Drug Recall Lawyer Blog

Some interesting news to follow this week:

• Vioxx: The Pop Tort reports on how “lawsuits played a key role unearthing documents showing what lengths Merck went to cover up mounting evidence that patients taking Vioxx were experiencing a high number of heart attacks and strokes.” Now, Vioxx manufacturer Merck settles some shareholder lawsuits, and includes some proactive measures to protect against these abuses in the future.
• Benzene: The Accident and Injury Lawyer Blog reports on the dangers of benzene.
• Medical Radiation: Much continues to be written about radiation as it relates to diagnostic procedures, especially in the wake of the FDA’s newest guidelines. The Mass Tort Defense Blog opines that plaintiffs’ lawyers seeking medical monitoring for their patients may do more harm than good on the basis that it will increase radiation exposure. There is some logic to this, but shouldn’t patients be the ones to choose?
• Lipitor Whistleblower Lawsuit: FiercePharma reports on an amended complaint by a whistleblower, alleging that Pfizer unethically expanded its marketing base by ignoring cholesterol guidelines.
• Recall of Luer Access Devices: The FDA is posting recalls of Luer Access Devices, including certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems and certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. These devices do not properly lock, causing leakage of intravenous materials or blood, or causing air emboli.
• Pain Pumps: This is a good graphic representation of the pain pump system

Happy Monday!

The FDA issued a press release Tuesday focusing on unnecessary radiation exposure from CT scans, nuclear medicine studies (use of radiopharmaceuticals taken internally creates the radiation, unlike an x-ray, which bombards the body with radiation externally) and fluoroscopy (process to see real-time moving images of internal structures).

The FDA reports that these three types of diagnostic imaging use ionizing radiation, which can increase lifetime cancer risks. Single exposure to high levels of ionizing radiation causes hair loss, skin burns and cataracts.

The FDA recommends two areas to minimize radiation risk:

1. Appropriate justification of the radiation procedure; and
2. Optimization of the radiation dose used for each procedure

To meet these goals, the FDA will work to issue guidelines for manufacturers of these radiation-emitting devices to create safeguards and appropriate training protocols. Further, health care providers will work with the FDA to implement quality assurance standards.

One of the most important parts of this process is, of course, the patients. Patients should discuss the risks of any procedure involving radiation with their doctors. The FDA is working to develop a patient medical imaging history card, which (if used properly) will better enable physicians to understand the lifetime radiation history of patients, and enable them to better inform patients as to the real risks of subsequent exposure.

The press release focused mostly on the CT images and fluoroscopy, and did not seem to address the procedures for radiopharmaceuticals (nuclear medicine studies), though perhaps that is subsumed in the section on protocols for health care providers who perform imaging services. But, the manufacturers of those pharmaceuticals should also be part of the discussion.

Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

• Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
• Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
• FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
• Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
• Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
• Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.

Happy Tuesday!

Some noteworthy news items to start your week:

• Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
• Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.
• FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
• Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

The FDA is making temporary recommendations about Perfusion CT scans. We first wrote about the concern of excessive radiation exposure in our December 16, 2009 post.

The recommendations include:

• Facilities assess whether patients who underwent CT perfusion scans received excess radiation
• Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study
• Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered
• Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient
• If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study

Additionally, manufacturers of the scanners should reevaluate their training manuals and procedures, and improve surveillance systems to more quickly identify problems with particular machines or in particular hospitals.

Of course, it’s very important that patients take their own safety into their own hands, and ask specific questions when receiving any type of scan involving radiation. See the American College of Radiology’s website for more information.

There are more than 70 million CT scans performed in the United States every year. The FDA is investigating problems with overexposure to radiation by CT scans. This is an ongoing problem everywhere, but is complicated by significant overexposure of special types of CT scans (called perfusion CTs) at two hospitals.

First, some background: CT scans (also called CAT scans, or computerized tomography) is a type of x-ray that uses radiation to visualize internal structures of the body through a cross-section of images (unlike the flat images of normal x-rays). One CT scan is equivalent to about 100 chest x-rays. One perfusion CT scan (used to examine blood vessels and often used to diagnose stroke or aneurysm) is equivalent to several hundred chest x-rays.

Sample Perfusion CT

Continue reading "CT Scans And Radiation Poisoning" »