Petition for Rehearing — Boston & Maine R. Co. v. United States

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UNrrep STATES OF AMERICA, :

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“AN ARTICLE OF DRUG ore BacTo-UNDISK “oe.

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ca PETITION OF C DIFCO LABORATORIES, INC.

FOR REHEARING OF, ORDER GRANTING PETITIGN

oe: ' - FOR WRIT OF acai ma °

. alah ‘ .. EDWARD BROWN WILLIAMS -

See rn aif : ' Counsel for Difco ~ .

| et wees . Laboratories, Inc.

0 ~ 423 Washington Building

. Sa Washington, D. C. 20005

Of Counsel: . :

Jay Epwakp WILLIAMS) ,

Harter, CALHOUY, & WILLIAMS .-

° 423 A oreages fgg ee!

Washington, D C. 20005

; _ WILSON - Epes PAINTING Co. - RE 7-6002 - WASHINGTON, D. C. 20001

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ie @ IN THE Chae

8 - Supreme Court uf the United States ar

: OCTOBER 7m, 1968 :

mR 8 .

4 . | | .

: No. 343

mee f aie Unrrep STATES OF AMERICA, : :

Be ia ee et ee _* Petitioner, & ea

ah Ze . ee eee | on

a AN ARTICLE oF Druc * * * Bacto-UNDDISK oe Pe

| PETITION OF CLAIMANT DIFCO LABORATORIES, INC.

ne FOR REHEARING OF ORDER GRANTING PETITION’

Vee - -. KOR WRIT OF CERTIORARI te

ae nw hoes eee,

; Respondent petitions this Court for rehearing of its.

“nae order of: Octeber 21, 1968 granting the ‘petition of the

- Government for a writ of. certiorari to review the judg-

° ment of the United States Court éf*Appéals for the Sixth

-Circuit herein, and, upon such rehearing, for denial of

tS the writ. i

. ’

emg weer

REASONS FOR GRANTING REHEARING

' " AND DENYING THE WRIT

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Since the Brief of Claimant Difco ° Laboratories in.

‘ Opposition was filed in the instant Bacto-Unidisk case

this Court, on. October 14, 19€8, denied the petition for

. @ writ of certiorari in AMP. Incorporated v. Cohen, \

- 86, this term. Following the granting of the petition for j

@ writ in the instant case, petitioner in AMP. filed a Peti- _

tion for Rehearing of the order denying. its petition, stat-

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ing ij in oy as ‘grounds Ghrelin ‘that this Court in the

case at bar will be deciding the same issues as presented

in AMP. On the other hand, the Government in its Brief

in Opposition to the AMP petition had stated that the

decision of the Court of Appgals for the Sixth Circuit in

the instant case was not in conflict with the decision of oe :

‘the Appellate Court in AMP: and that “whether or not. agian,

the Sixth Circuit decision is correct,-the case differs from Bie

the present one both factually: “and legally” (Brief in Op- )

. position, 8-9). 'We agree with that statement of the Gov- - |

ernment. ‘The Government, nevertheless, in its . petition See

for a writ of certiorari in the instant case, contended

that the Sixth Circuit decision represents“ ‘ere: | |

approach to the interpretation of the Act” (Pet. 15). ae ,

‘ is submitted that, in view ofthe denial of the petition in

___AMP and the’ conflicting views with respect to the instant

» ease stated by petitioner in AMP, by the Government, and -

by this respondent, the differences of law and fact in- . |

volved in the two cases should be clearly delineated for | |

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this Court as set forth below. . We believe that such a~

- delineation should’ lead this- Court. to grant a rehearing

in the case’at bar and to deny the Government’s petition

for a writ of certiorari.

1. The articles involved in the. es cases are of entirely

_ different kinds and the portions of the definitions of —— —-——-—

~ “drug” and “devied? ‘relating tothe structure ¢ or function. _—_. ?

“of the- body (Sections 201(g) (1) (ec) and 201(h) (2) of

the Act), which are pertinent in AMP, are not appli-

_eable in any way in the Bacto-Unidisk case. It is clear

from the testimony of the witnesses for both the Govern- ee

ment and the respondént that the Bacto-Unidisk is used i

in-the laboratory only and not in the “treatment of dis- - ~ !

ease” within. the meaning of Section 201(g) (1) (B), the

only portion of the definition ‘of “drug” which the’ Gov- |

ernment seriously contends is” applicable.* The disk, —

: “Dp

* The ‘ocigtial ieunioenth section: that the disks were used in |

diagnosis and prevention was not aera in the Court of een

‘At is untenable. ee

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therefore, satisfies no fartedietional requiremant of. Ne

definition of “drug” under Section 201(g) (1) of the Act. \

‘AMP, on the other hand, involves appliances which are

used to ligate or tie off bleeding blood vessels during a

surgical operation and which therefore affect the strue-

ture or function of the body within the meaning of Sec-

tion 201(z) (1) (ec) or 201(h)(2).. The Government so

noted in its Brief. in Opposition in that case ‘(p 7). More-

over, nylon suture material is “recognized” in the United ©

States Pharmacopeia and sensitivity disks are not,

No witness either for the ‘Government or respondent:

. would accede to the Government’s suggestion that the

Bacto-Unidisk was used in the treatment of disease (e.g.,

_Dr. Truant, a witness for the Government, R. 74a-76a).

Finding No. 8 .(R. 146a-147a) states that “the informa- ~

tion obtained from the sensitivity testing procedure out-

— lined in Finding Number 7 is-used by the physician as a

guideline to treatment of the patient . . .”. Since all witness-

es agreed, there is no basis for disturbing this finding. It

‘follows that no amount.of argument can bring the Bacto-

Unidisk into the scope of the definition of “drug” under

the statute and that, -therefore, there is no occasion for --.

consideration of this case by this Court. Itseems obvious —.

ae the .issues- in the Bacto-Unidisk case and those in

Sie: AMP are entirely different.: : :

The decision in AMP is not “principally relied on”

by the United States in its petition in the Bacto-Unidisk

_ ease, as. stated in the Petition for Rehearing in AMP

Incorporated v. Cohen (p.2).°

On the contrary, both the petition of the Gioesdiahoisl

in the Bacto-Unidisk case and the Reply Memorandum .

for the Petitioner therein seek primarily to persuade this .

Court to disregard the findings of fact and decisions ‘be-

low and to expand judicially the statutory definition of.

drug ‘on the ground that, otherwise, harm may come to -

some patients by reason of the use of faulty sensitivity p

sedate the fact that no data mowing, eyen one in-

¢ ae :

"stance of such an occurrence could be produced at ‘the

| _, tal by any Government witness.

The Government did state,’ in its ‘petition, ‘that AMP

ane -etheér- cases cited were in conflict with the Bacto-

Unidisk decision because they rejected somaya usage as

- determinative of what constitutes a drug” (p. 15).

The Bacto-Unidisk decisions did not, however, turn

oe ~upon “common, usage” 28’ to what is a drug. The term .

“treatment of -disease”. in the definition of “drug” is a

term of technical significance in medical science and was -

so treated: by the Courts below and the parties, both of ©

ee psig presented expert testimony as to its meaning. This

"wag proper. United States v. American-Prucking Asso-—

. ¢iations, 310 U.S. 534, 543-544 (1940) ; St. Luke’s Hosp. -

' Assoc, of Cleveland, Ohio v. United States, 333 F. 2d 157

_ +(6th-Cir., 1964) ; Wigmore on Evidence, Vol. VII, Sec-

\~ tions 1918, 1923, 1955, pp. 11, @1, 85. This testimony, and

j that ‘relating to ‘the meaning ‘of the term “drug” did- not

deal with “common usage” but with the meanin medi-.

‘eal terms to medical doctors. Moreover, although it is

-not used in or on the body and is therefore not a drug

_ in the medical sense (Finding No. 9, R. 147a), the Bacto-

Unidisk would be a drug in the statutory sense if it pur-

ported to be or were represented to be for the treatment

of disease (as the District Court found it was not, Firiding

>. No. 11, R..148a), despite the fact that it could not be so

classified on the basis of “commen usage”.

> Obviously, therefore (a) the ‘decisions below in AMP

' . were not “principally relied on” by the Government in its

Bacte-Unidisk petition and (b) to the extent there was

reliance upon the AMP decisions it-was misplaced.

"It is submitted, therefore, that this case presents no |

- material. question of law or fact to this Court while AMP ©

presents a substantial question of law. It is suggested

further that the decision in AMP has no material rele- ©

vance to the instant case because of the clear legal and me:

factual differences herein set: forth.

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- For these reasons..and — jeatea in the Brief of

Claimant Difco Laboratories, Inc. in Opposition we urge ~

that rehearing be granted and that, thereupon, the peti-

‘tion for writ of‘certiorari to the-U nited States Court of —

Appeals for the.Sixth Circuit be denied. 2 :

oe ne . ' Respectfully submitted,

’

—

&

. Epwarp BROWN WILLIAMS ~—

Rees _ Counsel for. Difco

- any Laboratories, Inc. “.

“>

~ Of Counsel:

JAN EDWARD WILLIAMS:

“HARTER, CALHOUN & WILLIAMS

* Bes

| CERTIFICATE OF COUNSEL

I hereby certify, that the foregoing petition for reheat- :

ing is presented in good faith: and not for delay“and is

restricted to grounds — in —_ 58 of the rules

’ of this Court.

EDWARD BROWN WILLIAMS ;

Counsel for Difco —

Laboratories; Ine.

~ November 1968 _ | - 4