Drug Recall Lawyer Blog

The FDA has announced today the recall of Vagifresh Ball and Vagifresh Gel. An analysis by the FDA has found that Vagifresh Gel contains benzocaine, an active ingredient for many anesthetic drug products. An analysis of Vagifresh Ball found the product to contain bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.

The FDA has further determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

These products, marketed as cosmetics, are applied by inserting deeply into the vagina for a prolonged period of time. Sold in herbal stores, beauty shops, drug stores, the internet, and by mail order. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid, though this recall does not involve Vagifresh liquid.

Consumers are being instructed to immediately stop using the products and contact their physician if they experienced any problem that may be related to use.

I'm a man. It is not exactly comfortable putting this kind of information out there. But when safety is at issue, you really have to put that kinda stuff aside.

American Regent has recalled seven lots of injectable dexamethasone sodium phosphate because the agent may form particulates before its labeled expiration date. The recall involves 30-mL multiple dose vials at 4 mg/ml.

American Regent was silent on the issue of whether there have been any injuries or problems reported from this injectable steroid. This can mean they don't want to say or it can mean absolutely nothing. But the best thing to do is to just tell us from jump street whether anyone has reported injuries and whether those injuries were significant. Because if we are taking a drug or using a product, it is something we really want to know.

Here are this week’s stories:

• Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
• Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
• Scientist-CEOs: Should pharmaceutical companies bring back the scientist-CEO business model?
• Kickbacks and Hip Implants: Read about a former umpire’s quest for justice when a hip implant fails, and he finds out about the moneyed relationship between his surgeon and the medical device manufacturer.
• Benicar: The Drug Injury Watch has a post on the possible dangers of Benicar.
• Motrin’s Phantom Recall: See Brian Nash’s blog for his take on the J&J recall.

Happy Monday!

The new romaine lettuce recall is the latest in a series of dangerous fruits and vegetables. The impact of clean agricultural practices first really hit public consciousness in 2006 with the massive E.Coli outbreak in Dole spinach. And then in 2008 with the tomato recall. And then in 2009 with the peanut butter recall.

Now, the FDA is telling us that Freshway Food’s bagged romaine lettuce, potentially with sell by (not use by) dates of May 9 and May 10 can contain e.coli O145, which is harmful. The outbreak has likely harmed at least 19 people in Michigan, Ohio and New York. The FDA believes a farm in Yuma Arizona may be the source. Injuries include hospitalizations and hemolytic uremic syndrome (a disease that destroys red blood cells, and may be indicated by bloody diarrhea and acute kidney failure). Adults typically recover quickly, but it can be life threatening to children, the elderly, and people with impaired immune systems.

The lettuce at issue was sold to wholesalers, food service outlets and some stores with salad bars or delis, and may include pre-packaged salads from Kroger, Giant Eagle, Ingles Markets, and Marsh stores. Other states where the salad was sold include Alabama, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia and Wisconsin. Importantly, Freshway Foods does not produce prepackaged salads for supermarket sales.

I don’t usually post on agricultural recalls, but it is such a big trend lately, that it seems important to at least get the information out there. As an aside, any product lawyer who has faced the uphill battle of specific product identification in medical device or drug cases knows how difficult it can be to discovery specific brands or manufacturers of products used in hospitals. By comparison, agricultural detection is a fine-tuned science. DNA from the E.coli can be checked. The food industry typically has terrific identification protocols that allow us to track a specific box of lettuce used at a restaurant to a state, a farm, and even an area in the farm, not to mention time of day it was picked.

Eat healthy.

The FDA Law Blog has a great post on the recent Baxter Colleague Infusion Pump Recall. They outline the authority the FDA is using to demand the recall (it is based on a consent agreement entered some years back between Baxter and the FDA after continued pump problems). The FDA Law Blog questions whether Baxter is required to refund purchase prices or reimburse for current pump values. There's an interesting calculation of Baxter's expected loss (though, Baxter is hoping to be able to replace the Colleague pumps with other Baxter pumps).

See our prior post on the Baxter pump recall here.

Here are this week’s stories:

• FDA: The FDA is changing the medical device approval process. See the FDA announcement (HT: Eye on FDA).
• FDA II: Little progress on more FDA independence and power in drug safety reviews (An appropriate lament by Tom Lamb).
• Heparin: Congressional examination into the contaminated Heparin debacle (HT: FiercePharma).
• Tylenol Recall: Seems we just went through this. Here’s another one, affecting infant/children Tylenol, Motrin, Zyrtec and Benadryl. See the recall notice.
• Pain Pumps: Drug and Device Law Blog’s view of the recent MDL denial.

Happy Monday!

Heart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed sprint fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subject recall and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

Continue reading "Boston Scientific Defibrillators Recalled " »

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!

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 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.