Product Liability Attorney Blog

A woman from Galveston, Texas, is the newest plaintiff in a long list of women to file a lawsuit against Bayer, the makers of the controversial birth control pill Yaz. The lawsuit was filed on January 30, 2011.

Lana Speck's Yaz lawsuit was filed amid claims that the drug caused her to suffer through a cholecystectomy (removal of the gallbladder). Speck says that she suffered from stomach pains related to gallstones after taking Yaz as a way to regulate her menstrual cycle. She took the pills from 2001-2008, but had started getting the pains in 2006. Speck was on the brink of renewing her prescription when she had found the gallstones.

According to what was said in the original lawsuit filing, "After her gallbladder was removed, the plaintiff was in constant severe chest and upper abdominal pain as a result of her removed gallbladder. In addition, the plaintiff suffered continuous issues with her digestion that caused extreme diarrhea, indigestion, and crippling abdominal pain." Speck is still suffering from post-cholecystectomy syndrome as a result of Yaz.

Speck is suing Bayer under claims that the company knowingly hid the adverse side effects of the drugs from the public. Bayer has already gone under fire for using misleading ads that seem to recommend the drug's off-label uses (uses not approved by the FDA) including clearing up acne, regulating menstrual cycles and clearing up symptoms of PMS. Yaz and Yasmin have been the source of many lawsuits against Bayer because of their potentially life-threatening side effects such as blood clots, heart attacks, strokes, gallbladder disease and pulmonary embolisms.

Women that have suffered from any of these conditions after taking Yaz, Yasmin or Beyaz are encouraged to speak to an attorney as soon as possible. There is still time to file a Yaz lawsuit and recover money for your injuries.

With thousands of young women filing lawsuits against the makers of the popular birth control pills Yaz and Yasmin, many people are wondering if the FDA will finally see the light and issue a recall.

Generally, the FDA will recall drugs that have been proven dangerous to patients and/or if the drug's been proven to present a high enough risk that it actually outweighs the good that the drug does. While it is not possible yet to prove when a drug's risk outweighs the benefits in a scientific way, the fact remains that many young women have died as a result of using Yaz and its sister drug Yasmin.

Research has proven that Yaz and Yasmin pose a direct threat to the health of some users. These potentially life-threatening side effects include heart attacks, strokes, pulmonary embolisms, gallbladder disease and blood clots. Research also shows that it is the pill's main medicinal ingredient drosperinone that poses this threat. More studies will have to be done on birth control pills that have drosperinone in them. These studies will be crucial when it comes time for the FDA to decide upon the risk/benefit profile of drugs like these.

The risk shouldn't be hard to prove since there have been at least 50 deaths reported between the years 2004-2008 alone by the families of young women that were taking Yaz or Yasmin. There are plenty of current studies that already show the links between drosperinone and life-threatening conditions. In addition, as many as 6,000 women have already filed lawsuits against Bayer alleging that they didn't properly represent the dangers in taking the pills. They are also alleging that Bayer misadvertised the pills and their benefits to clearing acne and helping to reduce the symptoms of PMS.

Whatever the results are from future studies, many women and their families are hoping that Yaz and Yasmin are taken off the market soon. They hope the question isn't so much a matter of if the FDA will recall the pills that contain drosperinone, but when.

A law firm in Texas is ready to start the first 5 cases against GlaxoSmithKline, the makers of the controversial antidepressant Paxil. The birth defects cases will be tried in a Philadelphia State Court in May. These are the first birth defects cases that will tried in the U.S. and Ryan Zehl is excited about being the first firm to take the Paxil birth defects cases to court.

"We've taken steps to ensure that no other Paxil trials take place before our May trials," he says. "This will be the third time GSK goes to trial over Paxil since the FDA required them to disclose the increased risk of congenital heart defects in babies born to mothers taking Paxil during the first trimester of pregnancy in December 2005."

These Paxil trials allege that Glaxo didn't properly warn doctors about the adverse side effects of the drug such as birth defects. The suits also claim that Glaxo outright ignored study results that showed Paxil caused the birth defects. If these first 5 cases are won, it could set a precedent for other birth defects cases that make it to trial with the same claims. That is why these first trials are so important.

GlaxoSmithKline has been battling lawsuits against Paxil, already having paid more than $1 billion dollars. The drug giant has even settled a lawsuit for $750 million when a whistleblower came out against the manufacturing process in its plant in Cidra, Puerto Rico. That lawsuit alleged that Glaxo ignored warnings of the plant manufacturing and packaging adulterated drugs, including Paxil.

The birth defects lawsuits against Glaxo have been filed by the thousands. If your baby was born with birth defects and you took Paxil during the pregnancy, there is still time to file a lawsuit.

While there is plenty of information about the adverse side effects of the popular gastroreflux drug Reglan, most of them are centered around patients developing Tardive Dyskinesia after receiving Reglan treatments. However, there are other side effects of Reglan that are starting to gain more popularity lately.

One of those side effects is called Neuroleptic Malignant syndrome (NMS). This condition causes sufferers to suffer from rigid muscles, hypothermia, and changes in blood pressure and pulse. The good news is that while NMS is caused by Reglan, it will usually go away after the patient stops taking it.

Another condition caused by Reglan is called Akathisia,  a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion.  People with akathisia are unable to sit or keep still, complain of restlessness, fidget, rock from foot to foot, and pace.  The condition might persist for many years after Reglan is stopped.

Finally, there is ocular deviation and blepharospasm. This causes sufferers to experience abnormal blinking or irregular twitching of the eyelid. Patients also experience an abnormal  type of eye movement in both eyes. All of these symptoms may not be as well-known as the tardive dyskinesia that is suffered from Reglan users, but more and more patients are coming forward and reporting these side effects.

If you suffering from any of the above symptoms, you should contact your doctor immediately because Reglan may be the cause. You should also contact a lawyer before the statute of limitations runs out for filing Reglan lawsuits. You may be eligible for compensation and a good lawyer can make sure that you get every dime that you are entitled to.

When Paxil first was conceptualized, it was considered to be a Category C drug. However, all that changed once the FDA re-categorized it as a Category D drug after studies showed the drug posed a significant risk to unborn babies of developing birth defects when their mothers took Paxil during pregnancy.

Originally, the FDA put Paxil in Category C because the agency acknowledged that the drug could cause some birth defects, but the extent of the damage the pills could do wasn't known yet. Paxil dangers were upgraded to Category D when it was known that the pill could cause heart defects in the fetus.

Drugs like Paxil and Effexor are selective serotonin reuptake inhibitors, or SSRI medications, that affect the neurotransmitters in the brain which some experts believe are the chemicals that lead to depression when they are imbalanced. Since the drug hit the market, research has shown that women who took Paxil in the first trimester had a one-and-a-half percent higher chance to have a baby with heart defects than the women that didn't take antidepressants, or in women that took a different antidepressant. The specific heart defect that Paxil babies had were holes in the walls of their hearts and ventricles.

The specific announcement by the FDA stated: "FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate."

This announcement has people wondering if other SSRI medications like Effexor will be next. It's a reasonable question, considering test results that were made public as part of the discovery during a 2009 Paxil (SSRI) lawsuit. During that trial, an expert of teratogenicity from the UK testified that tests proved that Paxil could cause teratogenicity, which was explained as an agent with the potential to cause birth defects.

According to a new report from Research and Markets, an increasing number of patients are developing what is known as “antibiotic resistance.” Because of this, the amount of critically ill patients has also increased.

Research and Markets analyzes the drug market's driving force as well as what barriers exists in the growth of certain bacterial infections that patients get while they are in the hospital. The report specifically analyzes the number of bacterial infections acquired in hospitals across the United States, the United Kingdom, Germany, France, Italy, Spain and Japan.

They conduct their reports based on the information they gather about treatment usage patterns, sales and price.

This report also offers information regarding the competitive benchmarking for the leading pharmaceutical companies. The report keeps track of all business conducted by following such things as company mergers and acquisitions — even licensing agreements that all change the way the global drug market conducts business. This report gathers its information by checking data that can be found in proprietary databases, primary and secondary research data, and by conducting an in-house analysis that is done by industry experts.

What they found during this research is that since many antibiotic drug patents like Levaquin are getting ready to expire between now and 2016, a lot of companies do not want to buy into these drugs because the cost of therapy will inevitably go down. The reason that Markets and Research gives for this is because patients are slowly developing a resistance to antibiotic medications like Levaquin.

"There is low or zero investment in R&D for antibacterials by large pharmaceutical companies because of the small life-cycle of antibacterials as resistance is developed against them,” the report says. “So the investment done in R&D for antibacterials does not give a good return on investment."

Sara, a nurse from Boyerton, Pa., has a Levaquin side effects story to tell to anyone who will listen. Sara claims that she started taking 500mg doses of Levaquin last summer to fight an upper respiratory infection and that within 24 hours, she felt pain in the lower part of her leg. Even her doctor believes that Levaquin was to blame.

What started as an aching leg ended up leaving Sara unable to walk and minus one fiancé in her life. To top it off, her respiratory problems got worse instead of better.

"At first I didn't think much of the pain in my leg because my whole body ached from the fever I had, but once the fever broke I still had severe pain in my feet and lower calves,” she says. “I continued on the Levaquin and finished it Thursday. On Friday I could barely walk."

When she told her story to her doctor, he asked her what she had been doing. When she told the doctor that she was taking Levaquin, all he could do was ask her if she bothered to read the insert that came with the drug. She was diagnosed with severe bilateral Achilles tendinitis caused by Levaquin.

The doctor then explained all of the terrible information about Levaquin side effects to her and told her that many doctors were trying to get the drug removed from the market. He advised her to stay off of her feet, and this eventually led to her getting pneumonia 3 times. Sara has been immobilized by the Levaquin and continues to have problems with her lungs because she can't get around enough. Even her health insurance company gave up on paying for her rehab and wound up sending the 51-year-old to a nursing home.

All of this was too much for Sara's fiancé, who eventually left her. Since then, Sara has moved in with her brother.

There are Levaquin horror stories happening all of the time, and they will continue to happen until the drug is no longer prescribed. As far as any advice Sara is now receiving, she says her friends tell her "'you should go after the makers of Levaquin because you don't know the future."

"I'm going to take their advice,” she goes on to say.

While as many as 4,800 women in Canada and the United States already have filed lawsuits against Bayer, the manufacturer of the popular birth control pills Yaz and Yasmin, this number is expected to rise after Yaz was featured on the Canadian news show “Marketplace.”

In a segment titled "Spinning a Pill," co-host Erica Johnson interviewed a group of young women that either had taken currently were taking Yaz and experienced serious health problems. Of those young women, one was a university student that has developed a blood clot in her lungs as a result of taking Yaz. She was diagnosed with a pulmonary embolism. In fact, there were women interviewed that seemed to have a story for every side effect that has been the subject of the various lawsuits filed against Bayer.

Another woman profiled starting taking Yaz for treatment of her PMS (as Yaz was advertised to help with but not FDA-approved for) had problems with her gallbladder and had to have surgery to correct it. While the show’s co-host stated that Bayer originally had agreed to do an interview, company officials changed their mind and suggested that the show speak to a doctor whose opinion was that research designed to show Yaz to be more dangerous than other birth control pills was as yet inconclusive and flawed.

Susan Jick from Boston University disagreed with Bayer's statement, saying, "those flaws (in the study), had they been corrected, in fact, the risks might have been even higher than they already showed." Jick also is planning to publish two studies that she did herself on the subject. During the interview, she hinted that the results of her research will actually end up being more consistent with newer information from more recent studies that are suggesting that there is a small, yet higher risk of patients experiencing blood clots while taking Yasmin.

The State of Vermont has agreed to receive a $136,000 settlement from GlaxoSmithKline over its controversial antidepressant, Paxil.

The settlement comes on the heels of previous claims that Glaxo sold drugs including Paxil and Avandia that were defective. This is the result of an earlier settlement that was made by Glaxo after it was discovered that there were manufacturing problems at the company’s plant in Cidra, Puerto Rico. That case was brought to life by a whistleblower who spoke about the drugs being made with tainted water, dosage errors as well as packaging mistakes. The whistleblower recently was interviewed on the news show 60 Minutes.

Originally, Glaxo admitted fault to charges of bad practices at the Cidra plant and agreed to pay out $750 million: $600 million in damages and another $150 million in fines. The current $136,000 awarded to the State of Vermont is the state's share of this money, which it will receive as a means of making up for the damage that was caused to Vermont's Medicaid program that paid for the adulterated drugs. This settlement given to Vermont is actually double what the state paid. The whistleblower in this matter received an unprecedented $96 million for her part in bringing this information to light.

As a result of the settlement, Glaxo also has agreed to be a part of a Corporate Integrity Agreement that will keep a close eye on the company's overall manufacturing practices in the future. This agreement was made with the federal government. The Cidra plant has since been closed down, but Glaxo maintains that it has nothing to do with the charges that were laid against the company nor the settlement that it reached as a result of them.

So far, thousands of lawsuits have been filed against Glaxo and Paxil under claims that the company failed to properly warn the public about the drug’s adverse side effects. Lawsuits are also alleging that Glaxo has hidden test data that showed Paxil's adverse side effects. While Glaxo did settle some cases, they continue to defend the overall potency of the pills.

The popular birth control pills Yaz and Yasmin have become almost synonymous with controversy. While the pills have worked wonders in preventing pregnancies, they are also making many young women very sick. Traditionally, this has been blamed on drosperinone, the main ingredient in the pills. But some critics are now saying that these drugs are created with a combination of medications that could be deadly.

The popular pills have gotten a bad reputation for causing serious adverse side effects such as strokes, heart attacks, pulmonary embolisms and gallbladder disease. While it is true that the drosperinone on its own has been found to cause the side effects mentioned, the addition of ethinyl estradiol is now believed to be what makes the pills deadly.

The drosperinone is found in Bayer products such as Yaz, Yasmin, Beyaz and Safyral. It is also found in Teva Pharmaceuticals’ generic versions like Gianvi and Ocella. Despite the deadly combination of drosperinone and ethinyl, these pills are still the most popular birth control pills on the market today.

While the chemical combination works well to prevent unwanted pregnancies, it also causes many women to experience higher potassium levels which can cause hyperkalemia which, in turn, can cause death. It is for this reason that women that have hepatic dysfunction, or adrenal insufficiency, should not take the pills. For these women in particular, the drug combination could be fatal.

While lawsuits continue to be filed against Bayer from women that feel that Bayer did not properly warn them of the side effects of Yaz or Yasmin, most of the them didn't include the women that have experienced hyperkalemia from the drug. This little-known information about the effects women may experience from the combination of the drosperinone and ethinyl may again open Bayer up to even more litigation.

During the first round of Yaz lawsuit hearings, much ado has been made about Bayer producing documentation that verifies the adverse side effects of its popular birth control pills Yaz and Yasmin.

The plaintiffs involved in the first round of lawsuits filed against Bayer are making repeated requests for documents from Bayer that verify the adverse side effects of the drugs. Bayer has been trying to get a global protection order from more than 100 nations that want to get their hands on this very long paper trail that includes information about any and all warnings, safety of the pill, label contents and sales and marketing. Since the lawsuits against Yaz and Yasmin have all been regulated to take place in the U.S. District Court for the Southern District of Illinois, all of the plaintiffs want to see all of the documents that Bayer has at the same time. This means that all plaintiffs (even if the claims are separate) are requesting these documents simultaneously.

As I already mentioned in a previous article, U.S. District Judge David Herndon, who is presiding over the bellwether trials against Yaz, decided to stop the depositions of German experts until guidelines could be changed so that he could send the information simultaneously to state courts in Pennsylvania, California and New Jersey, where the Yaz trials are also centralized.

The protective motion filed by Bayer Lawyer Susan Weber states that the documents that Bayer has already given to the court “would be more than 7,000 pages long if the pages were laid end to end, and would weigh approximately 200 tons. It would take months to address plaintiffs’ demands, and months or years more for plaintiffs to translate and examine the documents they demand (that is if the plaintiffs actually read them).”

According to an article in the Montreal Gazette, the Canadian Society of Obstetricians and Gynecologists has stated that while there were two studies conducted that have been able to link the condition of venous thromboembolism (VTE) to the use of Yaz and Yasmin birth control pills, the studies may not be accurate.

The basis of the statement is founded on how the studies were conducted. One of the studies, conducted in 2010, claims that during the study researchers found that the women who were taking Yaz or Yasmin only made up a small number of the subjects tested. The other women were taking other birth control pills. The study did find that those women taking Yaz were 6 times more at risk than the other women of suffering from VTE. However, since only a small number of the women tested took Yaz, the study was deemed flawed. This original study was published in the British Medical Journal.

In the end, the Society of Obstetricians and Gynecologists ruled that there is no real proof that Yaz or Yasmin increases a patient's risk of getting VTE any more than any other birth control pill. In fact, IMS Brogan, a prescription drug tracking company. has stated, "Recent contradictory evidence and the ensuing media coverage of the venous thromboembolism risk attributed to the progestin component of certain newer oral contraceptive products have led to fear and confusion about the safety of oral contraceptives in general and drospirenone-containing oral contraceptives in particular."

They go on to express their fears that the studies that link Yaz and Yasmin to VTE will scare women away from taking birth control pills and potentially lead to many unwanted pregnancies. VTE is a rare but scary condition that causes potentially life-threatening blood clots in the veins of the legs. However, the clots can eventually reach the lungs and cause a pulmonary embolism.