A Tax on Malpractice Victims is Unfair!
September 10, 2009
Let me start by saying I love my president, and support him in most things. His push for universal healthcare coverage is admirable, and long overdue in my opinion. That being said, I take issue with his recent announcement to further restrict the rights of injury victims. His recent speech on the issue mentioned limiting medical malpractice lawsuits as a point in his plan. This is an offer of compromise, no doubt, aimed at getting more support for his plan from the medical community. But it is just plain unfair to those tho have suffered due to medical negligence, and will do little to contain costs.
The Missouri Department of Insurance noted that malpractice claims are at a ten year low-and malpractice insurers recorded a profit for the fifth year in a row. This hardly seems like a crisis in malpractice. To take away the right to recover from those hurt by malpractice will do nothing to benefit cost, and devastate those already suffering! It amounts to a tax on malpractice victims, and is unfair.
The folks at the Center for Justice and Democracy say it better:
PRESIDENT OBAMA’S MEDICAL MALPRACTICE PROPOSAL WILL
HURT PATIENTS AND DUMP MORE COSTS ON TAXPAYERS
Statement by Joanne Doroshow, Executive Director, Center for Justice & Democracy, on President Obama’s medical malpractice proposal:
The Center for Justice & Democracy strongly opposes President Obama’s plan to implement Bush Administration measures to limit the legal rights of severely injured patients, which has become part of the health care discussion apparently as a bargaining chip to reduce Republican opposition to much needed health care reform.
Any scheme that places undue burdens on injured patients or requires that cases be heard in informal settings tilt the legal playing field heavily in favor of insurance companies that represent health care providers and are fundamentally unfair.
Proposals that ends up shielding unsafe hospitals or grossly negligent doctors from accountability by intruding upon the legal system are terrible public policy. Medical errors are at epidemic levels and this proposal will not only fail to fully compensate catastrophically injured patients, but also will undermine restraints the civil justice system currently imposes on dangerous misconduct. Reducing legal accountability will lead to more errors and system costs.
Moreover, such provisions would dump even more costs on taxpayers. They would not eliminate death and injuries but merely shift costs of caring for malpractice victims from perpetrators of malpractice to hard-pressed state Medicaid systems, for which state and federal taxpayers share the costs.
The arguments used to support liability restrictions are unfounded. Indeed, according to an analysis of the insurance industry’s own data by Americans for Insurance Reform, medical malpractice insurance claims and premiums have both been trending downward for years. Premiums and claims are each less than one percent of health care costs.
Clearly, we need to look for ways to insure everyone while improving the quality of health care in our country by reducing preventable medical errors. The best way to reduce malpractice deaths, injuries, claims and lawsuits is to reduce medical malpractice.
Let your Senator and Congress Person know how you feel about this- your voice is important!
Doctors Question Avandia Safety
June 10, 2009
Some doctors don’t agree that a recent safety study which claims Avandia (rosiglitazone) is safe, is as conclusive as presented at the American Diabetes Association meeting. Some physicians are calling the study “flawed.” Avandia is used used with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes).
In an editorial in the Lancet–where the research was published–two doctors wrote that the study’s limitations prevent any “definitive conclusions” about Avandia’s effects on cardiac safety. Avandia has been haunted by safety concerns for two years, ever since an analysis found that patients using the diabetes med were more likely to suffer a heart attack than people taking other diabetes remedies were.
A GlaxoSmithKline (the makers of Avandia) funded study, called the Record, found that Avandia does not boost overall cardiovascular risk, though it does increase the risk of heart failure. “Record provides important and reassuring information about Avandia for physicians fighting diabetes,” said Dr. Ellen Strahlman, GSK’s chief medical officer,said in a statement on the study’s release. “Clinical outcomes trials like this offer the highest standard of evidence when considering the benefits and risks of medicines.”
Some doctors beg to differ. They told the Wall Street Journal that the overall rate of cardiovascular problems among patients in the trial was abnormally low. A significant number of Avandia patients took statins–10 percent more than the non-Avandia users, Forbes reports—and those cholesterol-fighters are known to cut heart attack risk. Plus, a relatively high level of patients dropped out of the trial entirely, which could have compromised the results, they said. (Glaxo said about 45 percent of participants dropped out at some point, but that dropout rate didn’t affect the primary aim of the study.)
Meanwhile, another physician told the WSJ that the Record trial may have been too small to be sure Avandia is clear of increased heart attack risk. And Forbes is questioning the fact that Glaxo didn’t make clear that so many patients had dropped out of the Record study. Steve Nissen, the cardiologist who launched the Avandia controversy with his meta-analysis, went so far as to call the trial “worthless” because of the dropouts and the statin-drug use.
James Stein of the University of Wisconsin-Madison told Forbes that Record patients and doctors knew which drugs they were on, weakening the result. Plus, in a subset of Avandia patients who had established heart disease, the risk of heart attack increased by nearly 26 percent, he said.
So it appears the debate over Avandia is far from over.
If you or a loved one has suffered a heart attack which you believe may be related to Avandia use, contact The S.E. Farris Law Firm for a Free consultation. You may reach us at 314-A-LAWYER or by clicking here.
Medical Community for Lawsuits, When they Aren’t Getting Sued!
May 21, 2009
The US Supreme Court ruled that Food and Drug Administration (FDA) approval of medical devices immunized the manufacturer from a lawsuit for damages. Sure, the FDA is understaffed, and often referred to as a revolving door for medical device company employees. Still, this was a big blow to injury vicims seeking to recover their losses due to a defective product.
Today, none other than a doctor writing in The New England Journal of Medicine called for legislation to allow victims of defective medical devices to pursue their claims in state court. Whether this was to look out for patient well being or simply avoid lawsuits against doctors is anyone’s guess. Read it for yourself and decide!
The S.E. Farris Law Firm has experience representing victims of dangerous medical products. If you or a loved one believe you have been injured by a medical device or drug, contact The S.E. Farris Law Firm, at 314-252-9937. We will provide you with initial legal advice for free, and never charge anything unless we win for you.
Preemption and Malpractice Liability
Volume 360:2257-2258 May 21, 2009 Number 21
To the Editor:
In their Perspective article about the Supreme Court, preemption, and malpractice liability (Feb. 5 issue),1 Kesselheim and Studdert suggest that preemption will not result in more malpractice claims against physicians for failure to warn, which they say are uncommon and financially unattractive to plaintiff’s attorneys. I hope they are correct but have yet to find a plaintiff’s attorney who agrees with them.
In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic2 that a product-liability lawsuit brought against Medtronic in a state court was preempted because the device (an angioplasty catheter) had received marketing approval from the Food and Drug Administration (FDA). Recently, a federal judge in Minnesota, citing that ruling, dismissed scores of patients’ lawsuits involving the Medtronic’s Sprint Fidelis lead, which the manufacturer had recalled because it was fracturing in patients. Thus, FDA approval now immunizes medical-device manufacturers from state tort liability. As a result, plaintiffs will target physicians, hospitals, and health care systems.
Plaintiffs will assert, not unreasonably, that physicians who are qualified to use medical devices should be able to assess the quality and completeness of the data supporting a product’s safety and efficacy. A defense based on the fact of FDA approval may be insufficient if other practitioners would not use the product because of inadequate safety or efficacy data. Hence, preemption should make physicians wary of devices approved on the basis of limited or short-term studies.
Congress must consider the long-term implications of preemption. Rather than spurring innovation, preemption may create an environment in which, for fear of liability, physicians and hospitals decline to use promising new therapies, to the detriment of patients. If Congress decides that medical-device companies are to be immunized through preemption, then physicians and hospitals should be similarly protected from tort lawsuits when using products according to FDA-approved labeling or guidelines.
Preemption underscores the need for the FDA to become a rigorous scientific organization whose primary objective is patients’ safety. To achieve this goal, the agency must be led by distinguished scientists empowered to apply scientific methods to regulation. Some FDA officials may say the agency is already strictly applying such methods, but its record of miscues suggests otherwise.
Congress should pass tort-reform legislation preserving a patient’s right to legal redress while excluding claims that lack merit. Liability offers a strong incentive for companies to develop and manufacture safe drugs and devices. If companies are not accountable for their products, the public loses a safeguard that has motivated quality improvements in the health care industry for the past half-century.
Robert G. Hauser, M.D.
Minneapolis Heart Institute
Minneapolis, MN 55407
rhauser747@aol.com
Dr. Hauser reports holding stock in Atritech and Sonosite. No other potential conflict of interest relevant to this letter was reported.
References
1. Kesselheim AS, Studdert DM. The Supreme Court, preemption, and malpractice liability. N Engl J Med 2009;360:559-561. [Free Full Text]
2. Riegel v. Medtronic, 128 S.Ct. 999 (2008).
The authors reply: Our analysis of how preemption of product-liability litigation may affect physicians’ malpractice risks focused on pharmaceuticals, the issue before the Supreme Court in Wyeth v. Levine, not medical devices, the subject of Hauser’s letter.
Since the publication of our article, the Court has issued its decision: approval of warning labels on pharmaceuticals by the FDA does not preempt state product-liability claims against the manufacturer.
We applaud this outcome. However, Levine now puts the preemption status of pharmaceuticals and devices somewhat at odds, as Justice Samuel Alito’s dissenting opinion in Levine points out. In Riegel v. Medtronic, the Court found that a federal statutory provision barred state claims against device manufacturers when the device in question had FDA approval. This decision may well have increased the scrutiny of the role of physicians with regard to the use of devices.
An important policy argument against the type of preemption Wyeth sought in Levine is that the FDA has a limited capacity to oversee the vast array of drugs on the market. The same is surely true for devices. Consequently, we agree with Hauser that preemption of device claims is problematic and support the passage of legislation currently before Congress that would reverse the effect of Riegel.
Aaron S. Kesselheim, M.D., J.D.
Brigham and Women’s Hospital
Boston, MA 02115
akesselheim@partners.org
David M. Studdert, LL.B., Sc.D.
University of Melbourne
Melbourne, VIC 3010, Australia