Fisher v. Professional Compounding Centers of Am.

• Decision Date: 29 March 2004
• Docket Number: No. CVS011031PMPPAL.,CVS011031PMPPAL.
• Parties: Wanda FISHER; Scott Fisher; and Brandy Fisher, Plaintiffs, v. PROFESSIONAL COMPOUNDING CENTERS OF AMERICA, INC., a foreign corporation; Alfa Chemicals Italiana, a foreign corporation; Sagran, a foreign corporation; CPS, Inc., a California corporation; and HBS, Inc., a California corporation, Defendants.
• Court: U.S. District Court — District of Nevada

311 F.Supp.2d 1008

Wanda FISHER; Scott Fisher; and Brandy Fisher, Plaintiffs, v. PROFESSIONAL COMPOUNDING CENTERS OF AMERICA, INC., a foreign corporation; Alfa Chemicals Italiana, a foreign corporation; Sagran, a foreign corporation; CPS, Inc., a California corporation; and HBS, Inc., a California corporation, Defendants.

No. CVS011031PMPPAL.

United States District Court, D. Nevada.

March 29, 2004.

COPYRIGHT MATERIAL OMITTED

Will Kemp, Esq., Harrision, Kemp & Jones, Chtd., Las Vegas, NV, Counsel for Plaintiffs.

Steve Morris, Esq., Margaret L. Sanner, Esq., Jenny Sullivan Parker, Esq., Morris Pickering & Sanner, Las Vegas, NV, Counsel for Defendant Alfa Chemicals Italiana.

Carrie McCrea Hanlon, Esq., Pyatt Silvestri & Hanlon, Las Vegas, NV, Counsel for Defendant Professional Compounding Centers.

ORDER

PRO, Chief Judge.

Presently before the Court are two motions for summary judgment filed on behalf of Defendants Professional Compounding Centers of America, Inc. ("PCCA") (Doc. # 188) and Alfa Chemicals Italiana ("Alfa") (Docs.# 189, 190), both filed on September 29, 2003. Alfa filed an Errata (Doc. # 194) on October 3, 2003. PCCA filed an Opposition to Alfa's motion for summary judgment (Doc. # 201) on October 17, 2003. Plaintiffs filed a joint Opposition to PCCA and Alfa's motions (Docs.# 196, 197) on October 15, 2003. Plaintiffs filed an Addendum to their Opposition (Doc. # 204) on October 20, 2003, and four Supplements (Docs.# 212, 238, 253, 256) on November 4, 2003, January 8, 2004, March 15, 2004, and March 17, 2004. PCCA filed a Reply (Doc. # 206) on October 27, 2003. Alfa filed a Reply to PCCA's Opposition to Alfa's motion for summary judgment (Doc. # 208) on October 28, 2003. Alfa also filed a Reply to Plaintiffs' Opposition (Doc. # 214) on November 5, 2003. Alfa filed an Errata to this Reply (Doc. # 216) on November 6, 2003. PCCA filed a Supplement to its motion for summary judgment (Doc. # 234) on January 7, 2004. Finally, Alfa filed a Supplement to its Reply (Doc. # 255) on March 17, 2004. The Court held a hearing on the above motions on March 17, 2004.

I. BACKGROUND

Plaintiffs Wanda Fisher and her husband Scott Fisher bring this suit for damages arising out of Wanda's consumption of the diet drug fen/phen, a compound of two drugs, fenfluramine and phentermine. (Notice of Removal [Doc. # 3], Ex. A; Exs. to Pls.' Opp'n to Alfa and Def. PCCA Motions for Summ. J. [hereinafter "Exs. to Pls.' Opp'n"], Ex. 2 at 15.) Wanda and Scott Fisher, and their daughter Brandy, were living in Utah when they went to a physician named Dr. James Brinton in the spring of 1997. (Exs. to Mot. for Summ. J. of Def. Alfa ["Exs. to Alfa's Mot."], Ex. S at 70, Ex. T at 52-53.) Dr. Brinton, a Utah licensed physician, was a gynecologist who began to offer weight loss drugs in 1996, after learning about fen/phen and its effectiveness for both long and short term weight loss. (Def. PCCA's Mot. for Summ. J. ["PCCA's Mot."], Ex. A at 6, 15.) At the time Dr. Brinton first began prescribing fen/phen, he prescribed the fenfluramine and phentermine separately, and consequently his patients had to take a total of four pills daily. (Id. at 107-08.) Dr. Brinton subsequently learned that it was possible for patients to take only one pill per day if they obtained the pill from a compounding pharmacist who would combine the fenfluramine and phentermine with a time release agent. (Id. at 118-20.)

Dr. Brinton suggested his patients obtain the compounded pill at Stewart's Pharmacy, operated by pharmacist Stewart Koeven, located across the street from Dr. Brinton's office in Provo, Utah. (Id. at 107-08, 118-19.) Wanda obtained the once-a-day fen/phen pill from Stewart's pharmacy. (Def. Alfa's Reply in Supp. of Mot. for Summ. J., Ex. I at 191; Exs. to Alfa's Mot., Ex. T at 68, 75.) She consumed most of the pills in Utah over a period of three months, although occasionally she may have taken one when she was visiting her husband in Mesquite, Nevada where he worked, and where they planned to move. (Exs. to Alfa's Mot., Ex. S at 86-102, Ex. T at 8-9; Exs. to Pls.' Opp'n, Exs. 9-12.)

In July 1997, the Food and Drug Administration ("FDA") issued a Public Health Advisory which recommended close monitoring of patients who had taken fen/phen for more than three months. (PCCA's Mot., Ex. C.) In August and September 1997, major producers of fenfluramine and phentermine, including Wyeth-Ayerst Laboratories and Medeva Pharmaceuticals, announced they were withdrawing their weight loss drugs from the market due to the apparent relationship between the drugs and valvular heart disease. (Id., Ex. D.) In response to these developments and other warnings about fenfluramine's association with heart problems, Dr. Brinton shut down his weight loss practice. (Exs. to Pls.' Opp'n, Ex. 23 at 136, 155-56.)

In 1998, Wanda noticed some symptoms, including pressure in her chest, shortness of breath, heart "fluttering," and intermittent swelling in her feet. (Alfa's Reply, Ex. N at 23.) She did not consult with a physician until after she saw an advertisement for a clinic by Utah lawyers regarding heart problems associated with fen/phen use. (PCCA's Reply, Ex. A at 106.) Wand visited Dr. Kolda, a Utah physician, in March 2001 for a physical examination based on her prior fen/phen use. During this exam, Dr. Kolda performed an echocardiogram. (Id.; PCCA's Mot., Ex. F at 25.) Wanda subsequently visited Dr. Channick, a California physician, in May 2001. (PCCA's Mot., Ex. F at 25.) Dr. Channick diagnosed Wanda with primary pulmonary hypertension ("PPH"). (Id.) PPH causes fibrosis in pulmonary arteries, thereby preventing oxygenation of the blood, restricting blood flow, and increasing blood pressure. In response, the heart works harder to pump blood through the body. As the heart works harder, it becomes more muscular and enlarges, eventually leading to heart failure and death. (Supplement to Pls.' Opp'n [Doc. # 212], Ex. 1 at 6-7.) Shortly after Dr. Channick diagnosed Wanda with PPH, the Fishers brought suit against those in the distribution chain of the fenfluramine contained in the drug compound Wanda used. (Notice of Removal [Doc. # 3], Ex. A.)

Defendant Alfa is an Italian company which formerly owned a subsidiary named Industria Chimica Farmeceutica Italiana ("ICFI"). (Exs. to Alfa's Mot., Ex. A at 5-9.) ICFI produced in bulk the active pharmaceutical ingredient fenfluramine at a plant in Italy. (Id. at 12-13, 22.) Alfa distributed the fenfluramine to five companies in the United States for research and development purposes only, not for consumer use. (Exs. to Alfa's Mot., Ex. B at 93.) It is undisputed that none of this fenfluramine reached the U.S. consumer market or Wanda Fisher.

Unrelated to these research and development sales, Alfa sold several kilograms of fenfluramine to an exporter named Gino Messeca. (Exs. to Alfa's Mot., Ex. L at 8.) Alfa knew the fenfluramine sold to Messeca was to be exported from Italy and that it was intended for human consumption. (Exs. to Pls.' Opp'n, Ex. 4 at 50.) But Alfa claims it did not know the fenfluramine would reach America. Rather, Alfa claims it did not give Messeca key documents he would need to import the fenfluramine into the United States under FDA and customs regulations so that Messeca could not import Alfa's fenfluramine into the U.S. absent some violation of U.S. law. (Exs. to Alfa's Mot., Ex. C at 21, 45.)

Plaintiffs contend ICFI and Alfa "unofficially" knew the fenfluramine was destined for the U.S. When questioned on this subject, Messeca offered rather ambiguous testimony, stating that Alfa did not "officially" or "unofficially" know. When pressed on the point, Messeca conceded Alfa might have known, in part because Alfa was "not stupid" and could have surmised from the quantity Messeca ordered that the fenfluramine was headed to the U.S.¹

Messeca sold the fenfluramine to two U.S. companies, Defendants CPS and HBS. (Exs. to Alfa's Mot., Ex. L at 7, 31.) CPS and HBS passed the fenfluramine on to Defendant PCCA. (Errata to Alfa's Mot. for Summ. J. [Doc. # 194], Ex. K at 107-08.) Alfa claims Messeca and PCCA conspired to illegally bring the fenfluramine into the United States without Alfa's participation or knowledge. At the time the fenfluramine was imported, FDA had prohibited PCCA from importing any foreign chemicals because of a prior violation; PCCA had imported chemicals marked for research and development only and sold them to consumers without proper labeling. (Exs. to Pls.' Opp'n, Ex. I.) FDA also banned Messeca's company TopChem from importing bulk chemicals into the U.S. (Exs. to Pls.' Opp'n, Ex. M.) Despite these prohibitions, according to Messeca, he used a company named Sagran to purchase the fenfluramine and sold the fenfluramine to CPS and HBS even though he knew PCCA was the entity ultimately ordering and purchasing it. (Exs. to Alfa's Mot., Ex. L at 6-8, 66-72.) As a result, Alfa contends Messeca and PCCA were able to circumvent FDA prohibitions against TopChem and PCCA's importation of foreign bulk chemicals.

After acquiring the fenfluramine, PCCA repackaged the bulk fenfluramine into smaller packages. (Exs. to Pls.' Opp'n, Ex. 2 at 12.) PCCA then sent out those smaller quantities to compounding pharmacists, such as Koeven at Stewart's Pharmacy, for incorporation into fen/phen one-a-day pills. (Id. at 14, 70.) PCCA supplied pharmacists such as Koeven with instructions or recipes on compounding fen/phen, as well as a compounding machine. (Id. at 14, 16, 19, 36, 84.) Koeven then would combine the ingredients and place them in the compounding machine thus producing a fen/phen pill. (Id. at 15-16.)

Plaintiffs sued Alfa, PCCA, Sagran, CPS and HBS for strict products liability failure to warn (count 1), strict products liability design defect (count 2), negligence (count 3), breach of implied warranty (count 4), fraudulent concealment (count 5), and negligent misrepresentation (count 6). D...