Glen E. Conrad, Chief United States District Judge.
On the fourth day of a bifurcated trial, a jury returned a verdict in favor of the plaintiff, Concordia Pharmaceuticals, Inc. ("Concordia"), on its claim that the defendants, Method Pharmaceuticals, LLC ("Defendant Method") and Matthew Scott Tucker ("Defendant Tucker, and collectively, "Method"), engaged in false advertising in violation of the Lanham Act, 15 U.S.C. § 1125(a)(1)(B). In the subsequent damages phase of trial, the jury found that Concordia was entitled to $733,200.00 in actual or compensatory damages. However, the jury also found that Method's false advertising was not willful. Concordia subsequently filed a motion for judgment as a matter of law or a new trial on the issue of willfulness, a motion for enhanced damages and prejudgment interest, and a motion for attorneys' fees and litigation costs. This memorandum opinion sets forth the court's rulings on Concordia's motions.
In May of 2014, Concordia acquired the Donnatal® line of products ("Donnatal") from PBM Pharmaceuticals, Inc. ("PBM"). Donnatal is a line of combination phenobarbital and belladonna alkaloid ("PBA") products that is used as adjunctive therapy in the treatment of irritable bowel syndrome and acute enterocolitis. Donnatal is available by prescription in the form of a tablet and an elixir.
Donnatal was first introduced in the 1930s, before drug manufacturers were required to prove that drugs were both safe and effective in order to obtain approval by the Food and Drug Administration ("FDA"). Although Donnatal products have been approved for safety, the FDA has yet to determine their effectiveness.
For many years, Donnatal faced competition from generic PBA products that were pharmaceutically equivalent to Donnatal. In 2011, manufacturers of the generic versions began to take their products off the market. Once the inventories of previously manufactured generic products were eliminated, Donnatal was the only line of PBA products available for prescription.
Defendant Method is a wholesale drug distribution company based in Arlington, Texas. The company was founded by Defendant Tucker in 2012 and he is the sole owner. During the time period at issue,
Method sells approximately thirty pharmaceutical products that are manufactured for the company by contract manufacturing organizations. Rather than employing a sales force, Method utilizes pharmaceutical databases to promote its products. Method's admitted business strategy is to ensure that its products are "linked" to existing drugs in the databases, which are used by members of the pharmaceutical industry to determine whether generic substitutes are available for brand name products.
In 2013, Method began making plans to market a new product that would be pharmaceutically equivalent to Donnatal. The new product was eventually named Me-PB-Hyos. Method contacted Winder Laboratories, LLC ("Winder") and expressed an interest in having Winder manufacture the new product. In December of 2013, Method issued a purchase order for initial stability testing. However, Winder never performed the stability testing necessary to develop Me-PB-Hyos, and no finished product was manufactured by Winder or any other manufacturer.
Nonetheless, in March of 2014, Method moved forward with its plans to market Me-PB-Hyos as a generic alternative to Donnatal. Method used the product labels and package inserts for Donnatal tablets and elixir to create labels and inserts for Me-PB-Hyos tablets and elixir. Method then proceeded to list the nonexistent Me-PB-Hyos products with two of the major pharmaceutical databases, Medi-Span and First Databank.
On March 31, 2014, Method submitted the Me-PB-Hyos product labels, along with new product submission forms, to Medi-Span. As part of its efforts to have Me-PB-Hyos linked to Donnatal in the Medi-Span database, Method listed Donnatal's National Drug Code ("NDC") as the Reference NDC.
In addition to Medi-Span, Method undertook to have its Me-PB-Hyos products listed in First Databank's pharmaceutical database. However, First Databank refused to list the Me-PB-Hyos products without validation from DailyMed, a website operated by the National Library of Medicine. Consequently, Method endeavored to list the Me-PB-Hyos products with DailyMed. Method sent DailyMed the product labels for the nonexistent Me-PB-Hyos products. Despite knowing that the products described in the labels did not exist, and that no stability testing had been performed to develop the products, Method indicated that it intended to start marketing the products on June 1, 2014.
By that point, the Medi-Span listing also showed a marketing start date of June 1, 2014 for the Me-PB-Hyos products. Method was aware of this fact, and even reviewed the Medi-Span listing on June 3, 2014 to confirm that the marketing start date had been added.
On September 15, 2014, after the instant action was filed, Method contacted Winder via email regarding the Me-PB-Hyos project. Method indicated that it knew that Winder had not started anything on the project, and that the company had decided that it "might be best to bail on [the] project." Pl.'s Trial Ex. 25. Nonetheless, that same day, in response to an inquiry from Medi-Span regarding the status of Me-PB-Hyos, Method advised Medi-Span that "Me-PB-Hyos is an active product and will be available to ship by November 15, 2014." Boone Tr. at 40. Method also confirmed that "[t]he pricing and label ... are current and correct."
Ultimately, Method never launched the Me-PB-Hyos products, and the products were not manufactured by Winder or any other company. In mid-October 2014, Medi-Span removed the listings for the Me-PB-Hyos products. Around the same time, First Databank moved its listings for the Me-PB-Hyos products from active listings to archived listings.
After the Me-PB-Hyos products were listed with Medi-Span and First Databank, Donnatal prescriptions and unit sales decreased. During the course of the litigation, the parties strenuously disputed whether the listings were the sole cause of the reduction in prescriptions and unit sales. At trial, Concordia presented evidence indicating that it experienced lost sales in excess of $29.4 million dollars after the Me-PB-Hyos products were listed with the databases. Concordia maintained that the database listings for the nonexistent products were solely responsible for the decline in sales. Method, on the other hand, presented evidence indicating that a number of other factors contributed to the reduction in Donnatal unit sales, including significant increases in the prices of Donnatal products.
Concordia also presented evidence regarding the efforts it undertook to alleviate confusion in the marketplace regarding the existence and availability of a generic alternative to Donnatal. For instance, Concordia spent $885,015.00 on a coupon buy-down program implemented to combat the negative effects of the listings for Me-PB-Hyos. The company also revamped its marketing strategy and engaged in increased promotional efforts targeting pharmacies and prescribers.
PBM commenced this action against Method on April 29, 2014, asserting claims under the Lanham Act and Virginia law. PBM filed a motion for preliminary injunction on May 6, 2014. That motion was ultimately withdrawn without prejudice on September 16, 2014.
Following a series of amendments, Concordia pursued claims for damages against Defendant Method and Defendant Tucker.
Prior to trial, Concordia and Method moved to exclude certain opinions offered by the opposing side's expert witnesses. On April 13, 2016, the court granted Method's motion to exclude Ivan Hofmann's opinion on the amount of lost profit damages incurred by Concordia. Specifically, the court excluded Hofmann's opinion that Concordia suffered no less than $29.4 million dollars in lost profits as a result of the pharmaceutical database listings for Me-PB-Hyos. The court concluded that Concordia had failed to meet its burden of showing that Hofmann's lost profits calculations rested upon a sufficient factual basis and a reliable application of established principles and methods, insofar as they attributed all of the measured lost profits to the database listings for Me-PB-Hyos. Accordingly, the court ruled that Hofmann's opinion as to the total amount of lost profit damages incurred by Concordia must be excluded under Federal Rule of Evidence 702,
Concordia's claim for false advertising under the Lanham Act proceeded to trial on April 18, 2016. The issues of liability and damages were presented to the jury in a bifurcated fashion. During the liability phase, the jury found in favor of Concordia on its claim for false advertising. During the damages phase, both parties presented evidence concerning the extent of the damages suffered by Concordia, including the testimony of experts. After both parties rested, the court submitted the issues of damages and willfulness to the jury. The jury ultimately found that Concordia was entitled to recover $733,200.00 in actual or compensatory damages. With respect to the issue of willfulness, the jury indicated that it was unable to find that the defendants willfully engaged in false advertising.
Concordia has since filed a motion for judgment as a matter of law or a new trial on the issue of willfulness, a motion for enhanced damages and prejudgment interest, and a motion for attorneys' fees and litigation costs. The motions have been fully briefed and are ripe for adjudication.
In the first motion, Concordia moves for judgment as a matter of law or a new trial on the issue of willfulness. Concordia initially argues that the jury's finding on that issue is only advisory, and that the court may make its own determination based upon the facts and circumstances of the case. In the event that the court disagrees and decides that the jury's determination is binding, Concordia argues that it is entitled to judgment as a matter of law or a new trial on that issue.
Method does not appear to contest Concordia's argument regarding the advisory nature of the jury's verdict on the issue of willfulness. Upon review of existing caselaw, the court agrees with Concordia that the jury's finding on that issue is not binding. "It is well-settled that no
Accordingly, Concordia's motion for judgment as a matter of law or a new trial on the issue of willfulness will be denied as moot.
In its second motion, Concordia seeks to recover enhanced damages and prejudgment interest. Before turning to the parties' arguments, the court will briefly summarize the relevant statutory provision. The Lanham Act provides that a plaintiff who prevails on a claim under 15 U.S.C. § 1125(a) "shall be entitled, ... subject to the principles of equity, to recover (1) defendant's profits, (2) any damages sustained by the plaintiff, and (3) the costs of the action." 15 U.S.C. § 1117(a). The Act further provides that "[i]n assessing damages the court may enter judgment, according to the circumstances of the case, for any sum above the amount found as actual damages, not exceeding three times such amount."
Although the Lanham Act itself provides "little guidance on the equitable principles to be applied by a court in making an award of damages," the United States Court of Appeals for the Fourth Circuit has "identified six factors to guide the process."
The first factor — whether the defendants had the intent to confuse or deceive — addresses whether the defendants acted willfully or in bad faith.
In this case, the jury found that the defendants did not willfully engage in false advertising. Based on the court's own review of the record, however, the court believes that the evidence supports a contrary finding. Specifically, the court finds that the defendants, at a minimum, acted with indifference to whether their affirmative representations regarding the existence and availability of Me-PB-Hyos were false or misleading. Therefore, the court declines to accept the jury's verdict on the issue of willfulness. In light of the court's finding on this issue, the first
The court's decision in this regard is supported by the majority of the remaining factors, including the second factor. This factor — whether sales were diverted — "involves the issue of whether the
The third factor — the adequacy of other remedies — addresses whether other forms of relief, such as an injunction, "might more appropriately correct any injury the plaintiff suffered from the defendant's infringing activities."
The same is true for the fourth factor, which "addresses the temporal issue of whether the plaintiff waited too long, after the infringement activities began, before seeking court relief."
The fifth and final relevant factor is "the public interest in making the infringing misconduct unprofitable."
Based on the foregoing analysis, the court finds that the applicable
In the same motion, Concordia seeks an award of prejudgment interest, at a rate selected by the court, "for all amounts ultimately awarded in this action." Pl.'s Mot. for Enhanced Damages, Docket No. 266 at 11. Although the Lanham Act does not specifically provide for prejudgment interest, such an award is within the discretion of the trial court.
In the instant case, the court declines to exercise its discretion to award prejudgment interest. The court believes that an award of treble damages will fairly and adequately compensate Concordia for the harm that resulted from the defendants' misconduct, and that the imposition of prejudgment interest on that amount could be viewed as punitive in nature, rather than compensatory.
In its third motion, Concordia seeks to recover its attorneys' fees and litigation costs. The court will address each request in turn.
The Lanham Act authorizes a district court to award reasonable attorneys' fees to the prevailing party in "exceptional cases." 15 U.S.C. § 1117(a). Although the statute does not define the criteria that a case must satisfy in order to qualify as "exceptional," the Fourth Circuit has made clear that an "exceptional" case requires more than just volitional conduct.
After considering the totality of the circumstances in the instant case, the court is unable to conclude that it qualifies as "exceptional." First, Concordia has not established that the defendants' position on the claim for false advertising was frivolous or objectively unreasonable. While Concordia ultimately prevailed at trial, the court denied its dispositive motions on the issue of liability, both at the summary judgment stage and at the close of the defendants' evidence. Accordingly, the court cannot say that the defendants' arguments in defense of the false advertising claim were so frivolous or objectively baseless as to justify an award of attorneys' fees.
The court is also unable to find that this case was litigated in an unreasonable manner. The Supreme Court has explained that "a district court may award fees in the rare case in which a party's unreasonable conduct — while not necessarily independently sanctionable — is nonetheless so `exceptional' as to justify an award of fees."
Finally, the court does not believe that an award of fees is necessary to advance considerations of compensation or deterrence. The court considered the need for compensation in ruling on Concordia's request for enhanced damages. As indicated above, the court is of the opinion that an award of treble damages will fairly compensate Concordia for the harm caused by the defendants' conduct. Likewise, under the facts and circumstances of this case, the court is convinced that the award of treble damages will more than adequately deter the defendants and others from engaging in similar unlawful conduct in the future. Accordingly, Concordia's motion for attorneys' fees will be denied.
In its final request, Concordia seeks to recover its litigation costs. As noted above, the Lanham Act provides that prevailing
For the reasons stated, the plaintiffs motion for judgment as a matter of law or a new trial will be denied as moot, the plaintiffs motion for enhanced damages and prejudgment interest will be granted in part and denied in part, and the plaintiffs motion for attorneys' fees and litigation costs will be denied in part and denied without prejudice in part. The judgment will be amended to reflect an award of damages in the total amount of $2,199,600.00.
The Clerk is directed to send copies of this order and the accompanying memorandum opinion to all counsel of record.