Drug Recall Lawyer Blog

Here are the week’s stories:

• Adverse Events: Our friends at the US Recall News have a link to governmental agencies in charge of adverse event complaints and concerns.
• Avandia: Lots of concern recently about diabetes drug Avandia and heart problems (HT: Nursing Home Abuse Blog).
• Iqbal: The Lewis & Clark law review released its symposium “Pondering Iqbal.” There’s some good topics here—a must read (HT: PrawfsBlog).
• BPA: More on BPA research (HT: Nash & Associates).
• Fentora: This narcotic painkiller is the subject of possible off-label promotion (HT: Drug Injury Lawyer Blog).
• Pharmaceutical Marketing: The title says it all: “A Snarky Look at Sneaky Marketing Tactics Pharma hasn’t Avoided" (HT: Pharma Marketing Blog).
• Gadolinium/Omniscan: A settlement has been reached in the libel suit brought by General Electric (GE) against Danish researcher Henrik Thomsen.

Happy Monday!

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!

It’s a winter wonderland here in Maryland, and our office is running on a skeleton crew. Here are the top drug injury-related stories for the past few days:

• Digitek: Tom Lamb and the Drug Injury Watch post on the status of this litigation (surprisingly, it is not defunct yet, despite long problems in finding the mythical creature, “The Double-Dose Pill.”
• Preemption: An upcoming article by Mary J. Davis in the Hastings Law Journal titled “The ‘New’ Presumption Against Preemption.”
• Gadolinium: A Danish radiologist complains to The Guardian that the United Kingdom’s laws on libel are preventing him from speaking about the dangers of General Electric’s MRI contrast dye, Omniscan. He states that, "I am not giving lectures any more in the UK where it seems you can be sued for telling the truth." He is being sued by GE Healthcare. GE: “We Bring Good Things to Light [or, do our best to quash them through litigation].”
• Fosamax: Exposé by NPR about how Fosamax came to be so popular, and whether it actually works. (Hat tip to Shearlings Got Plowed)

Happy Monday!

Two FDA committees met yesterday to discuss the future of gadolinium warnings. Gadolinium is a contrast dye given to some patients before MRIs and MRAs that better highlights damaged parts of the body. Unfortunately, when given to patients with impaired renal function, it can be deadly.

The committees recommended that two particular brands of gadolinium dye, GE Healthcare’s Omniscan and Covidien’s OptiMark, should feature enhanced warnings against use in patients with severe kidney disease (the drugs all feature a warning about the risks of nephrogenic systemic fibrosis). After reviewing evidence, the committees clearly believe that these two products are more dangerous than the other gadolinium-based contrast agents on the market, including Bayer’s Magnevist. Whether the FDA takes action on the panel’s opinion remains to be seen.

GE, for its part, is arguing against the changes. They claim that there is insufficient evidence that any gadolinium-based contrast agent is more dangerous than any other. This fits the profile of GE’s approach on all things related to the gadolinium litigation—they are fighting everything tooth-and-nail, sometimes unreasonably so.

In fact, Covidien appears poised to receive the most conscientious drug company award—they have already made moves to modify their label, contraindicating use in patients with severe kidney dysfunction. We like to see the drug companies step up to their responsibilities, especially to prevent more injuries.

In other gadolinium news, it looks like the first prospect for trial is Bayer’s Magnevist in the San Francisco Superior Court (a non-MDL case). The Plaintiff, Peter Gerber, alleges that Magnevist caused him to develop nephrogenic systemic fibrosis (NSF).

For more information:

• Reuters’ story on the FDA committee meeting
• Drug Recall Lawyer Blog posts on gadolinium
• Miller & Zois’ main gadolinium injury page

Not drug related, but Happy Anniversary is in order.

Now that you know more about me than you are probably comfortable with (who celebrates that?), let’s get to business with some noteworthy items:

• Reuters discusses the FDAs investigation of using drugs like Seroquel on children.
• Recently expanded indications for Seroquel by children.
• The Chicago Tribune writes about abuses in prescribing psychotropic medications without consent and without a valid medical reason. Note the front-and-center picture of Seroquel.
• The Wall Street Journal discusses a clinical study showing that an experimental once-a-week treatment woks better to treat type-2 diabetes than Januvia.
• Tomorrow (December 8, 2009) the FDA will convene a joint meeting of the Cardiovascular and Renal Drugs Committee and Drug Safety and Risk Management Advisory Committee. They will discuss safety as it pertains to Gadolinium-based contrast agents, which are used before MRI procedures. A copy of the background material (agenda, briefing information and meeting roster) is located here. More information on Gadolinium-based contrast agents can be found at our blog and our website.
• More on Ghostwriting (courtesy Brian Ketterer). I like this excerpt:

If a professional writer is paid by a company to write a piece and a non-author doctor is asked to approve it, the appropriate outcome would be for the professional writer to be listed as the author and for the non-author doctor to be thanked in an acknowledgement for having reviewed the paper. If the non-author doctor makes substantial enough changes to the paper, he or she might be listed as a coauthor. In either case, the funding for the paper should be disclosed.

Happy Monday!

A new article on Business Week came out yesterday on gadolinium, with the focus on GE. First, a little background:
Gadolinium is a metal that is injected as a contrast agent into patients before specific diagnostic tests, MRIs and MRAs. The metal allows physicians to better visualize damaged parts of the body. Most of us excrete the gadolinium easily with the help of our kidneys.

However, many people have kidney disorders, like renal impairment, and they cannot get the gadolinium out of their bodies. The metal is toxic to the body, and long-term toxicity causes a condition known alternatively as Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD). The hallmarks of that disease is painful swelling of the limbs, skin lesions, discoloring of the skin, and hardening of organ tissues. There is no cure, and the disease itself is oftentimes fatal. In fact, it is one of the most horrific diseases I have ever seen. Patients are disfigured, and robbed of their mobility and their health.

Continue reading "Gadolinium and General Electric" »

Ask any pharmaceutical or medical device lawyer—one of the biggest problems in tackling these cases is product identification (sometimes referred to as PID). As an example, in the gadolinium MRI cases, it can take months (or longer) to go through and determine (1) whether the patient had gadolinium used for any particular MRI or MRA scan, and if so then (2) what brand of gadolinium was used. The brand is important because the lawsuit must identify a proper defendant.

Continue reading "Tracking Defective and Recalled Drugs and Medical Devices" »