Free Redacted Document - District Court of Delaware - Delaware

Case 1 :08-cv-00338-JJF Document 52 Filed 07/01 /2008 Page 1 of 4
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
LANNETT COMPANY INC.,
Plaintiff
v.
Civil Action No. 08-338
KV PHARMACEUTICALS,
DRUGTECH CORPORATION, and
THER-RX CORPORATION,
D"JI’""“"“· msnacran
PUBLIC VERSION
KV PHARIMIACEUTICAL COMPANY,
THER-RX CORP., and DRUGTECH
CORP., _
Courztercicxim-pIaintQ'£s‘,
v.
LANNETT COMPANY, INC.,
Counterclaim-defendant.
REPLY DECLARATION OF SCOTT E. GOEDEKE
IN FURTHER SUPPORT OF MOTION FOR
TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION
I, Scott E. Goedeke, declare:
1. I am the same Scott Goedeke who submitted a declaration in this case dated June
17, 2008. I am fully familiar with the facts set forth herein.
2. The samples of Lannett product that were discussed in my June I'? declaration
were purchased by KV Pharmaceutical Company ("KV") from a pharmacy in St. Louis,
Missouri. They arrived in sealed containers with shrink wrap with no visible damage or signs of
improper handling, and have been kept at room temperature at KV’s offices.

Case 1:08-cv-00338-JJF Document 52 Filed 07/O1/2008 Page 2 of 4
3. As noted in my June 17 declaration, I opened and inspected several bottles of the
Lannett product. The strong fishy smell was present without any tampering, manipulation, or
even handling of the product. All that was required to note the smell was to sniff the open bottle.
Similarly, the leakage was clear just from pouring out a few ofthe gel caps, without any
crushing, squeezing, or other manipulation.
4. One of the Lannett bottles was sent to counsel at their request, along with two
bottles of PrimaCare ONE®. They were shipped together in a single Federal Express box.
5. The 1i.11l ingredients iisting for PrimaCare ONE® is contained on the package
insert. There is also a listing on the bottle label, which is abbreviated because of the limited
space on the label.
6. The package insert for PrimaCare ONE® did not originally show the DHA and
EPA content of the omega-3 fatty acids. In 2006, the formulation was updated and the package
insert was modiiied to show in part that the omega-3 fatty acid content includes 260mg of DHA
and 4(lrng of EPA.
7. PrimaCare ONE® is sold in sealed bottles of 30 capsules for dispensing by
pharmacies. Separately, samples of PrimaCare ONE® are made available to physicians in boxes
containing tive capsules so that physicians who desire to give samples to patients may do so.
The physician sample packaging is shown on the website for PrimaCare® and PrimaCare® ONE
in part because that is the packaging that many patients will first see (when they receive samples
from their doctors).
8. As noted in my previous declaration, Ther-Rx also sells a prescription prenatal
supplement called PrimaCare®. As also noted in my previous declaration, PrimaCare® has
separate dosage units for the EFAS andthe vitamins/minerals, the former contained in a gel cap
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Case 1 :08-cv-00338-JJF Document 52 Filed 07/01 /2008 Page 3 of 4
and the latter contained in a solid tablet. Because at daily desc of Pri·msCa1re®is one gel cap plus
one tablet, beth dosages are packaged together in e blister peck that is dispensed te the patient.
By eontrazst, beeausel’1·i1neCare-ONE® combines the EFAS, vitamins, amd minerals in a single
gel esp, e blister eek is not required and it is sold fer dispensing in bottles.
I declare under penalty of perjury that the foreggeing is true and correct.
Dated: June 24, 2008 _ _
Scott E. Goe elce
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Case 1:08-cv-00338-JJF Document 52 Filed 07/O1/2008 Page 4 of 4
CERTIFICATE OF SERVICE
I hereby certify that on July 1, 2008, I caused to be served by hand delivery the
foregoing document and electronically filed the same with the Clerk of Court using
CM/ECP which will send notification of such tiling(s) to the following:
Sophia Siddiqui
Fox Rothschild LLP
919 Market Street, Suite 1300
P. O. Box 2323
Wilmington, DE 19899-2323
1 hereby certify that on July 1, 2008, I sent by Electronic Mail the foregoing
document to the following non-registered participants:
Samuel H. Israel
Gerard P. Norton
Fox Rothschild LLP
2000 Market Street, 10th Floor
Philadelphia,. PA 19103
Cha M. Shandler (#3796)
[email protected]
ami-3292972-1

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