# Opposition Brief — Eddy v. Polymer Technology Corp.

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 1998
- **Citation:** 522 U.S. 1075

## Text

= Seca Bou, |S.

) he FIEED
| 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

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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.

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386013_1001%3A2. Public record. Not legal advice.