Chicago Medical Malpractice Lawyer Blog

As a medical malpractice lawyer, I am concerned by the following story. The FDA, as the chief regulatory agency for new medical devices, has a duty to make sure the devices are as safe as possible, and it is crucial, therefore, that the review process is untainted.

Matthew Perrone reports, “The Food and Drug Administration's top lawyer says the agency failed to follow its own rules when it approved a knee repair product last year against the recommendation of its own scientists” (9/24, AP for FindLaw).
An internal examination by the FDA’s Chief Counsel raised concern that “agency leadership caved to pressure from the company,” in approving the ReGen Biologics’ Menaflex device.

FDA scientists rejected the product in question in both 2006 and 2007. FDA’s device division chief, who retired last month, overruled those decisions in 2008 leading to the approval of the ReGen’s device.

The probe, which was requested by Obama administration officials detailed several problems where there was concern about “a clear deviation from the principles of integrity.”

As a medical malpractice lawyer, I am very disheartened by the following story, which illustrates the major affect that health insurance has on health outcomes and the health care system in general.

Madison part reports for CNN, “a freelance cameraman's appendix ruptured and by the time he was admitted to surgery, it was too late. A self-employed mother of two is found dead in bed from undiagnosed heart disease. A 26-year-old aspiring fashion designer collapsed in her bathroom after feeling unusually fatigued for days. What all three of these people have in common is that they experienced symptoms, but didn't seek care because they were uninsured and they worried about the hospital expense... All three died” (9/18).

Research released last week in the American Journal of Public Health estimated that 45,000 deaths per year in the United States are associated with the lack of health insurance, and have a 40 percent higher risk of death than those with private health insurance. The estimate came from careful examination of government health surveys from more than 9,000 people between the ages of 17 and 94.

A recent article broke down the key issues in the health care debate and supported assertions with nonpartisan Congressional Budget Office Data (AP for FindLaw, 9/10). As a medical malpractice lawyer, I am pleased to see the use of unbiased data to explain realistic conclusions. We have finite resources to address very complex healthcare issues, thus reform should be efficiently targeted.

The key issue addressed by the article was whether restrictions on medical malpractice lawsuits mean cheaper health insurance. The short answer is, if at all, not by much.

To summarize a large issue succinctly, the article stated:

Lawsuits - or the threat of them - can drive up health care costs in several ways, but it's questionable by how much. Most directly, malpractice insurance is expensive for medical professionals, and for lawyers as it can cost upward of $100,000 to bring a case to court. Still, the nonpartisan Congressional Budget Office estimated last year that savings achieved by limiting medical liability would amount to less than 0.5 percent of health care spending. In addition, the office studied states with their own controls on medical lawsuits and found no proof that those limits have reduced "defensive medicine" - expensive and unnecessary tests and procedures ordered by a doctor only to reduce the risk of a lawsuit.

With the recent press about health care reform, the issue of tort reform is once again at the forefront. As a medical malpractice lawyer, I want to expel the incorrect notion that litigation is the primary cause of the rising cost in health care. Several columns around the country have addressed this issue, and a few were summarized in a recent AAJ news brief.

For example, the Kansas City Star (8/28, Margolies) touched on the issue of tort reform and noted “the push for tort reform rests largely on anecdotal evidence of the occasional large jury verdict or outrageous lawsuit.” The column further went on to state that although the perception of “jackpot justice” had fueled rising healthcare costs, data produces a different picture. According to the column, the “most reliable estimates peg the cost of malpractice litigation at 2 percent of overall health care costs.” Therefore, the tort system is, at best, only a small contributor to the larger problems with healthcare.

The most important issue that must be addressed is the equity and affordability of healthcare. Since there is reliable data that “even when states have capped medical malpractice awards, and malpractice suits have dwindled to near zero, insurance companies have not reduced the premiums they charge doctors” (Green Bay Press, 8/29, Fagin). Therefore, perhaps more attention should focus at eliminating a larger problem at the source by targeting the insurance industry for reform.

The AP reports (8/28, FindLaw) “Federal regulators are questioning whether Genzyme’s leukemia drug should be approved for older patients based on limited studies conducted by the biotech drug maker.” Genzyme has asked the FDA to approve the drug Colar for use by adults who are over 60 years of age, but are not healthy enough to undergo chemotherapy.

However, the FDA reviews have complained about several problems with the company’s study. One such issue is “the 112-patient study did not compare patient’s taking the drug to those taking a sham treatment, a practice commonly used to gauge a drug’s effect.” As a part of the continuing review process, the FDA will ask a panel of cancer experts to evaluate the drug in the near future.

As a medical malpractice lawyer, I advocate for thorough reviews before approving a drug. One special, but necessary consideration should be how the drug might react differently in elderly patients, and drugs such as this one that will be use primarily by older patients should take that into account during the review process.