Vaccariello v. Smith & Nephew Richards, Inc.

763 N.E.2d 160, 94 Ohio St. 3d 380

Opinions

Pfeifer, J.

On June 8, 1993, Mary Vaccariello, n.k.a. Mary Resha, had back surgery, which included the implantation of a medical device known as a “pedicle screw” into her spine.¹ Pain similar to that which had precipitated the surgery recurred. On October 29, 1993, Vaccariello became aware that the pedicle screw itself might be the source of her then current pain. On November 10, 1993, Vaccariello was examined by a different doctor, who stated his belief that the pedicle screw was the source of her back pain.

On December 15, 1995, Vaccariello filed suit against appellee Smith & Nephew Richards, Inc., and others, claiming that they had failed to warn her of the medical risks associated with the pedicle screw and the federal Food and Drug Administration (“FDA”) regulatory status of the pedicle screw. As one of its twenty-nine enumerated defenses to Vaecariello’s amended' complaint, Smith & Nephew Richards asserted that Vaccariello’s suit was barred by the statute of limitations.

The trial court determined that the statute of limitations began to run on October 29, 1993, more than two years before the date the suit was filed. See R.C. 2305.10. However, the trial court found that the statute of limitations was tolled “by the pendency of the class action certification in MDL 1014 (Eastern District of Pennsylvania), in which [Smith & Nephew Richards] also was named as a defendant, and in which [Vaccariello] was one of the potential class members.” The court relied on Beavercreek Local Schools v. Basic, Inc. (1991), 71 Ohio App.3d 669, 689, 595 N.E.2d 360, 373, and Am. Pipe & Constr. Co. v. Utah (1974), 414 U.S. 538, 554, 94 S.Ct. 756, 766, 38 L.Ed.2d 713, 727. The trial court determined that the statute of limitations was stayed from the time the motion for class certification in the putative class action was filed on April 4,1994, until it was denied on February 22, 1995. The trial court thereby denied the defendant’s initial motion for summary judgment.

The court of appeals reversed the lower court’s denial of that motion for summary judgment. It relied on Ohio Hosp. Assn. v. Armstrong World Industries, Inc. (Apr. 6, 2000), Cuyahoga App. No. 76067, unreported, 2000 WL 354742,² where the same court of appeals had determined that “cross-jurisdictional class action tolling of statutes of limitations is not recognized in Ohio.” Quoted in Vaccariello v. Smith & Nephew Richards, Inc. (Aug. 3, 2000), Cuyahoga App. No. 76594, unreported, 2000 WL 1060649, at *4. The cause is now before this court pursuant to the allowance of a discretionary appeal.

I

In Howard v. Allen (1972), 30 Ohio St.2d 130, 59 O.O.2d 148, 283 N.E.2d 167, syllabus, this court stated that “R.C. 2305.19, the Ohio saving clause, applies only to actions ‘commenced or attempted to be commenced’ in Ohio within the appropriate statute of limitations.” The court stressed that it was following the majority rule. Id. at 133, 59 O.O.2d at 150, 283 N.E.2d at 169. This court has not had occasion to revisit, or even cite, Hoioard in the intervening thirty or so years.

Much has changed since Howard was decided. Most notably, in American Pipe, the United States Supreme Court found that “the commencement of a class action suspends the applicable statute of limitations as to all asserted members of the class who would have been parties had the suit been permitted to continue as a class action.” (Footnoted omitted.) American Pipe, 414 U.S. at 554, 94 S.Ct. at 766, 38 L.Ed.2d at 727. Since then, “the majority of states which have considered the tolling doctrine [of American Pipe and its progeny] have accepted it.” (Footnote omitted.) Ian Gallacher, Representative Litigation in Maryland: The Past, Present, and Future of the Class Action Rule in State Court (1999), 58 Md.L.Rev. 1510, 1550.

In Crown, Cork & Seal Co., Inc. v. Parker (1983), 462 U.S. 345, 352, 103 S.Ct. 2392, 2397, 76 L.Ed.2d 628, 635, the court expanded the scope of American Pipe, reasoning that “a tolling rule for class actions is not inconsistent with the purposes served by statutes of limitations [which are] intended to put defendants on notice of adverse claims and to prevent plaintiffs from sleeping on their rights.” (Citations omitted.) The court also stated that blind application of statutes of limitations would frustrate “[t]he principal purposes of the class-action procedure — promotion of efficiency and economy of litigation.” Id. at 349, 103 S.Ct. at 2395, 76 L.Ed.2d at 633.

We note that the bulk of Ohio’s class action rule, Civ.R. 23(A) through (E), is identical to the bulk of the federal class action rule, Fed.R.Civ.P. 23(a) through (e). See Staff Note to Civ.R. 23. This congruity convinces us that a class action filed in federal court serves the same purpose as a class action filed in Ohio. See Schmidt v. Avco Corp. (1984), 15 Ohio St.3d 310, 314, 15 OBR 439, 442, 473 N.E.2d 822, 825 (court required “to focus on the efficiency and economy elements of the class action”). See, also, Warner v. Waste Mgt., Inc. (1988), 36 Ohio St.3d 91, 96, 521 N.E.2d 1091, 1096; Hamilton v. Ohio Sav. Bank (1998), 82 Ohio St.3d 67, 80, 694 N.E.2d 442, 454.

We conclude that it is more important to ensure efficiency and economy of litigation than to rigidly adhere to the rule of Howard. Whether a class action is filed in Ohio or the federal court system, the defendant is put on notice of the substance and nature of the claims against it. Therefore, allowing the filing of a class action in the federal court system to toll the statute of limitations in Ohio does not defeat the purpose of the statute.

Despite our heavy reliance on the language and reasoning of the United States Supreme Court, we reach our conclusion independently, without regard to the federal cases discussed as binding on this court. See Michigan v. Long (1983), 463 U.S. 1032, 103 S.Ct. 3469, 77 L.Ed.2d 1201.

We hold that the filing of a class action, whether in Ohio or the federal court system, tolls the statute of limitations as to all asserted members of the class who would have been parties had the suit been permitted to continue as a class action. We modify Howard to the extent that it conflicts with this holding.

In Portwood v. Ford Motor Co. (1998), 183 Ill.2d 459, 465, 233 Ill.Dec. 828, 830, 701 N.E.2d 1102, 1104, the Supreme Court of Illinois rejected cross-jurisdictional tolling “because plaintiffs from across the country may elect to file a subsequent suit in that state solely to take advantage of the generous tolling rule,” thereby burdening Illinois’ court system. We are not persuaded that this is a realistic potential problem.

Our holding today merely allows a plaintiff who could have filed suit in Ohio irrespective of the class action filed in federal court in Pennsylvania to rely on that class action to protect her rights in Ohio. To do otherwise would encourage all potential plaintiffs in Ohio who might be part of a class that is seeking certification in a federal class action to file suit individually in Ohio courts to preserve their Ohio claims should the class certification be 'denied. The resulting multiplicity of filings would defeat the purpose of class actions. Our holding does not invite plaintiffs who have no relationship to Ohio to file suit in our courts. Instead, only those plaintiffs who could have otherwise filed suit in Ohio will be able to file suit pursuant to the tolling rule we espouse today.

The federal class action in this case failed “otherwise than upon the merits.” R.C. 2305.19. Therefore, Vaccariello had one year from the date of the denial of the class certification, February 22, 1995, to file her suit in Ohio. Since she filed on December 15, 1995, her suit is not barred by the statute of limitations.

II

In the lower court, Smith & Nephew Richards filed two motions in limine to prevent Vaccariello from presenting testimony regarding Smith & Nephew Richards’ alleged failure to warn her about the medical risks associated with the pedicle screw and the FDA regulatory status of the pedicle screw. Smith & Nephew Richards contended that such testimony would be irrelevant and prejudicial because it was under no duty to warn Vaccariello.

The trial court granted the motions in limine, concluding that there was “no compelling reason to limit the application of the learned intermediary doctrine only to prescription drugs.” The court relied on Tracy v. Merrell Dow Pharmaceuticals, Inc. (1991), 58 Ohio St.3d 147, 149, 569 N.E.2d 875, 878. Based on this ruling, the trial court sustained Smith & Nephew Richards’ second motion for summary judgment. The court of appeals affirmed this determination of the trial court.

In Seley v. G.D. Searle & Co. (1981), 67 Ohio St.2d 192, 21 O.O.3d 121, 423 N.E.2d 831, paragraph one of the syllabus, this court stated:

“A manufacturer of an unavoidably unsafe ethical (prescription) drug is not strictly liable in tort to a consumer who has suffered injury as a result of ingesting that drug where the manufacturer has provided adequate warning to the medical profession of all potential adverse reactions inherent in the use of the drug of which the manufacturer, being held to the standards of an expert in the field, knew or should have known to exist at the time of marketing.”

Smith & Nephew Richards argues that the learned intermediary doctrine should be expanded to include prescription medical devices. For the reasons that follow, we agree.

The learned intermediary doctrine is codified at R.C. 2307.76(C). This codification does not thereby abrogate the common law. Carrel v. Allied Products Corp. (1997), 78 Ohio St.3d 284, 287, 677 N.E.2d 795, 798-799. In Carrel, we stated that “in the absence of language clearly showing the intention to supersede the common law, the existing common law is not affected by the statute, but continues in full force.” Id. at 287, 677 N.E.2d at 798. We further stated that “ ‘[t]here is no repeal of the common law by mere implication.’ ” Id. at 287, 677 N. E.2d at 798-799, quoting Frantz v. Maher (1957), 106 Ohio App. 465, 472, 7 O.O.2d 209, 213, 155 N.E.2d 471, 476.

After reviewing the relevant statutes, we conclude that it is possible to believe that the General Assembly may have intended to exclude prescription medical devices from the application of the learned intermediary doctrine. See R.C. 2307.71(D) and (E) (“ethical drug” and “ethical medical device” are defined separately). However, we also conclude that the Revised Code does not contain a clear statement that the learned intermediary doctrine, a creature of the common law, cannot apply to prescription medical devices.

We stated in Tracy that “[t]he rationale behind [the learned intermediary doctrine] is that the physician stands between the manufacturer and the patient as a learned intermediary. The physician has the duty to know the patient’s condition as well as the qualities and characteristics of the drugs or products to be prescribed for the patient’s use. The physician is in the best position, therefore, to balance the needs of patients against the risks and benefits of a particular drug or therapy, and then supervise its use. * * * The learned intermediary doctrine achieves a proper allocation of responsibility, since not all patients are alike and it is the physician who best knows the patient.” Tracy, 58 Ohio St.3d at 149, 569 N.E.2d at 878. This rationale applies equally to prescription medical devices. Accordingly, we hold that the learned intermediary doctrine applies to prescription medical devices.

“The learned intermediary doctrine does not relieve the manufacturer of liability to the ultimate user for an inadequate or misleading warning; it only provides that the warning reaches the ultimate user through the learned intermediary.” Id. at 149-150, 569 N.E.2d at 878. We defer to the trial court’s determination that “Dr. Rozen [the surgeon] was aware of the inherent medical risks and side effects of the [pedicle screw], and since the insert provided with each [pedicle screw] listed the possible adverse effects (including the pain complained of by [Vaccariello]), pursuant to the learned intermediary doctrine [Smith & Nephew Richards] discharged all duties to warn [Vaccariello].”

We also defer to the trial court’s determinations that “[Smith & Nephew Richards] provided FDA-approved information concerning the [pedicle screw’s] FDA regulatory status to Dr. Rozen” and that “[e]ach [pedicle screw/Rogozinski System] which Dr. Rozen implanted into [Vaccariello] was accompanied by a package insert whose language was reviewed and cleared by the FDA prior to distribution by [Smith & Nephew Richards].”

Accordingly, we affirm the court of appeals’ judgment upholding the trial court’s granting of Smith & Nephew Richards’ motions in limine. Because this issue is dispositive, we also affirm the court of appeals’ decision upholding the trial court’s granting of Smith & Nephew Richards’ second motion for summary judgment.

Judgment affirmed as modified.

F.E. Sweeney, J., concurs. Moyer, C.J., and Cook, J., concur in judgment only. Douglas and Resnick, JJ., concur in part and dissent in part. Lundberg Stratton, J., concurs in part and dissents in part.

1 . This matter comes before the court pursuant to summary judgment proceedings. Accordingly, we have construed the facts most favorably towards plaintiffs-appellants.

2 . The Ohio Hosp. Assn, case is currently pending before this court (case No. 00-1030), with proceedings stayed pending bankruptcy determinations.