November 13, 2004
Three Strikes Law in Florida for Doctors
Is this the answer to the quality of care concern that we all share?
The ABA Journal has an interesting article concerning Florida's new Amendment 8. The amendent, dubbed the "three strikes, you’re out" amendment, passed by 71 percent of the popular vote on Nov. 2. The amendment provides that a doctor found guilty of three or more medical malpractice incidents loses his or her license to practice in Florida.
The amendment, Section 20 to Article X of the Florida Constitution, reads:
No person who has been found to have committed three or more incidents of medical malpractice shall be licensed or continue to be licensed by the State of Florida to provide health care services as a medical doctor.
- For purposes of this section, the following terms have the following meanings:
- The phrase "medical malpractice" means both the failure to practice medicine in Florida with that level of care, skill and treatment recognized in general law related to health care providers’ licensure, and any similar wrongful act, neglect or default in other states or countries which, if committed in Florida, would have been considered medical malpractice.
- The phrase "found to have committed" means that the malpractice has been found in a final judgment of a court of law, final administrative agency decision, or decision of binding arbitration."
Although the amendment becomes law on passage, many unanswered questions exist about its effectiveness. The ABA article reports that the Academy of Florida Trial Lawyers, supporters of the amendment, supported the amendment based on a desire to protect patients from bad doctors. They cite statistics showing that 6 percent of Florida doctors are responsible for most of the medical malpractice claims. On the other side, the article further reports that some doctors and lawyers predict that the amendment will create incentives for attorneys to file medical malpractice claims, leading to an increase in frivolous litigation.
November 12, 2004
WIth all the Viagra, Cilas, Levitra ads on television, you knew it was only a matter of time before scientists returned to the development of a male contraceptive. Although scientists have been experimenting with a variety of hormone therapies, more recently some scientists have had some luck using a technique called "immunocontraception." A brief description of the study from MSNBC states,
"In O’Rand’s experiments, which did not involve hormones, monkeys were immunized using a form of eppin. That is a protein produced in the testis and epididymis, the tightly coiled ducts that carry sperm.
Male monkeys that developed a strong immune response to the eppin were still able to copulate but could not impregnate females, the researchers said.
“We don’t understand the exact mechanism yet, but we think the immunocontraception works by preventing the sperm from freeing itself from the seminal fluid to make its way to the uterus and oviducts to fertilize the egg,” O’Rand said.
In the experiments, designed in the United States and carried out in India, seven of the nine males tested developed high antibody levels. Five of the seven recovered fertility once the immunization stopped. They were injected with eppin about every three weeks to maintain the immunization.
Dr. Patricia Anastasia DeLeon of the University of Delaware said the results were significant and that scientists were lucky to get a protein that would produce antibodies."
Saying You're Sorry
The AP reports that many medical schools are training their doctors to say, "I'm sorry" as a means to reduce medical malpractice lawsuits. A recent study of the hospitals in the University of Michigan Health System, which has encouraged such apologies since 2002, finds that the annual attorney fees have dropped by $2 million dollars and that malpractice lawsuits and intent to sue notice have declined from 262 filed in 2001 to approximately 130 per year.
The entire article is interesting and provides hope for a way to decrease medical malpractice lawsuits without adopting a variety of medical malpractice reforms which don't appear to be doing much to improve the quality of care or decreasing medical malpractice costs. More information about this apology campaign can be found at Salon.com, which is a subscription service.
Salon.com, a subscription service, also provides some more details on this study. If you are a subscriber, you might want to check it out.
November 11, 2004
Jailing the Mentally Ill
Last Sunday, October 31st, the New York Times ran a piece that discussed in detail the plight of the mentally ill in our prison system.
"Forty years ago, America's seriously mentally ill were housed in psychiatric hospitals that kept them too long and often without good cause. As those hospitals closed, a promise to provide care in communities went unfulfilled. At the same time, America's prison capacity grew; it has quadrupled since 1980. People with untreated mental illness are often poor and homeless. Many commit petty crimes, creating arrest records that often lead to harsh sentences. Today some 250,000 Americans with mental illness live in prisons, the nation's primary supplier of mental-health services."
The article is a sober reminder of need to reform our justice system so that we can better address the needs of the mentally ill community. If you missed, it is worth a read.
Trial Lawyer Victories
Although President George Bush's November 2 may be interpreted as a victory for doctors over trial lawyers, at least two states, Oregon and Wyoming, rejected limitations on liability in medical malpractice cases. In Oregon, state voters defeated an iniative that would have specifically capped damages for medical malpractice awards. The Wyoming iniative concerned the amount of noneconomic damages in medical malpractice cases. BNA's Health Law Reporter provides more information about these two state ballot iniatives.
Interestingly, Wyoming is the home state of Vice President Dick Cheney who stated during his debate with Senator John Edwards,
"In Wyoming, we've lost the top insurer of malpractice insurance in the state. The rates for a general practitioner have gone from $40,000 a year to $100,000 a year for an insurance policy. We think this has a devastating impact on the quality of health care. High risk patients don't get covered anymore. We've lost one out of eleven OB/GYN practitioners in the country. We think it can be fixed, needs to be fixed."
It is unclear why voters didn't believe him (could it be because of his "I never met you before" gaff?) but perhaps Wyoming might try insurance reform so that some competition exists in the state for the provision of medical malpractice insurance.
November 10, 2004
Ashcroft's Final Farewell Appeal
John Ashcroft has asked the Supreme Court to overturn Oregon's Death with Dignity Act. According to MSNBC (and I am sure a number of other news sources):
"The Bush administration asked the Supreme Court on Tuesday to block the nation’s only law allowing doctors to help terminally ill patients die more quickly.
Oregon voters approved the law, and since 1998 more than 170 people have used it to end their lives. Most had cancer.
The Bush administration has argued that assisted suicide is not a “legitimate medical purpose” and that doctors take an oath to heal patients, not help them die."
New African American Drug
On November 9, 2004, Kevin Drum of the Washington Monthly provides an interesting perspective on the recent controversy concerning the development and testing of a new heart drug for African Americans.
FDA and Generic Drugs
If you have an interest in generic drug regulation, the FDA has issued a recent guidance that provides some answers to questions that have arisen after the enactment of the Medicare Prescription Drug Improvement and Modernization Act of 2003. Here is a brief statement from the FDA concerning the contents of its new guidance.
"The Food and Drug Administration (FDA) announced today that a Guidance for Industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Questions and Answers" is being made available at <
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) made significant changes to the generic drug approval process designed to provide more certainty to the generic drug approval process and help get generic drugs to the market more quickly. As indicated in our March 3, 2004, Federal Register notice (69 FR 9982), FDA has been considering what steps to take in light of the passage of the MMA. This guidance is one step.
As directed by the MMA, this document provides guidance on the definition of a listed drug. A listed drug is required to be referenced in a generic application and indicates the approved drug the generic company is relying upon for approval of its version of the product. The guidance is intended to clarify when a change to a generic application should reference a different listed drug from the listed drug referenced in the original generic application, and thus be made through the submission of an entirely new application that encompasses the desired change.
The document also provides guidance to industry on certain sections of the MMA that significantly change provisions of the Food, Drug, and Cosmetic (FD&C) Act that were originally added by the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch-Waxman).
These provisions affect the Act's 30-month stay of approval of a generic or section 505(b)(2) application upon the filing of a patent infringement suit and the 180-day exclusivity periods available to the first generic applicants to challenge innovator patents."
This guidance clarifies changes made by the MMA with respect to (1) the availability and termination of 30-month stays of approval of generic and section 505(b)(2) applications, (2) requirements for notice of patent certifications (paragraph IV certifications) by generic and section 505(b)(2) applicants, and (3) the 180-day exclusivity for "first" generic applicants. The guidance also explains the various effective dates that apply to the MMA's generic drug provisions.
November 9, 2004
For those of you interested in the latest federalism battle, all of the briefs in Raich v. Ashcroft, the "medicinal marijuana" Commerce Clause case, No. 03-1454, have now been collected at the Angeljustice.org website.
In addition, a "blawg" has been formed that provides further information about the Raich case.
Thanks to the scotusblog for this informative update.
Healty States/Unhealthy States
Well, perhaps the latest study by United Health Foundation does not provide the same excitement as the red state/blue state divide, but in case you were wondering about the overall health of your state, you may want to check their latest survey results. As reported in the Washington Post,
Minnesota is the nation's healthiest state, while Louisiana is the least healthy, a ranking it has held for 14 of the last 15 years of a national survey, officials said.
CNN also provides some further details.
HIPAA Privacy Rule Update
The GAO published a recent study of organizations representing providers and health plans and reported that implementation of the HIPAA Privacy Rule went more smoothly than exected furing the first year of required compliance. Some organizations did complain that certain provisions of the Privacy Rule were unnecessarily burdensome, such as the requirement for accounting for certain dsiclosures and the reuaiment to enter into business associate agreemente. The GAO also found that the general pbulic isnot well informed about their rights under the Privacy Rule. To read the GAO report, "Health Information: First Year Experiences Under the Federal Privacy Rule" (GAO-04-965), go to: http://www.healthlawyers.org/doc/ask2004/GAO04965.pdf.
Thanks to Orly Rumberg, Esq., Schwartz, Manes & Ruby for this HIPAA update.
November 8, 2004
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Good Election News
Congratulations to Professor David Orentlicher, Samuel R. Rosen Professor of Law, and Co-director of the William S. and Christine S. Hall Center for Law and Health at the Indiana University School of Law - Indianapolis! On Tuesday, November 2d, the voters of Indiana District 86 voted to send him back to the Indiana legislature. We wish him the best of luck as he continues to work to make life better for the citizens of Indiana.
Thanks to Jeff Cooper of Cooped Up for this item.
Future Health Law Policy
Following last week's Presidential election, some individuals may be concerned about the future health policy of the United States. Based on Bush's first news conference and announced agenda for the second term, wholescale changes in our health care system do not appear to be a major priority for the administration (which depending on your viewpoint - may be a good thing). For a brief overview of President Bush's health law policy, you may want to check out the brief primer from Professor Uwe Reinhardt from before the election. He provided a comparision of the Bush and Kerry plans. This policy review was written for journalists so your students (no matter if giddy or depressed post-election) should be able to understand and follow where our health policy may be headed. Note also that he discloses his bias upfront.