzyme.  No factual allegations are, however, 
provided upon which to ground these "labels and conclusions."  
Iannacchino, 451 Mass. at 636, quoting Twombly, 550 U.S. at 555.  
In contrast to the judge, we discern insufficient facts in the 
complaint "'plausibly [to suggest]' . . . an entitlement to 
relief."  Iannacchino, supra, quoting Twombly, supra.  The 
complaint, as is, "require[s] a fact finder to jump from one 
inference to another absent any of the necessary factual 
support."  Edwards, 477 Mass. at 265. 
 
Fundamentally, the complaint does not proffer sufficient 
factual assertions that plausibly establish causality between 
Genzyme's purportedly tortious activities and Dunn's injuries.  
Rather, the complaint seems to imply that the temporal proximity 
between the injections of Synvisc-One and Dunn's injuries alone 
is sufficient to establish the necessary element of causality.9 
                                                          
 
 
9 At the hearing on Genzyme's motion to dismiss, and during 
argument before this court, both parties referenced the legal 
doctrine of res ipsa loquitur.  This doctrine "permits a trier 
of fact to draw an inference of negligence in the absence of a 
finding of a specific cause of the occurrence when an accident 
is of the kind that does not ordinarily happen unless the 
18 
 
 
 
 
A comparison with complaints that courts have deemed 
sufficient to allege parallel State-law claims is instructive.  
For instance, a Superior Court judge determined that a 
plaintiff's factual allegations, which drew upon the defendant's 
own admissions, plausibly suggested "a causal connection" 
between the purported defect in the medical device at issue and 
the resultant harm.  This connection was sufficient to survive 
the defendant's motion to dismiss.  See Dwyer vs. Boston 
Scientific Corp., Mass. Super. Ct., No. MICV2014-04747 
(Middlesex County Apr. 2, 2015).  Similarly, in Bausch, 630 F.3d 
at 559, the United States Court of Appeals for the Seventh 
Circuit concluded that the plaintiff's complaint was adequate 
based, in part, on the inclusion of evidence that the defendant 
manufacturer not only had received complaints regarding the 
failure of its medical device but also recalled the device based 
on that specific defect, the same defect that allegedly caused 
the plaintiff's injury.  The complaints in these cases contrast 
markedly with Dunn's complaint, which invokes no facts -- 
                                                          
 
defendant was negligent in some respect and other responsible 
causes including conduct of the plaintiff are sufficiently 
eliminated by the evidence."  Enrich v. Windmere Corp., 416 
Mass. 83, 88 (1993).  It does not "overcome the lack of evidence 
of the defendant's negligence."  Id.  Because Dunn did not plead 
adequate facts to establish negligence, she may not invoke this 
doctrine. 
19 
 
 
 
regulatory, medical, or otherwise -- that connect Genzyme's 
actions with the purported harm. 
 
In her assessment of the sufficiency of Dunn's complaint, 
the judge here emphasized the disparity between the information 
available to Dunn and to Genzyme.  Specifically, she pointed to 
the limited information accessible to Dunn, for example, 
regarding the manufacturing of Synvisc-One, as somehow 
justifying the sufficiency of Dunn's assertions prior to 
discovery.  Dunn supports her bare-bones complaint, at least in 
part, in similar terms, drawing attention to Genzyme's 
"superior, and likely exclusive, knowledge of what exactly went 
wrong in its production, manufacture, packaging and distribution 
of the Synvisc-One that was ultimately injected into [her] knees 
and caused such catastrophic harm to her."  Genzyme, on the 
other hand, asserts that a "[l]ack of access to information at 
the pleading stage does not nullify a plaintiff's pleading 
obligations." 
 
 
 
 
 
 
 
Order denying motion to 
 
 
 
 
 
 
 
  dismiss reversed.