Drug and Medical Device Manufacturers
July 28, 2005
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that "[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system." The tools -- the variety of different criminal statutes and theories used to prosecute drug and device manufacturers -- are so diverse as to defy easy summary.
In the Courts
July 28, 2005
Recent rulings of interest to you and your practice.
What to Do When an Audit Committee Complaint Arrives
July 28, 2005
Much attention has been paid to the requirements of the Sarbanes-Oxley Act (SOX) and the stock exchanges and Nasdaq that issuers establish procedures under which their audit committees can receive complaints, including anonymous complaints. Various service providers now offer issuers solutions in this area, including procedures to submit complaints through hotlines and e-mail addresses maintained by the service providers. But none of the Sarbanes-Oxley Act, the rules or the extensive commentary about establishing complaint procedures addresses what the audit committee is required to do with a complaint when one is received. This article briefly discusses some considerations in dealing with such a complaint.
Defending the Pediatric Traumatic Brain Injury Case
July 28, 2005
Every year, millions of Americans, including some children, suffer non-penetrating, or closed, head injuries. When lawsuits result, they involve complex medical, academic, and legal issues. When the plaintiff is a child, the defense attorney faces numerous additional challenges in defending the matter. Certain discovery tools are necessary to simplify and defend the pediatric traumatic brain injury (TBI) lawsuit. These tools, although also used in traditional personal injury cases, take on added significance because of the age of the plaintiff and the nature of the injury.
Should We All Move to Canada?
July 28, 2005
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?
Drug and Medical Device Manufacturers
July 28, 2005
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that "[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system." The tools -- the variety of different criminal statutes and theories used to prosecute drug and device manufacturers -- are so diverse as to defy easy summary.
Restrictive Covenants in Commercial Developments
July 28, 2005
Recorded restrictive covenants in commercial developments present many issues. Two important factors to consider when granting such covenants include: 1) the reoccurring impact that they may have over the life span of a shopping center, and 2) the potential impact of such covenants on the current and future objectives of landlords and tenants who are parties to them.
Are Prisoners Medical Captives?
July 28, 2005
In this article, we focus on prospective living organ donors who face capital punishment. Some of the issues raised may also apply to The use of prisoners as living organ donors raises many ethical concerns. As evidenced by the different decisions that have been reached in the cases cited, there is no clear consensus as to how these cases should be handled. Beyond weighing the motives and mental capacity of the prisoner, it is important to determine whether or not someone on death row is capable of giving truly informed consent to the transplant procedure. The fact that donating an organ could prolong an inmate's life can significantly influence the decision, whether by adding a rational incentive in the inmate's best interest, by creating conflict and mixed motives, or by compromising the inmate's decision-making ability even to the extent of exerting undue influence. Moreover, there needs to be an awareness of various secondary gains for a prisoner in consenting to organ donation. Such secondary gains as expressing genuine remorse or salvaging some sense of pride in the face of certain death by engaging in an altruistic act need not be denied to prisoners in the absence of a psychosis that impairs choice behavior.
Dilemma over Drug Safety
July 28, 2005
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.
The Leasing Hotline
July 28, 2005
Highlights of the latest commercial leasing cases from around the country.
