In Re Bendectin Litigation.

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. Sec. 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.

On appeal, plaintiffs argue that the federal district court did not have jurisdiction over actions brought by Ohio plaintiffs, actions originally filed in state courts, or actions originally filed in the federal district courts in any of the fifty states and later transferred to the United States District Court for the Southern District of Ohio. Other issues raised on appeal concern various aspects of the trial, including certain evidentiary rulings and the district court's decision to create the Plaintiffs' Lead Counsel Committee, to prevent withdrawal from the common issues trial while permitting new transfers into the case, to apply Ohio law to all plaintiffs, to trifurcate on the causation question, and to exclude visibly deformed plaintiffs.

We direct the dismissal without prejudice of those thirteen actions brought by Ohio citizens in federal court in which Merrell Dow has conceded that no federal question jurisdiction was invoked and has further conceded that the district court was therefore without jurisdiction to render judgment on the merits against those plaintiffs.3 As to all other suits brought by Ohio citizens in federal courts and subject to this appeal, we hold that the district court did have federal question jurisdiction and thus the adverse jury verdict is binding on those plaintiffs. Finally, we do not disturb the district court's post-trial order remanding all cases brought by Ohio citizens in state courts back to the courts from which they were removed. In all other respects, we affirm.

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. Sec. 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. Sec. 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. Sec. 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.

The district court asked counsel to stipulate as to all common issues of liability that could be tried during the first phase of the trial. Defendant suggested a trial only on the issue of whether Bendectin was an unreasonably dangerous product imposing upon Merrell Dow a duty to warn about such dangers. It argued that substantive law differences among the various jurisdictions represented by plaintiffs prevented consolidation as to any other issue, regardless of whether the cases had been originally filed in Ohio or had been subsequently transferred there. The plaintiffs requested a trial of all common interrelated issues of law and fact, including whether Bendectin increased the risk of birth defects in the children of pregnant mothers who ingested the drug. They also indicated that the liability issues were inextricably interwoven and needed to be tried together with causation. Because the parties could not agree which issues should be tried during the first phase of trial, the court itself decided that the common issues to be tried beginning on June 11, 1984, would be whether: (1) taken as prescribed, Bendectin caused any of a list of birth defects; (2) Bendectin was unreasonably dangerous as defined by Ohio courts; and (3) Merrell Dow provided to the medical profession adequate warnings of the danger of the product. On April 12, 1984, the district court amended this order. Rather than bifurcating the trial on issues of liability and damages, the court instead decided to trifurcate the case, or bifurcate the liability question into liability and causation. Initially, a jury determination would be made on the causation question. If plaintiffs prevailed on the causation question, the jury would then consider the other liability questions. Conversely, if defendant received a favorable verdict on the causation issue, the trial would cease. Because the case would now be trifurcated rather than bifurcated, the district judge allowed any plaintiffs whose cases had been brought originally in courts outside Ohio to rescind their agreement to participate in the trial, provided that they notify the court of their decision by May 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 December 19, 1984, the district court then rescheduled the trial to begin in February, 1985 and ordered that it proceed in the same manner and with the same issues as had been indicated in the trifurcation order of April 1984. The district judge then said that while, as before, cases originally brought in Ohio would necessarily be part of the common issues trial, new cases originating in any other district and transferred under MDL 486 would have the option of electing to participate in the February 1985 trial, provided the plaintiffs did so by February 1, 1985. The court would not allow any plaintiff whose case had been filed in any state other than in Ohio and had been voluntarily consolidated in the common issues trial prior to the date of that order, December 19, 1984, to rescind the decision to participate.

The trifurcated trial commenced in February, 1985. Fearing undue prejudice to defendant, the trial judge, without actually viewing any plaintiffs, granted defendant's motion in limine to exclude all visibly deformed plaintiffs as well as all plaintiffs below the age of ten, whether or not they displayed birth defects. In another room in the courthouse, the court provided video arrangements to enable any excluded plaintiff to view the course of trial, as well as communications equipment so that plaintiffs could assist counsel. Further, the jurors and the deformed plaintiffs used different elevator banks so as to preclude the possibility of even accidental contact. Following trial, judgment was entered for defendant upon the jury's negative answer to the question whether plaintiffs had proven that ingestion of Bendectin proximately causes birth defects.

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. Sec. 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. Sec. 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. Sec. 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. Sec. 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. Sec. 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. Sec. 1331. Under 28 U.S.C. Sec. 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.

We modify the district court order insofar as we find that the district court did have federal question jurisdiction over those Ohio plaintiffs who filed their complaints in federal court. Thus, with the exception of those few cases noted infra, the Ohio plaintiffs who initially brought suit in federal court and went to trial on the issue of causation are bound by the jury's verdict. As to them, Merrell Dow is entitled to the entry of judgment on the merits in its favor. An exception exists for those thirteen cases filed by Ohio plaintiffs in federal court which are properly conceded by defendants not to allege any substantial federal question in their complaints. In all other respects, we affirm.

In explanation of the above holding, it is necessary first to consider whether the district court had jurisdiction over those Ohio citizens who filed their original actions in federal court. The crux of this inquiry necessarily turns on whether these plaintiffs alleged a substantial federal question in their complaints. Absent diversity there was, as noted earlier, no basis other than the allegation of a federal question for the trial court to exercise authority over these controversies.

Although more than 800 complaints were filed and consolidated in this appeal, many of the causes of action are identical among the complaints. In the typical complaint, the first cause of action sounds in negligence; the second cause of action is for breach of warranty; the third pleads strict liability; and the sixth alleges willful and wanton behavior. There is no question that these four causes of action are completely state created and do not support federal question jurisdiction. The fourth and fifth causes of action are the only two that could possibly be considered federal causes of action. Typical is the complaint in Basalyga v. Merrell Dow Pharmaceuticals, Inc., No. C-1-84-1497. That complaint alleges jurisdiction based on both federal question and diversity jurisdiction:

17. The Plaintiffs reallege and restate as if fully incorporated herein Paragraphs 1 through 16 and for their Fourth Cause of Action state as follows.

18. That the applicable Federal law covering the manufacturing and distributing of drugs during the time period in controversy was the Federal Food, Drug and Cosmetics [sic] Act passed by the 7th [sic] Congress on June 25, 1938, and cited as 52 Stat 1040, as amended.

19. That the purpose of 52 Stat 1040, among other purposes, was to prohibit the movement in Interstate Commerce of misbranded drugs.

20. That per Sec. 201(n) of 52 Stat 1040, the determination as to whether a drug is misbranded includes "not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences, which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary and usual."

21. That Defendant did not at any time during the time period in controversy, reveal or attempt to reveal any facts material to consequences which may result in the unborn offspring of mothers receiving the drug in question for indications relating to pregnancy.

22. That pursuant to Sec. 502(a) of 52 Stat 1040, a drug is deemed misbranded if its labeling is false or misleading in any particular.

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.

26. That violation of said Federal Statutes in the promotion of said drug, Bendectin, by the Defendant herein enumerated, constitutes a rebuttable presumption of negligence.

27. That the Defendant's violation of said Federal Statutes directly and proximately caused the injuries suffered by said Minor Plaintiffs and directly and proximately caused and will cause said Minor Plaintiffs to suffer considerable pain and suffering and to undergo continuous medical treatment, and the Adult Plaintiffs, as parents of the Minor Plaintiffs, were and will be caused to incur considerable medical and other expenses and to suffer anxiety and anguish, all to which the Adult Plaintiffs, as Next Friends and Guardians of the Minor Plaintiffs, have been damaged in the amount of Ten Million ($10,000,000.00) Dollars compensatory damages, and the Adult Plaintiffs Individually, have been damaged in the amount of Five Million ($5,000,000.00) Dollars compensatory damages.

28. The Plaintiffs reallege and restate as if fully incorporated herein Paragraphs 1 through 27 and for their Fifth Cause of Action state as follows.

29. The Defendant has made false and fraudulent representations of fact as to the safety, nontoxicity, and freedom from side effects of its product Bendectin and those representations were made under circumstances that the said Defendant knew or should have known that they were false, or alternatively, were represented to be true while said Defendant had no knowledge as to the truth thereof and the said Defendant stood to benefit financially by its misrepresentations, active and constructive. These representations were made in promotional literature, product inserts and by detailmen to prescribing physicians. By these representations the Defendant worked a fraud and deceit upon the consuming public, and more particularly, upon the Plaintiffs.

30. The Defendant deliberately pursued a policy of non-disclosure with regard to adverse reactions attributable to the product Bendectin, especially, but not limited to, a number of reporting physicians, each reporting that a number of mothers who used Bendectin during pregnancy gave birth to physically deformed babies. The said Defendant thereby deprived the medical community and the public and the Plaintiffs of significant facts which, if known, would have permitted an informed judgement [sic] of the drug in light of the grave risks attending its use.

31. 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.

32. That the acts and omissions of the Defendant, as aforementioned, directly and proximately caused the injuries suffered by said Minor Plaintiffs and directly and proximately caused and will cause said Minor Plaintiffs to suffer considerable pain and suffering and to undergo continuous medical treatment, and the Adult Plaintiffs, as parents of the Minor Plaintiffs, were and will be caused to incur considerable medical and other expenses and to suffer anxiety and anguish, all to which the Adult Plaintiffs, as Next Friends and Guardians of the Minor Plaintiffs, have been damaged in the amount of Ten Million ($10,000,000.00) Dollars compensatory damages, and the Adult Plaintiffs Individually, have been damaged in the amount of Five Million ($5,000,000.00) Dollars compensatory damages.

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. Sec. 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.

In summary, we have concluded that, with the exception of the thirteen cases previously noted, all Ohio plaintiffs who originally filed their actions in federal court intended to invoke federal question jurisdiction based, at least in part, on an implied cause of action under the FDCA. It is also evident that under existing case law a sufficient basis for section 1331 jurisdiction existed to make binding on those plaintiffs the adverse verdict which actually resulted.

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. Sec. 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).

In summary, the thirteen cases brought by Ohio plaintiffs in which it is conceded that no federal question was alleged are dismissed without prejudice; and the cases brought by Ohio plaintiffs in federal court must be considered on the merits since we hold that the district court did have federal question jurisdiction.

The Davis plaintiffs make the argument that they, too, are not bound by the district court judgment. Originally, these four plaintiffs brought suit in Arizona federal court. On February 1, 1984, these plaintiffs chose to participate in the joint trial in the Southern District of Ohio. On December 19, 1984, the district court, while allowing additional plaintiffs to opt in to the consolidated trials until February 1, 1985, ruled that previous decisions by out-of-state plaintiffs to participate in the common issues trial would be deemed binding. On January 25, 1985, these plaintiffs sought to opt out of the joint issues trial. The district court, consistent with its December 19 order, refused to allow plaintiffs to do so. Judgment was thus entered against them when the jury returned the verdict for defendant, despite their having indicated a desire to opt out. No doubt these parties would have fought to stay in had the jury finding been favorable to them.8

After the jury verdict, these defendants filed a motion to set aside the judgment because of their earlier expressed desire to opt out. The grounds for this motion were that the court could not enter judgment against them as a result of a trial that they had participated in without their consent. They argued that their decision to opt out was based on changes in the manner in which the court planned to try the common issues trial, including the exclusion of visibly deformed plaintiffs, trifurcation, prohibition of references to Thalidomide, and other issues of which they were not informed before the court's December 19 order making their previous election to participate binding. The district court denied this motion, in part because each of these plaintiffs had an opportunity to withdraw after the court changed its decision to trifurcate rather than bifurcate the case in May of 1984. The court also rejected plaintiffs' other arguments. These included some statements regarding the exclusion of plaintiffs that the court denied were ever made, and on the exclusion of references to Thalidomide. The plaintiffs could not have been ignorant of these matters when they made their decision to stay in the case after 1984. The district judge also noted that plaintiffs cited no legal authority to support their claim of entitlement to a second opportunity to opt out.

On appeal, these plaintiffs argue that had the court enabled them to opt out, the defendant would have suffered no prejudice. Therefore, it was an abuse of discretion for the district judge to refuse to allow them to opt out, especially since the court was willing to allow new plaintiffs to enter into the case after the opt-out date. Thus, the district judge would not know until after the opt-in process subsequently ceased, indeed until the trial itself, how many plaintiffs would be participating. The plaintiffs also argue that in the particular case of Davis, his alleged defect was dwarfism, which was not one of the specific defects the jury was to address if it found for plaintiffs on the first issue. This argument was raised for the first time in this appeal. It is in all events mooted by the jury's verdict that Bendectin did not cause any birth defects. Further, Davis continued to participate long after Judge Rubin indicated which specific defects the jury would decide Bendectin caused. Judge Rubin in fact provided these plaintiffs an opportunity to opt out of the trial after the trifurcation decision was made and held the option open for an additional eight months and until only a few months before the trial. Under such circumstances we cannot find that the district judge abused his discretion in denying this untimely motion.

The Davis plaintiffs also argue that the district judge could not apply Ohio law to them, because, since their complaints had been brought in Arizona federal court, only Arizona law could govern them. They maintain it would be impermissible to allow the court's procedural rule denying their opting out to cancel their substantive right to have the law of Arizona apply. Similarly, the Wood plaintiffs argue that the district court was required to apply the law of Texas to