Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caed-2_03-cv-02602/USCOURTS-caed-2_03-cv-02602-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Personal Injury

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1

 

 

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF CALIFORNIA

SHERRILL MORTON and WILLIAM )

MORTON, ) NO. CIV S-03-2602 GEB GGH

)

Plaintiffs, )

)

v. ) ORDER 

)

CENTERPULSE ORTHOPEDICS, INC., )

)

Defendant. )

)

Defendant Centerpulse Orthopedics Inc. moves for summary

judgment on all of Plaintiffs’ claims, contending that the claims are

preempted by 21 U.S.C. § 360k(a) (the Medical Devices and Cosmetics

Act), and that the claims are legally untenable under state law and

are not factually supported. Plaintiffs oppose the motion.

Background

In January 1999, after it was determined that Plaintiff

Sherrill Morton needed a knee replacement surgery, Ms. Morton’s

doctor, Dr. Ronald Carn, implanted a Natural Knee System which was

manufactured by Defendant in Ms. Morton’s right knee. In July 2002,

Ms. Morton experienced an acute pain in her right knee, and in August

2002, Dr. Carn replaced three of the components of her Natural Knee

Case 2:03-cv-02602-GEB-GGH Document 38 Filed 05/11/05 Page 1 of 8
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System. Upon examination, Dr. Carn determined that the polyethylene

portion of the patella component of the system (“Patella Component”)

had broken. Plaintiffs then initiated this action for strict product

liability based on manufacturing and design defects; general

negligence based on negligent design, manufacture, and provision of

warnings; breach of warranty; and loss of consortium. (Pls.’

Complaint at 4-6; Pls.’ Opp’n to Mot. for Summ. J. at 4.)

The Medical Device Amendments (“MDA”) to the Food, Drug and

Cosmetic Act created three classes of medical devices based on the

degree of regulation needed to assure the safety and effectiveness of

the medical device. 21 U.S.C. § 360c(a)(1). Class I devices present

no unreasonable risk of illness or injury and are subject only to

minimal regulation by “general controls.” Id. § 360c(a)(1)(A). Class

II devices are potentially more harmful and are subject to certain

“special controls.” Id. § 360c(a)(1)(B). Class III devices either

“present[] a potential unreasonable risk of illness or injury” or are

“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.” Id. § 360c(a)(1)(C). In

order to introduce a Class III device to the market, manufacturers of

Class III devices must receive premarket approval (“PMA”) from the

United States Food and Drug Administration (“FDA”) by providing the

FDA with a “reasonable assurance” that the device is both safe and

effective. Id. § 360e(d)(2). “Manufacturers must submit detailed

information regarding the safety and efficacy of their devices, which

the FDA then reviews, spending an average of 1,200 hours on each

submission.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). 

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1 This is not disputed. Local Rule 56-260 obligates the

parties to “cite the particular portions of any pleading, affidavit,

deposition, interrogatory answer, admission or other document relied

upon to establish [a] fact” asserted to be undisputed or disputed.

3

The Natural Knee System Patella Component is a Class III

medical device. (See Beeman Decl. at ¶ 4.) Prior to its introduction

into the market, the FDA granted premarket approval of the Natural

Knee System’s Patella Component that is at issue in this litigation. 

(Def.’s Statement of Undisputed Facts (“SUF”) ¶ 1.)1

Standard

Summary judgment is proper where the pleadings, depositions,

answers to interrogatories, affidavits, and admissions on file show

that there is no genuine issue as to any material fact, and the moving

party is entitled to judgment as a matter of law. Fed. R. Civ. P.

56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). In

considering a motion for summary judgment, the court must examine all

evidence in a light most favorable to the nonmovant, and draw all

reasonable inferences in that party’s favor. Matsushita Elec. Indus.

Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (citations

omitted). The “purpose of summary judgment is to ‘pierce the

pleadings and to assess the proof in order to see whether there is a

genuine need for trial.’” Id. (quoting Advisory Committee Note to

1963 Amendment of Fed. Rule Civ. Proc. 56(e), 28 U.S.C. App., p.626).

Discussion

Defendant argues that the MDA preempts Plaintiffs’ claims. 

Defendant contends that through the premarket approval process, the

FDA established device specific requirements for the Natural Knee

System, and Plaintiffs’ claims based upon state law theories of

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liability assert standards which are inconsistent with the FDA

requirements. (Def.’s Mot. for Summ. J. at 9-24.)

The MDA has a preemption provision which provides:

[N]o 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). There is a split in authority regarding whether

this provision preempts state tort claims in which damages are sought

for alleged defective “medical devices that have received PMA

approval.” Gilleon v. Medtronic USA, Inc., 2002 WL 31300694, at *4

(N.D. Cal. Aug. 28, 2002). “The majority of circuits to have

addressed the issue have held that the PMA process results in

preemption, at least of common law claims contending that the approved

product design is defective or unreasonably dangerous or that allege

that the approved labeling or warnings are inadequate.” Id. (citing

Brooks v. Howmedica, Inc., 273 F.3d 785, 799 (8th Cir. 2001); Martin

v. Medtronic, 254 F.3d 573, 584 (5th Cir. 2001); Kemp v. Medtronic,

231 F.3d 216, 226-28 (6th Cir. 2000); Mitchell v. Collagen Corp., 126

F.3d 902, 911 (7th Cir. 1997); see also Steele v. Collagen Corp., 54

Cal. App. 4th 1476, 1487 (1997)). “The Eleventh Circuit, however,

reached a contrary conclusion, in Goodlin v. Medtronic, 167 F.3d 1367

(11th Cir. 1999), finding that the common law tort claims are not

preempted by the MDA.” Gilleon, at *4. 

“[T]he cases on both sides of the split are well-reasoned

and defensible.” Id. “The substantive split among the circuits

reveals a methodological difference: the majority focuses on the rigor

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of the PMA process and often restrictive post-approval conditions,

whereas the minority focus on congressional intent as expressed in the

statute.” Webster v. Pacesetter, Inc., 171 F. Supp. 2d 1, 9 (D.D.C.

2001). “Thus, courts that look to the rigors of the PMA approval

process, the FDA's involvement in approving the design of the device,

the warnings to be given for the device, and the contents of labeling,

conclude that the PMA approval constitutes device specific federal

requirements which would be undermined if state common law claims

could be brought and which would impose different or additional

requirements.” Gilleon, 2002 WL 31300694, at *4. 

Although the Ninth Circuit has not decided whether the MDA

preempts state products liability lawsuits over medical devices that

have received PMA approval, the district court in Gilleon, after

considering Ninth Circuit authority on whether “state common law

claims can amount to ‘requirements’ which may be preempted under the

MDA,” predicted that “the Ninth Circuit would agree with the majority

view and hold that PMA approval of a Class III device gives rise to

preemption of state law claims.” Gilleon, 2002 WL 31300694, at *4, 5.

The rationale of Gilleon is persuasive and will be followed.

Therefore, in accordance with the majority view, the PMA approval of

the Natural Knee System Patella Component “results in preemption of

state common law claims, to the extent those claims seek to impose

requirements that are different or in addition to those required by

federal law.” Id. But, Plaintiffs also allege that “there is a

genuine issue of material fact related to whether or not defendant

followed federal regulations and its PMA related [to] the design,

manufacturing, and labeling of the product which is the subject of

this lawsuit.” (Pls.’ Opp’n to Mot. for Summ. J. at 12.)

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Ms. Morton alleges Defendant defectively manufactured the

Patella Component. However, no genuine issue of material fact has

been raised as to whether Defendant complied with all FDA requirements

related to the manufacture of the Patella Component. (SUF ¶¶ 3,4.) 

Therefore, summary judgment is granted for Defendant on Ms. Morton’s

defective manufacturing claims.

Ms. Morton also alleges a product liability claim based on

defective design of the Patella Component. The FDA granted premarket

approval of the design of the device, but Defendant has not set forth

specific facts in its Statement of Undisputed Facts indicating that it

complied with the design which was approved by the FDA. However, in

California, “the entire category of medical implants available only by

resort to the services of a physician are immune from design defect

strict liability.” Artiglio v. Superior Court, 22 Cal. App. 4th 1388,

1396-97 (1994). Since no genuine issue of material fact exists as to

whether the Patella Component is an implanted prescription medical

device that may only be sold to physicians, Defendant’s motion for

summary judgment on Ms. Morton’s strict liability claim for defective

design is granted. 

Ms. Morton also alleges Defendant failed to adequately warn

her or her physician about the potential adverse effects of the

Patella Component. However, Defendant included with the device a

package insert titled “Important Information for the Operating

Surgeon,” which was specifically approved by the FDA, and which warned

that “the potential adverse effects of the Intermedics Natural Knee

System are similar to those occurring with any total knee replacement. 

These effects are often attributable to factors listed under Warnings

and Precautions and commonly include: (1) Changing position of the

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2 Plaintiffs cite to the declaration of Larry Beeman at Page

2, lines 10 and 11; the deposition of Sherrill Morton at page 30, line

23 to page 31, line 4; and the deposition of William Morton at page

13, line 24 to page 14, line 15. However, none of this evidence

indicates that Defendant made any warranties to Ms. Morton.

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prosthesis with or without loosening of cement or clinical symptoms.

Bending and/or fracture of the components . . . .” (SUF ¶¶ 8,9.) 

Plaintiffs dispute paragraph 8, citing to a portion of Dr. Ronald M.

Carn’s Declaration, but the cited portion says nothing about whether a

warning was given. Plaintiffs also dispute paragraph 9, citing to

evidence that does not controvert Defendant’s statement that this

information was given to Ms. Morton’s physician. Therefore, summary

judgment is granted for Defendant on Ms. Morton’s claims for failure

to adequately warn.

Ms. Morton also claims Defendant breached both express and

implied warranties. However, Ms. Morton admitted in her deposition

testimony that “neither Dr. Carn nor anybody else made any

representations or assurances about the outcome of the operation.” 

(Deposition of Sherrill Morton at 37, lines 8-11.) (See also SUF ¶

11.) Plaintiffs dispute paragraph 11, citing to evidence which does

not controvert Defendant’s factual showing that it made no warranties

to her.2 Accordingly, Defendant’s summary judgment motion on Ms.

Morton’s claim for breach of an express warranty is granted. 

Defendant also asserts it did not breach an implied warranty

to Ms. Morton because Ms. Morton was never in privity of contract with

Defendant. (SUF ¶ 12.) See Fieldstone Co. v. Briggs Plumbing

Products, Inc., 54 Cal. App. 4th 357, 362 (1997) (citations omitted)

(stating that “Vertical privity is a prerequisite in California for

recovery on a theory of breach of the implied warranties of fitness

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3 Plaintiffs cite to the declaration of Larry Beeman at Page

7, lines 4 to 6, and page 2, lines 10 and 11; the deposition of

Sherrill Morton at page 112, lines 4 to 8, and lines 16 to 25; and the

declaration of Dr. Ronald M. Carn. However, none of this evidence

indicates that Ms. Morton was ever in privity with Defendant.

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and merchantability.”). Plaintiffs dispute paragraph 12, citing to

evidence which does not controvert Defendant’s factual showing that it

was never in privity with Ms. Morton.3 Therefore, Defendant is

granted summary judgment on Ms. Morton’s claim for breach of an

implied warranty.

Defendant also seeks summary judgment on Ms. Morton’s claim

that Defendant was negligent. However, Defendant has not set forth

specific facts in its Statement of Undisputed Facts that it complied

with the FDA-approved design. Since Defendant has not met its burden

of establishing that there is no genuine issue of material fact as to

this claim, Defendant’s motion for summary judgment on Ms. Morton’s

negligence claim is denied. 

Finally, Plaintiff William Morton alleges loss of

consortium. Since this claim is derivative, and Defendant has not

established that there is no genuine issue of material fact as to

Defendant’s negligence, Defendant’s motion for summary judgment on Mr.

Morton’s loss of consortium claim based on Defendant’s negligence is

denied.

IT IS SO ORDERED.

Dated: May 10, 2005

/s/ Garland E. Burrell, Jr.

GARLAND E. BURRELL, JR.

United States District Judge

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