author: GETZENDANNER, District Judge:

text:
    UNITED STATES of America, Plaintiff, v. ARTICLES OF DRUG ... Promise Toothpaste for Sensitive Teeth ... Active Ingredients: Potassium Nitrate, Sodium Monofluorophosphate ... Sensodyne-F Toothpaste for Sensitive Teeth ... Active Ingredients: Potassium Nitrate, Sodium Monofluorophosphate ... and Block Drug Company, Inc., and Leonard N. Block and James A. Block, Defendants.
    No. 83 C 6129.
    United States District Court, N.D. Illinois, E.D.
    Nov. 20, 1985.
    As Amended Dec. 5, 1985.

      Michael S. O’Connel, Asst. U.S. Atty., Chicago, 111., Ann H. Wion, FDA Associate Chief Counsel for Enforcement, Rockville, Md., for plaintiff.
    Joan M. Hall, Daniel J. King, Jenner & Block, Chicago, 111., Alan H. Kaplan, Thomas O. Henteleff, David E. Kaplan, Kleinfeld, Kaplan & Becker, Washington, D.C., for defendants.
   MEMORANDUM OPINION AND ORDER

GETZENDANNER, District Judge:

In this drug enforcement action, the United States seeks seizure and condemnation of certain over-the-counter (“OTC”) drug products, Promise toothpaste with Fluoride and Sensodyne-F toothpaste. The government alleges that these products are “new drugs” within the meaning of 21 U.S.C. § 321(p)(l), and were introduced into interstate commerce without an approved New Drug Application (“NDA”), as required by 21 U.S.C. § 355(a). The government also seeks injunctive relief against the manufacturer Block Drug Company, Inc. (“Block”), and two of its officers, Leonard N. Block and James A. Block, to restrain further marketing of these products. Block has filed a claim in the in rem proceeding.

On July 30, 1984, this court denied the defendants’ motion to dismiss and ruled that the Compliance Policy Guide (“CPG”) of the Food and Drug Administration (“FDA”) did not bar the present action pending completion of further administration review; the court also ruled that a remand of proceedings to the FDA would be inappropriate. United States v. Articles of Drug ... Promise Toothpaste for Sensitive Teeth, 594 F.Supp. 211 (N.D.Ill. 1984). The opinion denying that motion contains an extensive overview of new drug regulations and the FDA’s review of OTC dentifrices, which will not be repeated here. The matter is currently before the court on the government’s motion for summary judgment, or alternatively, for a preliminary injunction. For the reasons set forth herein, the motion for summary judgment is granted.

Statement of the Case

The sole issue presented by the motion for summary judgment is whether, as a matter of law, Promise with Fluoride and Sensodyne-F are “new drugs” within the meaning of § 321(p)(l). Under the Food Drug and Cosmetic Act, a drug product must be classified as a new drug unless its manufacturer can show that it is “generally recognized among experts” to be “safe and effective” for its recommended uses. 21 U.S.C. § 321(p)(l). It is established by regulation that the “newness of a drug may arise by reason ... of” combining two or more drugs. 21 C.F.R. § 310.3(h). See also 21 C.F.R. § 330.10(a)(4)(iv). Thus, even though the component parts of a new drug may be generally recognized as safe and effective, the combination itself may not be. See United States v. Articles of Food and Drug ... Coli-Trol 80, 518 F.2d 743, 746 (5th Cir.1975); United States v. An Article of Drug ... Entrol-C Medicated, 513 F.2d 1127, 1129 (9th Cir.1975); United States v. An Article of Drug ... Neo-Terramycin, 540 F.Supp. 363, 376 (N.D.Tex.1982), aff'd 725 F.2d 976 (5th Cir. 1984); United States v. X-Otag Plus Tablets, 441 F.Supp. 105, 111 (D.Colo.1977), aff'd in part, remanded in part, 602 F.2d 1387 (10th Cir.1979); United States v. An Article of Drug ... Mykocert, 345 F.Supp. 571, 575 (N.D.Ill.1972). The rationale for this rigorous treatment of combination drugs is that a single component of a drug may react with other components, thereby reducing the total effect of the drug or producing unexpected side effects. Coli-Trol 80, 518 F.2d at 746; X-Otag Plus Tablets, 441 F.Supp. at 111.

The Food Drug and Cosmetic Act nowhere defines the term “generally recognized among experts ... [as] safe and effective.” Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 629, 93 S.Ct. 2469, 2483, 37 L.Ed.2d 207 (1973); United States v. Articles of Drug ... 5,906 Boxes, 745 F.2d 105, 119 n. 22 (1st Cir.1984), cert. denied, sub nom. Alcon Laboratories, Inc. v. United States, — U.S. -, 105 S.Ct. 1358, 84 L.Ed.2d 379 (1985). At a minimum, however, courts have construed “general recognition” to require a consensus of expert opinion based on the same “substantial evidence” of effectiveness based on “adequate and well-controlled investigations” which would be required for approval of a new drug application under 21 U.S.C. § 355(d). See, e.g., Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653, 93 S.Ct. 2488, 2494, 37 L.Ed.2d 235 (1973) (reach of scientific inquiry for effectiveness under § 355(d) and § 321(p) is “precisely the same”); Hynson, 412 U.S. at 628-32, 93 S.Ct. at 2482-84 (procedural requirements applicable for approval of new drugs must be applied to the definitional requirements for “new drugs”); 5,906 Boxes, 745 F.2d at 116-19 (same); United States v. An Article of Drug ... 4,680 Pails, 725 F.2d 976, 985-87 (5th Cir.1984) (general recognition requires a showing of both expert consensus in fact and substantial evidence (i.e., adequate and well controlled investigations) to support that consensus); United States v. Western Serum Co., 666 F.2d 335, 338 (9th Cir.1982) (consensus of informed opinion must be “founded on well-controlled clinical tests”).

Many courts have gone further and held that, in order for a drug to be “generally recognized” as effective, the data relied on for that opinion must not only constitute “substantial evidence” within the meaning of § 355(d) but must also be published and available generally to experts in drug evaluation. See, e.g., United States v. Undetermined Quantities ... Equidantin, 675 F.2d 994, 1001 (8th Cir.1982), cert. denied sub nom. Performance Products, Inc. v. United States, 460 U.S. 1051, 103 S.Ct. 1497, 75 L.Ed.2d 929 (1983); United States v. 41 Cases ... Naremco, 420 F.2d 1126, 1130 (5th Cir.1970); United States v. Articles of Drug ... Hormonin, 498 F.Supp. 424, 432 (D.N.J.1980), aff'd, 672 F.2d 904 (3d Cir.1981); United States v. Articles of Drug ... Colchicine, 442 F.Supp. 1236, 1243 (S.D.N.Y.1978). As the Supreme Court said in Bentex Pharmaceuticals, “[wjhether a particular drug is a ‘new drug’ depends in part on the expert knowledge and experience of scientists based on controlled clinical experimentation and backed by substantial support in scientific literataure.” 412 U.S. at 652, 93 S.Ct. at 2493. See Premo Pharmaceutical Laboratories, Inc. v. United States, 629 F.2d 795, 803 (2d Cir.1980) (“[n]ormally the general expert consensus is supported not only by clinical experience but by publication in the scientific literature”); 21 C.F.R. § 330.-10(4)(ii) (“[g]eneral recognition of effectiveness shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data”). The reason behind the publication requirement is inherent in the statutory concept of a “new ” drug. As explained in Premo Pharmaceutical, “only those pre-existing drug products found through careful study by scientific experts to have been generally recognized on the basis of usage and documentation to be safe and effective [are] entitled to the exemption____” 629 F.2d at 802-03. Unawareness of the drug by experts generally precludes its qualifying as a pre-existing drug. Id.

Finally, any drug which has become generally recognized as safe and effective due to clinical investigations, but which has not otherwise “been used to a material extent or for a material time” under the conditions prescribed, recommended, or suggested in the labeling of the drug must be considered a “new drug” requiring approval of an NDA before being marketed. 21 U.S.C. § 321(p)(2). See Hynson, 412 U.S. at 631, 93 S.Ct. at 2484 (Act is designed to exempt only those drugs on the market which “have mustered the requisite scientifically reliable evidence of effectiveness long before they are in a position to drop out of active regulation by ceasing to be a ‘new drug.’ ”) The government in this case has not argued that Promise with Fluoride and Sensodyne-F fail to meet this particular requirement, and the court will not address the issue further.

Pursuant to the above cases, the government can prove lack of “general recognition” by proving an absence of material fact as to any of the following three issues: (1) general recognition in fact among the nation’s experts that the seized drugs are safe and effective for their intended use; (2) the existence of adequate and well-controlled studies which constitute the “substantial evidence” of safety and effectiveness § 355(d) requires for approval of an NDA; and (3) generally available scientific literature substantiating an expert consensus of safety and effectiveness. The government has not alleged that the seized drugs are unsafe in any way, and the parties accordingly have confined their discussion to the question of “general recognition.” The actual effectiveness of the drug is not in issue. Undetermined Quantities ... Equidantin, 675 F.2d at 1001; Premo Pharmaceutical Laboratories, 629 F.2d at 803-04; Tyler Pharmacal Distributors, Inc. v. H.E.W., 408 F.2d 95, 99 (7th Cir.1969). With these overall standards in mind (to be elaborated further), the court now addresses the evidence presented by the parties.

Facts

The following facts are undisputed. On January 1, 1983, defendant and claimant Block Drug Company began to market the products Promise with Fluoride and Sensodyne-F. (Def. Response to Pltf’s First Set of Interrogatories Nos. 19 and 20). Each of these products contains a combination of .76% sodium monofluorophosphate (commonly known as “MFP”) to prevent cavities, and 5% potassium nitrate to desensitize dentin in people with hypersensitive teeth. The toothpaste thus serves to maintain anti-cavity fluoride protection for people who suffer from dentinal hypersensitivity and who require special toothpastes for that reason.

In 1980, sodium mfp was classified by the FDA’s Advisory Review Panel on OTC Dentifrices and Dental Care Drug Products to be generally recognized as safe and effective for preventing cavities. 45 Fed. Reg. 20682-90. Given the numerous clinical trials for fluoride compounds, the panel and the American Dental Association (ADA) both recommended that satisfaction of certain laboratory testing profiles could replace further clinical investigations in determining whether a particular toothpaste containing an approved fluoride combination is safe and effective for preventing cavities. Id. at 20677-78. The panel also recommended, however, that products combining an anticaries agent such as sodium mfp with another agent be considered new drugs and be required to submit NDAs. Id. at 20674, 20690.

In May 1982, the panel issued a proposed monograph for oral discomfort products. 47 Fed.Reg. 22712 (1982). The panel concluded that potassium nitrate, the other active ingredient in defendant’s toothpaste, was safe at specified dosages, but concluded that there was insufficient data to establish its effectiveness as a tooth desensitizer. Id. at 22754-55. The Panel recommended that certain combinations containing potassium nitrate be permitted; none of these combinations included mfp or any other anticaries agent. Id. at 22719-23. The panel also concluded that sodium monofluorophosphate was safe for use as a desensitizing agent, but that the data were insufficient to establish its effectiveness for the purpose. Id. at 22752-53.

The proposed monograph did not consider any data which had become available after 1978, and the panel invited the submission of comments and new data. 47 Fed.Reg. 22759. In response, both Block and Richardson-Vicks, Inc., manufacturer of Denquel, a toothpaste containing potassium nitrate, submitted post-1978 data on potassium nitrate, including at least six studies concerning the effectiveness of potassium nitrate, as well as copies of several studies published in scientific or medical journals. The ADA and the Proprietary Association, a health organization, also submitted comments on potassium nitrate; both organizations recommended it for its effectiveness as a tooth desensitizer. (Def.Ex. 8 at 2; Ex. 9 at 9-10). While there appears to be significant scholarly dispute on this point, see Mandel Dep. Exs. 8 & 9, at least one of the government’s experts, admitted his position to be a minority view. (Ash Dep. at 14). For purposes of the present motion, the court will therefore assume that 5% potassium nitrate is recognized by a majority of qualified experts as safe and effective for desensitizing teeth, and will confine its discussion to defendant’s combination of 5% potassium nitrate and .76% sodium mfp in a single product.

On October 18, 1982, Block also filed data on the safety and effectiveness of its MFP/potassium nitrate combination. This data contained no clinical testing of the combination, but discussed the rationale for the combination, toxicology data, fluoride bioavailability to demonstrate anticaries effectiveness, and nitrate bioavailability to demonstrate desensitizing effectiveness. On April 25, 1983, after it had begun marketing the drug, Block submitted additional fluoride bioavailability tests and animal anticaries studies, 4- and 8-week human safety studies, and the results of several clinical studies on potassium nitrate previously submitted by Richardson-Vicks.

On September 7, 1983, Block submitted the results of a recently completed 12-week clinical investigation (hereafter “Silverman study”), which tested a 5% potassium nitrate toothpaste (Vick’s “Denquel”), a Block sodium MFP/potassium nitrate toothpaste, and a placebo toothpaste, containing only the toothpaste vehicle used in the seized products (i.e., no active ingredients) (Def. Ex.- 22). The study did not include any testing of a .76% sodium mfp toothpaste, and did not test for cavity prevention. Sixty-eight patients were enrolled in the study, all of whom had complained of hypersensitive teeth and showed physical symptoms associated with hypersensitivity. A dental history taken before admission indicated that approximately 80% of these patients used fluoride toothpastes regularly before starting the study. The results showed that both Promise and Denquel reduced tooth hypersensitivity to a statistically significant greater level than the placebo toothpaste. There was no statistically significant difference between Promise and Denquel. The Silverman study is not published and defendant has not identified any other clinical study testing the combination product. (Def. Response to Pltf s First Set of Interrogatories, Nos. 7 and 30).

From this point on the material presented by the parties consists of opinion evidence from various experts in the field of dentistry or periodontics and differs sharply. The plaintiff has produced affidavits from three experts who have testified that they only became aware of products containing the combination sodium mfp and potassium nitrate when contacted by FDA employees in connection with this litigation. See Ash Declaration ¶16; Carlos Declaration 1110; Trammel Declaration 11 5. Each of these experts has declared that he does not recognize defendant’s products as safe and effective for their labeled indications, Ash at II13, Carlos at 11 9, Trammel at ¶ 9, and that he does not believe the drags to be generally recognized by qualified experts as safe and effective. Ash at ¶ 14, Carlos at 1110, Trammel at 1110.

These experts have also declared that they are unaware of any published article concerning a combination of sodium mfp and potassium nitrate for either anti-cavity protection or tooth desensitizing, and believe it is scientifically unsound to extrapolate solely from data on sodium mfp or potassium nitrate to make a determination about the effects of the combination. Ash at MI 9-10, Carlos at 1111 5-7, Trammel at 11116-7. Finally, these experts have declared that they do not consider the Silver-man study relied on by Block to be adequate and well controlled, because of inadequate selection of subjects, inadequate duration of the study, and inadequate methodology. Ash at H 8, Trammel at 117(b), Carlos at 117. In particular; these experts criticize the failure to test the combination product against a fluoride toothpaste without potassium nitrate, so as to eliminate the possibility that the mfp and not the potassium nitrate was responsible- for the decrease in dentinal hypersensitivity. Id.

To rebut the above submissions, the defendants have submitted three affidavits from experts who claim to be more qualified than plaintiff’s experts in the area of caries prevention and/or dentinal sensitivity. These experts uniformly agree that Block’s mfp/potassium nitrate combination is generally recognized as safe and effective for both anticaries and sensitivity treatment, and refer to at least ten other experts who share this opinion. (Mandel Declaration Ml 6, 16; Ciacio Declaration MI 8, 10; Featherstone Declaration 1121). According to these experts, there is no chemical, physical, or physiological basis, as substantiated through in vitro clinical studies, for concluding that sodium mfp and potassium nitrate will interact to affect the safety or efficacy of either active ingredient. Thus, the generally available scientific literature on the two different ingredients can rationally be extrapolated to form a basis for concluding that the combination found in Promise is also safe and effective. Mandel at MI 17(d), (e), 19; Ciancio at MI 13(B), 18; Featherstone at MI 14, 15, & 19(c). It is significant that the government experts, while disputing this assertion, have conceded that they have no theoretical basis for assuming that potassium nitrate is likely to interact with sodium mfp. See, e.g., Ash Dep. at 75.

Defendants’ experts have also disagreed with the criticisms of the government experts regarding the Silverman study. Mandel at ¶ 17; Ciancio at If 19; Featherstone at MI 18-20. In particular, these experts maintain that it is questionable whether sodium mfp has a desensitizing effect, and therefore that Silverman’s failure to test Promise against a fluoride toothpaste does not invalidate the research results, particularly since 80% of the test participants had used fluoride toothpaste before entering the study. Id. These experts further note that the duration of the experiment — 12 weeks — is in excess of the 8-week period recommended by the FDA expert advisory panel and considered adequate by the ADA in testing for the safety and effectiveness of potassium nitrate alone. Id. For purposes of the present motion, the court has assumed that the opinions expressed by defendants’ declarants represent those of the majority of qualified experts. The court will assess whether relevant statutory standards nonetheless compel a conclusion that Promise with Fluoride and Sensodyne-F are “new drugs.”

Discussion

A. General Recognition in Fact

In its memoranda for summary judgment, the FDA argues, as it apparently has in other cases, see, 5,906 Boxes, 745 F.2d at 119 n. 22, that any “conflict” of opinion among medical experts is sufficient to mandate a legal conclusion that general recognition of Promise’s effectiveness does not exist. Many cases contain a statement to this effect. See, e.g., Premo Pharmaceutical Laboratories, 629 F.2d at 803 (“either the unawareness of the drug product by experts generally or a genuine dispute among qualified experts regarding a drug product’s safety and effectiveness preclude its qualifying for exclusion as ‘generally recognized.’ ”). Accord, Equidantin, 675 F.2d at 1000; Western Serum Co., 666 F.2d at 338; United States v. An Article of Drug ... “Bentex Ulcerine, 469 F.2d 875, 880 (5th Cir.1972), cert. denied, 412 U.S. 938, 93 S.Ct. 2772, 37 L.Ed.2d 397 (1973); United States v. Articles of Drug ... Hormonin, 498 F.Supp. 424, 431 (D.N. J.1980), aff'd, 672 F.2d 904 (3d Cir.1981).

Despite this impressive array of authority, the court must disagree. The above line of cases can be traced back to dicta in United States v. 354 Bulk Cartons ... Trim Reducing-Aid Cigarettes, 178 F.Supp. 847 (D.N.J.1959) and Merritt Corp. v. Folsom, 165 F.Supp. 418 (D.D.C.1958), in which it was stated that a mere conflict between qualified experts establishes a lack of general recognition as a matter of law. In United States v. 7 Cartons ... Ferro-Lac, 293 F.Supp. 660 (S.D.Ill.1968), aff'd in part, vacated in part, 424 F.2d 1364 (7th Cir.1970), the district court thoughtfully pointed out the inadequacies of this statement as a rule for general application:

[T]he government’s contention cannot be accepted as a sound principle of procedural law for application to this statute. The statute provides a test of general recognition. The rule stated in Merritt and subsequent cases would equate the statutory language, “generally recognized” to “unanimously recognized.” There is no justification for such equation. There is nothing in the statute to indicate that Congress intended “generally recognized” in other than its commonly understood meaning. The adverb, “generally,” is defined, inter alia, to mean “... extensively, though not universally” ____
Where, as here, each party has submitted affidavits in support of its position, the court must examine those affidavits to determine whether a genuine difference of expert opinion is presented. If such difference of opinion appears, decision must abide the results of a trial of the issues.

293 F.Supp. at 662-63 (citations omitted). See also 5,906 Boxes, 745 F.2d at 119 n. 22. (“[Ujnanimity among experts is not required to demonstrate ‘general’ recognition.”) United States v. Articles of Food and Drug (Coli-Trol 80), 518 F.2d 743, 746 (5th Cir.1975) (“It is not enough to show merely a conflict in the evidence of general recognition, for even properly conducted studies may produce disagreement. What is required is not unanimous recognition but general recognition.”)

The implications of this principle for the present case are obvious. The government should not be given license to seize non-new drugs simply because it can find a small contingent within the scientific community dissenting from the view that the drugs are safe and effective. By the same token, however, the manufacturer cannot avoid summary judgment simply by recruiting experts to testify that a particular drug is generally recognized as effective: “[t]he congressional purpose of removing the complex medical and scientific aspects of drug disputes from the courts to the expert province of the FDA would be frustrated if any and every divergence in expert opinion could serve to send a new drug case to the jury.” 5,906 Boxes, 745 F.2d at 119 n. 22. Hence, a district court must scrutinize opposing affidavits carefully to determine whether there really is a triable issue of disputed fact as to general recognition. Id.

As explained earlier, the relevant issue on the present motion is not whether potassium nitrate is generally considered by experts to be “safe and effective” for desensitizing teeth, but whether the combination of potassium nitrate and sodium mfp is safe and effective both for combating cavities and dentinal sensitivity. The government argues that the conflict among experts in this case is sufficient to preclude a finding of general recognition at trial. In particular, the government stresses defendants’ failure, after deposition, to impeach the credentials of those experts supporting the government’s position. While the question is close, the court finds on the present record that it cannot determine the existence of a “genuine” difference of opinion among experts without improperly assessing the probative weight of the evidence presented. See United States v. An Article of Food ... 345/50-Pound Bags, 622 F.2d 768, 773 (5th Cir.1980) (court should not “weigh” conflicting evidence on motion for summary judgment in drug seizure case). The court has reviewed the depositions of the various experts and finds no basis on which one set of experts can undisputedly be preferred over the other. On the government’s side, the court finds significant that defendants’ experts all appear to rely on unpublished data provided to them by defendants. Nonetheless, defendants have presented evidence that many if not most experts recognize 5% potassium nitrate as safe and effective (government expert Timothy Ash admitted upon cross-examination that his view in this regard was a minority position). Defendants have also presented evidence that there is no reasonable scientific basis for distinguishing the effects of sodium mfp and potassium nitrate when combined from their effects when used separately, and that most scientists therefore recognize defendants’ products as safe and effective. Finally, defendants have submitted a survey which shows that 75% of periodontists recommend a desensitizing toothpaste containing fluoride, and that over fifty percent recommend Promise. (Def.Ex. 17). While there are apparent grounds raised by the government for criticizing the survey, and while defendants’ inability to impeach the government witnesses thoroughly suggests a bona fide dispute among qualified experts, the court cannot conclude on the present record that the government has established a lack of general recognition in fact which would warrant a grant of summary judgment. The court therefore turns to the other arguments raised by the government.

B. Substantial Evidence of Effectiveness

Given the rigors of the FDA’s combination policy, many courts have held that a combination of known drugs be considered a “new drug” absent controlled clinical experimentation and substantial support in the scientific literature regarding the combination in its exact form or dosage. See Entrol-C Medicated, 513 F.2d at 1129; Neo-Terramycin, 540 F.Supp. at 376; Mykocert, 345 F.Supp. at 575; United States v. Asper-Sleep [1970-1973 Transfer Binder] Food Drug Cosm.L.Rep. (CCH) II 40,836 (N.D.Ill. April 30,1971). Cf. International Nutrition, Inc. v. H.H.S., 676 F.2d 338, 341 (8th Cir.1982) (upholding FDA rejection of NDA for animal drug combination product where manufacturer combined two approved drugs without showing that the combination itself was safe and effective).

Although FDA policy regarding OTC drugs does not always require increased effectiveness, see 37 Fed.Reg. 9470 (1972) (increased effectiveness not necessary absent a decrease in safety), each ingredient described as active must nonetheless make a contribution to the effect claimed or suggested in the labeling. 21 C.F.R. § 330.-10(a)(4)(iv). Proof that the active ingredients are separately recognized as effective does not satisfy this requirement. Accordingly, courts have ruled that studies supporting the safety and effectiveness of a combination drug will not be considered “adequate and well-controlled” within the meaning of 21 U.S.C. § 355(d) unless those studies compare the effectiveness of the combination with the effectiveness of each active ingredient as well as with a control group. Masti-Kure Product Co. v. Califano, 587 F.2d 1099, 1101-03 (D.C.Cir.1978); Neo-Terramycin, 540 F.Supp. at 377.

In the present case, it is undisputed that the only clinical (i.e., human) study conducted of Promise with Fluoride and Sensodyne-F failed to test the effects of the sodium mfp/potassium nitrate combination against the desensitizing effects of sodium mfp toothpaste alone. Defendants’ expert Sebastian Ciancio argued that such a procedure is scientifically acceptable since it is “questionable” whether sodium mfp has a desensitizing effect (Ciancio Decl. at ¶ 19). None of the defendants’ experts testified affirmatively that sodium mfp does not aid in treating dentin sensitivity, however, and only one testified that there is no scientific evidence confirming that possibility. (Ciancio Decl. at 1119). This vagueness is notable since defendants’ experts elsewhere categorically and affirmatively rejected the government’s purported theory that sodium mfp and potassium nitrate might chemically react with one another to weaken their respective effectiveness in dentinal hygiene and treatment. (Mandel Decl. at ¶ 17(d)-(e); Ciancio at ¶ 13(B); Feather-stone at 111114-15).

Defendants’ experts also point out that 80% of the test participants, chosen because they were suffering from dentinal hypersensitivity, had reported using a fluoride toothpaste before entering the study, and that the sodium mfp/potassium nitrate combination, although clinically and statistically more effective than the placebo in relieving hypersensitivity, was neither clinically nor statistically different in effect from the use of potassium nitrate alone. From these facts, defendants’ experts contend that most scientists would interpret the results as indicating that the potassium nitrate component of the combination was primarily responsible for the combination’s effectiveness in treating dentinal hypersensitivity.

The court does not dispute the logic of this argument. It is clear, however, that “substantial evidence” of effectiveness as defined in 21 U.S.C. § 355 is as much a term of law as it is one of scientific consensus, and that the evidence of effectiveness required for approval of a new drug application is, if anything, lesser than the evidence of effectiveness required for determining that a drug escapes “new drug” status altogether. Given defendants' failure to rebut the. government’s evidence that sodium mfp is potentially effective for hypersensitivity treatment and the Silver-man study’s failure to test the mfp/nitrate combination against mfp alone, there is no adequate and well-controlled study that potassium nitrate contributes to the desensitizing effects of fluoride toothpaste. Summary judgment for the government is therefore warranted, and the defendants must await FDA approval before engaging in further marketing of the seized drug products.

Defendants have vigorously argued that the Silverman study, when considered in light of the nitrate bioavailability studies and the clinical literature on potassium nitrate alone, constitutes substantial evidence which would support a conclusion that the mfp/nitrate combination is generally recognized as safe and effective for desensitizing teeth. While certain conditions may make it scientifically appropriate to extrapolate solely from data on potassium nitrate and sodium mfp separately to make a determination about the effects of the combination, the statute and applicable FDA regulations require more. None of Block’s experts was willing to say that the Silverman study on the combination was unnecessary to their determination that the combination product was safe and effective. (Mandel Dep. at 18-19; Ciancio Dep. at 21; Featherstone Dep. at 8.) Ciancio specifically stated that the Silverman study was necessary to such determination. (Ciancio Dep. at 21.) Because the Silver-man study did not demonstrate that each ingredient contributes to the claimed effect, the necessary scientific basis for a judicial conclusion of general recognition simply does not exist.

In further opposition to the government’s motion, defendants argue that the government is not entitled to rely on “new drug” case law concerning prescription products in determining whether nontoxic over-the-counter items such as Sensodyne-F require premarket clearance. The Act clearly requires premarket approval of “new” OTC drugs as well as new prescription drugs, however, 21 U.S.C. § 331, and the regulations bear out that the OTC combination policy is essentially the same as that used for prescription drugs. 37 Fed. Reg. 9464, 9470 (1972). While the FDA’s OTC policy has been applied less strictly than its prescription policy, see Def. Brief at 20-21, that difference does not license manufacturers to ignore the strictures of the Act as to premarket clearance for all “new drugs.”

Defendants’ clinical studies are secondly inadequate to support a finding of general recognition since the mfp/nitrate combination has never been tested for its effectiveness in preventing cavities. The Silverman study never purports to study the anticaries effect of the drug, and defendants concede that no other clinical study exists. Defendants instead argue that Promise with Fluoride satisfies the laboratory testing profiles propounded by the FDA in 1980 for various fluoride dentifrice formulations, and that clinical testing is therefore not required. See 45 Fed.Reg. 20666, 20677. That same FDA monograph, however, expressly restricts approved OTC anticaries drug products to those containing “single active ingredients.” Id. at 10674. The language about laboratory testing profiles in lieu of clinical tests is followed by a list of approved fluoride/abrasive combinations, none of which contains potassium nitrate. Accordingly, any general scientific opinion that mfp/potassium nitrate in combination is safe and effective for cavity prevention is based on the prediction that the potassium nitrate will not affect the fluoride’s effectiveness, and not on controlled clinical studies testing the product itself. This predictive evidence, whatever its wide acceptance among qualified experts, is statutorily insufficient for side-stepping the administrative review procedures of the Food Drug and Cosmetic Act.

Defendants correctly point out that the Supreme Court, in dicta, once stated that certain circumstances might allow for a finding of “general recognition that a drug is efficacious ... without the kind of scientific support necessary to obtain approval of an NDA.” Bentex Pharmaceuticals, 412 U.S. at 652, 93 S.Ct. at 2493. Defendants in this case suggest that the known chemical inability of potassium nitrate and mfp to interact, as has been scientifically demonstrated, avoids the need for controlled clinical studies demonstrating their effect when combined. Defendants have been unable to point to any cases which follow up on this dictum, however, and the overall tenor of the decision in Bentex Pharmaceuticals is to incorporate the standards of § 355 into the definition of “new drug” under § 321(p). The circumstance most likely envisioned by the Supreme Court is one of longstanding market acceptance so that the body of experience alone, without controlled research, could support a finding of general recognition. The relatively recent marketing of defendants’ products precludes such an exception here, and the court will not require a jury trial because of an undefined “possibility” suggested in passing by the Supreme Court.

C. Published Scientific Literature

The final ground on which the government asserts the propriety of summary judgment is that of publication. Because the statute requires that expert recognition of a drug’s effectiveness be “general,” several courts have held that the data on which that consensus is based be generally available to the community of experts before a determination of “general recognition” can be made. See, e.g., Equidantin, 675 F.2d at 1001; Naremco, 420 F.2d at 1130; Hormonin, 498 F.Supp. at 432; Colchicine, 442 F.Supp. at 1243; Mykocert, 345 F.Supp. at 574. Since it is undisputed that the only clinical in vivo study concerning ■ defendants’ products is unpublished, the government argues that absence of such publication establishes newness as a matter of law.

Defendants correctly point out that some of the authorities cited by the government do not require publication per se but instead merely note that the presence or absence of published literature should “normally” or “generally” be considered in determining whether a drug is generally recognized as effective. Bentex Pharmaceuticals, 412 U.S. at 652, 93 S.Ct. at 2493; Premo Pharmaceutical Laboratories, 629 F.2d at 803; 21 C.F.R. § 330.10(4)(iii). There is no statutory or regulatory requirement that the data supporting effectiveness be published, only that it be “substantial.” Defendants therefore argue that the various studies submitted to the FDA concerning the mfp/potassium nitrate combination, including the Silverman study, constitute publicly available evidence on which a finding of general recognition could be based.

The court disagrees. The “publication” requirement imposed by many courts is based on a common sense understanding that a “lack of documented sources of information perforce curtails the widespread knowledge of the drug’s effectiveness or safety” and is therefore often determinative of “newness.” Mykocert, 345 F.Supp. at 574. No judicial opinion has allowed a new drug case to go to the jury on the basis of unpublished data alone, and the court agrees with the government that there is no principled basis for doing so here. A manufacturer should not be allowed to create general recognition of safety and effectiveness by sending unpublished data to the FDA for administrative review and then arguing that the submission itself creates the public availability which would obviate the need for FDA review altogether. In the present case, the lack of published clinical studies conclusively shows that Promise with Fluoride and Sensodyne-F are “new drugs” within the meaning of the Act. The fact that most scientists would extrapolate from other largely available data that the drugs are safe and effective does not change this conclusion.

Conclusion

The court has not addressed all of the arguments raised by the government, in part because it finds the above discussion dispositive, and also because many of the more refined criticisms made by the government go to credibility determinations which are inappropriate on a motion for summary judgment. The court does determine, however, that the government has met its burden of demonstrating as a matter of law that Promise with Fluoride and Sensodyne-F are “new drugs” within the meaning of the Food Drug and Cosmetic Act. The government is therefore entitled to destroy the seized drugs and to enjoin defendants from further marketing of Promise and Sensodyne-F. The court agrees with defendants, however, that the scope of the injunction as requested goes beyond what is necessary or appropriate: the injunction should be limited to the new drugs listed in the complaint, with appropriate language to cover the possibility that defendants might attempt to market similarly labeled and/or formulated drugs under a slightly different form or name. The court will not enjoin defendants from marketing any other new drug for which no approved NDA is on file, as the government has not demonstrated the likelihood of such an event.

Accordingly, the government’s motion for summary judgment is granted. The parties should confer for the purposes of preparing a draft final order. The parties should report for status on December 5, 1985. If the parties cannot agree on the language of a final order, at that time each side should submit a proposed order to the court. The defendants should also inform the court at that time whether they intend to appeal, and, if so, whether they intend to seek a stay pending appeal.

It is so ordered.

      . After this opinion was issued, counsel for the government alerted the court to the fact that the Silverman study was published last February, after the defendants filed their opposition memorandum but well before the court ruled. Although this development was mentioned in a footnote to the government’s reply brief, that footnote escaped the court’s attention. The court does not believe that this subsequent publication, approximately i'A years after the case was filed, affects its conclusion that the reliance of Block’s experts on largely unpublished data precludes general recognition as a matter of law.


source: Caselaw Access Project

author: KEVIN THOMAS DUFFY, District Judge:

license: Public Domain

text:
    Thomas IRVING, Petitioner, v. Theodore C. REID, Superintendent, of the Fishkill Correctional Facility, et al., Respondents.
    No. 84 Civ. 5783 (KTD).
    United States District Court, S.D. New York.
    Nov. 20, 1985.

      Thomas Irving, pro se.
    Patrick Henry, Dist. Atty. of Suffolk County, Riverhead, N.Y. (Patricia A. Murphy, Asst. Dist. Atty., of counsel), for respondents.
   MEMORANDUM & ORDER

KEVIN THOMAS DUFFY, District Judge:

Pro se petitioner, Thomas Irving, seeks a writ of habeas corpus to set aside a judgment of conviction entered against him by the Supreme Court of Suffolk County (Jaspan, J.) after a jury trial, on December 3, 1981. Irving was convicted of Criminal Possession and Sale of a Controlled Substance in the Second Degree. He was sentenced to concurrent indeterminate terms of incarceration for three years to life. The Appellate Division, Second Department, unanimously affirmed Irving’s conviction on February 22, 1983. Leave to appeal to the New York Court of Appeals was denied on March 30, 1983. Irving’s subsequent coram nobis application to vacate his conviction pursuant to N.Y.Crim. Proc.Law 440.10 was denied on July 25, 1983. Irving has not challenged that order.

Irving sets forth four grounds in support of his contention that he was deprived of due process and a fair trial. He claims (1) that he was incompetent to stand trial and was denied a full opportunity to challenge the results of examining psychiatrists; (2) that there was insufficient evidence to establish his guilt beyond a reasonable doubt; (3) that the prosecutor’s inflammatory opening statement deprived him of a fair trial; and (4) that the trial judge improperly intervened in the proceedings, thus bolstering the People’s case.

A petition for a writ of habeas corpus will only be granted if the petitioner has exhausted all of his state remedies. 28 U.S.C. § 2254(b) and (c). The exhaustion doctrine provides that, in the interests of both comity and expeditious federal review, the state courts must be afforded an adequate opportunity to pass on the federal claims with which petitioner seeks to upset the state conviction. Daye v. Attorney General of the State of New York, 696 F.2d 186, 190-91 (2d Cir.1982). Under Rose v. Lundy, 455 U.S. 509, 102 S.Ct. 1198, 71 L.Ed.2d 379 (1982), a habeas petition must be dismissed if it contains any unexhausted claim. 455 U.S. at 522, 102 S.Ct. at 1205.

To be considered exhausted, a claim must not only have been “fairly presented” to the state court, but it must also have been presented “to the highest state court from which a decision can be had.” Daye, 696 F.2d at 190 n. 3 (citation omitted). It should be noted, however, that “a petitioner need not give the state court system more than one full opportunity to rule on his claims; if he has presented his claims to the highest state court on direct appeal he need not also seek state collateral relief.” Id. at 190-91 n. 3 (citations omitted).

Of petitioner’s four claims, grounds three and four were raised on direct appeal to the appellate division where his conviction was unanimously affirmed. Leave to appeal to the New York Court of Appeals was subsequently denied. Thus, petitioner has satisfied, albeit marginally, the exhaustion requirement with respect to grounds three and four.

Petitioner’s first and second grounds, however, were not asserted on his direct appeal. “A petitioner who has failed to exhaust state remedies by pursuing a direct appeal must utilize available state methods for collaterally attacking his state conviction. Klein v. Harris, 667 F.2d [274, 282-83 (2d Cir.1981) ]; see Johnson v. Metz, 609 F.2d 1052, 1055-56 (2d Cir.1979).” Hill v. Snow, 590 F.Supp. 1157, 1159 (S.D.N.Y. 1984). Petitioner did collaterally attack his conviction by filing a coram nobis application pursuant to N.Y.Crim.Proc.Law § 440.10. However, although the first ground of the instant petition was asserted as part of the coram nobis application, the second ground was not. Thus, as it is apparent that petitioner never asserted his second claim to the state courts, this claim must be considered unexhausted. Moreover, petitioner did not appeal the denial of his coram nobis application alleging “[i]t was futile.” Petition under 28 U.S.C. § 2254 for Writ of Habeas Corpus by a Person in State Custody, 1111(e). When the relief sought by the collateral attack is denied, petitioner must “employ[] all the state appellate procedures available for review of such denial” in order to satisfy the exhaustion requirement. Klein v. Harris, 667 F.2d at 283 (citations omitted). Accordingly, as petitioner did not appeal the denial of his collateral attack, his first claim must also be considered unexhausted.

In sum, the petition contains both unexhausted and exhausted claims. Under Rose v. Lundy, 455 U.S. at 522, 102 S.Ct. at 1205, the petition must be dismissed in its entirety.

SO ORDERED.

      . Since the filing of this petition Irving has been released from the' Edgecombe Correctional Facility and is currently on parole.

      . The exhaustion requirement of the federal habeas corpus statute is set forth in 28 U.S.C. §§ 2254(b) and (c) which provide as follows:
      (b) An application for a writ of habeas corpus in behalf of a person in custody pursuant to the judgment of a State court shall not be granted unless it appears that the applicant has exhausted the remedies available in the courts of the State, or that there is either an absence of available State corrective process or the existence of circumstances rendering such process ineffective to protect the rights of the prisoner.
      (c) An applicant shall not be deemed to have exhausted the remedies available in the courts of the State, within the meaning of this section, if he has the right under the law of the State to raise, by any available procedure, the question presented.

      . "[T]he ways in which a state defendant may fairly present to the state courts the constitutional nature of his claim, even without citing chapter and verse of the Constitution, include (a) reliance on pertinent federal cases employing constitutional analysis, (b) reliance on state cases employing constitutional analysis in like fact situations, (c) assertion of the claim in terms so particular as to call to mind a specific right protected by the Constitution, and (d) allegation of a pattern of facts that is well within the mainstream of constitutional litigation.” Daye v. Attorney General of the State of New York, 696 F.2d at 194.

      . Grounds three and four of the present petition are basically restatements of Points II and IV of petitioner’s state appéal. Whether grounds three and four were "fairly presented” to the state courts as federal constitutional claims is an arguable question in that these claims were advanced as essentially evidentiary or procedural errors under state law. However, given the language in petitioner’s point headings regarding these claims, I find that the state courts were given sufficient notice of the constitutional dimensions of petitioner’s claims. Following a description of the allegedly improper acts, each of the relevant point headings ends with the phrase "deprived Appellant of his Due Process right to a fair trial.”


author: PLUNKETT, District Judge.

text:
    UNITED STATES of America ex rel. Ernest A. MOTA, Petitioner, v. James W. FAIRMAN, Warden, Respondent.
    No. 84 C 10370.
    United States District Court, N.D. Illinois, E.D.
    Nov. 21, 1985.

      William H. Theis, Chicago, 111., for petitioner.
    Mark Rotert, Asst. Atty. Gen., Chicago, 111., for respondent.
   MEMORANDUM OPINION AND ORDER

PLUNKETT, District Judge.

Petitioner, Ernest A. Mota (“Mota”) brought this petition for habeas corpus relief, seeking a remand to the state court for a new sentencing hearing. Presently before the court are the parties’ cross-motions for summary judgment. For the reasons set forth below, Mota’s motion is granted and, accordingly, Respondent’s motion is denied.

The facts are not in dispute. In August 1982, Mota committed an armed robbery of a restaurant in Calumet City, Illinois. Holding eleven people at bay, Mota robbed the store of $7,000 and then took one of the restaurant employees as a hostage to aid him in his escape. Counts I through XI of the resulting indictment charged Mota with armed robbery, one count representing each employee present in the restaurant during the incident. Count XII charged Mota with burglary of the restaurant. Counts XIII through XXIV each charged Mota with the offense of armed violence, Ill.Rev.Stat. ch. 38, § 33A-2; i.e., the commission of eleven acts of unlawful restraint on the eleven employees while armed with a gun. Count XXIV specifically dealt with Mota’s conduct toward the employee whom Mota took hostage during his escape. Counts XXV through XXXV charged Mota with unlawful restraint. Finally, Count XXXVI charged Mota with aggravated kidnapping of the employee taken hostage.

Mota pleaded guilty to all thirty-six counts; however, the judge accepted his plea only as to Counts I through XI and Count XXIV. The court viewed all other counts as being “merged” into those accepted. Thus, Count XII, the burglary count, was merged into the eleven counts of armed robbery, as were Counts XIII through XXIII and Counts XXV through XXXV. Count XXXVI, the aggravated kidnapping count, was merged into Count XXIV, the armed violence count. The court sentenced Mota to thirteen years on Counts I through XI and thirteen years on Count XXIV, the sentences to run concurrently.

Mota’s lawyer, a privately retained attorney, subsequently filed a motion to reduce sentence or, in the alternative, for a new trial. Counsel specifically told the court that the motion was not one to vacate the guilty plea. Rather, the motion simply expressed the view that the sentence was too harsh. Mota’s lawyer argued that the evidence did not support ten of the armed robbery counts. He contended that the manager of the restaurant was the only person who had actually been robbed; the other employees were present, but had had nothing taken from them. Thus, counsel was concerned that the judge had relied improperly on the guilty findings as to eleven counts of armed robbery when, in his view, the evidence substantiated only one count.

The court responded that it did not find Mota’s actions to constitute thirteen separate armed robberies. The judge considered it to be only one armed robbery, “one taking of one quantity of money.” (Transcript at 104.) The court further stated that “whether it is one or thirteen complainants all persons present, that in no way affected the Defendant’s sentence____ I am in no way regarding this as any more than one armed robbery.” (Transcript at 104-105.) The court did note that it found the armed violence directed toward the hostage to be a separate act, even though the sentence for that offense was to run concurrently. Finding the sentences to be otherwise fair and correct, the court denied Mota’s motion.

Mota then appealed to the Illinois Appellate Court. That court held that Mota could properly be convicted and sentenced on only one count of armed robbery, as only one sum of money had been taken from the restaurant manager. Accordingly, the court affirmed the conviction and sentence for the armed robbery of the manager, and vacated the ten other armed robbery convictions. The court also reversed the judgment for armed violence based on unlawful restraint (Count XXIV), relying on precedent set by the Illinois Supreme Court in People v. Wisslead, 94 Ill.2d 190, 68 Ill.Dec. 606, 446 N.E.2d 512 (1983) (affirming the finding of the circuit court that allowing the crime of armed violence to be predicated on the offense of unlawful restraint is unconstitutional).

Discussion

It is clear that the sentencing process, as well as the trial itself, must satisfy the requirements of the Due Process Clause. Gardner v. Florida, 430 U.S. 349, 358, 97 S.Ct. 1197, 1204, 51 L.Ed.2d 393 (1977). In United States v. Tucker, 404 U.S. 443, 92 S.Ct. 589, 30 L.Ed.2d 592 (1972), the respondent was found guilty of armed bank robbery and, after an inquiry into his background by the district judge which revealed three previous felony convictions, sentenced to twenty-five years in prison. It was subsequently determined that two of the respondent’s previous convictions were constitutionally invalid.

The respondent filed a motion, claiming that the introduction of evidence of his prior invalid convictions had fatally tainted the jury’s guilty verdict. The district court found that error had in fact occurred, but held it was harmless error in light of the other overwhelming evidence of the respondent’s guilt. On appeal, the Ninth Circuit affirmed the guilty verdict, but concluded that the defective prior convictions might have led the trial court to impose a heavier sentence than it otherwise would have, and, accordingly, remanded the case to the district court for resentencing without consideration of any prior invalid convictions.

The Supreme Court affirmed, holding that the court of appeals was correct in remanding the case for resentencing, “[f]or if the trial judge in 1953 had been aware of the constitutional infirmity of two of the previous convictions, the factual circumstances of the respondent’s background would have appeared in a dramatically different light at the sentencing proceeding.” Id. at 448, 92 S.Ct. at 592. See also United States v. Cardi, 519 F.2d 309, 311-12 (7th Cir.1975); Tyler v. Swenson, 527 F.2d 876, 877 (8th Cir.), cert. denied, 425 U.S. 979, 96 S.Ct. 2185, 48 L.Ed.2d 805 (1976); United States v. Walters, 526 F.2d 359, 361 (3d Cir.1975); Garrett v. Swenson, 459 F.2d 464, 466 (8th Cir.1972).

The Court in Tucker acknowledged the trial judge’s wide discretion in determining what sentence to impose, and also acknowledged that a sentence imposed by a trial judge, if within statutory limits, is generally not subject to review. The Court, however, rejected the petitioner’s arguments that these considerations disposed of the respondent’s request, concluding that such general propositions could not decide the case because the Court was dealing “not with a sentence imposed in the informed discretion of a trial judge, but with a sentence founded at least in part upon misinformation of constitutional magnitude.” 404 U.S. at 447, 92 S.Ct. at 591. In light of this reasoning, we reject Respondent’s similar arguments in this case.

The Supreme Court’s analysis in Tucker was extended by Judge Friendly in McGee v. United States, 462 F.2d 243 (2d Cir. 1972), to eases in which a conviction on one or more counts of a multi-count indictment is subsequently found to be invalid. The defendant in McGee was convicted on four counts which were prosecuted in one trial and upon which identical concurrent sentences were imposed. Later, however, it was determined that the conviction under one of those counts was unlawful. Relying on Tucker, the court noted that:

[t]he trial judge’s original sentencing determination with respect to counts 2 through 4 could have been influenced by appellant’s conviction under count 1— just as evidence of a prior conviction might influence a sentencing judge on a subsequent one. If such were in fact the case, appellant’s initial sentences under counts 2 through 4 would require reconsideration.

Id. at 245. The court further stated that “[w]hen the invalidity of the conviction on one count which may have influenced the sentence becomes apparent on an appeal, whether on direct or collateral attack, the proper course is usually to vacate the sentences and remand for resentencing on the valid counts without consideration of the invalid one.” Id. at 246 (emphasis added). Because the court could not determine whether the trial judge was influenced by the invalid conviction in setting sentence, the case was remanded. The court took this action even though, pursuant to a Rule 35 motion, the trial judge had already had an opportunity to reconsider the sentences on the remaining counts after being made aware of the invalidity of one of the counts. The Second Circuit determined that some explanation was needed for allowing the original sentences on the valid counts to stand unaltered. Id. at 246-247.

In view of this case law, a remand of Mota’s case is appropriate if there is a possibility that the trial judge might have been led to impose a heavier sentence than he otherwise would have because he considered convictions that were later determined to be invalid. We conclude that the trial judge may well have been so influenced. With respect to the armed robbery counts, the record is ambiguous. The trial judge indicated that he was imposing only one sentence and considered this to be only one armed robbery, yet he allowed Mota’s guilty plea on eleven separate counts to stand and did not “merge” these counts as he did with many of the other counts. Rather, the judge stated that he felt the evidence supported a finding of guilty on all eleven counts, though he would not sentence Mota eleven separate times. (Transcript at 29-30.) It thus appears plausible to us that the court relied, at least in part, on the fact that there were eleven convictions for armed robbery.

Even if we were to find otherwise on the question of the armed robbery convictions, we would still grant Mota a rehearing because it is clear that the court was influenced by the conviction for armed violence subsequently declared unconstitutional by the Illinois Appellate Court. The judge considered the hostage-taking to be an extremely serious offense. For example, at the original sentencing, the judge indicated:

not only are the people that he [Mota] confronts in danger, but additional danger is given when he takes at gunpoint Ray Marschke off as a hostage and drives away. There is obvious great serious harm threatened. And not only in the taking of a hostage, but in the driving away at a speed such as to endanger the lives of not only the captive passenger, but of other members of the public. It’s fortunate notoby [sic] got killed.
Mr. Hynes, I don’t really see wanton cruelty or exceptional brutality here, but I do see a couple of separate offenses that both are very serious. First of all, the armed robbery, whether it’s of one or two victims, or 11 on the scene, coupled with the taking of an innocent hostage. Both the crimes — the original crime of the armed robbery, and the following crime of the hostage taking which is reflected in the armed violence, predicated on the unlawful restraint of Mr. Marschke are serious offenses; and I must also consider the factor in view of the nature of the crime, as well as reformation and the factors in aggravation and mitigation.

(Transcript at 94-95.) At the hearing on the motion to reduce sentence, the judge reiterated his concern over Mota’s acts of armed violence:

Then, the Defendant takes a hostage while armed with a loaded gun or still loaded and thereby endangering the life and safety of the hostage in the car, drives off at a high speed not only endangering the hostage further, but endangering the general public in a high speed chase and only by the grace of God nobody was killed by the Defendant’s driving either.

(Transcript at 106.) The armed violence charge is a Class X felony, carrying a sentence of six to thirty years. Mota is entitled to a new sentencing hearing. At that hearing the court may consider all the facts in aggravation of the armed robbery conviction, including the taking of a hostage. The court may not, however, consider a conviction for the taking of that hostage as an aggravating circumstance.

In sum, Mota was indicted on thirty-six counts; he was sentenced on twelve; and stands now, after his appeal, convicted on only one. The court was clearly influenced in setting sentence by his conviction on Count XXIV, which was unconstitutionally obtained, and was perhaps also influenced by the fact that Mota stood convicted of eleven counts of armed robbery, when only one conviction on one count was valid. Accordingly, the ease is remanded to the circuit court for a new sentencing hearing. This court is in no way ordering a reduction of Mota’s sentence. This order requires only that the court review the sentence without considering the invalid convictions and provide an explanation of its conclusions.

Conclusion

For all the foregoing reasons, Mota’s motion for summary judgment is granted. Respondent’s cross-motion for summary judgment is denied.

       Mota argued on appeal that he was denied the effective assistance of counsel because his attorney failed to file a motion to vacate his guilty plea before appealing, as required by Supreme Court Rule 604(d), and asked that the court modify the judgment entered and remand the case for resentencing. The State argued that by failing to comply with the Rule 604(d) requirement, Mota had waived his right to appeal the judgments entered on the guilty plea. The court held that Mota had, in fact, been denied effective assistance of counsel, and therefore proceeded to consider the merits, despite the procedural flaw.


author: ASPEN, District Judge:

text:
    Plecidio MANFREDINI, Plaintiff, v. Gordon RUTH, Regional Commissioner of the Immigration and Naturalization Service of the United States Department of Justice, and as Custodian of a Certain 1982 Toyota, Vehicle Identification Number: JT4RN48D9C0039987, Defendant.
    No. 85 C 4887.
    United States District Court, N.D. Illinois, E.D.
    Nov. 22, 1985.

      Thomas R. Nash, Chicago, 111., for plaintiff.
    Jack Penca, Asst. U.S. Atty., Chicago, 111., for defendant.
   MEMORANDUM OPINION AND ORDER

ASPEN, District Judge:

Plaintiff Plecidio Manfredini (“Manfredini”) brought this action to recover a truck used in his landscaping business from defendant Gordon Ruth (“Ruth”), Regional Commissioner of the U.S. Immigration and Naturalization Service. Ruth has moved to dismiss for lack of subject matter jurisdiction. For the reasons stated below, his motion to dismiss is granted.

On April 23, 1985, agents of the Immigration and Naturalization Service (“INS”) seized a 1982 Toyota truck owned by Manfredini for use in his landscaping business. Just before this seizure, the truck was being driven by Manfredini’s son with passenger Jesus Garcia, an employee of the plaintiff. At a storage site for landscaping materials used in plaintiff’s business, the INS seized individuals who were alleged to be illegal aliens and took control of plaintiff’s truck. Apparently, the INS agents suspected Garcia was an illegal alien and seized the truck pursuant to a federal statutory provision authorizing the seizure of vehicles used to illegally transport aliens. See 8 U.S.C. § 1324(b) (1982). Manfredini denies that the truck was ever used to transport illegal aliens and claims that his son and Garcia were in transit for the purposes of the landscaping business only.

As required by federal regulations regarding INS vehicle seizures, 8 C.F.R. § 274.8 (1984), INS agent Robert Magidson (“Magidson”) sent written notice to Manfredini indicating the basis for the seizure, including copies of the relevant regulations governing the administrative forfeiture proceedings. Also included was a notice of a statutory change indicating that the amount of the bond required to be filed in conjunction with any administrative claim had been increased from $250 to the lesser of $2,500 or ten percent of the vehicle’s appraised value.

There are factual disputes regarding the various attempts made by plaintiff’s counsel Thomas Nash (“Nash”) to follow the appropriate administrative procedures to prevent a summary forfeiture and force the government to initiate judicial forfeiture. Nash claims that he made repeated attempts in good faith to comply with the regulations. He visited the INS offices on at least three occasions in an attempt to file the administrative claim and bond required by 8 C.F.R. § 274.10 (1984); 50 Fed. Reg. 7575 (1985). On May 7, 1985, Nash sent a letter and a $500 certified check to the INS seizure office. The letter clearly indicated that Nash and his client wanted to have judicial forfeiture proceedings initiated. He had also requested in the letter that the INS inform him of any other requirements necessary to adequately comply with the regulations. He earlier had visited the INS offices on May 1, 1985, and spoke with Agent Robert Magidson regarding the vehicle seizure. Nash claims in an affidavit submitted to the Court that he does not recall Agent Magidson mentioning the appraisal value of $5,875 for the seized vehicle. However, defendant submitted Agent Magidson’s affidavit which states that on May 1, 1985, Agent Magidson personally informed Nash that the appraised blue book value of the vehicle was $5,875, and that a. bond of ten percent of that amount was required before judicial forfeiture would be initiated.

Defendant Ruth has moved to dismiss this case under Fed.R.Civ.P. 12(b)(1), claiming that the Court lacks subject matter jurisdiction over this dispute. We agree. Plaintiff Manfredini has not asserted a sufficient basis for this Court to exercise subject matter jurisdiction over the present dispute. In his complaint, plaintiff asserts that this action was brought under 8 U.S.C. § 1324(b)(3) (1982) and 8 C.F.R. § 274.10 (1984) (modified by 50 Fed.Reg. 7575 (1985)). However, neither of these provisions creates a cause of action for a person who claims a wrongful seizure of his or her vehicle by the INS. The cited statutory provision merely directs that all provisions of law regarding vehicle seizures and forfeitures under the federal customs laws are equally applicable to seizures and forfeitures under the immigration laws. The cited regulation merely sets forth the procedures by which the owner of a seized vehicle can forestall summary forfeiture of his or her vehicle and require the government to file judicial forfeiture proceedings.

If a vehicle owner files a claim and bond under 8 C.F.R. § 274.10, the vehicle is protected from summary administrative forfeiture. The regulation proscribes that upon receipt of the claim and bond, the regional commissioner of the INS, defendant Ruth in this case, must transmit the claim to the United States Attorney. Thereafter, the United States Attorney must initiate judicial forfeiture proceedings “in the manner prescribed by law.” 8 C.F.R. § 274.10(b). See 50 Fed.Reg. 7575 (1985). That manner is described at 8 U.S.C. § 1324(b)(5) (1982). Under the statute, the government must demonstrate probable cause for the forfeiture, after which the burden shifts to the claimant to prove that the vehicle was not used in violation of § 1324. However, it is the government which must initiate the judicial forfeiture proceedings in federal court, not the owner of the vehicle.

The plaintiffs plea that 28 U.S.C. § 1346(a)(2) (1982) establishes jurisdiction is incorrect. It is clear that jurisdiction under that statute is appropriate only where the plaintiff is seeking damages against the United States and not, as here, where purely injunctive relief is sought. Lee v. Thornton, 420 U.S. 139, 140, 95 S.Ct. 853, 854, 43 L.Ed.2d 85 (1975); Willis v. United States, 600 F.Supp. 1407, 1412 (N.D.Ill.1985). Furthermore, this case was not filed as a mandamus action to require the United States Attorney to initiate the forfeiture proceedings in the district court or to require defendant to return the plaintiffs truck.

We note that a substantial part of the papers filed in this case deal with the question of whether or not plaintiffs counsel Nash adequately complied with the claim and bond requirement in order to protect plaintiffs truck from summary forfeiture. Nash has argued that he made good faith efforts to comply with the relevant administrative regulations but that INS employees prevented him from doing so. Furthermore, there is an ongoing dispute regarding whether Nash was adequately informed of the required bond amount. There is no question that Nash was on notice that a ten percent bond was necessary, but there is a question concerning the appraised value from which the ten percent was to be measured. We do not need to decide here whether the May 7, 1985 letter sent by Nash to the INS was sufficient to constitute a “claim” under 8 C.F.R. § 274.-10, although we assume that it was adequate to preserve his client’s rights. Furthermore, the dispute over the bond amount is a matter to be resolved by the parties, although we feel the prudent course for all involved would be to allow plaintiff to file an additional bond at this point and allow matters to proceed as they should have from the inception of this entire chain of events.

Conclusion

The defendant’s motion to dismiss this action under Fed.R.Civ.P. 12(b)(1) for lack of subject matter jurisdiction is hereby granted. It is so ordered.

      . That provision states:
      All provisions of law relating to the seizure, summary and judicial forfeiture, and condemnation of property for the violation of the customs laws: the disposition of such property or the proceeds from the sale thereof; the remission or mitigation of such forfeitures; and the compromise of claims and the award of compensation to informers in respect of such forfeitures shall apply to seizures and forfeitures incurred, or alleged to have been incurred, under the provisions of this section, insofar as applicable and not inconsistent with the provisions hereof, except that duties imposed on customs officers or other persons regarding the seizure and forfeiture of conveyances under the customs laws shall be performed with respect to seizures and forfeitures carried out under the provisions of this section by such officers or persons authorized for that purpose by the Attorney General.

      . That provision states:
      (a) Any person claiming ownership of a seized conveyance may obtain judicial review by filing a claim within 20 days of the date of first publication of the notice of seizure, alleging that the conveyance was improperly seized, and posting bond to cover all the costs and expenses of the proceedings if forfeiture is denied. The bond in the sum of the lesser of $2,500 or ten percent of the value of the property, but in no event less that [sic] $250 must be in cash, certified check, or on Form 1-637 (Bond of Claimant of Seized Conveyance for Costs of Court), if the surety is approved by the regional commissioner. The bond must be made payable to the Immigration and Naturalization Service and will be maintained in the custody of the regional commissioner. The regional commissioner may waive the bond requirement in the manner provided by Waiver of fees in § 103.-7(c)(1) of this chapter.
      (b) The regional commissioner shall transmit the claim, notice that a satisfactory surety has been accepted, and provide a description of the facts and circumstances of the seizure to the United States Attorney for the judicial district in which the seizure was made, for forfeiture proceedings on the vehicle in the manner prescribed by law.
      (c) The filing of a claim and the posting of bond does not entitle the claimant to possession of the vehicle but does stop the summary forfeiture proceedings. Upon conclusion of the action, the regional commissioner shall disburse the money to pay costs up to the amount of the bond and shall return any additional sum to the obligor.

        See 8 C.F.R. § 274.10 (1984); 50 Fed.Reg. 7575 (1985).

      . That provision states:
      (5) In all suits or actions brought for the forfeiture of any conveyance seized under this section, where the conveyance is claimed by any person, the burden of proof shall lie upon such claimant: Provided, That probable cause shall be first shown for the institution of such suit or action. In determining whether probable cause exists, any of the following shall be prima facie evidence that an alien involved in the alleged violation was not lawfully entitled to enter, or reside within, the United States:
      (A) Records of any judicial or administrative proceeding in which that alien’s status was an issue and in which it was determined that the alien was not lawfully entitled to enter, or reside within, the United States.
      (B) Official records of the Service showing that the alien was not lawfully entitled to enter, or reside within, the United States.
      (C) Testimony, by an immigration officer having personal knowledge of the facts concerning that alien's status, that the alien was not entitled to enter, or reside within, the United States.

      . That provision states:
      (a) The district courts shall have original jurisdiction, concurrent with the United States Claims Court, of:
      ******
      (2) Any other civil action or claim against the United States, not exceeding $10,000 in amount, founded either upon the Constitution, or any Act of Congress, or any regulation of an executive department, or upon any express or implied contract with the United States, or for liquidated or unliquidated damages in cases not sounding in tort, except that the district courts shall not have jurisdiction of any civil action or claim against the United States founded upon any express or implied contract with the United States or for liquidated or unliquidated damages in cases not sounding in tort which are subject to sections 8(g)(1) and 10(a)(1) of the Contract Disputes Act of 1978. For the purpose of this paragraph, an express or implied contract with the Army and Air Force Exchange Service, Navy Exchanges, Marine Corps Exchanges, Coast Guard Exchanges, or Exchange Councils of the National Aeronautics and Space Administration shall be considered an express or implied contract with the United States.

      . Plaintiff has moved for summary judgment. However, because we grant Ruth’s motion to dismiss, we need not decide plaintiffs motion, which, in any event, would not likely be successful because of the underlying disputed facts.


text:
    CO-OPERATIVE SHIPPERS, INC., Plaintiff, v. The ATCHISON, TOPEKA AND SANTA FE RAILWAY COMPANY, Defendant.
    No. 84C2359.
    United States District Court, N.D. Illinois, E.D.
    Nov. 25, 1985.

      Richard Billik, Jr., Billik & Billik, Ltd., Chicago, 111., Ronald N. Cobert, Joseph Michael Roberts, Grove, Jaskiewicz, Gilliam & Cobert, Washington, D.C., for plaintiff.
    Dennis A. Kearns, John C. Palmer, Ellen L. Falkof, Chicago, 111., for defendant.
   MEMORANDUM OPINION AND ORDER

ASPEN, District Judge:

As courts of limited jurisdiction, federal district courts always must decide whether they have subject matter jurisdiction, and thus power, to rule in a case. This case adds a wrinkle to that question. In deciding whether we have jurisdiction, we must decide whether the appellate court has jurisdiction over an appeal which defendant has filed. On July 3, 1985, we granted plaintiff Co-Operative Shippers, Inc.’s (“CoOp”) motion for partial summary judgment. See 613 F.Supp. 788 (N.D.Ill.1985). Defendant (“Santa Fe”) had already admitted liability for damaging goods which CoOp had shipped through Santa Fe but had contested Co-Op’s claim for the full actual cost of the damaged freight. We held that Santa Fe was liable for the full cost of the goods but not for court costs, attorney’s fees or interest. 613 F.Supp. at 795. We did not determine the actual value of the goods or the amount of damages. Also on July 3, the Court’s clerk completed and docketed a form entitled “Judgment in a Civil Case” which repeated the final paragraph of our opinion. See Id. at 795. This form is the one specified in Fed.R.Civ.P. 58 and, when docketed, starts the running of the 30-day clock for filing of a notice of appeal. Santa Fe filed a notice of appeal on August 1, 1985. One day later, Co-Op filed a “motion for Judgment in a Sum Certain.” Santa Fe promptly moved to strike this motion, arguing that the notice of appeal divested this Court of jurisdiction to decide the motion. Co-Op filed a “Motion to Ignore the Notice of Appeal,” asserting that the July 3 decision was not final and thus not appealable. The Court of Appeals has held the briefing of the appeal in abeyance pending our resolution of these motions. For the reasons stated below in Part A, we conclude that the July 3 order was not appealable, and that therefore we have jurisdiction to rule on Co-Op’s motion for judgment in a sum certain. In Part B, we grant that motion.

A.

Our resolution of the jurisdictional issue involves several straightforward principles of law. We begin with the premise, which Santa Fe does not dispute, that we have jurisdiction to determine our own jurisdiction. Whether we have jurisdiction depends in turn on whether the appellate court has jurisdiction. That is because the filing of a notice appeal usually divests the district court of jurisdiction. See, e.g., Ced’s Inc. v. United States EPA, 745 F.2d 1092, 1095 (7th Cir.1984), cert. denied, — U.S. -, 105 S.Ct. 2017, 85 L.Ed.2d 299 (1985); United States v. Bastanipour, 697 F.2d 170, 173 (7th Cir.1982), cert. denied, 460 U.S. 1091, 103 S.Ct. 1790, 76 L.Ed.2d 358 (1983). However, this rule does not operate where the order appealed from is non-appealable. Id. Thus, we must decide whether the order appealed from, the July 3 opinion, was appealable.

Appellate jurisdiction usually depends on 28 U.S.C. § 1291, which says in relevant part, “[t]he courts of appeal ... shall have jurisdiction of appeals from all final decisions of the district courts ...” (emphasis added). An order is “final” (and thus appealable) under § 1291 if it “ ‘ends the litigation on the merits and leaves nothing for the court to do but execute the judgment.’” Local P-171 v. Thompson Farms Co., 642 F.2d 1065, 1069 (7th Cir. 1981), quoting Catlin v. United States, 324 U.S. 229, 233, 65 S.Ct. 631, 633, 89 L.Ed. 911 (1945). It is clear that our July 3 opinion is not final under this definition of finality. The litigation on the merits is not over: the parties are still skirmishing over the proper amount of damages. There is no money judgment to execute.

Our conclusion that the July 3 order is not final is consistent with those cases involving appeals from grants of partial summary judgment. When a court grants “partial” summary judgment on one issue, see Fed.R.Civ.P. 56(d), or grants so-called “interlocutory” summary judgment, see Fed.R.Civ.P. 56(c) (authorizing summary judgment as to liability only), the order is not “final” under § 1291. See Liberty Mutual Ins. Co. v. Wetzel, 424 U.S. 737, 744, 96 S.Ct. 1202, 1206-07, 47 L.Ed.2d 435 (1976); Wolf v. Banco Nacional De Mexico, S.A., 721 F.2d 660, 662 (9th Cir.1983); Local P-171, 642 F.2d at 1070; 10 C. Wright, A. Miller & M. Kane, Federal Practice & Procedure, § 2715 at 631-34 (1983). This case involved just such a “partial” summary judgment. Liability had been conceded and our July 3 opinion defined the scope of damages available. This was a generic rather than specific decision. We did not decide the actual amount of damages to be awarded. That the parties now dispute the proper amount of damages shows that the damages question is not merely a ministerial or accounting one. This case is a fairly straightforward one and should, if possible, be decided in one appeal. Santa Fe would needlessly have us divide and thereby complicate and delay the case. Instead of separating the pending damage issue from the one we decided on July 3, and create the likelihood and delay of two appeals, judicial economy dictates that we decide all remaining issues before review by the court of appeals.

In summary, we granted summary judgment in part on July 3, deciding that Co-Op was entitled to the full actual value of its damaged goods, but leaving undecided the issue of what the actual value is. Accordingly, under the principles stated herein, we hold that our July 3 opinion was not a “final” decision and hence was not appealable. It follows from this conclusion that the notice of appeal has not stripped us of jurisdiction, and that the “separate document” filed on July 3 under Rule 58 was improvidently docketed and is void. Having so ruled, we are ready to consider Co-Op’s motion for judgment in sum certain.

B.

The parties agree on several elements of damages: that the value of the damaged goods was $95,103.40, that Co-Op salvaged them for $42,332.16, and that it incurred $17,227.40 to salvage the goods, leaving a net loss of $73,656.46. Co-Op claims, however, that it is entitled as a matter of law to pre-judgment interest on the damages from the date of the accident. Santa Fe disagrees and also contends that the $17,-227.40 in salvage costs were excessive and unreasonable. We consider each issue in turn.

1. Interest

Initially we must dispel any doubts that our July 3 opinion forecloses assessment of pre-judgment interest. In that opinion, we held that Co-Op could not contractually recover interest under Item 37 of ATSF Circular No. TOFC-1. See 613 F.Supp. at 795. In so ruling, we did not decide whether some other basis for claiming interest exists. Our opinion thus does not foreclose Co-Op’s current argument that it is statutorily entitled to pre-judgment interest.

Co-Op is correct that an award of prejudgment interest as part of the “full actual loss” is proper under both the Carmack Amendment, 49 U.S.C. § 11707, and common law. See, e.g., George R. Hall, Inc. v. Superior Trucking Co., 532 F.Supp. 985, 996-98 (N.D.Ga.1982); also Lehigh Valley R. Co. v. State of Russia, 21 F.2d 396, 406 (2d Cir.1927); Ex Parte No. 263, Rules, Regulations, and Practices of Regulated Carriers with Respect to the Processing of Loss and Damage Claims, 340 I.C.C. 515, 569-70 (1972). Such an award is discretionary, see George R. Hall, 532 F.Supp. at 985, and we see no reason why pre-judgment interest should not be awarded. Such an award will make Co-Op whole. To the extent the “liquidated” nature of the damages is relevant, if at all, see George R. Hall, 532 F.Supp. at 997, the actual damages in this case have been largely admitted and certain. We do not see why the few disputes as to the damages argues against interest as part of a make-whole remedy. Santa Fe’s remaining arguments about the propriety of pre-judgment interest also lack merit and are rejected.

Having decided that pre-judgment interest is properly part of the “full actual value” of the damaged goods, we must determine which interest rate to apply, federal or state. Since federal law has controlled up to this point, including our decision to award pre-judgment interest, we think federal law should determine the interest rate as well. While no federal statute directly prescribes the rate for a case like this, an appropriate federal rate can be discerned from analogous statutes and cases.

Before 1982, the statute which governs post -judgment interest for civil money judgments in federal court, 28 U.S.C. § 1961, provided that the forum state’s law determined the rate of interest. In 1982, § 1961 was amended to create a uniform federal rate, to be calculated

at a rate equal to the coupon issue yield equivalent (as determined by the Secretary of the Treasury) of the average accepted auction price for the last auction of fifty-two week United States treasury bills settled immediately prior to the date of the judgment.

Although this statute specifically applies only to post -judgment interest, we think that so long as pre-judgment interest is proper in this case under federal law, it too should be determined by a federal rate. Congress thought a federal rate appropriate for post-judgment interest, and we see no sensible reason to set a non-federal rate for the pre-judgment situation. . Indeed, § 1961 sets a workable market value for the rate that is easily applied and consistent with a make-whole remedy.

In like circumstances, courts have applied a federal rate to calculate an award of pre-judgment interest. In Western Pacific Fisheries, Inc. v. SS President Grant, 730 F.2d 1280, 1288-89 (9th Cir.1984), the Court applied the § 1961 rate in a maritime case to an award of pre-judgment interest. See also Blanton v. Anzalone, 760 F.2d 989, 992-93 (9th Cir.1985) (using § 1961 to calculate pre-judgment interest in an ERISA case). In Southern Pacific Transportation Co. v. San Antonio, Texas, 748 F.2d 266, 275 (5th Cir.1984), the court also applied a federal rate to an award of prejudgment interest. That was a suit under the Interstate Commerce Act for freight undercharges. The Court noted that an award at the § 1961 rate would be appropriate, but it noted that the Act itself, at 49 U.S.C. § 10707, provides a different rate for cases involving railroad tariffs. That rate is one

equal to the average yield of marketable securities of the United States Government having a duration of 90 days.

49 U.S.C. § 10707(d)(1) & (2). While that Section did not directly apply to that case either, the court reasoned that it, like § 1961, guided it as to federal policy. Id. at 275. Faced with a choice between the general statute, 28 U.S.C. § 1961, and a more specific one, 49 U.S.C. § 10707, the court decided to apply the rate specified in the latter, because it related to the Interstate Commerce area. Id. We do the same. While an award under § 1961 would be proper, one under § 10707 is more closely analogous and promotes uniformity in the commerce area. In sum, then, prejudgment interest should be awarded at the § 10707 rate from the date of the derailment until the date of judgment.

2. Storage Charges

Santa Fe admits that reasonable salvage expenses are allowable as damages, and that Co-Op spent $17,227.41 for salvage, but that part of this amount was unreasonably excessive. We disagree.

Specifically, Santa Fe asserts that some $11,000.00 was too much to pay for storing the damaged goods. However, we think that the deposition testimony to which both parties refer is clear that the expenses paid and efforts of Co-Op were reasonable. The cargo had contained laboratory glassware and other glassware, which, when damaged, had limited acceptability on the market because of the risk of suits on non-sterile goods. Co-Op took many steps to salvage the goods, and the poor market was in large part responsible for the delay that caused the storage charges. Co-Op’s efforts yielded over $40,-000 in salvage value to the benefit of Santa Fe, and the cost of $17,000 to realize that value was not unreasonable under the circumstances. While the actions of a third-party, VWR Scientific, conceivably hampered the process, it is speculative to conclude that VWR actually delayed the ultimate sale of what was a hard-to-sell freight; moreover, it would be speculative to estimate how much delay there might have been. Considering the totality of circumstances in the record, we find the salvage costs to have been reasonable.

Conclusion

We have jurisdiction over the case. CoOp is entitled to judgment in the sum of $73,656.46 plus interest computed from the date of the derailment, at a rate specified above. Co-Op shall serve a draft judgment order on Santa Fe within five days which includes a dollar value for this amount of interest. Santa Fe shall examine and approve this order — without waiving its position on the merits — as to form. Co-Op shall within five days thereafter submit the draft judgment order to the Court. After we receive this order — and assuming it is in proper form — our clerk will docket a new, valid “Rule 58” final judgment form. It is so ordered.

      . Co-Op says it mailed this motion two days earlier, on July 31.

      . Santa Fe does not assert any other basis for appellate jurisdiction, such as 28 U.S.C. § 1292 or the “collateral order doctrine” of Cohen v. Beneficial Industrial Loan Corp., 337 U.S. 541, 69 S.Ct. 1221, 93 L.Ed. 1528 (1949) and its progeny.

      . Santa Fe does not argue that appellate jurisdiction could have been triggered by operation of Fed.R.Civ.P. 54(b). Such an argument would have been fruitless since we made no certification under Rule 54(b), and, in any event, that Rule can be invoked only when multiple claims or parties are involved and when one of those discrete claims is decided finally. See, e.g., Local P-171, 642 F.2d at 1069. Such is obviously not the case here.