FLORIDA BRECKENRIDGE, INC. d.b.a. Breckenridge Pharmaceutical, Inc., Plaintiff-Counterclaim-Defendant-Appellee, v. SOLVAY PHARMACEUTICALS, INC., a Georgia corporation, Defendant-Counterclaim-Plaintiff-Appellant,
Solvay Pharmaceuticals, Inc. (“Solvay”) has marketed Estratest, a hormone replacement drug, for well over thirty years. In the spring of 1997, Florida Breckenridge, Inc. and Napean Enterprises, Inc. (collectively, “Breckenridge”) introduced a drug, Menogen, that purported to be a generic equivalent to Estratest. After receiving notice that Solvay believed that Breckenridge was infringing on its trade rights, Breckenridge filed this action for a declaratory judgment that the manufacture, sale and marketing of Menogen did not constitute trade dress infringement or false advertising under the Lanham Act. Solvay then counterclaimed for trade dress infringement and false advertising under the Lanham Act, as well as under Florida statutory and common law of unfair trade practices. Following discovery, both parties moved for summary judgment. The district court denied Solvay's motion and granted summary judgment for Breckenridge. After Solvay filed notice of appeal, both parties submitted briefs and the United States filed an amicus curiae brief to address errors in the district court's order that the government felt needed to be corrected. Both parties and the government presented oral argument before this Court, and were requested to file supplemental briefs. Shortly before the deadline for Solvay to file its brief, it instead filed a motion to dismiss its case with prejudice. Breckenridge responded by requesting attorneys' fees and costs pursuant to Fed.R.App.P. 38, arguing that Solvay's appeal was frivolous. We grant Solvay's motion to dismiss with prejudice, but because of the conduct of the attorneys for both parties before the district court and this Court, we raise, sua sponte, whether this conduct merits referral to our court disciplinary committee for review.
A. The Regulatory Framework
Since 1938, the Food, Drug, and Cosmetic Act (“FDCA”) has required drug companies to get pre-approval by the FDA before they could lawfully market their new drugs. In order to get approval, a company merely had to file a New Drug Application (“NDA”) or an Abbreviated New Drug Application (“ANDA”) and prove that their product was safe. In 1962, the FDCA was amended to require proof that the product was effective as well as safe. Congress made this new efficacy requirement retroactive to apply to all drugs that already had approved NDAs based on safety. The companies producing these drugs were given a two year window to submit revisions of their NDAs to prove their efficacy. In order to facilitate the efficacy evaluations of these drugs, the FDA set up the Drug Efficacy Study Implementation (“DESI”) program. Under this program, groups of drugs with approved NDAs were evaluated by an independent panel. If the panel found that the drugs met a certain standard for efficacy, the evidence was submitted to the FDA. If the FDA concurred with the DESI determination, a notice was published in the federal register and a supplemental NDA would be approved for these drugs. Under the FDCA, all drugs are new drugs and therefore require an approved NDA or ANDA before marketing unless they are generally recognized among experts as safe and effective for their labeled use (the “GRASE” exception) or are grandfathered. 21 U.S.C. § 321(p)(1); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 613, 93 S.Ct. 2469, 2475, 37 L.Ed.2d 207 (1973).
By its terms, the DESI program applied only to drugs that already had approved NDAs as of 1962. In conjunction with the DESI program, the FDA developed a policy whereby drugs that were identical, similar or related (“ISR drugs”) to an approved drug in the DESI review program could “piggy-back” off of the DESI review by submitting an ANDA after the DESI review established the efficacy of the pioneer drug. For a time, FDA policy allowed a drug manufacturer to market an ISR drug after filing, but before approval of an ISR drug's ANDA. This policy was challenged in court and overturned in 1975. Hoffmann-Laroche, Inc. v. Weinberger, 425 F.Supp. 890, 894 (D.D.C.1975)( “[T]he Court holds that the FDA's policy of permitting new drugs to be marketed without an approved new drug application contravenes the clear statutory requirement of preclearance mandated by 21 U.S.C. § 355.”). In response to this case, the FDA published a revision to its policy guidelines that “clarified” the agency's position. CPG 7132c.02, which Breckenridge submitted as an appendix to its brief, reads in part:
The agency has decided to reaffirm that all products marketed as drugs under the DESI program are new drugs, and therefore, require an approved NDA or ANDA for marketing. In view of the reaffirmation of this policy, the agency must proceed to remove from the market all current DESI-effective prescription products that are not subjects of approved NDA's or ANDA's, and to prevent in the future the marketing of such unapproved products.
FDA Compliance Policy Guidelines § 440.100 (emphasis added). This policy guideline document goes on to create priorities for the removal of unapproved drugs from the market. According to the FDA, there were so many unapproved drugs on the market that they needed to establish a triage system: “Considering the magnitude of the problem, the limitation on FDA's resources, and the resulting long time period before compliance can be fully attained, the agency has developed a strategy to handle unapproved products on a priority basis.” Id. In stunning testament to the efficiency of the FDA's strategy, this policy is still in effect today because twenty-four years later, and thirty-six years after the 1962 amendments to the FDCA, there are still thousands of these unapproved drugs on the market. One of these drugs is Estratest, produced by Solvay.
B. Solvay Markets the Estratest Drug
Although the record contains conflicting dates, Solvay began marketing its Estratest drug in 1964 at the earliest. Estratest is a hormone supplement, consisting of esterified estrogens and methyltestosterone, that is widely prescribed to women who are suffering from the physical symptoms associated with menopause and who do not obtain relief from estrogen therapy alone. At the time of Estratest's entry into the marketplace, Solvay did not have, nor has it ever had over the past thirty-five years, an NDA or ANDA approved by the FDA. Obviously, Estratest could not have been directly subject to DESI review because it was not marketed, nor was it the subject of an approved NDA based on its safety, before the 1962 amendments to the FDCA became effective.
As part of the DESI process, a study evaluated the efficacy of a class of drugs that combined estrogens and androgens. The drugs under review all had approved NDAs from before 1962. None of these drugs contained Estratest's combination of esterified estrogens and methyltestosterone. The drugs were evaluated in a published notice, DESI 7661. On November 22, 1972, as noted in the correspondence log submitted by Solvay in their reply brief, Solvay's predecessor corporation contacted the FDA to determine whether Estratest could be considered ISR under the DESI 7661 notice. After an undescribed response from the FDA, there is a gap in the log until a letter from the FDA in July of 1979, which indicates that the FDA notified Solvay that Estratest was under legal review and that temporarily no action relating to the NDA requirement would be taken but that any continued marketing of Estratest was at Solvay's risk. Since that time and to this date, Solvay, while continuing to market Estratest, has been trying to get approval of NDAs for Estratest, but has gotten a series of not-approvable letters.
C. Breckenridge Enters the Market
In the spring of 1997, Breckenridge introduced a drug, Menogen, into the marketplace. This drug contained esterified estrogens and methyltestosterone in the same dosages as Estratest and was marketed as the generic equivalent of Estratest. Breckenridge did not obtain approval of an NDA or ANDA before marketing Menogen, and has not obtained approval to this date. Breckenridge relies on Solvay's contention that Estratest is legally on the market without approval to extend also to Menogen. Shortly after Breckenridge began marketing Menogen, they received notification from Solvay that they believed Menogen infringed on Estratest's trade dress and that the generic equivalency claims constituted false advertising. In response, Breckenridge filed this suit for a declaratory judgment that their marketing of Menogen did not infringe the Estratest trade dress or constitute false advertising under the Lanham Act. Solvay counterclaimed, asserting claims for trade dress infringement and false advertising under the Lanham Act, the Florida Deceptive and Unfair Trade Practices Act and common law unfair competition law.
After discovery, both parties moved for summary judgment. The district court granted summary judgment for Breckenridge. On the trade dress infringement claim, the court held that no reasonable fact-finder could find a likelihood of confusion as to source between Estratest and Menogen. On the false advertising claim, the court held that because both parties were allowed on the market without FDA approval, the false advertising analysis was not governed by the FDA regulations regarding generic drugs and that in this world of non-regulated pharmaceuticals, a lower standard of equivalence was sufficient to render Breckenridge's claims literally true.
Solvay appealed the summary judgment to this Court, arguing that the district court erred in its likelihood of confusion analysis and that drugs allowed on the market without FDA approval should still be subject to the FDA equivalency standards for advertised claims of generic equivalency. After Solvay filed its initial brief, the Department of Justice and the FDA filed an amicus curiae brief to address what they perceived as errors in the district court's opinion regarding the regulatory status of Estratest and Menogen and the resulting use of a different equivalency standard for generic drugs than is specified in the FDCA and FDA regulations. The government pointed out that the FDA's position is that neither drug is lawfully on the market because both require an approved NDA or ANDA before they may be legally sold, raising the point that unclean hands might bar either party from benefitting from trade law protection. The government did not explain why the FDA failed, for well over thirty years, to enforce the law and remove Estratest from the market. In response to the government's brief, both Solvay and Breckenridge harshly criticized the government for not reading the record, claiming that neither party ever told the court that they weren't subject to FDA regulation. Both parties continued to maintain, however, that although regulated they were not subject to FDA approval.
At oral argument, both parties continued to assert that they were lawfully on the market, although they could not articulate consistent or specific reasons why.1 They claimed to be surprised by the issue, claiming that it was never raised before the district court. At the end of oral argument, both parties agreed to submit supplemental briefs on the issue of whether protection was available under the Lanham Act for drugs sold in violation of the FDCA. Instead, two days before their supplemental brief was due, Solvay filed this motion to dismiss their appeal with prejudice. Breckenridge responded by requesting sanctions for a frivolous appeal pursuant to Fed.R.App.P. 38, and in the process executed a head-snapping reversal of position regarding Solvay's representations to the district court about Estratest's regulatory status. They did not, however, oppose Solvay's motion to dismiss.
It seems obvious to this Court that this last-moment motion to dismiss, after the completion of oral arguments and without a settlement agreement, resulted from Solvay's realization that it was caught misrepresenting Estratest's regulatory status and wishes to avoid a published opinion that would alert the world to its misdeeds. This case comes right up to the line where the interests of justice would require us to deny Solvay's motion. See Shellman v. United States Lines, Inc., 528 F.2d 675, 678 (9th Cir.1975). Especially in light of the fact that the motion is unopposed, we will grant it. In our supervisory capacity, however, we feel that we must review the attorneys' conduct before this Court and the district court and determine whether a disciplinary referral is appropriate.2 Careful review of the record has uncovered a pattern of conduct by both parties' attorneys designed to mislead and confuse the court regarding the regulatory status of Estratest and Menogen. Unfortunately, we must remind these attorneys that they are officers of the court. As such, they “owe duties of complete candor and primary loyalty to the court before which they practice.” Malautea v. Suzuki Motor Co., 987 F.2d 1536, 1546 (11th Cir.1993). These duties are never subservient to a lawyer's duty to advocate zealously for his or her client. In this case, the attorneys for both parties have frustrated the system of justice, which depends on their candor and loyalty to the court, because they wanted to avoid an unpleasant truth about their clients' conduct. “In short, they have sold out to the client.” Id., at 1547.
Normally, this sort of conduct is caught before it can do much harm by the adversarial nature of our system of justice. In this case, however, the adversarial parties both had an interest in hiding the fact that they needed FDA approval from the court. In Solvay's case, admitting that Estratest was not legally on the market would be fatal to their claims because the Lanham Act only protects parties engaged in lawful commerce. Erva Pharmaceuticals, Inc. v. American Cyanamid Co., 755 F.Supp. 36, 39-40 (D.P.R.1991)(applying federal trademark law to equivalent state unfair competition statute and holding that party who shipped pharmaceutical in violation of the FDCA did not have standing to sue for trademark infringement); Clorox Co. v. Armour-Dial, Inc., 214 U.S.P.Q. 850, 851, 1982 WL 50434 (T.T.A.B.1982)(“It has been the consistent position of this Board and the policy of the Patent and Trademark Office that a ‘use in commerce’ means a ‘lawful use in commerce’, and the shipment of goods in violation of federal statute, including the Food, Drug and Cosmetic Act, may not be recognized as the basis for establishing trademark rights.”). This fundamental rule predates the Lanham Act, and would apply to Solvay's common law claims, as well. Knights of the Ku Klux Klan v. Strayer, 34 F.2d 432, 434 (3rd Cir.1929)(affirming dismissal of case brought by K.K.K. against former members who were using the Klan's trademark, because Klan was using the mark while conducting unlawful activities).3
Likewise, Breckenridge had an interest in hiding the FDCA violations from the court. Since this litigation began, the FDA has taken action against Breckenridge for, among other things, marketing Menogen without FDA approval.4 Naturally, they would like to avoid making any admissions in this case. Furthermore, Breckenridge based its entire defense to the false advertising claim on the theory that there is a segment of the pharmaceutical market that is not subject to FDA approval, and that these drugs should be subject to a less stringent equivalency standard for the purposes of advertising generic equivalency. This theory is entirely dependent on misleading the court into believing that neither Estratest nor Menogen require FDA approval.
As discussed above, we believe that there is no magical exception that allows Solvay or Breckenridge to opt out of the FDA approval process. As the government's brief points out, both Estratest and Menogen are “new drugs” under the FDCA and require approved NDAs or ANDAs before they may be lawfully marketed. Because both parties had incentive to avoid addressing this threshold issue, the attorneys on both sides actively attempted to mislead and confuse the district court and this Court regarding the regulatory status of both drugs.
A. District Court Proceedings
Despite both parties' assertions that the effect of Estratest's regulatory status on Solvay's claims was not before the district court, review of the record reveals that the court was intensely interested in why the drugs were sold without FDA approval. The fact that the court did not specifically address the legal effect of the unapproved sale of Estratest is unsurprising, given that the attorneys misled the court into thinking that their clients did not need approval. It is only because of the attorneys' misconduct that the issue was not directly addressed.
Prior to the summary judgment motions, there were two hearings before Judge Ryskamp at which the attorneys successfully confused and misled the court. On several separate occasions, Judge Ryskamp inquired about why neither drug needed FDA approval. When confronted with these questions, the attorneys either changed the subject without answering or gave a vague explanation claiming that for historical reasons the drugs were either not subject to FDA regulation or did not require FDA approval.
At a hearing on January 15, 1997, L. Norwood Jameson, attorney for Solvay, made the following excerpted statements in response to questions from the judge regarding Estratest's regulatory status:
“Besides, these are not approved or these are not subject to FDA regulation ․”
“It is that this drug [referring to Menogen] is not technically subject to FDA regulation. We can't help that this drug is not subject to FDA regulation, because quite frankly, if it was, there is no chance that their drug would be on the marketplace today.”
At the same hearing, Susan Allison, attorney for Florida Breckenridge, made the following statements:
“It's a historical anomaly, but these are not approved drugs and they are not required to be approved drugs.”
“It's a historical. That takes the too much time to explain, your honor, but basically for historical reasons, they are allowed on the market at this time without FDA approval.”
“That's true, but basically it is a regulatory, historical regulatory issue as to why Estratest is not approved, but as a result, Menogen doesn't have to be literally approved either. That's the situation we are in. We are in an exception, an exceptional case, your Honor.”
There can be no question as to whether the attorneys knew that they were confusing the court. Besides the repeated questions about FDA approval, the judge stated, “It just seems strange to me-it does require a doctor's prescription, but apparently it may be so simple it doesn't require FDA examination. I don't know why the FDA is involved in it.”
At a later hearing, on June 25, 1997, Mr. Jameson made the following statements:
“There are certain exceptions to that rule [referring to FDA approval] and this case falls within that exception.”
“Quite frankly, I found it mind boggling when I got involved in this litigation that in fact a company could come on to the marketplace and sell a drug that has not been approved by the FDA, but in fact that can happen. There are certain situations when that can happen and that's what's going on right here.”
“ ․ is that the drugs at issue, okay, the Menogen drug at issue, they don't have to have FDA approval to have it in the marketplace.”
Jameson also introduced a colleague he described as an FDA law specialist to bolster his assertions. This specialist, Mr. Howard, said, “Estratest, your Honor, was introduced back in 1966. At that time, it was shortly after the Food and Drug Act [sic] had been substantially revised by Congress and in that context, Estratest was introduced without going through the NDA approval process. Estratest today remains a product that is permitted on the market without prior NDA approval.” Once again, there is ample evidence that the attorneys' misrepresentations effectively confused the court. Judge Ryskamp stated, “[I]f I am hearing you correctly, neither one is FDA approved and neither one has been tested by the FDA, and yet it sounds, if I understand Solvay's argument correctly, they say well, we may be grandfathered in because we made this long before certain regulation were in effect, but now there are new regulations that affect the competitor but not us.”
The attorneys effectively misled Judge Ryskamp into believing that Estratest's legal status had been established under a grandfather provision that caused them not to be regulated by the FDA. As previously discussed, there is no possibly valid legal argument that would make this characterization true. Both parties admit that they are not subject to the grandfather provisions of the FDCA, and both drugs were introduced after the 1962 amendments. The judge clearly relied on the attorney's representations, and, in fact, based his decision on the false advertising claims on these misrepresentations.
B. Circuit Court Proceedings
In their briefs, the parties continued to make the general assertion that they were allowed on the market without approval. After the government filed its amicus brief, pointing out that both products were marketed unlawfully and that the attorneys had misrepresented the drugs' regulatory status, both parties responded by misrepresenting their own conduct at the trial level. Breckenridge accused the government of not reading any portion of the record below and of fabricating its charge, claiming that neither party ever represented to the court that the drugs were not subject to FDA regulation: “[N]either Solvay nor Breckenridge ever referred to Menogen or Estratest as ‘unregulated.’ ” Solvay then jumped on the government-bashing bandwagon, claiming that “neither party made any such representation,” and claiming to be “perplexed by the district court's statement that the drugs were not ‘regulated’ by the FDA.” These assertions are outrageous. As quoted above, Mr. Jameson specifically told the court on two occasions that the drugs were “not subject to FDA regulation.” Such mischaracterizations of the record are particularly egregious, considering that both attorneys made them while accusing the government of lying about the record.
At oral argument, the misconduct continued. Jameson first argued that Estratest was lawfully on the market as a direct result of the DESI review process. Jameson's statements give the impression that Estratest, itself, was subject to DESI review. It was not. As discussed above, Estratest was not even on the market in 1962, nor did it ever have an approved NDA. Further, his description of the purpose of DESI as being to examine drugs on the marketplace to see if they should remain on the marketplace is very misleading. The purpose was to examine drugs already approved as safe by the FDA, and to help drug companies provide the FDA with an evaluation of their efficacy. Estratest has never, to this date, been approved by the FDA as safe or effective. Jameson further misled the Court by characterizing the DESI process as an “alternative to the ‘formal’ approval process.” In fact, there are no alternatives to the “formal” approval process for DESI or ISR drugs. All DESI and ISR drugs are “new drugs” under the FDCA and require approval of an NDA or ANDA before lawful marketing. FDA Compliance Policy Guidelines § 440.100; United States v. Hiland, 909 F.2d 1114, 1126 (8th Cir.1990). DESI never operates as an alternative to such approval. The falsity of this characterization is further proved by the fact that, subsequent to the publication of the DESI 7661 notice, Solvay filed an ANDA in an attempt to get approval and was warned by the FDA that marketing of the drug was at Solvay's risk. Jameson knew this-the information is all in papers that he appended to his reply brief as evidence that FDA knew that Estratest was on the market.
After realizing that this Court would not be so easily bamboozled, Jameson attempted to refine his argument, arguing that the DESI review somehow operated as conclusive proof that Estratest falls under an exception under the FDCA known as the GRASE exception. Because we dismiss this appeal, we are precluded from ruling definitively on this claim. However, our review of the law, at this stage, points to the conclusion that it is wholly without merit.
If a drug is generally recognized among qualified experts as safe and effective, it is not a new drug under the FDCA and therefore does not need an NDA. 21 U.S.C. § 321(p)(1); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 613, 93 S.Ct. 2469, 2475, 37 L.Ed.2d 207 (1973). However, GRASE is a term of art, and the Supreme Court has explained that it really is not much of an exception because it requires at least the same exacting proof that NDA approval requires. Hynson, 412 U.S. at 629, 93 S.Ct. 2469 (“We agree with FDA, however, that the statutory scheme and overriding purpose of the 1962 amendments compel the conclusion that the hurdle of ‘general recognition’ of effectiveness requires at least ‘substantial evidence’ of effectiveness for approval of an NDA.”). Furthermore, GRASE cannot be construed to provide a way to evade the regulatory process by allowing a firm that has repeatedly failed to gain approval of an existing NDA to opt out of the approval process. Id., at 631, 93 S.Ct. 2469 (“But, we cannot construe [the GRASE exception] to deprive the FDA of jurisdiction over a drug which, if subject to FDA regulation, could not be marketed because it had not passed the ‘substantial evidence’ test. To do so ‘would be to impute to Congress a purpose to paralyze with one hand what it sought to promote with the other.’ ”). Consequently, it would appear that Estratest cannot satisfy the GRASE exception.
Finally, Jameson argued that the FDA's failure to take action to remove them from the market proves that they are GRASE. Obviously, this is nonsense. Courts have already held that the FDA policy of deferring the removal of ISR drugs from the marketplace is not a defense, even to criminal prosecution for marketing a new drug without an approved NDA. Hiland, 909 F.2d at 1125-27. In order to fall under the GRASE exception, a drug must meet requirements at least as stringent as those for NDA approval. Solvay has continually failed to obtain approval based on the evidence it has provided the FDA. They may not, then, circumvent the approval process merely by marketing their drug in defiance of the FDA for thirty-five years. Solvay has been attempting to get approval of its ANDA/NDA for 27 years, and has gotten a continual stream of not-approvable letters. The very fact that they are seeking approval indicates that they do not honestly believe that they fall under the GRASE exception. Furthermore, the exception cannot be used to succeed where the FDA screening process has specifically denied approval. This would pervert the statute, as the Supreme Court noted. Finally, even if Estratest could be said to now, in 1999, to have gained GRASE status, that status would not retroactively render the past thirty-five years of illegal marketing lawful.
After oral argument, Solvay filed this motion to dismiss its appeal with prejudice, pursuant to Fed.R.App.P. 42(b). The motion gave no reason for the dismissal. In response, Breckenridge filed a request for sanctions pursuant to Fed.R.App.P. 38, arguing that the sudden, last-minute request for dismissal confirmed that the appeal was frivolous. In contrast to the fervent and accusatory denial in their brief, suddenly Breckenridge complains that they were prejudiced because of various affirmative misrepresentations that Solvay made to the court regarding Estratest's regulatory status. They even, most helpfully, quote one of Mr. Jameson's claims to the district court that the drugs are not subject to FDA regulation. As a reminder, this is one of those claims that Breckenridge previously insisted was never made. According to Breckenridge, Solvay's continuous misrepresentations kept a frivolous appeal going and forced Breckenridge to defend it. Breckenridge's sudden dismay over the misrepresentations brings to mind Captain Renault from Casablanca (Metro-Goldwyn-Mayer 1942) who, in the midst of collecting his nightly winnings, closed Rick's Café down because he was “shocked; shocked to find that gambling is going on here!” It is quite bad enough that Breckenridge cooperated with Solvay in misleading the Court; it is offensive that they now complain they were prejudiced by the very misrepresentations that they aided and abetted.
During the course of this litigation, Mr. Jameson and Ms. Allison (and by extension their respective law firms, King & Spalding and Jeffer, Mangels, Butler & Marmaro) engaged in a pattern of practice designed to mislead and confuse the court regarding the regulatory status of their clients's drugs. Although we grant the unopposed motion, we are referring this matter to the disciplinary committee of this Court for further consideration.
Appellant's motion to dismiss this appeal with prejudice is GRANTED.
Appellee's motion for damages pursuant to Fed.R.App.P. 38 is DENIED.
REFERRED to the disciplinary committee.
1. The parties may have been attempting to argue that, because it declined to order Solvay to remove Estratest from the market and instead warned Solvay that continuing to market Estratest was “at its own risk,” the FDA's behavior amounted to a waiver of sorts. We need not reach the merits of this argument, because, among other reasons, it was never clearly raised before the district court or before us. Instead, the parties misrepresented the facts to both courts, arguing that neither Estratest nor Menogen needed FDA approval.
2. Although this order focuses on the conduct of the attorneys for Solvay and Breckenridge, we note that the FDA is also due a share of criticism. It is incomprehensible that Estratest has been allowed on the market without approval for thirty-five years. It seems reasonable that most patients undergoing treatment for menopause fairly assume that any medication freely available and prescribed by their doctor has been proven safe and effective to the satisfaction of the FDA. They have a right to expect that the laws, as passed by Congress to protect them, are being enforced. To this date, Estratest has failed to satisfy the FDA that it is safe or effective as required by the FDCA, and yet the FDA has taken no action to remove the drug from the market. We are accustomed to hearing arguments in situations like this bemoaning scarce governmental resources and the like, but there can be no good excuse for allowing a company to violate the law for thirty-five years. If the drug is not safe or effective enough to be approved, thirty-five years seems like sufficient time to get around to taking some action. Certainly, Solvay was on notice that they were violating the law, and the FDA's inaction in no way excuses Solvay's conduct, but neither does Solvay's notice excuse the FDA's inaction.
3. This issue was to have been addressed by the parties' supplemental briefs. Instead, Solvay filed its motion to dismiss, thereby seeking to avoid what could very well have been an adverse ruling.
4. Once again, we are baffled as to why the FDA decided to go after the generic manufacturer, which had been marketing the drug for approximately one year, while ignoring Solvay's violations, which had been ongoing for thirty-five years. If we understand the government's argument, Breckenridge had violated other provisions of the FDCA, which made the enforcement action more urgent. Nonetheless, this seems insufficient to explain an enforcement differential of thirty-four years.
BY THE COURT: