The FDA is convening an advisory panel of outside medical experts to discuss what actions might be taken to minimize risks associated with the devices in these recall situations
Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.

The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.

The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.

Manufacturers are required to report problems potentially associated with devices to the FDA. The FDA conducted a review of insulin pump-related adverse-event reports and found nearly 17,000 reports from Oct. 1, 2006, through Sept. 30, 2009. The reports don't necessarily mean a device caused a problem but serve as a signal for more investigation. Even if a device is functioning properly patients can inadvertently misuse the device. Of the reports, about 12,000 reported a patient injury (such as problems with blood glucose levels) and 310 deaths.

The agency said the information provided by manufacturers involving deaths "was typically incomplete." The agency said in 225 of the deaths reported the device problem was listed as "unknown," although in many cases the device was never returned to the manufacturer for additional follow-up.

However, in 41 death reports, a device problem wasn't identified but the circumstances involving the death involved diabetic coma and problems associated with blood-sugar levels being too high or too low, suggesting the device may not have been working properly.

Now, under the Obama administration, a pattern of more rigorous regulatory action is evolving, particularly at the Federal Trade Commission and the FDA.

In a recent crackdown on false and misleading claims on food packages, the Food and Drug Administration has sent warning letters to 17 producers for making what it alleges are misleading statements about nutrition and health benefits.

The warning letters apply to 22 products and challenge labeling language on such issues as fat content, nutrient standards and the purported ability of a particular food to prevent medical problems. The increased enforcement was applauded by the Center for Science in the Public Interest, the nonprofit advocacy group which recently released a report documenting purported labeling abuses.

Among the targets of the FDA action was a label for Mrs. Smith's Coconut Custard Pie, produced by Schwan's Consumer Brands North America of Bloomington, Minn. It advertised that the pie contained no trans fat, but did not disclose that it contained significant levels of saturated fat and total fat.

Diamond Food of Stockton was cited for making claims that its shelled walnuts warded off maladies such as arthritis, cancer and heart disease.

The agency also issued an industrywide challenge to upgrade the quality of nutrition labeling. FDA Commissioner Margaret Hamburg released a "Dear Industry" letter in which she invited food producers to collaborate on improving nutrition information, particularly on the front of food labels, where consumers are most likely to see it.

This week CNN covered a story that everyone concerned about high medical costs should view. Their reporters uncovered massive overbillings by hospitals. These outrageous billings included $1,000 for a common toothbrush. You can go to your pharmacy and buy 100 Tylenol pills for $10, yet one hospital billed $140 for a single pill. An alcohol prep pad, a piece of gauze, was billed at $44.00 by a hospital when the retail cost at a pharmacy is 23 cents. In another example a hospital billed an emergency room patient for 41 bags of IV fluid during a 2 hour visit. This of course is impossible.

Our own lawyers can tell similar stories. We had one client who was severely injured in an automobile accident and pronounced dead upon arrival at the hospital. Yet, when reviewing the bill we discovered a $25 dollar charge for a “mouthcare kit” which consisted of a plastic cup, a toothbrush, and mouthwash. Also charged for this patient who was dead upon arrival was $45 for a pillow.

These are just a few of the overbillings we have seen. In fact, CNN reported that health insurance companies rarely review hospital bills unless they are in excess of $100,00.00.

If the proponents of tort reform really want to lower healthcare costs these outrageous charges might be a good place to start.

The hospital, CoxHealth in Springfield, Missouri, blamed the errors on powerful new radiation equipment which had been calibrated incorrectly even with a representative of the manufacturer watching as it was done.

According to the hospital, half of all patients undergoing stereotactic radiation therapy were overdosed by about 50 percent after a physicist at the hospital miscalibrated the new equipment and routine checks over the next five years failed to catch the error.

Stereotactic therapy delivers radiation in such high doses that usually only one treatment is required. It is commonly used to treat small tumors in the head.

The overradiations were discovered in September 2009 after a second physicist received training on the equipment and the hospital began questioning whether the machine had been installed correctly in 2004.

In Missouri, like many states, there is little or no government oversight of radiation therapy. However, The FDA has recently announced plans to increase its oversight of medical radiation. Predictably, this proposal is being opposed by many hospitals and manufacturers of radiation equipment.

Notably, the president of the Missouri hospital where these errors occurred urged the FDA to go even further in regulating radiation therapy. His statement was as follows:

“The initiative should be broadened to include regulation of medical radiation therapy as well. We have also learned that the incident here at CoxHealth is, unfortunately, not an isolated occurrence. Rather, similar instances of medical overradiation have occurred at other hospitals throughout the country. Without increased regulation and oversight, these instances of medical overradiation will likely continue.”