CARSON v. ATRIUM MEDICAL CORPORATION et al
Filing
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MEMORANDUM ORDER. For the reasons stated in the Memorandum filed herewith, Defendants Atrium Medical Corporation, Maquet Cardiovascular US Sales, LLC, Maquet Cardiovascular, LLC, and Maquet Medical Systems USA's Motion to Dismiss (Doc. 17) is GRANTED IN PART and DENIED IN PART. With respect to Plaintiff's claims of negligent failure to warn and negligent misrepresentation, the Motion to Dismiss is DENIED. In every other respect, the Motion to Dismiss is GRANTED.Specifically, the fo llowing claims are hereby DISMISSED WITH PREJUDICE: Plaintiff's strict liability claim for failure to warn (Count I), claim for breach of express warranty (Count III), claim for breach of implied warranty (Count IV), and claim for fraud (Count V ). Additionally, the following claims are hereby DISMISSED WITHOUT PREJUDICE: Plaintiff's negligence claims for negligent failure to test (Count II), negligent marketing (Count II), and manufacturing defect (Count II). Signed by Judge Cathy Bissoon on 6/8/16. (jwr)
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
CATHLEEN CARSON,
Plaintiff,
v.
ATRIUM MEDICAL CORPORATION,
et al.,
Defendants.
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Case No. 15-830
Judge Cathy Bissoon
MEMORANDUM ORDER
For the reasons stated below, the Atrium Medical Corporation, Maquet Cardiovascular US
Sales, LLC, 1 Maquet Cardiovascular, LLC and Maquet Medical System USA’s Motion to Dismiss
(Doc. 17) will be GRANTED IN PART and DENIED IN PART.
I. MEMORANDUM
BACKGROUND 2
On May 27, 2009, Cathleen Carson (“Plaintiff” or “Ms. Carson”) underwent a repair to a
right inguinal hernia. Am. Compl. (Doc. 15) at ¶ 26. The hernia was repaired by physicians at
Jefferson Regional Medical Center using a polypropylene mesh. Id. The mesh implanted in
Maquet Cardiovascular US Sales, LLC appears to have been incorrectly identified in the
caption of this case as “Maquest Cardiovascular US Sales, LLC.” Because it is evident from
both the Amended Complaint and the pending motion that this is a typographical error, the Court
will refer to this Defendant by its correct name. The parties should, at their earliest convenience,
file a motion to correct the caption of this case.
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The following background facts are taken from Plaintiff’s Amended Complaint (Doc. 15).
Because the case presently is before this Court on a motion to dismiss under Federal Rule of
Civil Procedure 12(b)(6), the Court accepts as true all allegations in the complaint and all
reasonable inferences that can be drawn therefrom. See Rocks v. City of Philadelphia, 868 F.2d
644, 645 (3d Cir. 1989). In addition, the Court views all well pleaded factual averments and
reasonable inferences in the light most favorable to Plaintiff.
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Plaintiff was manufactured, promoted, marketed, distributed and sold by Defendants. Id. at 27.
Following the surgery, Plaintiff suffered from a variety of complications, including “severe
abdominal pain, inability to eat solid food, difficulty ambulating and severe leg pain due to nerve
damage. Id. at 33. Plaintiff has undergone additional surgical procedures, which would be
unnecessary but for the complications caused by the mesh implant. Id. at 34. Plaintiff suffers
from chronic neuropathic pain, constipation, decreased sensation in her rectal area, pain radiating
into her right leg, abdominal pain after eating, right lower quadrant pain, abdominal distention,
weight loss, weakness and cramps, all as a result of the injuries she suffered due to the
polypropylene mesh. Id. at 35. Plaintiff has been told by her physicians, that the mesh implant
cannot safely be removed. Id. at 36-37. Accordingly, Plaintiff will continue to suffer from this
harm and take medication for the pain and discomfort for the remainder of her life. Id. at 37-38.
On June 24, 2015, Plaintiff filed a complaint against Atrium Medical Corporation, Does
1-20, Getinge Group, Getinge USA, Inc., Maquet Cardiovascular US Sales, LLC, Maquet
Cardiovascular, LLC, Maquet Medical Systems USA, and Premier Healthcare Alliance L.P..
Compl. (Doc. 1). Plaintiff voluntarily dismissed Premier Healthcare Alliance on August 5, 2015.
(Doc. 3). On September 8, 2015, Defendant Atrium Medical Corporation Filed a Motion to
Dismiss for Failure to State a Claim. (Doc. 6). Plaintiff subsequently filed an Amended
Complaint against Atrium Medical Corporation, Does 1-20, Getinge Group, Getinge USA, Inc.,
Maquet Cardiovascular US Sales, LLC, Maquet Cardiovascular, LLC, and Maquet Medical
Systems USA. (Doc. 15). Plaintiff’s six-count Amended Complaint, filed on October 30, 2016,
asserts causes of action in strict liability for failure to warn, (Counts I), as well as causes of
action for negligence (Count II), breach of express and implied warranties (Counts III-IV), fraud
(Count V), and negligent misrepresentation (Count VI). Defendants Atrium Medical
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Corporation, Maquet Cardiovascular US Sales, LLC, Maquet Cardiovascular, LLC, and Maquet
Medical Systems USA (hereinafter “Defendants”) filed this Motion to Dismiss the Complaint on
November 23, 2015, pursuant to Federal Rules of Civil Procedure 8, 9 and 12(b)(6). Def.’s Mot.
(Doc. 17).
ANALYSIS
A.
Strict Liability – Failure to Warn (Count I)
Defendants contend that Plaintiff’s strict liability claim is barred by Pennsylvania law.
(Doc. 18) at 5-7. Although the Pennsylvania Supreme Court has not explicitly held this to be the
case, many courts, including this Court, have so held. See e.g., Creazzo v. Medtronic, Inc., 903
A.2d 24, 31 (Pa. Super. Ct. 2006); Cogswell v. Wright Medical Tech., Inc., 2015 WL 4393385,
at *5(W.D. Pa. July 16, 2015); Gross v. Stryker Corp., 848 F. Supp. 2d 466, 482 (W.D. Pa.
2012); Horson v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov 10, 2011);
Kee v. Zimmer, Inc., 871 F. Supp. 2d 405, 409 (E.D. Pa. 2012).
The central issue is whether Comment k of the Restatement (Second) of Torts bars strict
liability claims for medical devices. Comment k, titled “Unavoidably unsafe products,” provides
that:
[t]here are some products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and ordinary use. These are
especially common in the field of drugs . . . Such a product, properly prepared,
and accompanied by proper directions and warning, is not defective, nor is it
unreasonably dangerous. The seller of such products . . . is not to be held to strict
liability for unfortunate consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and desirable product,
attended with a known but apparently reasonable risk.
Restatement (Second) of Torts § 402A cmt. k (1965) (emphasis in original). Although the
Pennsylvania Supreme Court has not yet decided whether the application of Comment k extends
to medical devices, the Superior Court of Pennsylvania explained that there is “no reason why
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the same rational [sic] applicable to prescription drugs may not be applied to medical devices.”
Creazzo, 903 A.2d at 31 (Pa. Super. Ct. 2006) (affirming the trial court determination that the
plaintiffs’ strict liability claim for a medical device was barred by Comment k). Several federal
district courts applying Pennsylvania law have similarly extended the application of Comment k
to medical devices. See, e.g., Terrell v. Davol, Inc., 2014 WL 3746532, at *4 (E.D. Pa. July 30,
2014); Gross v. Stryker Corp., 858 F. Supp. 2d 466, 482 (W.D. Pa. 2012); Horsmon 2011 WL
5509420, at *2.
Plaintiff argues that, if Comment k applies, a product is only covered by Comment k if it
meets the definition that it is “properly prepared, and accompanied by proper directions and
warning.” (Doc. 19) at 6. However, the Pennsylvania Supreme Court has rejected this exception
as it applies to prescription drugs. See Lance v. Wyeth, 85 A.3d 434, 453 (Pa. 2014)(holding
that, “for policy reasons this Court has declined to extend strict liability into the prescription drug
arena”); Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996)(holding that “where the adequacy of
warnings associated with prescription drugs is at issue . . . the manufacturer's negligence, is the
only recognized basis of liability”). In Horsmon, 2011 WL 5509420, at *2, and Cogswell, 2015
WL 4393385, at *3, this Court noted that “while other jurisdictions might recognize caveats to
Comment k’s exclusion of strict liability claims, this Court must apply Pennsylvania law, which
does not recognize such caveats.” Thus, Plaintiff’s argument that exceptions be made is
unpersuasive, and the Court will apply Comment k, without exceptions, to medical devices.
Accordingly, Plaintiff’s strict liability claim for failure to warn will be dismissed.
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E.
Negligence (Count II)
Plaintiff makes a number of negligence related claims without specifically stating on
which theory or theories of negligence she premises her claims. Defendants argue first, that to
the extent Plaintiff is asserting a negligent failure to test claim, the theory fails as a matter of law,
as Pennsylvania law imposes no affirmative duty to test. (Doc. 18) at 7-8. Next, Defendants
argue that to the extent that Plaintiff is asserting a negligent marketing claim, that claim is
likewise not recognized by Pennsylvania law. Id. Defendants also argue that Plaintiff’s
manufacturing defect claim is really a res ipsa loquitor claim that fails to meet the necessary
elements of such a claim. (Doc. 21) at 3. Finally, Defendants argue that to the extent Plaintiff
argues a negligent failure to warn claim, it too must fail due to Pennsylvania’s learned
intermediary doctrine. (Doc. 18) at 8-9
Plaintiff concedes that Pennsylvania law prohibits her negligent marketing and negligent
testing claims. However, she asserts her negligence claims for manufacturing defect and failure
to warn are plausible. The manufacturing defect claim should proceed, she argues, because it
reasonably can be inferred, based on the allegations in the complaint, that the product was
manufactured in such a way that it was unreasonably safe and that lack of safety led to Plaintiff’s
health problems. As to the negligent failure to warn claim, Plaintiff argues that she has put forth
sufficient facts in the Amended Complaint to establish that the physicians in this case were not
adequately informed, thus overcoming Pennsylvania’s learned intermediary doctrine.
As to the manufacturing defect claim, the Court agrees with Defendants that the
allegations in Plaintiff’s complaint are conclusory statements insufficient to overcome the
pleading standard established by the United States Supreme Court in Iqbal and Twombly. Rule
8(a) requires that pleadings contain “a short and plain statement of the claim showing that the
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pleader is entitled to relief.” Fed. R. Civ. P. 8(a). The complaint “must contain sufficient factual
matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570
(2007)). Mere ‘“labels and conclusions’ or ‘a formulaic recitation of the elements of a cause of
action will not do.’” Ashcroft, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 555). Plaintiff
does not point to specific facts to support negligence in the manufacturing process; she simply
makes general statements that Defendants were negligent in the manufacturing process. See
(Doc. 15) at ¶¶ 52 and 52(b). Under Iqbal and Twombley, that is not enough. Accordingly,
Plaintiff’s manufacturing defect claim will be dismissed without prejudice.
As to Plaintiff’s failure to warn claim, it is well established that a “manufacture’s duty to
warn is directed toward physicians,” not to the patient or general public. Lance, 85 A.3d at 438
n.6; Kline v. Pfizer, 2008 WL 4787577, *3 (E.D. Pa. Oct. 31, 2008) (citing Baldino v. Castagna,
478 A.2d 807, 812 (Pa. 1984)). Plaintiff makes multiple allegations that not only did Defendants
fail to provide adequate warning of the risks associated with the polypropylene mesh to her, but
Defendants likewise failed to inform Plaintiff’s physicians. See (Doc. 15) at ¶¶ 25, 45(a)-(t), 4647 and 53. Specifically, she alleges:
Despite the abundance of scientific and medical information published in the literature
relating to the dangerous properties of polypropylene mesh, Defendants made a deliberate
decision to ignore these dangers and to aggressively promote polypropylene mesh to
healthcare providers and consumers. Defendants misrepresented and concealed from
Plaintiff, her physicians and consumers, the serious risks, damages and defects
enumerated in this complaint.
(Doc. 15) at ¶ 25. Thus, after reading the Amended Complaint as a whole and in the light most
favorable to Plaintiff, the Court finds Plaintiff has alleged sufficient facts to establish that
Defendants failed to exercise reasonable care in informing Plaintiff’s doctors of the alleged
defects of polypropylene mesh, thereby depriving Plaintiff of advice from a fully informed
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physician. See Wilson v. Synthes USA Products, LLC, 116 F. Supp. 3d 463, 469 (E.D. Pa.
2015) (finding a negligent failure to warn claim could proceed where plaintiff alleged that
physicians were not adequately warned of storage and handling requirements, of manufacturing
defects and that the device could fail). Defendants Motion will be denied as to Plaintiff’s
negligent failure to warn claim.
C.
Breach of Implied Warranty (Count III)
Defendants assert that Plaintiff’s breach of implied warranty claim is barred by
Pennsylvania law. (Doc. 18) at 10-11. Plaintiff does not make any specific argument in support
of her implied warranty claim. The Superior Court of Pennsylvania addressed this issue for
prescription drugs, explaining that “the very nature of prescription drugs themselves precludes
the imposition of a warranty of fitness for ‘ordinary purposes’, as each individual for whom they
are prescribed is a unique organism.” Makripodis by Makripodis v. Merrell-Dow Pharm., Inc.,
523 A.2d 374, 377 (Pa. Super. Ct. 1987). A number of Pennsylvania federal courts have
extended this reasoning to preclude implied warranty of fitness and merchantability claims for
medical devices as well. E.g., Terrell, 2014 WL 3746532, at *7; Horsmon, 2011 WL 5509420,
at *3; Kester v. Zimmer Holdings, Inc., 2010 WL 2696467, at *11 (W.D. Pa. June 16, 2010)
(invoking the same logic for implied warranties that bars strict liability for medical devices);
Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 752 (E.D. Pa. 2007) (dismissing both implied
warranty of fitness and merchantability claims); Parkinson v. Guidant Corp., 315 F. Supp. 2d
741, 753 (W.D. Pa. 2004) (noting that “there is no basis in law or logic to treat prescription drugs
differently than prescription medical devices”).
In a claim for breach of implied warranty of merchantability, “[t]he essence of the
warranty of merchantability is that the item sold is fit for the ordinary purposes for which such
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goods are used.” Makripodis v. Merrell–Dow Pharms., Inc., 523 A.2d 374, 376
(Pa.Super.Ct.1987) (citing Wisniewski v. Great Atl. & Pac. Tea Co., 323 A.2d 744, 746–47
(Pa.Super.Ct.1974); 13 Pa.C.S. § 2314(b)(3)). Since this Court has determined, both in this case
and in previous cases, that medical devices fall under the umbrella of Comment k, and thus are
unavoidably unsafe products, there can be no breach of implied warranty. See Cogswell 2015
WL 4393385, at *5; Horsmon, 2011 WL 5509420, at *2. Thus, Plaintiff’s claim for breach of
implied warranty will be dismissed.
D. Breach of Express Warranty (Count IV)
Defendants argue that Plaintiff’s express warranty claim is similarly barred by
Pennsylvania law. Def.’s Reply (Doc. 12) at 4. Federal courts in Pennsylvania are split on the
viability of an express warranty claim for a medical device. Killen v. Stryker Spine, 2012 WL
4498865, at *4 (W.D. Pa. Sept. 28, 2012). This Court has previously held such a claim to be
barred under Pennsylvania law, Cogswell, 2015 WL 4393385, at *4, and will so find in this case.
Plaintiff’s claim for breach of express warranty will dismissed.
F. Fraud (Count V)
Plaintiff concedes that her fraud claim is barred due to precedential case law. This claim
will be dismissed.
G. Negligent Misrepresentation (Count VI)
Defendants argue that Plaintiff’s allegations as to her negligent misrepresentation count
do not meet the pleading requirements of Rule 8(a) and the standards established in Twombly
and Iqbal. Defendants argue that the Amended Complaint “fails to aver the statements that are
allegedly false, by whom those specific statements were made, in what manner they were
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allegedly false, and how the allegedly false nature of the statements induced reliance by Plaintiff
and her physicians.” (Doc. 18) at 15-16.
Although Defendant claims that Plaintiff’s allegations do not have the requisite level of
particularity, Plaintiff does, in fact, allege that Defendants marketed the product as “safe, fit and
effective for use in hernia repair.” (Doc. 15) at ¶ 74. Plaintiff additionally alleges that Defendant
intended Plaintiff to rely on its misrepresentations, which Plaintiff indicates she did. Id. at ¶ 7778. Reading the Amended Complaint as a whole and taking into account Plaintiff’s allegations
regarding Defendants inadequate warnings, Defendants’ misrepresentations and Defendants’
failure to provide adequate information to consumers, including Plaintiff, and physicians, id. at ¶
45(a)-(t), Plaintiff has met the Rule 8(a) standard to place Defendants on notice of the
misconduct charged. Moreover, the facts alleged are sufficient to state a claim for negligent
misrepresentation.
Therefore, the motion to dismiss Plaintiff’s negligent misrepresentation claim will be
denied.
II. ORDER
For the reasons stated above, Defendants Atrium Medical Corporation, Maquet
Cardiovascular US Sales, LLC, Maquet Cardiovascular, LLC, and Maquet Medical Systems
USA’s Motion to Dismiss (Doc. 17) is GRANTED IN PART and DENIED IN PART. With
respect to Plaintiff’s claims of negligent failure to warn and negligent misrepresentation, the
Motion to Dismiss is DENIED. In every other respect, the Motion to Dismiss is GRANTED.
Specifically, the following claims are hereby DISMISSED WITH PREJUDICE:
Plaintiff’s strict liability claim for failure to warn (Count I), claim for breach of express warranty
(Count III), claim for breach of implied warranty (Count IV), and claim for fraud (Count V).
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Additionally, the following claims are hereby DISMISSED WITHOUT PREJUDICE:
Plaintiff’s negligence claims for negligent failure to test (Count II), negligent marketing (Count
II), and manufacturing defect (Count II).
IT IS SO ORDERED.
June 8, 2016
s\Cathy Bissoon
Cathy Bissoon
United States District Judge
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