Dorothy L. Payne, App. v. Medtronic Inc. Medtronic Xomed, Inc., Res.

CourtCourt of Appeals of Washington
DecidedSeptember 28, 2015
Docket71411-2
StatusPublished

This text of Dorothy L. Payne, App. v. Medtronic Inc. Medtronic Xomed, Inc., Res. (Dorothy L. Payne, App. v. Medtronic Inc. Medtronic Xomed, Inc., Res.) is published on Counsel Stack Legal Research, covering Court of Appeals of Washington primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dorothy L. Payne, App. v. Medtronic Inc. Medtronic Xomed, Inc., Res., (Wash. Ct. App. 2015).

Opinion

IN THE COURT OF APPEALS OF THE STATE OF WASHINGTON

DOROTHY L. PAYNE, Individually and No. 71411-2-1 as the personal representative of the o~ Estate of BECKY S. ANDERSON, DIVISION ONE deceased,

Appellant,

v.

DONALD R. PAUGH; WENATCHEE VALLEY MEDICAL CENTER, P.S.; LINDA K. SCHATZ; WENATCHEE ANESTHESIA ASSOCIATES; LASER PUBLISHED OPINION ENGINEERING, INC., a foreign corporation; MEDTRONIC, INC.; MEDTRONIC XOMED, INC.; and UNKNOWN JOHN DOES,

Respondents,

CENTRAL WASHINGTON HEALTH SERVICES ASSOCIATION d/b/a CENTRAL WASHINGTON HOSPITAL, a Washington Corporation;

Nonparty Defendant. FILED: September 28, 2015

Schindler, J. — Becky S. Anderson was seriously injured during elective throat

surgery. Anderson filed a negligence lawsuit against otolaryngologist Dr. Donald Paugh

and Wenatchee Valley Medical Center PS, anesthesiologist Dr. Linda Schatz and

Wenatchee Anesthesia Associates, Central Washington Hospital, and medical device No. 71411-2-1/2

manufacturer Medtronic Inc. and Medtronic Xomed Inc. (Medtronic). Following a seven-

week trial, the jury found Dr. Paugh and Wenatchee Valley Medical Center, Dr. Schatz

and Wenatchee Anesthesia Associates, and nonparty Central Washington Hospital

negligent and that the negligence was a proximate cause of the injury to Anderson. The

jury found medical device manufacturer Medtronic was not negligent. The jury awarded

Anderson $18 million in damages. The jury attributed 42.5 percent of the negligence to

Dr. Paugh and Wenatchee Valley Medical Center, 52.5 percent to Dr. Schatz and

Wenatchee Anesthesia Associates, and 5 percent to the hospital. The court entered a

judgment on the jury verdict against Dr. Paugh and Wenatchee Valley Medical Center,

and Dr. Schatz and Wenatchee Anesthesia Associates. Anderson appeals the jury

verdict in favor of Medtronic. Anderson concedes a negligence standard applies to the

design defect claim against medical device manufacturer Medtronic under Restatement

(Second) of Torts section 402A comment k (1965). Nonetheless, Anderson claims the

court erred in refusing to give a proposed supplemental jury instruction that is used for a

strict liability design defect claim to define the duty of a medical device manufacturer

under Restatement (Second) of Torts section 402A comment k. We disagree, and

affirm the jury verdict.

FACTS

The Surgery

In January 2012, Becky S. Anderson went to see otolaryngologist Dr. Donald

Paugh about "[a] cough and some hoarseness." Dr. Paugh diagnosed a benign vocal

cord polyp and recommended tracheal laser surgery. Anderson decided to proceed No. 71411-2-1/3

with the elective tracheal laser surgery. Dr. Paugh scheduled the surgery for February

3, 2012 at Central Washington Hospital.

Before the surgery began, the hospital operating room staff mistakenly told Dr.

Paugh and anesthesiologist Dr. Linda Schatz that only the single-cuff "Laser-Shield II"

endotracheal tube manufactured by Medtronic was available.

The Laser-Shield II is designed for endotracheal intubation during laser surgeries

and has "a laser resistant overwrap on the main shaft." However, the "Instructions for

Use" state the inflatable cuff that seals the airway and prevents oxygen and other

flammable gas from reaching the surgical field is not laser resistant. The Instructions for

Use warn users that contacting the cuff with a laser "may cause deflation of the cuff and

result in combustion and fire." The instructions tell users to place wet cotton gauze

around the cuff to protect from laser strike. To alert users to a rupture, the Laser-Shield

II cuff-inflation valve is equipped with blue methylene dye that stains the cotton gauze if

the cuff is punctured. The Instructions for Use warn of the risk of fire due to "elevated

oxygen levels or other flammable gases" and recommend using a "30% oxygen / 70%

helium, or 30% oxygen / 70% room air" combination.

Neither Dr. Paugh nor Dr. Schatz had ever used the Laser-Shield II. Dr. Paugh

had used only a double-cuff endotracheal tube manufactured by Mallinckrodt Inc. The

double-cuff tube has a lower cuff that seals the airway to prevent oxygen from leaking

out and an upper cuff that shields the lower cuff from damage from the laser.

Nonetheless, Dr. Paugh and Dr. Schatz decided to proceed with the surgery and

use the Laser-Shield II. Neither Dr. Paugh nor Dr. Schatz read the Laser-Shield II

Instructions for Use. Contrary to the Instructions for Use, Dr. Schatz administered 100 No. 71411-2-1/4

percent oxygen, not the recommended 30 percent. During the surgery, Dr. Paugh

perforated the inflatable cuff of the tube with the laser causing oxygen to leak into the

surgical site and ignite. The airway fire caused serious burns to Anderson's trachea

and lungs.

The Lawsuit

Anderson filed a complaint against Central Washington Hospital, Dr. Paugh and

Wenatchee Valley Medical Center, and Dr. Schatz and Wenatchee Anesthesia

Associates alleging medical negligence, and alleging product liability against medical

device manufacturer Medtronic Inc. and Medtronic Xomed Inc. (Medtronic). Anderson

alleged Dr. Paugh and Dr. Schatz breached the standard of care resulting in the injuries

to Anderson. Anderson alleged Medtronic was "liable under the Washington Products

Liability Act R.C.W. Chapter 7.72" for defect in production or construction. In the

amended complaint, Anderson alleged Medtronic was liable under the Washington

product liability act, chapter 7.72 RCW.

Summary Judgment

Anderson filed a motion for partial summary judgment arguing there was no

dispute Dr. Schatz was negligent in administering 100 percent oxygen. Anderson also

argued Dr. Schatz acted as an agent of the hospital. The court granted the motion in

part, ruling Dr. Schatz and Wenatchee Anesthesia Associates were negligent as a

matter of law.

Following discovery, Medtronic filed a motion for summary judgment dismissal of

claims alleging design defect, failure to warn, and manufacturing or production defect.

Medtronic argued the Laser-Shield II is a prescription medical device governed by the No. 71411-2-1/5

negligence standard under Restatement (Second) of Torts section 402A comment k

(1965), and there was no evidence of defective design. Medtronic argued that because

the Laser-Shield II warnings "were adequate as a matter of law," it was entitled to

dismissal of the failure to warn claim. Medtronic also argued Anderson could not show

that "any allegedly deficient warnings or instructions proximately caused her injuries."

Medtronic submitted the deposition testimony of Dr. Paugh and Dr. Schatz admitting

they did not read the Laser-Shield II Instructions for Use before the surgery.

In response, Anderson did not dispute that the negligence standard under

Restatement (Second) of Torts section 402A comment k applied to the design defect

claim. Relying on the Washington Pattern Jury Instruction 110.02.01, "Manufacturer's

Duty—Design—Unavoidably Unsafe Products—Negligence—Comment K," Anderson

argued there were material issues of fact as to Medtronic's breach of the duty to use

reasonable care to design a product that was reasonably safe and on proximate cause.1

6 Washington Practice: Washington Pattern Jury Instructions: Civil 110.02.01, at

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