author: SPENCER WILLIAMS, District Judge.

text:
    Nadine WARREN, Plaintiff, v. Margaret M. HECKLER, Secretary of Health and Human Services, Defendant.
    No. C-84-0897 SW.
    United States District Court, N.D. California.
    June 4, 1985.
    Brent Kato, Bruce A. Feder, Legal Assistance to the Elderly, Inc., San Francisco, Cal., for plaintiff.
    Joseph P. Russoniello, U.S. Atty., Patrick R.S. Bupara, Chief, Civil Div., Joann Swanson, Asst. U.S. Atty., San Francisco, Cal., for defendant.
   ORDER ON DEFENDANT’S MOTION FOR RECONSIDERATION

SPENCER WILLIAMS, District Judge.

FACTS

This matter is before the court on defendant’s motion for reconsideration of this court’s January 25, 1985 order denying the parties’ cross-motions for summary judgment and remanding the case.

Nadine Warren, currently age 65, was found disabled as of October 26, 1978 (Tr. 149). Plaintiff suffered from, among other diseases, diabetes mellitus, degenerative arthritis of the spine, essential hypertension and morbid obesity. (Tr. 149, 203). Her benefit payments were suspended on October 31, 1979 due to ineligibility based on her spouse’s increased income. (20 C.F.R. § 416.1313 suspensions due to excess income) (Tr. 157, 184). At that time, no determination regarding plaintiff’s medical condition was made nor were termination proceedings instituted.

On December 24, 1981, after her husband’s income had decreased, Plaintiff filed an application for reinstatement of benefits due to a change in her financial condition. Her application was denied by the AU who, after conducting a “de novo” hearing, found her not to be under a disability. (Tr. 222-224). On review, the Appeals Council also denied benefits to plaintiff.

Plaintiff then instituted this action under §§ 205(g) and 1631(c)(3) of the Social Security Act, 42 U.S.C. §§ 405(g) and 1383(c)(3), seeking review of a final decision of the Secretary of Health and Human Services denying her claims for disability insurance benefits based on disability under Title II and XVI of the Social Security Act. She claimed the AU did not evaluate the evidence under the proper legal standard. Specifically, claimant argued that the ALJ erroneously failed to afford her a presumption of continuing disability.

ANALYSIS

Applicants whose benefits have been suspended due to financial ineligibility are exempt from having to prove disability, 20 C.F.R. § 416.1321(b), and enjoy a presumption of continuing disability upon application for reinstatement. Upon initial consideration this court found plaintiff’s benefits to have been suspended and remanded this action to comport with such a finding. However, the regulations provide that once an individual’s benefits have been suspended for a period of 12 months, the suspension becomes a termination. 20 C.F.R. § 416.1335. Because Plaintiff’s benefits were suspended on October 31, 1979, this court finds that plaintiff was terminated as of October 31, 1983.

The cases in this circuit have established that an individual terminated for medical reasons enjoys a presumption of continuing disability upon appeal from that termination. Patti v. Schweiker, 669 F.2d 582,-587 (9th Cir.1982). The Patti found no reason why, in that circumstance, a condition of disability once proved to exist should not be presumed to continue to exist. What the presumption does is “impose on the Secretary a burden to come forward with evidence that (claimant’s) condition has changed.” Id. The Secretary must introduce evidence that recipient’s medical condition has changed before disability benefits can be terminated on the ground that a recipient is no longer disabled. Lopez v. Heckler, 713 F.2d 1432, 1434 (9th Cir.1983).

Plaintiff claims that the presumption of continuing disability should be extended to her. The question presented in this case is whether non-medical terminees, who have been terminated for excess income, non-residence or, as in this case, when suspension of benefits has lasted for more than one year, should be afforded the presumption of continuing disability when they later submit a new initial application for benefits. In the case of these terminees, no ruling on their medical condition is made at the time of termination because that termination results from non-medical factors.

In the absence of any statutory authority to the contrary, the court finds that a claimant who has been terminated for non-medical reasons and at some later date submits an initial application for benefits must establish that he or she satisfies all the requirements, including medical disability, of the Act. The presumption of disability which is extended to claimants who appeal their terminations should not be extended to those who re-apply months, years, or even decades after they have been terminated for non-medical reasons. There is no evidence that Congress intended that result.

Accordingly, defendant’s motion for reconsideration is GRANTED. Judgment shall be entered in favor of defendant and against plaintiff.

IT IS SO ORDERED.


source: Caselaw Access Project

author: MacLAUGHLIN, District Judge.

license: Public Domain

text:
    Paul E. VILLAUME and Katherine Villaume, Plaintiffs, v. The UNITED STATES of America, Defendant.
    Civ. No. 4-84-970.
    United States District Court, D. Minnesota, Fourth Division.
    June 7, 1985.

      Lee N. Johnson, Green, Merrigan, Johnson & Quayle, Minneapolis, Minn., for plaintiffs.
    James M. Rosenbaum, U.S. Atty., and Mary Carlson, Asst. U.S. Atty., Minneapolis, Minn., and Beth Sabbath, Trial Atty., Tax Div., U.S. Dept. of Justice, Washington, D.C., for defendant.
   MEMORANDUM AND ORDER

MacLAUGHLIN, District Judge.

This matter is before the Court on defendant’s motion for partial summary judgment. Defendant’s motion will be granted.

FACTS

The case before the Court is a refund action brought by plaintiffs Paul and Katherine Villaume to recover income taxes paid by them to the United States for the year 1980. Plaintiffs allege that $17,968 which they received in settlement of a lawsuit is excludable from income.

Plaintiff Paul Villaume was employed as a real estate salesman for the sale of the St. Paul Hotel in 1978. Plaintiff alleges that there was an agreement that he would receive a $40,000 commission for this sale, and that he only received $20,000 of this commission. At some point in 1979, plaintiff filed an action in Ramsey County District Court which sought to recover the $20,000 in unpaid commissions as well as $100,000 in exemplary or punitive damages resulting from the defendants' actions in “willfully, wrongfully and maliciously” withholding the amount of money due to plaintiff. While plaintiffs’ complaint in the state court action did not seek damages for personal injury or set forth a cause of action in slander or libel, the plaintiffs now contend that a major ingredient of the lawsuit was plaintiff Paul Villaume’s loss of business and personal reputation as a result of alleged defamatory remarks made by one of the principals or agents for the state court defendants. The action settled in 1980, prior to trial, for $20,000. There was no allocation in this settlement made between punitive damages and regular contract damages. Likewise, the parties did not expressly agree that any portion of the settlement was attributable to personal injury damages. The plaintiffs were allowed for tax purposes to reduce the $20,000 figure by $2,032, the amount of legal expense incurred by them in bringing the action. The remaining sum, $17,968, is the amount at issue in the instant lawsuit.

Plaintiffs filed the instant action in September, 1984, seeking, inter alia, a refund of the taxes paid to the United States on the proceeds from the settlement, on the ground that this money did not constitute income. Defendants now move for partial summary judgment, arguing that the character of plaintiffs’ settlement of the state court lawsuit is beyond factual dispute, and that the proceeds of that settlement are includable as income.

DISCUSSION

A defendant is not entitled to summary judgment unless the defendant can show that no genuine issue exists as to any material fact. Ped.R.Civ.P. 56(c). Summary judgment is an extreme remedy that should not be granted unless the moving party has established a right to judgment with such clarity as to leave no room for doubt and unless the nonmoving party is not entitled to recover under any discernible circumstances. E.g., Vette Co. v. Aetna Casualty & Surety Co., 612 F.2d 1076, 1077 (8th Cir.1980). In considering a summary judgment motion, a court must view the facts most favorably to the nonmoving party and give that party the benefit of all reasonable inferences that can be drawn from the facts. E.g., Hartford Accident & Indemnity Co. v. Stauffer Chemical Co., 741 F.2d 1142, 1144-45 (8th Cir.1984). The non-moving party may not merely rest upon the allegations or denials of the party’s pleading, but must set forth specific facts, by affidavits or otherwise, showing that there is a genuine issue for trial. Salinas v. School District of Kansas City, 751 F.2d 288, 289 (8th Cir.1984).

The Internal Revenue Code adopts a broad, all-inclusive definition of gross income: “[ejxcept as otherwise provided in this subtitle, gross income means all income from whatever source derived____” 26 U.S.C. § 61(a). The United States Supreme Court has recognized on a number of occasions that the language of the Code’s definition of gross income was used by Congress to exert “the full measure of its taxing power.” Commissioner v. Glenshaw Glass Co., 348 U.S. 426, 429, 75 S.Ct. 473, 475, 99 L.Ed. 483 (1955); Helvering v. Clifford, 309 U.S. 331, 334, 60 S.Ct. 554, 556, 84 L.Ed. 788 (1940). The Code specifically excludes from income “the amount of any damages received (whether by suit or agreement and whether as lump sums or as periodic payments) on account of personal injuries or sickness.” Id. § 104(a)(2).

The tax consequences of an award of damages or a settlement depends upon the nature of the litigation and on the origin and character of the claims, but not on the validity of such claims. Woodward v. Commissioner, 397 U.S. 572, 90 S.Ct. 1302, 25 L.Ed.2d 577 (1970). The proper inquiry is to determine for what purpose the damages were awarded or the settlement made. Fono v. Commissioner, 79 T.C. 680 (1982), aff’d, 749 F.2d 37 (9th Cir.1984). In order to ascertain the nature of the damages or settlement, courts look to the allegations contained in the taxpayer’s original and amended complaints, the evidence presented, and the arguments made in the state court proceeding. See Church v. Commissioner, 80 T.C. 1104 (1983). Several courts have noted that the most important fact in the determination of the nature of the settlement is the intent of the payor in making the settlement. Whitehead v. Commissioner, 41 T.C.Memo 1980-508 (1980); Knuckles v. Commissioner, 349 F.2d 610 (10th Cir.1965); Agar v. Commissioner, 290 F.2d 283 (2d Cir.1961).

In the instant case, the plaintiffs concede that the proceeds of the settlement are includable as income to the extent that they represent recovery of plaintiff Paul Villaume’s unpaid commissions. Recovery of unpaid commissions would clearly be compensation for services rendered and would therefore be taxable. Fono v. Commissioner; Glynn v. Commissioner, 76 T.C. 116 (1981), aff’d, 676 F.2d 682 (1st Cir. 1982). Plaintiffs contend, however, that the settlement must be apportioned between the amount attributable to the commissions and the amount attributable to personal damages, the latter being excluded from income. Defendant argues that since the $20,000 received in settlement is the exact amount which plaintiff Paul Villaume sought to recover in commissions, it is reasonable to conclude that the entire settlement is attributable to the commissions. The tax court in Whitehead v. Commissioner found that a settlement was intended to cover lost income, and in so doing noted that it was significant that the amount settled for was the same amount as the plaintiffs salary. Despite the tax court’s comment in Whitehead, the Court will reach its determination on other grounds.

Defendant contends that even if the settlement is not entirely attributable to unpaid commissions, it is nevertheless taxable in its entirety because the remainder of plaintiff Paul Villaume’s complaint in state court sought punitive damages or damages for injury to Villaume’s business reputation. In Commissioner v. Glenshaw Glass Co., 348 U.S. 426, 75 S.Ct. 473, 99 L.Ed. 483 (1955), the Supreme Court held that money received as exemplary damages for fraud or as the punitive two-thirds portion of a treble-damage antitrust recovery must be reported by a taxpayer as gross income. Accordingly, the defendant contends that to the extent the settlement was intended to cover punitive damages or damages to business reputation, the proceeds must be considered income. Defendant therefore argues that the entire settlement must be included as income.

Plaintiffs’ opposition to defendant’s motion for summary judgment rests primarily on their assertion that a major ingredient in the state court suit was a claim for damages for personal injuries to plaintiff Paul Villaume. These damages allegedly arose from the state court defendants’ libel and slander of Villaume. Plaintiffs concede that the complaint in state court only sought damages for breach of contract and punitive damages, and that it did not make any reference to slander or libel, or otherwise seek personal damages. They argue, however, that the complaint alone cannot be considered determinative as to the nature of Villaume’s settlement, since the complaint could and would have been amended before trial. Minnesota Rule of Civil Procedure 15. In support of their contention that a substantial amount of the settlement was for personal injuries suffered by Paul Villaume, plaintiffs submit an affidavit by Paul E. Thuet, Jr., Villaume’s attorney in the state court action. Thuet makes the following statements in his affidavit:

That upon the institution of the lawsuit and shortly thereafter, it developed that a principal issue for determination was the personal injury to the plaintiff, Paul E. Villaume, by way of libel, slander and disparagement of character.
That the attorneys for the defendants in that action were aware of the claims he made on behalf of his client for libel, slander and disparagement of character.
That all parties in that action fully understood after the inception of the lawsuit that any settlement would include substantial amounts for libel, slander and disparagement of character.

Affidavit of Paul E. Thuet, April 19, 1985, ¶¶ 4, 5, 6.

Plaintiffs place considerable emphasis on the Tax Court’s decision in Church v. Commissioner, 80 T.C. 1104 (1983). Church involved a libel action brought by a public figure for damage resulting from a newspaper article in which he was labelled a “communist.” Based on the complaint, an amended complaint, and the evidence and arguments presented at trial, the court found that “the entire thrust of petitioner’s case was how the libelous editorial affected him personally.” Id. at 1108. Plaintiffs presumably cite the decision in Church because it contains considerable language to the effect that injuries arising in a professional and business context can cause personal, and therefore nontaxable, damages.

The Court has concluded that the entire amount of the settlement must be included as income, and will therefore grant defendant’s motion for partial summary judgment. There is no genuine dispute over the fact that the settlement paid to plaintiff Paul Villaume was intended to cover lost income and related contractual and business damages. The complaint filed in the state court action contained no indication that the suit was intended to recover damages for personal injuries. Plaintiffs’ argument that the complaint could and would have been amended to include a plea for personal injury damages is entirely unpersuasive and requires the Court to indulge in speculation. Moreover, plaintiffs’ own descriptions of the state court action prior to defendant’s motion in this case fail to indicate that it was intended to recover for personal injury. In plaintiffs’ answer to defendant’s interrogatories, plaintiff Paul Villaume stated that “[i]t is my position that one-sixth of the amounts of monies received by me ... represents ordinary income and the rest is compensation to me for punitive damages for interference with my contract relationships.” Plaintiff Paul Villaume’s Answer to Defendant’s Interrogatory No. 1, January 10, 1985. In the claim for refund which plaintiffs submitted prior to the institution of the present action, plaintiffs make no reference to injuries to Villaume’s personal reputation. Instead, plaintiffs asserted in this claim that “it was apparent that the entire amount collected in this controversy by lawsuit was because of punative [sic] damages due the taxpayer because of the misconduct and bad faith of the defendants.” Plaintiff’s Complaint, Exhibit A. Under either of these two descriptions of the settlement, the entire amount would be taxable income.

Plaintiffs’ reliance on Church v. Commissioner is misplaced. The decision in Church that plaintiff’s damages award did not constitute income was based upon substantial evidence from the trial of the state court action that a major thrust of the action was to recover damages for personal injuries. In the present case, of course, the Court does not have the benefit of trial testimony and evidence to aid in determining the character of plaintiff Paul Villaume’s suit. There is simply no competent evidence before the Court, however, that plaintiffs’ suit in state court was a personal injury action. The Church decision is therefore clearly distinguishable.

Plaintiffs’ attempt to characterize the settlement proceeds as compensation for personal injury rests solely on the affidavit submitted by plaintiffs’ attorney in the state court action. Defendant argues that the affidavit is inadmissible under Fed.R. Civ.P. 56(e), which provides that “[supporting and opposing affidavits shall be made on personal knowledge, shall set forth such facts as would be admissible in evidence, and shall show affirmatively that the affiant is competent to testify to the matters stated therein.” The Court agrees with defendant that the affidavit is not admissible. Thuet’s affidavit merely contains conclusory assertions that all of the negotiating parties were aware of Villaume’s “claims” for personal injury damages, and that all parties understood that any settlement would include substantial amounts for these claims. The affidavit does not set forth any factual detail to support these assertions. Moreover, it makes no reference to the negotiations leading up to the actual settlement, or to the actual settlement itself. Thuet asserts that all of the parties knew that any settlement would have to include compensation for personal injury, but he does not specify the basis for this knowledge. For all of the above reasons, the Court will refuse to consider the affidavit. Because there is no other evidence that the settlement was intended to compensate for anything but lost income and related contractual damages, the Court must grant defendant’s motion.

Even if the Court were to consider the affidavit of plaintiffs’ attorney, however, it would still be compelled to grant defendant’s motion. In Whitehead v. Commissioner, 41 T.C.Memo 1980-508 (1980), the tax court held that even if the taxpayer plaintiff could have established that a portion of his settlement was attributable to a personal tort claim, the entire settlement payment would be considered income since no allocation had been made between lost compensation and tort damages at the time of the settlement. This rule applies to the action before the Court. The parties did not specify at the time of settlement which portion of the settlement was attributable to lost income or business damages and which portion was attributable to personal injury damages. The Court will therefore treat the entire settlement payment as income.

Based on the foregoing, IT IS ORDERED that defendant’s motion for partial summary judgment is granted.

      . Plaintiffs also allege that they are entitled to take $1,160.53 in deductions as business expenses. This portion of the complaint is not before the Court on the instant motion.

      . Plaintiff Paul Villaume did state in this answer that "it became apparent” to him at some point in 1979 that the defendants in the state court action "had made a statement of disparagement of my professional reputation.”

      . The Court finds for the same reasons that the affidavit of plaintiff Paul Villaume is not admissible. This affidavit merely alleges in conclusory fashion that plaintiff "claims” that the settlement proceeds "were for defamation, slander and disparagement." Affidavit of Paul E. Villaume, April 2, 1985, ¶ 2.


author: THOMAS F. HOGAN, District Judge.

text:
    George Robert P. FARQUHAR, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, Defendant.
    Civ. A. No. 84-1021.
    United States District Court, District of Columbia.
    June 13, 1985.

      George Robert P. Farquhar, pro se.
    Edith Marshall, Washington, D.C., for defendant.
   MEMORANDUM OPINION

THOMAS F. HOGAN, District Judge.

Plaintiff, pro se, has applied to this Court for relief from economic injuries allegedly caused by the actions of the defendant, Food and Drug Administration (FDA). It appears that Mr. Farquhar has developed a topical antimicrobial product for use on intact skin that he believes to be a safe and effective product for certain uses such as a surgical scrub. Mr. Farquhar’s complaint arises from what he believes to be the unfair treatment he received at the hands of the FDA. To understand the issues at hand in the cross-motions for summary judgment presently before the Court it is necessary to examine Mr. Farquhar’s administrative actions in light of the procedural requirements of the FDA.

I. INTRODUCTION

On April 3, 1983 plaintiff submitted a citizen’s petition to the FDA requesting that the agency “reopen” the rulemaking record for over-the-counter (OTC) topical antimicrobial drugs in order that the defendant might grant “approval” of the combination of ingredients in plaintiff’s newly developed product. See 21 C.F.R. § 10.30. Because of the “undue delay” in receiving a response, plaintiff filed the original complaint asking this Court to compel the FDA to act. A short time later, in July, 1984, the FDA denied plaintiff’s petition, explaining that because plaintiff’s compound was a “new drug” it could not appropriately be considered in the ongoing OTC antimicrobial product review.

Plaintiff subsequently amended his complaint several times, without objection from the defendant, to revise his claims against the FDA. While plaintiff has not been precise in his allegations of error, the Court has construed the amended complaints as set forth below in an effort to fit Mr. Farquhar’s allegations within the recognized form of actions against a federal agency.

Mr. Farquhar’s arguments in the pleadings before this Court are largely scientific in nature; that is, his memoranda and attachments focus for the most part on proving that his drug is “safe and effective” and that the FDA erred in not granting approval for its OTC sale. Plaintiff has phrased his argument in various ways. In essence, it is either a claim for review of the administrative action in denying the reopening of the rulemaking procedure or a request for a declaratory judgment that the agency erred in not finding plaintiff’s product to be safe and effective and appropriate for the indicated uses.

II. THE OTC RULEMAKING

The rulemaking which plaintiff sought to have reopened is part of the FDA’s ongoing retrospective review of approved OTC drugs. See Cutler v. Kennedy, 475 F.Supp. 838, 843 (D.D.C.1979). Unfortunately, it is not the procedure that plaintiff should have followed in order to have his “new drug” approved. In short, the FDA correctly denied plaintiff’s petition on the ground that the product in question was a “new drug” for which an approved new drug application must be filed. 21 U.S.C. § 321(p); 21 U.S.C. § 355.

The Federal Food, Drug & Cosmetic Act defines a “new drug” as a drug that has either: 1) not been generally recognized by qualified experts as safe and effective “for use under the conditions prescribed, recommended, or suggested in the labeling thereof,” or 2) not been used to a “material extent for a material time” under such conditions. 21 U.S.C. § 321(p).

In the case of plaintiff’s product, neither the individual chemical ingredients nor the combination had ever been marketed for .uses for which plaintiff proposed. Letter from William Randolph, Acting Assoc. Commissioner for Regulatory Affairs to George Farquhar (July 27, 1984). Thus, even if plaintiff’s product is in fact as safe and effective as plaintiff claims, the absence of marketing data (“to a material extent for a material time”) required the FDA to treat plaintiff’s product as a “new drug.” Plaintiff’s attempt to have his product included in the OTC review was therefore inappropriate, and the FDA was justified in requiring plaintiff to proceed through a new drug application. See United States v. Articles of Drug ... Hormonin, 498 F.Supp. 424, 430-31 (D.N.J.1980).

III. THE NEW DRUG APPLICATION

In what the Court must assume was a strategic response to defendant’s position as set forth above, plaintiff has repeatedly amended his complaint in an effort to avoid the conclusion that his product requires new drug licensing. In its latest (fourth) incarnation, plaintiff seeks a declaratory judgment that his product is not a “new drug” when used as a sanitizing agent for food handlers.

In an early pleading, the FDA conceded that “plaintiffs combination product had been marketed as a hand sanitizer for food handlers.” Defendant’s Memorandum in Opposition to plaintiff’s Motion for Summary Judgment at 6. Of course, the question of whether a drug has been “marketed” is not the same as the question of whether it is or is not a new drug. See, e.g., Tyler Phamacal Distributors, Inc. v. United States, 408 F.2d 95 (7th Cir.1969). In order to make this “new drug” determination, the Court is required to find and enter a judgment to the effect that plaintiffs compound of myristalkonium chldoride and quaternium 14 is “safe and effective” and that it has been used to a material extent for a material time. See Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973).

This is not a question for the judiciary to properly consider in the first instance. The FDA has the established procedures and expertise as well as the statutory authority to make this difficult determination. Judicial review will of course be available at a later time, but plaintiff must first exhaust his administrative remedies. Parisi v. Davidson, 405 U.S. 34, 37, 92 S.Ct. 815, 817, 31 L.Ed.2d 17 (1972); National Conservative Political Action Committee v. FEC, 626 F.2d 953, 957 (D.C. Cir.1980); Hoffman-LaRoche, Inc. v. Harris, 484 F.Supp. 58 (D.D.C.1979). Exhaustion of administrative remedies requires more (and better directed) effort before the agency than plaintiff has attempted to date. Exhaustion implies a good faith effort to “effectively pursue” one’s goals in the administrative arena. See NICPAC, 626 F.2d at 957 n. 8. This includes pursuing those goals through the proper channels—especially when plaintiff is made aware of the need to follow the proper regulatory scheme. See supra note 6.

The Court finds no error in the FDA’s denial of Mr. Farquhar’s petition and will on the grounds set forth above grant summary judgment for the defendant. However, because plaintiff has pursued other issues in this litigation so vigorously, the Court will briefly set forth its reasoning in these areas.

IV. PLAINTIFF’S OTHER ARGUMENTS

Mr. Farquhar has claimed violation of two constitutional rights: the fifth amendment right to equal protection and the protections of the takings clause. With respect to equal protection, Mr. Farquhar has not pled the essential element of unequal government treatment of similarly situated persons. See Reynolds v. Sims, 377 U.S. 533, 565, 84 S.Ct. 1362, 1383, 12 L.Ed.2d 506 (1969). Contrary to the allegations of the complaint, plaintiff is simply not “similarly situated” to those persons whose products were included in the OTC review rulemaking, see supra page 192, and thus his exclusion from that process does not state a claim for denial of equal protection.

With respect to the “takings” claim (for 45 million dollars) the Court is uncertain what property the plaintiff believes has been taken, other than potential future earnings from sale of his product. In any event this claim is not properly before this Court. Statutes such as 42 U.S.C. § 1983 and 1985 and other civil rights statutes cited by the plaintiff are an appropriate basis for jurisdiction only when the states (not the federal government) are defendants. Similarly, the Administrative Procedure Act—which provides jurisdiction for the Court to review agency action— does not provide a jurisdictional basis for money damage claims. See Califano v. Sanders, 430 U.S. 99, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977).

The Federal Tort Claims Act specifically excludes claims for money damages based on an “act or omission” of a Government agency or employee “in the execution of a statute or regulation____” 28 U.S.C. 2680(a); see Dalehite v. United States, 346 U.S. 15, 36, 73 S.Ct. 956, 968, 97 L.Ed. 1427 (1953). Under the Tucker Act, jurisdiction of the district courts in civil actions “founded either upon the Constitution, or any Act of Congress or any regulation ...” is limited to damage claims of under ten thousand dollars ($10,000). 28 U.S.C. § 1346(a)(2). Compare 28 U.S.C. § 1491. In short, despite plaintiffs arguments to the contrary, the Court has no jurisdiction over plaintiffs claim for money damages.

Finally, plaintiff has requested that this Court compel FDA to reconsider its approval of certain products. However, the action which plaintiff seeks to compel has already been underway for some time. The FDA process of reviewing certain OTC drugs (with approved NDA’s) dates back at least to the 1972 opinion of Judge Bryant in American Public Health Association v. Veneman, 349 F.Supp. 1311 (D.D.C.1972). Under the terms of the Veneman order (dated October 11, 1972), the FDA was ordered to “proceed expeditiously ... to complete implementation of the drug effectiveness review ... as soon as possible.” Judge Bryant retains jurisdiction to enforce or modify any aspect of that order which, according to defendant, still requires ongoing effort by the FDA. This Court will not interfere with that ongoing administrative proceeding.

Plaintiffs request for injunctive relief is based on a misunderstanding of a case on which he places great reliance, Cutler v. Kennedy, 475 F.Supp. 838 (D.D.C.1979). Cutler held that the FDA could not allow continued marketing of entire categories of OTC drugs that the agency determined were lacking in sufficient data to classify as generally recognized as safe and effective. The drugs in question in Cutler had been categorized, after review, as lacking substantial evidence of effectiveness. Id. at 853. The court reasoned that absent such a determination of safety and effectiveness, the regulation allowing marketing of such a category of drugs was “unlawful.” Id. at 855.

Although Cutler held that the regulation in question was unlawful, the court did not “agree with plaintiffs that the Commission must move to take such drugs off the market.” Id. at 856. Instead, the court held that the agency would retain its traditional prosecutorial discretion “to seek enforcement actions or not to seek enforcement action” against individual OTC drugs. Id. at 856. Thus contrary to plaintiffs assertions, Cutler does not mandate the injunction which he requests. On the contrary, the Cutler case defers to agency expertise in determining which OTC drugs may remain on the market.

The Court has made an effort in this case to discuss—at least briefly—all of the allegations and arguments in plaintiffs motions and memoranda. It has done so in the hope that plaintiff will better understand some of the difficulty and complexity that he must face in the course of his pro se litigation crusade. This is not to suggest that plaintiff has undertaken this or any other case for the purpose of harassment or other improper motive; on the contrary, plaintiff has been quite civil in his demeanor and has undertaken what the Court perceives to be a good faith effort to meet the government’s arguments.

However, one cannot help regretting the time and money invested by all parties in this unnecessary litigation. It is especially troublesome because plaintiff could easily have pursued the proper FDA procedures to obtain a new drug application when the agency originally brought the problem to his attention. In fact, the FDA even provided plaintiff with the information necessary to file the proper application, including the address and telephone number of a local FDA official who could assist plaintiff.

Rather than pursuing the proper administrative course, which might have fulfilled plaintiffs original goals, plaintiff launched this lengthy and expensive federal litigation. As so often happens, plaintiffs lawsuit has brought him nothing but an extra year’s delay in obtaining the license—the denial of which he claims cost him forty-five million dollars in lost profits.

The Court is not in the habit of challenging the sincerity or motivation of the litigants that appear in this courthouse and the parties may be assured that this is not the purpose of this discussion. Nor does the Court intend to impugn the character of the plaintiff or challenge the strength of his convictions. Instead, the Court offers these observations in the hope that plaintiff—and others—who rush to the courthouse at the first hint of any perceived injustice might temper their enthusiasm for litigation with a careful reflection on how their cause, and the cause of justice, will best be served.

An appropriate order will issue in accordance with the terms of this opinion.

      . Otherwise known to non-scientists as a soap or cleanser.

      . This action by the FDA rendered plaintiff's complaint moot to the extent it sought to compel FDA action on his petition.

      . The Court has endeavored to give plaintiff's pleadings every benefit of the doubt, as is justified for a pro se litigant. See Boag v. MacDougall, 454 U.S. 364, 102 S.Ct. 700, 70 L.Ed.2d 551 (1982); Haines v. Kerner, 404 U.S. 519, 92 S.Ct. 594, 30 L.Ed.2d 652 (1972). In doing so, it is sometimes necessary to read plaintiff s legal arguments quite liberally in order to discern what appears to be the "best” argument within the scope of the available legal doctrines.

      . Plaintiff's original proposed uses included health care personnel handwashes, preoperative skin preparation, skin antiseptic, and surgical hand scrubs.

      . This was not among the uses or indications originally set forth by plaintiff, see supra note 4.

      . The procedures for doing so are known to plaintiff and, in fact, the FDA’s denial of plaintiff’s original petition directs plaintiff to the appropriate authorities to begin the procedure.

      . See 5 U.S.C. § 706(2).

      . Plaintiff has also failed to allege any invidious basis for this perceived discrimination.

      . Cutler is also inapposite to the present claim because the Cutler case deals with drugs that have been reviewed and classified, not drugs— such as those in the present case—which are undergoing FDA review or the new drug application process.

      . This is not plaintiff’s first case before this Court, see Farquhar v. GSA, C.A. No. 83-3111, nor is it his last. A recently filed complaint seeks injunctive relief requiring the GSA to investigate alleged fraud and misrepresentation in the purchase of disinfectant cleaners by the United States Government. Farquhar v. Ink, C.A. No. 85-0859.