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

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.

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

The device is prone to malfunction because humidity may affect analysis of a patient’s heart rhythm, causing it to delay or fail to administer electric shocks.

Maryland attorney Ron Miller confronts the speculation about whether the lawsuits and medical studies surrounding Yaz, Yasmin and Ocella will lead to a recall. His analysis is spot on. Besides, Bayer will sell as long as there is decent money to be made.

See Yaz/Yasmin Recall? By the Accident and Injury Lawyer Blog.

We posted a couple of days ago on the Libipower recall, the libido drug "officially" marketed for weight loss. 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 marketing genius to combine the two. However, in this case it is just pure fancy.

The FDA just announced yesterday the voluntary recall of Libipower Plus, a drug marketed for dietary use by Haloteco. The recall is prompted by FDA analysis of the drug, which revealed traces of Tadalalafil, the active ingredient of drugs used to treat erectile dysfunction. The danger here is that Tadalalafil can react badly to nitrates, which are often taken by patients with high blood pressure, high cholesterol, diabetes and heart disease.

Something doesn’t add up, here. A google search of “Libipower” yielded a host of results like the following:

all-natural male libido enhancer supplement
a male all-natural enhancer pill

The press release mentions that Haloteco “sincerely regrets any inconvenience to consumers.” But look at the name—Libipower—it even sounds like libido. I’m sure this is no issue of cross-contamination; rather, the “diet drug” is being indirectly marketed for male enhancement, without the appropriate warnings.

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.

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. 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.

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. In addition to suits alleging the drug causes IBD, others 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).

Of course, the company stated that it stands behind its drug, but simply had to withdraw because of insurmountable competition and the rising cost of personal injury lawsuits. It’s too bad they can’t just recognize that there may be problems with the drug. It’s like medical malpractice—sometimes, people just want an apology.

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.

Of course, the Drug Recall Lawyer Blog, by its very title, does not include the word “food.” So, we won’t regularly post on this issue. But, the FDA regulates food and drugs, so there’s a connection here. And, drug manufacturers can learn a lesson from how the agriculture industry reacts to issues of contamination—often by immediately segregating potentially contaminated products despite the cost (and, farmers have more to lose than the CEOs and stockholders of drug companies). That really tells you the value of human life.

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, and 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.

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?

Yesterday, the FDA listed nineteen types of drugs that it has flagged as potentially dangerous to consumers. From October to December 2008, the FDA’s Adverse Event Reporting System (AERS) has catalogued potential problems with each of the drugs. Of course, the FDA’s investigation is not complete; however, the goal is to notify consumers so that they can discuss their medications with their physician.

Miller & Zois has discussed some of these products already—see Reglan (polyethylene glycol oral laxative), Chantix (Varenicline) and Testosterone Gel. Other drugs on the list include:

 Apomorphine (Apokyn)
 Choriogonadotropin alfa (Ovidrel)
 Clomiphene citrate (Clomid)
 Clozapine orally disintegrating tablet (FazaClo)
 Darifenacin (Enablex) and Solifenacin (Vesicare)
 Drospirenone/ethinyl estradiol (Yasmin)
 Efavirenz (Sustiva)
 Fibrin sealant, human (Evicel)
 Hydrochlorothiazide
 Imiquimod cream (Aldara)
 Modafinil (Provigil) and Armodafinil (Nuvigil)
 Orlistat (Xenical, Alli)
 Raltegravir (Isentress)
 Selegiline (Emsam)
 Sumatriptan/naproxen (Treximet)
 Tolterodine tartrate (Detrol)

Of course, if you or a loved one take any of these medications, talk with your doctor to determine if the benefits outweigh the risks.

Yesterday, the FDA listed nineteen types of drugs that it has flagged as potentially dangerous to consumers. From October to December 2008, the FDA’s Adverse Event Reporting System (AERS) has catalogued potential problems with each of the drugs. Of course, the FDA’s investigation is not complete; however, the goal is to notify consumers so that they can discuss their medications with their physician.

Miller & Zois has discussed some of these products already—see Reglan (polyethylene glycol oral laxative), Chantix (Varenicline) and Testosterone Gel. Other drugs on the list include:

 Apomorphine (Apokyn)
 Choriogonadotropin alfa (Ovidrel)
 Clomiphene citrate (Clomid)
 Clozapine orally disintegrating tablet (FazaClo)
 Darifenacin (Enablex) and Solifenacin (Vesicare)
 Drospirenone/ethinyl estradiol (Yasmin)
 Efavirenz (Sustiva)
 Fibrin sealant, human (Evicel)
 Hydrochlorothiazide
 Imiquimod cream (Aldara)
 Modafinil (Provigil) and Armodafinil (Nuvigil)
 Orlistat (Xenical, Alli)
 Raltegravir (Isentress)
 Selegiline (Emsam)
 Sumatriptan/naproxen (Treximet)
 Tolterodine tartrate (Detrol)

Of course, if you or a loved one take any of these medications, talk with your doctor to determine if the benefits outweigh the risks.

Oral phosphate sodium drugs, including the over-the-counter drug Fleet Phospho-soda (manufactured by C.B. Fleet Inc.), and the prescription drugs Visicol and OsmoPrep (both manufactured by Salix Pharmaceuticals), are laxatives and bowel-cleansers, often used by doctors before colonoscopies and similar procedures. In late 2008, the FDA added a black box warning (the most stringent warning available) to these products.

The danger of the drugs is that they may cause acute phosphate nephropathy, a serious kidney injury which is characterized by the accumulation of calcium-phosphate crystals in renal tubles, renal impairment, and sometimes death. Affected patients may require dialysis or kidney transplants. Symptoms include lethargy, low urine output, and swollen legs and ankles. Patients are at a higher risk of contracting acute phosphate nephropathy if they are: over 55, dehydrated, have a history of kidney problems, have active bowel colitis, or take other medications that affect kidney function.

C.B. Fleet did an admirable job of voluntarily recalling its products once the FDA notice came along. They will work with the FDA to determine if their products are better used by prescription, only. However, they may have had an obligation to take action even sooner—the overworked folks at the FDA cannot be responsible for setting the benchmarks for response to injuries and complaints. Tellingly, there have been indications of problems since 2003, when a medical case report was published about acute phosphate nephropathy and renal insufficiency in a woman who took OsmoPrep. Then, in 2005, doctors published an article describing injuries, including renal failure, to 21 people who used OsmoPrep products. More potential cases were later identified by the FDA’s Adverse Event Reporting System.

You can see the FDA’s April, 2009 notice about the stronger boxed warnings here.

Kugel Mesh patches, used to repair ventral and incisional hernias, were approved by the FDA in 1996. By 2002, Davol Inc. began receiving complaints, but blamed injuries on the doctors who were installing the patches. However, they issued a recall in December of 2005.

The patch has a “memory recoil ring” that tends to break as it is placed into the body. Once broken, a patch-wearer risks bowel perforation, chronic intestinal fistulae, and abnormal connections between intestines and other organs. Sometimes, this can be fatal.

The best part of any litigation against a large corporation (in my opinion), is the documents. There is nothing better than requesting documents in discovery, receiving tens of thousands (or even hundreds of thousands, or sometimes millions) of pages of documents. Defendant corporations probably laugh as they hand over so many documents, thinking that we can’t possibly inspect them all. However, somehow, we manage to do just that. And that’s where you find out what the case is really about. Kugel Mesh lawsuits, now thickly embroiled in litigation, are no different.

Davol knew or should have known about a significant number of problems with the patch well before the recall. However, in the interests of the profit margin, or because the company was incompetent, the manufacturer decided that the reports did not justify warning the public or doctors of the potential problems. (See New York Times article). In fact, an FDA inspection of the facility uncovered serious problems with the company’s manufacturing process as well as the methods it used to handle product complaints. The FDA believes that these problems hindered Davol’s ability to timely and effectively deal with the problems. A company that negligently (or intentionally) fails to monitor complaints, all the while making money on every product used will not recall a product as early as possible. These are considerations of safety, and it is astounding how many companies end up placing profit over safety.

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 makes 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:

Tardive Dyskinesia

Chronic treatment w/ metoclopramide may cause tardive dyskinesia, a serious, often irreversible movement disorder; risk increases with treatment duration and cumulative dose, and in elderly patients, especially women; Discontinue metoclopramide if signs or symptoms of tardive dyskinesia develop; avoid prolonged treatment over 12 weeks in all but rare cases where benefit may outweigh risk.

Reglan drug injury lawyers are accepting these cases on an individual basis—no class actions are filed, and none are expected. However, Reglan lawyers have petitioned for consolidation and/or coordination into an MDL (“MultiDistrict Litigation”). Basically, the hope is that these cases are grouped together for the purpose of common discovery, then individually litigated. If approved, this makes these cases more inexpensive for injured clients. The Judicial Panel on MultiDistrict Litigation (JPML) is hearing arguments for and against consolidation today. Rulings typically come within about 2 months after the hearing.

Our lawyers are investigating Reglan drug injuries subject to this new warning for patients with tardive dyskinesia. If you want to speak with a Reglan lawyer about potential lawsuits involving Reglan, call 800-553-8082 or click here for a free Reglan lawsuit case evaluation.

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.

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 benefit. 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 little 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—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.

It’s hard to say whether there are any injuries caused by either Digitek or the Caraco brand of digoxin. It is curious that the same type of medication, though manufactured separately, has very similar manufacturing problems. Of course, if you feel you or a loved one may have been harmed by any medication, it is important to save whatever remaining medication you have—in some cases, it may be the only way to identify the specific drug used, and whether it was in fact defective.

Biosite Incorporated has announced a voluntary recall for one lot of its Triage Cardiac Panel (Catalog No. 97000HS, Lot #W44467B). The test is designed to be used by healthcare professionals to help diagnose heart attacks. The issue, as I understand it, is that the recalled lot may report falsely low values of CK-MB, myoglobin, and troponin I, which are proteins that increase when a heart attack is occurring. What this means is that the test underreports potential heart attacks—the worst possible scenario.

Kudos to the manufacturer, Biosite for instituting the recall. However, I can’t help but notice that Biosite’s website makes absolutely no mention of the recall—despite today being one week after the press release. If I’m a doctor and I hear about the recall in passing, my first stop will be to the internet to get some solid information. This is the information age—there is no excuse not to use the most widely means of communication, especially when lives are in danger.

What were we just saying about responsible corporations?

Universal ABC Beauty Supply International has joined Hydroxycut in issuing a recall for several brands of its diet pills. Universal ABC Beauty Supply International's recall covers more than 30 brands.

The FDA said the recalled diet pills contain sibutramine. Sibutramine (sibutramine hydrochloride monohydrate) is an FDA-approved drug for weight loss drug manufactured by Abbott Laboratories. The Universal diet pills because those pills are not regulated because they are not "drugs." I cannot put my mind around this logic.

Sibutramine can substantially increase blood pressure and heart rate something that could be fatal for people with a history of heart disease or other heart problems (as many obese people do). Drug safety expert Dr. David Graham, who has spoken up on a lot of FDA drugs that need to be recalled such as Seroquel, has testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than obesity.

It has been a bad few weeks for quick fix diet drugs.

The title of this blog sounds like an oxymoron. But it is the subject of an interesting article in Reliable Plant which writes about how a swift recall and restitution to consumers can minimize harm to the company – and even improve customer satisfaction after the recall.

Of course, it depends on the product. Hydroxycut is through. Samantha Jones herself could not save Hydroxycut. But the author cites the Tylenol scare in the 80s as a good example:

The best example of how to deal with a product recall is the Tylenol tampering case in the 1980s. Johnson & Johnson demonstrated that the safety of consumers was paramount by swiftly recalling the product, cooperating fully with regulators, and communicating openly about the issue, the researchers noted. Subsequently, the firm undertook a series of operational and design measures to ensure that such tampering would not occur again.

The big problem that drug and medical device companies usually fall into is that they wait too long to cut their losses. Look at drugs like Chantix and Seroquel that have not been recalled and remain on the market. If the manufacturers of these drugs would cut their losses and recall the product, it would be a good outcome not only for patients but for the companies themselves.