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Valerie Mahtani, Carlos Munoz, and Michelle Munoz, On Behalf of Themselves v. Wyeth and Animal Health International

June 30, 2011

VALERIE MAHTANI, CARLOS MUNOZ, AND MICHELLE MUNOZ, ON BEHALF OF THEMSELVES
AND ALL OTHERS SIMILARLY SITUATED
PLAINTIFF,
v.
WYETH AND ANIMAL HEALTH INTERNATIONAL, INC. DEFENDANTS.



The opinion of the court was delivered by: Katharine S. Hayden, U.S.D.J.

NOT FOR PUBLICATION

OPINION

I. Introduction

The named plaintiffs in this action, Valerie Mahtani, Carlos Munoz, and Michelle Munoz, used defendant Wyeth's flea and tick treatment, ProMeris, on their dogs and claim that it

(1) failed to eradicate their dogs' fleas and ticks and (2) caused their dogs to suffer lethargy, vomiting, and diarrhea. They assert causes of action for violation of the New Jersey Consumer Fraud Act ("NJCFA"), unjust enrichment, and breach of warranty, and in this motion, they seek to certify a class consisting of all purchasers of ProMeris in the United States.

II. Facts

A. ProMeris: Its Ingredients and Function

In 2007, Wyeth's Fort Dodge Animal Health ("FDAH") operation, which is based in Princeton, N.J., introduced to the market ProMeris, a topical flea and tick treatment for dogs. ProMeris, which is applied with an applicator at the base of the dog's neck, contains two active ingredients, metaflumizone and amitraz. (Flea Biology and Epidemiology, attached to Chaleff Aff. as Ex. J; Letter from Dr. Wang to Dr. Laws, attached to Chaleff Aff. as Ex. A.) Other inactive ingredients hold the active ingredients in solution and assist the distribution of the active ingredients throughout the dog's coat. (Veterinary Parasitology Vol. 150, attached to George Decl. as Ex. 4, at 197.) Consumers can only obtain the product from their veterinarian. (Hoffman Dep. 41:17--42:9.) While amitraz had previously been used on animals to treat mange, metaflumizone was relatively new with regard to the treatment of fleas. (Plunkett Report, attached to George Decl. as Ex. 3, ¶¶ 17, 48, 49.) Due to the potential for amitraz to cause harm when it enters the bloodstream, Mitaban, a prescription-only dog-bathing product that included amitraz, came accompanied by detailed warnings about potential adverse effects. (Chaleff Dep. 24:10--18; Boeckh Dep. 159:7--10, 160:5--16; Mitaban Package Insert, attached to George Decl. as Ex. 7.) The ProMeris packaging indicated that the product was safe and effective for dogs eight weeks of age and older. (ProMeris Packaging, attached to George Decl. as Exs. 8--9; ProMeris Brochure, attached to George Decl. as Ex. 10.) The warning printed on the ProMeris packaging is as follows:

For external use only. For use on dogs only. DO NOT USE ON ANY ANIMALS OTHER THAN DOGS. Do not use on puppies younger than 8 weeks of age. Certain medications can interact with pesticides. Consult a veterinarian before using this product on aged, debilitated, medicated, pregnant or nursing animals. Individual sensitivities, while rare, may occur after the use of any pesticide product. If skin irritation, change in behavior, vomiting or diarrhea is observed and persists after the use of the product, call your veterinarian immediately. (ProMeris Packaging, attached to George Decl. as Exs. 8--9; ProMeris Brochure, attached to George Decl. as Ex. 10.) In addition to this warning, the ProMeris packaging included a limited warranty and disclaimer. It stated,

Directions for use of this product are based upon tests believed to be reliable. The use of this product being beyond the control of the seller, no guarantee, express or implied, is made as to the effects of such use or the results to be obtained if not used in accordance with printed directions and established safe practice. (ProMeris Packaging, attached to George Decl. as Exs. 8--9; ProMeris Brochure, attached to George Decl. as Ex. 10.)

B. Tests and Studies of ProMeris

Before introducing ProMeris to the market, Wyeth conducted efficacy, animal safety, and toxicology studies requested by the EPA. (FDAH Notes from Aug. 29, 2002 Meeting with EPA, attached to Chaleff Aff. as Ex. B.) The efficacy testing consisted of eight studies performed by outside contract researchers, which determined that ProMeris had greater than 90 percent effectiveness and that water immersion and shampooing slightly reduced the product's effectiveness. (ProMeris Efficacy Review, attached to Chaleff Aff. as Ex. G.) Two of the studies used Frontline, a leading flea and tick control product, as a positive control to which they compared ProMeris. (Id.) In each study, ProMeris's performance was almost identical to Frontline's. (Id.) The safety and toxicology testing showed no significant adverse reactions; while one dog died, FDAH determined that the death was unrelated to ProMeris. (Rugg Dep. 82:10--87:17.) In April 2006, the EPA classified the efficacy studies as acceptable. (ProMeris Efficacy Review, attached to Chaleff Aff. as Ex. G.) After some negotiations between FDAH and the EPA regarding the content of the packaging, the EPA registered ProMeris on August 10, 2007. (ProMeris Registration, attached to Chaleff Aff. as Ex. I.)

The EPA-requested studies were not the only ones conducted. A 2007 study published in the journal Veterinary Parasitology tested ProMeris for efficacy against a non-treated control, a placebo control, and fipronil, the active ingredient in Frontline. (Veterinary Parasitology Vol. 150, attached to George Decl. as Ex. 4, at 209, 213.) ProMeris proved to be at or very near 100 percent efficacy up to 28 days after treatment, when its effectiveness dipped to 98.8 percent. (Id. at 214.) Frontline, meanwhile was at or near 100 percent efficacy throughout the 42-day study. (Id.) In addition, Wyeth conducted a field study in Europe prior to the launch of ProMeris in the United States. In that study, 293 dogs were treated with ProMeris and 149 were treated with Frontline; of the 293 dogs treated with ProMeris, 12, or 4 percent, showed adverse reactions that were considered possible, probable, or likely results of treatment. (ProMeris Reference Manual, attached to George Decl. as Ex. 30, at Canine Safety 17.) Furthermore, FDAH conducted a post-launch study of 263 dogs owned by FDAH clients and observed lethargy in only one dog. (Chaleff Aff. ¶ 30.) FDAH therefore determined that improper application was likely at fault for adverse events that had been reported. (Id. ¶ 31.)

On top of their contentions about the implications of the ProMeris testing-specifically, that the testing demonstrates that ProMeris is harmful and less effective than Frontline- plaintiffs attack Wyeth for the tests they failed to conduct. According to plaintiffs, Wyeth failed to perform tests to determine how much amitraz could be introduced into a dog's bloodstream before it started to affect the health of the dog. (Boeckh Dep. 94:11--95:4, 183:12--16.)

C. ProMeris's Post-Launch Performance

ProMeris was launched in October 2007. Thereafter, as Wyeth expected, customers began to call the company to report adverse effects their dogs had experienced. According to Wyeth, this was consistent with the "new product effect," whereby adverse event reports spike and then decrease over time as consumers come to know and understand the product's characteristics and effects. (Letter from FDAH to EPA, attached to Chaleff Aff. as Ex. L.) Among these reports were some noting the presence of skin conditions similar to autoimmune reactions to pemphigus folicaeus ("PF") and skin burns. (Lenz Dep. 88:1--89:24; Wallace Email, attached to George Decl. as Ex. 28.) Plaintiffs, through their expert Laura Plunkett, contend that these problems were caused by the fact that ProMeris can enter the bloodstream by absorbing through the skin and through licking and grooming. (Plunkett Report, attached to George Decl. as Ex. 3, ¶ 22.) Plaintiffs claim that Wyeth designed ProMeris to absorb into the skin despite the potential for amitraz to enter the bloodstream, and that Wyeth intended for ProMeris to spread through a dog's coat despite the potential for a dog to ingest enough of the active ingredients to cause lethargy and other adverse effects. (Id. ¶¶ 20, 31.)

The number of reported adverse events, however, was small compared to ProMeris's sales. Out of 2,211,990 ProMeris doses sold in 2008, Wyeth received 3,195 adverse event reports, equivalent to approximately .14 percent of the total doses sold. (Chaleff Aff. ¶ 33.) Wyeth asserts that this percentage is within the parameters of the new product effect (id.), while plaintiffs assert that the proportion of adverse events reported to the EPA in 2009 that were linked to ProMeris exceeded the product's market share. (Enhanced Adverse Effect Reporting to EPA for ProMeris for Dogs, attached to George Decl. as Ex. 46.) In addition, plaintiffs suggest that the adverse reporting statistics are understated.

According to plaintiffs, Wyeth did not properly respond to the adverse event reports. (Moving Br. at 19.) Plaintiffs' expert states that even trace levels of amitraz could be linked to lethargy. (Plunkett Report, attached to George Decl. as Ex. 3, ¶ 40.) Based on this fact and other test results, plaintiffs assert, Wyeth considered replacing amitraz with another active ingredient while maintaining publicly that improper application was really to blame. (Boeckh Dep. 131:7-- 18; FDAH Meeting Notes, attached to George Decl. as Ex. 48; ProMeris Brainstorming PowerPoint, attached to George Decl. as Ex. 49; Veterinarian Technical Manual, attached to George Decl. as Ex. 12; 2008 Dear Doctor Letter, attached to George Decl. as Ex. 13; 2009 Dear Doctor Letter, attached to George Decl. as Ex. 14.) Plaintiffs also assert that at the time ProMeris was introduced, Frontline and Advantage were effective, well established products, and that ProMeris was better than nothing but inferior to Frontline and Advantage and Wyeth knew it. (ProMeris Launch Doc., attached to George Decl. as Ex. 16, at 2; Development Recommendation, attached to George Decl. as Ex. 21, at Tbls. 3, 4, 10, 12, 13.) Since the events underlying this action, Wyeth, which is now owned by Pfizer, has decided to discontinue ProMeris. (Oral Arg. Tr. 4:24--5:22.)

D. The Experiences of the Named Plaintiffs

The named plaintiffs claim that ProMeris either did not work or caused harm to their dogs. Michele and Carlos Munoz, of Kensington, Maryland, bought ProMeris from their veterinarian to use on their dog, Goldie. (Michelle Munoz Dep. 155:18--21.) They applied it to the dog on August 19, 2008, after which the dog became agitated and then lethargic. (Id. 181:1--5.) According to Michelle Munoz, Goldie had bloody diarrhea and vomited in the kitchen that night, and the next day, she was still lethargic. (Id. 187:4--19.) On August 21, the Munozes noticed that Goldie was still lethargic and had developed lameness in one of her front legs. (Id. 196:23--197:4.) Because their usual veterinarian, Dr. Ira Silver, was away on vacation, they went to see Dr. Jeffrey Zolkiewicz, who administered Antisedan, an amitraz antidote. (Zolkiewicz Dep. 70:3--16.) While Carlos Munoz testified that Zolkiewicz told them ProMeris may have caused their dog's problems, Michelle Munoz stated that no doctor or veterinarian ever told them that ProMeris did in fact cause Goldie's illness. (Carlos Munoz Dep. 95:9--16; Michelle Munoz Dep. 215:12--216:8.) In any event, despite Zolkiewicz's administration of Antisedan, Goldie remained lethargic and lame in one leg on August 22. (MichelleMunoz Dep. 228:3--8.) The Munozes again took the dog to the animal hospital, where Dr. Martine Moore prescribed Rimadyl, an anti-inflammatory drug. (Id. 231:24--232:2.) Though Goldie seemed all right on August 23, she had vomiting and bloody diarrhea on August 24 and diarrhea on August 25. (Id. 238:20--240:11, 247:12--16.) Dr. Moore testified that he believed Rimadyl to be the cause of Goldie's problems on August 24 and 25 and told the Munozes to stop using it. (Moore Dep. 45:14--18.) The Munozes later received a full refund for ProMeris from their vet. (Silver Dep. 30:9--13.) While they claim that ProMeris harmed their dog, they do not claim that it was not effective. (Carlos Munoz Dep. 32:24--33:7, 71:24--72:6, 144:7--13.)

Meanwhile, Valerie Mahtani of Short Hills, New Jersey, received a free sample of ProMeris from her veterinarian in August or September 2008. (Mahtani Dep. 62:4.) She called the ProMeris hotline to ensure proper use, but noticed after she applied it to her dog, Flake, that the dog began to scratch himself and that he had bugs all over him. (Id. 66:7--10; 80:8--9; 81:15-- 82:5.) The information Mahtani received from the ProMeris hotline indicated that the fleas would die off. (Id. 82:6--13, 85:24, 87:21, 86:12, 93:5.) However, the fleas did not die without treatment other than ProMeris. (Id.) Mahtani claims that Flake's constant scratching caused him to bleed from his head, ears, and rectum. (Id. 91:1--11.) Mahtani testified that her veterinarian, Dr. Mitterman, told her that ProMeris caused all of ...


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