Pedinol Pharmacal, Inc. v. Rising Pharmaceuticals, Inc.Pedinol Pharmacal, Inc. v. Rising Pharmaceuticals, Inc.
MEMORANDUM AND ORDER ON RULE 50 MOTIONS DAMAGES AND INJUNCTIVE RELIEF
This is a Lanham Act false advertising case that was tried before a jury. The jury heard the Lanham Act claim of Plaintiff Pedinol Pharmacal, Inc. (“Pedinol”) against Defendant Rising Pharmaceuticals, Inc. (“Rising”) as well as the Lanham Act claim of Rising against Pedinol. 1 The jury found that both sides engaged in false advertising. As noted in previous opinions of this court, the jury decided the damages claim against Rising, awarding only nominal damages in the amount of $1. Pursuant to a stipulation of the parties agreed upon prior to trial, the damages claim of Rising against Pedinol was reserved for the court to decide.
Presently before the court are the parties’ motions pursuant to
DISCUSSION
I.
A. Legal Principles
The standard governing
The standard for a motion for judgment as a matter of law is the same as for summary judgment under Rule 56 of the Federal Rules.
Nadel,
B.
Disposition of
As the foregoing standard makes clear, the burden on a party seeking to set aside a jury verdict is extremely high. Upon review of the trial, and the submissions of the parties, the court holds that neither party is entitled to have the jury verdict set aside. There was ample factual and expert testimony presented to the jury. It was for the jury, and not the court, to weigh the evidence admitted, and that is exactly what occurred.
See Reeves v. Sanderson Plumbing Prods., Inc.,
This case was highly contested and well tried by all counsel. Indeed, the court is hard pressed to recall a trial in which the claims of the parties was so competently and clearly presented by counsel to a jury. The jury was presented with compelling factual and capable expert evidence by both sides. Under the circumstances here, the court holds that because it cannot be said that no reasonable jury could have found as did the jury in this case, there is no basis for setting aside the verdict. Accordingly, the motions pursuant to
II. Rising’s Damages Claim
A. Legal Principles
The claim upon which Rising prevailed alleged false advertising pursuant to Section 43(a) of the Lanham Act.
See
The express use of the term “wilful” with respect to a violation of
The seminal case in the Second Circuit setting forth the wilfulness requirement is
George Basch Co., Inc. v. Blue Coral Inc.,
The continuing viability of the wilfulness requirement set forth in
Basch,
decided prior to the amendment of
This court finds more convincing those cases holding that wilfulness remains a requirement for the recovery of a defendant’s profits under
B. Evidence of Wilfulness
Since the court has determined that wilfulness is a prerequisite to recovery of Pedinol’s profits, the court considers whether there was such a showing in this case. As demonstrated below, there was ample evidence of wilfulness and intentional deception demonstrated at trial.
This case involved the sale and marketing of Pedinol’s name brand “Lactinol” 10% lactic acid product, in competition with Rising’s non-name brand lactic acid product. Not surprisingly, Rising’s product sold for a fraction of the price of the Pedinol product. When faced with this competition, Pedinol embarked upon a campaign, lasting several years, aimed at destroying the ability of Rising to compete with Pedinol’s Lactinol.
To achieve its objective, and as part of its aptly named “Sinking Rising” campaign, Pedinol sent a series of false and deceptive letters to Rising’s customers. Despite the clear knowledge of Pedinol’s management that Lactinol was not a “single source” product, as that term is known in the relevant regulatory marketplace, Pedinol sent thousands of letters falsely stating that Lactinol was “single source” and that no generic product could be substituted by the pharmacist. 3 These letters were sent to small neighborhood pharmacists and to large chain stores alike.
Not only were these letters false in their statements as to the “single source” nature of Lactinol, they were threatening. Recipients of letters sent pursuant to Pedinol’s false letter writing campaign were advised that substitution of Lactinol products for a non-name brand product “violates laws that govern the substitution of prescription pharmaceuticals.” (emphasis in original). Recipients were further informed that there is
no legally
appropriate substitute for Lactinol products. Finally, pharmacists receiving false letters from Pedinol were advised that the failure to stop substituting a 10% lactic acid product for Lactinol would lead to “corrective action such as notifying the Office of Professional Discipline [and] New York State Medicaid.... ” The evidence at trial established that such threats were empty, and the likelihood of professional repercussions following substitution of 10% lactic acid for Lactinol was either remote or nonexistent. It is not a leap of faith, however, to con-
C. Factors to Consider When Determining Entitlement and Amount of Lost Profits
The court turns now to consider the impact of several factors that bear upon this court’s exercise of its equity jurisdiction. Equitable principles applicable to the Lanham Act hold that a plaintiff is not automatically entitled to all of defendant’s profits over the time period of the false statements. Indeed, in
Basch,
the Second Circuit recognized the “conceivably draconian impact that a profits remedy may have in some cases.”
Basch,
An award of defendant’s profits is justified by three possible rationales: “(1) the defendant is unjustly enriched; (2) the plaintiff sustained damages from the [defendant’s false statements]; or (3) the award of profits is necessary to deter a wilful [wrongdoer] from doing so again.”
Basch,
The court agrees with Rising that Pedinol was unjustly enriched by its false statements. Evidence produced at trial showed the success of Pedinol’s false letter writing campaign. Specifically, a Pedinol internal memo, dated May 29, 2003, lists twenty-one large retailers that were no longer substituting Lactinol for non-name brand products. Five retailers were noted to be continuing substitution. It was noted, however, that one of those retailers, CVS, was only substituting one product, and that substitution was a result of a “glitch” in the CVS computer system.
As to CVS, the court also notes that Pedinol’s false statements were demonstrated to be directly responsible for Rising’s inability to sell its product to the CVS chain of stores. Ronald Gold, Rising’s president, (“Gold”) testified credibly that Dave Marshall (a CVS buyer, who received Pedinol’s letter, and was visited by Pedinol management), refused to sell Rising’s product. According to Gold, the refusal to carry Rising’s product led to a loss of $400,000 in sales to CVS, which kept Rising’s product off the store’s shelves until Marshall left CVS. Gold’s testimony regarding Dave Marshall also supports the conclusion that Rising suffered damage to its reputation as a result of Pedinol’s false statements.
Unclean hands is argued by both sides. Rising claims that Pedinol’s unclean hands should enhance the profit award, while Pedinol argues that Rising’s unclean hands bars a recovery of profits. The burden of proving that unclean hands bars equitable relief is on the party asserting the defense.
See Gidatex, S.r.L. v. Campaniello Imports, Ltd.,
Pedinol’s unclean hands argument relies on the finding of liability against Rising on Pedinol’s Lanham Act claim. The court holds that the verdict against Rising is insufficient to support a finding of unclean hands. Even the jury that found against Rising was unimpressed with the magnitude of its behavior, deciding to award Pedinol only nominal damages of $1. While this may reflect the jury’s decision as to the ability of Pedinol to show any monetary damage, it also demonstrates that even after considering “any other factor” bearing on damages, as instructed by the court, the jury was not moved to award anything to Pedinol as a result of Rising’s Lanham Act violation.
What matters ultimately as to the unclean hands issue is this court’s conclusion as to Rising’s behavior. On that issue, the court cannot find any conduct rising to the level of unclean hands that would bar recovery for lost profits. At worst, Rising was liable for wrongly stating that the brand name of its product was Lactinol and this may have led to some confusion on the part of buyers. This behavior, however, pales in comparison to that of Pedinol which, as demonstrated above, disseminated a barrage of false letters aimed at destroying Rising’s ability to compete with Pedinol. Under these circumstances, the court holds that unclean hands, standing alone, neither bars nor diminishes Rising’s claim for lost profits.
D. Profit Award
The court has concluded that Rising has established its right to Pedinol’s profit as a measure of its recovery under the Lanham Act. The time period for calculating that profit is the period during which the false statements were disseminated — from April of 2003 through 2006. In accord with
Not surprisingly, the parties set forth different numbers as to the profitability of Pedinol’s Lactinol. Rising seeks a total of $3,018,671, representing what it claims to
The vast discrepancy in the parties’ calculations is explained by their different approaches. Rising calculates Pedinol’s profits based upon the model introduced by Pedinol at trial. At that stage of the proceedings, Pedinol was in the position of seeking Rising’s profits, instead of defending against a claim that its own profits be disgorged. At trial, Pedinol sought profits in excess of $11 million. This figure was based upon the assumption that all sales made by Rising would have been made by Pedinol, at the prices set by Pedinol.
Rising’s present claim does not claim as high a profit margin as that claimed by Pedinol at trial, but seeks what it describes as a more conservative profit margin of 33%. Rising sets forth Pedinol’s total revenues of products at issue during the relevant time period (from documents introduced by Pedinol at trial) as follows:
4-12/2003: $2,552,540
2004: $1,997,427
2005: $2,094,064
2006: $1,114,088
Deduction of selling expenses and general and administrative expenses, according to Rising, as deduced from documents introduced at trial, yields profits of $589,459 for the relevant portion of 2003, and profits of $644,687, $1,154,504 and $630,021 for the years 2004, 2005 and 2006. The total profit sought by Rising is thus $3,018,671. Additionally, Rising seeks interest, at the prevailing prime rate of interest in the amount of $374,286, for a total recovery of $3,392,957.
Rising’s profit claim of over $3 million is contrasted with Pedinol’s profit calculation, over the same time period, of $774,448. Pedinol’s accounting expert relies on documents demonstrating that Rising’s revenue figures are inflated because they reflect gross sales only, without taking into account discounts, chargebacks and rebates. These factors, according to Pedinol, reduce its sales by over $595,000. Additionally, Pedinol asserts that selling costs associated with the marketing of Lactinol, a highly promoted product, are higher than those assumed by Rising. Pedinol also claims that 2005 and 2006 promotional expenses, not taken into account by Rising, decreased Lactinol’s profitability. Finally, Pedinol asserts that Rising has failed to take into account costs of sampling, warehousing and shipping, and has incorrectly calculated general and administrative expenses.
While Rising’s profit calculation is certainly less that the $11 million dollar award sought by Pedinol at trial, it is substantially higher than the $774,448 claimed by Pedinol as the proper profit at this stage of the proceedings. As illustrated by Rising, when Pedinol sought profits it claimed a profit rate of 66%, Rising seeks a profit rate of approximately 33%, and Pedinol now claims profitability at the rate of approximately 8.5%. At least part of this difference must be attributed to the fact that Pedinol’s trial request for damages sought Rising’s profits and Rising now seeks Pedinol’s actual profit based upon its sales of Lactinol.
With the focus properly set on Pedinol’s actual profits, and not its claim for Rising’s profits, the court holds that Rising has made a reasonable showing of profits based upon the limited documents available at trial. Pedinol has, according to its
In addition to considering the numbers set forth by the parties, the court must also consider the equities. Wfiiile Rising is entitled to a profit award, it would be inequitable for the court to. assume that Pedinol was unjustly enriched as to each and every sale of Lactinol made during the relevant time period. To award Rising the full profit of all Lactinol sales would, in the court’s view, result in a windfall, an outcome not contemplated by the Lanham Act. As noted, recovery under the Lanham Act should constitute “compensation and not a penalty.”
Taking into account the parties’ submissions, and principles of equity, the court holds that a lost profit award to Rising in the amount of $774,448 is an appropriate measure of recovery for Pedinol’s wilful Lanham Act violation.
III. The Parties’ Requests for Injunctive Relief
A. Legal Principles
The Lanham Act provides for the issuance of injunctive relief, “according to the principles of equity and upon such terms as the court may deem reasonable to prevent the violation of ... [the Lanham Act]”
The historic purpose of an injunction is to ensure that past wrongdoing is not repeated, not to further punish the wrongdoer.
Rondeau v. Mosinee Paper Corp.,
B. Pedinol’s Request for Injunctive Relief
Pedinol seeks to have the court issue an injunction preventing Rising from stating that its products are generic drugs, therapeutic alternatives, the pharmaceutical equivalent, of, or “bioequivalent” of Lactinol. Pedinol further seeks to prevent Rising from stating that its product contains 10% lactic acid or engaging in advertising stating that the Rising product can be compared to Lactinol. Pedinol also requests an order requiring Rising to engage in corrective advertising with respect to each of these terms and statements.
The court declines to order any of the injunctive relief sought by Pedinol. First, the court holds that Pedinol’s unclean hands, characterized by the company’s wilful misstatements regarding its product, and aimed directly at destroying
More importantly, however, the court holds that the evidence adduced at trial does not support the broad relief sought. There was insufficient expert evidence to support Pedinol’s claim that Rising’s product does not contain 10% lactic acid. Nor did the evidence support the broad request regarding the ambiguous terms “therapeutic equivalent,” “pharmaceutical equivalent” or “bioequivalence” and whether these terms dictate how a particular audience might interpret the term “generic.” The court also denies to order the relief sought on the ground that it is overly broad and non-specific, and would therefore result in difficulties with both compliance and monitoring by the court.
See Imig, Inc.,
Additionally, the court declines to enter any order preventing Rising from engaging in non-misleading comparative advertising. Such advertising is entirely acceptable.
See Tommy Hilfiger Licensing, Inc. v. Nature Labs, LLC,
Finally, to the extent that Rising made any misstatement regarding the relation between Rising and Lactinol and FDA approval, such statements have been discontinued and there is no likelihood that Rising will make any misstatements regarding its relation to Lactinol in the future.
C. Rising’s Request for Injunctive Relief
Rising seeks to have the court enter an injunction preventing Pedinol from stating that Lactinol is a single source product covered under the Drug Efficacy Safety Initiative (“DESI”), or that Lactinol is otherwise an FDA approved drug. Rising further seeks to prevent Pedinol from stating that dispensing Rising’s 10% lactic acid product violates state or federal laws or that Rising’s product is not reimbursable by state Medicaid pharmacy programs. While the court agrees that there was sufficient evidence at trial to support the finding that Pedinol made several false statements regarding Rising, the court holds that the evidence also demonstrated that these statements were discontinued. There is no reason to believe that Pedinol will make such misstatements in the future. Because Rising has been compensated by an award of Pedinol’s lost profits and there is no reasonable likelihood that Pedinol’s conduct will be repeated, the court declines to enter the injunction sought by Rising.
CONCLUSION
The court denies both parties’ motions pursuant to
SO ORDERED.
Notes
. A claim brought by Pedinol against individual Defendant Ronald Gold was dismissed before submission of the case to the jury.
.
Basch
involved a trade dress violation and not, as here, a false advertising violation. Recovery for a violation of either of these provisions of
. It was established at trial that a "single source” product is one that has been issued a New Drug Application ("NDA”) by the FDA. While it was, and remains, legal to market Lactinol, as well as 10% lactic acid products, there is no question but that Lactinol was never granted the NDA status that would allow Pedinol to claim single source status for its product.