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Articles Posted in FDA/Voluntary Recalls

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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.
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The LifePak CR Plus Automated External Defibrillators manufactured by Physio-Control, Inc. (which is owned by Medtronic), is subject to a Class I recall. These recalls are the most serious and are conducted when there is a reasonable probability that use of the device will cause serious injury or death.

The automatic defibrillators are used to treat patients suffering from cardiac arrest in hospitals, by emergency response personnel, and even by those without medical training in public places (defibrillators like these are often seen at airports, swimming pools, and other public places). The recall affects devices with the following serial numbers:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

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We posted a couple of days ago on the Libipower recall, the libido drug “officially” marketed for weight loss. It looks like the FDA has spotted some other drugs that fit the bill of weight-loss drugs, which are also used for erectile dysfunction.

Since being notified by the FDA that the supplement products contain unapproved drug ingredients, the manufacturer (Opteron 1 Inc., doing business as Nature & Health Co.) of LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac has “voluntarily” recalled those products. See the recall press release here.

Of course, a drug/supplement that worked for weight loss and erectile dysfunction would make billions and billions of dollars–just look at Viagra and Fen-Phen. It’s a marketing genius to combine the two. However, in this case, it is just pure fancy.

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Already plagued by problems with their Sprint Fidelis leads (though, enjoying unprecedented success in the litigation arena, despite causing horrific injuries to many), Medtronic is now recalling select lots of their Paradigm Quick-Set Infusion sets. Quick-Set is used with the Medtronic MiniMed Paradigm insulin pumps by diabetes patients. It is a disposable device that delivers insulin to the patient and is then replaced after three days of use.

Two percent of these devices, around 60,000 units, may malfunction, causing delivery of too little or too much insulin. Controlling insulin levels is tricky under the best of circumstances, so the effects of these defective devices could be fatal. The recalled lot numbers begin with an ‘8.’ (i.e., 8XXXXXX), and are located on the product’s box and the individual unit.

Read the press release here. More information is available from Medtronic here.

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Covidien’s subsidiary Mallinckrodt yesterday voluntarily recalled lot 370-9004 of its Sodium Chromate Cr-51 Injection. Post-market testing revealed that the drug had decreased potency. It is used diagnostically to determine red blood cell mass or volume, survival time, and blood loss evaluation. The use of the recalled product may lead to misdiagnosis and consequential stroke or embolus because of false low readings in red blood cell volume.

Mallinckrodt is perhaps best known in the litigation world for manufacturing the MRI gadolinium-based contrast agent known as OptiMARK, which causes Nephrogenic Systemic Fibrosis, NSF (also known as Nephrogenic Fibrosing Dermopathy, NSD) when used in patients suffering from renal failure. Those cases are pending in an MDL before Judge Polster in the Ohio federal court.

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Accutane is being taken off of shelves by manufacturer Roche Holding AG after yet another successful jury verdict found that the drug causes inflammatory bowel disease (IBD). Jury verdicts for IBD have totaled about $33 million to date.

The drug was introduced in 1982, has been taken by 13 million people, and was the company’s second-best-selling drug before generic drugs began competing with it in 2002. After that time, the manufacturer only has 5% of the market share.

The drug has been besieged by lawsuits for some time. Besides suits alleging the drug causes IBD, other suits allege the drug causes birth defects and depression. You may recall a recent suit by U.S Representative Bart Stupak of Michigan, who alleged that his son’s suicide was caused by Accutane (the judge granted summary judgment in favor of the company, there).

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It’s a new world we live in. In recent years, public recognition of the importance of food safety has grown and is being fed by the media and our federal government. Perhaps this is because we all need to eat to live; perhaps this is because of the movement toward more organic food and healthy foods; or perhaps it is because we have the technology now to digest complicated facts and determine the genetic make-up of various strains of E. coli, linking them to the source. Whatever the reason, promoting healthy food processing is a good thing.

At any rate, food recalls are often most important for the elderly and young. Those two groups traditionally have weaker immune systems than the rest of us, and salmonella or E. coli can have a disastrous and frequently deadly effect. (For the rest of us, eating tainted food may result in a few days or weeks of terrible stomach pain, and sometimes hospitalizations). We’ve been learning these lessons on a regular basis in the past few years—lettuce, spinach, hamburger, peppers, peanuts, peanut butter, pistachios, and pot pies are the teachers.

With the media regularly focused on tainted food products, the legislature is moving to take action. A U.S. House panel recently approved giving the FDA the power to order food recalls. Though the FDA is overworked and understaffed, this is a step in the right direction. Of course, the primary responsibility must fall on the agricultural industry to educate itself, police itself, and protect the public.

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For two years, Florida attorney Frederick Schaffer has sought the answer to his lack of smell. He’s gone to doctor after doctor, searching for a solution and cause to the medical condition known as anosmia. He had a camera rammed down his nasal passage, as well as an MRI and a CT scan. He’s visited specialists. But he finally realized the problem when he saw the FDA’s recall of Zicam.

Schaffer’s claims really highlight what tort victims understand, but the general public often overlooks. Seemingly insignificant injuries often have a lifelong cost. Schaffer misses the smell of coffee (which most people use to help wake up). He misses his wife’s perfume. He misses the smell of his kids’ hair after they’ve taken baths.

The smell is also intricately enmeshed in our sense of taste. Imagine not being able to really taste homemade apple pie, much less smell it. Losing that one sense dulls the taste buds. And, if it can’t be corrected, that’s a lifelong condition. How much is that worth?

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Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. The danger that Reglan lawyers are investigating is tardive dyskinesia (also known as TD), a neurological disorder that manifests as repeated involuntary movements. Injured patients may experience grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for tardive dyskinesia.

Not to say that heartburn isn’t painful, but how many of us would risk contracting tardive dyskinesia just to compensate for bad eating habits? Reglan lawyers have discovered that the label, unfortunately, minimized that risk, implying that there wasn’t much danger. The original label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicate that tardive dyskinesia is a low risk.

However, earlier this year the FDA required makers of Reglan and other metoclopramide medications to put a black box warning on their labels, the most stringent act the FDA can take. That label now reads:

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New from Twitter (side-issue—I’ve been trying to figure out decent work-related uses for Twitter for some time. This might be it—I can get instantaneous reports from the FDA about recalls and other safety issues related to drugs and devices—if you’d like to join the club, then just go to your Twitter account, search for the FDA, and click ‘Follow’): the FDA just posted a recall from AS Medication Solutions, LLC. AS Medication distributes Digoxin 0.25 mg tablets under the Caraco brand.

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Digoxin is used to treat heart failure and abnormal heart rhythms. The drugs are being pulled because some tablets may have more or less of the active ingredient. I’ve been to seminars about this drug, and my understanding is that there is a very narrow range of therapeutic benefits. The analogy is that a patient’s digoxin levels are represented by a ball balanced on the point of a pyramid—too much digoxin, even by a bit, will cause the levels to rapidly change, with disastrous results (including cardiac instability, slow heart rate, and death).

Plaintiffs’ lawyers have been advertising for digoxin cases for some time—a word first came out of the problems with Digitek tablets in April 2008 (trademarked by Activis Totowa, distributed by Mylan Pharmaceuticals Inc. under a Bertek label, and distributed by UDL Laboratories, Inc. under a UDL label). Those pills, manufactured in New Jersey, were reported to have a similar problem—some of the pills were supposedly “double-thick.” While there were verified accounts of major problems with the manufacturing facility in that instance, I don’t know of any lawyers who actually located any double-strength pills. The cases moved rapidly in the beginning but seemed to lose steam.