Opposition Brief — Eddy v. Polymer Technology Corp.

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| I Rije 31 1997

No. 97-26

CLERK

In The

Supreme Court of the United States

October Term, 1996

¢

DEBORAH EDDY AND THOMAS EDDY,

Petitioners,

V.

POLYMER TECHNOLOGY CORPORATION, THRIFT

DRUG CO. AND DR. JAMES H. LETHAM, O.D.,

Respondents.

¢

On Petition For A Writ Of Certiorari

To The Superior Court Of Pennsylvania

+

BRIEF OF RESPONDENT

DR. JAMES H. LETHAM, O.D., IN OPPOSITION

TO PETITION FOR WRIT OF CERTIORARI

,

7

Rosert J. BEHLING

Counsel of Record

BRIAN S. KANE

Jeanette H. Ho

PIETRAGALLO, Bosick

& GORDON

One Oxford Centre, 38th Floor

Pittsburgh, PA 15219

(412) 263-2000

Counsel for Respondent

Dr. James H. Letham, O.D.

COCKLE LAW BRIEF PRINTING CO., (800) 225-6964

OR CALL COLLECT (402) 342-2831

EDITOR'S NOTE

THE FOLLOWING PAGES WERE POOR HARD COPY

AT THE TIME OF FILMING. Uf AND WHENA

BETTER COPY CAN BE OBTAINED, A NEW FICHE

WILL BE ISSUED.

QUESTION PRESENTED

Whether 21 U.S.C. § 360k(a) mandates preemption of

state common law claims which seek to impose require-

ments which would conflict with the requirements

imposed by the Food and Drug Administration in the

course of the pre-market approval process?

STATEMENT OF THE CASE

Petitioners filed the suit which gives rise to this

Petition for Writ of Certiorari on September 9, 1992 seek-

ing to recover for damages allegedly sustained as a result

of using contact lens cleaner and solution manufactured

by Respondent, Polymer Technology Corporation (“Poly-

mer”) and sold by Respondent, Thrift Drug, Inc. (“Thrift

Drug”). Wife-Petitioner alleges that she developed acan-

thamoeba keratitis as a result of rinsing her contact lenses

with tap water as required by the directions which

accompanied the sale of the cleaner and solution. .

Between September 16 and September 25, 1990, Wife-

Petitioner was a patient of Respondent, Dr. James H.

Letham, an optometrist. Plaintiff was a patient of Dr.

Letham for several years prior to this incident. On or

about September 16, 1990, Dr. Letham examined the Wife-

Petitioner and prescribed a gas permeable right contact

lens manufactured by Respondent, Polymer. Dr. Letham

fitted the lens and provided Wife-Petitioner with a starter

kit supplied to Dr. Letham by Polymer. The starter kit

contained small, sample-sized containers of cleaner and

solution also manufactured by Polymer. Wife-Petitioner

eventually purchased a larger bottle of the cleaner and

solution from Thrift Drug.

The cleaner and solution contained explicit instruc-

tion for the proper use of the products. These directions

were approved by the Food and Drug Administration

(“FDA”) prior to the introduction of these products into

the open market. See Affidavit of William Gleason, O.D.,

which is attached at S.A. 1.

Petitioners have asserted claims of negligence, strict

liability and breach of implied warranties against Dr.

Letham. Essentially, Petitioners contend that Dr. Letham

is liable for failing to warn or instruct the Wife-Petitioner

on the use of the cleaner and solution or that she could

develop acanthamoeba keratitis through the use of the

cleaner and solution manufactured by Polymer.

oa

REASONS WHY THE PETITION FOR

WRIT OF CERTIORARI SHOULD BE DENIED

Dr. James Letham is Not a Proper

Respondent to this Petition

The only question presented by Petitioners in this

Petition for Writ of Certiorari is “[w]hether 21 U.S.C.

§ 360k(a) mandates preemption of all state law causes of

action for injuries caused by medical devices which have

received pre-market approval from the Food and Drug

Administration?” See Petition for Writ of Certiorari, p. i.

By order dated October 24, 1994, the Court of Com-

mon Pleas of Allegheny County, Pennsylvania granted

summary judgment in favor of Polymer, Thrift Drug and

Dr. Letham on the grounds that Petitioners’ claims

against these parties were preempted by the Medical

Device Amendments.

Petitioners filed a notice of appeal to the Superior

Court of Pennsylvania from this order. Said notice of

appeal stated: “Notice is hereby given that the Plaintiffs,

above named, hereby appeal to the Superior Court of

Pennsylvania from the Order granting Summary Judg-

ment to the Defendant(s), Polymer Technology Corp. and

Thrift Drug, Inc. entered in this matter on the 20th day of

October, 1994. This order has been entered into the docket

as evidenced by the attached copy of the docket entry.”

(emphasis added).

While Polymer and Thrift Drug are named in the

notice of appeal, Dr. Letham is not named. Furthermore,

in the argument presented to the Superior Court of Penn-

sylvania, the Petitioners completely failed to address the

causes of action brought individually against Dr. Letham.

See Opinion of the Superior Court of Pennsylvania dated

December 5, 1995, App. 6. The only time the claims

against Dr. Letham were mentioned was in the Peti-

tioners’ reply brief where they argued that Dr. Letham

could be held strictly liable under Pennsylvania law. Id.

The Superior Court found this argument to be totally

without merit and held that Dr. Letham was not subject

to strict liability under Pennsylvania law. Id. As a result,

the Pennsylvania Superior Court held that the Petitioners

had “. . . . waived any claims that the trial court erred in

granting summary judgment in favor of Dr. Letham on

the negligence and breach of implied warranty causes of

action for failure to argue them in their brief.” Id.

Petitioners, in their Petition for Writ of Certiorari, do

not challenge the Superior Court’s finding of waiver with

respect to their claims against Dr. Letham. They also do

not challenge the Superior Court’s conclusion that Dr.

Letham cannot be held strictly liable under Pennsylvania

law. Rather, the only issue which they raise is whether

their state law causes of action are pre-empted by 21

U.S.C. § 360k(a). Since the judgment in favor of Dr.

Letham was not based on preemption, but on waiver and

the application of Pennsylvania state law, Dr. Letham is

not a proper party to this Petition for Writ of Certiorari

and Certiorari should be denied as to him.

*

CONCLUSION

Therefore, Respondent, Dr. James H. Letham, respect- i

fully requests that the Petition for Writ of Certiorari be

denied.

Respectfully submitted,

PIETRAGALLO, Bosick &

GORDON

Rosert J. BEHLING, Esquire

Brian S. Kane, Esquire

Jeanette H. Ho, Esquire

One Oxford Centre, 38th Floor

Pittsburgh, PA 15219

(412) 263-2000

Counsel for Respondent, ;

Dr. James H. Letham :

aba RS tice GR AE

DEBORAH EDDY and

THOMAS EDDY,

Plaintiffs,

Vv.

POLYMER

TECHNOLOGY

CORPORATION,

THRIFT DRUG INC.,

and DR. JAMES H.

LETHAM, O.D.

Defendanits.

la

APPENDIX

IN THE COURT OF COMMON PLEAS OF

ALLEGHENY COUNTY, PENNSYLVANIA

-CIVIL DIVISION-

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No. GD 92-16038

Code No. 004

DECLARATION OF

WILLIAM GLEASON, O.D.,

IN SUPPORT OF

DEFENDANTS POLYMER

TECHNOLOGY

CORPORATION AND

THRIFT DRUG, DRUG,

INC.’S MOTION FOR

SUMMARY JUDGMENT

Filed on behalf of Polymer

Technology Corporation and

Thrift Drug, Inc.

Counsel of Record for this

party:

Kerry A. Kearney

Pa. I.D. No. 20120

REED SMITH SHAW &

McCLAY

Firm I.D. No. 234

435 Sixth Avenue

Pittsburgh, PA 15219

(412) 288-3046

2a

IN THE COURT OF COMMON PLEAS OF

ALLEGHENY COUNTY, PENNSYLVANIA

-CIVIL DIVISION-

DEBORAH EDDY and

THOMAS EDDY,

) No. GD 92-16038

)

Plaintiffs,

)

)

Code No. 004

DECLARATION OF

WILLIAM GLEASON,

O.D., IN SUPPORT OF

) DEFENDANTS POLYMER

) TECHNOLOGY

) CORPORATION AND

THRIFT DRUG, DRUG,

INC.’S MOTION FOR

CUMMARY JUDGMENT

V.

POLYMER TECHNOLOGY

CORPORATION, THRIFT

DRUG INC., and

DR. JAMES H. LETHAM,

O.D.

wee eee See”

Defendants.

I, William Gleason, O.D., declare:

1. I have been employed by Polymer Technology

Corporation (“Polymer”) since October 1987. From Octo-

ber 1, 1987, until May 1991, I served as Polymer’s Direc-

tor of Clinical and Regulatory Affairs. From May 1991

until January 1994 I was Polymer’s Director of Product

Development and Quality Affairs. Since January 1994, I

have been Polymer’s Director of Quality and Regulatory

Affairs.

2. As Director of Quality and Regulatory Affairs,

my responsibilities include overseeing Polymer’s deal-

ings with the Federal Food and Drug Administration

(“FDA”) in gaining FDA approval of Polymer’s products

and maintaining the approval status of those products. I

am knowledgeable in regulatory practices and various

governmental requirements for medical devices, includ-

ing FDA regulations, concerning approval of medical

icSanh Abele Sabi essa gucsthice Beale

2 aa

Kieth Wales, idintidt inci etnias niet

3a

devices, post-approval surveillance and good manufac-

turing practices. I participate on product development

teams to determine regulatory requirements for new

Polymer products, review safety and efficacy information

generated on Polymer products, submit applications to

the FDA for pre-market approval for new Polymer prod-

ucts, and respond to FDA review or requests for clarifica-

tion and additional information during the regulatory

review process. Additionally, my department is responsi-

ble for reviewing and approving all Polymer label

changes to insure compliance with FDA regulations and I

manage all approved Polymer products to insure compli-

ance with current regulatory requirements. I am familiar

with all documentation regarding FDA approval of Poly-

mer’s products.

3. Polymer manufactures and distributes the Bos-

ton® line of contact lens solutions designed for use with

rigid gas permeable (“RGP”) contact lenses. The Boston®

Solutions include Boston® and Boston Advance®

Cleaners and Conditioning Solutions. The Boston® line of

products has been on the market since 1983. The Boston

Advance® Cleaner (“Cleaner”) has been formulated for

daily cleaning of RGP lenses to remove surface deposits

which build up during lens wear. The Boston Advance®

Conditioning Solution (“Solution”) has been formulated

to disinfect RGP lenses after cleaning and rinsing and to

enhance the wettability characteristics of RGP lenses.

4. The attached package insert and labeling for the

Boston Advance® Cleaner recommends that the user

“rub lens carefully with several drops of Boston

Advance® Cleaner in the palm of your hand for twenty

(20) seconds” and then “rinse off thoroughly with fresh

4a

tap water.” The directions then tell the user to “place lens

in storage case and cover with a fresh supply of Condi-

tioning Solution. Soak for at least 4 hours or overnight

before wearing.” A true copy of the package insert for the

Boston Advance® Cleaner is attached as “Exhibit A.” The

package insert and labeling for the Boston® Conditioning

Solution states that after disinfection with the Condition-

ing Solution for at least four hours or overnight the user

should “reapply fresh Boston Advance® Conditioning

Solution if desired and insert.” A true copy of the pack-

age insert for the Boston Advance® Conditioning Solu-

tion is attached as “Exhibit B.”

5. In 21 C.F.R. 886.5918 (1993), the FDA classifies

rigid gas permeable contact lens solutions as Class III

medical devices pursuant to the Medical Device Amend-

ments of 1976 to the Food, Drug and Cosmetic Act. Pub.

L. 94-295, § 2, 90 Stat. 574, amending 21 U.S.C. § 301 et

seq. (codified at 21 U.S.C. § 360c et seq.). Both the Cleaner

and the Solution are RGP lens solutions, classified by the

FDA pursuant to 21 C.F.R. 886.5918 as Class III medical

devices:

(a) A rigid gas permeable contact lens solution

is a device intended to clean, disinfect, wet or

store a rigid gas permeable contact lens.

(b) Classification. Class II.

(c) Date PMA or notice of completion of a [Product

Development Protocol] is required. ... An approval

under section 515 of the act is required before

this device may be commercially distributed.

21 C.ER. § 886.5918.

5a

6. Under 21 C.F.R. § 886.3, the FDA requires that the

Solution and Cleaner, as Class III medical devices, receive

pre-market approval (“PMA”) to determine the safety

and efficacy of these solutions prior to being marketed or

sold by Polymer:

a device in this part [of the regulation] that is

classified into class III (premarket approval)

shall not be commercially distributed . . . unless

the manufacturer has an approval under section

515 of the act... An approval under section 515

of the act consists of FDA’s issuance of an order

approving an application for premarket

approval for the device or declaring completed a

product development protocol for the device.

21 C.ER. § 886.3.

7. On September 14, 1989, Polymer submitted

detailed applications to the FDA seeking pre-market

approval for the Cleaner and detailed applications for the

Solution on November 3, 1988. The applications disclosed

the proposed directions for use of these products, includ-

ing directions concerning rinsing the RGP lenses with tap

water after use of the Cleaner and prior to disinfection

with the Solution. As part of the PMA application process

for the Cleaner and Solution, the FDA considered the

propriety of all the labeling associated with the products,

including tap water rinsing. The cover letters submitted

with the applications are attached as “Exhibit C” and

“Exhibit D.”

8. The PMA applications for the Cleaner and the

Solution included information regarding product speci-

fications, intended use, manufacturing methods, and data

6a

from clinical studies conducted of patients using the Bos-

ton® Solutions. As part of the review process, the FDA

referred Polymer’s original PMA applications to the FDA

Ophthalmic Devices Panel of the Center of Devices and

Radiological Health for review by experts in the ophthal-

mology.

9. Ina letter dated June 1, 1989, the FDA approved a

supplemental PMA application for the Solution, stating

that “based upon the information submitted, the PMA

supplement is approved subject to the conditions

described”, thereby permitting the Solution to be mar-

keted as a Class III medical device. (Attached as “Exhibit

E”.) In a letter dated May 3, 1990, the FDA approved the

PMA application for the Cleaner, permitting it also to be

marketed as a Class III medical device. The approval

letter states that “you may begin commercial distribution

of the device upon receipt of this letter.” (Attached as

“Exhibit F”.)

10. The FDA approved the PMA application for the

original formula Boston® Cleaner and the original for-

mula Boston® Conditioning Solution on November 17,

1983. In this original 1983 PMA, the FDA approved tap

water rinsing of RGP lenses.

11. Rinsing of the RGP lenses in tap water prior to

disinfection with Boston® products has been approved as

safe and effective through the PMA approval process by

the FDA three times (1987, 1989, and 1990) since the

original 1983 approval.

12. At all times since the products were approved

by the FDA as Class III medical devices, Polymer has

maintained FDA approval for the Cleaner, Solution, the

7a

original formula Boston® Conditioning Solution, and

original formula Boston® Cleaner, including all labeling

and direc

I decl

tions for use associated with these products.

are under penalty of perjury under the laws of

the Commonwealth of Pennsylvania pursuant to 18

Pa.C.S.A.

§ 4904 that the foregoing is true and correct.

/s/ William J. Gleason, O.D.

William J. Gleason, O.D.

Director of Quality &

Regulatory Affairs

Polymer Technology

100 Research Drive

Wilmington, MA 01887

Date: August 2, 1994

Exhibit A ...

Exhibit B

Exhibit C

Exhibit D ...

Exhibit E

Exhibit F

LIST OF EXHIBITS

Boston Advance® Cleaner Instructions

sewed Boston Advance® Conditioning Solution

Instructions

Pe PMA Cover Letter for Boston Advance®

Cleaner

PMA Cover Letter for Boston Advance®

Conditioning Solution

eee FDA Approval Letter for Boston Advance®

Conditioning Solution

ig FDA Approval Letter for Boston Advance®

Cleaner

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EXHIBIT C

POLYMER TECHNOLOGY CORPORATION

[LOGO] 100 RESEARCH DRIVE e WILMINGTON

(608) 658-6111 e MASSACHUSETTS

September 14, 1989

RE: PMA Application

for the BOSTON™ Cleaner II

FDA

Center for Devices and Radiological Health

PMA — Document Mail Center (HFZ-401)

8757 Georgia Avenue

Silver Spring, MD 20910

Dear Sirs:

Enclosed herein, please find six (6) copies of the

original PMA Application for the BOSTON™ Cleaner II

for use in the care regimen for fluoro-silicone-acrylate

and silicone-acrylate rigid gas permeable contact lenses.

Generic Name: Cleaning Solution For Rigid Gas Per-

meable Contact Lenses

Trade Name: The BOSTON™ Cleaner II

The BOSTON™ Cleaner II is indicated for daily or

periodic cleaning of fluoro-silicone-acrylate and silicone-

acrylate rigid gas permeable contact lenses. In addition,

when combined with the BOSTON™ Conditioning Solu-

tion or the BOSTON™ Conditioning Solution II as in the

BOSTON™ Care System, the system is proven to be an

effective disinfecting agent. The BOSTON™ Cleaner II is

available in 5 mL, 10 mL, 15 mL and 30 mL units. The

shelf-life of this product is seven (7) months. Shelf-like

extensions and qualifications of alternate bottle resins

17a

will be performed in accordance with 1985 FDA Solution

Guidelines.

During the development of this product the

BOSTON™ Cleaner II was referred to as the SPD-KST1

Lipid Cleaner. This application and accompanying

reports contain references to both names. According to 21

CFR 25.23 (c) this product is excluded from the environ-

mental impact requirement.

This application is sponsored by Polymer Technology

Corporation of Wilmington, Massachusetts. The manufac-

turing site of the BOSTON Cleaner II is Bausch & Lomb

Solutions Plant in Greensville, South Carolina.

CONFIDENTIALITY

The information contained in this document is

exempt from disclosure pursuant to section 812.38 of Title

21 of the Code of Federal Regulations and to Section 552

of Title 5 of the United States Code. In addition, specific

information marked CONFIDENTIAL is considered to be

Proprietary Information belonging to Polymer Technol-

ogy Corporation which may not, under any circum-

stances, be disclosed.

If you should require additional information or have

questions, please do not hesitate to contact me.

Sincerely,

/s/ Ellen M. Beueler

Ellen M. Beueler

Clinical and Regulatory

Affairs Associate

emb

18a

EXHIBIT D

POLYMER TECHNOLOGY CORPORATION

[LOGO] 100 RESEARCH DRIVE ¢ WILMINGTON

(608) 658-6111 ¢ MASSACHUSETTS

November 3, 1988

RE: PMA Application

for the BOSTON™ Conditioning

Solution II and The BOSTON™

Reconditioning Drops II.

FDA

Center for Devices and Radiological Health

PMA - Document Mail Center (HFZ-401)

8757 Georgia Avenue

Silver Spring, MD 20910

Dear Sirs:

Enclosed herein, please find six (6) copies of the PMA

Application for the BOSTON™ Conditioning Solution II

and the BOSTON™ Reconditioning Drops II when used as

the care regimen for rigid gas permeable contact lenses.

Generic Name: Wetting and soaking solution for rigid

gas permeable contact lenses

Trade Name: The BOSTON™ Conditioning Solution

II and The BOSTON™ Reconditioning

Drops II

The BOSTON™ Conditioning Solution II and the

BOSTON™ Reconditioning Drops II, hereafter referred to

as the BOSTON CJP1 Solutions, are designed to be effec-

tive conditioning and rewetting agents for the care and

maintenance of rigid gas permeable contact lenses. In

19a

addition, when combined with the BOSTON™ Cleaner as

in the BOSTON™ Care System, the conditioner is proven

to be an effective disinfecting agent. The conditioning

solution is intended for wetting and soaking the contact

lenses. The reconditioning drops are intended to be

instilled directly into the eye to enhance lens wettability

characteristics and reduce friction against the cornea

while the lens is being worn by the patient.

These solutions are similar to the currently marketed

BOSTON™ Conditioning Solution and BOSTON™ Recon-

ditioning Drops. The difference is a decrease in the vis-

cosity and a change in the preservative system from

chlorhexidine gluconate (CHG) to polyaminopropy]l big-

uanide (PAPB). This preservative is also referred to as

polyhexamethylene biguanide (PHMB) or polyhex-

amethylene diguanide (PHMD). According to 21 CFR

25.23 (c) this product is excluded from the environmental

impact requirement.

This application is sponsored by Polymer Technology

Corporation of Wilmington, Massachusetts. The manufac-

turing site of the BOSTON CJP1 Solutions is Bausch &

Lomb Solutions Plant in Greenville, South Carolina.

If you should require additional information or have

questions, please do not hesitate to contact me.

Sincerely,

/s/ William J. Gleason (emb)

William J. Gleason, O.D.

Director, Clinical and

Regulatory Affairs

emb

20a

EXHIBIT E

[LOGO]

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

8757 Georgia Avenue

Si'ver Spring, MD 20910

William J. Gleason, O.D.

Director, Clinical and Regulatory Affairs

Polymer Technology Corporation

100 Research Drive

Wilmington, Massachusetts 01887

RE: P820070/S14

THE BOSTON™ Conditioning Solution and

THE BOSTON™ Reconditioning Drops

Filed: November 9, 1988

Amended: April 24, and 25; and

May 3, 23, and 25, 1989

Dear Dr. Gleason:

The Center for Devices and Radiological Health (CDRH)

of the Food and Drug Administration (FDA) has com-

pleted its evaluation of your premarket approval applica-

tion (PMA) supplement, which requested approval to

decrease the viscosity and change the preservative sys-

tem from chlorhexidine gluconate to polyaminopropyl

biguanide for the above referenced devices. THE

BOSTON™ Conditioning Solution, as modified, will be

marketed under the trade name BOSTON™ Conditioning

Solution II and supplied in 30 ml and 120 ml plastic

2la

bottles. THE BOSTON™ Reconditioning Drops, as mod-

ified, will be marketed under the trade name BOSTON™

Reconditioning Drops II and supplied in a 10 ml plastic

bottle.

The BOSTON™ Conditioning Solution II is indicated for

disinfecting and soaking after cleaning and rinsing of

silicone-acrylate and fluoro-silicone-acrylate rigid gas

permeable contact lenses (as listed in the labeling). The

BOSTON™ Reconditioning Drops II is indicated for use

directly in the eye to lubricate and rewet silicone-acrylate

and fluoro-silicone-acrylate rigid gas permeable contact

lenses (as sisted in the labeling) during lens wear.

Based upon the information submitted, the PMA supple-

ment is approved subject to the conditions described in

the “Conditions of approval” (enclosed). You may begin

commercial distribution of the device as modified by

your PMA supplement upon receipt of this letter.

The expiration dating for the BOSTON™ Conditioning

Solution II and BOSTON™ Reconditioning Drops II has

been established and approved at 6 months. This is to

advise you that the protocol used to establish this expira-

tion dating is considered an approved protocol for the

purpose of extending the expiration dating as provided

by 21 CFR 814.38(a)(8).

Failure to comply with the conditions of approval invali-

dates this approval order. Commercial distribution of a

device that is not in compliance with these conditions is a

violation of the Federal Food, Drug, and Cosmetic Act.

:

22a

All required documents must be submitted in triplicate,

unless otherwise specified, to the address below and shall

reference the above PMA number to expedite processing.

PMA Document Mail Center (HFZ-401)

Center for Devices and Radiological Health

Food and Drug Administration

8757 Georgia Avenue

Silver Spring, Maryland 20910

If you have any questions concerning the approval of this

supplemental application, please contact Ms. Alice Yoza

or Mr. David M. Whipple at (301) 427-7940.

Sincerely yours,

/s/ Richard E. Lippman

Richard E. Lippman,

O.D., F.A.A.O.

Director

Division of Ophthalmic Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

Enclosure 1

CONDITIONS OF APPROVAL

Approved Labeling. As soon as possible, and before

commercial distribution of your device, submit two

copies of an amendment to this PMA submission with

copies of all approved labeling in final printed form to

the Food and Drug Administration (FDA), Center for

23a

Devices and Radiological Health, PMA Document Mail

Center (HFZ-401), 8757 Georgia Avenue, Silver Spring,

Maryland 20910.

Advertisement. No advertisement and other descriptive

printed material issued by the applicant or private label

distributor with respect to this device shall recommend

or imply that the device may be used for any use that is

not included in the FDA approved labeling for the device.

If FDA has restricted the sale, distribution and use of the

device to prescription use in accordance with 21 CFR

801.109 within the meaning of section 520(e) of the act

under the authority of section 515(d)(1)(B)(ii) of the act,

all advertisements and other descriptive printed material

issued by the applicant or distributor with respect to the

device shall include a brief statement of the intended uses

of the device and relevant warnings, precautions, side

effects and contraindications.

Premarket Approval Application (PMA) Supplement. Before

making any change affecting the safety or effectiveness of

the device, submit a PMA supplement for review and

approval by FDA unless the change is of a type for which

a “Special PMA Supplement-Changes Being Effected” is

permitted under 21 CFR 814.39(d) or for which FDA has

advised in an advisory opinion or in correspondence in

accordance with 21 CFR 814.39(e) that an alternate sub-

mission is permitted. A PMA supplement or alternate

submission shall comply with applicable requirements

under 21 CFR 814.39 of the final rule for Premarket

Approval of Medical Devices (51 FR 26342) published in

the Federal Register of July 22, 1986.

24a

Postapproval Reports. Continued approval of this PMA is

contingent upon the submission of postapproval reports

required under 21 CFR 814.84 at intervals of 1 year from

the date of approval of the original PMA. Postapproval

reports for supplements approved under the original

PMA, if applicable, are to be included in the next and

subsequent annual reports for the original PMA unless

specified otherwise in the approval order for the PMA

supplement. Two copies identified as “Annual Report” and

bearing the applicable PMA reference number are to be

submitted to the Food and Drug Administration, Center

for Devices and Radiological Health, PMA Document

Mail Center (HFZ-401), 8757 Georgia Avenue, Silver

Spring, Maryland 20910. The postapproval report shall

indicate the beginning and ending date of the period

covered by the report and shall include the following

information required by 21 CFR 814.84:

(1) Identification of changes described in 21

CFR 814.39(a) and changes required to be

reported to FDA under 21 CFR 814.39(b).

(2) Bibliography and summary of the follow-

ing information not previously submitted

as part of the PMA and that is known to or

reasonably should be known to the appli-

cant:

(a) unpublished reports of data from any

clinical investigations or nonclinical

laboratory studies involving the

device or related devices (“related”

devices include devices which are the

same or substantially similar to the

applicant’s device); and

25a

(b) reports in the scientific literature con-

cerning the device.

If, after reviewing the bibliography and sum-

mary, FDA concludes that agency review of one

or more of the above reports is required, the

applicant shall submit two copies of each identi-

fied report when so notified by FDA.

Adverse Reaction and Device Defect Reporting. As provided

by 21 CFR 814.82(a)(9), FDA has determined that in order

to provide continued reasonable assurance of the safety

and effectiveness of the device, the applicant shall submit

3 copies of a written report identified as an “Adverse

Reaction Report” or “Device Defect Report”, as applicable,

to the Food and Drug Administration, Center for Devices

and Radiological Health, 8757 Georgia Avenue, Silver

Spring, Maryland 20910 within 10 days after the applicant

receives or has knowledge of information concerning:

(1) A mixup of the device or its labeling with

another article.

(2) Any adverse reaction, side effect, injury,

toxicity, or sensitivity reaction that is attrib-

utable in the device and

(a) has not been addressed by the device's

labeling or

(b) has been addressed by the device’s

labeling, but is occuring with unex-

pected severity or frequency.

(3) Any significant chemical, physical or other

change or deterioration in the device or any

failure of the device to meet the specifica-

tions established in the approved PMA that

could not cause or contribute to death or

26a

serious injury but are not correctable by

adjustments or other maintenance pro-

cedures described in the approved labeling.

The report shall include a discussion of the

applicant’s assessment of the change, dete-

rioration or failure and any proposed or

implemented corrective action by the appli-

cant. When such events are correctable by

adjustments or other maintenance pro-

cedures described in the approved labeling,

all such events known to the applicant shall

be included in the Annual Report described

under “Postapproval Reports” above unless

specified otherwise in the conditions of

approval to this PMA. This postapproval

report shall appropriately categorize these

events and include the number of reported

and otherwise known instances of each cat-

egory during the reporting period. Addi-

tional information regarding the events

discussed above shall be submitted by the

applicant when determined by FDA to be

necessary to provide continued reasonable

assurance of the safety and effectiveness of

the device for its intended use.

Reporting under the Medical Device Reporting (MDR) Regu-

lation. The Medical Device Reporting (MDR) Regulation

became effective on December 13, 1984, and requires that

all manufacturers and importers of medical devices,

including in vitro diagnostic devices, report to FDA

whenever they receive or otherwise become aware of

information that reasonably suggests that one of its mar-

keted devices (1) may have caused or contributed to a

death or serious injury or (2) has malfunctioned and that

27a

the device or any other device marketed by the manufac-

turer or importer would be likely to cause or contribute

to a death or serious injury if the malfunction were to

reoccur.

The conditions of approval accompanying PMA approval

orders may require that the same events subject to report-

ing under the MDR Regulation must also be included in

periodic reports to the PMA. FDA has determined that

such duplicative reporting is unnecessary. Whenever an

event involving a device is subject to reporting under

both the MDR Regulation and the conditions of approval

for this PMA, you shall submit the appropriate reports

required by the MDR Regulation and identified with the

PMA reference number to the following office:

Device Monitoring Branch (HFZ-343)

Center for Devices and Radiological Health

Food and Drug Administration

8757 Georgia Avenue

Silver Spring, Maryland 20910

Telephone (301) 427-7500

Events included in periodic reports to the PMA that have

also been reported under the MDR Regulation must be so

identified in the periodic report to the PMA to prevent

duplicative entry into FDA information systems.

Copies of the MDR Regulation and a FDA publication

entitled, “An Overview of the Medical Device Reporting

Regulation”, are available by written request to the above

address or by telephoning (301) 427-8100.

28a

EXHIBIT F

[LOGO]

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

1390 Piccard Drive

Rockville, MD 20850

MAY 3 1990

Ms. Ellen M. Beucler

Clinical and Regulatory Affairs Associate

Polymer Technology Corporation

100 Research Drive

Wilmington, Massachusetts 01887

RE: P890054

BOSTON™ Cleaner II

Filed: September 15, 1989

Amended: November 24, 1989; and February 24,

March 23, and April 24, 1990

Dear Ms. Beucler:

The Center for Devices and Radiological Health (CDRH)

of the Food and Drug Administration (FDA) has com-

pleted its review of your premarket approval application

(PMA) for the BOSTON™ Cleaner II. This device is indi-

cated for use to clean fluoro silicone acrylate and silicone

acrylate rigid gas permeable contact lenses before condi-

tioning (wetting, soaking, disinfecting). The solution is to

be marketed in 5mL, 10 mL, 15 mL and 30 mL bottle

sizes. The PMA is approved subject to the conditions

described below and in the “Conditions of Approval”

(enclosed). You may begin commercial distribution of the

device upon receipt of this letter.

29a

Expiration dating for this device has been established and

approved at 7 months. This is to advise you that the

protocol used to establish this expiration dating is consid-

ered an approval protocol for the purpose of extending

the expiration dating as provided by 21 CFR 814.39(a)(8).

CDRH will publish a notice of its decision to approve

your PMA in the FEDERAL REGISTER. The notice will

state that a summary of the safety and effectiveness data

upon which the approval is based is available to the

public upon request. In addition, the notice will state that

a copy of all approved labeling (which may be a draft of

the final labeling) is available for public inspection at the

CDRH. Within 30 days of publication of the notice of

approval in the FEDERAL REGISTER, any interested per-

son may seek review of this decision by requesting an

opportunity for administrative review, either through a

hearing or review by an independent advisory commit-

tee, under section 515(g) of the Federal Food, Drug, and

Cosmetic Act (act).

Failure to comply with the conditions of approval invali-

dates this approval order. Commercial distribution of a

device that is not in compliance with these conditions is a

violation of the act.

All required documents must be submitted in triplicate,

unless otherwise specified, to the address below and shall

reference the above PMA number to expedite processing.

PMA Document Mail Center (HFZ-401)

Center for Devices and Radiological Health

Food and Drug Administration

1390 Piccard Drive

Rockville, Maryland 20850-4302

30a

If you have any questions concerning this approval order,

please contact Ms. Eleanor M. Felton or Mr. David M.

Whipple at (301) 427-1080.

Sincerely yours,

/s/ D R West

for Robert L. Sheridan

Director

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

ENCLOSURE 1

REVISED: September 12, 1989

CONDITIONS OF APPROVAL

Approved Labeling. As soon as possible, and before

commercial distribution of your device, submit two

copies of an amendment to this PMA submission with

copies of all approved labeling in final printed form to

the PMA Document Mail Center (HFZ-401), Center for

Devices and Radiological Health, Food and Drug Admin-

istration (FDA), 1390 Piccard Drive, Rockville, Maryland

20850.

Advertisement. No advertisement and other descriptive

printed material issued by the applicant or private label

distributor with respect to this device shall recommend

or imply that the device may be used for any use that is

not included in the FDA approved labeling for the device.

3la

If FDA has restricted the sale, distribution and use of the

device to prescription use in accordance with 21 CFR

801.109 within the meaning of section 520(e) of the act

under the authority of section 515(d)(1)(B)(ii) of the act,

all advertisements and other descriptive printed material

issued by the applicant or distributor with respect to the

device shall include a brief statement of the intended uses

of the device and relevant warnings, precautions, side

effects and contraindications.

Pre-market Approval Application (PMA) Supple-

ment. Before making any change affecting the safety or

effectiveness of the device, submit a PMA supplement for

review and approval by FDA unless the change is of a

type for which a “Special PMA Supplement-Changes

Being Effected” is permitted under 21 CFR 814.39(d) or

for which FDA has advised in an advisory opinion or in

correspondence in accordance with 21 CFR 814.39(e) that

an alternate submission is permitted. A PMA supplement

or alternate submission shall comply with applicable

requirements under 21 CFR 814.39 of the final rule for

Premarket Approval of Medical Devices (51 FR 26342)

published in the Federal Register of July 22, 1986.

Postapproval Reports. Continued approval of this PMA

is contingent upon the submission of postapproval

reports required under 21 CFR 814.84 at intervals of 1

year from the date of approval of the original PMA.

Postapproval reports for supplements approved under

the original PMA, if applicable, are to be included in the

next and subsequent annual reports for the original PMA

unless specified otherwise in the approval order for the

PMA supplement. Two copies identified as “Annual

Report” and bearing the applicable PMA reference

32a

number are to be submitted to the PMA Document Mail

Center (HFZ-401), Center for Devices and Radiological

Health, Food and Drug Administration, 1390 Piccard

Drive, Rockville, Maryland 20850. The postapproval

report shall indicate the beginning and ending date of the

period covered by the report and shall include the follow-

ing information required by 21 CFR 814.84:

(1) Identification of changes described in 21

CFR 814.39(a) and changes required to be

reported to FDA under 21 CFR 814.39(b).

(2) Bibliography and summary of the follow-

ing information not previously submitted

as part of the PMA and that is known to or

reasonably should be known to the appli-

cant:

(a) unpublished reports of data from any

clinical investigations or nonclinical

laboratory studies involving the

device or related devices (“related”

devices include devices which are the

same or substantially similar to the

applicant’s device); and

(b) reports in the scientific literature con-

cerning the device.

The “Conditions of Approval” accompanying PMA

approval orders may require that the same events subject

to reporting under the MDR Regulation must also be

included in periodic reports to the PMA. FDA has deter-

mined that such duplicative reporting is unnecessary.

Whenever an event involving a device is subject to

reporting under both the MDR Regulation and the “Con-

ditions of Approval” for this PMA, you shall submit the

appropriate reports required by the MDR Regulation and

33a

identified with the PMA reference number to the follow-

ing office:

Device Monitoring Branch (HFZ-343)

Center for Devices and Radiological Health

Food and Drug Administration

1390 Piccard Drive

Rockville, Maryland 20850

Telephone (301) 427-1144

Events included in periodic reports to th. PMA that have

also been reported under the MDR Regulation must be so

identified in the periodic report to the PMA to prevent

duplicative entry into FDA information systems.

Copies of the MDR Regulation and an FDA publication

entitled, “An Overview of the Medical Device Reporting

Regulation”, are available by written request to the above

address or by telephoning (301) 427-1140.