The rapid growth in claims involving hazardous products has spawned a new area of practice, mass tort litigation. The public is acutely aware of billions of dollars offered to resolve claims from thousands of victims related to asbestos, the Dalkon Shield, breast implants and tobacco. Now, another mass tort arrives on the scene, Phen/Fen.
As research continues, litigation have begun to protect the public and to provide compensation for those injured by this diet therapy. Legal claims based on the dangers of Phen/Fen will affect every user, from those who have no symptoms to the seriously ill. This article will explore the history of Phen/Fen, its medical risks, and relief available to victims who have suffered injury, disability or death.
DRUG HISTORY & MEDICAL RISKS:
The adverse health effects of Phen/Fen are now the focus of intense attention. On July 8, l997, CNN had a pre-publication story about an article in The New England Journal of Medicine, published August 27, l997. Early release of a medical article is usually reserved for the most serious health matters. Prior to this study, Phen/Fen's most serious side-effect was Primary Pulmonary Hypertension (PPH), a potentially fatal disorder which produces high blood pressure, shortness of breath and fatigue. Now, the NEJM, a respected journal, linked the drugs to another major problem - heart valve damage.
The NEJM article was based on observations at the Mayo Clinic. On July 8th, the Clinic reported unusual heart valve disease in 24 patients who had taken Phen/Fen. As U.S. physicians had written 18 million prescriptions in 1996, the Clinic acted quickly, and the FDA responded. On Sept. 12, 1997, the FDA notified doctors and drug makers of evidence of cardiovascular symptoms in 30% of Phen/Fen users. Testing showed that one or more heart valves in each patient was thickened and blood leaked backwards, making the heart work harder. Some patients had pulmonary PPH, at times fatal, and others needed surgery to repair damaged valves. These alarming results forced Wyeth-Ayerst, the maker of dexfenfluramine (Redux) and fenfluramine, to withdraw them from the market. As to causation, Dr. Heidi Connolly, a Mayo cardiologist said: "We know that fenfluramine and phentermine alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause valve injury". The 24 women in the Mayo report used Phen/Fen for 1 year and had no prior heart disease. The first case of heart disease was noticed 1 year ago, and doctors have seen an increase in patients with serious problems.
Criticism of the Phen/Fen craze had been widespread before the regulatory warnings were issued. Over the past few years, many experts had become very concerned about the soaring misuse of drugs in the treatment of obesity. In a commentary in the March 24, l997 journal Archives of Internal Medicine, Dr. Robert Kushner, a professor of medicine and Director of the Weight Loss Clinic at the University of Chicago, warned that many physicians without adequate training or expertise were establishing "Phen/Fen" treatment centers. Dr. Kushner expressed the concern that many of these programs were placing profit above the health concerns of their customers. Because of safety risks, he recommend that diet drugs only be used by people defined as obese and that drug therapy is only one component of a comprehensive approach to weight loss.
The FDA investigation has been infected with conflicts and potentially dangerous regulatory mistakes. Although Redux was narrowly approved in the Spring, l996, neuroscientists continued to press for public hearings into studies which showed potential brain damage as a side effect. The scientists, including Dr. Mark Molliver of Johns Hopkins and Dr. Lewis Seiden of the University of Chicago, attacked the FDA for postponing hearings concerning findings that Redux causes neurotoxicity, or brain damage. The agency was accused of contributing to a public health crisis by consumer advocates. The debate intensified until the Drug Enforcement Agency listed Redux as a controlled substance, meaning that distribution would be closely monitored, though in reality this did not occur.
After two years of debate and mounting evidence of serious side effects, a lone cardiologist almost single-handedly took on a mega pharmaceutical company and a recalcitrant regulatory agency. Dr. Heidi Connolly of the Mayo Clinic sent shock waves through the diet pill industry when she produced findings that 30% of Phen/Fen users may be at risk for heart value damage. The FDA summoned executives from American Home, and, after reviewing disturbing data, the drug maker relented. Emergency notices were mailed to health care providers and Redux and Pondimin, one-half of the Phen/Fen combination, were withdrawn. Overnight Phen/Fen centers closed and weight loss centers, like Jenny Craig, sought to reorganize their programs and emphasize total health diet therapy.
The Phen/Fen ban has now shifted the focus from a regulatory debate to an onslaught of legal actions against every entity involved in the diet drug industry. Now, the legal community - the most effective and powerful consumer protection sector in the country - is mobilizing to enforce drugs rules and to obtain fair compensation for those injured, and meet out a measure of punishment to those at fault. With evidence of such callous disregard for the health of a diet conscious public, an army of lawyers will attack every enemy, ranging from the drug makers and distributors to profit driven diet centers and quack doctors who handed out prescriptions like candy in a drugstore.
THE LEGAL RESPONSE:
Legal maneuvers will lead to thousands of suits, including class actions, injury claims, multi-district proceedings, bankruptcies, hearings, appeals and a litany of rulings that will affect public health for decades. The response has been swift and pervasive & may ultimately result in tort plans that rival the $2.4 billion Dalkon Shield and the $4.5 billion breast implant accords.
Fenfluramine (Fen) and Phentermine (Phen) have been on the market since the 1970s. In l992, Dr. Michael Weintraub conducted a Rochester University study describing the long term successful results of combining the drugs. Thereafter, the Phen/Fen craze swept the weight loss industry and drug makers sought to ride the crest of a marketing wave that promised hundreds of millions of dollars in new revenue. With lax prescription controls, the users, and profits, increased into 1997. The obesity problem compelled the need for a quick and effective remedy. When this issue combines with the public's obsession with beauty and appearance, millions joined the Phen/Fen craze, from the morbidly obese to those who just wanted to be cosmetically thinner. Phen/Fen became the "magic bullet" for over 60 million worldwide. Doctors, Internet sites, diet centers and "snakeoil salesmen" got on the bandwagon touting the wonders of Phen/Fen. Now, the parade stops and the law suits begin.
The liability for mistakes in selling the drugs is enormous and will touch every entity involved in America's addiction to Phen/Fen. With studies linking serious heart damage to the drugs, some experts predict that the exposure for those at fault may be 100s of millions of dollars, or even greater. The chain of responsibility begins with drug makers and leads to diet centers. A user who can show Phen/Fen-related injuries can explore a number of options. First, class actions seek special equitable relief, but may not provide fair compensation for pain and disability. At the present time, class actions exist to help those without symptoms obtain medical supervision and assistance to determine if they have PPH or heart valve problems. See, Gardner v.Gate Pharmaceuticals, No. C97-2542 (ND CA).
The large number of cases may result in the exercise of control by the Judicial Panel on Multidistrict Litigation under 28 U.S.C. Sec. 1407. An MDL petition has been filed requesting that all cases be transferred to one district to coordinate pre-trial discovery and liability issues, to achieve consistency of rulings and judicial economy. See, In re Diet Drugs Litigation, No. 1203 (JPML, filed Sept. 20, 1997). The petition seeks joint control over "identical legal and factual issues" that control the litigation, such as failures to test and warn, and equitable issues like medical monitoring and revised notifications. The application cites precedent that may warrant judicial oversight from the securities and antitrust arenas, and includes similar mass tort cases. See, In re "Agent Orange" Prod. Liablity Litig., 597 F. Supp. 740 (EDNY l984), affirmed, 818 F.2d l45 (2nd Cir. L987).
Mass tort litigation on this scale has resulted in coordinated plans which serve judicial economy and some plaintiffs. The large number of breast implant claims justified MDL status and the cases have been managed by one Federal judge. See, In re Silicone Gel Breast Implant Litigation, MDL 926 (USDC AL). The transfer resulted in a "global settlement" with short-term relief, limited recovery rights, a claims process, and complex rules controlling future law suits. In complex cases, federal judges are considered "gatekeepers" under the Federal Rules, and can also screen scientific testimony to make certain that an expert's methodology is "reliable" and "qualified". See, Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Although the wisdom of Daubert has been questioned, it may force an MDL judge to establish an independent Phen/Fen panel to determine medical causation issues that may bind related cases.
The implant MDL experience provides guidance as to how Phen/Fen claims will play out in the courts. Since both cases involve thousands of potential injuries and medical science that has not been fully developed, lower level claimants may benefit from a common plan, but the seriously injured can be held hostage by restrictive rules that do not give an adequate remedy. The recovery rights of the seriously injured must be protected at the state and federal levels. The job of the litigator is to find the best avenue of recovery and to use complex mass tort rules to the client's advantage.
A full appraisal involves intricate issues related to negligence, strict liability, fraud, failure to warn, and malpractice. Since warnings on prescription drugs are regulated by the government, a review of rights will involve preemption rules and whether or not the manufacturer complied with FDA regulations. Also, a court may apply the "learned intermediary doctrine" to the distribution of drugs, meaning that the maker has the duty to warn the medical community of risks, not the individual patient. See, Hawkins v. Richardson-Merrell, Inc., 249 S.E.2d 286 (1978); McKee v. American Home Products Co., 782 P.2d 1045 (Wash. 1989). However, if a manufacturer fails to warn of risks it had reason to foresee, the maker can be held liable in strict liability and negligence. See, Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (ND GA 1985). Based on strict liability, the first Phen/Fen case was recently settled for a confidential amount in Jonez v. A. H. Robins Co., No. 96-4310 (ND CA). The plaintiff had pulmonary hypertension (PPH), after taking Phen/Fen for two years.
As a general rule, most courts have held that a pharmacist does not have a duty to warn of a drug's adverse effects. See, Ramirez v. Richardson-Merrill, Inc., 628 F. Supp. 85 (ED PA 1986). Pharmacists are responsible for properly filling prescriptions, while the physician is obligated to assess health and to determine the proper treatment. Notwithstanding, a trend has developed to expand the pharmacist's duty to include advising a patient of drug risks, or dangers in combining medications. Government regulations require pharmacists to provide some degree of drug counseling, particularly to Medicaid recipients. 42 U.S.C. Sec. 1396r-8(g)(2)(A); Fla. Admin. Code Ann. Sec. 21s-1.035 (1990). Based on these laws, one court has ruled that pharmacists have a duty to warn of the adverse effects of the drugs they distribute. See, Lasley v. Shrake's County Club Pharmacy, Inc., 880 P.2d 1129 (Ariz. 1994). Although Congress and most states have passed statutory standards, the courts must decide whether negligence or failure to warn claims can be brought against a pharmacist.
The potential parties also include a doctor or weight loss clinics. Because the drugs required a prescription, the health care consultant should take a medical history and discuss Phen/Fen risks. Phen/Fen did not undergo full FDA testing and utmost care should be exercised before using the drugs. During therapy, patients should be supervised to make certain Phen/Fen provides a safe and effective diet program. The failure to monitor a user's condition recently forced a doctor to pay $250,000 in damages for disability and emotional injury. This is one of the first known Phen/Fen recoveries, and indicates that liability will include medical malpractice. See, Tresemer v. Barke, 150 Cal. Rptr. 384 (1978).
Once a claim is discovered, it must be brought within a certain period of time from the date injuries are manifest, which may be as short as 1 year in California. If an action is against a treating doctor, the time for filing may run from the date of negligent therapy related to a Phen/Fen prescription. See, O.C.G.A. Sec. 9-3-71. The decision to file requires a detailed legal-medical review as to the type claim and forum. If a client is a class member, an action will only involve the filing of claim forms. Phen/Fen federal cases may be controlled by the judge to whom it is assigned, meaning that all pre-trial discovery will be coordinated and that issues will be uniformly decided. On the state level, it may benefit a plaintiff to keep the case in state court to get the best recovery against all parties, while still being able to utilize discovery work and liability rulings from the federal arena.
The courts face many challenges and great opportunities. A party is usually faced with suit when death or irreparable injury has already happened. Now, the judiciary can act quickly to monitor the health of Phen/Fen users to help restore their health. For many, serious damage has not yet been discovered and a medical fund may serve the public health system. As to those who are injured, the civil justice system should expeditiously move to provide remedies in the form of fair compensation. This can be done through a plan that provides settlement options and the preservation of the right to bring individual law suits in either state or federal court.
Marketing forces placed Phen/Fen profits above the health care of diet patients. The lessons of the Dalkon Shield tragedy and its progeny have not been learned, and the courts will now intervene to enforce laws which require the safe use of prescription drugs. The law will address the Phen/Fen catastrophe and find a way to repair the lives of those who have been innocently injured.
THE AUTHOR: Guerry R. Thornton, Jr., a lawyer in Atlanta, handles Phen/Fen claims & is counsel in the Sankey action; he has prosecuted claims in the $2.5 billion Dalkon Shield plan & the $230 million Dupont Plaza Hotel disaster; he is a member of The Association of Trial Lawyers of America & has published articles on mass tort litigation in Trial Magazine & The National Law Journal; his Internet cite is: www.netlaw.net.