Aug 1 2008

If Patient Information Is Good For Your Health, Why Is It Being Withheld?

There can be no question that the sharing of information positively influences the quality of medical care, whether that care is being provided by a top hospital in New York or Boston, or by a country doctor in a remote area of Appalachia. The sharing might occur through an article in a medical journal, such as the New England Journal of Medicine. Or, it could take place through the wonders of closed circuit videocasts, during which a physician on one side of the country can observe a physician on the other side perform a surgery about which that first physician needs to know. The bottom line is that physicians have plenty of knowledge that could benefit their younger and less experienced colleagues, which, when shared, ends up benefitting you, the medical consumer, because of the better medical care it generates.

Why, then, does American medicine not do all it can to exploit this principle for the greater good? We are in a political climate in which state medical associations, and medical liability insurers react to medical malpractice lawsuits by blaming the lawyers who bring them, instead of looking to how the healthcare system could be improved so that the mistakes that underlie such suits happen less frequently, or even not at all.

A case in point is our failure to implement a national registry—a nationwide data bank of results for particular surgeries using particular medical devices—so that problems can be detected early, and fixed quickly. The “fix” might be a modification to the medical device, i.e., an artificial hip socket, or additional training to the surgeons installing them. The New York Times addressed this subject on its front page earlier this week (7-29-08) in the context of artificial joints (“A Call for a Warning System on Artificial Joints”). Because we do not have such a registry, patients undergoing joint replacement surgery here run up to twice the risk as patients in countries with a registry that they will need to undergo a replacement procedure in the future, according to the Times article. This failure to implement such a basic system results in more, and unnecessary surgeries, along with more surgical risks, including infection; more costs to patients and insurers; and more time lost from work. And, not having the benefits of the wealth of information such a registry would provide means that many surgeons end up providing less- than- optimal care, when they could easily have the best and most recent knowledge at their fingertips.

To the same deleterious effect is the HIPAA law (The Health Insurance Portability and Accountability Act of 1996). Ostensibly created to protect the privacy rights of patients, it has resulted in a system in which obtaining a patient’s medical records in a timely manner requires needless paperwork, and sometimes dangerously large amounts of time. Wouldn’t it make more sense to create and maintain a national databank of medical records of everyone who has ever received medical care, and make it accessible to every hospital and doctor in the United States? When you are brought into your local emergency room, unconscious after a car accident, and your family cannot be contacted, wouldn’t it be wonderful if the hospital’s staff could plug your name into a computer, and learn what medications you are fatally allergic to? Would it really be so bad if the staff learned about that anal fissure repair surgery from 20 years ago? This is another step that would be relatively painless to implement, and would end up saving lives, in addition to medical costs. Why is it not yet in place?

Solutions are out there. It is up to our government and the healthcare industry to make use of them. And the sooner, the better.

Jul 11 2008

Why Current Legal Trends Will Hurt Us

You may not know it yet, and hopefully, you will never have to learn it. But from now on, if you are injured or killed as a result of a medical device that was FDA approved, but negligently manufactured, you will not be able to seek redress in state courts. Due to a principle called “preemption,” as in, federal law preempts state law in these circumstances, state laws regulating medical devices are trumped by the FDA’s authority to do so. So, if the FDA approved the device, the manufacturer is immunized from any state lawsuits seeking compensation for injury or death. If you would like to read the U.S. Supreme Court decision that deprived us of this right, the citation is Riegel v. Medtronic, 128 S.Ct. 999 (2008).

You would think that physicians and hospitals all over the United States would be celebrating this decision, as it insulates the companies that make the medical devices they use from liability. But you would be wrong. In the July 3, 2008 issue of The New England Journal of Medicine, three of its top editor-physicians spoke out against the Riegel decision, and expressed their grave concerns about a similar case about to be decided by the U.S. Supreme Court, Wyeth v. Levine, 128 S.Ct. 1118 (2008). If the Wyeth case is decided in favor of Wyeth, a drug manufacturer, drug companies may also be immunized against state lawsuits, if the drug in question was FDA approved when used by the injured individual.

Why are they concerned? Clearly because patient care and well-being are at the top of their list of priorities. As the authors point out, FDA approval is not a guarantee of any drug’s safety, due to limitations inherent in pre-approval studies of such drugs. As they also note, preemption of the right to bring such suits will result in a decrease in the safety of drugs and medical devices, and unjustly deprive injured patients of the ability to seek the legal redress to which they are entitled.

Should you be concerned about these trends? If you are not, may I suggest that you be very, very careful.

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