Managed care liability today: laws, cases, theories, and current issues

Managed care entities face numerous liability issues in today's changing healthcare environment. This Article provides the plaintiff with a comprehensive road map for navigating the many avenues of managed care liability. The author describes ERISA pre-emption provisions and suggests ways plaintiffs' attorneys can strive to narrow the pre-emption. The Article also provides in-depth analysis of each theory of managed care liability that has been litigated against managed care entities to date, and then goes on to explore state laws imposing liability on managed care entities, and how HMO liability is being reformed through legislative action. For plaintiffs' attorneys seeking the full spectrum of theories of managed care liability, or for defendants' attorneys wanting to remain updated on all potential claims to defend, this Article constitutes an extensive primer on the current issues.     

"It's Darwinism – Survival of the Fittest:" How Markets and Reputations Shape the Ways in Which Plaintiffs' Lawyers Obtain Clients

The survival of a plaintiffs' lawyer's practice depends upon the generation of an ongoing flow of clients with injuries that the civil justice system will compensate adequately. If this requirement is not met, lawyers will leave this aspect of the legal market for more promising ones. If they do, legal services for injured people will be diminished as a result. In order to find out how this personal services legal market is defined and developed, we interviewed ninety‐five plaintiffs' lawyers in Texas. These lawyers use four major strategies to get clients: client referrals, lawyer referrals, direct marketing, and other referrals. What any particular lawyer does is shaped by the geographic market from which clients are drawn, and by the lawyer's reputation. Our findings provide fresh insights for the empirical literature on plaintiffs' lawyers, and they provide an empirical context for assessing the potential impact of changes in the civil justice system, like tort reform, on the ability of plaintiffs' lawyers to obtain clients.     

Changing legal standards for proof of causation in hazardous waste tort cases. Plaintiffs' problems and congressional responses

Increasing public awareness and concern over the possible dangers of exposure to toxic chemicals and hazardous wastes has resulted in a variety of lawsuits brought by plaintiffs claiming injury resulting from chemical exposure. The legal system and its traditional approach to tort cases demands that a plaintiff demonstrate that a particular chemical substance was the "cause in fact" of his injury. However, a plaintiff's inability to present credible scientific evidence sufficient to pinpoint conclusively the specific cause of his injury or disease, particularly in cancer cases, leads to defeat in courts of law. This article discusses the existing barriers to plaintiffs' recovery in toxic tort cases and reviews congressional proposals designed to ease plaintiffs' evidentiary burden and increase their chances of prevailing.     

Red Cross and federal government held liable for hemophiliacs' HIV infection

After eight years of litigation, on 21 June 2000 three hemophiliacs infected with HIV finally won a judgment against the Canadian Red Cross Society and the federal government. An Ontario trial court ruled the Red Cross and the government were negligent for having delayed the implementation of heat treatment for blood products, which resulted in the plaintiffs' infections. Since starting their lawsuits in 1992, two of the three plaintiffs died of AIDS before the trial judgment. But the damage awards were criticized by the plaintiffs' lawyer.     

Disclosure obligations of the newly public healthcare company: practical strategies for the company and its counsel

Founders of healthcare companies, like entrepreneurs in general, dream of the opportunity to take their companies public. The benefits flowing from access to the public markets, however, carry with them additional responsibilities that are enforceable both by the regulatory authorities and the well-organized plaintiffs' securities bar. The authors of this Article provide the newly public company and its counsel extensive guidance for the navigation of this regulatory maze.     

Presbyterian Hospital of Dallas v. Harris: a dubious consequence of piecemeal health care legislation

For almost forty years, legislators have advocated comprehensive measures designed to assure Americans quality health care. Instead of implementing an integrated health care plan, Congress has intermittently enacted statutes which address specific health care delivery problems. At times the judiciary has stretched the ambit of existing health legislation in response to particular plaintiffs' urgent claims. This Case Comment examines the dilemma of piecemeal legislation and judicial policymaking as exemplified by Presbyterian Hospital of Dallas v. Harris, a Fifth Circuit Court of Appeals health care financing decision whose outcome Congress has flatly rejected.     

Suing "the welfare": the diminishing immunity for child protection authorities

Until recently, child protection authorities enjoyed significant levels of immunity in respect of civil actions arising from their action or inaction. However, the tide has turned in Australia, New Zealand and the United Kingdom. The decision of Redlich J of the Victorian Supreme Court in the complex case of SB v New South Wales (2004) 13 VR 527; [2004] VSC 513 consolidates the trend in Australia with a further repudiation of the assertion that child welfare authorities should be specially advantaged. It appears that henceforth actions will regularly be able to be brought against the state by persons who have been harmed by the negligent discharge of child protection duties. In the future, plaintiffs' biggest impediment will lie in the evidentiary challenge of establishing the extent of the harm flowing from the breach of the state's duty as against the harm wrought by previous and supervening events.     

Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.     

Litigating the science of breast cancer treatment

Beginning in the late 1980s, many health insurers refused to cover high-dose chemotherapy with autologous bone marrow transplant (HDC/ABMT) for high-risk and metastatic breast cancer patients. Insurers denied coverage because there was no persuasive evidence of clinical effectiveness. In response, many women sued to compel coverage. After years of litigation and the expenditure of approximately $3 billion, randomized clinical trials (RCTs) showed that the procedure was no more effective and possibly more harmful than conventional therapy. To understand whether and how litigation contributed to the diffusion of the procedure, we conducted a series of case studies that examine the litigation tactics and strategies used by defense and plaintiffs' counsel. Despite the fact that HDC/ABMT lacked proven scientific effectiveness, insurance defense attorneys were unable to stop the procedure's diffusion. Plaintiffs' attorneys had a much easier and more sympathetic story to tell and were able to exploit vulnerabilities facing the defense.     

Philip Corboy and the Construction of the Plaintiffs' Personal Injury Bar

Drawing on the career of Philip Corboy, this article examines the construction of the plaintiffs' personal injury bar in the second half of the 20th century. Through a relational biography based on Mr. Corboy's career, we look at the development of this subprofession in the context of the sociopolitical environment within which Mr. Corboy and his peers operated, the social capital they possessed, and the particular strategies they used as they worked to establish both a professional and market niche. This analysis shows how and why Mr. Corboy and his peers constructed a thriving subprofession that is characterized by a unique blend of working-class ideology, trial craft, professional bar leadership, Democratic politics, local philanthropy, and a market referral system — all of which reinforce the dominance and prestige of its own elite .     

Wrongful death claims. Harriton v Stephens. [2002] NSWSC 461. Edwards v Blomeley. [2002] NSWSC 460. Waller v James [2002] NSWSC 462

Studdert J in all three cases went to great length to summarise the global judicial position of "wrongful life" claims. He did not, however, examine in great length how or whether "wrongful life" claims or "wrongful birth" claims are reconcilable with tort and common law principles. Although the cases identify the difficulty in assessing and quantifying damages, they do not directly address the strict legal principles which apply in the assessment of damages. The main conclusion of the three judgments was that no duty of care is owed to the plaintiff in these circumstances and, even if a duty could be established, the impossibility of quantifying damages and public policy considerations warrant the rejection of such a claim: "thus conscience does make cowards of us all." The significance of the decisions cannot be understand. The decisions deny recognition of "wrongful life" claims in circumstances where a disabled person has incurred injuries en ventre sa mere (in the mother's womb) as a result of infections contracted by a plaintiff's mother or genetic material passed on by a plaintiff's parents. Some countries have now legislated for the abolition of "wrongful life and birth" suits. In January 2002 the French legislature passed a Bill overturning the "wrongful life" decision of the Cour de Cassation in Perruche (17 November 2000). As the issue now falls for ultimate determination by the French Senate, the French pro-life movement continues to lobby for the prohibition of "wrongful birth" suits as well. Furthermore, eight States in the United States have prohibited either one or both actions and the State of Michigan prohibited both actions in 2001. It is likely that all three cases will be appealed. The appeal in Harriton will re-examine the viability of a "wrongful life" claim in Australia whereas the cases of Edwards and Waller still need to determine the "wrongful birth" claims brought by the plaintiffs' parents. It is likely that the latter two cases will not be determined until the High Court has considered the Queensland "wrongful birth" case of Melchior v Cattanach, expected to be late in 2002.     

Equity: Effects of Input and Outcome Orientation on Taking, Giving, and Dividing Money

Participants who were more inclined to consider ambiguous work elements as inputs (input-oriented or Type-I persons) or as outcomes (outcome-oriented or Type-O persons) were presented with situations in which they had delivered a higher or lower work performance than another person. They were asked to take money for themselves, give money to the other person, and divide a fixed sum of money between themselves and the other as reward for the performances. The specific combination of (input or outcome) orientation of the participant and the type of transfer (giving, taking, or dividing) determined the reward the participant allocated to him- or herself and/or to the other person. Type-I persons showed an egocentric bias in their allocation behavior, whereas Type-O persons allocated according to a maximin strategy.     

Punishing the Awkward, the Stupid, the Weak, and the Selfish: The Culpability of Negligence

Negligence is a problematic basis for being morally blamed and punished for having caused some harm, because in such cases there is no choice to cause or allow—or risk causing or allowing—such harm to occur. The standard theories as to why inadvertent risk creation can be blameworthy despite the lack of culpable choice are that in such cases there is blame for: (1) an unexercised capacity to have adverted to the risk; (2) a defect in character explaining why one did not advert to the risk; (3) culpably acquiring or failing to rid oneself of these defects of character at some earlier time; (4) flawed use of those practical reasoning capacities that make one the person one is; or (5) chosen violation of per se rules about known precautions. Although each of these five theories can justify blame in some cases of negligence, none can justify blame in all cases intuitively thought to be cases of negligence, nor can any of these five theories show why inadvertent creation of an unreasonable risk, pure and simple, can be blameworthy.     

Contradictions, Law, and State Socialism

The relationship of law to antagonisms and contradictions within state socialism is explored from a Weberian and a Marxian perspective. Examining legislation, court decision making, legal control of economic behavior, and law enforcement reveals contradictions between (I) a radical participatory ideology versus muted or extinct civil society; (2) the ideology of comprehensive planning versus the impotence of law; (3) strategies aiming at total control of public life versus the emergence of a niche society outside the reach of the state; (4) regulatory norms versus the functional necessity of norm-breaking behavior; (5) reliance on a revolutionary sense of justice versus the cultivation of "doublethought"; (6) a program of total control of economic behavior versus the emergence of deviant, even criminal, forms of organization to fulfill functionally necessary but ideologically unapproved economic tasks; and finally, (7) two distinct practices of law, responsive or postliberal versus repressive. Yet, contradictions typically did not lead through conflict to subsequent reform during the state socialist era, as conflicts were repressed. When reforms were attempted, they furthered conflict and system breakdown.     

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user. As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol.     

Deaths among criminal suspects, law enforcement officers, civilians, and prison inmates: a coroner-based study

During the interaction between a criminal suspect and a law enforcement officer, the risk of death to the suspect, police, or civilians is increased. Unfortunately, very little information is available on the death risks arising from this interaction. This study provides an assessment of the risk of death to law enforcement officers, suspects, and bystanders by separating the interactions into the following 4 phases: (1) events prior to and during arrest; (2) police pursuits or chases; (3) transport of the suspects; and (4) during incarceration. A 5-year (1994-1998) retrospective coroner-based study of all deaths that occurred during these 4 phases was conducted in Allegheny County, Pennsylvania. A total of 77 cases were identified; 14 deaths (18.1%) occurred prior to or during arrest, 10 (12.9%) during police chases, 2 (2.6%) occurred while the actors were being transported, and 51 (66.2%) during incarceration. The majority of cases (98.7%) were males, blacks (63.6%), and single (50.6%). The respective risks of death by phase were prearrest/arrest, 6.5 per 100,000 arrests; transport, 0.93 deaths per 100,000 arrests; and incarceration, 268 deaths per 100,000 inmates. Study showed the following: (1) risk of death to offenders was greatest during police pursuits; (2) the risks during arrests are not insignificant and involved an officer being threatened with a weapon in one-third of the events; and (3) deaths among inmates were primarily due to natural causes.     

Strain,Crime, and Contingencies

Hypotheses from General Strain theory are addressed using data from a random sample of adults in Raleigh, NC. Analyses examine three issues: (1) whether strain predicts self‐projected criminal behavior; controlling for past self‐reported crime; (2) whether negative emotions mediate the relationship between strain and projected crime; and (3) whether social support and criminal peers serve as contingencies or mediators for strain in predicting criminality. Results are generally consistent with previous studies focusing on youth. Three of four measures of strain are found to predict the crime measures. However, that relationship is not mediated by negative emotion and the measures of social support and criminal peers do not act as contingencies or mediators. The results suggest that strain may not operate through negative emotions and that theoretical refinement is needed to identify which potential contingencies are likely to be operating under various circumstances.     

Interaction of butorphanol, with monoamine oxidase inhibitor, tranylcypromine.

This investigation examines the possibility of interaction between tranylcypromine and butorphanol in comparison to pethidine. The LD50 of pethidine and butorphanol were determined in mice pretreated with the non-selective monoamine oxidase (MAO) inhibitor, tranylcypromine orally for 8 days or with oral saline solution. Tranylcypromine decreased the LD50 of both pethidine and butorphanol by 78% and 41%, respectively. Anesthetized rabbits with halothane pretreated with tranylcypromine or saline were given pethidine (5 mg/kg i.v.) or butorphanol (0.5, 1 and 2 mg/kg i.v.). Pethidine produced a marked increase in blood pressure in rabbits pretreated with tranylcypromine and did not affect significantly the heart rate. Butorphanol did not affect either blood pressure or heart rate at doses of 0.5 or 1 mg/kg. However, the largest dose of butorphanol (2 mg/kg) produced hypotension and tachycardia in rabbits pretreated with tranylcypromine. Neither pethidine nor butorphanol affected the temperature of anesthetized rabbits pretreated with tranylcypromine or saline.     

Meeting our friend, the genome.

(1) Encounter with the genome. (2) Difficulties in the path. (3) Legal and ethical implications. (4) Patenting genes. (5) The genome and evolution. (6) An adjunct to medicine or a new world? (7) Forbidden territory or the next step for humanity? (8) Informed decisions.     

New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule

The Food and Drug Administration (FDA) is issuing final regulations under which the agency will accelerate approval of certain new drugs and biological products for serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary. These new procedures are intended to provide expedited marketing of drugs for patients suffering from such illnesses when the drugs provide meaningful therapeutic benefit compared to existing treatment. Accelerated approval will be considered in two situations: (1) When approval can be reliably based on evidence from adequate and well-controlled studies of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients; and (2) when FDA determines that a drug, effective for the treatment of a disease, can be used safely only if distribution or use is modified or restricted. Drugs or biological products approved under these procedures will have met the requisite standards for safety and effectiveness under the Federal Food, Drug and Cosmetic Act (the act) or the Public Health Service Act (the PHS Act) and, thus, will have full approval for marketing.