Source: https://law.justia.com/cases/federal/appellate-courts/F2/857/290/114816/
Timestamp: 2019-10-14 06:49:59
Document Index: 304831978

Matched Legal Cases: ['§ 301', '§ 1407', '§ 1404', '§ 1404', '§ 1447', '§ 1441', '§ 1441', '§ 1331', '§ 1332', '§ 1331', '§ 1441', '§ 1331', '§ 1447', '§ 1404', '§ 1404', '§ 1332']

In Re Bendectin Litigation.sarah Ann Hoffman; et al. (85-3858), Elizabeth Ann Davis;et al. (85-3876), Shane Ross Wood; et al.(85-3877), Plaintiffs-appellants, v. Merrell Dow Pharmaceuticals, Inc., (formerly Known As)richardson-merrell, Inc., Defendant-appellee, 857 F.2d 290 (6th Cir. 1988) :: Justia
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In Re Bendectin Litigation.sarah Ann Hoffman; et al. (85-3858), Elizabeth Ann Davis;et al. (85-3876), Shane Ross Wood; et al.(85-3877), Plaintiffs-appellants, v. Merrell Dow Pharmaceuticals, Inc., (formerly Known As)richardson-merrell, Inc., Defendant-appellee, 857 F.2d 290 (6th Cir. 1988)
US Court of Appeals for the Sixth Circuit - 857 F.2d 290 (6th Cir. 1988) Argued Oct. 9, 1986. Decided Aug. 30, 1988
These actions were brought on behalf of children with birth defects against Merrell Dow Pharmaceuticals, Inc., alleging that their birth defects were caused by their mothers' ingestion during pregnancy of defendant's anti-nausea drug Bendectin. Immediately involved are eleven hundred eighty claims in approximately eight hundred forty-four multidistrict cases.1 These cases represent only a part of the Bendectin cases which have been brought in numerous federal and state courts around the nation.2 Although there are some differences among the complaints, most are virtually identical, requesting relief on the grounds of negligence, breach of warranty, strict liability, fraud, and gross negligence, and asserting a rebuttable presumption of negligence per se for defendant's alleged violation of the misbranding provisions of the federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.
After twenty-two days of trial on the sole question of causation, the jury answered the following interrogatory in the negative: "Have the plaintiffs established by a preponderance of the evidence that ingestion of Bendectin at therapeutic doses during the period of fetal organogenesis is a proximate cause of human birth defects?" In re Richardson-Merrell, Inc., Bendectin Products, 624 F. Supp. 1212, 1269 (S.D. Ohio 1985). Had the jury answered this question in the affirmative, it then would have answered a second question concerning the particular categories of birth defects that Bendectin caused when administered at therapeutic doses: musculoskceletal defects, central nervous system defects, heart and circulatory defects, head defects, respiratory defects, gastrointestinal defects, genitourinary defects, and death. Id. Accordingly, the district judge entered judgment for defendant.
The unusually large number of individual cases involved here found their way to the United States District Court for the Southern District of Ohio in a variety of ways. Eight hundred thirty-four of these claims were filed either in the Northern or Southern Districts of Ohio, while seventy-three claims, originally filed in Ohio state courts, were removed to Ohio federal courts. Only twenty-nine of the cases were initially filed in Ohio by Ohio citizens. The remainder included sixty-two plaintiffs from California, five from Texas, six from Pennsylvania, and sixty-six from other states or foreign countries. Two hundred seventy-three claims were filed or removed to federal district courts outside Ohio and were transferred to the Southern District of Ohio by the Judicial Panel on Multidistrict Litigation. In addition to these cases, the Judicial Panel on Multidistrict Litigation referred, pursuant to 28 U.S.C. § 1407, forty-seven cases under MDL 486 for consolidated pretrial discovery. Between 1982 and the completion of the trial in 1985, 582 additional cases were referred by the panel and 557 cases were filed in the Southern District of Ohio.
The court designated a five-member Plaintiffs' Lead Counsel Committee to act as the counsel for all plaintiffs. After the completion of discovery, on November 16, 1983, the district court consolidated under Rule 42(a) of the Federal Rules of Civil Procedure all Bendectin cases originally filed in the Southern District of Ohio or transferred in MDL 486 from the Northern District of Ohio and set those cases for trial beginning June 4, 1984 on all common issues of liability. The original decision was to bifurcate the trial, and if the plaintiffs were successful in obtaining a verdict finding liability, the court would schedule individual damages trials. While consolidation for trial was mandated for all cases pending in federal court in Ohio, the trial judge also permitted consolidation upon the liability issues for any case which had been transferred to the Southern District of Ohio under MDL 486. 28 U.S.C. § 1404. Those cases would be returned to the originating district if the verdict in the first portion of the bifurcated trial was for the plaintiffs. The district judge indicated that under Erie Railroad Co. v. Tompkins, 304 U.S. 64, 58 S. Ct. 817, 82 L. Ed. 1188 (1938), all claims which had been originally brought or removed to federal court in Ohio would necessarily be governed by Ohio law, and that plaintiffs who had originally filed in other districts and who voluntarily chose to participate in the common issues trial would consent to application of the law of Ohio by so agreeing to participate. A number of plaintiffs chose to leave the consolidated proceedings after the completion of discovery and this order, and the district court accordingly returned those suits to the district in which they had been originally filed.4
In this order, the judge continued to allow additional plaintiffs to "opt in" to the trial, whether they had filed originally in the Southern District of Ohio or had filed in other districts and wished to have their cases transferred pursuant to 28 U.S.C. § 1404, so that by the date opt-ins were barred on March 1, 1985, 557 cases originating in the Southern District of Ohio and 261 transferred cases were subject to the jury decision. A total of 368 cases assigned by the Judicial Panel on Multidistrict Litigation did not go to trial, either because of failure to opt in or because they were otherwise disposed of. One set of plaintiffs who opted in after the district court ordered a bifurcated trial on the issues of liability and damages were the Davis plaintiffs, who had originally filed in Arizona federal court, and who opted into the joint liability trial on February 1, 1984.
After a jury had been selected for the June 1984 trial, settlement negotiations between the parties reached a successful conclusion. The district judge certified a class for purposes of settlement. However, on appeal, another panel of this court held that class certification was inappropriate and issued a writ of mandamus vacating the district court's order. In re Bendectin Product Liability Litigation, 749 F.2d 300 (6th Cir. 1984).
On August 27, 1985, after the entry of judgment and during the pendency of plaintiffs' motion for judgment NOV or new trial, the district court issued an order concerning its jurisdiction over those plaintiffs who were citizens of Ohio. This order was prompted by litigation involving two foreign plaintiffs whose claims were before the district court but are not before us on this appeal. In that related litigation, the defendant had sought to dismiss, on the ground of forum non conveniens, two cases which Merrell Dow had removed to the Southern District of Ohio from state courts in Ohio. The plaintiffs opposed this motion, and instead filed a motion to remand under 28 U.S.C. § 1447(c) for lack of subject matter jurisdiction, as the district court would not have had original jurisdiction to hear the cases under its grant of federal question jurisdiction. The trial judge granted defendant's motion to dismiss, but this court reversed, Thompson v. Merrell Dow Pharmaceuticals, Inc., 766 F.2d 1005 (6th Cir. 1985), aff'd, 478 U.S. 804, 106 S. Ct. 3229, 92 L. Ed. 2d 650 (1986). The parties agreed that the FDCA did not create a private right of action for its violation, and our court said that federal question subject matter jurisdiction would thus exist only if the plaintiffs' right to relief depended "necessarily" on a substantial question of federal law. Finding that recovery would not "necessarily" be barred by a failure to establish a violation of the FDCA, we held that plaintiffs' motion to remand to state court should have been granted on the ground that the district court did not have federal question jurisdiction.5 Similarly, in this case, reasoning that Merrell Dow's status as an Ohio citizen prevented removal on the basis of diversity jurisdiction in cases brought in state court by Ohio residents, 28 U.S.C. § 1441(b), and that there was no subject matter jurisdiction over Ohio plaintiffs' complaints alleging causes of action under the FDCA because the statute does not create an implied right of action, the district court remanded all complaints brought by Ohio plaintiffs in Ohio state courts under 28 U.S.C. § 1441(c) and dismissed without prejudice the Ohio resident complaints that had been brought in federal court in Ohio pursuant to 28 U.S.C. § 1331. It then issued a stay of this order pending appeal. Plaintiffs' motion for judgment NOV or new trial was denied on September 17, 1985, and these appeals followed.
On April 30, 1982, the district judge appointed a Lead Counsel Committee, selecting only some of the plaintiffs' attorneys, but only after counsel for a majority of the plaintiffs agreed to the formation of this Committee. He gave plaintiffs' attorneys time to object or propose others to serve on it. The Wood plaintiffs claimed that this decision denied them the right freely to choose counsel, in that the four counsel that the trial judge chose did not include their own attorney. No plaintiff responded to the district judge's order to show cause why such appointment should not be confirmed. In complex cases, it is well established that the district judge may create a Plaintiffs' Lead Counsel Committee. Vincent v. Hughes Air West, Inc., 557 F.2d 759, 773-74 (9th Cir. 1977); In Re Air Crash Disaster at Florida Everglades, 549 F.2d 1006, 1014-15 (5th Cir. 1977); Farber v. Riker-Maxson Corp., 442 F.2d 457, 459 (2d Cir. 1971). We find no error in creating such a committee in this case, especially given the failure below to object to such a procedure.
For most of the plaintiffs in this case, there is no question that both the district court and this court have jurisdiction. The defendant, because it is incorporated in Delaware but has its principal place of business in Ohio, is for diversity purposes a citizen both of Ohio and Delaware, 28 U.S.C. § 1332(c), and most of the plaintiffs are citizens of other states or foreign countries. Since all of such plaintiffs allege damages of a sum exceeding $10,000, there is diversity jurisdiction over all of their cases. The more difficult question concerns federal jurisdiction over Ohio plaintiffs. The only basis for these plaintiffs to assert jurisdiction in this court is federal question jurisdiction, 28 U.S.C. § 1331. Under 28 U.S.C. § 1441(b), the defendant may remove cases to federal court only if there is federal question jurisdiction. For federal courts to exercise jurisdiction over Ohio cases, the cases must "arise under" the constitution, laws or treaties of the United States. The district judge found as a result of this court's opinion in Thompson v. Merrell Dow, 766 F.2d at 1005, that there was no basis for federal question jurisdiction. Accordingly, he dismissed without prejudice cases originally filed by Ohio residents in Ohio federal court, and remanded to state court those cases which had been originally filed in Ohio state courts and removed by defendant.
23. That pursuant to Sec. 502(f) (2) of 52 Stat 1040, a drug is deemed misbranded unless its labeling bears "such adequate warning against use in those pathologic conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods, or duration of administration or application, in such manner and form, as are necessary for the protection of users."
24. That pursuant to Sec. 502(j) of 52 Stat 1040, a drug is deemed misbranded if it is "dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof."25. That the promotion of said drug, Bendectin, by the Defendant for the use in females during the time period in controversy, without revealing or attempting to reveal any facts material to consequences which may result in the unborn offspring of mothers receiving the drug, constituted misbranding of said pharmaceutical drug per subsections (a), (f) (2) and (j) of Sec. 502 and (n) of Sec. 201 of 52 Stat 1040.
Merrell Dow argues that plaintiffs employing this language did in fact allege a substantial federal claim based on an implied private right of action under the FDCA, even though later developments in the federal case law might have led to a contrary conclusion. Following a careful examination of the complaints and the record, including portions of the trial memorandum and pretrial conference transcript cited by plaintiffs, we agree. A straightforward reading of plaintiffs' complaints gives the undeniable impression that plaintiffs intended to allege an implied cause of action under the FDCA. As the Basalyga's complaint states: "This Court has jurisdiction based on [28 U.S.C. § 1331] inasmuch as liability arising under a federal statute is alleged.... The Defendant failed to submit all relevant data bearing on the safety of the drug Bendectin to the Food and Drug Administration, as required by law, [which] ... directly and proximately caused [plaintiffs'] injuries." Identical or similar express assertions of section 1331 jurisdiction appear in most if not all of the complaints in question. Moreover, unlike the parties in Merrell Dow v. Thompson, 106 S. Ct. at 3233; 106 S. Ct. at 3241 n. 4 (Brennan, J., dissenting), the parties in the instant suit never conceded that there was no implied cause of action under the FDCA. In fact, contrary assertions were made by some of plaintiffs' counsel at various points during trial. Although strategically it may be profitable for plaintiffs' counsel now to argue that they never intended to plead an implied cause of action, the language of their complaints leads to an opposite conclusion. These plaintiffs went to trial in federal court intending to take full advantage of any ruling that an implied cause of action existed, no doubt intending as well to take advantage of a favorable verdict on the issue of causation if the jury could be persuaded by the evidence to return it.
As the case law indicates, a substantial federal question is presented as long as the pleadings invoking federal question jurisdiction are not "so attenuated and unsubstantial as to be absolutely devoid of merit," "wholly insubstantial," "obviously frivolous," "plainly unsubstantial," or "no longer open to discussion." Hagans v. Lavine, 415 U.S. 528, 536-37, 94 S. Ct. 1372, 1379, 39 L. Ed. 2d 577 (1974) (quoting Newburyport Water Co. v. Newburyport, 193 U.S. 561, 579, 24 S. Ct. 553, 557, 48 L. Ed. 795 (1904); Bailey v. Patterson, 369 U.S. 31, 33, 82 S. Ct. 549, 550-51, 7 L. Ed. 2d 512 (1962); Hannis Distilling Co. v. Baltimore, 216 U.S. 285, 288, 30 S. Ct. 326, 327, 54 L. Ed. 482 (1910); Levering & Garrigues Co. v. Morrin, 289 U.S. 103, 105, 53 S. Ct. 549, 550, 77 L. Ed. 1062 (1933); and McGilvra v. Ross, 215 U.S. 70, 80, 30 S. Ct. 27, 31, 54 L. Ed. 95 (1909)). See Mt. Healthy City School District Board of Education v. Doyle, 429 U.S. 274, 279, 97 S. Ct. 568, 572, 50 L. Ed. 2d 471 (1977) ("jurisdiction is sufficiently established by allegation of a claim under the Constitution or federal statutes, unless it 'clearly appears to be immaterial and made solely for the purpose of obtaining jurisdiction' ") (emphasis added, citations omitted). The standard "is easily met--an arguably plausible claim must be allowed to proceed." Robbins v. Reagan, 780 F.2d 37, 43 (D.C. Cir. 1985) (emphasis added). The test, according to Wright and Miller, is "whether there is any legal substance to the position the plaintiff is presenting." 13B C. Wright, A. Miller & E. Cooper, Federal Practice and Procedure Sec. 3564, at 67 (2d ed. 1984) (emphasis added, footnote omitted). Until this court or the Supreme Court holds that there is no implied private right of action under the FDCA, the opposite position cannot be deemed either frivolous or unsubstantial.
A different analysis, however, may apply to those Ohio plaintiffs who originally brought suit in state courts. Since these plaintiffs invoked the jurisdiction of state and not federal court, it is perhaps unlikely, even where the language might arguably include an implied cause of action under the FDCA, that these plaintiffs intended to plead such a cause of action.6 In any case, even had the Ohio citizens filing in state court intended to plead an implied cause of action under the FDCA, 28 U.S.C. § 1447(d) precludes this court from reviewing the district court's remand on direct appeal. Gravitt v. Southwestern Bell Telephone Co., 430 U.S. 723, 97 S. Ct. 1439, 52 L. Ed. 2d 1 (1977) (per curiam).7
Finally, defendant has conceded that thirteen cases filed by Ohio citizens in federal court are unique insofar as these plaintiffs failed to allege any substantial federal question in their complaints. See cases listed supra note 3. Since no federal question is alleged, we dismiss these thirteen cases without prejudice for lack of federal jurisdiction. Fed. R. Civ. P. 12(b) (1).
Before determining whether proximate causation should properly be considered a separate issue for purposes of Rule 42(b), it is necessary first to determine under which jurisdiction's law of proximate causation we are operating. At trial, Judge Rubin applied the substantive law of Ohio to any case brought in Ohio, citing Erie, 304 U.S. 64, 58 S. Ct. 817, and required all plaintiffs who transferred their cases to the Southern District of Ohio under MDL 486 and 28 U.S.C. § 1404 also to consent to have the liability issues tried in accordance with the substantive law of Ohio. Since the question of proximate causation was tried under the law of Ohio for all cases, and since the judge determined that the law of Ohio considered causation a separate issue from fraud, he prohibited the plaintiffs from introducing evidence that defendant had committed fraud in its submission to the FDA of test results regarding the safety of Bendectin. Because he found that fraud, even if proved, had no relation to the causation question under Ohio law, he concluded that the trifurcated case could proceed on the separate issue of causation.
We agree with Judge Rubin's conclusion that under Fed. R. Civ. P. 51 any objections that the instructions on causation were not couched in terms of Arizona or Texas law were waived when not made before the jury retired. Even if such a claim were construed as plain error, we observe that there was no showing that the law of these states differed in any material respect from that of Ohio. Out of caution, however, we inspect this issue more closely.
The conflict of laws rules to be applied by the federal court in [a state] must conform to those prevailing in [that] state ['s] courts. Otherwise, the accident of diversity of citizenship would constantly disturb equal administration of justice in coordinate state and federal courts sitting side by side.... Any other ruling would do violence to the principle of uniformity within a state, upon which the Tompkins decision is based.
Klaxon Co. v. Stentor Electric Manufacturing Co., 313 U.S. 487, 496, 61 S. Ct. 1020, 1021-22, 85 L. Ed. 1477 (1941) (citations omitted). " [T]he conflict-of-laws rules to be applied by a federal court in Texas must conform to those prevailing in the Texas state courts. A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits." Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4, 96 S. Ct. 167, 168, 46 L. Ed. 2d 3 (1975) (per curiam).
The choice of Ohio law is even more persuasive when we apply, as we must under Morgan, the factors set forth in section 6 of the Restatement: " [T]he needs of the interstate and international systems"; "the protection of justified expectations"; "the basic policies underlying the particular field of law"; "certainty, predictability and uniformity of result"; and "ease in the determination and application of law to be applied" provide, in our judgment, a persuasive basis for holding that the more significant relationships were those of the place of manufacture. We therefore conclude that under Ohio conflicts law as applied to the circumstances of these cases, the substantive law of Ohio was properly applied to those parties over whom the district court had jurisdiction.
One final choice of law problem, however, remains. When a defendant transfers a case to another district under 28 U.S.C. § 1404, the Erie doctrine requires that the court apply the choice of law rules of the transferor state. Van Dusen v. Barrack, 376 U.S. 612, 637-39, 84 S. Ct. 805, 819-21, 11 L. Ed. 2d 945 (1964). The holding of Van Dusen is that when a plaintiff files suit in a federal court with proper venue, and the defendant transfers it to a new federal court for convenience, the transferor state's law (including its conflicts law) applies. The Supreme Court noted that section 1404(a) was not designed to defeat the plaintiff's right to obtain the state law advantages that might accrue from the exercise of the venue privilege. Id. at 635, 84 S. Ct. at 818-19. "A change of venue under Sec. 1404(a) generally should be, with respect to state law, but a change in courtrooms." Id. at 639, 84 S. Ct. at 820-21 (footnote omitted). The Court expressly reserved the question whether section 1404(a) would require the application of the law of the transferor state when the plaintiff, rather than the defendant, seeks transfer under that statute. That is the situation here for the plaintiffs who voluntarily transferred their cases to the Southern District of Ohio after they had been originally filed in federal courts in other states.
Martin v. Stokes, 623 F.2d 469, 473 (6th Cir. 1980). No true conflict exists, however, where another state's choice of law rules would have applied the substantive law of Ohio to this case.
Of all the issues on appeal, the validity of the trifurcation ruling has been most troubling to us. We reiterate that the standard of review is abuse of discretion. " [T]he district court ha [s] broad discretion to order separate trials; the exercise of that discretion will be set aside only if clearly abused." United States v. 1071.08 Acres of Land, 564 F.2d 1350, 1352 (9th Cir. 1977). See also Parmer v. National Cash Register Co., 503 F.2d 275, 277 (6th Cir. 1974) (per curiam). "The decision whether to try issues separately is within the sound discretion of the court.... Abuse of discretion exists only where there is 'definite and firm conviction that the court below committed a clear error of judgment in the conclusion it reached upon a weighing of the relevant factors.' " Yung v. Raymark Industries, 789 F.2d 397, 400 (6th Cir. 1986) (citation omitted).
The standards for separating issues is set forth in the language of Fed. R. Civ. P. 42(b):
Id. at 279 (footnotes omitted). Neither Rule 42(b) nor the textual elaboration cited gives any precise guidelines for the trial judge in considering the propriety of ordering separate trials, probably because of the wide variety of circumstances in which it might come into play. Consequently, courts have adopted a case-by-case approach. "Essentially, the question is one that seems to depend on the facts of each case, a matter to be determined by the trial judge exercising a sound discretion." Southern Ry. Co. v. Tennessee Valley Authority, 294 F.2d 491, 494 (5th Cir. 1961). "In deciding whether one trial or separate trials will best serve the convenience of the parties and the court, avoid prejudice, and minimize expense and delay, the major consideration is directed toward the choice most likely to result in a just final disposition of the litigation." In re Innotron Diagnostics, 800 F.2d 1077, 1084 (Fed. Cir. 1986) (citation omitted). Courts, including our own, have measured trial court decisions to try issues separately by whether fairness was advanced in the particular case:
We add the caveat expressed in Frasier v. Twentieth Century-Fox Film Corp., 119 F. Supp. 495, 497 (D. Neb. 1954) that separation of issues "should be resorted to only in the exercise of informed discretion and in case and at a juncture which move the court to conclude that such action will really further convenience or avoid prejudice" and observe further that " [a] paramount consideration at all times in the administration of justice is a fair and impartial trial to all litigants. Considerations of economy of time, money and convenience of witnesses must yield thereto." Baker v. Waterman S.S. Corp. 11 F.R.D. 440, 441 (S.D.N.Y. 1951).
Moss v. Associated Transport Inc., 344 F.2d 23, 26 (6th Cir. 1965).
In our case this same test applies to whether the decision is to try only one or more than one issue separately. Our opinion in In re Beverly Hills Five Litigation, 695 F.2d 207 (6th Cir. 1982), approving trifurcation on the causation question, did not indicate any different standard of review than that applicable to bifurcation nor has our research led us to authority suggesting such a distinction. While few cases appear to have been trifurcated on the issue of causation,12 there are nonetheless numerous cases that have tried an individual issue separately under circumstances that, had the issue been decided in favor of the plaintiff, the trial would have had more than two phases to it.13 In affirming a trial solely on the issue of the defense of statute of limitations, Yung v. Raymark, 789 F.2d at 400, we quoted Wright & Miller and held that "Rule 42(b) is sweeping in its terms and allows the court, in its discretion, to grant a separate trial of any kind of issue in any kind of case." C. Wright, A. Miller & F. Elliott, supra, Sec. 2389 at 284. It follows, therefore, that a decision to try an issue separately will be affirmed unless the potential for prejudice to the parties is such as to clearly demonstrate an abuse of discretion. Beverly Hills, 695 F.2d at 216.
Fundamental to plaintiffs' challenge of the trifurcation decision is their argument that the causation question in this case was not an issue which could be tried separately. In support of their claim, plaintiffs rely heavily on Gasoline Products Co. v. Champlin Refining Co., 283 U.S. 494, 500, 51 S. Ct. 513, 515, 75 L. Ed. 1188 (1931). There, the Court held that " [w]here the practice permits a partial new trial, it may not properly be resorted to unless it clearly appears that the issue to be retried is so distinct and separable from the others that a trial of it alone may be had without injustice." The Court noted that the issue in that case could not be submitted independently of the others without creating jury confusion and uncertainty that would "amount to a denial of a fair trial." Id. Many courts consider the issue's ability to be tried separately, and without injustice, to be the standard for determining whether the Seventh Amendment has been violated by conducting a trial only on that one issue. Thus, they apply the Gasoline Products standard to initial determinations whether a district judge properly ordered a separate trial in the first instance. Franchi Construction Co. v. Combined Insurance Co. of America, 580 F.2d 1, 7 (1st Cir. 1978). While Beverly Hills did not cite Gasoline Products, our court in Helminski v. Ayerst Laboratories, 766 F.2d 208, 212 (6th Cir. 1985), cited Gasoline Products as the standard for determining whether the issues of liability and damages in that case were sufficiently separable to justify a separate trial. See also In re Innotron Diagnostics, 800 F.2d at 1086 (separate jury trials appropriate where issues to be tried are "distinct and separable"). We affirm the appropriateness of the Gasoline Products standard to the context of Rule 42(b).
Under this standard, many courts have upheld cases bifurcated between liability and damages because the evidence pertinent to the two issues is wholly unrelated, and as a logical matter, liability must be resolved before the question of damages. See C. Wright, A. Miller & F. Elliott, supra, Sec. 2390 at 296-97. By the same token, courts have refused to permit even bifurcation of liability and damages where these issues could not be tried separately. In C.W. Regan, Inc. v. Parsons, 411 F.2d 1379, 1388 (4th Cir. 1969), the court disapproved bifurcation because under the law of Virginia, liability and damages could not be divided when the separate and unconnected actions of several people may have produced the total damage.
In re Richardson-Merrell, Inc. Bendectin Products, 624 F. Supp. 1212, 1263 app. D (S.D. Ohio 1985) (footnotes omitted).
In arguing that Judge Rubin's instructions were erroneous and that the substantial factor test should have been applied to the causation issue, plaintiffs cite various cases which they assert support the use of the test by Ohio courts, such as Cascone v. Herb Kay Co., 6 Ohio St.3d 155, 451 N.E.2d 815 (1983). However, Cascone does not address the "but for" versus "substantial contributing factor" issue, but the quite different question whether an initial actor should be held liable for injuries caused by an intervening or superseding actor. The court there held that the initial actor could still be held liable if his conduct remained a substantial contributing factor to the injury. In this context, that is all "substantial contributing legal cause" refers to. Thropp v. Bache Halsey Stuart Shields, Inc., 650 F.2d 817, 821 (6th Cir. 1981). Under Cascone, even where there is an intervening actor, however, the first step of the proximate cause analysis is whether the original tortfeasor's negligence was an actual cause or a "cause in fact" of the injury. Id. at 821. Plaintiffs also cite Utzinger v. United States, 432 F.2d 485 (6th Cir. 1970), but again that case states the rule for an intervening agent. Cf. Hupp v. United States, 563 F. Supp. 25, 30 (S.D. Ohio 1982). To this we must add the observation that the plaintiffs never argued that Merrell Dow was an initial tortfeasor whose drug Bendectin caused birth defects because of the act of any intervening third party. The plaintiffs affirmatively alleged in their complaint and argued at trial that the drug itself was a direct cause of birth defects without the interference of any third party. Insofar as we can ascertain, the district judge's denial of plaintiffs' proposed instruction would have been proper under the law of any state.
Plaintiffs also raise the argument that if causation had been tried simultaneously with their claims for breach of warranty and failure to warn, they would have had to prove merely that Bendectin increased the risk of birth defects, and not that it was a "but for" cause of them. They cite Tinnerholm v. Parke Davis & Co., 285 F. Supp. 432 (S.D.N.Y. 1968), aff'd, 411 F.2d 48 (2d Cir. 1969), in support of this position. However, Tinnerholm is distinguishable. There, a child received a vaccine which contained four antigens, one of which was whooping cough. He subsequently suffered a degenerative disease. At a bench trial the judge found with reasonable medical certainty that the whooping cough vaccine was a cause in fact of this degenerative disease. But to find liability under the breach of warranty, it was not sufficient that the degenerative disease could be caused by the vaccine. Rather, an implied warranty breach could occur only because by manufacturing the vaccine as it did, defendant increased the chances of contracting the disease. In short, the increased risk standard came into play only after it had been determined that the vaccine could have caused the disease. Similarly, plaintiffs here could not prevail on a breach of warranty claim absent proof that Bendectin could in fact have caused their birth defects. Even if defendant failed to warn potential users that Bendectin caused birth defects, such failure to warn would be inconsequential if Bendectin could not have in fact caused birth defects:
At oral argument on appeal, counsel raised yet another argument: that the trifurcation order prevented the plaintiffs from showing alternate causation. Under alternate causation, the burden would have shifted to the defendant to prove that its negligence was not a proximate cause of the birth defects. If this argument applies, the district judge would have been bound to instruct the jury that defendant had the burden of proof, since a federal court in a diversity case must apply the state court's burden of proof rules. Palmer v. Hoffman, 318 U.S. 109, 117, 63 S. Ct. 477, 482, 87 L. Ed. 645 (1943). According to the plaintiffs' complaints, however, not only would plaintiffs not have been entitled to an alternate liability instruction with the shifted burden of proof in a trifurcated trial; they would not have been entitled to such an instruction even at a unitary trial. The doctrine of alternate liability simply does not apply to the facts alleged here. Cases that apply this doctrine, such as Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 163 Cal. Rptr. 132 (1980), and Summers v. Tice, 33 Cal. 2d 80, 199 P.2d 1 (1948), do so only when two or more defendants have been at fault, and one and only one caused the injury. Rather than dismissing for plaintiff's inability to show causation by a preponderance of evidence against any individual plaintiff, courts in this situation shift the burden of proof to the defendant to prove that he was not the negligent actor that caused the injury. This is codified in section 433B(3) of the Restatement:
Plaintiffs raise an additional argument for shifting the burden of proof to defendant regarding proximate cause. They claim that proof of a violation of the FDCA would give rise to negligence per se under Toole v. Richardson-Merrell, 251 Cal. App. 2d 689, 60 Cal. Rptr. 398 (1967), and shift the burden to defendant to prove that Bendectin did not cause their injuries. Without trifurcation, they allege that some plaintiffs could have demonstrated negligence per se which would have enabled them to rely on a rebuttable presumption of causation based upon the violation of a statute designed to protect their safety. A cited example in support of this negligence per se argument is Haft v. Lone Palm Hotel, 3 Cal. 3d 756, 91 Cal. Rptr. 745, 478 P.2d 465 (1970), in which a father and son drowned in a motel swimming pool, cause unknown. Contrary to the requirements of a California statute, the motel owner had failed either to place a lifeguard on duty at the pool, or post a sign indicating that no lifeguard was on duty. The court allowed plaintiffs to sustain their initial burden of proof on the issue of causation by proving that the violation of the statutory lifeguard requirement had occurred. Then, the burden shifted to the defendant to show that its violation did not proximately cause the death. Since defendant had been negligent by violating the statute, and since the failure to provide a lifeguard greatly increased the chances that the drownings would occur, and since the facts suggested that a competent lifeguard would have prevented the deaths, the plaintiffs according to the court, had done all that they could to prove the requisite causal connection between the negligence and the accidents. When there exists a substantial probability that a defendant's negligence caused an accident, and "when the defendant's negligence makes it impossible, as a practical matter, for plaintiff to prove 'proximate causation' conclusively, it is more appropriate to hold the defendant liable than to deny an innocent plaintiff recovery, unless the defendant can prove that his negligence was not a cause of the injury." Id., 91 Cal. Rptr. at 756 n. 19, 478 P.2d at 476 n. 19.
An additional issue that arises in considering the negligence per se argument, but which we do not address here, concerns whether Congress intended the FDCA to be used as a behaviorial standard in such cases. It is clear that whether a state chooses to recognize violations of its own statutes as negligence per se is purely a question of state law. Therefore, states like Ohio are perfectly free to apply the negligence per se doctrine to violations of its own pure food and drug law, Ohio Revised Code sections 3715.52 and 3715.64. Taugher v. Ling, 127 Ohio St. 142, 187 N.E. 19 (1933); Portage Markets Co. v. George, 111 Ohio St. 775, 146 N.E. 283 (1924); Schell v. Du Bois, 94 Ohio St. 93, 113 N.E. 664 (1916). However, the determination that a violation of a federal statute such as the FDCA will create state tort liability is not a matter solely of state law. A state's ability to use a federal statute violation as a basis for state tort liability and negligence per se depends on the intent of Congress, and not merely on the intent of the state. See W. Prosser and R. Keeton, supra, Sec. 36 at 220-21. Thus, the congressional decision not to provide a private cause of action under the FDCA becomes quite important in considering the propriety of a state negligence per se action for violation of the FDCA. "It may be that a decision by Congress not to create a private remedy is intended to preclude all private enforcement. If that is so, then a state cause of action that makes relief available to private individuals for violations of the FDCA is pre-empted." Merrell Dow v. Thompson, 106 S. Ct. at 3245 (Brennan, J., dissenting). The majority in that case also recognized that preemption might be a potential problem. Id. at 3236-37 (majority opinion). We recognize that a mere congressional intent to preclude a private right of action at the federal level for violations of the FDCA would not necessarily indicate that Congress intended to preclude a state remedy under a theory of negligence per se. We only observe that preemption could be yet another obstacle to plaintiffs' reliance on a theory of negligence per se.
Section 433B has its roots in Judge Learned Hand's opinion in Zinnel v. United States Shipping Board Emergency Fleet Corp., 10 F.2d 47, 49 (2d Cir. 1925). That case involved the death by drowning of a seaman. The owner of the ship did not provide ropes in the ship that might have been used to rescue drowning sailors. The circumstances of death were such that the plaintiff could not prove that had the defendant provided the rope the decedent would have survived. Although the plaintiff could not prove "but for" causation of the injury by the defendant's negligence, Judge Hand allowed recovery because the jury could rely on its common experience that had the rope been provided the result would have been more likely than not that the sailor would not have drowned.
Finally, plaintiffs argue that Judge Rubin failed to consider the caveats of Rule 42(b) in his trifurcation decision, and instead justified trifurcation only upon unsubstantiated claims of judicial efficiency, thus unduly prejudicing plaintiffs' case without good reason. We believe, however, that the district judge carefully made the necessary inquiry. In his final order the trial judge noted that Bendectin litigation could "substantially immobiliz [e] the entire Federal Judiciary. There have been only four cases involving Bendectin which have been individually tried. They required an average of 38 trial days." In re Bendectin, 624 F. Supp. at 1221. Judge Rubin calculated that if all 1100 cases were tried at that average length on an individual basis, they would be able to keep 182 judges occupied for one year. Id. at n. 6. Contrary to the plaintiffs' claims that Judge Rubin never considered the language of Rule 42(b), he did correctly require plaintiffs to prove that the defendant's drug caused their injury, and would not allow plaintiffs to buttress a weak causation case with a strong negligence case. Thus, in line with the language of Rule 42(b), the trial judge considered the causation question to be a separate issue.
In reviewing the district court's decision to trifurcate we further note Rule 42 which "giv [es] the court virtually unlimited freedom to try the issues in whatever way trial convenience requires." C.Wright, A.Miller & F. Elliott, supra, Sec. 2387 at 278. Thus, a court may try an issue separately if "in the exercise of reasonable discretion [it] thinks that course would save trial time or effort or make the trial of other issues unnecessary." Richmond v. Weiner, 353 F.2d 41, 44 (9th Cir. 1965). In this case, the district judge considered the time savings in trying this case in this fashion, and surmised that if the plaintiffs won on this issue, another eight weeks of trial would be necessary to resolve the other questions.
Many courts have in fact permitted separate issue trials when the issue first tried would be dispositive of the litigation. The courts do so because the efficiency of the trial proceedings is greatly enhanced when a small part of the case can be tried separately and resolve the case completely. For example, in Yung v. Raymark, 789 F.2d at 401, we recently approved the separate trial of the issue of statute of limitations because if that issue were resolved to bar recovery, the court would be spared the necessity of trying liability and damages. "Whether resolution of a single issue would likely dispose of an entire claim is extremely relevant in determining the usefulness of a separate trial on the issue.... This procedure should be encouraged because court time and litigation expenses are minimized." Id. (citation omitted). The defendant relies heavily on language like this. As the defense correctly observed: " [T]he plaintiffs can never win a case if they can't prove the drug caused the problem. That is the central issue in this case." And later, " [a]ll claims depended upon the answer to a single question. Does Bendectin, taken in therapeutic doses cause birth defects?" Plainly, Judge Rubin had a massive case management problem to resolve, and chose to do so by trying the case on a separate issue that would be dispositive.
Plaintiffs were similarly afforded broad latitude in their efforts to prove that various other studies by the defendant were false. Much of plaintiffs' efforts in this regard were focussed on discrediting the Bunde-Bowles study. For example, Dr. Done testified that Bunde-Bowles was "a poorly designed study, and one really destined not to be likely to provide very useful information." He indicated that the numbers in the Bunde-Bowles samples were too small, that the controls were not matched for age or for other drugs, and that the study suffered from poor record keeping. Dr. Done also testified that the Bunde-Bowles data were suspect because the test found fewer malformations in the treated group which might suggest a protective effect for the drug, while there was no reason that a pharmacist would expect this to happen. He further testified that patients who were supposed to have used Bendectin, i.e., the experimental group, may not have in fact ingested it because there was nothing to record that they had ever been administered the drug. He testified that from looking at the original patient records, he could not be sure whether the patients alleged to have taken Bendectin actually did. Moreover, some patients were included as both Bendectin takers and controls. " [T]here were enough of them to make the entire contribution from that particular practice to this study have [sic] to be very seriously questioned." Dr. Done stated that if someone were to eliminate what he thought were the suspect data in Bunde-Bowles, instead of producing a 50% greater relative risk for birth defects among the control group than among Bendectin users, there would be rather a 30% higher risk for those who had taken Bendectin. Dr. Done further testified that the Bunde-Bowles study may not have used a normal population group and that this might have been particularly a problem if the control group was not similar in its preselection criteria. He highlighted the fact that many of the survey participants had come from one doctor's practice. Finally, he said " [t]hat from the scientific standpoint, the [Bunde-Bowles] study is totally worthless." Dr. Swan also criticized the study. She said that the study was incapable of detecting a relative risk for limb reductions that was smaller than sixfold. She also criticized the sample size in the Bunde-Bowles study. Defendant, of course, vigorously contested these assertions.
Judge Rubin specifically told the plaintiffs that, " [i]f a witness has relied upon a study and it is demonstrably inaccurate, false, you are entitled to develop that in cross-examination." Thus the plaintiffs not only attacked Bunde-Bowles in direct examination of their own witnesses, but they also attacked Bunde-Bowles when cross-examining the defendant's witnesses. For example, plaintiffs' attorney Skinner cross-examined defendant's witness Dr. McClain about the Bunde article. The plaintiffs also criticized Bunde-Bowles in their closing arguments. For example, one of plaintiffs' attorneys, Mr. Eaton, admitted that plaintiffs had been able to criticize the Bunde-Bowles study:
One evidentiary challenge that the plaintiffs raise concerns the defendant's ability to argue that it has complied with all FDA statutory and regulatory requirements, while the plaintiffs were precluded from introducing evidence tending to show that the defendant deceived the FDA regarding the validity of their test results. Despite plaintiffs' allegations, however, FDA approval of Bendectin was not allowed to be admitted. The trial judge indicated this was to benefit plaintiffs, because they did not have to make an additional argument that the tests that the FDA relied on were inadequate. Nonetheless, defense attorney Woodside did say in his opening argument, "Now, it's important to understand that Merrell followed the rules completely as it pertains to the submission of the MDA and submission of data to the Food and Drug Administration." In fact, that issue had already been injected by plaintiffs' attorney Eaton when he mentioned that the FDA had not effectively monitored the testing of this drug. Eaton also asserted that the FDA would not have approved it had they known the facts of the testing. However, at trial, Judge Rubin scrupulously indicated that he would not allow either side to address the issue of FDA approval. For example, when defendant's witness Newberne, unprompted by the defense attorney, referred to the FDA a few times, the district judge twice told the defendant's attorney, " [t]ell your witness not to refer to the Food and Drug Administration." The plaintiffs also challenged introduction of testimony by defense witness Goddard, a former FDA commissioner, because this would allegedly imply that he and the FDA had approved the safety of the drug. The judge, however, drew a distinction, and said he would not allow testimony regarding FDA approval or lack of approval. He told the defense attorney to let him know if FDA compliance would come up in the testimony. However, the plaintiffs asked this witness about the FDA anyway. They introduced his appointment book as FDA commissioner, and then the judge indicated that they had opened the FDA door:
The objections of the plaintiffs and the trial court's response to them are set forth in detail in its published opinion denying plaintiffs' motions for judgment NOV and for new trial. In Re Richardson-Merrell, Inc. Bendectin Products, 624 F. Supp. 1212, 1236-37 (S.D. Ohio 1985). The record demonstrates that the trial court administered its Fed.R.Evid. 403 ruling evenhandedly. For example, Judge Rubin instructed the jury to disregard the question and answer when defendant's counsel Woodside questioned Dr. McMahon about an analogous drug (referring to Thalidomide), even though no reference had been made to that drug. Early in the trial the judge showed some willingness to permit reference to Thalidomide by plaintiffs' attorneys who told him that an article that the defendant wanted to introduce said that Thalidomide was not a teratogen. The judge indicated he would allow this reference, but that he would not allow Merrell Dow to be tied to Thalidomide since it had not manufactured it (it had, however, researched and tested it). The judge then learned that the article did not actually say that Thalidomide was not a teratogen, however, and he thereupon refused to allow the plaintiffs to refer to Thalidomide in that context. Moreover, Judge Rubin allowed references to the defendant's studies' inability to detect that Thalidomide was a teratogen, although he would not allow reference to Thalidomide by name. For example, Dr. Newman testified for the plaintiffs that some of the studies had failed to miss " [v]ery powerful substances, maybe the most powerful teratogen known to man." Dr. Melnick testified that one of the studies did not indicate that "the most devastating teratogen that we know" was missed by rat studies until the defects were found later in humans.
United States v. Zipkin, 729 F.2d 384, 390 (6th Cir. 1984), quoting United States v. Long, 574 F.2d 761, 767 (3d Cir. 1978). Under this standard of review, we uphold Judge Rubin's determination that references to Thalidomide would be extremely prejudicial. We do not believe that plaintiffs were hindered by prohibition of references to Thalidomide. The credentials of the plaintiffs' expert were presented to the jury in the same manner as the defendant's experts were.
In considering both parties' arguments we are also cognizent of a very similar case decided by our court, Helminski v. Ayerst Laboratories, 766 F.2d 208 (6th Cir. 1985). In Helminski, the minor plaintiff, who suffered arrested neurological development and was autistic, was called as a witness for five minutes. The defendant objected on the ground that the jury had already been graphically told about the plaintiff's condition, and the defendant argued that the plaintiff's presence in the courtroom would prejudice the jury. We recognized there that neither the Due Process Clause of the Fifth Amendment nor the Seventh Amendment's guarantee of a jury trial granted a civil litigant the absolute right to be present during the trial of his case. We did, however, hold that " [c]onsistent with due process, a plaintiff who can comprehend the proceedings and aid counsel may not be excluded from any portion of the proceedings absent disruptive behavior or a knowing and voluntary waiver. Thus, a plaintiff with a solely physical abnormality may not be excluded involuntarily, absent disruptive behavior, even when the abnormality is due allegedly to the defendant's wrongful conduct." Id. at 216-17. We noted that a hearing on the potential jury prejudice issue, in which the court observes the injured party, will best protect the litigant's right to be present, as well as the other side's right to a fair trial. At the hearing, the defendant who claims that a plaintiff's mere presence will prejudice the jury must bear the burden of persuasion on this issue. Id. at 217. We refused to permit a presumption that an injured party's mere presence will always deter the jury from deciding the case on the facts. Id. "The issue which the district court must resolve at the hearing is whether the party's presence would 'prevent or substantially impair' the jury from performing its duties 'in accordance with [its] instructions and [its] oath.' " Id. at 217 (citation omitted). The defendant must establish that the plaintiff's appearance or conduct is likely to prevent the jury from performing its duty. At the hearing, the plaintiff's ability to comprehend the proceedings or assist counsel is not the relevant inquiry. Id. at 218. If after the hearing, the district court determines the threshold inquiry, that a party's mere presence would be prejudicial, the court must next consider whether the party can assist counsel and understand the proceedings. If the court concludes that the party can so assist and comprehend, then the party may not be involuntarily excluded regardless of prejudicial impact. Id. at 218. In those cases, cautionary instructions can be read that would protect the interests of the defendant. If the party can aid counsel and comprehend the proceedings, due process requires that he be present. In Helminski, we decided that the injured minor party was improperly excluded from the courtroom because the district court never observed him to see whether his appearance or behavior would create prejudice. However, because it was evident the minor plaintiff had been unable to comprehend the proceedings or aid counsel, we did not reverse. Id. at 218-19.
More important, the verdict in this case was returned in March of 1985, and Helminski was not decided until the following June. Denial of plaintiffs' motion for judgment NOV or new trial did not occur until September 1985. Concerning retroactivity Chevron Oil Co. v. Huson, 404 U.S. 97, 106-07, 92 S. Ct. 349, 355-56, 30 L. Ed. 2d 296 (1971), has this to say:
First, the decision to be applied nonretroactively must establish a new principle of law, either by overruling clear past precedent on which litigants may have relied, or by deciding an issue of first impression whose resolution was not clearly foreshadowed. Second, it has been stressed that "we must ... weigh the merits and demerits in each case by looking to the prior history of the rule in question, its purpose and effect, and whether retrospective operation will further or retard its operation." Finally, we have weighed the inequity imposed by retroactive application, for " [w]here a decision of this Court could produce substantial inequitable results if applied retroactively, there is ample basis in our cases for avoiding the 'injustice or hardship' by a holding of nonretroactivity." (citations omitted).
In Chevron itself, the Court held that the decision whose retroactivity was at issue would not be applied retroactively because the case was one of first impression and it overruled a long line of decisions in that particular circuit. See id. at 107-08. In fact, the retroactivity analysis was applied to all aspects of that decision, even though the case was only in discovery at the time that the decision whose retroactivity to be analyzed was handed down. See id. at 99, 92 S. Ct. at 351-52.
We noted in Cochran v. Birkel, 651 F.2d 1219, 1223 n. 8 (6th Cir. 1981), that under Chevron the presumption is that a newly announced rule will apply retroactively and that the burden of persuasion is upon the party asserting prospective-only application. Applied here, the fact that a twenty-two day trial had already been concluded, and a jury verdict rendered, before the Helminski decision came down is certainly a factor to be considered in determining whether or not it would be equitable to apply Helminski retroactively. Pitts v. Frito-Lay, Inc., 700 F.2d 330, 334 (6th Cir. 1983). Further, the rule announced in Helminski, requiring a hearing to determine prejudice and permitting a plaintiff to attend despite that prejudice if he or she may assist or aid counsel, was not supported by any specific Sixth Circuit or Supreme Court cases. The cases relied upon were state cases from places such as New York and Florida. In short, Helminski was a case of first impression in this circuit, and the result was not clearly foreshadowed. Thus, we conclude that the burden of establishing the non-retroactivity of Helminski was met. There is no pre-Helminski law in this circuit that would prohibit the district court's decision.
Finally, we note that Helminski deals not with the cause of action at issue nor with the evidence to prove it but with the important but not controlling question of trial conduct. As such, it is here believed to be subject to the harmless error provision of Fed. R. Civ. P. 61. Helminski will, of course, be retroactive as to any pending cases which have yet to be tried or retried in this circuit.
Although I concur in the final result of the majority opinion with regard to the district court's trifurcation order, I do so reluctantly and with serious reservation. However, pursuant to the applicable standard of review, i.e., an abuse of discretion standard which favors the district court's ability and judgment to fairly and expeditiously handle its docket, and to case law within this circuit where such a procedure has previously been approved, i.e., In re Beverly Hills Fire Litigation, 695 F.2d 207 (6th Cir. 1982), I agree with the majority that, in this instance, the district court did not abuse its discretion in trifurcating the issues of causation, liability and damages. However, I do express my concerns about the fairness of this mechanism as a tool for handling complex cases such as this. In so doing, I do not re-analyze all of the relevant factors to which courts look in making their decisions as to trifurcation; Chief Judge Engel has quite thoroughly analyzed those factors. See supra pp. 306-320. Instead, I point out potential problems and prejudices that can arise by the use of this procedure.
While, on the whole, Judge Rubin conducted the potentially mammoth proceedings at issue with great caution, I find that his decision to exclude certain plaintiffs from the courtroom, without first conducting a hearing, was clearly erroneous. By relying upon representations made by the defendant's attorneys, the district court excluded all plaintiffs under ten years of age and certain plaintiffs over ten, i.e., those with noticeable deformities, from the courtroom during the jury trial on causation. To make such a decision without first observing or speaking to those plaintiffs is certainly a violation of the principles of due process. Although, as recognized by the majority in this case and this court in Helminski v. Ayerst Laboratories, 766 F.2d 208, 213 (6th Cir. 1985), a civil litigant does not have an "absolute right to be present personally during the trial of his [or her] case," a decision to exclude a plaintiff from the trial of his or her action must be consistent with due process principles. Id. at 216. To be consistent with due process, such a decision must be an informed one. This is necessary to ensure that an excluded party receives a fundamentally fair trial. In meeting this requirement, a district court must take that extra step and conduct a hearing, thereby allowing such plaintiffs to be seen and heard. Such a procedure prevents any arbitrary exclusion of a party from the courtroom. In this case, the lower court did not follow such procedures, but instead relied upon representations of the defendant's attorneys. I simply cannot sanction such an action.
Because I disagree with the majority's finding that no case law existed within this circuit or the Supreme Court, prior to Helminski, which would have placed the district court on notice as to its duties vis-a-vis the exclusion of plaintiffs from the courtroom, thereby precluding the application of Helminski to this case because of the applicable Chevron [Chevron Oil Co. v. Huson, 404 U.S. 97, 92 S. Ct. 349, 30 L. Ed. 2d 296 (1971) ] rules on retroactivity, I respectively offer my dissent.
No language in Helminski is indicative of the fact that this decision is one of first impression within this circuit. Rather, the opinion draws from a variety of Supreme Court and circuit courts of appeals' due process opinions in holding, ultimately, that a hearing is necessary prior to the time a party may be excluded from the courtroom. Indeed, the court cites to a prior Sixth Circuit opinion, Drayton v. Jiffee Chemical Corp., 591 F.2d 352 (6th Cir. 1978), for the proposition that:
Because, in my judgment the decision in Helminski was a continuation of this court and the Supreme Court's prior due process analyses, it should be applied retroactively to this case, thereby resulting in a finding that the lower court erred in arbitrarily excluding certain plaintiffs from the courtroom without the benefit of an opportunity to be heard and seen. As noted by the majority, the presumption is that a newly announced rule of law will apply retroactively and the burden of persuasion to demonstrate that such an application is unjust is on the party asserting prospective-only application. See Cochran v. Birkel, 651 F.2d 1219, 1223 n. 8 (6th Cir. 1981). Here, that burden has not been met. The lower court made no findings, with support, as to whether the plaintiffs' presence would prejudice the jurors or as to whether the excluded plaintiffs would have been able to comprehend the proceedings and aid their counsel in presenting their case. Such findings are requirements of due process. I find that the district court's error in this regard should allow those plaintiffs who were arbitrarily excluded from the courtroom during the trial of their action an opportunity to have another day--a fundamentally fair one--in court. Therefore, I respectfully dissent.
See, e.g., Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 106 S. Ct. 3229, 92 L. Ed. 2d 650 (1986); Richardson-Merrell, Inc. v. Koller, 472 U.S. 424, 105 S. Ct. 2757, 86 L. Ed. 2d 340 (1985); Watson v. Merrell Dow Pharmaceuticals, Inc., 769 F.2d 354 (6th Cir. 1985); Dowling v. Richardson-Merrell, Inc., 727 F.2d 608 (6th Cir. 1984); Mekdeci, by and through Mekdeci v. Merrell National Laboratories, 711 F.2d 1510 (11th Cir. 1983); Shelhamer v. Merrell Dow Pharmaceuticals, Inc., Civ.A. No. 87-0782 (W.D. Pa. 1987); Engel v. Merrell Dow Pharmaceuticals, Inc., No. Civ. 83-1189E (E.D.N.Y. 1987); Richardson v. Richardson-Merrell, Inc., 649 F. Supp. 799 (D.D.C. 1986); Lynch v. Merrell-National Laboratories, 646 F. Supp. 856 (D. Mass. 1986), aff'd, 830 F.2d 1190; Will v. Richardson-Merrell, Inc., 647 F. Supp. 544 (S.D. Ga. 1986); Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238 (D.D.C. 1986); Haddad v. Richardson-Merrell, Inc., 588 F. Supp. 1158 (N.D. Ohio 1984); Chambers v. Merrell Dow Pharmaceuticals, Inc., No. C-850888 (Hamilton County, Ohio, Court of Appeals, Dec. 24, 1986); Dralle by Dralle v. Ruder, 148 Ill.App.3d 961, 102 Ill.Dec. 621, 500 N.E.2d 514 (1986); Oxendine v. Merrell Dow Pharmaceuticals, Inc., 506 A.2d 1100 (D.C.1986); Albertson v. Richardson-Merrell, Inc., 441 So. 2d 1146 (Fla.Dist.Ct.App.1983)
See, e.g., McFeggan v. Merrell Dow Pharmaceuticals, Inc., No. 87 C 70 (N.D. Ill. 1987); Whelan v. Merrell Dow Pharmaceuticals, Inc., Civ.A. No. 83-3108 (D.D.C. 1987)
On appeal the Supreme Court assumed that the FDCA did not create a private right of action but carefully avoided any definitive ruling on that question. 106 S. Ct. at 3233
While the same logic would appear to apply to any cases brought by Delaware citizens in state court given Merrell Dow's status as a Delaware citizen due to its incorporation in that state, 28 U.S.C. § 1332(c), we are aware of no such cases brought before the district court and our attention has been called to none
See Marder v. G.D. Searle & Co., 630 F. Supp. 1087 (D. Md. 1986), aff'd sub. nom., Wheelahan v. G.D. Searle and Co., 814 F.2d 655 (4th Cir. 1987); Beverly Hills, 695 F.2d at 207
Beeck v. Aquaslide 'N' Dive, Corp., 562 F.2d 537 (8th Cir. 1977) (trial limited to whether defendant had manufactured the product); Rossano v. Blue Plate Foods, Inc., 314 F.2d 174, 176 (5th Cir. 1963) (separate trial on issue of agency in negligence case); Bowie v. Sorrell, 209 F.2d 49 (4th Cir. 1953) (separate trial on question of validity of release; tried before two juries)
See e.g., Wright, Causation in Tort Law, 73 Cal. L. Rev. 1735, 1772-74 (1985). In Stanton by Brooks v. Astra Pharmaceutical Products, Inc., 718 F.2d 553 (3d Cir. 1983), the court applied the negligence per se standard specically to a claim of violation of the FDCA. Although in that case the court permitted plaintiffs to rely on negligence per se for defendant's violation of the FDCA and then shifted the burden of proof to defendant, it was already resolved that the cardiac arrest that plaintiff suffered was in fact caused by the drug which defendant manufactured. The question was whether defendant was liable for plaintiff's injury for failing to provide the FDA with information on the drug after the agency had approved it. In this case, even if the doctors would have considered Merrell Dow's wrongful withholding of information from the FDA to be sufficient to stop them from prescribing Bendectin, the fact that they continued to do so despite the statutory violation would be irrelevant if Bendectin does not in fact cause birth defects. The Fourth Circuit has also allowed negligence per se upon proof of a violation of the FDCA, even though it admitted that there was no express private civil remedy. Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 460-61 (4th Cir. 1960)
Merrell Dow argues that the real plaintiffs in this case are the parents and that therefore no plaintiff, i.e. parent, has standing to raise the exclusion of the children. This argument is without merit. Plaintiffs generally must assert their own legal rights and interests and cannot base their claim to relief on legal rights or interests of third parties. See Warth v. Seldin, 422 U.S. 490, 499, 95 S. Ct. 2197, 2205, 45 L. Ed. 2d 343 (1975). Where, however, "as a result of the very litigation in question, the constitutional rights of one not a party would be impaired, and where he has no effective way to preserve them himself, the Court may consider those rights as before it." United States v. Raines, 362 U.S. 17, 22, 80 S. Ct. 519, 523, 4 L. Ed. 2d 524 (1960). Thus, the only way for the rights of these plaintiffs to be protected, assuming that they have been violated, is for the parents to be able to raise their children's due process rights. Additionally, "the minor is the real party in interest in a suit brought by a next friend." Helminski v. Ayerst Laboratories, 766 F.2d 208, 213 (6th Cir. 1985)