Coleman et al v. Boston Scientific Corporation

Filing 48

MEMORANDUM, DECISION re: 34 Motion to Dismiss First Amended Complaint, signed by Senior Judge Oliver W. Wanger on 8/29/2011. (Kusamura, W)

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UNITED STATES DISTRICT COURT
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EASTERN DISTRICT OF CALIFORNIA
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1:10-cv-01968-OWW-SKO
PAMELA COLEMAN,

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MEMORANDUM DECISION REGARDING
MOTION TO DISMISS FIRST
AMENDED COMPLAINT (Doc.34)

Plaintiff,

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v.

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BOSTON SCIENTIFIC CORPORATION,
et al.,

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Defendants.

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I. INTRODUCTION.

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Pamela Coleman (“Plaintiff”) proceeds with an action for

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damages against Boston Scientific Corporation (“Defendant”) and

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various Doe Defendants.

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(“FAC”) on June 17, 2011.

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Plaintiff filed a First Amended Complaint
(Doc. 31).

Defendant filed a motion to dismiss the FAC on July 7, 2011.

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(Doc. 34). Plaintiff filed opposition to the motion to dismiss on

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August 1, 2011.

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2011.

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(Doc. 39).

Defendant filed a reply on August 8,

(Doc. 44).
II. FACTUAL BACKGROUND.

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On December 5, 2006, a physician implanted a surgical mesh

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device manufactured by Defendant into Plaintiff in connection with

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treatment of Plaintiff’s stress urinary incontinence. The surgical

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mesh device is described as an Obtryx Transobturator Mid-Urethral
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Sling System (“Mesh Device”) and is designed to restore normal

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vaginal structure secondary to pelvic organ prolapse.

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began to experience “recurrent pelvic pain, erosions, and recurrent

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infection of the tissue around the mesh” subsequent to implantation

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of the Mesh Device. From July 2007 through January 2009, Plaintiff

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underwent surgery, vaginal reconstruction, and mesh removal “to

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correct the injuries caused by the mesh.”

Plaintiff

(FAC at 8).

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The FAC alleges that Defendant marketed the Mesh Device in a

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deceptive manner to the medical community and patients at medical

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conferences, hospitals, private offices, and through documents,

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brochures, and websites.

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the Mesh Device has high failure, injury, and complication rates,

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fails to perform as intended, and requires frequent re-operations.

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Defendant withheld and underreported information about the safety

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of its Mesh Device.

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and test its Mesh Product.

Defendants also failed to adequately research

III. LEGAL STANDARD.

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Contrary to Defendant’s representations,

Dismissal

under

Rule

12(b)(6)

is

appropriate

where

the

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complaint lacks sufficient facts to support a cognizable legal

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theory. Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th

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Cir.1990). To sufficiently state a claim to relief and survive a

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12(b) (6) motion, the pleading "does not need detailed factual

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allegations" but the "[f]actual allegations must be enough to raise

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a right to relief above the speculative level." Bell Atl. Corp. v.

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Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007).

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Mere "labels and conclusions" or a "formulaic recitation of the

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elements of a cause of action will not do." Id. Rather, there must

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be "enough facts to state a claim to relief that is plausible on
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its face." Id. at 570. In other words, the "complaint must contain

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sufficient factual matter, accepted as true, to state a claim to

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relief that is plausible on its face." Ashcroft v. Iqbal, --- U.S.

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----, ----, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (internal

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quotation marks omitted).

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The Ninth Circuit has summarized the governing standard, in

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light of Twombly and Iqbal, as follows: "In sum, for a complaint to

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survive a motion to dismiss, the nonconclusory factual content, and

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reasonable

inferences

from

that

content,

must

be

plausibly

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suggestive of a claim entitling the plaintiff to relief." Moss v.

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U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir.2009) (internal

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quotation marks omitted). Apart from factual insufficiency, a

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complaint is also subject to dismissal under Rule 12(b)(6) where it

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lacks a cognizable legal theory, Balistreri, 901 F.2d at 699, or

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where the allegations on their face "show that relief is barred"

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for some legal reason, Jones v. Bock, 549 U.S. 199, 215, 127 S.Ct.

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910, 166 L.Ed.2d 798 (2007).

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In deciding whether to grant a motion to dismiss, the court

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must accept as true all "well-pleaded factual allegations" in the

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pleading under attack. Iqbal, 129 S.Ct. at 1950. A court is not,

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however, "required to accept as true allegations that are merely

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conclusory,

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inferences." Sprewell v. Golden State Warriors, 266 F.3d 979, 988

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(9th Cir.2001). "When ruling on a Rule 12(b)(6) motion to dismiss,

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if a district court considers evidence outside the pleadings, it

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must normally convert the 12(b)(6) motion into a Rule 56 motion for

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summary

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opportunity to respond."

unwarranted

judgment,

and

deductions

it

must

of

give

fact,

the

or

unreasonable

nonmoving

party

an

United States v. Ritchie, 342 F.3d 903,
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907

(9th

Cir.2003).

"A

court

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materials-documents

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incorporated by reference in the complaint, or matters of judicial

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notice-without converting the motion to dismiss into a motion for

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summary judgment." Id. at 908.

attached

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to

however,
the

consider

complaint,

certain

documents

IV. DISCUSSION.

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may,

A. Statute of Limitations
California law establishes a two-year statute of limitations
for personal injury actions.

Cal. Code Civ. Proc. 335.1; e.g.,

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Mito v. Temple Recycling Center Corp., 187 Cal. App. 4th 276, 278-

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79 (Cal. Ct. App. 2011).

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accrues “when, under the substantive law, the wrongful act is done,

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or the wrongful result occurs.”

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University of California, 162 Cal. App. 4th 343, 359 (Cal. Ct. App.

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2008).

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the ‘discovery rule,’ which postpones accrual of a cause of action

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until the plaintiff discovers, or has reason to discover, the cause

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of action.”

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807) (citing Norgart v. Upjohn Co., 21 Cal. 4th 383, 397 (Cal.

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1999)).

As a general rule, a cause of action

E.g., Unruh-Haxton v. Regents of

“An important exception to the general rule of accrual is

Fox v. Ethicon Endo-Surgery, Inc., 35 Cal. 4th 797,

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A plaintiff has reason to discover a cause of action when he

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or she “has reason at least to suspect a factual basis for its

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elements.”

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knowledge of an injury if they have “ information of circumstances

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to put them on inquiry,” or if they have “the opportunity to obtain

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knowledge

from

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(citations

and

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California is that it is not enough to commence the running of the

Id. at 808.

sources

Plaintiffs are charged with presumptive

open

quotations

to

their

omitted).

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investigation.”
However,

“the

rule

Id.
in

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limitations period when the plaintiff knows of her injury and its

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factual cause (or physical cause).”

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Corp., 83 Cal. App. 4th 1048, 1056 (Cal. Ct. App. 2000).

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the plaintiff must be aware of her injury, its factual cause, and

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sufficient facts to put her on inquiry notice of a [wrongful] cause

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[of injury].”

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1103, 1109-1114 (Cal. 1988)).

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objective standard that looks not to what the particular plaintiff

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actually knew but to what a reasonable inquiry would have revealed.

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Mills v. Forestex Co., 108 Cal. App. 4th 625, 648 (Cal. Ct. App.

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2003) (citation omitted); accord Landale-Cameron Court, Inc. v.

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Ahonen, 155 Cal. App. 4th 1401, 1407 (Cal. Ct. App. 2007) (citing

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Mills).

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Clark v. Baxter Healthcare
“Rather,

Id. (citing Jolly v. Eli Lilly & Co., 44 Cal. 3d
The discovery rule is based on an

The FAC alleges that Plaintiff underwent surgery in July 2007

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in order to effect vaginal reconstruction, mesh removal, and

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correction of “injuries caused by the mesh.” (FAC at 8).

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the FAC’s allegations are vague, the plain meaning of the FAC’s

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allegation

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surgery vaginal reconstruction, and mesh removal to correct the

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injuries caused by the mesh” suggests that Plaintiff was aware of

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sufficient facts to put her on inquiry notice in July 2007 that

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reconstructive surgery was necessary because the device did not

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perform.

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device, which requires a second corrective surgery to remove the

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device and correct injuries resulting there from within a year of

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implantation should suspect the defectiveness of the device and

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conduct a reasonable inquiry and examination into the suitability

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of the device.

that

Plaintiff

“was

forced

to

undergo

Although

revisionary

A reasonable person who is implanted with a medical

See Henderson v. Pfizer, Inc., 285 Fed. Appx. 370,
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372

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limitations period under California Code of Civil Procedure 335.1

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for claim arising out of injury caused by medical device accrued at

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the time plaintiff required surgery to remove the device).

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FAC’s own allegations suggest that Plaintiff’s claim is time-

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barred, as it was not filed within two years of Plaintiff’s July

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2007 surgery.1

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(9th

Cir.

2008)

(unpublished)

(holding

that

two-year

The

Plaintiff contends she was not put on inquiry notice of her
claim until publication of an FDA warning in 2008.

The FDA

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publication discussed a range of potential risks associated with

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implantation of medical devices such as the Mesh Device that

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injured

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publication is unavailing, as it did not put Plaintiff on notice of

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any new facts relevant to her claim.

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publication in 2008, at least one of the types of risks discussed

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in the FDA publication had already materialized for Plaintiff and

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required surgery in July 2007.

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the reason for her July 2007 surgery, she was on inquiry notice at

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that

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concealment are also unavailing.

Plaintiff.

time.

Plaintiff’s

Plaintiff’s

attempt

to

rely

on

the

FDA

By the time of the FDA

To the extent Plaintiff understood

conclusory

averments

of

fraud

and

The FAC does not allege ultimate

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Due to the lack of detail concerning the nature of Plaintiff’s 2007 surgery,
it cannot be said as a matter of law that Plaintiff was on inquiry notice of her
claims in 2007. For this reason, Plaintiff is given leave to amend. Because
Plaintiff’s FAC suggests on its face that her claims are time-barred, any amended
complaint must plead facts sufficient to suggest application of the discovery
rule. See, e.g., McKelvey v. Boeing North American, Inc., 74 Cal. App. 4th 151,
160, 86 Cal. Rptr. 2d 645 (Cal. Ct. App. 1999) partially superceded on other
grounds as stated in Grisham v. Philip Morris U.S.A., Inc., 40 Cal. 4th 623, 637
n.8, 54 Cal. Rptr. 3d 735, 151 P.3d 1151 (Cal. Ct. App. 2007). In the context
of Plaintiff’s July 2007 surgery, Plaintiff must allege facts to suggest that,
due to the nature of the surgery and the information Plaintiff possessed
regarding the procedure, a reasonable person in Plaintiff’s position would not
have suspected that the Mesh Device was defective.

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facts sufficient to suggest that Defendant engaged in any conduct

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that prevented Plaintiff from investigating the circumstances that

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required her to undergo surgery in July 2007.

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Plaintiff will be given one last opportunity to amend her

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complaint to allege facts sufficient to suggest that Plaintiff’s

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claims are not time-barred, subject to the requirements of Federal

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Rule of Civil Procedure 11.

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instructions of the court.

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orders will be handled accordingly.

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Plaintiff has not heeded the prior

Her continued disregard of the court’s

B. Defendant’s Learned Intermediary Argument

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Defendant

invokes

California’s

“learned

intermediary

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doctrine,” which imposes the duty to warn of dangers associated

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with a medical product on the physician, not the patient, under

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appropriate circumstances.

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Cal.

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learned-intermediary

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associated with its usage runs to the physician, not the patient”).

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The

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disclose material information concerning use of the Mesh Device to

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“Plaintiff and/or Plaintiff’s healthcare providers.” (FAC at 6-7).

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The FAC also alleges that Defendant’s product literature falsely

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assured “Plaintiff’s healthcare providers and physicians” that the

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Mesh Device was safe for treating Plaintiff’s conditions.

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The learned intermediary argument articulated in Defendant’s Motion

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to Dismiss does not provide a basis for dismissing the FAC. The

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motion to dismiss on this ground is DENIED.

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C. Express Warranty Claim

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App.

4th

complaint

89,

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n.5

See, e.g., Conte v. Wyeth, Inc., 168
(Cal.

doctrine

sufficiently

Ct.

App.

2008)

Wyeth's

duty

to

alleges

that

(“under

warn

Defendant

of

the

risks

failed

to

(Id.).

“As a general rule, privity of contract is a required element
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of

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Fieldstone Co. v. Briggs Plumbing Products, Inc., 54 Cal. App. 4th

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357, n.10 (Cal. Ct. App. 1997).

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absolute requirement for express warranty claims under California

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law, because reliance on a seller’s representations may provide the

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basis for an express warranty claim even absent privity.

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memorandum

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provides, in pertinent part:

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an

express

breach

decision

of

warranty

dismissing

cause

of

action.”

E.g.,

However, privity is not an

Plaintiff’s

original

Id.

complaint

Defendants’ contention that privity is an element of an
express warranty claim is incorrect. E.g., Evraets, 29
Cal. App. 4th at 857 n.4 ("privity is not a requirement
for actions based upon an express warranty"); Fieldstone
Co. v. Briggs Plumbing Products, Inc., 54 Cal. App. 4th
357, n.10 (Cal. Ct. App. 1997) ("As a general rule,
privity of contract is a required element of an express
breach of warranty cause of action. However, there is an
exception where plaintiff's decision to purchase the
product was made in reliance on the manufacturers'
written representations in labels or advertising
materials.") (citations omitted). However, Plaintiffs
express warranty claims must be dismissed, as the
complaint does not allege facts sufficient to give rise
to a plausible basis to believe that Plaintiffs relied on
any representations made by Defendants. See, e.g., id.

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Plaintiffs' conclusory allegations that Defendants
advertised their products as safe and effective lack even
general information describing such alleged conduct. As
one
district
court
has
aptly
noted,
conclusory
allegations such as those advanced by Plaintiffs are
insufficient to support a plausible basis for an express
warranty claim:

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Evraets stands as clear authority that at
least at the pleading stage, California law
permits a claim for breach of an express
warranty to go forward under circumstances
[where reliance is alleged]. That said, the
complaint as presently constituted fails to
allege any express warranties actually made by
Stryker, except in the most general and
conclusory terms. Accordingly, the claim for
breach of express warranty will be denied,
with leave to amend.

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Quatela v. Stryker Corp., 2010 U.S. Dist. LEXIS 133706 *
4-6 (N.D. Cal. 2010).
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The

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The FAC alleges neither privity nor reliance as the basis for
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Plaintiff’s express warranty claim. Plaintiff’s argument that she
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need not plead reliance in order to state a cognizable breach of
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express warranty claim is contrary to California law and ignores
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the analysis provided in the memorandum decision.2

None of the

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authorities Plaintiff cites in her opposition support the erroneous
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proposition that reliance is not required in an express warranty
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action not founded on privity.
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Plaintiff cites Weinstat v. Dentsply Intern., Inc., 180 Cal.
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App. 4th 1213, 1225 (Cal. Ct. App. 2010) and Keith v. Buchanan, 173
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Cal. App. 3d 13, 21 (Cal. Ct. App. 1985) for the proposition that
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reliance is not a requirement of her express warranty claim.

In

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Winestat the purchasers of dental equipment sued the seller, and
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the express warranty claim was based on

privity.

See id.

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Similarly, in Keith, the purchaser of a boat sued the company that
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sold him the boat and allegedly made express warranties antecedent
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to

the

transaction.

Neither

Weinstat

nor

Keith

supports

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Plaintiff’s erroneous contention that reliance is not required
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where privity is absent.
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Plaintiff’s invocation of California Commercial Code section
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2313 is unavailing, as it does not alter the requirement that
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reliance (or some other substitute for privity) is required for an
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express warranty claim against a non-selling manufacturer of a
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In light of the memorandum decision, Plaintiff’s counsel’s argument that
neither reliance nor privity is required, without so much as attempting to
address the court’s prior analysis, violates Federal Rule of Civil Procedure 11
and applicable standards of professional conduct.
Plaintiff’s disingenuous
attempt to characterize the correct arguments advanced in Defendant’s brief as
misleading compounds counsel’s breach of duty.

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product. See, e.g., Wiley v. Yihua Int'l Group, 2009 Cal. App.

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Unpub. LEXIS 8880 * 13-16 (Cal. Ct. App. 2009) (unpublished).

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In Burr v. Sherwin Williams Co. 42 Cal.2d 682, (1954) the
California Supreme Court held "[t]he general rule is that
privity of contract is required in an action for breach
of either express or implied warranty and that there is
no privity between the original seller and a subsequent
purchaser who is in no way a party to the original sale."
Id. at p. 695; see also Windham at Carmel Mountain Ranch
Assn. v. Superior Court 109 Cal. App. 4th 1162, 1169
(Cal. 2003) [same, quoting Burr]; Arnold v. Dow Chemical
Co. 91 Cal. App. 4th 698, 720 (Cal. Ct. App. 2001) [same,
quoting Burr]; All West Electronics, Inc. v. M-B-W, Inc.
64 Cal.App.4th 717, 725
(1998)[same, quoting Burr].)
Burr observed that courts created exceptions to the
privity rule for items such as foodstuffs (Burr, at p.
695), and after Burr, the exception
was extended to
drugs and pesticides. See Windham at Carmel Mountain
Ranch, at p. 1169 & fn. 7 [observing these exceptions
were created by courts before the establishment of the
doctrine of strict liability in tort]; Arnold v. Dow
Chemical Co., at pp. 720-721; Fundin v. Chicago Pneumatic
Tool Co. (1984) 152 Cal.App.3d 951, 956, fn. 1.) Burr
also recognized that "[a]nother possible exception to the
general rule is found in a few cases where the purchaser
of a product relied on representations made by the
manufacturer in labels or advertising material, and
recovery from the manufacturer was allowed on the theory
of express warranty without a showing of privity." (Burr,
42 Cal.2d at p. 696; see also Smith v. Gates Rubber Co.
Sales Division (1965) 237 Cal.App.2d 766, 768.)
Since Burr, the California Supreme Court has made
statements in cases broadly suggesting that courts no
longer require privity in express warranty cases. (See
Seely v. White Motor Co. (1965) 63 Cal.2d 9, 14 ["Since
there was an express warranty to plaintiff in the
purchase order, no privity of contract was required"];
Hauter, supra, 14 Cal.3d at p. 115, fn. 8 ["The fact that
[plaintiff] is not in privity with defendants [*20] does
not bar recovery. Privity is not required for an action
based upon an express warranty"].) However, Seely and
Hauter did not overrule Burr, and, unlike the case at
hand, both cases involve written warranties similar to
advertisements and labels where the plaintiffs saw and
relied upon the written statements in purchasing the
product at issue. (Seely, at p. 13 [plaintiff relied on
statements in purchase order when buying a truck];
Hauter, at pp. 109, 117 [plaintiff read and relied on
defendant's representation on the label of a shipping
carton].) The broad language in Seely and Hauter narrows
significantly when read in the context of those facts.
Further, as indicated above, several cases decided after
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Seely reflect the continuing validity of Burr's privity
requirement. (Windham at Carmel Mountain Ranch Assn. v.
Superior Court, supra, 109 Cal.App.4th at p. 1169; Arnold
v. Dow Chemical Co., supra, 91 Cal.App.4th at p. 720; All
West Electronics, Inc. v. M-B-W, Inc., supra, 64
Cal.App.4th at p. 725.) We conclude plaintiffs' asserted
"independent liability" theory under section 2313 is
defeated by the fact they did not bargain with or
directly purchase the products from Yihua, and were not
in privity of contract with it.

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Id.
Finally, Plaintiff’s attempt to rely on California Civil Code
section 1791.2 fails.

Section 1791 defines the term “consumer

goods” as
any new product or part thereof that is used, bought, or
leased for use primarily for personal, family, or
household purposes, except for clothing and consumables.
"Consumer goods" shall include new and used assistive
devices sold at retail.

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Cal Civ. Code. 1791(a).

Assistive device is defined as:

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any instrument, apparatus, or contrivance, including any
component or part thereof or accessory thereto, that is
used or intended to be used, to assist an individual with
a disability in the mitigation or treatment of an injury
or disease or to assist or affect or replace the
structure or any function of the body of an individual
with a disability, except that this term does not include
prescriptive lenses and other ophthalmic goods unless
they are sold or dispensed to a blind person, as defined
in Section 19153 of the Welfare and Institutions Code and
unless they are intended to assist the limited vision of
the person so disabled.

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Cal. Civ. Code 1791 (p).

Although the Mesh Device appears to fall

23
within the scope of the term “assistive device,” the FAC does not
24
allege the “sale at retail” of any assistive device.
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In light of Plaintiff’s inability to amend her complaint to
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allege reliance or privity after being provided with express
27
instructions

in

the

Memorandum

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11

Decision,

Plaintiff’s

express

1

warranty claim is DISMISSED WITH PREJUDICE.
ORDER

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For the reasons stated, IT IS ORDERED:

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1)

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PREJUDICE;

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2)Plaintiff’s

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prejudice;

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3) Plaintiff shall file an amended complaint within thirty

9

days of electronic service of this decision; no further leave

Plaintiff’s

express

warranty

remaining

claims

claim

are

is

DISMISSED

dismissed,

WITH

without

10

to amend will be given.

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amended complaint within thirty days; and

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4) Defendant shall file a form of order consistent with this

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memorandum decision within five days of electronic service of

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this decision.

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IT IS SO ORDERED.

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Dated:
hkh80h

August 29, 2011

Defendant shall respond to any

/s/ Oliver W. Wanger
UNITED STATES DISTRICT JUDGE

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