David H. Bernstein ([email protected]) Michael ...i.bnet.com/blogs/bayer-v-lilly-pet-drugs.pdf · distribution agents and veterinarians to stop selling Bayer’s products,

David H. Bernstein ([email protected])Michael Schaper ([email protected])Christopher J. Hamilton ([email protected])DEBEVOISE & PLIMPTON LLP919 Third AvenueNew York, New York 10022(212) 909-6696 (telephone)(212) 521-7696 (facsimile)

Attorneys for Plaintiff Bayer HealthCare LLC

UNITED STATES DISTRICT COURTSOUTHERN DISTRICT OF NEW YORK- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - XBAYER HEALTHCARE LLC,

Plaintiff,

v.

ELI LILLY AND COMPANY,

Defendant.

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11 Civ. 3047 (AKH)ECF CASE

COMPLAINT AND DEMAND FOR JURY TRIAL

Bayer HealthCare LLC (“Bayer”), by its attorneys, Debevoise & Plimpton LLP,

for its complaint, alleges as follows:

NATURE OF THE ACTION

1. This is an action for false advertising and unfair competition, under federal

and state law against Eli Lilly and Company, whose Elanco division competes directly

against Bayer’s Animal Health Division in the sale of pet medicines. Rather than

Case 1:11-cv-03047-AKH Document 1 Filed 05/04/11 Page 1 of 38

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compete fairly, Elanco is engaged in an unfair and deceptive campaign to convince

distribution agents and veterinarians to terminate business relations with Bayer.

2. Specifically, Elanco has embarked on an unlawful campaign to convince

distribution agents and veterinarians to stop selling Bayer’s products, ostensibly because

Bayer’s sale of pet medicines through retail stores is responsible for a decline in profits

for veterinarians. That is maliciously false. Elanco also deceptively claims to

distribution agents and veterinarians that its pet medicines are sold to pet owners only

through veterinarians, despite the fact that Elanco’s products are widely available to the

public through non-veterinarian Internet websites.

3. Elanco’s unlawful conduct is causing and will continue to cause harm to

Bayer. On information and belief, Bayer has lost sales and relationships with distribution

agents and veterinarians as a result of Elanco’s campaign of deception. This conduct, if

not enjoined, will cause irreparable harm to Bayer’s business relationships with

distribution agents and veterinarians.

THE PARTIES

4. Bayer HealthCare LLC is a limited liability company organized and existing

under the laws of the State of Delaware with its principal place of business at 511

Benedict Avenue, Tarrytown, New York 10591. Bayer owns rights in the United States

to a number of pet medicine brands, including flea and tick preventatives such as

Advantage® II and K9 Advantix® II. These brands are distributed in New York,

throughout the United States, and in many international markets.


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5. Upon information and belief, Elanco is an unincorporated division of Eli Lilly

and Company, with its principal place of business at 2001 West Main Street, Greenfield,

Indiana 46140. Eli Lilly and Company is a corporation organized and existing under the

laws of the State of Indiana with its principal place of business at Lilly Corporate Center,

Indianapolis, Indiana 46285. Upon information and belief, Elanco produces pet

medicines including flea and tick preventatives such as Comfortis, Assurity and Trifexis,

and sells its products throughout the United States, including in this District.

JURISDICTION AND VENUE

6. This Court has original jurisdiction over the subject matter of this action

pursuant to 15 U.S.C. § 1121 and 28 U.S.C. §§ 1331, 1332 and 1338 and has

supplemental jurisdiction pursuant to 28 U.S.C. § 1367. The amount in controversy is in

excess of $75,000, exclusive of interest and costs.

7. This Court has personal jurisdiction over Elanco pursuant to N.Y. Civ. Prac.

L. & R. §§ 301 & 302(a). Upon information and belief, Elanco regularly has solicited

business in the State of New York and in this District, has transacted and done business

in the State of New York and in this District, has wrongfully caused injury to Bayer in the

State of New York and in this District, such injury being reasonably foreseeable, and

derives substantial revenue from interstate commerce.

8. On information and belief, venue is proper in this District pursuant to 28

U.S.C. § 1391(b) because a substantial part of the events giving rise to this action

occurred in this District, including the distribution of the false advertising to veterinarians


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in this District. Venue also is proper in this District pursuant to 28 U.S.C. § 1391(c)

because Elanco is deemed to reside in this District.

THE PET MEDICINE MARKET

9. Bayer and Elanco are direct competitors in the market for pet medicines. Both

companies manufacture, among other products, flea and tick preventatives for cats and

dogs.

10. Bayer manufactures the flea and tick preventatives Advantage® II and K9

Advantix® II. Bayer is the second largest manufacturer of flea and tick preventatives in

the United States. Bayer also manufactures other pet medicines, such as the heartworm

preventative Advantage Multi®. Bayer has sold pet medicines since 1921.

11. Elanco has manufactured medicine products for food animals, such as cattle,

swine and poultry, since 1954. Elanco entered the market for pet medicine more

recently, in 2007. In that year, Elanco launched its first flea preventative, Comfortis. In

2011, Elanco introduced two additional flea and tick preventatives, Assurity and Trifexis.

Elanco also makes the Reconcile product, for treatment of canine separation anxiety.

12. With its entry into the field, Elanco joined a crowded field of competitors,

including Novartis, Merial, Pfizer, Merck, Hartz and Farnam. Bayer welcomes such

competition, but that competition should be fair and legal. As explained below, Elanco

has used tactics that are unfair and illegal.

13. In the United States, manufacturers sell pet medicines primarily through two

distinct distribution systems. First, manufacturers sell pet medicines to retail stores,

including pet stores (e.g., Petco, Petsmart) and pharmacies. Second, manufacturers sell


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pet medicines to veterinarians, including pet hospitals and veterinary clinics. For the

most part, these veterinarians sell the pet medicines directly to pet owners. In both cases,

some sales are made directly from the manufacturer to the retailers and veterinarians, and

others are made through distributors or distribution agents. In most cases, the distributors

through which products are sold to the retail trade are distinct from the distribution agents

through which products are sold to veterinarians.

14. Some pet medicines are subject to Food and Drug Administration (the

“FDA”) regulations, and thus are available only by prescription. These prescription

products can be purchased by pet owners only from veterinarians and pharmacies.

Manufacturers cannot legally sell prescription pet medicines to retail stores or websites

other than pharmacies. Examples of such prescription pet medicines include Bayer’s

Advantage Multi® product and Elanco’s Comfortis, Trifexis and Reconcile products.

15. Other pet medicines (including topical applications not regulated by the FDA)

can legally be sold through pet stores and general retail outlets. Examples of such non-

prescription pet medicines include Bayer’s Advantage® II and K9 Advantix® II products,

and Elanco’s Assurity product.

16. Until March 2010, both Bayer and Elanco sold their entire lines of pet

medicines exclusively to veterinarians.

17. Although Bayer and Elanco did not sell their pet medicines to retail stores or

Internet pharmacies during that period, a number of these products nevertheless could be

purchased in retail stores or via the Internet because some veterinarians resold – or

“diverted” – pet medicines to retail stores or Internet pharmacies in large quantities at a


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considerable profit. Although veterinarians’ diversion of pet medicines from the

veterinary market to this non-veterinary market violated the terms of Bayer’s and

Elanco’s sales policies, this practice was and is common in the sale of many pet

medicines. For example, Merial also only sells its Frontline products to veterinarians, but

its products also are diverted and widely available at retail stores and the Internet.

18. Bayer recognized that the small number of veterinarians who were diverting

products to the retail market were profiting at the expense both of Bayer and of honest

veterinarians. In March 2010, after a lengthy business evaluation, Bayer announced its

decision to begin selling directly to the pet specialty market (i.e., those retailers where at

least fifty percent of sales are products, services and goods for pets) through purchase

agreements and through authorized distributors for this retail channel. These direct sales

are leading to a replacement of diversion from the veterinary channel to this retail

channel.

19. Even after March 2010, Bayer has continued to sell its pet medicines to

veterinarians; in fact, the majority of its flea and tick preventatives and other products

still remain in the veterinary channel. To support veterinarians’ sales of Advantage® II

and K9 Advantix® II, Bayer offers promotions that encourage consumers to take their

pets to see their veterinarian. For example, Bayer coupon offers, whether made available

through direct mail, email, Internet, or veterinary clinics, are valid for use only on

products purchased at the veterinary clinic. In addition, Bayer provides veterinarians

with promotional materials – for example, product displays, “shelf talkers,” window

clings, and posters – for display in their offices. Bayer also educates consumers about the


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importance of taking their pets to the vet. All Bayer television advertising – including the

current K9 Advantix® II commercial and an unbranded public service announcement

regarding canine heartworm prevention – include a call to action for viewers to talk to or

see their veterinarian. In 2010, Bayer spent $2 million on a print advertisement that

stressed the importance of visiting veterinarians and getting wellness checks for pets,

building on the 2009 “Get Your Pet to the Vet” nationwide sweepstakes campaign which

provided $20 vouchers for pet owners for use on veterinary care.

20. Bayer has also continued to support the veterinary market and practice in

other ways. For example, Bayer commissioned a study of veterinary care usage

published in the May 15, 2011 issue of the Journal of the American Veterinary Medical

Association that suggested ways in which veterinarians can increase the frequency of

patient visits. See Ex. A. Further, Bayer contributes to veterinary education, including

through scientific research, the production of online seminars on a variety of topics, the

provision of continuing veterinary medical educational credits and the endowment of

educational grants to a number of universities and veterinary schools. Bayer also

supports veterinary associations and organizations – for example, the American

Veterinary Medical Association and state and local veterinary medical associations, the

Companion Animal Parasite Council, and the American Heartworm Society – through

sponsorships and involvement on their boards.

ELANCO’S FALSE AND MISLEADING STATEMENTS TO VETERINARIANS

21. On or before April 18, 2001, Elanco distributed a “Dear Doctor” letter to a

large number of veterinarians nationwide, including in New York and in this District (the


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“Letter,” attached as Ex. B). The Letter contained a series of false and misleading

statements which falsely and maliciously portrayed Bayer as undermining the business

interests of veterinarians and as being solely responsible for a decline in sales of flea

preventatives by veterinarians.

22. The Letter stated:

In the past year, Bayer began selling Advantage® and K9

Advantix® products directly to pet retailers and websites.

There appears to be a direct correlation between the decline

in veterinary-dispensed flea medication and the availability

of these products outside the veterinary channel. Sales at

Bayer Animal Health rose by 14.6 percent in 2010.

According to Bayer’s financial statements this came as a

result of strong increases in North America.

23. This statement falsely implies that Bayer’s decision to sell certain products to

pet retailers and websites directly caused a decline in sales of flea preventatives by

veterinarians.

24. In fact, as Elanco undoubtedly is aware, veterinary usage has been in decline

over the past five to ten years, significantly predating Bayer’s decision to sell certain pet

medicines to retail stores. The Bayer-sponsored study of veterinary usage shows that the

major factors contributing to this decline have been the weak economy, the fragmentation

of veterinary services, pet owners’ use of Internet sources to get information about pet

health issues, pet owners’ inadequate understanding of the need for routine examinations,

the cost of veterinary care, and cats’ resistance to be being put in carriers. Ex. A. The

study does not identify the availability of pet medicines in retail stores as a factor in the

decline.


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25. The decline in sales of other pet medicines also demonstrates the falsity of

Elanco’s attempt to blame Bayer for the decline in veterinary sales of flea medicine. For

example, sales of heartworm preventatives by veterinarians declined from 2009 to 2010,

despite the fact that heartworm preventatives are available only by prescription and thus

could not possibly be diverted to non-pharmacy retail stores (which are legally prohibited

from selling such products). Bayer does not sell its heartworm preventative products to

retail stores.

26. The Letter also falsely and maliciously portrayed Bayer as having abandoned

veterinarians to focus on selling to retail stores. The Letter stated:

Not only has Bayer chosen to distribute product outside the

veterinary channel, they have shifted their support for

veterinarians by working directly with large retailers. In

December 2010, a marketing manager for Bayer Animal

Health acknowledged, “Advantage has enjoyed the

recommendation of veterinarians worldwide for the control

of fleas on dogs and cats.” When asked how pet specialty

stores can compete effectively with veterinarians in selling

these products, he responded, “With direct support from

Bayer Animal Health, we can help pet retailers leverage our

expertise in parasite prevention and treatment to get the

message to their customers.”

In fact, (a) Bayer still sells many prescription pet medicines which are not available

through pet stores, (b) the majority of Bayer’s sales of flea and tick preventatives are still

to veterinarians, and (c) as described in paragraphs 19 and 20, Bayer has continued to

support veterinarians with research and promotions.


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27. The statement quoted in paragraph 26 also misrepresents Bayer marketing

manager Daniel Peizer’s statements to Pet Business magazine by taking them out of

context. Mr. Peizer was asked: “How can pet specialty stores effectively compete with

veterinary clinics in selling these products?” His response in its entirety stated:

By building awareness and making flea and tick control an

essential part of pet care for your customers. Visiting the

veterinarian on a regular basis is still the single most

important thing a pet owner can do for the health of their

pet. That said, pet owners visit pet specialty retailers more

frequently than they do their veterinarian on an annual

basis to purchase food and other essential items. While

experts like the Companion Animal Parasite Council

recommend that pet owners apply flea and tick control

year-round in most areas of the country, research shows

that on average pet owners only apply about one-third of

the recommended doses. With direct support from Bayer

Animal Health, we can help pet retailers leverage our

expertise in parasite prevention and treatment to get the

message to their customers.

Ex. C (emphasis added). Mr. Peizer’s full response made clear that pet owners should

visit their veterinarians on a regular basis, and could not reasonably be interpreted as

“shifting support” to retail stores and away from veterinarians. Elanco’s selective

quotations from this interview deliberately create a false and misleading impression.

28. In addition to falsely and maliciously asserting that Bayer is responsible for a

decline in sales by veterinarians of pet medicines, Elanco falsely implied in the Letter

that Elanco ensures that its products are sold only through veterinarians:

Since launching Elanco Companion Animal Health, we

have introduced four products into the marketplace – each

sold exclusively to veterinarians through our veterinary


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distributor partners. To retain the dispensing of these

products within the veterinary channel, Elanco has

implemented Track and Trace technology with our

parasiticide products. Unique identification numbers and

bar coding on boxes and cartons help ensure product

integrity and guard against theft, while helping to keep

these products within the context of the

veterinary/client/patient relationship.

29. This statement falsely implies that Elanco’s products are only available to pet

owners through sales by veterinarians, and that veterinarians need not worry about any

competing sales of Elanco products at retail pharmacies. This is demonstrably not the

case. As Elanco must know, its products are available for purchase through a number of

non-veterinarian Internet pharmacies, including 1800petmeds.com, drsfostersmith.com,

and vetsmall.com. See Ex. D. As evidenced by the detail from vetsmall.com at the top of

the following page, Elanco’s Comfortis product is readily available to Internet

consumers:


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30. Elanco’s statements in the Dear Doctor Letter are literally false and

misleading and were designed by Elanco to cause veterinarians to refrain from

purchasing Bayer pet medicines in a misguided attempt to punish Bayer for allowing

competition at retail stores.

31. In the Letter, Elanco also urged veterinarians to engage in a boycott of Bayer:

Your business is at a crossroad. Will you stand by and

watch while industry “leaders” redirect your patients

outside your office for veterinary products? Will you

endorse companies which disrespect your profession and

redirect patients to other sources? Or will you support

companies whose words are supported by action? At

Elanco, we believe it is critically important to align actions

and words.


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32. On April 19, 2011, Bayer formally requested that Elanco take affirmative

steps to retract and correct the false and misleading statements made in the Letter.

Elanco, however, has refused to correct the problem.

33. This campaign to unfairly interfere with Bayer’s relationship with distributors

and veterinarians is not accidental or new. From 2007 to 2010, Elanco hired twenty-two

former Bayer employees, who had knowledge of Bayer’s business and marketing

strategies, including knowledge of key customers and of Bayer’s relationships with

customers and distribution agents. On information and belief, Elanco has used that

knowledge to disrupt Bayer’s business relationships with distribution agents and

veterinarians by maliciously spreading false statements.

34. On information and belief, during 2010 and 2011, Elanco sales representatives

have also stated to distribution agents and veterinarians during detailer and sales visits

that Bayer’s sale of certain pet medicines to pet retailers and websites has caused a

decline in sales of pet medicine by veterinarians, and have urged distribution agents and

veterinarians to stop purchasing and distributing Bayer’s products and to engage in a

boycott of Bayer.

35. On information and belief, Elanco’s deceptive and unlawful campaign to keep

Bayer from competing in the veterinary market has already caused significant harm to

Bayer’s business, including the loss of sales and of business relationships with

distribution agents and veterinarians. Bayer has lost over a thousand veterinary accounts

during this period of unfair competition by Elanco. These lost accounts had provided

over $16 million in sales in 2010.


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COUNT I: FALSE ADVERTISING

UNDER SECTION 43(a) OF THE LANHAM ACT

36. Bayer repeats and realleges each and every allegation in the foregoing

paragraphs as if fully set forth herein.

37. The false, misleading and deceptive statements set forth above are material

and will tend to deceive distribution agents and veterinarians.

38. Elanco, in connection with goods and services distributed in interstate

commerce, has made and is continuing to make false, deceptive and misleading

descriptions and representations of fact in commercial advertising and promotion, which

misrepresent the nature, characteristics and qualities of Bayer’s and Elanco’s goods,

services and commercial activities, in violation of 15 U.S.C. § 1125(a).

39. These violations have injured and will continue to injure Bayer and the public,

causing deception, confusion and damage in an amount that cannot presently be

ascertained.

40. Elanco’s acts of false advertising and unfair competition have caused

irreparable injury to Bayer and, unless restrained, will cause further irreparable injury,

leaving Bayer with no adequate remedy at law.

41. By reason of the foregoing, Bayer is entitled to permanent injunctive relief

against Elanco restraining further acts of false advertising and unfair competition and

requiring Elanco to correct its false and misleading statements, and to recover damages

caused by reason of Elanco’s aforesaid acts in an amount to be determined at trial.


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COUNT II: FALSE ADVERTISING

UNDER STATE LAW



43. Elanco’s advertising has had an impact on consumers and is deceptive or

misleading in a material way.

44. Bayer has suffered injury as a result of Elanco’s advertising.

45. Elanco’s acts as described above constitute false advertising violations under

N.Y. Gen. Bus. Law § 350 (McKinney 2011) and under analogous laws in other states in

which Elanco’s products and services are sold. See, e.g., Kan. Stat. Ann. § 65-672.

COUNT III: UNFAIR COMPETITION

UNDER STATE COMMON LAW



47. The acts of Elanco as described above constitute unfair competition in

violation of Bayer’s rights under New York State common law and under analogous

unfair competition law in other states in which Elanco has circulated the Letter or made

oral statements as part of its deceptive campaign against Bayer.

PRAYER FOR RELIEF

WHEREFORE, Bayer respectfully prays:

A. That Eli Lilly and Company, Elanco and all those in active

concert or participation with Eli Lilly and Company and Elanco (including, but not

limited to, Eli Lilly and Company’s and Elanco’s officers, directors, agents, servants,


16

wholesalers, distributors, retailers, employees, representatives, attorneys, subsidiaries,

related companies, successors, assigns and contracting parties) be permanently enjoined

from distributing, publishing, broadcasting or otherwise disseminating, in any manner or

in any medium, any claims stating, suggesting or implying, directly or indirectly, that:

i. Bayer’s sales of certain pet medicines through retail

stores are responsible for any decline in veterinarians’ profits;

ii. Bayer has shifted its support in the sale of pet

medicines from veterinarians to retail stores; or

iii. Elanco’s pet medicines cannot be purchased by pet

owners from retail stores, such as Internet retailers.

B. That Elanco withdraw and recall from its sales representatives

and any and all channels of distribution any letters, flyers, advertising, promotional

materials, office display materials, or any other matter distributed by it or on its behalf

bearing any descriptions or representations constituting false advertising concerning

Bayer or its products.

C. That Elanco and those in active concert or participation with

Elanco (including, but not limited to, Eli Lilly and Company’s and Elanco’s officers,

directors, agents, servants, wholesalers, distributors, retailers, employees, representatives,

attorneys, subsidiaries, related companies, successors, assigns and contracting parties)

take affirmative steps to dispel such false impressions that heretofore have been created

by the false advertising campaign described above, including, but not limited to,


17

notifying all veterinarians, clinics and distribution agents exposed to the false claims

described above that said statements are false.

D. That Eli Lilly and Company account to Bayer for Elanco’s

profits arising from the foregoing acts of false advertising and unfair competition.

E. That, in accordance with such accounting, Bayer be awarded

judgment for such profits and for three times Bayer’s actual damages arising from Eli

Lilly and Company’s and Elanco’s unlawful conduct, pursuant to 15 U.S.C. § 1117, N.Y.

Gen. Bus. Law § 349(h) and analogous state laws, as a result of the willful and

intentional violations of Eli Lilly and Company and Elanco.

F. That Bayer be awarded its costs, including its reasonable

attorneys’ fees and disbursements in this action, pursuant to 15 U.S.C. § 1117, N.Y. Gen.

Bus. Law § 349(h), and analogous state laws.

G. That Bayer be awarded punitive damages pursuant to the law

of the State of New York and the laws of the other states in view of Eli Lilly and

Company’s and Elanco’s malicious acts.

H. That Eli Lilly and Company file with the Court and serve on

counsel for Bayer within thirty (30) days after entry of any injunction issued by the Court

in this action, a sworn written statement pursuant to 15 U.S.C. § 1116(a) setting forth in

detail the manner and form in which Eli Lilly and Company and Elanco have complied

with any injunction which the Court may enter in this action.

I. That Bayer have such other and further relief as the Court may

deem just and proper.


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JURY TRIAL DEMAND

Bayer demands a trial by jury on all claims as to which a jury trial may be had.

Dated: May 4, 2011New York, New York

DEBEVOISE & PLIMPTON LLP

By: /s/ David H. BernsteinDavid H. Bernstein ([email protected])Michael Schaper ([email protected])Christopher J. Hamilton ([email protected])

919 Third AvenueNew York, New York 10022(212) 909-6696 (telephone)(212) 521-7696 (facsimile)

Attorneys for Plaintiff Bayer HealthCare LLC


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Adams Flea & Tick Mist 16oz

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Advantage Cat Orange 0-9lbs - 4Dose Pack

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Our Price: $60.52 Our Price: $46.54 Our Price: $64.62

Advantage Dog Teal 11-20lbs - 4Dose Pack

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Advantage Dog Teal 11-20lbs - 6 DosePack

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Advantage Multi Cat Orange 5.1-9lbs -6 Dose Pack

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Advantage Multi Cat Purple 9.1-18lbs- 6 Dose Pack

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Advantage Multi Dog Blue 55.1-88lbs- 6 Dose Pack

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Advantage Multi Dog Green 3-9lbs - 6Dose Pack

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Advantage Multi Dog Red 20.1-55lbs -6 Dose Pack

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Advantage Multi Dog Teal 9.1-20lbs -6 Dose Pack

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Advantage Multi Kitten Turquoise 2-5lbs - 3 Dose Pack

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Assurity 6 Dose

Our Price: $76.20

Assurity is a once-a-month topical fleacontrol for cats only

Assurity Single Dose

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Capstar 11.4mg Blue 2-25lbs 6Tablets

Our Price: $25.88

Page 2 of 6Vets Mall - Flea & Tick



Capstar 57mg Green 25-125lbs 6Tablets

Our Price: $28.13

Comfortis 10.1-20lbs Orange 6Tablets/ 6 Months

Our Price: $67.76

Comfortis 20.1-40lbs Teal 6 Tablets/ 6Months

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Comfortis 40.1-60lbs Blue 6 Tablets/ 6Months

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Comfortis 5-10lbs Pink 6 Tablets/ 6Months

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Comfortis 60.1-120lbs Brown 6Tablets/ 6 Months

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Frontline Plus Cat Teal (All Sizes) 3Dose Pack

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Frontline Plus Cat Teal (All Sizes) 6Dose Pack

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Frontline Plus Dog Blue 23-44lbs- 6Dose Pack

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Frontline Plus Dog Orange under22lbs - 3 Dose Pack

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Frontline Plus Dog Orange under22lbs - 6 Dose Pack

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Frontline Plus Dog Purple 45-88lbs - 3Dose Pack

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Frontline Plus Dog Purple 45-88lbs - 6Dose pack.

Our Price: $74.53Frontline Plus Dog Red 89-132lbs - 3

Dose pack

Our Price: $38.99

Page 3 of 6Vets Mall - Flea & Tick



Documents

David H. Bernstein ([email protected]) Michael ...i.bnet.com/blogs/bayer-v-lilly-pet-drugs.pdf · distribution agents and veterinarians to stop selling Bayer’s products,