The Double Blind Placebo Controlled Trial
January 27, 2006
The blind allegiance to what I call the "fool's gold standard" lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances. The exceptions are where: 1) there is no risk of harm if the patient forgoes treatment during the placebo phase such as in a trial for a drug that seeks to cure hair loss or impotence; 2) the standard therapy carries such severe side effects that patients might choose to avoid it; or 3) the standard therapy is otherwise of questionable efficacy. Still, sponsors and researches continue to design and conduct such trials, providing the familiar excuse: "The FDA made us do it."
Testimony from Life Partners
January 04, 2006
Attorneys representing clients in same-sex, committed relationships sometimes are unprepared to deal with opposing counsel's efforts to seek testimony disclosing the content of communications between a client and his or her same-sex life partner. In many jurisdictions, the non-client partner will be unsuccessful in asserting a privilege not to disclose this information, and forced at deposition -- and maybe at trial -- to divulge statements made by the client. Clients challenging the harms of negligence, medical malpractice, and even intentional torts have experienced a second round of harm as they watch a loved one testify about what they believed were secret exchanges.
Med Mal News
January 04, 2006
Recent developments you need to know.
Verdicts
January 04, 2006
Recent rulings you need to know.
Federal Preemption and Tort Claims
January 04, 2006
For medical device manufacturers, federal preemption can be a powerful defense to state tort claims. Although there is some split of authority, most federal courts of appeals that have addressed the issue have held that when a medical device reaches the market via the Food and Drug Administration's (FDA) rigorous "premarket approval" (PMA) process, many state common law claims are expressly preempted by the Medical Device Amendments (MDA) of 1976.
Experts on Juries
January 04, 2006
As blanket occupational exemptions for jury duty become a relic, litigators are split on whether there is a need for specific jury instructions to keep jurors from relying on their expertise in evidentiary matters. This issue tends to be particularly troubling for medical malpractice attorneys, as the pool of potential jurors with knowledge of medical issues -- doctors, nurses, physical therapists, etc. -- is so large. One court system -- New York's - instructs professionals to keep their expertise outside of the jury room. No other court currently singles out professional jury-deliberation conduct in jury instructions.
Causes of Action for Loss of Cryopreserved Embryos
January 04, 2006
There has been much discussion of the ethics and liability issues created by recent advances in reproductive science. While fertility treatments allow couples that might otherwise not be able to conceive or carry a baby to term create much-wanted families, fertility clinics and the health care professionals working in them are dealing with a highly emotional issue. When patients don't get the results they wanted -- particularly when mistakes are made -- the chances of being sued run high.
Drug & Device News
January 04, 2006
Recent developments of importance to you and your practice.
Third Circuit: Excess Insurer Need Not Prove Prejudice in Order to Enforce a Claims-Made and Reported Requirement
January 03, 2006
In a 2-1 opinion, the Third Circuit recently affirmed summary judgment in favor of an excess medical malpractice insurer in a case involving both policy construction and evidentiary issues. In <i>Lexington Insurance Company v. Western Pennsylvania Hospital, et al.</i>, 2005 WL 2174003 (3d Cir. 9/9/05), West Penn Hospital had three layers of medical malpractice coverage. The first layer was a primary policy issued by PHICO. The PHICO policy provided both general liability, on an occurrence basis, and medical malpractice coverage on a claims-made and reported basis. The next layer was $1 million worth of excess coverage provided by the Pennsylvania Medical Professional Liability Catastrophe Fund (the "CAT Fund"). Lexington issued an excess policy over those first two layers. The CAT Fund coverage was also claims-made and reported.
