Holland & Hart Healthcare Law Blog

OKLAHOMA FEDERAL JUDGE AUTHORIZES SUBSTITUTE USE OF NEMBUTOL TO AID IN EXECUTIONS.

 

There has been a shortage of thiopetal sodium recently, the anesthetic of choice in executions by lethal injections, which has temporarily halted executions in a number of jurisdictions that unlike, Texas,  have not stocked up on the drug. The manufacturer of the drug Hospira, Inc. of Illinois has indicated that it has had manufacturing issues with the drug and replacement supplies would not be available until early 2011.  Hospira, which markets its drugs, under the tag line of “Advancing Wellness” has indicated that it does not favor the “off-label” use of its drug in state sponsored executions. Death penalty opponents have been objecting to the substitution of other drugs because of the potential for pain and suffering by the prisoner in potential violation of the Eighth Amendment prohibition against cruel and unusual punishment.

 

THE EVOLUTION OF INTEGRATED HEALTH CARE DELIVERY SYSTEMS AND THE SINGULARITY

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    If one had to design a health care system that would seem doomed to failure one might start with one in which the providers of care were fragmented, independent and driven through the reimbursement system to provide ever more services that generate higher income on a fee for service basis. The system would provide care to patients who were isolated from the economic costs of the services by third party payments, through employer funded insurance coverage.  Third party payers would make their money through reducing premium payouts, by simply delaying or not paying out what they contracted to provide or extorting deep provider discounts in exchange for directed volume. The approach to care of individual patients would be ad hoc, without significant oversight. Severely ill patients would be passed back and forth by all providers like the black queen of spades in a deck of cards. Bad debts would be written off as “charity care.” Insurance premiums would rise faster than the world’s oceans in global warming. Sound familiar?

    

HEALTH CARE REFORM BILL (II): MEDICAL DEVICE TAX - CONTROLLING COSTS OR STIFLING INNOVATION

There were not any easy choices in the Patient Protection and Affordable Care Act  (“PPACA”)as amended by the Health Care and Education Affordability Reconciliation Act (“HCEAR”), except perhaps the opportunity to stick it to the perpetually tanned Rep. John Boehner (R.Ohio), by imposing a 10 percent excise tax on tanning salons using ultraviolet lamps.  The Congress did impose a 2.9 percent excise tax on the sales of medical devices which is expected to raise $2OB in revenues to fund the expanded coverage of health care reform.  (The  original proposal was for $40B.) (See section 9009 of the PPACA and section 1405 of the HCEAR)  In addition new rules on proof of safety first and the implementation of “effective research” requirements are expected to further raise the cost of doing business in  the Medical Device field.

COLORADO MEDICAL POT LAW ALL SMOKE?

The good news for Colorado Medical Marijuana smokers is that the Colorado State Constitutional Amendment making possession of pot more medically qualified users and their “personal care providers” is Constitutional. The bad news is that it is still illegal to sell it. On October 29, 2009, in People v. Stacy Clendenen, 08CA064, a panel of the Colorado Court of Appeals affirmed the conviction of apparent pot entrepreneur, Stacy Clendenen, for cultivation of marijuana, possession with intent to distribute marijuana, possession of marijuana-eight ounces or more, and possession of drug paraphernalia, after rejecting her defense that she was a “primary care giver, “protected under the Constitution.

THE REPUBLICAN HEALTH CARE LIABILITY REFORM PACKAGE

 Deep in the Republican Alternative Healthcare reform proposal unveiled by Rep. John Boehner (R) Ohio on November third, (The “Common sense Health Care Reform and Affordability Act,” can be found “Division C- Enacting Real Medical Liability Reform.” This section purports to nationalize state medical malpractice and medical product liability law and procedure into a uniform federal code which provides greater protection for doctors, pharmaceutical companies and medical device manufacturers.

INTERNET MEDICINE: PART VI –CHALLENGES TO DATA SECURITY IN INTERNET MEDICAL DEVICE INFORMATION LINKS.

The growing interoperability between medical devices and electronic medical records gives rise to new opportunities in the transmittal and collection of vital medical data. New vulnerabilities arise as well. Last month, the Internet Storm Center sponsored by SANS (SysAdmin, Audit, Network, Security Institute) warned that the Conflicker worm had infected approximately ten million internet devices including MRIs. SANS is a cooperative research and education organization that since 1989 has specialized in information security technology training and awareness.

The Conflicker worm attacks holes in Windows OS with advanced malware techniques. It is the largest worm infection since the SQL Slammer worm. Many of the infected devices were not designed for internet connectivity. The efficacy of the infection repair is complicated by a FDA regulation which limits the ability to issue an internet “patch” for 90 days, and apparent triumph of law over common sense in crisis with a unique and unanticipated need.

Internet Medicine Part IV: “Health 2.0.”

“Health 2.0” or “Medicare 2.0” relates to a new paradigm in the relationship between patients and physicians, in particular the application of Web 2.0 interconnectivity tools or social media technology to the provision of health care.  One of the ironies of this movement is the emphasis on sharing rather than protecting or hiding health care information.  The www.patientslikeme.com  website sponsors  patients as partners with their physicians in assembling and sharing information related to specific diseases.  Patientslikeme assembles and aggregates patient information related to 5 chronic illness categories: Amyotrophic Lateral Sclerosis (ALS); Parkinson’s Disease, HIV/AIDS, Multiple Sclerosis and Mood Disorders.  Participants share treatment experiences, drug side effects, new treatment regimens and even organize and participate in their own clinical trials. 

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.

FDA Review to “Pre-Empt” State Pharmaceutical Litigation?

The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA’s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth’s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine’s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.

The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.

Supreme Court Pre-empts State Medical Device Litigation.

.  The U.S. Supreme Court issued its long awaited opinion in Riegel v. Medtronic, Inc. ____U.S.___  (2008) as to whether the Medical Device Amendments of 1976 passed by Congress to provide federal oversight for medical devices pre-empted state product liability tort actions. It does. The Plaintiff, Charles Riegel suffered a myocardial infarction in 1996 and underwent a coronary angioplasty. His right coronary artery was diffusely diseased and heavily calcified. When his physician inserted the Evergreen Balloon Catheter into the artery it ruptured and Riegel developed a heart block requiring emergency coronary bypass surgery.  The use of the catheter was contraindicated for the artery according to label warnings and the catheter was over inflated during installation.