Ashworth v. Albers Medical, Inc.

395 F. Supp. 2d 395, 2005 U.S. Dist. LEXIS 22596, 2005 WL 2620561
CourtDistrict Court, S.D. West Virginia
DecidedJuly 25, 2005
DocketCIV.A. 2:05-0139
StatusPublished
Cited by14 cases

This text of 395 F. Supp. 2d 395 (Ashworth v. Albers Medical, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. West Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ashworth v. Albers Medical, Inc., 395 F. Supp. 2d 395, 2005 U.S. Dist. LEXIS 22596, 2005 WL 2620561 (S.D.W. Va. 2005).

Opinion

MEMORANDUM ORDER

COPENHAVER, District Judge.

Pending before the court is the motion of plaintiff Tammy Ashworth, filed March 7, 2005, seeking remand of the above-captioned action to the Circuit Court of Kana-wha County, West Virginia. Also pending before the court is the motion of defendant Rite Aid of West Virginia, Inc., filed February 22, 2005, seeking to dismiss the entirety of plaintiffs action against it.

I.

A. Consumption of Counterfeit Drugs.

According to the allegations of her complaint, the plaintiff, a resident of West Virginia, suffers from high cholesterol for which she was prescribed the pharmaceutical drug LIPITOR™. Compl. at ¶ 11. LIPITOR™ contains the active ingredient atrovastatin calcium and is used in the treatment of cardiovascular disorders and cholesterol reduction. Id. at ¶ 10. According to the complaint, defendant Pfizer, Inc. (“Pifzer”), retains exclusive control of the “patents, trademarks, manufacturing, labeling, packaging, re-packaging, distribution, and sale of LIPITOR™.” Id. at ¶ 6. On April 24, 2003, and again on May 22, 2003, plaintiff purchased, pursuant to her prescription, thirty tablets purporting to be 10 mg LIPITOR™ from a pharmacy in Big Chimney, West Virginia, operated by the defendant Rite Aid of West Virginia, Inc. (“Rite Aid”). Id. at ¶ 23.

On May 23, 2003, the day after her second identified purchase at Rite Aid, the United States Food and Drug Administration (“FDA”) announced that the defendant Albers Medical, Inc. (“Albers”), had agreed to a voluntary recall of three lots of *399 90-tablet bottles of 10 mg LIPITOR™ that had been repackaged by the defendant Med-Pro, Inc. Id. at ¶ 12. Apparently, in response to consumer complaints, the FDA tested and found that bottles in those lots contained counterfeit tablets. As part of the announcement, Albers acknowledged that the counterfeit tablets may pose a significant health risk to consumers. Id. On June 3, 2003, the FDA identified additional lots repackaged by Med-Pro, Inc., as containing counterfeit tablets. Id. at ¶ 15. As of July 16, 2003, “approximately 200,000 bottles” had been recalled.

On June 9, 2003, the plaintiff received a form letter from Rite Aid dated May 31, 2003. In that letter, Rite Aid stated that it was notifying those customers who had purchased lOmg Lipitor™ between April 3, 2003, and May 23, 2003, of the recall. The letter further states that:

Since it is impossible to tell through inspection whether or not the product is counterfeit, we are asking our customers who have purchased Lipitor™ lOmg between April 3, 2003, and May 23, 2003, not to take any remaining tablets and return them to Rite Aid Pharmacy for replacement.

Id. at ¶ 26.

Subsequent to receipt of this notification, the plaintiff had an office visit with her treating physician. Plaintiff informed her physician that she may have consumed counterfeit tablets. Id. at ¶ 27. Plaintiff further informed her physician that she had experienced dizziness, sluggishness and chest pains during the period of April 24 to June 9, 2003. Id. at ¶¶ 25 & 27. Her physician ordered blood tests which revealed plaintiff to have “dangerously high” levels of triglycerides and she was admitted to a hospital for treatment. Id. at ¶¶ 28-29. Plaintiff contends that “[s]he has sustained numerous and severe painful injuries including, but not limited to dangerously increased Triglyceride levels, and injuries to her body as a whole.” Id. at ¶ 31.

B. Chain of Distribution.

In her complaint, plaintiff alleges that defendants Med-Pro, Inc., and Albers Medical, Inc. (“Albers”), were engaged in the business of repackaging, distributing and selling pharmaceutical products. Compl. at ¶¶ 3-4. Defendant H.D. Smith Wholesale Drug Co. (“H.D.Smith”) is a national distributor of pharmaceutical products and Rite Aid is seller of pharmaceutical products in the West Virginia market. Id. at ¶¶ 5 & 7. Plaintiff further alleges, based upon statements of Rite Aid made apparently in separate litigation, that bottles containing counterfeit tablets were purchased by Rite Aid from H.D. Smith and that H.D. Smith had purchased the same from Albers. Id. at ¶¶ 17-18. Plaintiff contends that “[defendant Albers sold and distributed LIPITOR™ repacked and sold by Defendant Med-Pro.” Id. at ¶ 19. Moreover, the counterfeits were “colorable imitations of genuine LIPITOR.” Id. at ¶ 20.

In making this motion, plaintiff has appended several exhibits in support, including the affidavit of Stephen M. Holt, a Special Agent for the FDA’s Office of Criminal Investigation. Pl.’s Reply at Ex. E (“Holt Aff.”). His affidavit sheds some light on how counterfeit tablets may have infiltrated the market.

Holt asserts that Albers Medical Distributors, Inc., purchased 203 bottles from G & K Pharma LLC on December 9, 2002. Holt Aff. at ¶ 9. Each of the bottles contained 5,000 tablets purporting to be lOmg LIPITOR™. Id.

G & K Pharma LLC purchased this LIPITOR™ from Pharma Medical LLC, whose authorized agent, R.J. Garcia a/k/a *400 Julio Cesar Cruz, is a convicted drug trafficker. 1 Id. at ¶¶ 9, 12-13. The LIPITOR™ purportedly came to Pharma Medical LLC through each of two companies, Droguería Javiness and J M Blanco, in Puerto Rico. Id. at ¶ 9. Although Javiness and Blanco do exist, neither company has any records concerning sales of LIPITOR™ between them or to Pharma Medical LLC. Id. at ¶¶ 10-11.

At the direction of Albers and Cruz, all of the bottles were shipped to Med-Pro, Inc., a pharmaceutical repackager in Lexington, Nebraska. When Med-Pro, Inc., received the 5,000-count bottles, “each of the 203 were marked and labeled as having been manufactured by Warner-Lambert, Ltd., Dublin, Ireland, and bore Lot # 04132V with an expiration date of January 2004.” Id. at ¶ 18. Pursuant to Albers’ instructions, the contents of those bottles were repackaged into 11,299 90-count bottles, all bearing lot # 04132V 6 and having an expiration date of January 2004. Id. All 11,299 bottles were sold to H.D. Smith, who sold those bottles in the wholesale and retail markets. 2 Id. at ¶ 19. Forensic tests on 90-count bottles bearing that lot number have shown that each bottle contained tablets not manufactured by Pfizer. 3 Id. at ¶ 20.

The testimony of a material witness is also cited in the Holt affidavit. That witness purportedly confirms that “he/she” personally participated with Cruz in a scheme to make counterfeit LIPITOR™. Id. at ¶ 21.

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Bluebook (online)
395 F. Supp. 2d 395, 2005 U.S. Dist. LEXIS 22596, 2005 WL 2620561, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ashworth-v-albers-medical-inc-wvsd-2005.