Holland & Hart Healthcare Law Blog

Pfizer's "Double Blind" Bextra Bind -The Value of Clinical Data

Shortly before Christmas a Santa Clara County, California jury entered a $38 Million Dollar Judgment Against Pfizer, Inc. for allegedly stealing clinical data from the Ischemia Research and Education Foundation ("IREF"), concerning its acute arthritic pain drug, Bextra. Pfizer pulled Bextra from the market in 2005, followig concerns about its safety for heart patients. Not long ago Pfizer entered into a $900,000,000.00 product liability settlement for Bextra and for Cerebrex, both Cox 2 inhibitor drugs that raised safety concerns. IREF filed its suit in 2004, claiming that Pfizer obtained access to the clinical data developed by IREF after its negotiations with IREF collapsed through the device of a contract with an IREF employee and statistican, Ping Hsu. IREF is a non-profit research organization founded by Dr. Dennis Mangano, PhD, M.D., in 1987.IREF has developed a substantial data base of clinical information through the cooperation and participation of over 300 research centers around the world in the twenty plus years of its existence. There was apparently some evidence presented to the jury that Pfizer and Mr. Hsu destroyed or otherwise attemped a coverup of the use of the IREF information. Pfizer asserts that it has been unjustly caught up in the dispute between Mr. Hsu and IREF and denies any theft of the IREF information. It will likely appeal.

MT. Constitution Protects Doctor Assisted Suicide

The United States Supreme Court has thus far declined to find a constitutional right to doctor assisted suicide under either the Due Process Clause (Washington v. Glucksberg, 521 U.S. 702 (1997)) or under the Equal Protection Clause (Vacco v. Quill, 521 U.S. 793 (1997)). There are a very few number of states that have incuded the Right to privacy in their State Constitutions. Montana is one of them. In Robert Baxter et alv. State of Montana, Cause No. ADV-2007-787, an action brought by Mr. Baxter who has a terminal condition, several physicians and Compassion & Choices, an advocacy group, against the State to declare the application of state homicide statutes to physician assited suicide to be unconstitutional. District Court Judge, Dorothy McCarter from Lewis & Clark County issued an opinion and order earlier this month finding that the Montana Constituion protected doctor assisted suicide, wherein a doctor provides drugs for a terminal patient, who administers the lethal drug and the homicide statutes could not punish the doctor for his or her assistance.

Minn. Court Holds Medical Battery Does Not Require Expert Affidavit.

Most states have some form of statute or common law obligation that requires a plaintiff in a medical malpractice case to obtain an opinion or affidavit from a qualified physician that the conduct of a defendant physician was outside the standard of care. The reason is ostensibly that issues of medical standards and causation are outside the knowledge base of most jurors and courts and therefore must be supported by expert opinion. On Jane Doe v. Dr. Albert Tsai in the United States Disctrict Court for the District of Minnesota, 2008 WL 4949156 (D.Minn. 2008), the Plaintiffs allege that Jane Doe was a minor who was sedated amd subjected to an involuntary gnyecological and rectal exam, without the consent of her paremt pr guardian. The story behind the story is not related here. Jane Doe's mother was apparently escorted against her will from the Henneprin County Medical Center by law enforcement officials when she objected to the procedure on her daughter.

Federal Appeals Court "Clocks" Nebraska Doc On Board's Letter of Concern

The Eigth Circuit Court of Appeals reversed a summary judgment in favor of the plaintiff physician in Kloch v. Kohl, No. 07-2120 ( 8th Cir.2008). Dr. Kloch received a Letter of Concern from the Nebraska Board of Medicine and Surgery, which was placed in his public file. Under Nebrasak statutes investigations of complaints against physicians are referred to the Nebraksa Attorney General for assessment. The AG can refer the matter back to the board and recommend closing the case with a letter of concern, which is not technically discipline, which precipitates due process rights and protections under Nebraska law.