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Pfizer Recalling Effexor Due to Possible Contamination

Pfizer, Inc. is recalling the anti-depressant Effexor because it may have been contaminated with a heart drug. Interaction between the two could be fatal.

The recall affects 30-count and 90-count bottles of Effexor XR 150-milligram extended release capsules and 90-count bottles of Greenstone-branded Venlafaxine 150-milligram extended release capsules.

According to a press release, a pharmacist had reported that a bottle of Pfizer's Effexor XR contained one capsule of Tikosyn. There have been no other reports, but three lots that were packaged on the same line are being voluntarily recalled as a precaution.

The use of Tikosyn by someone taking Effexor or Venlafaxine could have "serious adverse health consequences that could be fatal," the press release states.

Patients should watch out for signs of abnormal heartbeat and contact their doctors if they have any problems.

Merck & Co. to Pay $100 Million in Contraceptive Settlement

Merck & Company, Inc. (the second-biggest U.S. drug maker) will pay $100 million to settle product liability lawsuits against its NuvaRing contraceptive devices.

The lawsuits were from women who allegedly were harmed by using Merck and Company’s NuvaRing. Under the settlement, “Merck will be paying a fraction of what at least one company has paid in a similar settlement.” Last year, Bayer AG (a German drug maker) paid $1.6 million to settle lawsuits against its Yaz and Yazmin birth control pills, which allegedly were causing women to have clots, strokes, and heart attacks.

Sleep aids increase risk of sleep driving for women

Manufacturers of popular sleeping pills are now required to lower recommended dosages for women after simulation studies confirmed the medication could cause impaired driving among users.

Zolpidem was first introduced in the early 1990s as a safe and effective treatment for insomnia. It is sedative-hypnotic commonly sold under the brands of Ambien, Edluar and Solpimist.

While agency officials are aware that sleepwalking and residual drowsiness are common, these side effects have a greater impact on women, who metabolizes the drug slower than men. According to FDA evaluations, 33% of women taking XR(extended release) zolpidem will still have enough of the drug in their blood to influence motor skills even after eight hours. FDA officials declared that doses will be reduced by half from 10 mg to 5 mg for instant releases and 12.5 mg to 6.25 mg for extended release. The agency also suggested lower dosages for men but it will not be a requirement.

Over the years, the Food and Drug Administration have allegedly obtained an estimated 700 reported car accidents in which the driver was on zolpidem. In some cases, the driver purports no recollection of the mishap.

Trial Begins Today in Pregnancy Drug Lawsuit

Four sisters whose mother took the pregnancy drug DES, or diethylstilbestrol, while pregnant are suing the Indianapolis-based drug company Eli Lilly and Co.  This lawsuit is set to begin trial today, and is the first of many such claims against various pharmaceutical companies.

DES, a synthetic estrogen, was prescribed from the late 1930s to the early 1970s to prevent pregnancy problems such as miscarriage and premature births.  The drug was pulled from the market in 1971 by the FDA when a study found that DES appeared to increase the risk of DES daughters developing a rare vaginal cancer.

The case going to trial today centers around the claims of these four sisters, each of whom have developed breast cancer.  Additionally, each of the four sisters has had miscarriages and fertility problems as well as other reproductive tract problems.  Their mother did not take DES while pregnant with their fifth and youngest sister who has not developed breast cancer nor has she had any sort of fertility issue. 

The sisters’ lawyers cite a 2011 study by Dr. Robert Hoover that suggests that the risk of breast cancer in DES daughters over 40 is nearly double.  The study found that the chance of developing breast cancer by age 55 in a DES daughter is about 1 in 25 while for the average woman, the chance is about 1 in 50.  Thousands of lawsuits have been filed since 1971 alleging the link between DES and vaginal cancer, cervical cancer, and fertility problems and many of those cases have settled.

Generic Version of Lipitor Recalled by Ranbaxy Pharmaceuticals

Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Laboratories and also India’s largest drug maker, has recalled its generic version of the drug Lipitor due to the possibility of certain lots containing tiny glass particles. 

The 10, 20, and 40-milligram doses of the atorvastatin calcium tablets are being recalled while the 80-milligram doses are unaffected.  This includes 41 lots of the generic cholesterol drug.  The majority of the lots affected contain bottles with 90 pills in each, while three lots contain bottles with 500 pills.  It is unclear how many bottles are in each lot. 

This recall is the latest of many quality lapses at Ranbaxy factories over the past several years. The FDA has sanctioned the company in the past, as well as previously barring the shipment of certain drugs.  Currently, Ranbaxy is operating under a consent decree with the FDA which means that it is required to improve its manufacturing procedures, ensure that the data on its products is accurate and have all of this reviewed and overseen by a third party for five years.

Generic Drug Pulled from Shelves by the FDA

On Wednesday, the FDA asked Teva Pharmaceuticals to withdraw the drug Budeprion XL 300, the generic version of Wellbutrin XL, from shelves.  Budeprion and Wellbutrin are both prescribed to treat anxiety, depression, and nicotine withdrawal symptoms. 

Attention was brought to Budeprion XL 300 after ConsumerLab published a report saying that the drug released its active ingredient much faster than Wellbutrin.  The FDA had also received hundreds of complaints from patients who said that after switching to the generic drug they experience insomnia, anxiety, and headaches.

The FDA originally approved the drug after testing the 150mg dose.  Generic drug manufacturers are not required to repeat the costly studies required of original name brand drugs (which is how manufacturers are able to keep generic prices lower), they are only required to show that the drug is the same dose and that it functions in a similar way.  The FDA assumed that the 300mg dosage would behave similarly to the 150mg dosage in the body.

This kind of testing and extrapolation of results is done to avoid exposing patients to high doses of medication if it isn’t necessary.  However, the director of bioequivalence for the FDA now says that this approach “is no longer appropriate” and that in the future, the highest dose will be tested.

105 Meningitis Cases Confirmed in NECC Recalls

The Center for Disease Control and Prevention has reported more than 100 cases and 7 deaths thus far in a widespread meningitis outbreak, spanning over 23 states. Officials of the Food and Drug Administration confirmed that the epidemic stems from contaminated lots of steroid injections (methlyprednisolone acetate) manufactured by the New England Compound Center (NECC). Methlyprednisolone acetate is a common treatment injected in the spinal area for chronic back pain.

Last week, US health inspectors found and tested foreign particles in unopened vials at the Massachusetts-based plant and concluded the matter to be the fungus, Aspergillus NECC have recalled three lots of the steroid injections as well as other products for safety precautions. Approximately 17,700 vials of steroids were shipped from NECC. In addition to the recall, the NECC suspended its operations continuing the investigation.

While fungal meningitis is not contagious, health officials speculate thousands of patients could be infected. Clinics and hospitals urge individuals who received any steroid injections since May, to seek immediate medical attention. The sooner one receives the proper anti-fungal treatment, the greater the chances of survival.

Recent Report Questions the Accelerated Approval of Anticoagulant Drug

A September 5, 2012 report published in the Journal of American Medical Association (JAMA) questions the accelerated approval of the anticoagulant drug, Pradaxa.

In the 2011 fiscal year, Pradaxa was one of three drugs that received Accelerated Approval by the FDA.  This program is one that relies on the preliminary findings of safety and efficacy studies, not the definitive evidence. The report questions whether these drugs should have been approved while there were still safety questions that remained unanswered.

Pradaxa was approved by the FDA to reduce the risk of blood clots and stroke in patients who have atrial fibrillation.  Usage of Pradaxa, as well as usage of its predecessor, warfarin, carries the risk of uncontrollable bleeding.  Unlike warfarin which had an antidote for such bleeding in the form of Vitamin K, Pradaxa has none. 

A patient who bleeds while on Pradaxa can suffer permanent injury or even death.  There are some patients who have suffered injuries such as gastrointestinal bleeding, heart attack, and cerebral hemorrhage.

The defective drug attorneys at Arias, Ozzello & Gignac are currently researching claims against Boehringer Ingelheim for Pradaxa’s adverse side effects. If you or someone you know has experienced complications from taking Pradaxa, call our experienced attorneys today for a free consultation. You may be entitled to compensation for your damages.

Potential Fixes Posed to Improve Injection Safety

Though rare, disease outbreaks continue to arise from unsafe injection practices.

From the years 2001-2006, there were approximately 300 patients infected at ambulatory clinics with blood borne diseases such as hepatitis C due to nine outbreaks.  From 2007-2011, another nine outbreaks infected 66 additional patients. 

One of the reasons for these outbreaks is unsafe injection practices such as the reuse of syringes and of single-dose vials.  There have been a few innovations proposed to alleviate the problem. 

One innovation by Becton, Dickinson and Co., is a syringe that automatically disables after one use.  Another by the same company, are prefilled heparin and saline syringes which reduces the additional risk of infection that arises when fluid is drawn into a syringe from a single dose vial.  A third device is a injection device called Integra.  The needle of the Integra syringe retracts into the barrel after use which prevents needle sticks and reuse. 

These devices, as discussed at a CDC and FDA sponsored meeting amongst health professionals, could help to improve the future safety of health care employees and patients alike. 

Risperdal Personal Injury Lawsuit Settles on First Day of Trial

A lawsuit against Johnson & Johnson concerning allegations that their anti-psychotic drug, Risperdal, caused a male plaintiff to grow breasts settled on the first day of trial. 

Aron Banks, the plaintiff, says that he experienced psychological trauma when he took the drug between the years of 2000-2004, years when the drug was not approved for use in children.  This lawsuit is one of 130 cases which center on the claim that Risperdal caused young males to grow breast tissue.  There are about 420 cases alleging personal injury arising from use of Risperdal.  The next trial is set to begin on September 20th. 

The drug was approved by the FDA in 1993 for psychotic disorders including schizophrenia and was later approved for other uses.   In addition to personal injury claims, Johnson & Johnson has been under investigation since 2004 for their sales practices of Risperdal, including allegations that the drug was marketed for unapproved uses.  

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