COURT OF APPEALS OF OHIO, EIGHTH DISTRICT COUNTY OF CUYAHOGA NO. 76594 MARY VACCARIELLO, ET AL. : : JOURNAL ENTRY PLAINTIFFS-APPELLANTS : : AND v. : : OPINION SMITH & NEPHEW RICHARDS, INC. : : DEFENDANT-APPELLEE : DATE OF ANNOUNCEMENT OF DECISION: AUGUST 3, 2000 CHARACTER OF PROCEEDING: Civil appeal from Common Pleas Court, No. CV-300174. JUDGMENT: AFFIRMED IN PART; REVERSED IN PART. DATE OF JOURNALIZATION: APPEARANCES: For Plaintiffs-Appellants: Cara L. Santosuosso, Esq. Michael J. O'Shea, Esq. Suite 450 Lakeside Place 325 Lakeside Avenue Cleveland, OH 44113 For Defendant-Appellee: Martin J. Murphy, Esq. Kevin M. Norchi, Esq. Davis & Young, L.P.A. 1700 Midland Building 101 West Prospect Avenue Cleveland, OH 44115-1027 -2- [CONTINUED] For Defendant-Appellee: Nathan T. Gisclair, Jr., Esq. James B. Irwin, Esq. Kim E. Moore, Esq. Montgomery, Barnett, Brown, Read, Hammond & Mintz, L.L.P. 3200 Energy Centre 1100 Poydras Street New Orleans, LA 70163-3200 -3- TIMOTHY E. McMONAGLE, P.J.: I. INTRODUCTION Plaintiffs-appellants, Ma Louis Vaccarariello, Resha's former spouse, brought this lawsuit seeking damages for injuries allegedly caused by an inadequate warning about the FDA regulatory status of, and the medical risks related to, the use by Resha's surgeon of the Rogozinski Spinal Rod System in her spinal fusion surgery.1 The Rogozinski System, manufactured by defendant-appellee/cross-appellant, Smith & Nephew, Inc., f/k/a Smith & Nephew Richards, Inc., is an internal spinal fixation device that was affixed by appellant's surgeon, Dr. Michael J. Rozen, to appellant's spine by screws in the vertebral pedicles. At the time of appellant's surgery in June 1993, appellee was marketing the Rogozinski ry Vaccariello, n/k/a Mary Resha, andSystem pursuant to the FDA for another use. The Rogozinski System was not specifically approved for pedicle screw fixation; nonetheless, such off-label use2 was permissible because Dr. Rozen was utilizing 1Hereafter, all references to appellants will be singular as Louis Vaccariello's claims are merely derivative of those of his former spouse. 2 Off-label use refers to the use of a lawfully marketed device by a surgeon in a manner which he or she feels is in the best interest of the patient, regardless of whether the use has been identified in FDA-cleared labeling. Such use is not regulated or prohibited by the FDA because it falls within the practice of 2[Continued] medicine, which is not subject to FDA regulation. See Weaver v. Reagen (8th Cir. 1989), 886 F.2d 194; U.S. v. Algon Chemical, Inc. (3rd Cir. 1989), 879 F.2d 1154. -4- the System in a manner which he felt was in the best interest of his patient. The record demonstrates that prior to performing the surgery, Dr. Rozen was made aware of the risks and dangers associated with the surgery, including post-operative pain and discomfort, through package inserts included with each of the Rogozinski Systems. The record is also clear that prior to appellant's surgery, Dr. Rozen was aware that the use of pedicle screw fixation was considered investigational by the FDA. Nevertheless, Dr. Rozen determined that installing the Rogozinski System directly into appellant's spine was in her best interests. Despite the surgery, appellant continued to suffer from increasing pain. On October 29, 1993, while watching an evening news program, appellant learned that the Rogozinski System was alleged to have caused similar problems for other patients. Appellant ordered a transcript of the program, and six days later sought a second medical opinion. On November 10, 1993, appellant was seen by Dr. Alfred Kahn for an evaluation of her back. According to appellant, Dr. Kahn informed her that he believed the metal was causing the majority of [her] problems, and he therefore recommended its removal. On December 15, 1995, appellant filed this action against multiple manufacturers, subsequently dismissing all of the originally named defendants except appellee after discovering that appellee was the manufacturer of the device installed in her back. Appellant eventually amended her complaint to assert only an -5- inadequate warning claim pursuant to R.C. 2307.76 and a non- conformance with representations claim pursuant to R.C. 2307.77 against appellee. The thrust of appellant's case was her allegation that appellee had a duty to inform her and the general public about the FDA regulatory status of the Rogozinski System and that many representations made by appellee to the FDA in connection with its regulatory history were false. Appellee filed three motions relating to appellant's claims: 1) a motion for summary judgment based on the statute of limitations; 2) a motion in limine to exclude any evidence relating to the alleged inadequacy of appellee's warning of the medical risks of using the Rogozinski System; and 3) a motion in limine to exclude any evidence relating to appellee's alleged failure to warn of the System's FDA regulatory status. Appellee's motions in limine were based upon the proposition that the learned intermediary doctrine, which holds that a manufacturer's duty to warn is discharged if the manufacturer adequately warns the physician, Tracey v. Merrell Dow Pharmaceuticals (1991), 58 Ohio St.3d 147; Sealey v. G.D. Searle & Co. (1981), 67 Ohio St.2d 192, also applies to prescription medical devices and, because appellee had provided adequate warnings to Dr. Rozen regarding the FDA status of the Rogozinski System and the risks associated with using it in the manner in which he used it in connection with appellant's fusion surgery, appellee was under no duty to provide warnings directly to appellant. The trial court denied appellee's motion for summary judgment -6- regarding the statute of limitations but granted appellee's motions in limine. Because the trial court's rulings regarding appellee's motions in limine left appellant without sufficient evidence to show there was a genuine issue as to any material fact concerning the claims set forth in her complaint, the trial court subsequently granted appellee's second motion for summary judgment. Appellant appealed the trial court's order granting appellee's second motion for summary judgment and appellee cross-appealed the judgment denying its motion for summary judgment based on the statute of limitations. For the reasons that follow, we affirm the trial court's judgment granting appellee's second motion for summary judgment and reverse the judgment of the trial court denying appellee's motion for summary judgment based on the statute of limitations. -7- II. APPELLANT'S ASSIGNMENT OF ERROR In her single assignment of error, appellant asserts that the trial court erred in granting appellee's motions in limine, and subsequently, its second motion for summary judgment, because the learned intermediary doctrine, which has traditionally been applied only in the context of prescription drugs, does not also apply to prescription medical devices. This appears to be an issue of first impression in the State of Ohio. We find appellant's arguments to be without merit. Instead, we adopt pages four through eight of the June 4, 1999 Memorandum of Opinion of Judge Stuart A. Friedman, attached hereto as Exhibit A, in which Judge Friedman considered appellant's arguments and set forth a well-reasoned analysis regarding why the learned intermediary doctrine encompasses prescription medical devices.3 Moreover, we agree with the trial court that the record reflects that appellee fulfilled its duty to warn appellant's surgeon, Dr. Rozen, regarding the potential medical risks associated with use of the Rogozinski System and provided Dr. Rozen with FDA-approved information concerning the System's FDA 3Appellant's argument that the trial court's analysis of Carrel v. Allied Products Corp. (1997), 78 Ohio St.3d 284, was incorrect is without merit. Contrary to appellant's contention, the trial court did not erroneously conclude, based upon Carrel, that Ohio recognized the learned intermediary doctrine in the context of prescription medical devices prior to the enactment of the Ohio Products Liability Act. Rather, the trial court concluded that the common law learned intermediary doctrine as applied to prescription drugs was not eliminated or modified by the Ohio Products Liability Act; thus, because it remains a viable doctrine, the trial court could properly consider whether its scope of application extended to prescription medical devices. -8- regulatory status. Accordingly, pursuant to the learned intermediary doctrine, appellee discharged its duty to warn appellant of possible adverse effects of the Rogozinski System and its FDA status. Consequently, because appellee was under no duty to personally warn appellant, any testimony or evidence regarding appellee's alleged failure to adequately warn appellant of the potential medical risks of the Rogozinski System or its FDA status would have been irrelevant and prejudicial. Therefore, the trial court properly granted appellee's motions in limine and subsequently, its second motion for summary judgment. Appellant's assignment of error is overruled. III. APPELLEE'S CROSS-APPEAL In its cross-appeal, appellee asserts that the trial court erred in denying its motion for summary judgment based on the statue of limitations because appellant's product liability action is time-barred by R.C. 2305.10. R.C. 2305.10 provides that an action for bodily injury *** shall be brought within two years after the cause of action accrues. Personal injury claims arising from product liability actions are governed by the two-year statute of limitations set forth in Section 2305.10. Gates v. Precision Post Co. (1996), 74 Ohio St.3d 439; McAuliffe v. Western States Import Co. (1995), 72 Ohio St.3d 534. When the injury associated with a defendant's conduct does not manifest itself immediately, the cause of action accrues when the plaintiff knows or, by the exercise of reasonable diligence should -9- have known, that he or she has been injured by the conduct of defendant, for purposes of the statute of limitations contained in R.C. 2305.10. O'Stricker v. Jim Walter Corp. (1983), 4 Ohio St.3d 84, paragraph two of the syllabus. This rule of accrual is known as the discovery rule. Appellee contends that under the discovery rule, the statute of limitations began running on October 29, 1993 when appellant viewed the evening news program in which she learned that the device implanted in her back could be the source of her problems. Alternatively, appellee contends that the statute of limitations began running on November 10, 1993, when Dr. Kahn informed appellant that the metal in her back needed to come out and that it was causing the majority of her problems. Appellee asserts that either event was an alerting event that began the running of the statute of limitations and, therefore, appellant's complaint, filed on December 15, 1995, more than two years after either event, was untimely. Appellant argues, however, and the trial court held, that the two year statute of limitations set forth in R.C. 2305.10 was tolled by the pendency of the class action certification in MDL 1014 (Eastern District of Pennsylvania), a federal class action against pedicle screw manufacturers in which appellee was named as a defendant and appellant was a potential class member. In its Memorandum of Opinion and Order denying appellee's motion for summary judgment, the trial court indicated that the rule tolling -10- the statute of limitations during the period when a plaintiff is an asserted class member: stems from the United States Supreme Court opinion in American Pipe Construction Co. v. Utah (1974), 414 U.S. 538, and its subsequent ruling in Crown, Cork & Seal Co. v. Parker (1983), 462 U.S. 345, which states 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. American Pipe at 554. Accordingly, during the period between when the Motion for Class Certification was filed on April 4, 1994, and when it was denied on February 22, 1995, the statute of limitations as to Plaintiff's Ohio action was tolled. Thus, the additional three hundred and thirteen days which was tacked onto Plaintiff's original two year statute of limitations more than encompasses Plaintiff's December 15, 1995 filing, and Defendant's Motion for Summary Judgment accordingly is denied. In The Ohio Hospital Assn. v. Armstrong World Industries, Inc. (Apr. 6, 2000) Cuyahoga App. No. 76067, unreported, this court recently addressed the issue raised by appellee, i.e., whether Ohio recognizes a cross-jurisdictional tolling doctrine similar to that recognized in federal courts whereby an applicable statute of limitations period is tolled during the period in which a plaintiff is an asserted member of a class in class action litigation prior to a decision denying class certification. Upon reflection, we held that cross-jurisdictional class action tolling of statutes of limitations is not recognized in Ohio. Finding the reasoning of the Illinois Supreme Court in Portwood v. Ford Motor Co. (1998), 183 Ill.2d 459, persuasive, we noted that tolling the statute of limitations for individual -11- actions filed after the dismissal of a class action is not sound public policy where both actions are not brought in the same court system: The [Portwood] court reasoned that any state which independently adopted a rule of cross- jurisdictional tolling will invite into its courts a disproportionate share of suits which the federal courts have refused to certify as class actions after the statute of limitations has run. Portwood at 465. *** In the present case, the appellant asks that this court adopt a policy which would not only invite litigants who were unsuccessful in federal court to file suit in Ohio, but, also, litigants from nearly every other state in the nation. This sort of court sanctioned forum shopping would likely result in an influx of cases into this state. This court believes that it is sounder public policy not to expose the Ohio courts to such risks. The Portwood decision also recognized the inability of a state court system to regulate or control the proceedings of a foreign jurisdiction. Conceivably a case could languish for years in another state, or in the federal system, before class action status is denied. As stated in Portwood, [s]tate courts should not be required to entertain stale claims simply because the controlling statute of limitations expired while a federal court considered whether to certify a class action. By joining other jurisdictions which have declined to recognize cross-jurisdictional class tolling, Ohio also recognizes the potential for abuse whereby any putative plaintiff in any class action around the country could potentially benefit from a toll of the statute of limitations by merely pointing to a class action lawsuit that was pending anywhere in the country during the time in which the statute of limitations was running, whether or not said plaintiff was even aware of the existence of the class action litigation during its pendency. By requiring a plaintiff to pursue his cause of -12- action within the statute of limitations period proscribed by the legislature, or to file a protective action in this state during the pendency of a class action in another jurisdiction, the potential that defendants will be required to defend stale claims where evidence has been lost, memories have faded, and witnesses have disappeared is minimized. Id. We agree with appellee, and the trial court, that the statute of limitations began to run on October 29, 1993, the date that appellant viewed the news program which spurred her to order a transcript and begin the process of seeking a legal remedy. See Browning v. Burt (1993), 66 Ohio St.3d 544. Upon viewing the news program, appellant learned that the Rogozinski System was not FDA approved for pedicle screw surgery, may cause more problems than it solves, causes people more discomfort, more disability and more pain, in some cases, patients end up worse after the surgery than before, and that some patients continued to have pain almost a year after the surgery. At that point, appellant had already been experiencing continued, severe pain in her right leg and low back and difficulty with her leg giving out, which she had not experienced prior to the subject fusion surgery. In addition, appellant knew that she now had an abnormal EMG study,4 whereas her pre-surgery study was normal. Thus, after watching the news program appellant knew, or should have known, that her alleged injuries (low back pain, leg pain and stumbling) may have been caused by appellee's device. Appellant's argument that she did not 4EMG stands for electromyogram, which is a type of nerve conduction study. -13- discover her cause of action against appellee until the pedicle screws were removed from her spine in July 1998 is therefore without merit. Accordingly, appellant's complaint--filed December 15, 1995-- is barred by the two year statute of limitations in R.C. 2305.10 and, therefore, the trial court, which did not have the benefit of our opinion when it rendered its decision, erred in denying appellee's motion for summary judgment based on the statute of limitations. The judgment of the trial court denying appellee's motion for summary judgment is therefore reversed. Appellee/cross-appellant's assignment of error is sustained. -14- This cause is affirmed in part and reversed in part for further proceedings consistent with the opinion herein. It is, therefore, ordered that the parties equally share the costs herein. It is ordered that a special mandate be sent to said court to carry this judgment into execution. A certified copy of this entry shall constitute the mandate pursuant to Rule 27 of the Rules of Appellate Procedure. TIMOTHY E. McMONAGLE PRESIDING JUDGE JOHN T. PATTON, J. and JAMES D. SWEENEY, J., CONCUR. N.B. This entry is an announcement of the court's decision. See App.R. 22(B), 22(D) and 26(A); Loc.App.R. 22. This decision will be journalized and will become the judgment and order of the court pursuant to App.R. 22(E) unless a motion for reconsideration with supporting brief, per App.R. 26(A), is filed within ten (10) days of the announcement of the court's decision. The time period for review by the Supreme Court of Ohio shall begin to run upon the journalization of this court's announcement of decision by the clerk per App.R. 22(E). See, also, S.Ct.Prac.R. II, Section 2(A)(1). EXHIBIT A THE COURT OF COMMON PLEAS CUYAHOGA COUNTY, OHIO MARY VACCARIELLO, et al. Plaintiff(s) CASE NO. 300174 vs. SMITH & NEPHEW RICHARDS, MEMORANDUM OF OPINION INC. AND ORDER Defendant(s) FRIEDMAN, J: *** Defendant's Motions In Limine A motion in limine is designed to avoid the injection into trial of a potentially prejudicial matter which is not relevant and is inadmissible. Rinehart v. Toledo Blade Co. (1985), 21 Ohio App.3d 274, 278. In this case the Defendant asserts that to allow testimony regarding its alleged failure to provide the Plaintiff with an inadequate warning, or its alleged failure to warn the Plaintiff of the Rogozinski System's FDA status, would be irrelevant and prejudicial, as the Defendant was under no duty to provide such warnings directly to the Plaintiff. Based upon the following, this Court finds that such testimony or evidence would be unfairly prejudicially to the Defendant and grants both of Defendant's Motions In Limine. Defendant's Motion to Exclude Testimony on Alleged Inadequate Warning The Defendant moves to exclude all testimony regarding the Plaintiff's claim of an alleged inadequate warning of potential medical risks related to her surgeon's use of the Rogozinski Spinal Rod System manufactured by the Defendant. The Defendant bases its motion upon the Ohio Supreme Court's adoption of the learned intermediary doctrine, which establishes that a manufacturer's -2- duty to warn is discharged if the manufacturer adequately warns the physician. Tracey v. Merrell Dow Pharmaceuticals (1991), 58 Ohio St.3d 147; Sealey v. G.D. Searle & Co. (1981), 67 Ohio St.2d 192. Traditionally, this doctrine has been applied to prescription drugs, and the question of whether the doctrine would apply to prescription medical devices appears to be one of first impression in the State of Ohio. Plaintiff argues the Ohio Products Liability Act, Ohio Revised Code S2307.71, et seq, which applies a form of the learned intermediary doctrine to prescription drugs in S2307.76, yet is silent regarding the application to prescription medical devices, indicates the legislature's intent to exclude prescription medical devices from the application of the learned intermediary doctrine. As further support of this contention, Plaintiff points to the fact that both categories are defined elsewhere in the Code which, it asserts, indicates the intent to apply the doctrine to one category of products and not the other. See Ohio Revised Code S2307.71 (definition of Ethical Drug ) and S2307.71(E) (definition of Ethical Medical Device ). While this Court recognizes the classifications, it is also mindful of the Ohio Supreme Court's refusal in Carrel v. Allied Products Corporation (1997), 78 Ohio St.3d 284, 287, to interpret the General Assembly's silence in crafting the Ohio Products Liability Act as indicative of any sort of legislative intent with regard to common-law theories and causes of actions. In that case the Court stated that: the General Assembly will not be presumed -3- to have intended to abrogate a common-law rule unless the language used in the statute clearly shows that intent ; it thus determined that the General Assembly's failure to specifically codify the common-law action of negligent design did not eliminate it. Id. at 287-288. In so ruling, the Carrel Court recognized that the language employed by the Ohio Products Liability Act specifically states that product liability claims (and by necessary implication product liability doctrines and defenses) are only subject to the Ohio Products Liability Act, language which fails to completely eliminate unmentioned common-law theories. Id. Based upon this, the Carrel Court stated that: The rule of strict construction refuses to extend the law by implication or inference and recognizes nothing that is not expressed. Accordingly, it would be a departure from well-recognized principles of statutory construction to read into a statute words not found in its text. Id. Utilizing the same analysis this Court similarly finds that the common-law learned intermediary doctrine was not specifically eliminated or modified by the Ohio products Liability Act; it thus remains a viable common-law doctrine whose scope of application must be considered by this Court. In analyzing whether the learned intermediary doctrine should be extended beyond prescription drugs to encompass prescription medical devices as well, this Court notes that recently, under similar circumstances, Judge David A. Katz of the U.S. District Court for the Northern District of Ohio extended the application of the learned intermediary doctrine to prescription medical devices. -4- Dunlap v. Medtronic, Inc. (N.D.Ohio, Western Div., March 31, 1999), No. 3:97CV7148. While that decision is not binding upon this Court, it does provide persuasive support for this Court's decision that the learned intermediary doctrine is applicable both to prescription medical devices and to prescription drugs. A review of non-Ohio jurisdictions which have considered this issue reveals that, without exception, every court has extended the doctrine to prescription medical devices as well. See Id.; Mozes v. Medtronic, Inc. (D.Minn. 1998), 14 F.Supp.2d 1124; Talley v. Danek Medical, Inc. (E.D.Va. 1998), 7 F.Supp.2d 725; Brayman v. Baxter Healthcare Corp. (2nd Cir. 1993), 984 F.2d 71; Piper v. Bear Medical Sys. (Ariz. App. 1993), 883 P.2d 407; Harwell v. American Medical Systems, Inc. (M.D.Tenn. 1992), 803 F.Supp. 1287; Knowlton v. Deseret Medical Inc. (1st Cir. 1991), 930 F.2d 116; Phelps v. Sherwood Medical Indus. (7th Cir. 1987), 836 F.2d 296; Kirsch v. Picker International, Inc. (8th cir. 1985), 753 F.2d 670; Brooks v. Medtronic, Inc. (4th Cir. 1984), 750 F.2d 1227. In each of those cases, the primary issue considered by the courts was whether there was any basis for drawing a distinction between prescription drugs and prescription medical devices. In each instance the court found no compelling reason to draw such distinction and chose to extend the doctrine. The Ohio Supreme Court in Tracy v. Merrell Dow Pharmaceuticals, Inc. (1991), 58 Ohio St.3d 147, determined that The 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 -5- 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 the patient 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. Id. at 149. Based upon this expressed rationale, this Court similarly can find no compelling reason to limit the application of the learned intermediary doctrine only to prescription drugs. The same policy considerations that serve to protect drug manufacturers are equally applicable to the manufacturers of prescription medical devices. To force the manufacturer of a prescription medical device to track down and warn every patient that is prescribed its device places an unfair burden upon the manufacturer. Just as with the prescription drugs, the learned intermediary doctrine achieves the proper allocation of responsibility when applied to prescription medical devices, since the physician is the individual best suited to balance the needs of the patient against the risks and benefits of a particular drug or therapy, and then supervise its use. Id. Accordingly, since Dr. Rozen was aware of the inherent medical risks and side-effects of the Rogozinski System, and since the insert provided with each Rogozinski System listed the possible adverse effects (including the pain complained of by Plaintiff), pursuant to the learned intermediary doctrine the Defendant discharged all duties to warn the Plaintiff and similarly situated patients. Since the Defendant was under no duty to personally warn -6- the Plaintiff, any testimony or evidence regarding the Defendant's failure to adequately warn the Plaintiff regarding the potential risks related to Rogozinski System or risks associated with her surgeon's use of the Rogozinski System would be unfairly prejudicial and shall be excluded. Defendant's Motion In Limine to Exclude Evidence of Failure to Warn of FDA Regulatory Status Defendant bases its second motion on the grounds that it had no duty to warn Plaintiff about the FDA regulatory status of the Rogozinski System. The Ohio Supreme Court has already stated that pursuant to the learned intermediary doctrine, the status of the drug with the FDA does not alter the relationship between drug manufacturer, physician, and patient [since] *** [w]hether the drug is under investigation or FDA approved, it is the physician who selects it as appropriate for the patient. This Court has already ruled that the learned intermediary doctrine is applicable to prescription medical devices; inasmuch as the Defendant provided FDA-approved information concerning the Rogozinski System's FDA regulatory status to Dr. Rozen3 and Dr. Rozen--in light of such warning--decided to employ an off-label use of the Rogozinski System, any duty which Defendant may have had was discharged. Deposition of Dr. Rozen, attached as Exhibit Q to Defendant's Motion In Limine to Exclude Evidence of Failure to Warn of FDA Regulatory Status. Ergo, pursuant to the learned intermediary doctrine, any evidence that plaintiff may seek to introduce at trial regarding -7- whether the Defendant had a duty to warn or disclose to the Plaintiff information regarding the FDA regulatory status of the Rogozinski System, or that the manner in which Dr. Rozen chose to use it had not been cleared by the FDA is excluded. IT IS SO ORDERED. /S/ Stuart A. Friedman Judge Stuart A. Friedman 3Each Rogozinski System which Dr. Rozen implanted into the Plaintiff was accompanied by a package insert whose language was reviewed and cleared by the FDA prior to distribution by the Defendant. The insert specifically states that THE USE OF VERTEBRAL PEDICLE SCREW FIXATION IS CONSIDERED INVESTIGATIONAL BY THE U.S. FDA. (Emphasis in original). .