A law guardian is an attorney who is appointed to ensure that the best interests of the child, who is the subject of the litigation, are served, while the guardian <i>ad litem</i> is a person appointed to protect the rights and interests of a party to the action, who is under a disability. For many years, the appointment of a law guardian has been mandatory in certain Family Court proceedings, such as juvenile delinquency, PINS (Persons in Need of Supervision) and child protective proceedings. See FCA 249(a). Every once in a while we read a decision in which the Supreme Court has appointed a guardian ad litem for a child in a custody case. Such appointments are unusual, since the rights and obligations of the guardian <i>ad litem</i> differ from those of a law guardian. What are the differences, and when is appointment of one or the other appropriate?

The Pharmaceutical Research and Manufacturers of America reported on Feb. 22 that a record number of patients received free or discounted medications from America's pharmaceutical companies last year as part of an industry initiative to help low-income consumers access the medications they need. "PhRMA member companies know a medication that sits on a shelf, out of financial reach of patients, helps no one," said Billy Tauzin, president and chief executive officer of PhRMA. Under these programs, consumers received more than 22 million prescriptions with a wholesale value of $4.17 billion in 2004, up from 18 million prescriptions with a value of $3.4 billion in 2003.

In this Special Issue, we explore some of the new safeguards that are being proposed and put into place to protect consumers from the unintended side effects of using medications and medical devices. We also look at the controversy surrounding the importation of lower-cost medications from foreign sources, and at one case that highlighted the interplay between medical providers and drug manufacturers in marketing pharmaceutical products.

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The high cost of prescription medications in the United States has been troubling health care providers and their patients for years. Physicians worry that it will do no good to prescribe a medication to someone who won't be able to afford to buy it, and patients who try to save money by taking less than the prescribed dose worry that that they're putting their health in danger. Any failed medical treatment that harms a patient is fertile ground for a lawsuit against the physician, even if he or she is not the one to blame. Should medical practitioners suggest imported drugs to their patients who might otherwise not be able to afford their prescribed medications?

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In 2001, the U.S. Attorney in Boston charged TAP Pharmaceutical Products Inc. (TAP) with conspiring to provide urologists with thousands of free samples of Lupron', for which the doctors billed Medicare and their patients. In order to survive and continue selling its blockbuster product for advanced prostate cancer, TAP made a reasoned decision to pay the government $885 million to resolve both civil and criminal charges. With this resolution, Boston's talented federal prosecutors continued their remarkable success in bringing major pharmaceuticals to their knees and reaching landmark settlements.

There is a newly urgent push from outside the pharmaceutical research and development community to get drug firms and the government to disclose the results of all tests conducted on new drugs and to immediately reveal information about problems that develop after those drugs go on the market. Consumers and health care providers say they're tired of finding out belatedly that negative information has come to light about the drugs they take or prescribe.

Medical malpractice cases often reflect a series of events unique to one patient, independent of broader health care issues or a larger patient population. On occasion, however, the medico-legal issues of a single case may reflect an overarching social phenomenon, requiring counsel and the courts to address both factors if a just result is to be achieved. This is the story of one such case.

The plaintiff's bar has discovered an opportunity in clinical research. The deep pockets of pharmaceutical companies provide one attraction, but attorneys are seldom shy about suing anyone who might even remotely be found liable for an injury. Successful litigation is rare, but the judgments can be expensive. Because of this, many physicians who conduct clinical research are reviewing their medical malpractice insurance policies. Many others, however, have no concept of the looming risks and of whether they are protected by their medical malpractice insurance policies when taking part in clinical trials.