Drug Recall Lawyer Blog

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.

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

Continue reading "Pennsylvania Appellate Court Overturns JNOV In Hormone Therapy Case" »

The Tylenol recall has been expanding. When it first started in November 2009, it was limited to five specific lots. Now, the FDA is reporting that the recall includes all Tylenol Arthritis Pain 100 Count with [Red] EZ-Open Cap.

The defect at issue is that the pills feature a moldy, musty smell, and some users have complained of nausea, stomach pain, diarrhea and/or vomiting. The source of that defect is the chemical 2,4,6-tribromoanisole (interestingly enough, also a component to some issues of cork taint in wine), which was used to treat wood pallets transporting and storing the packaging materials.

The Tylenol recall page has more information on refunds and returns. They’ve done a solid job of advertising the recall in the media and on their websites. Good job to the manufacturer, McNeil Consumer Healthcare.

Here are some links to what’s going on the world of drug and device recalls, and pharmaceutical litigation:

• Numerous blog posts featuring inside information on Vytorin and Zetia research studies, including the Arbiter 6 study that we recently posted on (courtesy Schearlings-Got-Plowed).
  
• Twitter hashtag of information on the FDA’s Social Media Meeting (courtesy @skypen).
• FDA celebrates International Internet Week of Action by sending 22 warning letters to operators of websites for illegally selling unapproved or misbranded drugs to U.S. customers.
• Procter & Gamble recalls three lots of Vicks Sinex Nasal Spray, because of bacterial contamination.
• Google Scholar now available to perform legal research—free opinions from U.S. federal and state district, appellate and supreme court opinions.
• Visit the Drug Industry Document Archive (DIDA) for over 1500 drug company documents, many only revealed after litigation. Included are some Wyeth ghostwriting documents (courtesy Tom Lamb).
• Fun new blog on Evidence in Medicine.

Here’s a list of some important stories we’ve been tracking.

• Boston Globe article probing the financial ties between Massachusetts doctors and Eli Lilly, a large drug manufacturer. “When the [drug] company provides the power point [for the doctor’s presentation], the risk of bias is even greater.”
• Seattle Post Intelligencer article examining the fatal overdose of a 15-year-old teen with autism. Michael Blankenship had a dental procedure and was given a Fentanyl Pain Patch. These are typically product liability cases, but it looks like Michael never should have received the patch in the first place, so Michael’s family has filed a medical negligence complaint.
• Drug Recall of specific lots of Infants’ and Children’s Tylenol (Johnson & Johnson) because of bacterial contamination.
• Update on Vioxx settlement: $4.85 billion.

Stevens-Johnson Syndrome, courtesy MayoClinic.com

Johnson & Johnson’s HIV drug Intelence may cause deadly allergic reactions and liver damage. It has been linked to Stevens-Johnson Syndrome (also known as toxic epidermal necrolysis), an allergic reaction that starts with flu-like symptoms and a rash, and which may develop into blisters and shedding of skin. There has been one reported death from Intelence-related Stevens-Johnson Syndrome.

The drug company has appropriately warned physicians to watch for possible reactions, and the drug’s label has been revised. A copy of the letter (through Johnson & Johnson’s subsidiary, Tibotec Therapeutics) is posted here.

The FDA just issued a press release describing problems with TNF Blockers. TNF blockers have been approved for treatment of immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

The problems are severe—these drugs may cause an increased risk of lymphoma, leukemia and other cancers, particularly in children. The FDA first disclosed problems in a June 4, 2008 communication, based on about 30 reports of cancer in children. The updated FDA analysis leading to this week’s warning is based on a review of 48 cases of malignancies, including 11 deaths. The FDA also had reports of 147 cases of leukemia in children and adults, including 30 deaths. It is still unclear how strong the association is, because there is a small population of children on TNF blockers, and those children are typically concurrently prescribed other immunosuppressive therapies.

Exmples of these TNF blockers include:

• Simponi (golimumab) by Johnson & Johnson
• Remicade (infliximab) by Johnson & Johnson
• Humira (adalimumab) by Humira
• Cimzia (certolizumab pegol) by UCB SA
• Enbrel (etanercept) by Amgen Inc. and Wyeth

We expect that lawsuits will be coming in, though there remains much work to be done on the science end. Hopefully there aren’t many children who have been affected by these drugs.

Our Yasmin/Yaz lawyers are investigating potential Yasmin/Yaz lawsuits throughout the country for women who have taken this birth control medication and now suffer from deep vein thrombosis (blood clot), pulmonary embolism, and/or strokes.

Yasmin/Yaz lawsuits allege, among other things, that Bayer knew or should have known that Yaz/Yasmin caused risks and did not adequately warn doctors about the risk.

Click on the link to find out more about the Yaz/Yasmin lawsuits.

Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we’re going to continue calling it a “black box warning”). This week, we had a one day trial that turned into a three day trial, so we’re just now getting to follow up on it.

The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion) and generic smoking cessation drugs (note—buproprion like Wellbutrin are often prescribed for depression and seasonal affective disorder). In addition to the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who are prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.

The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a possible problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.

Today, the FDA stated that it will require Black Box warnings on Chantix (and related generics) to reflect the serious neuropsychiatric symptoms associated with patients who use the drugs. In particular, suicide and attempted suicide have been widely reported among those who attempt to use Chantix as an aid to stop smoking.

We'll update on this issue later this week. For now, see the FDA's notification here.

The FDA just released its Drug Safety Newsletter (Vol. 2, No. 2). The purpose of the newsletter is to provide post-market information to doctors and other healthcare providers about drugs on the market, and to encourage reporting of adverse events through the FDA’s MedWatch program. You can find the newsletter here.

The current issue focuses on three drugs, highlighted here:

1) Qualaquin (quinine sulfate): approved to treat malaria, Qualaquin is frequently prescribed off-label for nocturnal leg cramps, restless leg syndrome, neuropathy, and other problems. The adverse reporting system indicates that it may hematologic events, including thrombocytopenia (low platelet count). There’s no indication that the off-label use is effective.
2) Reclast (zolendronic acid): Reclast is used to treat osteoporosis and Paget’s disease. This bisphosphonate may cause acute renal failure.
3) R-Gene 10 (argine hydrochloride injection): R-Gene 10 is used to evaluate pituitary function. Most of the adverse event reports center around medication errors, including fatal overdoses, hypersensitivity, and other events.

Of course, consumers and healthcare providers should take care to notify the FDA of potential problems with any drug or medical device at www.fda.gov/medwatch/report.htm or 1-800-FDA-1088. This will help to get dangerous drugs recalled, and provides the impetus for additional safety tests.

The FDA is highlighting more potential problems with drugs that contain zinc—we blogged earlier about the zinc-containing Fixodent and Poligrip denture cream products. Now, the FDA is advising consumers to immediately stop using zinc-containing nasal sprays. You can view today’s news release here.

There have been over 130 reports submitted to the FDA revealing a potential relationship between three Zicam products (Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size). Many reports indicate the loss of smell occurred after one use. A warning letter has been sent to Matrixx Initiatives, the manufacturer, advising them that they cannot market the products without FDA approval.

Lawsuits have been filed against the manufacturer of Zicam products. They post on their website that “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell." This ignores the fact that they settled around 340 cases for $11.9 million back in January of 2006. It doesn’t sound like they are being entirely forthcoming, does it?

It’s important to remember—Zicam is an alternative therapy, and is not thoroughly regulated the by the FDA. As a homeopathic remedy, the manufacturer has not had to prove the products’ safety. If they have data showing it is safe, now is the time to do it. And, a company like that should be checking out those 130 reports to determine exactly what happened.

Graves’ disease is a type of hyperthyroidism, and autoimmune disease. The immune system attacks the thyroid gland, and causes it to mass produce the thyroxine hormone. This increases the body’s metabolic rate, and can be life-threatening. The thyroid grows, often to more than double its original size.

Propylthiouracil is used to treat hyperthyroidism associated with Graves’ disease. However, these reports may indicate that methimazole is a better alternative. Symptoms of hepatoxicity (liver damage) include dark urine, yellow eyes, and elevated liver enzymes.

The FDA reports at least 32 cases of severe liver injury, including 13 deaths and 11 liver transplants, in patients treated with Propylthiouracil. By comparison, only 5 cases of severe liver injury (3 resulting in death) have been reported to the FDA Adverse Events Reporting System (AERS) for methimazole.