Pfizer has recently recalled one million packs of birth control for a packaging error in the amount of active versus inactive pills. The error may leave women without adequate contraception if this is the preferred method of birth control. Blister packs of birth control normally include 21 active pills and 7 inactive pills. However, Pfizer noticed that certain packs contained fewer than 21 active pills and others that contained more than 21 active pills. Pfizer also discovered that some of the inactive pills were intermixed with the active pills, disrupting the normal cycle and raising the risk of accidental pregnancy.

The lots included in the recall are Lo/Ovral-28 tablets and Norgestrel and Ethinyl Estradiol tablets. The packaging error was a result of mechanical errors and visual oversight, and Pfizer reports that the problem was promptly fixed upon realization. Although the recall does not affect the safety of its users, it does include a warning that it raises the risk of unintended pregnancy.

The pharmaceutical litigation attorneys are Arias, Ozzello & Gignac are currently researching consequences of this packaging error. If you or someone you know has used one of the recalled lots, contact us today for a free consultation. A list of the recalled lots can be found on the FDA website.

Last week, Bloomberg, a business and finance news website, reported that Pfizer has to pay more than $45 million in damages to two women who developed breast cancer as a result of using Prempro. One woman was awarded $11.2 million for her case while the other woman was awarded $34.3 million. These are just two of the 10,000 known lawsuits against Pfizer.

Prempro is a drug used by many women across the United States to treat the symptoms of menopause, namely hot flashes and mood swings. A Prempro study in 2002 linked this drug to cancer, but before the results of this study were discovered, it was estimated that more than 6 million women had taken Prempro.

Pfizer has begun settling some of the 10,000 lawsuits pending against them. It has been reported that the company has set aside $840 million so far to settle these cases. If you or someone you know has developed breast cancer as a result of taking Prempro, contact the Prempro litigation attorneys at Arias, Ozzello & Gignac today for a free consultation. 

It has been discovered that numerous research reports regarding pharmaceutical drugs or devices and their potential for adverse side effects have gone unreported. If a clinical trial of a specific drug has already received approval by the FDA, a law requires the manufacturers to submit a report within one year of the trial’s completion. In examining the number of trials to which this law applies, researchers discovered that only 22%, 163 out of 738 trials, actually submitted reports within the year.

When examining motives for omitting the reports, Harlan Krumholz, MD, from Yale University acknowledges that while profit is a driving factor, there are other reasons for concealing these findings as well. He postulates that medical journals do not want to report contradictory or negative findings, and that researchers avoid publishing unexpected findings that disprove their theory. Whatever the motives, this lack of reporting has caused numerous adverse side effects that could have been avoided.

Take Avandia for example. At one point, Avandia was the leading diabetes drug in the United States. Since then, however, it has been linked to an increased risk of heart failure and heart-related death. Researchers discovered 42 studies suggesting a link between the diabetes drug and heart failure, but only 7 of these studies were reported; 35 were unpublished and were only released because of a judge’s order. It is likely that had the medical community known of these adverse side effects, far less people would have suffered and Avandia would not have become the leading diabetes drug.

To avoid this problem in the future, certain people in the medical community are advocating that researchers and manufacturers who fail to publish results of clinical trials in accordance with the law should be subjected to disciplinary measures. Advocates of such disciplinary measures hope that punishments, in whatever form, will discourage researches and manufacturers from skewing results of their studies. It is unclear whether or not disciplinary measures provide an adequate solution to the nondisclosure problem, but what is clear is the necessity of change in this field. Numerous people across the United States are currently experiencing adverse side effects from pharmaceutical drugs or medical devices. These situations are especially tragic when there is ample yet concealed evidence that these side effects could and should have been conveyed to the public.

In February of 2009, the FDA issued a warning against long-term use of the drug Reglan (metoclopramide) because of its link to a neurological disorder, tardive dyskenesia. The FDA also required the manufacturers of Reglan to strengthen the label and include a boxed warning about its adverse side effects and the potential risk of developing this neurological disorder.

Tardive dyslenesia causes uncontrollable and repetitive movements of the body, face, and limbs. This disorder is rarely reversible, but the symptoms may decrease once Reglan use has stopped. The Reglan users who are at the greatest risk for tardive dyskenesia are elderly people, especially women, and those that have been using the drug for a long period of time.

Reglan is used to treat gastrointestinal disorders such as GERD in those people who have not responded to other forms of treatment. It is also used to treat diabetic gastroparesis, a condition in which the stomach slowly empties its contents into the intestines.  It is recommended for use by adults only and has been approved for short-term use, no longer than three months.

Many people across America are filing lawsuits against the manufacturers of Reglan for its adverse side effects. If you believe you or someone you know has been negatively affected by use of this drug, contact our Reglan litigation attorneys today.

Lawsuits against Abbott Laboratories, the manufacturer of Depakote, have been increasing recently due to the high incidence of birth defects in children whose mother’s took Depakote while pregnant. Research into these serious adverse side effects have become more diligent and have yielded some interesting findings. Specifically, researchers discovered that using this medication during the first trimester of pregnancy significantly increased the risk of six different types of birth defects including spina bifida, cleft palate, and skeletal defects. Also, in a study of over 98,000 pregnancies, researchers found that the risk of children born with spina bifida, a serious spinal defect, increased by more than 12 times if mothers took Depakote.

Depakote is a pharmaceutical drug used to treat epilepsy by interacting with the chemicals in the body that are likely to cause them. It can also be used to treat migraines and certain types of manic episodes in people with bipolar disorder. It was approved by the FDA in 1983. It's long existence on the market and widespread use demonstrate the severity of this issue.

Due to the current research exposing the high risk of birth defects, women across America are filing suit against Abbott Laboratories, the manufacturer of Depakote. If you or someone you know had a child born with serious birth defects after using Depakote, you may be entitled to compensation for your medical bills or other damages. Contact the Depakote litigation attorneys at Arias, Ozzello & Gignac today to discuss your legal options. We will do everything we can to help you or your child.

Since as early as 2006, hundreds, if not thousands, of lawsuits have been filed against the manufacturers of Fosamax, Merck & Company, due to the high risk of developing osteonecrosis of the jaw or ONJ. Approximately 2,400 people who have used Fosamax have developed ONJ, or dead jaw. ONJ usually occurs when the jaw bone is exposed and begins to suffer from a lack of blood. The bone then begins to weaken and die, which can be excruciatingly painful. People across the United States are currently filing suit against Merck for marketing the benefits of Fosamax while minimizing, or allegedly hiding, the harsh side effects.

Fosamax was approved by the FDA in 1995 to treat osteoporosis in post-menopausal women, osteoporosis in men, steroid-induced osteoporosis, and Paget’s disease of the bone. It is in a class of drugs called bisphosphonates that helps prevent loss of bone mass and inhibits the breakdown of old or damaged bones. Since its approval, Fosamax has been used by over 20 million people worldwide. The severity of the adverse side effects and the widespread use of this osteoporosis drug demonstrate that this legal issue should not be taken lightly.

If you or someone you know has experienced ONJ or dead jaw as a result of taking Fosamax, you may be entitled to compensation for you medical bills or other related damages. To see if you have a claim or to discuss your legal options, contact the Fosamax litigation attorneys at Arias, Ozzello & Gignac today for a free consultation.

In June 2011, the FDA released an announcement regarding the safety of the diabetes drug, Actos, and issued a warning to consumers of this drug. The FDA had been researching its link to bladder cancer and found that those people taking Actos for over a year were at an increased risk of developing bladder cancer. This warning came just a few days after both France and Germany took this pharmaceutical drug off the market completely.

The warning came as a result of an investigation the FDA conducted after hearing numerous instances of bladder cancer and tumors developing in patients taking Actos. In an ongoing study including over 193,000 participants of people with diabetes over the age of 40, the FDA discovered that those taking Actos for over a year are at a 40% higher increase for developing bladder cancer. It is alleged that the manufacturers of Actos, Takeda Pharmaceuticals, failed to adequately warn consumers of the link to bladder cancer and tumors, opening the door for possible lawsuits to ensue.

Actos has also already been linked to an increased risk of heart failure and stroke. Actos and drugs like Actos may trigger or worsen cardiac failure and other cardiac events in some patients. The high risk of not only having a heart attack but also developing bladder cancer has led the FDA to investigate carefully the complications currently associated with Actos.

Actos is a drug used to treat Type 2 diabetes by regulating the insulin levels. People with Type 2 diabetes are not able to produce enough insulin to efficiently manage the sugar levels in the blood. Actos acts to increase the sensitivity of body cells to insulin and prevent the levels of sugar in blood from rising to dangerous levels.

People across America are filing suit against Takeda Pharmaceuticals for complications arising after taking Actos. If you or someone you know has experienced either of these complications, you may be entitled to compensation for your medical bills or other damages. To discuss your legal options, contact the Actos litigation attorneys and Arias, Ozzello & Gignac today for a free consultation.

Federal officials have confirmed that patients in at least three U.S. states have developed eye infections from contaminated Avastin injections. California pharmaceutical products liability attorneys now know of at least four eye infection cases in California too. According to a Veterans Affairs medical center in Los Angeles, five patients have developed eye infections from the use of contaminated Avastin, and have lost their vision as a result.

According to Avastin manufacturer, Roche Holding AG’s Genentech unit, the company has received several reports of infections leading to blindness. The company has confirmed several cases of eye infections from Miami, Florida; Nashville, Tennessee and Los Angeles, California.

The cases were first reported in three clinics in Miami, and the Florida Department of Health traced the infections to contaminated syringes. The syringes were then traced to a single pharmacy. The pharmacy had taken single-use vials of Avastin and repackaged them into 1 ml syringes. The 1 ml syringes were then distributed to hospitals.

Health officials believe that the contamination occurred while the drug was being transferred from the vials to the syringes. The vials themselves do not appear to have been contaminated. The Food and Drug Administration has confirmed at least twelve cases in Miami. There are varying reports about the number of infections in Tennessee.

The California cases involve at least five patients at a Veterans Affairs medical center in Los Angeles. In most of these cases, the patients who contracted infections were being treated with Avastin injections for eye diseases like macular degeneration. Avastin is approved as a cancer drug, but is also very often used for off-label purposes, like the treatment of age-related macular degeneration and other eye diseases. The patients who contracted the infections have lost all vision in the infected eye.

Veterans Affairs in California has released a statement saying that its Los Angeles facility has suspended the use of Avastin for treatment of macular degeneration.

In June 2011, the FDA issued a warning for Simvastatin (brand name Zocor) because of its link to muscle damage or rhabdomyolysis. Rhabdomyolysis, the most serious form of muscle damage or myopathy, damages the kidneys and could be fatal. The FDA recommended completely eliminating the prescription for 80 milligrams of Zocor, the current highest maximum dosage. The serious complications associated with Zocor are widespread as approximately 2.1 million people across the United States were prescribed a dosage of 80 milligrams of Simvastatin in the year 2010 alone.

The FDA has required Merck, the manufacturer of Zocor to add a warning to the label stipulating that Zocor dosage should be limited when mixed with other drugs. People taking the 80 milligram dosage of Zocor are at an increased risk of myopathy, especially during the first year of treatment. Most often, this increased risk, is due to the interaction of Zocor, or Simvastatin, with other medications.

Zocor is used in combination with diet and exercise to reduce cholesterol in the blood. A lower level of “bad” cholesterol helps reduce the risk of heart attack, stroke, and cardiovascular death. The 80 milligram dosage reduces the level of cholesterol by 6% more than the 40 milligram dosage. However, the high risk of muscle damage is severe enough to outweigh this increased effectiveness in the eyes of the FDA.

People across the United States are filing lawsuits against Merck for complications from taking Zocor. If you or someone you know has suffered from muscle damage, myopathy, or rhabdomyolysis, you may be entitled to compensation for your medical bills or other damages. To discuss your legal options, contact the Zocor litigation attorneys at Arias, Ozzello & Gignac today for a free consultation.

When the first lawsuits against Bayer, the manufacturer of Yaz/Yasmin, were filed in October 2009, only 32 complaints were included. But this number has increased exponentially over the past two years. The number of lawsuits now being filed against this pharmaceutical giant has reached 2,500 and this number is only predicted to increase in the next few years. Some experts have even predicted that this number could reach 25,000 before Bayer can even reach a decision on the initial lawsuits from 2009.

The high number of lawsuits being filed results from the widespread use of Yaz or Yasmin and the high number of women who have taken either of these drugs in the past. In 2008 alone, these birth control pills accounted for more than 28 percent of the birth control market with about $1 billion in sales for Bayer. Lawsuits allege that Bayer failed to warn women of the severe side effects and falsely advertised its benefits, possibly because of the immense revenue generated from marketing these birth control pills.

Yaz and Yasmin are contraceptives that combine estrogen and progesterone to stop ovulation and ultimately prevent pregnancy. These birth control pills have resulted in a number of serious side effects. Women taking Yaz or Yasmin are at a greater risk for stroke, heart attack, blood clots, deep vein thrombosis, pulmonary embolism, and gallbladder disease among other diseases. Women across the nation are filing suit against Bayer in pursuit of compensation for medical bills and other related damages. If you or someone you know has taken Yaz or Yasmin and experienced similar complications, contact the Yaz/Yasmin litigant attorneys at Arias, Ozzello & Gignac, LLP today for a free consultation.

For more information see Yasmin Attorneys.