Opinion
12648/03.
Decided January 24, 2005.
The plaintiffs, all prescribed users of the pain reliever drug OxyContin, seek an order of this court certifying them as representatives of a class of similarly prescribed users in a class action against the defendant manufacturers and distributors of the drug. This court finds that a class certification is not appropriate because of the different reasons and methods by which the drug was prescribed and used.
However, this court finds that there are some common issues of law and fact, especially the discovery issues concerning the defendant manufacturers and distributors, which would be repetitive, costly and inefficient if the cases were allowed to remain before multiple judges in different counties. Therefore, it is appropriate that these cases, and such other cases in other counties of the New York Supreme Court be coordinated before one justice pursuant to New York Rules for Trial Courts § 202.69. Accordingly, this case is remanded forthwith to the New York Litigation Coordinating Panel for review and further disposition.
FACTS
The plaintiffs, Pedro Hurtado, Reinee Pitt, James Wilson, Timothy Cosentino, and Frank Nostro on behalf of themselves and others similarly situated, brought this action for class certification pursuant to NY CPLR § 901 and 902 against Purdue Pharma Co., Purdue Pharma L.P., Purdue Pharma, Inc., Purdue Frederick Company, The P.F. Laboratories, Inc., Abbott Laboratories, and Abbott Laboratories, Inc.
OXYCONTIN
OxyContin, which is manufactured by the defendant, Purdue Pharma Company ("Purdue"), is the trade name for a prescription control released opioid analgesic drug sold in tablet form that contains oxycodone hydrochloride. The drug is produced in various dosages and is advertised to provide smooth and sustained 12-hour pain relief for moderate to severe pain. Oxycodone is a Schedule II controlled substance under the Federal Controlled Substances Act of 1970 and therefore requires a prescription for its use pursuant to 21 USC § 843(a). The defendant developed, patented, manufactured, marketed and distributed OxyContin, which was approved by the Federal Food and Drug Administration ("FDA") for sale in 1995. The original use of the drug which was approved by the FDA, was for the management of moderate to severe pain in cancer patients where the use of an opioid analgesic was to provide smooth and sustained 12 hour relief for a limited period of time and was prescribed in various dosages.
20 mg, 30 mg, 40 mg, 60 mg, and 80 mg. A dosage of 160 mg was discontinued.
The Purdue defendants collectively designed, manufactured, patented, developed, marketed and distributed OxyContin throughout the United States, including New York. The Purdue Frederick Company is a New York corporation. Abbott Laboratories and Abbott Laboratories, Inc. (collectively known as "Abbott") have a co-promotion agreement with Purdue to promote and sell OxyContin to hospitals, acute care and free-standing ambulatory care facilities throughout the United States, including New York.
In December 1995 OxyContin was launched for sale to the public. In its first year, sales were less than $200 million. Since then, total annual sales in the United States surpassed $1.6 billion, representing more than six million prescriptions.
Plaintiffs seek certification of the following class:
"All present or present residents of the State of New York, who, between January 1, 1996 and the date of the Court's Order certifying the class (I) were prescribed OxyContin and thereafter suffered and/or continue to suffer adverse effects of the drug such as the risk of addiction, actual addiction and the consequences of addiction; (ii) were prescribed OxyContin and thereafter suffered and/or continue to suffer adverse effects of the drug such as physical, mental, and/or emotional harm, death; (iii) 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 or abuse of OxyContin by others" (Plaintiffs' memorandum of law in support of motion for class certification at 5).
The named plaintiffs are all residents of Staten Island (Richmond County), New York who were legally prescribed OxyContin by different physicians for different physical conditions ranging from back pain, post-surgical pain and lymphoma. The plaintiffs each claim that they were not provided any warning that OxyContin could be addictive when taken as directed and each plaintiff claims to have become addicted to the drug.
The Plaintiffs:
Pedro Hurtado
The plaintiff, Pedro Hurtado is 38 years old and works at Bulgari Jewelers where he makes, repairs and polishes fine jewelry. In the fall of 2001, he was prescribed 20 mg of OxyContin twice a day for lower back pain. His prescription was increased in November, 2001 to 40 mg twice a day. He was also prescribed 5 mg of Oxycodone HCL. In August of 2002, his prescription was increased to 80 mg twice a day. He continues to take both prescriptions for OxyContin and Oxycodone HCL.
A few months after he began taking OxyContin he contends that he became anxious and depressed. He also claims that he was unable to concentrate and could not sleep. He also had difficulty breathing. He continues to suffer from these symptoms. In the summer of 2002, he decided to stop taking OxyContin because he was worried that he was dependent upon the drug. He experienced chills, itchiness, vomiting and cold sweats, and was taken to the emergency room. His symptoms ended when he began taking OxyContin again.
Mr. Hurtado claims that his prescription does not last for 12 hours and takes 5 mg of Oxycodone HCL everyday when the OxyContin begins to wear off. He also claims that if he had known that OxyContin was a synthetic morphine, he would never have taken the drug.
Renee Pitt
Reinee Pitt is a 36 year old medical transcriber and medical assistant. In January of 2002, she was prescribed OxyContin after hip surgery. The prescription was for 30 mg of OxyContin twice a day.
In March of 2002 she stopped taking OxyContin. As a result she experienced shaking, vomiting, body pains, panic and anxiety and was rushed to a local hospital. She was prescribed Vicodin at the hospital and her OxyContin prescription was slowly stepped down. She claims that her withdrawal symptoms lasted for several months and she experienced itchiness, sweats, shaking, anxiety, paranoia, body aches and nervous tics.
Ms. Pitt contends that her withdrawal from OxyContin crippled her for seven months and also interfered with her physical therapy after her hip surgery. She also claims that if she had known that OxyContin was a synthetic morphine, she would never have taken the drug.
James Wilson
The plaintiff, James Wilson, is 42 years old and works for Keyspan as an excavation inspector. In the fall of 2001 he was prescribed OxyContin during treatment for lymphoma B-cell cancer.
His first prescription was for 10 mg of OxyContin twice a day. A few months later his prescription was increased to 80 mg twice a day. In February of 2002, his doctor switched his prescription from OxyContin to the Duragesic patch. In May of 2002, he was switched back to OxyContin at 40 mg every eight hours.
James Wilson contends that while he was on OxyContin he was unable to function in a social manner. He claims that his mind and body craved the drug. In late September 2003, he enrolled himself into a detoxification program for five days where he was prescribed methadone. When he was released from the detox program he claims that he experienced severe withdrawal symptoms including, insomnia, crying, uncontrolled twitching, body aches, night horrors, desperation and suicidal thoughts. He was admitted into the psychiatric ward of Staten Island University Hospital where he was treated for his addiction to OxyContin. He contends that he experienced withdrawal symptoms for months after he stopped taking OxyContin.
Mr. Wilson claims that his prescription of OxyContin did not provide him 12 hours of pain relief as represented by the manufacturer, but only approximately 8 hours of pain relief.
Timothy Cosentino
Timothy Cosentino is a 42 year old retired New York City Police Officer. In September 2002, he was prescribed 20 mg of OxyContin three times a day for a back injury sustained as a result of a car accident. After a couple of months, he began to experience paranoia and insomnia. He lost weight and was depressed and anxious.
In March of 2003 he stopped taking OxyContin. As a result he had a psychiatric episode and was admitted to Bailey Seton Hospital for treatment. While there, he experienced withdrawal symptoms that included shaking, twitching, cold sweats, confusion, sleeplessness and body pain. He was treated for his addiction and did not take OxyContin from March 2003 until June or July of 2003. However, Mr. Cosentino now takes 20 mg of OxyContin three times a day despite the side effects.
Frank Nostro
Frank Nostro is 41 years old and is permanently disabled with a back injury as a result of a workplace accident in 1992. In the spring of 2001 he was prescribed 60 mg of OxyContin. Prior to taking OxyContin he was prescribed Percocet for his pain. He claims that his doctor told him that he could take fewer pills on OxyContin than on Percocet. He took both a 40 mg and a 20 mg OxyContin tablet twice a day. After a few months, his pain increased and he began to take 40 mg of OxyContin up to five times a day, which he has continued.
After one year of taking OxyContin, he claims to suffer from nightmares, panic attacks, forgetfulness, blurry vision, sudden twitching of body parts, loss of appetite and sexual interest. He contends that he also became anxious and moody. He claims to continue to suffer from these symptoms today.
Mr. Nostro believes that he is dependent on OxyContin. The few times when he ran out of OxyContin and could not reach his doctor he suffered from withdrawal symptoms including shaking, vomiting, pain, cold sweats, itchiness, and uncomfortable body aches. The symptoms stopped when he was able to fill his prescription. He claims that OxyContin no longer takes away his pain as when he first started taking it. He also claims that if he had known that OxyContin was a synthetic morphine, he would never have taken the drug.
DISCUSSION
The plaintiffs seek to establish a class of patients who were prescribed OxyContin to hold the defendants liable for personal injuries flowing from the design, manufacture and marketing of a defective product and for the unfair business practices and deceptive conduct underlying the promotion of a routine pain medication when it is arguably a highly addictive narcotic.
New York Class Action Suits Generally
The New York class action statute is contained in the New York Civil Practice Law and Rules (CPLR) Article 9, which is similar to, but not identical to the federal class action rules contained in Rule 23 of the Federal Rules of Civil Procedure.
The prerequisites to a class action are contained in New York CPLR § 901(a), which is identical to Fed.R.Civ.Pro. Rule 23(a) except for those factors listed in italics below, which were added to the NY CPLR § 901(a) which states:
CPLR § 901(a) Prerequisites to a Class Action
One or more members of a class may sue or be sued as representative parties on behalf of all if:
1. The class is so numerous that joinder of all members, whether otherwise required or permitted, is impracticable;
2. There are questions of law or fact common to the class which predominate over any questions affecting only individual members;
3. The claims or defenses of the representative parties are typical of the claims or defenses of the class;
4. The representative parties will fairly and adequately protect the interests of the class; and
5. A class action is superior to other available methods for the fair and efficient adjudication of the controversy.Numerosity
The first prerequisite of CPLR § 901(a) is numerosity, which appears to be adequately met because it is likely that the proposed class will number in the hundreds based upon the number of prescriptions of OxyContin prescribed in New York. The Appellate Division, Second Department has held that 300 persons satisfied the numerosity requirement ( Friar v. Vanguard Holding Corp., 78 AD2d 83 [2nd Dept. 1980]), (See, Pesantez v. Boyle Environmental Services, Inc., 251 AD2d 11 [1st Dept. 1998].) Here, the defendants do not even raise an objection to the numerosity requirement. Accordingly, the numerosity requirement of CPLR § 901(a) is satisfied by the plaintiff.
Commonality
The second factor of New York CPLR § 901(a)(2) differs from Rule 23(a)(2) of the Fed.R.Civ.Pro. in that it adds the requirement that the common facts or law "predominate over any questions affecting only individual members." Plaintiffs argue that the claims asserted are common, including products liability, breach of warranty, negligence, malicious conduct and other miscellaneous issues. The plaintiffs state that the conduct of the pharmaceutical companies were uniform towards the multiple issues raised. Therefore, such uniform treatment by the defendants satisfies this requirement.
On the other hand, the defendants contend that those causes of action are predicated on proximate causation which can only be determined on a case by case basis. Issues which will affect whether or not the defendant was liable for the production of a faulty product include the reasons for beginning the treatment; the type of the information patients' doctors had and the reasons why the particular doctors prescribed the medication; the dosages, the manner in which the patient took the prescription; whether or not the individual was taking other medications; past history with abuse of narcotics; and the specific injury that was sustained.
For example, both Mr. Cosentino and Mr. Nostro were prescribed OxyContin more than two times per day. Since the major marketing draw of OxyContin was its q12h dosage, it is necessary to determine why, from the outset, these patients were prescribed in excess of the recommended dosage. Were their cases special and did they warrant additional dosages of the drug? Were their doctors misinformed or mistaken? Did the doctors have information, not included in the package insert directly from Purdue regarding dosages in particular cases? Additionally, each of the named plaintiffs were prescribed the medication for a different reason and some were prescribed more than one drug at a time. An individual determination is necessary to ascertain whether they were prescribed the medication for an inappropriate reason and whether that was due to the marketing by Purdue or the plaintiffs' doctors; and whether the adverse side effects were due to drug interaction or OxyContin itself. These are important individual issues and to lump all of those issues together would be inappropriate for all of the parties involved. It appears that individual issues predominate over the common issues of fact. As such, the commonality requirement is not met.
q12h refers to taking the medicine every 12 hours, thereby taking it twice a day. In the marketing plans, this was considered to be a major draw so that patients would be able to sleep through the night without having to take their medication. The plaintiffs claim that the ineffectiveness of the q12h dosing contributed to the harm incurred and was related to Purdue's aggressive marketing tactics.
The Informed Intermediary Doctrine
The defense also relies upon the "informed intermediary doctrine" as further support for the fact that individual issues predominate over "common" issues. A drug manufacturer's duty to warn of potential dangers associated with its prescription drugs may be fulfilled by giving detailed, adequate warnings to the prescribing physician who acts as an "informed intermediary" between the manufacturer and the patient ( McDonnell v. Chelsea Mfrs., Inc., 259 AD2d 674 [2nd Dept. 1999], citing to Martin v. Hacker, 83 NY2d 1). However, the plaintiffs' claim that the informed intermediary doctrine makes the claims "common." The question of whether or not the doctors received adequate warnings is both a common issue and an individual issue. However, the fact that some issues are common does not preclude the fact that the majority of issues continue to be individual. Additionally, all of the members of this representative class were prescribed OxyContin after the amended warning in 2001. Plaintiffs' claims regarding inadequacy of warning does not appear to extend to the period of time after the complaint was amended. As such, the defendants' claim may be true regarding the informed intermediary doctrine, but is only marginally persuasive regarding whether individual issues predominate. It has been considered, but the greater merits of the predominance argument lie in other facets.
This does not mean the defendants are not liable to the plaintiffs' for various harms they may have caused. However, without a common injury or "signature disease" like asbestosis or mesothelioma, which only come from asbestos contact, it is difficult to define a class or establish causation. Signature diseases are those that are uniquely related to exposure to a certain substance and are rarely observed in individuals that are not exposed. If the plaintiffs proffer that addiction is a common injury to all parties, that does not substantiate their case. The Court of Appeals in New York has determined that issues of addiction are individualized and are not appropriate for class certification. ( Small v. Lorillard Tobacco Co., 94 NY2d 43, 53.) In addition, the Appellate Division, Second Department further held that it is immaterial whether plaintiffs contend that there is an issue of addiction because it is an underlying issue which requires plaintiffs to prove whether individual members were addicted to the particular product ( Geiger v. American Tobacco Co., 277 AD2d 420, 421 [2nd Dept. 2000]). Similarly, here, it is necessary to determine whether the plaintiff class was dependent upon the drug and if their dependence rose to the level of addiction.
Typicality
The third requirement of "typicality" is also not satisfied. While it is true that the Appellate Division in 1980 established that typicality is met if the plaintiffs' claims are due to the same legal theory ( Friar at 99]), more recent case law has interpreted that more specifically. In 1996, the Appellate Division, Second Department held that a class action against a doctor was inappropriate because the extent of damages for each individual had to be separately established and investigated ( Komonczi v. Fields, 232 AD2d 374, 375 [2nd Dept. 1996]). Similarly, the effect of the prescription on each individual class member is more likely than not to be individually determined. If, for instance, injuries range from sexual dysfunction, to nightmares, to symptoms of withdrawal and social ineptitude, it is difficult to claim there is any "typical" injury. Without a clearly defined common injury or signature disease, the five plaintiffs named cannot be typical of an entire group.
Adequacy
This court finds that the "adequacy" requirement of CPLR § 901(a)(4) would indeed be met by the named plaintiffs. They have all agreed to represent the class to the best of their ability and objections raised by the defendants to their adequacy speak more to typicality than adequacy.
Likewise, the plaintiffs' counsel would fairly represent the claims of the plaintiff class in the event that such a class would be formed. The denial of such class action has nothing to do with the adequacy of plaintiffs or their counsel.
Efficiency
It is conceded that class certification may be the most efficient means of handling numerous cases. With the apparently large number of plaintiffs that will be joined there is no doubt that it would be easier for all involved to try those cases in one class action. However, the "efficiency" provision does not trump the other factors and CPLR § 901(a) requires that all five provisions be met.
Generally, the courts have been unwilling to certify mass tort class actions under Article 9. The seminal products liability class action case in New York is Rosenfeld v. A.H. Robins Co. Inc. ( 63 AD2d 11 [2nd Dept 1978]). There the plaintiff, Doris Rosenfeld, claimed she was injured by the Dalkon Shield, an intra-uterine device manufactured by the defendant-pharmaceutical company on behalf of herself and other women similarly situated. Class certification in Rosenfeld was denied by the Supreme Court in Nassau County. On appeal, the Appellate Division, Second Department affirmed the order that denied class certification based on the complexities surrounding the issues of fact. The court noted that for mass tort or mass accident situations, "the courts should seriously consider isolating the issue of liability for class action treatment, while allowing the individual determination or damages to be tried separately" ( id. at 15). Interestingly, the court referred to Alfred S. Julian, a prominent plaintiff's attorney who represented 10 other Dalkon Shield users, who asserted that products liability class action suits are to be cautioned against because of "the difficult question of causation and the extent of injury which they represent" ( id. at 16, quoting Alfred S. Julien, NYLJ, May 31, 1972, p 6, col 4).
The Appellate Division did recognize that "it would be possible to determine several important factual issues on a class basis, including (1) the existence of a defect or defects in the Dalkon Shield, (2) the nature of the representations and warranties made with respect to the device and (3) whether the warranties and representations were false. But assuming, arguendo, that these issues were to be decided in plaintiffs' favor, individual determinations would still be required on several "key" issues, among them (1) whether the injuries to individual class members were, in fact, caused by the defect or defects and (2) whether the individual class members detrimentally relied on the false representations or warranties" ( Rosenfeld at 14). The difficulty in determining causality in personal injury claims warranted that they be resolved on an individual basis and hence, precluded the finding of common questions of fact or law and, in turn, denied class certification in Rosenfeld.
More recently, the issue of addiction has been asserted in other prominent tobacco class certification motions. The New York Court of Appeals addressed the issue of addiction and held that issues of addiction were individualized and therefore, not appropriate for class certification ( Small v. Lorillard Tobacco Co., 94 NY2d 43). Small consolidated five proposed class action suits where the plaintiffs alleged that defendants deceived them about the addictive properties of cigarettes and fraudulently induced them to purchase and continue to smoke cigarettes ( Small at 50). While the trial court granted class certification, the Appellate Division reversed because individual issues would "predominate" throughout the class. Under the General Business Law, the Appellate Division found that individual proof of addiction remains at the core of proving "injury" ( id. at 53).
Similarly, the Appellate Division, Second Department, affirmed the Supreme Court of Queens County, which denied class certification of New York State residents, who contracted lung and/or throat cancer from smoking cigarettes up to 1969, before warnings were placed upon cigarette packages ( Geiger v. American Tobacco Co., 277 AD2d 420 [2nd Dept. 2000]). In Geiger, the trial court judge had denied class certification because the "common" issues presented by the plaintiffs were actually issues dependent upon resolving the issues of addition and causation on each individual member of the class. The court went on to add that each issue of causation must be resolved on a case by case basis and thus, the difficult question of causation and the extent of injuries (citations omitted) weigh against class action."
The difficulties in finding a common issue of fact or law is compounded in personal injury and products liability mass tort cases because of the "predominance" of individualized or plaintiff-specific questions. There is no need to consider additional claims made by both parties, particularly those relating to CPLR § 902 concerning the nature of the order allowing a class action. It is clear that CPLR § 902 will not be considered if CPLR § 901(a) fails on the merits. Without initially granting a class, there can be no order governing that class.
NY Litigation Coordinating Panel
The New York Litigation Coordinating Panel was established pursuant to the New York Uniform Rules for Trial Courts § 202.69 in 2002. The Panel is the New York State version of the Federal Multi-District Litigation Panels of the U.S. District Courts, which handle complex matters of common law or facts in actions pending in the various venues of the jurisdiction. The Litigation Coordinating Panel is composed of four Supreme Court judges one from each judicial department. The procedures and standards for coordination are:
See Mark Hermann and Geoffrey J. Ritts, "New York Adopts Procedures for Statewide Coordination of Complex Litigation," New York State Bar Journal, October, 2003 at pg. 20-23. See also, David Fleischer and Jodi Kleinick, "Coordinating Multidistrict Cases in State Courts: Procedure Enables Parties to Manage Litigation, Minimize Discovery Costs and Share Tasks," New York Law Journal, December 1, 2003.
(2) Procedure. The panel shall determine, sua sponte or upon application of a party to an action, a justice before whom such an action is pending, or an administrative judge, whether the related actions should be coordinated before one or more individual justices. The panel shall provide notice and an opportunity to be heard to all parties to the actions sought to be coordinated and shall inform the justices before whom such actions are pending of the initiation of proceedings before the Panel.
(3) Standards for Coordination. In determining whether to issue an administrative order of coordination, the Panel shall consider, among other things, the complexity of the actions: whether common questions of fact or law exist, and the importance of such questions to the determination of the issues; the risk that coordination may unreasonably delay the progress, increase the expense, or complicate the processing of any action or otherwise prejudice a party; the risk of duplicative or inconsistent rulings, orders or judgments; the convenience of the parties, witnesses and counsel; whether coordinated discovery would be advantageous; efficient utilization of judicial resources and the facilities and personnel of the court; the manageability of a coordinated litigation; whether issues of insurance, limits on assets and potential bankruptcy can be best addressed in coordinated proceedings; and the pendency of related matters in the federal courts and in the courts of other states. The Panel may exclude particular actions from an otherwise applicable order of coordination when necessary to protect the rights of parties.
After reviewing these five cases it is apparent that the plaintiffs are all prescribed users of OxyContin, which is manufactured and distributed by the same defendants. Since the defendants are common to all of the OxyContin lawsuits, much savings can be afforded both the plaintiffs, the defendant and the Unified Court System by coordinating the discovery of documents and the deposition of witnesses. Those efficiencies can be extended to a lesser extent to the individual plaintiffs who have similar, but not identical, scenarios as to how and why they were prescribed the drug and their individual reactions to it. However, coordination may more efficiently depose and physically examine the plaintiffs in a more systematic fashion than can occur if these cases were to remain in several counties of the New York Supreme Court. Moreover, the law governing these cases will also be similar to the cases to be coordinated.
The Federal Experience with OxyContin
Federal courts have consistently denied class certification in OxyContin cases. Various U.S. District Courts have ruled that plaintiffs cannot meet the pre-requisites for class certification found in Rule 23(a) of the Federal Rules of Civil Procedure. In 2002, the U.S. District Court for the Eastern District of Kentucky denied class certification in two cases.
Federal Rules of Civil Procedure Rule 23(a): Prerequisites to a Class Action. One or more members of a class may sue or be sued as representative parties on behalf of all only if (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.
In Foister v. Purdue Pharma (2002 US Dist LEXIS 8192 [ED KY, 2002]) the plaintiff's motion for class certification was denied because the essential threshold question of whether a class existed was unanswered. "When examining whether a class exists, if 'the vague and indefinite description of the purported class depends upon the state of mind of a particular individual, rendering it difficult, if not impossible, to determine whether any given individual is within or without the alleged class,' certification is not appropriate" ( Foister at 13, citing Chaffee v. Johnson, 229 F Supp at 448 [SD Miss. 1964] and Simer v. Rios, 661 F.2d 655 [7th Cir. 1981].) Plaintiffs asserted that the proper class definition should be "all persons who have been harmed by the addictive nature of OxyContin," however the court found this to be an inadequate definition because of the "plaintiff-specific information" required in order to ascertain the class ( id. at 17).
The Purdue Defendants include Purdue Pharma, L.P., Purdue Pharma, Inc., The Purdue Frederick Co., and the "Partners Against Pain" website. The Abbott Defendants include Abbott Laboratories, Inc. And Abbott Laboratories, Inc., d/b/a, Abbott Sales Marketing and Distributing Company.
The U.S. District Court Judge in Foister also cited to Newton v. Southern Wood Piedmont Co. ( 163 FRD 625 [SD Ga. 1995], aff'd, 95 F.3d 59 [11th Cir. 1996]). In Newton, "plaintiff-specific information" was required where the plaintiffs sought a class certification based on medical problems from alleged chemical exposure. The types of questions required in ascertaining the class included: "the duration of exposure, dosage of the chemical each plaintiff received, method of exposure to the chemical and individual health and medical histories" ( id. at 14). "The Court would need to determine a number of highly subjective facts that are dependent on the state of mind of particular individuals to ascertain whether any given individual is within or outside the alleged class. As a result, this definition is vague and calls for subjective medical conclusions" ( id. at 18).
On October 17, 2002, Judge Danny C. Reeves, the same U.S. District Court Judge who decided Foister wrote in Gevedon v. Purdue Pharma ( 212 FRD 333 [ED KY, Oct. 17, 2002]) that the "plaintiff-specific information" required in ascertaining the class called for "subjective medical conclusions" and was too vague. In Gevedon, the plaintiffs sought to certify a class which included "all persons in the Commonwealth of Kentucky who have obtained OxyContin and/or who obtain OxyContin in the future." Finding that the plaintiffs sought to certify a class based on medical problems, addiction and damages, the "Court or jury would be faced with a number of questions that are highly individualized in nature and called for plaintiff-specific information" in determining liability.
The Purdue Defendants referred to collectively are: Purdue Pharma, L.P., Purdue Pharma, Inc., The Purdue Frederick Company, Purdue Pharmaceuticals L.P., the P.F. Laboratories, Inc., and PRA Holdings, Inc.
"Such an inquiry would include where the putative class member obtained the drug, whether possession of the drug was legal, and whether each member was, in fact, injured as a result of obtaining the drug. Further inquiries would include the assurances each Plaintiff received from his treating physician, individual medical histories, dosage and length of prescriptions and method of taking the drug. Basically, this Court would been to determine and resolve a number of highly subjective facts, many of which are dependent on the state of mind of particular individuals, in order to ascertain whether any given individual is within or outside the alleged class" ( Gevedon at 10)
While the existence of the class was at issue in the U.S. District Court in Eastern Kentucky, another U.S. District Court in the Southern District of Ohio similarly ruled in Wethington v. Purdue Pharma L.P., 218 FRD 577 (SD Ohio 2003), that the plaintiffs failed to satisfy the commonality requirement under Federal Rules of Civil Procedure Rule 23(a)(2). In Wethington, the court ruled that for class certification, plaintiffs must satisfy the four prerequisites, numerosity, commonality, typicality and adequacy, in addition to one of the three types of class actions under Federal Rules of Civil Procedure Rule 23(b). While Judge Reeves in the Eastern District of Kentucky rejected attempts to establish numerosity based on sales figures of OxyContin alone, Senior Judge S. Arthur Spiegel in Wethington found that inferences in favor of the plaintiffs could be made from prescription records ( id. at 22). "Plaintiffs represent that in Ohio alone there were almost a million prescriptions in one year. Although one million prescriptions does not necessarily translate into one million claimants, Plaintiffs have further submitted three hundred adverse event reports submitted to the FDA, documenting alleged problems with withdrawal and dependency" ( id. at 23).
To satisfy Fed.R.Civ.Pro. Rule 23(a)(2), there must be "questions of law or fact common to the class." The commonality requirement is satisfied "as long as the members of the class have allegedly been affected by a general policy of the defendant and the general policy is the focus of the litigation" ( Wethington at 23, quoting Day v. NLO, Inc., 144 FRD 330, 333 [SD Ohio 1991]). However, the existence of any question is not enough to satisfy the requirement. Rather, "what [the court looks] for is a common issue the resolution of which will advance the litigation" ( id., citing Sprague v. GMC, 133 F.3d 388, 397 [6th Cir. 1998]). In Wethington, the plaintiffs, under ten differing legal theories, alleged that defendants' actions have "resulted in risks of serious bodily harm, addiction, and death to member of the proposed class" ( id. at 3). The common issues alleged by the plaintiffs focused on the defendant's conduct rather than the individual medical histories of the members of the class ( id.). Referring to the reasoning of the Foister and Gevedon courts, the Wethington court opines that the claims at issue will "vary from plaintiff to plaintiff" ( id. at 31). In Foister "any harm suffered by Plaintiffs may be due to a number of factors, including, dosage, use and manner of administration of the drug, individual and family medical and psychological histories, level of personal awareness regarding the purported risk and medical reasons for use" ( Foister at 25). Therefore, commonality was not established. Likewise, in Wethington, the court states that "the factual circumstances of addiction are individualized" ( Wethington at 31) and therefore commonality is not established.
Moreover, "regardless of the defendants' marketing and promotional tactics, the learned intermediary doctrine operates as an exception to a manufacturer's duty to warn the ultimate consumer and shields manufacturers from liability where the warning to the prescribing physician is adequate" ( id. at 34). In Wethington, the putative class definition consists of individuals from four states who have a "legal prescription" for OxyContin. The defendants proffered evidence showing that there has always been disclosures of the relative potency of OxyContin as compared to morphine and other opioids in the package insert. Furthermore, the defendants stated that they have always told doctors that oxycodone (the main ingredient of OxyContin) is twice as potent as morphine and a potentially addictive drug. The Wethington court found that this adequately warned prescribing physicians of the relative potency of OxyContin as compared to morphine and thus, the learned intermediary doctrine discharges the duty to warn from the manufacturer to the physician ( id. at 34). Hence, in Wethington, liability turned on individual determinations.
In another attempt at a federal class certification in the U.S. District Court for the Eastern District of Missouri, Judge Mummert denied that application in for failure to satisfy three of the four pre-requisites of Federal Rules of Civil Procedure Rule 23(a) ( Campbell v. Purdue Pharma, L.P. No. 1:02 CV 00163 TCM (ED Mo. June 25, 2004) In Campbell, plaintiffs sought to represent a class described as "All persons residing in the state of Missouri who were prescribed and consumed OxyContin for the treatment of any condition other than moderate to severe pain caused by terminal illness or moderate to severe pain caused by non-chronic condition, who have suffered harm as a result, including but not limited to development of physical dependence to OxyContin and/or withdrawal symptoms as a result of discontinuing its use" ( id. at 1).
In examining the class certification prerequisites, Judge Mummert found that plaintiffs satisfied the numerosity requirement. The court was not persuaded by the Plaintiffs' estimate that there were "thousands of persons in the Class" however, "given the volume of OxyContin sales and prescriptions, it is reasonable to assume that the class defined by Plaintiffs would have such numbers that their joinder would be impractical and inconvenient" ( id. at 7-8).
However, the court found that the commonality, typicality and adequacy requirements were not satisfied. Like Foister and Gevedon, the court, in addressing the lack of a common question of law or fact, opined of the "necessity of determining whether any of the alleged wrongful acts of Defendants caused any harm to the class members." For such a determination to be made, inquiries must be made to each individual's physician's reasoning for prescribing OxyContin" ( id. at 10). Furthermore, there is "no identity of causation between Defendants' complained-of activities and the alleged harm" ( id. at 13).
The Campbell court also found that the plaintiffs' claims were not "typical of the claims or defenses of the class" (Fed Rules Civ Pro Rule 23[a]). Reciting the pharmaceutical records of both representative plaintiffs, the court points out "the individual nature of any inquiry into the essential element of causation, even as to the 'typical' claims of the putative class representatives" ( Campbell at 16). The court specifically stresses "the varied dosages of OxyContin taken by the Campbells, their concomitant use of other opioids and medications, the affirmative defenses available to Defendants . . . and the possible comparative fault of the Campbells" ( id. at 17).
David Campbell filled 436 prescriptions for various synthetic narcotics and antidepressants between January 9, 1999 to November 11, 2003. His first prescription for OxyContin was for 40 milligram tablets although, according to the Physicians' Desk Reference (55th ed. 2001), a "reasonable starting dose" for opioid naive patients is 10 milligrams and a five-step conversion process is indicated for patients currently on opioid therapy. "Thus, the propriety of OxyContin being prescribed for Mr. Campbell and any harmful effects of it being prescribed would necessarily require an inquiry into his other medications." Belinda Campbell filled 247 prescription from October 28, 2999 through November 11, 2003. She also was prescribed more than one opioid (OxyContin and Vioxx), at the same time she was prescribed an anti-anxiety medication and an antidepressant. Her physician noted that she was supplementing OxyContin on her own initiative. ( Campbell at 15-16).
Addressing the adequacy requirement, the court simply writes that "it is the individual nature of the Plaintiffs' claims as outlined above that precludes the Court from finding that they have 'common interests with unnamed members of the class'" ( id. at 17, citing Gevedon, 212 FRD 333 at 25). In Gevedon, the plaintiffs did not present any factual allegations to support this element of class certification. Rather, the court states "these allegations merely parrot the language of Rule 23(a)(4)" ( Gevedon at 26).
Ohio State Court
While no federal court has granted an OxyContin class certification motion, in July 2003, the Court of Appeals of Ohio affirmed the certification of three state-wide class actions from the Butler County Court of Common Pleas brought in August of 2002 by LaDonna Howland, et al. regarding the prescription drug OxyContin against Purdue and Abbott ( Howland v. Purdue Pharma, L.P., 2003 Ohio 3699 [Ohio App. 12th Dist., 2003]).
OxyContin was designed, tested, manufactured, promoted, marketed, sold, and distributed by Purdue Pharma, L.P., along with its affiliates, Purdue Pharma, Inc., The Purdue Frederick Company, Purdue Pharmaceuticals, L.P., The P.F. Laboratories, Inc., and PRA Holdings, Inc. Purdue had an agreement with Abbott Laboratories and Abbott Laboratories, Inc. to "co-promote" OxyContin to hospitals and certain physicians.
The Ohio Court of Appeals was not persuaded by the defendant's arguments that the plaintiffs failed to meet the requirements of Ohio's class action found in Ohio Rules of Civil Procedure, Rule 23(a) and (b). Ohio, unlike New York, had adopted rules identical to the Federal Rules of Civil Procedure. In Ohio, 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" ( id. at 9, citing Marks v. C.P. Chem. Co. Inc., 509 NE2d 1249 [Ohio 1987]). "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 [Ohio] 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" ( id., citing Hamilton v. Ohio Sav. Bank, 694 NE2d 442, 447 [Ohio 1998]).
However, on December 15, 2004 the Ohio Supreme Court reversed the Ohio Court of Appeal in a four to three majority decision, which held that the trial court did abuse its discretion in certifying OxyContin prescribed users as a class ( 2004 Ohio 6552). The majority of the Ohio Supreme Court held that the plaintiffs failed to meet the commonality requirement. The three dissenting judges held that the majority misapplied the abuse of discretion standard and should not have considered how all of the various other state courts and federal courts ruled in similar applications to establish a class action for OxyContin users.
Under the strict rules of stare decisis, the Howland minority is correct in that the Ohio trial courts are not bound to follow the holdings of sister states or federal courts on matters interpreting the Ohio class action statute. However, the minority of the Ohio Supreme Court faulting the members in the majority for reviewing such rulings appears to be more egregious. Similarly, here in New York, while this state trial court is not bound by the majority opinion of the Ohio Supreme Court or the various U.S. District Courts cited herein, in a world of instant computerized legal research, it would appear to be almost unenlightened to rule on a case of such magnitude, which could affect potentially thousands of people without knowing what other courts have done under similar circumstances, which may be persuasive. This court agrees with the majority holding of the Ohio Supreme Court which found an abuse of discretion on the part of the Butler County Judge's decision which misapplied the commonality requirement of Rule 23(a).
Notwithstanding the reversal of class certification by the Ohio Supreme Court, plaintiffs' counsel in this case urges this court to look to the well reasoned dissent and the trial court's original decision. Here, it is important to distinguish the Ohio trial court's decision. While Rule 23 of the Ohio Rules of Civil Procedure is similar to NY CPLR § 901, it is not identical. Rule 23 of the Ohio Rules of Civil Procedure, which outlines the prerequisites to a class action is identical to Rule 23 of the Federal Rules of Civil Procedure, except that the Ohio rules include a subdivision (F), which allows "The claims of the class shall be aggregated in determining the jurisdiction of the court. The provisions include numerosity, commonality, typicality and adequacy." However, the second provision, commonality, does not contain the further predominance standard found in CPLR § 901(a)(2). Rather, the predominance issue is raised in Ohio Rule 23(B)(3), which deals with whether a class action is maintainable. That provision is the equivalent of CPLR § 902, which covers the order allowing class action which is conditioned on whether all the requirements of CPLR § 901(a) have been met. Since the "commonality" and the "typicality" requirements have not been met the analogous considerations found in CPLR § 902 are not applicable.
Since New York law requires predominance before reaching the issue of maintaining the class, this is a significant difference between the Ohio and New York statutes. Further, Ohio case law appears to give greater deference to the discretion of its trial judges than New York appellate judges may in determining whether to sustain an order granting a class. New York Appellate Courts would review whether the statute was properly complied with as "a matter of law," and then whether there was an abuse of discretion before giving deference to the decision of the trial judge. Here, New York's case law as outlined above would be directly violated by granting certification in the instant manner. The present case is sufficiently distinguishable from the Ohio trial court decisions which in the end was reversed by the Ohio Supreme Court.
Indiana State Court
On December 31, 2004, a trial judge of the Indiana Circuit Court also denied a class action in another OxyContin case entitled Johnson, et al. v. Abbott Laboratories, et al. and Purdue Pharma L.P., et al. [Cause No. 06C01-0203-PL-89 and Cause No. 06C01-0206-CT-243 (Boone Circuit Ct. Ind., 2004)]. In the Johnson case, an Indiana Circuit Court Judge ruled that the plaintiffs did not satisfy the various requirements of the Indiana Trial Rules (TR) 23, 23(A) and 23(B) governing class actions which are similar to the Federal Rules of Civil Procedure. The court held that the plaintiffs failed to demonstrate that they were representative of a class of OxyContin users and that the class was so numerous that joinder of all members is impracticable as is required under TR 23(A)(1).
Moreover, the Indiana trial court decided that the plaintiffs failed to demonstrate that there were common issues of fact, especially since Indiana had adopted the informed intermediary doctrine, which provides that the duty of a pharmaceutical manufacturer to warn of a drug's risk and potential side effects extends not to the patient (plaintiffs), but to the patient's prescribing physician ( Ingram v. Hook's Drugs, Inc. 476 NE2d 881 (Ind.App. 1985)). The court also held that several of the plaintiffs were prescribed OxyContin for different reasons and that at least one of them had taken the drug illegally, while two others had extensive opioid histories, the plaintiffs could not establish that they were "typical" of all OxyContin users. Hence, the plaintiffs could not satisfy the requirements of TR 23(a)(3).
Lastly, the Indiana Circuit Court held that since the plaintiffs could not demonstrate that there were "common" issues, they could not predominate as required by TR 23(B)(3). Unlike the Indiana Johnson case, the plaintiffs in the instant New York case before this court are all legally prescribed users of OxyContin. However, the Johnson case was cited here to demonstrate again that no state or federal court has been sustained in maintaining a class action for OxyContin users.
Accordingly, it is hereby:
ORDERED, that the plaintiffs' motion for an order establishing a class action is denied; and it is further
ORDERED, that these matters are referred to the New York Litigation Coordinating Panel pursuant to NY CLS Unif. Rules, Trial Cts. § 202.69(3) to review whether the various cases pending in the Supreme Court of Richmond County and New York County, and such other counties of the state, should be subject to an order of coordination to conduct all discovery before one designated judge; and it is further
ORDERED, that a copy of this decision and order is being sent to the New York Litigation Coordinating Panel at 60 Centre Street, New York, New York 10001 so that the Justices on the panel may determine whether coordination would be appropriate; and it is further
ORDERED, that counsel for the plaintiffs and the defendants in the action submit by affidavit to the New York Litigation Coordinating Panel at 60 Centre Street, New York, New York, by February 18, 2005, whether they consent to or oppose coordination of discovery before one judge pursuant to the New York Unified Rules for Trial Courts § 202.69; and it is further
ORDERED, that a copy of this decision and order is to be forwarded to the plaintiffs' counsel and other Justices who have similar OxyContin cases pending before the courts of this state, which currently are:
Hurtado, et al. v. The Purdue Pharma Co., Index No. 12648/03 (Richmond Cty., Justice Joseph J. Maltese)
Sara v. The Purdue Pharma Co., Index No. 13699/03 (Richmond Cty., Justice Joseph J. Maltese)
Serafin v. Purdue Pharma, L.P., Index No. 103031/04 (New York Cty., Justice Stanley L. Sklar)
Washington v. Purdue Pharma L.P., Index No. 107841/04 (New York Cty., Justice Paul G. Feinman)
There are also five other individual cases in the United State District Court in the Southern District of New York.
Machey v. The Purdue Pharma Co., 1:04-CV-02098-TPG (Judge Thomas P. Griesa); Pratt v. The Purdue Pharma Co., 1:04-CV-02100-TPG (Judge Thomas P. Griesa); Wilson v. The Purdue Pharma Co., 1:04-CV-02103-BSJ (Judge Barbara S. Jones); Ruth v. The Purdue Pharma Co., 1:04-CV-02101-GEL (Judge Gerard E. Lynch); Terry v. The Purdue Pharma Co., 1:04-CV-02102-TPG (Judge Thomas P. Griesa).