McCracken v. Eli Lilly & Co., 1-1184A272

Decision Date08 July 1986
Docket NumberNo. 1-1184A272,1-1184A272
Citation494 N.E.2d 1289
PartiesThomas McCRACKEN, Administrator of the Estate of Annie McCracken, Deceased, et al., Appellant, Plaintiff Below, v. ELI LILLY & COMPANY, An Indiana Corporation, et al., Appellee, Defendants Below, And Other Consolidated Cases.
CourtIndiana Appellate Court

James E. Rocap, Jr., Thomas P. Ledgerwood, Rocap, Reese, Dowling & Heath, Indianapolis, Robert M. Gholston, Franklin, for appellant, plaintiff below.

Stephen W. Terry, Jr., Thomas G. Stayton, George M. Plews, Baker & Daniels, Indianapolis, Stephen L. Huddleston, Huddleston & Combs, Franklin, for appellee, defendants below.

ROBERTSON, Presiding Judge.

This appeal arises from a trial court ruling which, in substance, held that the cases of the plaintiff-appellants should be dismissed pursuant to the Indiana Rules of Trial Procedure 4.4(C) in that the United Kingdom is the more convenient forum. Nine cases are consolidated here and the 205 plaintiffs claim damages from personal injuries resulting from the ingestion of a drug known as Opren. Thirteen other plaintiffs are administrators, representing decedents who have wrongful death claims. In each instance, the plaintiffs and the decedents are subjects and residents of the United Kingdom. The defendants are Eli Lilly & Company, an Indiana Corporation; Harvey Barnett, a Hamilton County, Indiana, resident and United States citizen; and W. Ian H. Shedden, a subject and resident of the United Kingdom. Three other corporate defendants are shown to be United Kingdom corporations: Lilly Industries Limited, Lilly Research Centre Limited, and Dista Products Limited.

We affirm.

In ruling on the motion to dismiss, the trial court entered its opinion and order. Among other things, the trial court found that the Johnson Circuit Court was a forum non conveniens for the reasons that it was inconvenient; that the trial court would be required to apply the law of the United Kingdom; and that the plaintiffs have an adequate and proper remedy in the United Kingdom. Additionally, the trial court imposed the following conditions upon the defendant-appellees:

(a) to consent to suit in any action timely filed by the United Kingdom claimants in the United Kingdom;

(b) to waive any statute of limitations defense against the present Plaintiffs under United Kingdom law that may have arisen after these claims were filed in Indiana; and,

[sic]

(3) to comply in the United Kingdom at their own expense, with all discovery obligations in any actions instituted against them in the United Kingdom.

The issues are stated thus:

1. Whether the Court erred and abused its discretion in holding that the initiating Forum is so inconvenient to the Parties and Witnesses that under the Doctrine of Forum Non Conveniens the cause should be dismissed?

2. Whether the court erred and abused its discretion by holding that the Court would be required to apply the law of the United Kingdom at the trial and the more convenient forum would be the United Kingdom?

3. Whether the Court erred and abused its discretion in holding that the Courts of the United Kingdom provide an adequate and proper remedy in this cause of action?

4. Whether the conditions imposed upon the Defendants at the time the Court granted the Dismissal would be sufficient to permit the Plaintiffs substantial justice?

The trial court's ruling was based upon Indiana Rules of Trial Procedure, T.R. 4.4(C) which reads:

(C) More Convenient Forum. Jurisdiction under this rule is subject to the power of the court to order the litigation to be held elsewhere under such reasonable conditions as the court in its discretion may determine to be just

In the exercise of that discretion the court may appropriately consider such factors as:

(1) Amenability to personal jurisdiction in this state and in any alternative forum of the parties to the action;

(2) Convenience to the parties and witnesses of the trial in this state in any alternative forum;

(3) Differences in conflict of law rules applicable in this state and in the alternative forum; or

(4) Any other factors having substantial bearing upon the selection of a convenient, reasonable and fair place of trial.

A review of the facts before the trial court which militate in favor of the ruling show that Opren (chemically known as Benoxoprofen) is a prescription medication used in the United Kingdom to reduce inflammation in arthritis and similar diseases. Benoxoprofen was discovered and synthesized by Lilly Industries Limited (LIL) at facilities operated by Lilly Research Centre Limited (LRCL). LRCL is a wholly-owned subsidiary of LIL Dista Products Limited (Dista), another wholly-owned subsidiary of LIL, which marketed and sold all of the Opren consumed by the claimants. LIL funded and directed all of the basic research and holds the United Kingdom patents on Opren. All animal and human testing of Opren was done by LRCL in the United Kingdom.

Under the United Kingdom's New Medicines Act of 1968, a scheme requires a product license prior to marketing new drugs from a government agency named the Department of Health and Social Security (DHSS). In applying for a DHSS product license, information including proposed uses, dosages, clinical trial data, and side effects must be documented and submitted. A DHSS advisory committee of physicians, the Committee on Safety of Medicines (CSM), recommends a product license if the drug is found to be safe and effective. In March 1980, the DHSS issued a product license to LIL, and the manufacture of Opren commenced with about 192 million tablets eventually produced. As previously mentioned, all marketing and distribution of Opren in the United Kingdom was done by Dista.

The DHSS regulates the contents of the prescribing information sheet (data sheet) given to physicians in the United Kingdom. Information about the drug including proper dosages, contraindications, warnings and possible side effects is contained on the data sheet. Data sheets may not be changed without the permission of DHSS and providing information about a drug which is not in strict accordance with the data sheet is unlawful. The Adverse Reactions Subcommittee of the CSM monitors suspected adverse reactions to drugs. Most adverse reaction reporting is done by physicians who send "yellow cards" directly to the CSM with a description of the adverse reaction. CSM tabulates these cards and makes recommendations to the DHSS who, in turn, changes, when warranted, the data sheet or the product license. The original Opren data sheet, sent to all general practice physicians and rheumatic disease specialists in the United Kingdom, contained warnings about a number of possible side effects. LIL remained in touch with CSM about suspected adverse reactions with LIL, in October, 1981, seeking permission with DHSS to change the Opren data sheet to increase cautions and change dosages to elderly patients. Those changes were made in May, 1982, with the revised data sheet distributed as previously set forth. In August, 1982, the Opren product license was suspended by DHSS.

The relationship between Eli Lilly & Company, (Lilly) an Indiana corporation, and LIL is that LIL is related by a chain of ownership to Lilly. LIL has substantially different management from Lilly and functions independently without day-to-day direction, from Lilly.

ISSUE I

Our review of the trial court decision is limited to the question of whether the trial court abused its discretion. Drexel Burnhan Lambert v. Merchants Inv. Coun., (1983) Ind.App., 451 N.E.2d 346; Duncan v. Rogers, (1983) Ind.App., 444 N.E.2d 1255.

An abuse of discretion occurs only when the trial court reaches a conclusion against logic and the natural inferences to be drawn therefrom. Killearn Properties, Inc. v. Lambright, (1978) 176 Ind.App. 684, 377 N.E.2d 417. In reviewing discretionary motions, we shall affirm if there is any rational basis for the trial court's action.

Drexel, supra, 451 N.E.2d at 349.

Initially we note that we place reliance upon the holdings in four federal cases which bear a factual similarity to the case on appeal. Those cases are: In re Richardson-Merrell, Inc. (S.D.Ohio 1982), 545 F.Supp. 1130, aff'd. sub. nom. Dowling v. Richardson-Merrill, Inc. (6th Cir.1984) 727 F.2d 608; Harrison v. Wyeth Laboratories (E.D.Pa.1980) 510 F.Supp. 1, aff'd (3rd Cir.1982), 676 F.2d 685; and, Ledingham v. Parke-Davis Div. of Warner-Lambert Co. (E.D.N.Y.1986) 628 F.Supp. 1447. The language used in the federal cases displays a semantic difference in some degree from the language contained in T.R. 4.4. (C); however, there is a sufficient similarity in the spirit of the state and federal rules as they relate to the doctrine of forum non conveniens in the context of international litigation that we deem them to be appropriate authority in deciding this appeal.

Dowling, supra, citing Gulf Oil Co. v. Gilbert, 330 U.S. 501, 67 S.Ct. 839, 91 L.Ed. 1055 (1947); Koster v. Lumbermans Mutual Casualty 330 U.S. 518, 67 S.Ct. 828,...

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