Howland v. Purdue Pharma L.P.

104 Ohio St. 3d 584

• Court: Ohio Supreme Court
• Decided: December 15, 2004
• Docket: No. 2003-1538
• Status: Published

Opinions

O’Connor, J.

{¶ 1} This is a mass tort case involving the prescription drug OxyContin. The trial court granted a motion for class certification, and the court of appeals affirmed that decision. The parties to the appeal are plaintiffs-appellees, class representatives LaDonna Howland, Ronald Schaffer, Lillian Lakes, Martha Schaffer, and Fred Lakes, and defendants-appellants Purdue Pharma L.P., Purdue Pharma, Inc., Purdue Frederick Company, Purdue Pharmaceuticals L.P., P.F. Laboratories, Inc., and PRA Holdings, Inc. (collectively, “Purdue”) and Abbott Laboratories and Abbott Laboratories, Inc. (collectively, “Abbott”).¹

{¶ 2} OxyContin, which is manufactured by Purdue, is the trade name for oxycodone hydrochloride controlled-release tablets, an opioid analgesic drug. In 1995, the United States Food and Drug Administration (“FDA”) approved OxyContin for the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days.

{¶ 3} Oxycodone is a morphine-like drug that is highly addictive and is rated as a Schedule II narcotic, a designation given by the government that identifies a prescription medication as having a great potential for abuse. A Schedule II designation also means that the drug, while accepted for medical use, has severe restrictions, and abuse of the drug has a high potential to lead to severe psychological or physical dependence.

{¶ 4} OxyContin is a patented timed-release formula that releases the narcotic incrementally over 12 hours. This formulation distinguishes OxyContin from short-acting medications that must be taken more frequently. Because of the timed-release formulation, OxyContin contains more oxycodone than short-acting opioids.

{¶ 5} Shortly after its introduction, OxyContin became Purdue’s best selling and most profitable product, with sales in 2001 of $1.4 billion. A co-promotion agreement between Purdue and Abbott provided for the sharing of promotion obligations and the payment by Purdue to Abbott of a commission on net sales.

{¶ 6} While OxyContin quickly became a highly prescribed drug, public concerns arose regarding its safety. On May 11, 2000, Purdue received a letter from the FDA warning Purdue to cease the use of an advertisement for OxyContin that recommended using the drug to treat arthritis patients without first trying milder drugs. The United States Drug Enforcement Agency (“DEA”) also recognized problems associated with OxyContin, and reports linking OxyContin to various deaths and addiction problems began surfacing. According to the DEA, as of December 2001, 117 people had died from OxyContin in 31 states. On July 25, 2001, the FDA ordered Purdue to issue a “black box warning,” the strongest warning for an FDA-approved drug, on all OxyContin labels. The warning would call attention to the drug’s potential for misuse, abuse, and diversion and limit the class of patients for whom OxyContin is appropriate.

{¶ 7} In this case, Howland was prescribed OxyContin for nearly one year to treat pain stemming from injuries she suffered in a 1999 automobile accident. Howland alleges an OxyContin dependency, addiction, and withdrawal that led to her losing her job, suffering physical and mental injuries, and being convicted of a crime. Ronald Schaffer was prescribed OxyContin for approximately two years following his heart surgery in 1998. He alleges that he suffered from drug dependence as well as other adverse consequences as a result of taking OxyContin. Lillian Lakes took OxyContin for six months after her mastectomy in November 1999. She alleges drug dependence and other adverse consequences, including hospitalization. Martha Schaffer and Fred Lakes allege loss-of-support and loss-of-consortium claims.

{¶ 8} Appellees initiated this action on behalf of all individuals who have been detrimentally affected by OxyContin and who meet the criteria for three subclasses for which they seek certification. These subclasses are:

{¶ 9} Class I: “All persons in the State of Ohio that were prescribed OxyContin and thereafter suffered, and/or continue to suffer, the effects of the drug such as the risk of drug dependency, addiction, actual addiction, and the consequences of addiction.”

{¶ 10} Class II: “All persons in the State of Ohio that were prescribed OxyContin and thereafter suffered, and/or continue to suffer, the effects of the drug such as physical, mental, and/or emotional harm, death and/or loss of consortium, as a result of the use of OxyContin.”

{¶ 11} Class III: “All persons in the State of Ohio that suffered, and/or continue to suffer, the effects of the drug such as physical, mental, and/or emotional harm, death and/or loss of consortium, as a result of the use and abuse of OxyContin by others.”

{¶ 12} Appellees’ claims center on appellants’ allegedly tortious conduct in the manufacturing, marketing, promotion, selling, and distribution of OxyContin in disregard for the health and safety of appellees and others. They assert claims of negligence, failure to warn, and breach of express and implied warranties. Generally, appellees allege that they and hundreds of other Ohioans have sustained physical, mental, and economic harm through dependence on or addiction to OxyContin as a result of negligence and misrepresentation in the manufacture and aggressive marketing of the product. Appellees also claim that the drug companies failed to disclose to patients and doctors the risk for abuse and addiction associated with OxyContin.

{¶ 13} Some of the specific allegations are that widespread abuse of OxyContin has occurred because the existing formulation does not contain an “antagonistic drug” to prevent a person from destroying the controlled release feature of the tablet by crushing or dissolving it. Crushing or dissolving the tablet permits immediate administration of the total 12-hour dose, which results in a sudden and intense high similar to that caused by heroin. Appellees also assert that Purdue failed to produce tablets in a dosage small enough to permit a physician to safely prescribe OxyContin to an “opioid-naive” patient, i.e., a patient who has never taken an opioid.

{¶ 14} In addition, appellees claim that OxyContin’s enormous sales volume was due primarily to appellants’ highly coercive and seductive sales tactics that influenced the prescription, distribution, and consumption of OxyContin. These tactics allegedly included paying transportation and hotel costs for doctors to attend meetings about pain management where they could be recruited and paid fees to recruit other doctors to prescribe OxyContin; telling pharmacists that their failure to fill prescriptions, even because of suspected abuse, might harm the patient; and aggressively promoting the drug directly to consumers. Appellees also allege that appellants misrepresented OxyContin as safe and appropriate for the treatment of all kinds of pain, including back pain, pain from osteoarthritis, and short-term pain.

{¶ 15} After conducting an evidentiary hearing on appellees’ Civ.R. 23 motion to certify a class action and reviewing the submitted pleadings, briefs, and other documents, the Butler County Court of Common Pleas certified the class as requested pursuant to Civ.R. 23(B)(3). The court held that a class action offers the benefit of resolving the common questions regarding appellants’ alleged misconduct before the need arises to delve into the individual questions of each class member. The court stated that answers to common questions will not vary among the class members and concluded that if appellees cannot prove that appellants are negligent, did not fail to provide warning, and did not breach any express or implied warranties, the cause of action will end.

{¶ 16} The Twelfth District Court of Appeals affirmed.² The cause is now before the court upon the acceptance of a discretionary appeal.

{¶ 17} We are asked to determine whether the trial court abused its discretion in certifying a statewide class of individuals asserting injuries allegedly arising from use of the painkiller OxyContin. Because we determine that the trial court abused its discretion in certifying the class, we reverse the appellate court’s decision.

{¶ 18} Civ.R. 23(A) specifies four prerequisites to a class action: “(1) the class is so numerous that joinder of all members is impracticable, (2) there are questions of law or fact common to the class, (3) the claims or defenses of the representative parties are typical of the claims or defenses of the class, and (4) the representative parties will fairly and adequately protect the interests of the class.” Two other requirements are implicit: The class must be identifiable, and the representatives must be members of the class. Warner v. Waste Mgt., Inc. (1988), 36 Ohio St.3d 91, 96, 521 N.E.2d 1091.

{¶ 19} In addition to these threshold requirements, parties seeking class certification must show that the action is maintainable under one of the grounds contained in Civ.R. 23(B). Id. at 94, 521 N.E.2d 1091. In the case at bar, appellees claim that they satisfy the Civ.R. 23(B)(3) requirements that “questions of law or fact common to the members of the class predominate over any questions affecting only individual members, and that a class action is superior to other available methods for the fair and efficient adjudication of the controversy.” The test for commonality under Civ.R. 23(A) is typically met without difficulty. Id. at 97, 521 N.E.2d 1091. We have held, however, that to establish commonality predominance for purposes of Civ.R. 23(B)(3), “it is not sufficient that common questions merely exist; rather, the” common questions must represent a significant aspect of the case and they must be able to be resolved for all members of the class in a single adjudication.” Schmidt v. Avco Corp. (1984), 15 Ohio St.3d 310, 313, 15 OBR 439, 473 N.E.2d 822.

{¶ 20} Indeed, in Wilson v. Brush Wellman, Inc., 103 Ohio St.3d 538, 2004-Ohio-5847, 817 N.E.2d 59, we upheld the trial court’s determination that the proposed class met the commonality requirement in Civ.R. 23(A), though it failed to satisfy the predominance requirement in Civ.R. 23(B)(3).³ The trial court in Wilson went “into much detail in its Civ.R. 23(B)(3) predominance analysis, citing multiple individual questions of fact requiring examination for different plaintiffs within the proposed class.” Id. at ¶ 29. We held that we could not find an abuse of discretion by the trial court given such a detailed and thoughtful analysis. Id. at ¶ 30.

{¶ 21} In the case at bar, however, the trial court failed to analyze or even mention any of the specific problems argued by the appellants. Instead, the only reference to appellants’ position was: “Specifically, the Defendants contend the issues in mass product liability claims differ dramatically from individual to individual concerning damages, liability and defenses.” The court went on to summarily conclude, “As stated above, this Court has found there are common questions relating to the Defendants’ alleged wrongful conduct. Further, we believe that these common questions predominate over individual questions.”

{¶ 22} Federal courts, considering similar suits against these appellants, have demonstrated appropriate consideration of appellants’ arguments.⁴ In Wethington v. Purdue Pharma L.P. (S.D.Ohio 2003), 218 F.R.D. 577, 581, plaintiffs sought certification of “[a]ll Ohio, Kentucky, Indiana, and West Virginia residents who first used OxyContin after receiving a legal prescription between the years 1995 and the date of class certification. The class also includes those individuals who have loss of consortium claims.”⁵ The court recounted each party’s arguments in detail before concluding that each of the plaintiffs’ claims for negligence, failure to warn, manufacturing defect, negligence per se, conspiracy, breach of warranty, fraud, and other statutory claims “depended on questions of fact and law peculiar to each individual so that there was not sufficient commonality for a class to be certified.” Id. at 588. The court noted that addiction to the drug is an individualized question of fact. Id. Further, the “key distinction” found by the court was that “regardless of any alleged improper marketing, in order to obtain the product, a class member must make a request to a Learned Intermediary.” Id. at 589. The court held that “doctors were adequately warned of the powerful dosage of OxyContin relative to morphine, and thus the Learned Intermediary Doctrine discharges the duty to warn from the manufacturer to the physician.

{¶ 23} “Liability, in this case, therefore, turns on individual determinations.” Id.

{¶ 24} The learned-intermediary doctrine has been adopted and applied by this court. See Tracy v. Merrell Dow Pharmaceuticals, Inc. (1991), 58 Ohio St.3d 147, 569 N.E.2d 875. The doctrine is an exception to the rule that a manufacturer has a duty to warn the ultimate consumer. It precludes manufacturer liability for failure to warn the consumer when an adequate warning has been given to a “learned intermediary,” e.g., the consumer’s physician. Seley v. G.D. Searle & Co. (1981), 67 Ohio St.2d 192, 203, 21 O.O.3d 121, 423 N.E.2d 831. We find the Wethington decision well reasoned and persuasive. Yet neither the trial court nor the appellate court examined the doctrine’s applicability. Because an almost identical suit from the Southern District of Ohio had already been resolved based on this doctrine, the analysis should not have been disregarded.

{¶ 25} We have stated, “A trial judge has broad discretion in determining whether a class action may be maintained and that determination will not be disturbed absent a showing of an abuse of discretion.” Marks v. C.P. Chem. Co., Inc. (1987), 31 Ohio St.3d 200, 31 OBR 398, 509 N.E.2d 1249, syllabus. “However, the trial court’s discretion in deciding whether to certify a class action is not unlimited, and indeed is bounded by and must be exercised within the framework of Civ.R. 23. The trial court is required to carefully apply the class action requirements and conduct a rigorous analysis into whether the prerequisites of Civ.R. 23 have been satisfied.” Hamilton v. Ohio Sav. Bank (1998), 82 Ohio St.3d 67, 70, 694 N.E.2d 442.

{¶ 26} An abuse of discretion is “more than a mere error of law or judgment, instead requiring a finding that the trial court’s decision is unreasonable, arbitrary, or unconscionable.” Wilson v. Brush Wellman, Inc. 103 Ohio St.3d 538, 2004-Ohio-5847, 817 N.E.2d 59, ¶ 30, citing Blakemore v. Blakemore (1983), 5 Ohio St.3d 217, 219, 5 OBR 481, 450 N.E.2d 1140. “[W]here the trial court completely misconstrues the letter and spirit of the law, it is clear that the court has been unreasonable and has abused its discretion.” Warner v. Waste Mgt., 36 Ohio St.3d at 99, 521 N.E.2d 1091, fn. 10. A trial court that dispenses with a party’s arguments in such a fashion, fails to examine a well-established doctrine, and ignores nearly identical federal proceedings does not merely misconstrue the letter and spirit of the law — it ignores them. For the foregoing reasons, we reverse the judgment of the appellate court upholding class certification.

Judgment reversed.

Chkistley, Lundberg Stratton and O’Donnell, JJ., concur. Moyer, C.J., dissents. F.E. Sweeney and Pfeifer, JJ., dissent. Judith A. Christley, J., of the Eleventh Appellate District, sitting for Resnick, J.

1 . Several other parties were named as defendants, but they are not parties to this appeal.

2 . The affirmance directed the trial court to restrict class membership to Ohio residents who initially secured OxyContin through lawful means. A divided appellate court reversed class certification against an individual defendant-appellant, Timothy Smith, D.O. This latter determination was not appealed.

3 . The appellate court reversed the trial court’s decision but in doing so examined only Civ.R. 23(B)(2). We reversed the judgment of the appellate court, reinstating the trial court’s decision that the plaintiffs could not be certified under either Civ.R. 23(B)(1), (2), or (3).

4 . The courts in the following cases held that plaintiffs in each case failed to meet even the commonality requirement of Fed.R.Civ.P. 23(a)(2). Wethington v. Purdue Pharma L.P. (S.D.Ohio 2003), 218 F.R.D. 577, 588; Harris v. Purdue Pharma, L.P. (S.D.Ohio 2003), 218 F.R.D. 590, 596-597; Foister v. Purdue Phaima L.P. (Feb. 26, 2002), E.D.Ky. No. Civ. A. 01-268-DCR, 2002 WL 1008608, at * 7-8.

5 . The proposed class was similar to those in the case at bar, yet broader because the class description in Wethington did not speak to “suffering” as in this case.