Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-almd-2_04-cv-00836/USCOURTS-almd-2_04-cv-00836-4/pdf.json

Nature of Suit Code: 840
Nature of Suit: Trademark
Cause of Action: 15:1125 Trademark Infringement (Lanham Act)

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THE DISTRICT COURT OF THE UNITED STATES FOR THE

MIDDLE DISTRICT OF ALABAMA, NORTHERN DIVISION

MIDLOTHIAN LABORATORIES, )

L.L.C., )

)

Plaintiff, )

) CIVIL ACTION NO.

v. ) 2:04cv836-MHT

) (WO)

PAMLAB, L.L.C., and PAN )

AMERICAN LABORATORIES, )

L.L.C., )

)

Defendants. )

 

SUPPLEMENTAL OPINION

This lawsuit is again before the court, this time on

Midlothian’s motion for reconsideration of the opinion

and order entered on August 28, 2007, where this court

held that summary judgment was not due in favor of

Midlothian on Pamlab’s counterclaim and that the

counterclaim should go to trial. Midlothian

Laboratories, L.L.C. v. Pamlab, L.L.C., ___ F. Supp. 2d

___, 2007 WL 2458409 (M.D. Ala. 2007). The court

premised its holding on the following statements:

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“However, at least one test of

Midlothian’s product revealed the

presence of only two of the three active

ingredients found in Foltx. This

evidence alone indicates that Midlothian

at some time marketed a product that was

not pharmaceutically equivalent to

Foltx, a standard that Midlothian itself

argues is required for the

representation of bioequivalence made in

its advertisement. Therefore, the

evidence before the court, when viewed

in the light most favorable to Pamlab as

the non-moving party, creates a triable

issue of fact as to whether Midlothian’s

tests established pharmaceutical

equivalence (a standard for a ‘tests

prove’ claim), as well as whether

Midlothian’s product was in fact

pharmaceutically equivalent to Foltx

(the standard for a ‘bald’ claim of

literal falsity).”

Id. at ___, 2007 WL 2458409, at *17 (footnotes omitted).

The court further stated that, “for the same reasons

[that summary judgment on Pamlab’s false-advertisement

claim] was denied on the ‘bioequivalent’ statement,”

summary judgment “is [also] due to be denied on ... the

‘generic equivalent’ statement.” Id. at ___, 2007 WL

2459409, at *19. 

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In making these statements, the court relied on

“Exhibit 10 to Exhibit D to Pamlab’s unified supplemental

response to Midlothian’s motion for summary judgment on

counterclaim and reply in support of defendants’ motion

for summary judgment (Doc. No. 82), product analysis

report appended to the deposition of Roger Graben.” Id.

at ___, 2007 WL 2458409 at *17 n.55. Both Midlothian and

Pamlab have now informed the court that it was mistaken

about Exhibit 10 in that the testing described in Exhibit

10 was not on Midlothian’s product but rather on Foltx.

Pamlab maintains that its counterclaim must still

survive summary judgment for three reasons. First,

Pamlab argues that the certificates of analysis, upon

which Midlothian relied to show pharmaceutical

equivalence, are flawed because of the time and manner in

which the certificates were produced for this litigation.

Be that as it may, however, Pamlab’s argument, at best,

raises a mere discovery dispute over the timeliness of

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discovery production, and simply does not go to the issue

of the reliability of the certificates.

Pamlab also argues that the certificates are

unreliable because they were produced over 14 months

after Midlothian’s product appeared on the market.

However, there is undisputed deposition testimony of

Rhonda Yeater confirming that the certificates of

analysis bore the date of the request of the certificates

by Midlothian, not the date of the actual testing, and

that the data in the certificates of analysis were

generated and gathered at around the time of manufacture

of Midlothian's product on January 8, 2004, and not on

the date of request on the certificate of analysis, which

is March 18, 2005. See Exhibit 1 to Midlothian's reply

in support of its motion for summary judgment on

defendants' counterclaim (Doc. No. 85). Pamlab responds

that the certificates still do not meet FDA regulations

that provide that, “Laboratory records shall include

complete data derived from all tests necessary to assure

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compliance with established specifications and standards,

including examinations and assays, as follows: ... The

initials or signature of the person who performs each

test and the date(s) the tests were performed.” 21

C.F.R. § 211.194. However, Pamlab is making a falseadvertising claim, and Midlothian has not advertised its

product as meeting tests established under the FDA

regulations. 

Finally, Pamlab makes much of the fact that newly

submitted evidence shows that Exhibit 10 actually was a

test for the new, reformulated Foltx, not original Foltx

and that, as a result, the testimony of Midlothian’s

expert, Roger Graben is drawn into question because he

relied on Exhibit 10 to show the equivalency between

Midlothian’s product and original Foltx. Pamlab argues

that, for an equivalency determination, there must be an

equation with two sides and that, even if Midlothian

provided, with the certificates of analysis, the data for

the ‘generic side’ of the equation, it used the wrong

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product, that is, reformulated Foltx, for the ‘original

product side.’ In other words, according to Pamlab,

Midlothian’s equation compared apples with oranges.

Graben’s testimony is clear, however, that he compared

applies to apples, for, while he factored Exhibit 10 into

his thorough consideration of all evidence, it was not

Exhibit 10 but rather the label for original Foltx that

was the basis for the original product side of the

equation. Exhibit D to Pamlab’s unified supplemental

response to Midlothian’s motion for summary judgment on

counterclaim and reply in support of defendants’ motion

for summary judgment (Doc. No. 83), deposition of Roger

Graben, at 92. In response to the question about his

basis for stating that “Foltx and the Midlothian product[]

meet the conditions of pharmaceutical equivalents,” id.,

Graben testified:

“A. They have the same composition,

they’re the same strength and same

dosage form.

“Q. And how do you know that?

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“A. By comparison of the labeling.

“Q. So your evidence and support of the

statement that these are

pharmaceutically equivalent are the

labels?

“A. Yes

“Q. Is there anything else you relied on

to determine that these two products

are pharmaceutically equivalent?

“A. No.”

Id. PamLab tries to say that later testimony from Graben

makes the above testimony ambiguous. But, after reviewing

all of Graben’s testimony in the record, the court

concludes the Pamlab’s attempt to undermine the above

clear testimony must fail.

Midlothian’s motion for reconsideration should

therefore be granted, and summary judgment should be

entered in favor of Midlothian on Pamlab’s counterclaim.

An appropriate judgment will be entered.

DONE, this the 12th day of September, 2007.

 /s/ Myron H. Thompson 

UNITED STATES DISTRICT JUDGE

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