Drug & Device News

Merck Agrees to Pay Plaintiffs' Attorney Fees to Settle Vioxx Suits

In order to finally settle two shareholder derivative suits concerning its pain medication Vioxx, Merck & Co. has agreed to pay $12.15 million toward the plaintiffs' legal fees. The suits, one in federal court and another in New Jersey state court, claimed the company and some of its officers and directors failed when promoting their product to disclose the fact that Vioxx could cause heart problems. Merck spokesman Ronald Rogers said the company considered the agreement to pay plaintiffs' attorney fees “the best and most appropriate way to put these suits behind us.“ Rogers added, “We believe the company has always acted appropriately and in the best interests of patients and we believe this settlement is consistent with that belief.“ Still ongoing is another shareholders' suit against Merck, which is pending before the U.S. Supreme Court.

FDA Wants Changes Made to Avoid Radiation Overloads

The FDA is launching an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures because, according to Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health,
“[t]he amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years.” Although the use of sophisticated diagnostic imaging equipment can greatly aid in the treatment of various disorders and diseases, the per-procedure exposures and lifetime cumulative effects of multiple exposures may lead to the development of cancers. The three procedures targeted by the initiative are tomography (CT), nuclear medicine studies, and fluoroscopy, as these involve exposure to high levels of radiation. The FDA is therefore promoting the adoption of two principles of radiation protection in the clinical setting: 1) Appropriate justification of the radiation procedure; and 2) Optimization of the radiation dose used during each procedure. It is also working on new standards for manufacturers of CT and fluoroscopic devices, which might include a requirement that these devices display, record, and report equipment settings and radiation doses, and that they alert users when the dose exceeds the optimal dose. Also being considered is a requirement that devices be able to tally and transmit radiation dose information to a patient's electronic medical record and to national dose registries. This information would then be made available to patients and their medical care providers, who could use it when deciding whether a medical imaging test is appropriate for the patient.

Nearly a Decade Later, Settlement Reached in MRI Death Case

The family of a boy whose accidental death after an MRI (medical resonance imaging) accident prompted a call for nationwide revamp of safety standards has settled with the hospital where the accident occurred. In 2001, six-year-old Michael Colombini, who had had a benign tumor removed from his brain, was undergoing a follow-up MRI test at Westchester Medical Center, in Westchester County, NY. While he was being tested, a staff member walked into the room with an oxygen tank. The MRI's strong magnetic force pulled the metal tank into the chamber, where it hit Colombini in the head. Days later, he died of his injuries. The family and medical center settled the case for $2.9 million.

Merck Agrees to Pay Plaintiffs' Attorney Fees to Settle Vioxx Suits

In order to finally settle two shareholder derivative suits concerning its pain medication Vioxx, Merck & Co. has agreed to pay $12.15 million toward the plaintiffs' legal fees. The suits, one in federal court and another in New Jersey state court, claimed the company and some of its officers and directors failed when promoting their product to disclose the fact that Vioxx could cause heart problems. Merck spokesman Ronald Rogers said the company considered the agreement to pay plaintiffs' attorney fees “the best and most appropriate way to put these suits behind us.“ Rogers added, “We believe the company has always acted appropriately and in the best interests of patients and we believe this settlement is consistent with that belief.“ Still ongoing is another shareholders' suit against Merck, which is pending before the U.S. Supreme Court.

FDA Wants Changes Made to Avoid Radiation Overloads

The FDA is launching an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures because, according to Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health,
“[t]he amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years.” Although the use of sophisticated diagnostic imaging equipment can greatly aid in the treatment of various disorders and diseases, the per-procedure exposures and lifetime cumulative effects of multiple exposures may lead to the development of cancers. The three procedures targeted by the initiative are tomography (CT), nuclear medicine studies, and fluoroscopy, as these involve exposure to high levels of radiation. The FDA is therefore promoting the adoption of two principles of radiation protection in the clinical setting: 1) Appropriate justification of the radiation procedure; and 2) Optimization of the radiation dose used during each procedure. It is also working on new standards for manufacturers of CT and fluoroscopic devices, which might include a requirement that these devices display, record, and report equipment settings and radiation doses, and that they alert users when the dose exceeds the optimal dose. Also being considered is a requirement that devices be able to tally and transmit radiation dose information to a patient's electronic medical record and to national dose registries. This information would then be made available to patients and their medical care providers, who could use it when deciding whether a medical imaging test is appropriate for the patient.

Nearly a Decade Later, Settlement Reached in MRI Death Case

The family of a boy whose accidental death after an MRI (medical resonance imaging) accident prompted a call for nationwide revamp of safety standards has settled with the hospital where the accident occurred. In 2001, six-year-old Michael Colombini, who had had a benign tumor removed from his brain, was undergoing a follow-up MRI test at Westchester Medical Center, in Westchester County, NY. While he was being tested, a staff member walked into the room with an oxygen tank. The MRI's strong magnetic force pulled the metal tank into the chamber, where it hit Colombini in the head. Days later, he died of his injuries. The family and medical center settled the case for $2.9 million.