Rhynes et al v. Stryker Corporation et al

Filing 37

ORDER by Judge Samuel Conti granting 29 Motion to Dismiss (sclc1, COURT STAFF) (Filed on 10/27/2011)

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IN THE UNITED STATES DISTRICT COURT

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FOR THE NORTHERN DISTRICT OF CALIFORNIA

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GLORIA RHYNES, Individually and
on behalf of the general public,
and DARRELL JENKINS,

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Plaintiffs,

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United States District Court

For the Northern District of California

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v.

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STRYKER CORPORATION; STRYKER
ORTHOPEDICS; AND DOES 1 through
30, inclusive,
Defendants.

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) Case No. 10-5619 SC
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) ORDER GRANTING DEFENDANTS'
) MOTION TO DISMISS
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I.

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INTRODUCTION
This matter comes before the Court on a Motion to Dismiss

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Plaintiffs' First Amended Complaint ("FAC") filed by Defendants

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Stryker Corporation and Howmedica Osteonics Corporation, sued

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herein under the name Stryker Orthopedics, (collectively,

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"Defendants") against Plaintiffs Gloria Rhynes ("Rhynes") and

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Darrell Jenkins ("Jenkins") (collectively, "Plaintiffs").

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29 ("Mot.").

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31 ("Reply").

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Defendants' Motion and DISMISSES the FAC with leave to amend.

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The Motion is fully briefed.

ECF No.

ECF Nos. 30 ("Opp'n"),

For the reasons set forth below, the Court GRANTS

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II.

BACKGROUND
Plaintiffs commenced this action in the Superior Court of

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California, County of San Francisco, on September 30, 2010.

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No. 1 ("Not. Of Removal") Ex. A ("Compl.").

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asserted four claims against Defendants arising from an allegedly

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defective artificial hip prosthesis1 that she received during a hip

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replacement surgery on August 15, 2005: negligence, strict

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liability for defective product, violation of California's Unfair

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Competition Law ("UCL"), and wanton and reckless misconduct.

Plaintiff Rhynes

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United States District Court

For the Northern District of California

ECF

Plaintiff Jenkins asserted a derivative claim for loss of

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consortium.

Id.

Id.

The Court granted Defendants' initial Motions to Dismiss and

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Strike Plaintiffs' Complaint on May 31, 2011.

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2011 Order").

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and strict liability for two reasons.

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Rhynes had failed to include sufficient well-pleaded factual

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allegations to state a claim because she had not explained how the

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allegedly defective implant injured her.

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that Rhynes' attempt to avoid the statute of limitations for her

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claims by invoking the "discovery rule" failed because she had not

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adequately pled sufficient facts as to how she discovered the

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injury and why she could not have discovered it sooner.

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granted Rhynes leave to amend these two claims.

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The Court dismissed Rhynes' claims for negligence
First, the Court held that

Second, the Court held

The Court

The Court also dismissed Rhynes' UCL claim without leave to

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ECF No. 26 ("May 31,

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The prosthesis was approved by the U.S. Food and Drug
Administration ("FDA") as a Class III medical device, the class of
devices that "is 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" or
"presents a potential unreasonable risk of illness or injury." 21
U.S.C. § 360c(a)(1)(C).
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amend because it sought equitable relief where Plaintiffs had an

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adequate remedy at law.

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wanton and reckless misconduct with leave to amend.

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Court struck all strict liability design defect allegations from

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the Complaint under Hufft v. Horowitz, 4 Cal. App. 4th 8, 19-20

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(Ct. App. 1992) (manufacturers of prescription implanted medical

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devices are not subject to strict liability for design defects).

The Court dismissed Plaintiffs' claim for
Lastly, the

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On June 23, 2011, Plaintiffs filed a FAC in which Rhynes

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reasserted her claims for strict liability, negligence, and wanton

United States District Court

For the Northern District of California

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misconduct, and Jenkins reasserted his claim for loss of

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consortium.

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Rhynes was injured, the FAC alleges Rhynes underwent surgery on

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August 15, 2005, at which time she was implanted with a Trident

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acetabular shell hip prosthesis ("the device").

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explains that the device was defective because manufacturing

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discrepancies caused the loosening of the acetabular shell, causing

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"considerable inflammation and wear in the adjoining bone and joint

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including fragments from the component invading the nearby tissue

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and bone impairing [Rhynes'] mobility, causing intense pain and

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injury."

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ECF No. 27 ("FAC") ¶¶ 6-26.

With respect to how

Id. ¶ 5.

The FAC

Id.

With respect to the discovery rule, the FAC alleges Rhynes was

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unaware of the injury from the defect until February 2009, when

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surgery revealed the defective product.

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unable to discover the defect earlier because "she was only able to

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discover the defective product by undergoing a serious and invasive

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surgery which she undertook at the time prescribed by her treating

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physicians and after other treatments failed."

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Id.

Rhynes

was allegedly

Id.

The FAC also includes allegations regarding defects discovered

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by the FDA.

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surgery in which Rhynes was implanted with the device, the FDA

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conducted an investigation and advised Defendants in two separate

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warning letters that they had failed to conform to proper

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manufacturing and quality control standards.

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Plaintiffs also allege that, in spite of these warnings, Defendants

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failed to warn Rhynes of the possible defects in the device and the

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possible harms that it could cause.

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Specifically, Plaintiffs allege that, prior to the

Id. ¶¶ 18d, 20.

Id.

In their Motion, Defendants argue that (1) Plaintiffs' claims

United States District Court

For the Northern District of California

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are time-barred because Plaintiffs have again failed to properly

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plead application of the discovery rule, and (2) Plaintiffs' claims

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are preempted by the Medical Device Amendments ("MDA"), 21 U.S.C.

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360c et seq., to the Food, Drug and Cosmetics Act ("FDCA").

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III. LEGAL STANDARD
A motion to dismiss under Federal Rule of Civil Procedure

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12(b)(6) "tests the legal sufficiency of a claim."

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Block, 250 F.3d 729, 732 (9th Cir. 2001).

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on the lack of a cognizable legal theory or the absence of

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sufficient facts alleged under a cognizable legal theory."

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

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1988).

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should assume their veracity and then determine whether they

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plausibly give rise to an entitlement to relief."

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Iqbal, 129 S. Ct. 1937, 1950 (2009).

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court must accept as true all of the allegations contained in a

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[claim] is inapplicable to legal conclusions.

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of the elements of a cause of action, supported by mere conclusory

Navarro v.

"Dismissal can be based

"When there are well-pleaded factual allegations, a court

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Ashcroft v.

However, "the tenet that a

Threadbare recitals

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statements, do not suffice."

Id. (citing Bell Atl. Corp. v.

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Twombly, 550 U.S. 544, 555 (2007)).

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complaint or counterclaim must be both "sufficiently detailed to

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give fair notice to the opposing party of the nature of the claim

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so that the party may effectively defend against it" and

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"sufficiently plausible" such that "it is not unfair to require the

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opposing party to be subjected to the expense of discovery."

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v. Baca, 633 F.3d 1191, 1204 (9th Cir. 2011).

The allegations made in a

Starr

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United States District Court

For the Northern District of California

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IV.

DISCUSSION

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A.

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Defendants contend that Plaintiffs' claims are barred by the

Discovery Rule

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applicable statute of limitations because they were not brought

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within two years of the date on which Rhynes was allegedly

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injured.2

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rule" does not save Plaintiffs' time barred claims.

Mot. at 9.

Defendants further argue that the "discovery
Id.

California's discovery rule delays the accrual of a cause of

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action until a plaintiff either became aware of the injury and its

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cause or could have discovered the injury and cause through

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reasonable diligence.

Fox v. Ethicon Endo-Surgery, Inc., 35 Cal.

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4th 797, 808 (2005).

In order to rely on the discovery rule, "[a]

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plaintiff whose complaint shows on its face that his claim would be

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barred without the benefit of the discovery rule must specifically

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plead facts to show (1) the time and manner of discovery and (2)

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the inability to have made earlier discovery despite reasonable

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diligence."

Id. (internal quotation omitted).

Under the discovery

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The California Code of Civil Procedure provides that the
applicable statute of limitations for a personal injury action is
two years. Cal. Civ. Proc. Code § 335.1.
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rule, the statute of limitations begins to run "when the plaintiff

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suspects or should suspect that her injury was caused by

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wrongdoing."

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1988).3

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necessary to establish the claim."

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sufficiency of the allegations of delayed discovery, the court

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places the burden on the plaintiff to show diligence; conclusory

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allegations will not withstand demurrer."

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(internal quotations omitted).

United States District Court

"A plaintiff need not be aware of the specific 'facts'
Id. at 1111.

"In assessing the

Fox, 35 Cal. 4th at 808.

The Court finds that Plaintiffs have alleged sufficient facts

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For the Northern District of California

Jolly v. Eli Lilly & Co., 44 Cal. 3d 1103, 1110 (Cal.

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to invoke the discovery rule.

Plaintiffs pled that Rhynes did not

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discover the allegedly defective device until 2009 when she

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underwent surgery.

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could not have learned of Defendants' wrongdoing any earlier

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because Rhynes "was only able to discover the defective product by

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undergoing a serious and invasive surgery which she undertook at

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the time prescribed by her treating physicians and after other

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treatments failed."

See FAC ¶ 5.

Plaintiffs also pled that Rhynes

Id.

Defendants contend that Plaintiffs' allegations are

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insufficient, arguing that Rhynes should have suspected wrongdoing

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when she experienced "intense physical pain" after the acetabular

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shell allegedly loosened in August 2005.

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5).

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should have suspected that her pain was due to a defect in the

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device.

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number of other factors, including side effects of the operation or

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a difficult recuperation.

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Id. at 10 (citing FAC ¶

However, nothing in the FAC suggests that Rhynes suspected or

Rhynes could have reasonably attributed her pain to a

"The mere fact that an operation does

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See also Rivas v. Safety-Kleen Corp., 98 Cal. App. 4th, 218, 228
(Ct. App. 2002).
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not produce hoped-for results does not signify negligence and will

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not cause commencement of the statutory period."

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Nordquist, 81 Cal. App. 4th 1384, 1392 (Ct. App. 2000) (quoting

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Bristol-Myers Squibb Co. v. Super. Ct., 32 Cal. App. 4th 959, 964

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(Ct. App. 1995)).

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support their contention that pain alone should have caused Rhynes

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to suspect wrongdoing.4

The authority relied on by Defendants does not

Defendants also argue that Plaintiffs have not pled sufficient

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Kitzig v.

facts to establish that Rhynes was unable to discover the

United States District Court

For the Northern District of California

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wrongdoing until her 2009 surgery.

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disagrees.

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treatments recommended by her physicians, Rhynes was unable to

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discover the device was defective until she underwent "serious and

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invasive surgery."

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discover the negligent cause of her injuries at all costs to her

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own health and welfare.

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take all reasonable steps to protect her health."

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Aronsohn, 152 Cal. App. 3d 753, 760 (Ct. App. 1984).

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alleges that Rhynes took reasonable steps to address the pain

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resulting from her 2005 procedure and those steps did not give rise

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to suspicion that the pain was caused by the allegedly defective

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device.

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Mot. at 11-12.

The Court

Plaintiffs pled that, despite engaging in other medical

See FAC ¶ 5.

"A plaintiff is not required to

Rather, the plaintiff is only required to
Hills v.
The FAC

See Jolly, 44 Cal. 3d at 1107-08 (claims were time-barred because
plaintiff was aware that the defective product caused her injuries
as early as 1972, but delayed filing her action until 1981 because
she did not know the identity of its manufacturer); Knowles v.
Super. Ct., 118 Cal. App. 4th 1290, 1298 (Ct. App. 2004) (claims
time-barred because plaintiffs admitted that they suspected medical
negligence shortly after their parent's death); Rivas, 98 Cal. App.
4th at 228-29 (claims time-barred because, seven years before
plaintiff filed suit, he was diagnosed with kidney failure and told
to stay away from the defective product, a solvent he was using at
work).
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The Court finds that the FAC alleges sufficient facts to

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invoke the discovery rule.

Accordingly, the Court declines to

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dismiss Plaintiffs' claims as time-barred.

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B.

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Defendants argue that Plaintiffs' entire action is barred by

MDA Preemption

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the preemption clause of the MDA, 21 U.S.C. § 360c et seq.

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the MDA:

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United States District Court

For the Northern District of California

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Under

[N]o 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 Act to the
device, and

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(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
Act.

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21 U.S.C. § 360k(a).

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324-25 (2008), the Supreme Court held that this provision barred

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state law tort claims challenging the safety and effectiveness of a

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catheter that received FDA premarket approval.

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reasoned, "[s]tate tort law that requires a manufacturer's

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catheters to be safer, but hence less effective, than the model the

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FDA has approved disrupts the federal scheme no less than state

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regulatory law to the same effect."

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In Riegel v. Medtronic, Inc., 552 U.S. 312,

The Supreme Court

Id. at 325.

The Supreme Court also noted that the MDA only preempts state

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laws to the extent that they are "different from, or in addition

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to" the requirements of federal law.

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statute does not bar states from "providing a damages remedy for

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claims premised on a violation of FDA regulations" since "state

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Id. at 330.

Accordingly, the

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duties in such cases 'parallel' rather than add to federal

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requirements."

Id.

Defendants point out that at least fourteen district courts

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have dismissed actions brought against Defendants' hip replacement

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system based on the Supreme Court's holding in Riegel.5

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Defendants also cite to at least another thirteen cases in which

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courts applied Riegel in dismissing actions involving a number of

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other FDA approved Class III devices.6

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contend that the instant action is also preempted by the MDA, as

Id. at 7 n.6.

Mot. at 6.

Defendants

United States District Court

For the Northern District of California

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the device was approved by the FDA and Plaintiffs' claims are

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See Funk v. Stryker, 631 F.3d 777 (5th Cir. 2011), affirming Funk
v. Stryker, 673 F. Supp. 2d 522 (S.D. Tex. 2009); Wilhite v.
Howmedica Osteonics Corp., 10cv2471, 2011 WL 2530984 (N.D. Ohio
June 20, 2011); White v. Stryker, 10–CV–544–H, 2011 WL 1131496
(W.D. Ky. Mar. 25, 2011);; Cornwell v. Stryker Corp., 10-cv-00066EJL, 2010 WL 4641112 (D. Idaho, Nov. 1, 2010); Bass v. Stryker, 09–
CV–632–Y, 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010); Lewkut v.
Stryker Corp., 724 F. Supp. 2d 648 (S.D. Tex. 2010); Anthony v.
Stryker Corp., 09–cv–2343, 2010 WL 1387790 (N.D. Ohio March 31,
2010); Yost v. Stryker, 09-cv-28-FtM-29DNF, 2010 WL 1141586 (M.D.
Fla. March 23, 2010); Lemelle v. Stryker Orthopaedics, 698
F.Supp.2d 668 (W.D. La. 2010); Horowitz v. Stryker Corp., 613 F.
Supp. 2d 271 (E.D.N.Y. 2009); Hayes v. Howmedica Osteonics Corp.,
08-6104, 2009 WL 6841859 (D. N.J. Dec. 15, 2009); Covert v. Stryker
Corp., 08CV447, 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) (decision
recommending dismissal); Delaney v. Stryker Orthopaedics, 08-03210
(DMC), 2009 WL 564243 (D.N.J. Mar. 5, 2009); Parker v. Stryker
Corp., 584 F. Supp. 2d 1298 (D. Colo. 2008).
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See Nimtz v. Cepin, 08cv1294 L(AJB), 2011 WL 831182 (S.D. Cal.
Mar. 3, 2011); Cohen v. Guidant, CV-05-8070-R, 2011 WL 637472 (C.D.
Cal. Feb. 15, 2011); Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d
1296 (11th Cir. 2011) (affirming district court’s dismissal, 2009
WL 2190069 (M.D. Fla. July 22, 2009)); Steen v. Medtronic, Inc.,
10-CV-936-L, 2010 WL 2573455 (N.D. Tex. June 25, 2010); Heisner v.
Genzyme Corp., 08-C-593, 2010 WL 894054 (N.D. Ill. Mar. 8, 2010);
Hughes v. Boston Scientific Corp., 08cv79KS-MTP, 2009 WL 3817586
(S.D. Miss. Nov. 12, 2009); Williams v. Allergan USA, Inc., CV–09–
1160–PHX–GMS, 2009 WL 3294873 (D. Ariz. Oct. 14, 2009); Heisner v.
Genzyme Corp., 08-C-593, 2009 WL 1210633 (N.D. Ill. Apr. 30, 2009);
Dorsey v. Allergan, Inc., 08–0731, 2009 WL 703290 (M.D. Tenn. Mar.
11, 2009); In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab.
Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009); Link v. Zimmer
Holdings, Inc., 604 F. Supp. 2d 1174 (N.D. Ill. 2008); Clark v.
Medtronic, Inc., 572 F. Supp. 2d 1090 (D. Minn. 2008); Adkins v.
Cytyc Corp., 07CV00053, 2008 WL 2680474 (W.D. Va. Jul. 3, 2008).
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predicated on state law tort duties which constitute regulations

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that are "different from, or in addition to" established federal

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regulations.

Id. at 7-8.

Plaintiffs respond that their claims are not preempted by the

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MDA because, unlike the cases cited by Defendants, Plaintiffs'

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claims impose "requirements that are parallel with, not in addition

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to, federal requirements."

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Bausch v. Stryker Corp., 630 F.3d 546 (7th cir. 2010), where the

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Seventh Circuit reversed the district court's dismissal of state

Opp'n at 2.

Plaintiffs rely in part on

United States District Court

For the Northern District of California

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law tort claims involving an FDA approved Class III device.

The

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court found that the plaintiff's claims were not preempted because

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the plaintiff alleged that "the FDA found that the defendants

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failed to comply with [21 C.F.R.] section 820.90 regarding

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nonconforming products, and that the product implanted in [the

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plaintiff] failed to comply with product specifications as approved

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by the FDA through the pre-market approval process."

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Plaintiffs also point to Warren v. Howmedica Osteonics Corp., 10 CV

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1346 DDN, 2011 WL 1226975 (E.D. Mo. Mar. 29, 2011).

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the plaintiffs' claims survived a motion to dismiss where they

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alleged "that defendants failed to manufacture the Trident System

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in conformity with the FDA's [pre-market approval application]

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specifications, which resulted in a defective device whose

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manufacture and design were not approved by the FDA."

Id. at 556.

In that case,

Id. at *4.

Further, Plaintiffs argue their case is distinguishable from

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cases cited by Defendants such as Funk, 631 F.3d at 782, where tort

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law claims were dismissed because the plaintiffs' allegations of

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FDA violations were impermissibly conclusory and vague.

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5.

Opp'n at

In Funk, the Fifth Circuit affirmed dismissal because the

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complaint relied on res ipsa loquitur and did not explain "how the

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manufacturing process failed, or how it deviated from the FDA

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approved manufacturing process."

631 F.3d at 782.

The Court finds that Plaintiffs' claims are preempted by the

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law duties that parallel federal requirements.

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plaintiff may avoid preemption by stating a claim premised on a

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violation of FDA regulations.

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by Plaintiff where state law tort claims survived MDA preemption,

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United States District Court

MDA because Plaintiffs have failed to allege violations of state

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For the Northern District of California

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the plaintiffs alleged that the device at issue violated specific

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FDA regulations.

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1226975, at *4.

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FDA warned Defendants about "bad manufacturing and quality control

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practices."

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requirements were violated, much less how Defendants' manufacturing

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process deviated from those particular requirements.

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claims are closer to those rejected in Funk than those found to be

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sufficient in Bausch and Warren.7

552 U.S. at 330.

Under Reigel, a

In the cases cited

See Bausch, 630 F.3d at 556; Warren, 2011 WL
In the instant action, Plaintiffs allege that the

FAC ¶ 20.

However, Plaintiffs do not allege what FDA

Plaintiffs'

Accordingly, the Court GRANTS Defendants' Motion to Dismiss.

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The Court grants Plaintiffs leave to amend because they have

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indicated they are prepared to set forth more specific allegations

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regarding Defendants' violations of particular FDA requirements.

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See Opp'n at 6.

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granted leave to amend once, Defendants did not raise their MDA

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preemption arguments in the last round of pleading.

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Additionally, although the Court has already

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Defendants argue that Bausch and Warren are not controlling since
they ignore the Rule 8 pleading requirements set forth in Iqbal and
Twombly. Reply at 5-6. The Court need not presently address this
issue as it finds that, even under Bausch and Warren, Plaintiffs'
allegations are inadequate.
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V.

CONCLUSION

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The Court GRANTS Defendants Stryker Corporation and Howmedica

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Osteonics Corporation's Motion to Dismiss and DISMISSES Plaintiffs

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Gloria Rhynes and Darrell Jenkins' First Amended Complaint WITH

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LEAVE TO AMEND.

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it shall be filed within thirty (30) days of this Order.

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to do so will result in dismissal of the action with prejudice.

If Plaintiffs choose to file an amended complaint,
Failure

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United States District Court

For the Northern District of California

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IT IS SO ORDERED.

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Dated: October 27, 2011
UNITED STATES DISTRICT JUDGE

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