FDA to Investigate Safety of Essure Birth Control
August 6th, 2015 at 12:11 pm
Reports of serious concerns over a popular contraceptive, used by countless women, is coming under federal review due to multiple reports of dangerous medical complications suffered by women who have used the device.
The Food and Drug Administration (FDA) has announced that they are reviewing the safety of the implant Essure. The contraceptive device is manufactured by Bayer and has been on the market since 2002. The device is made of two metal coils which are inserted into the fallopian tubes as a way to block contraception.
However, the FDA says that they have received more than 5,000 complaints of medical issues, including abdominal pain, fatigue, headaches, and weight fluctuations, by female patients prescribed Essure since its approval. More than 400 women and/or their doctors have reported the coils moving away from the fallopian tubes and into other parts of the patient’s reproductive system.
There have also been reports of five fetal deaths, which occurred when the Essure device failed to prevent pregnancy.
Since its approval, the Essure device has been implanted into approximately 750,000 women. Based on the number of complaints the FDA has received, this means approximated one in every 150 women has had a problem with the device.
The FDA has scheduled a public hearing to be held on September 24, 2015 to review the safety of the product. The hearing will include the agency’s Obstetrics and Gynecology Devices Panel. This hearing is being scheduled due in part to a New York television news channel’s investigation regarding the inconsistencies which took place during the clinical trials of Essure. These trials, which failed to disclose complaints by trial patients, were presented to the FDA in order to get the agency’s approval for the device.
If you have experienced medical complications or other issues from having the Essure device implanted, or any other medical device issues, contact an experienced Westport personal injury attorney to find out what legal recourse you may have for your pain and loss. For a free initial consultation about your case, call Attorney Richard H. Raphael at 203-226-6168 today.
Telemedicine and Medical Malpractice in Connecticut
August 5th, 2015 at 7:00 am
The rise in technology has brought with it a rise in online services and solutions. One of the more recent rising trends is telemedicine. Most major television channels have some sort of doctor program where celebrity doctors offer advice and services —”Dr. Phil,” “Dr. Oz,” and “The Doctors” are just a few examples. Due to the popularity of these medical shows, other providers and companies have been experimenting in the field of telemedicine and potentially exposing themselves to medical malpractice liability.
Insurance companies are some of the more recent telemedicine bandwagoners. Anthem Blue Cross and Blue Shield, a Connecticut insurance company, offers an online forum called LiveHealth Online to connect patients and doctors. All the doctors who advise on the site are licensed to practice in the state; however many do not actually live and work in Connecticut. There is no guarantee that a user will talk to his or her own primary care provider or that he or she will even connect with the same doctor over multiple visits to the website.
Those who support online medical website and other telemedicine services say that it is similar to visiting a pharmacy versus a primary care provider; the goal is a quick consult for a minor medical problem. Many disagree with the comparison. At a pharmacy, a licensed pharmacist has an opportunity to physically examine any potential patients/customers, whereas the physical interaction is impossible in telemedicine. Opponents of the practice are concerned about the level of care that can be provided to a patient as well as continuity of care if a medical problem persists.
Because the risks of telemedicine include misdiagnosis, delayed diagnosis, and miscommunication, Connecticut state legislators are considering a bill that would limit the services provided through telemedicine. Senate Bill 467, if passed, would require that online doctors access medical records for each patient before making a diagnosis, as well as belong to a reputable medical practice that is held to the same accountability standards as traditional practices. Additionally, the bill would require that patients be made aware of the services and limitations of online medical treatment.
Telemedicine is a newer field and is thus not subject to the same medical malpractice rules and restrictions that limit other doctors and medical facilities. However, due to the absence of physical interaction, the risks for medical error can be even higher in telemedicine cases.
If you received treatment from a doctor, either online or in person, and believe a medical error or misdiagnosis occurred, please consult with a Westport medical malpractice attorney to discuss your case and options as soon as possible. We are proud to represent clients throughout Connecticut and we look forward to speaking with you.
Decrease Malpractice Claims: Improve Quality of Care, Not Tort Reform
July 30th, 2015 at 12:03 pm
There has been much movement—pushed along by the medical and insurance—to institute tort reform regarding a patient’s legal right to sue medical personal when treatment has caused injury or illness. This movement has included placing caps on the amount of non-economic damages, as well as placing stringent time limits on when an injured patient has to file his or her medical malpractice lawsuit.
Advocates for tort reform say it is necessary because there are too many false and/or frivolous lawsuits, causing medical and insurance costs to skyrocket. A new study, however, found there may be another way to cut down on the number of malpractice lawsuits that are filed—offer better medical care.
The study was conducted by researchers from Southern Illinois University School of Medicine, Springfield, IL, University of Utah, Salt Lake City, UT, Allscripts, Chicago, IL, and Griffin Hospital, Derby, CT. It was published in the American Journal of Medical Quality.
The research team used a hospital in Louisiana and a hospital in Texas to conduct their study. Both hospitals were owned by the same medical corporation. They chose those two locations because of the difference in tort reform which has occurred in those two states. During the time period from which the team took their data, Louisiana had not implemented significant tort reform; however, Texas had. In Texas, for example, attorneys have lost the ability to use contingency fees as compensation to represent injured clients.
Although there were no changes in tort reform during that time period in Louisiana, there were changes in the quality of care the hospital offered patients. This quality of care was based on the same 22 factors that Medicare uses to determine quality of care.
The study found that both hospitals had a reduction in malpractice claims, yet for different reasons. Therefore, this proved that the system does not need tort reform to decrease medical malpractice claims, but should instead be focusing on improving the care patients receive in hospitals and reducing medical errors which are one of the leading causes of patient injury.
If you have been injured or become ill because of medical treatment you have received, contact an experienced Westport personal injury attorney to find out what legal recourse you may have. Call Attorney Richard H. Raphael at 203-226-6168 for a free consultation.