Product Liability Attorney Blog

It has been a little longer than two years since the British Medical Journal started publishing its first articles containing warnings to patients about taking certain birth control pills containing drosperinone (Yaz and Yasmin). Finally, the FDA has decided to jump on the bandwagon and properly review the safety concerns.

On December 8 of this year, the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee will be getting together for a joint meeting where committee members will watch presentations given by the pharmaceutical industry, advocates for patient safety, researchers and even patients. Each of the presentations will be showing whether oral contraceptives containing drosperinone like Yaz and Yasmin are safe and effective. They will also be trying to figure out if the warnings given to healthcare professionals and on the labels are good enough.

The FDA's hearing date was called together because of the recent, various studies which continue to show that oral contraceptives like Yaz and Yasmin increase the risk of blood clots that can lead to other conditions, including heart attacks, strokes, pulmonary emboli (PE), deep vein thrombosis (DVT) and death. The studies also show that these drugs are more dangerous than other oral contraceptives that don’t contain drosperinone.

Even the FDA’s own research shows that patients taking Yaz and Yasmin were twice as likely to develop blood clots as the women who took birth control pills that contained levonorgestrel. While it is wonderful that the FDA is finally making deeper inquiries into Yaz and Yasmin safety concerns, it has many people wondering why it took the regulators so long to do it. Right now consumers and patient safety advocates alike are hoping that the FDA will issue a recall of Yaz and Yasmin, but it is unlikely that it will happen.

Five more women from various states across the country have filed Yaz lawsuits recently in the the United States District Court (Minnesota). All but one of the cases issue the same complaint, that the oral contraceptive caused them to suffer from gallbladder disease, with the fifth complaint alleging that the drug caused blood clots. Each of the women involved is also claiming that Bayer, the makers of Yaz, lied to them by fraudulently declaring that the drugs were safe and that the company tried to downplay the serious risks associated with taking Yaz.

One of the plaintiffs, Rachel M. Hart, is claiming that she started using Yaz back in January 2006, and because of that use, she says she has had a stroke after developing a blood clot. Ever since her stroke, Hart’s complaint says that she has “sustained severe and permanent injuries, pain, suffering, and emotional distress, as well as other injuries.”

The other four plaintiffs — Eva Takashima, Rita L. Zuniga, Ashley Yauger and Jennifer Marcki — are alleging that taking the controversial oral contraceptive caused them to suffer from gallbladder disease. As for the Yaz use timeline, Ms. Takashima was taking Yaz in 2008 and eventually had to have her gallbladder removed because of it. Zuniga started Yaz in 2005 and had her gallbladder removed in 2008, whereas the other two women, Yauger and Marcki, have been through similar problems as well.

Studies have shown Yaz and Yasmin links to gallbladder disease and blood clots for years because of the pills’ main ingredient, drosperinone. Drosperinone has been linked with various other conditions as well and is now under serious review by the FDA. These serious risks have caused thousands of Yaz lawsuits to be filed all across the country. So many lawsuits have been filed that they had to be consolidated into MDL and bellwether trials which are set to begin in January 2012. Judge David Herndon will be presiding.

With the Bellwether trial start date just months away, more and more Yaz lawsuits are popping up all over the country. Plaintiff Jennifer Rich’s Yaz lawsuit is the most recent complaint to be added to the mass tort that is to be heard in Los Angeles County Superior Court. The complaint was filed on September 20 amid claims that taking the controversial birth control pill caused Rich to suffer from deep vein thrombosis (DVT).

Rich’s official complaint states that she developed DVT and other injuries in 2009. Her lawyers are claiming that Bayer (the makers of Yaz and its sister pill, Yasmin) “defectively manufactured the oral contraceptive, and sold it under the fraudulent pretense that it was safe.” Rich’s case also alleges that the birth control pills didn’t just cause her injuries, but also that “Bayer neglected to warn Rich and her doctor about the risks associated with the drug, including blood clots, DVT and heart attack.”

Rich is seeking to recover damages which cover a wide range of things including punitive or exemplary damages, medical expenses, lost wages and attorney fees. As well as the mass tort in Los Angeles, Rich’s case will join the thousands of other trials set to begin in New Jersey, including the Bellwether trials that are said to be underway as early as January 2012. Plaintiffs all over the country have been filing lawsuits against Bayer over its fraudulent marketing tactics which downplayed Yaz risks. In addition, the mass tort claims that the drug makers knowingly hid the negative side effects linked with the pills from the public and healthcare practitioners.

Many different studies link Yaz and its key ingredient, drosperinone, to adverse side effects which include blood clots, deep vein thrombosis, heart attacks, strokes, pulmonary embolisms, gallbladder disease and death. For its part, Bayer stubbornly stands by Yaz and Yasmin, claiming that the company's own study revealed that Yaz and Yasmin are no more dangerous than any other form of birth control pill.

In the last two weeks of August, the State of California saw three new Reglan lawsuits filed against the makers of the acid reflux drug, Wyeth.

The first of the new cases filed was on behalf of Dorothy Caldwell, who filed her claim in the Superior Court of San Diego County. Within a week, another lawsuit was filed by Fossie Smith in the Superior Court of San Francisco County. Finally, Nancy Rakowitz filed her Reglan lawsuit on Aug. 29 in the City of San Francisco.

As with most Reglan lawsuits, these cases accuse the defendant Wyeth of hiding the real risks involved in taking Reglan for periods lasting longer than 12 weeks. The lawsuits are also alleging that the plaintiffs each suffered from tardive dyskinesia (TD), which is a Parkinson’s-like disease that causes patients to suffer from symptoms such as lip smacking, involuntary movements in the appendages and excessive blinking. Right now there is no cure for the condition. Reglan labels were updated by the FDA in February 2009 to include the increased risks of patients developing TD as well as to include the warning that informs patients that they should not take the drug for longer than 12 weeks.

Reglan is generally used as a treatment for acid reflux conditions including GERD. Some women have been prescribed Reglan to help them with milk production if they are breastfeeding. Reglan (metoclopramide) is also made in generic forms (like Maxolon and Octamide). Recently, the U.S. Supreme Court ruled against patients being able to hold generic drug companies liable for their TD and other conditions allegedly caused by the drug; this ruling caused Public Citizen to file a petition with the FDA to change its current drug labeling regulations in a bid to get the FDA to force generic drug companies to list all risks associated with the drugs they are selling — even if their name brand counterparts don’t. It was Public Citizen’s way of trying to make the generic drug makers act responsibly toward its consumers because so much of the population use generic versions over name brands.

On September 28, Bayer won a dismissal of U.S. antitrust claims that were made against it by Sandoz Inc. The lawsuit was filed against Bayer's Yaz and Yasmin birth control pills three years ago.

The judge presiding over the case, Paul Gardephe, has said that Bayer got the dismissal because Sandoz was unable to prove that Bayer held a monopoly in the birth control market. The judge defended this position by pointing out that Bayer only had a 29 percent share of the market, which was well below the 50 percent that is required for a monopoly.

"Sandoz's allegations concerning its attempted monopolization claim are conclusory and speculative," Gardephe wrote.

The judge also said that Sandoz, which is a unit of Switzerland's Novartis, didn’t even make the right kind of allegations to show that there was “no combination of drugs to serve as a functional substitute for Yaz or Yasmin to treat premenstrual dysphoric disorder and related symptoms such as premenstrual syndrome.” Gardephe wound up dismissing Sandoz’s antitrust claims under the Sherman Act and stated that Sandoz cannot make the same charges against Bayer again.

A year ago, Gardephe also dismissed a claim made by Bayer against Sandoz and Watson Pharma, both of which were trying to make a generic version of Yasmin. Despite the growing number of lawsuits against the controversial drosperinone-based birth control pills, Yaz remains one of the biggest oral contraceptive sellers on the market. The pills are known to cause serious adverse side effects including blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolisms and gallbladder disease that can be deadly for some women.

While this latest win by Bayer may help boost the company’s morale, the company still must battle against all of the lawsuits filed by women and their families — the first of which will be from the bellwether trials that are set to begin in January 2012.

Reglan, a drug most commonly prescribed for the treatment of acid reflux, has long been associated with a Parkinson’s-like condition called tardive dyskinesia. However, what is not so commonly known is that the drug also has been linked to depression.

Reglan, it seems, is contraindicated in people using the drug who have a history of depression. Specifically, the drug comes with a warning which reads: “Metoclopramide can cause depression. Some cases are mild, while others are quite severe and may involve suicidal thinking or behavior. Make sure to tell your healthcare provider if you have depression or even a history of depression. If you start to notice any depression symptoms while taking metoclopramide, contact your healthcare provider right away.”

With Reglan’s side effects getting more attention that the drug’s benefits these days, it can be easy to overlook some of its lesser-known side effects as well, including neuroleptic malignant syndrome (NMS), akathisia, ocular deviation and blepharospasm. Metoclopramide also comes with a warning that it has the potential to make some conditions worse, such as high blood pressure, congestive heart failure and cirrhosis.

With so many warnings posted against Reglan, it is a wonder why patients don’t simply opt to take something else for their acid reflux symptoms. Over-the-counter medication like Rolaids or TUMS are a far safer alternative. However, for the new mothers who are consideration using Reglan for its off-label use of increasing milk production, Reglan can feel like the only option. One thing that should be noted if you plan on taking Reglan despite the warnings posted against it about the risks of developing conditions like those mentioned here: Be sure to do so only under the supervision of a doctor and for no longer than the FDA’s warning period (no more than 12 weeks). Doing this may help prevent you from developing tardive dyskinesia as well as the other symptoms mentioned.

It comes as no surprise that Yaz lawsuits are continuing to be filed on a regular basis; yet another Florida woman, Shana N. Vetter, and her husband, Wilson D. Enriquez, have filed a Yaz lawsuit.

The complaint was filed in the Southern District Court in Florida on September 20. Bayer Corporation, the makers of the popular but controversial oral contraceptive Yaz, is listed as a defendant along with Bayer Pharmaceuticals Inc., Bayer Healthcare LLC and Berlex Laboratories (which originated the manufacturing of Yaz).

Vetter’s case is similar to thousands of cases that were filed before hers in that she developed conditions as a result of taking the drosperinone-based pills. Vetter’s lawsuit claims that she has suffered from a pulmonary embolism, deep vein thrombosis and myocardial infarction after taking the drug. Her attorney states that Bayer and the other defendants “negligently designed, manufactured and distributed the contraceptives.” Vetter is asking for more than $75,000 in damages in her lawsuit.

The conditions mentioned in Vetter’s lawsuit are the same as those that are the subject of the upcoming bellwether trials (federal and state) which focus on Yaz and Yasmin’s side effects, and include pulmonary embolism, deep vein thrombosis and gallbladder disease. According to information listed in a Case Management Order that was issued by Judge David R. Herndon, who is presiding over the bellwether trials, “43 percent of plaintiffs suffered gallbladder disease, 40-41 percent experienced either pulmonary embolism or deep vein thrombosis and 9-10 percent were heart attack or stroke victims.”

There is much research to back up Vetter’s claims as to what caused her conditions and she is only one of thousands of women who have already filed suit. For its part, Bayer stubbornly refuses to accept liability and stands behinds its own study that found that there is no higher risk in taking contraceptives containing drosperinone than in taking older pills that contain levonorgestrel.

The high number of Yaz and Yasmin lawsuits getting ready to play out in court has many people wondering just how dangerous the drugs really are. At the heart of the lawsuits is the allegation that Bayer, the maker of the pills, didn’t properly warn the public of the real dangers associated with taking Yaz and Yasmin. These dangers have proven to be more than harmful; in fact, many women have died.

Various clinical trials have proven that Yaz and other drosperinone-based birth control pills cause young and otherwise healthy women to suffer from side effects including heart attacks, strokes, pulmonary embolism, deep vein thrombosis, thromboembolism and gallbladder disease. The problem is that these conditions, while serious on their own, can lead to more serious and deadly consequences.

In one recent case, a young woman from Florida developed a blood clot after taking Yaz, which led to her developing a pulmonary embolism as well as deep vein thrombosis, which can lead to a stroke. In this way, the pills can cause a chain reaction that can eventually lead to death. Along with plaintiffs claiming that Bayer hid Yaz's side effects, many are claiming that Bayer knowing hid the increased risks of developing the side effects after they were reported to the FDA. Some cases also attack Bayer’s aggressive marketing strategy that listed Yaz as a cure for acne and severe PMS, as well.

No matter what Yaz lawsuits are claiming, it has become very clear that Bayer just won’t acknowledge its drugs' role in these injuries and deaths. There have been many deaths reported from women’s families and the lawsuits are so numerous that some of the trials have been consolidated into MDL and Bellewether trials just to help move things along. As long as Bayer continues to ignore the research-based facts about their oral contraceptives containing drosperinone, women will continue to file lawsuits in the hopes of holding them accountable.

An antibacterial pneumonia drug made by Cempra Pharmaceuticals may have turned out to be a safe alternative to taking levofloxacin, according to a recent announcement by Cempra.

The results of a phase 2 clinical trial on solithromycin show the drug to be as effective as levofloxacin (brand name Levaquin), according to Cempra officials. Solithromycin is also said to be safer than Levaquin, since Levaquin has long been associated with tendon ruptures.

Solithromycin is used as a treatment for potentially life-threatening bacterial infections as well as when other antibiotic treatments didn’t work. Cempra’s research centers on creating new drugs that target antibiotic-resistent bacteria. Solithromycin, which used to be known as CEM-101, is currently being studied as a potential treatment for community-acquired bacterial pneumonia (CABP). This drug is also expected to be just as good at fighting against Legionnaires’ disease and some STDs like syphilis.

Dr. David Oldach, Cempra’s senior vice president of clinical research, has said that Cempra believes that the information gathered in the most recent trials supports the drug being moved into phase 3 trials.

Levaquin has been swarmed with lawsuits filed against its maker, drug giant Johnson & Johnson, amid claims that the drug company tried to hide the serious dangers associated with it, or at least that it didn’t properly warn the public of the increased risks of tendon ruptures. The risk of tendon ruptures is even more significant in patients who are older than 65. At least one of those plaintiffs, John Schedin, won almost $2 million in his lawsuit.

Solithromycin may prove to be safer than Levaquin, but it's too bad that most patients who have taken Levaquin and suffered tendon ruptures as a result of it had to wait so long for the alternative.

It has been announced that the first Yaz jury trial against Bayer Healthcare Pharmaceuticals Inc., is going to go to trial in Pennsylvania state court in January 2012. Judge Sandra Mazer Moss is scheduled to hear the pre-trial issues on Monday, September 26.

The plaintiff in this Yaz lawsuit, Petrina Moore, claims that Bayer’s controversial birth control pill has caused her lasting injuries. She is also claiming that Bayer didn’t properly warn her of the potential injuries prior to her taking the pill. The woman’s attorney says, “Bayer failed to warn patients and doctors, we allege, that Yaz poses a greater risk of serious injuries than earlier generation birth control pills. Bayer will have to answer allegations that its blockbuster birth control drug Yaz caused a thirty-five-year-old woman’s severe and near fatal pulmonary emboli, cardiopulmonary arrest, and horrible blood clots in her legs.”

Moore’s complaint is charging that Yaz is sold to the public without any proper warning of the drug’s higher risk factor of injuries than other birth control pills. Some of the risks associated with taking Yaz include blood clots, deep vein thrombosis, strokes, heart attacks, gallbladder disease and thromboembolism.

Of this, the plaintiff’s lawyer says, "The FDA's adverse event database for Yaz reveals a very high number of serious adverse events associated with these drugs, including strokes, heart attacks, blood clots and deaths in young women."

Research has proven the truth of the claims being made against Bayer’s potential dangers, and thousands of lawsuits have been filed because of it. Other lawsuits are also claiming that Bayer knowingly advertised the drug’s off-label uses (the company claims the drug cures everything from acne to severe PMS) while downplaying the pill’s risks.

Plaintiff lawyers in the Levaquin trial currently underway in a New Jersey court have alleged that Johnson & Johnson, the makers of the controversial antibiotic, hired ghostwriters to pen articles declaring the drug’s efficacy and safety in a bid to hide the real tendon dangers from the public.

The case that is currently underway was filed on behalf of Paul Gaffney and Robert Bear, who both claim that they were not properly warned of the tendon rupture risk associated with Levaquin before taking the drug. Their complaint states that because of J&J’s efforts to hide the risks from healthcare professionals as well as the public, both men developed tendon ruptures after taking Levaquin. While the men initially filed separate complaints, their cases were eventually combined into one because they were so similar in nature.

The plaintiffs' lawyer said in an opening statement that “J&J officials knew there was a problem and did everything they could to hide it to protect Levaquin’s sales.” The lawyer also said that neither man can walk after having suffered from the tendon ruptures as well as mentioning that both required surgery to treat their conditions. It was then that the lawyer accused the drug giant of hiring the ghostwriters to write about how safe and effective Levaquin is while downplaying the safety risks.

Since this trial is only the third to reach a courtroom so far, it is expected to be a big one even though it is being tried in state court instead of federal court. It is seen by many as the tie-breaker case, since the first two Levaquin lawsuits that went to trial resulted in one win and one loss. All of the New Jersey cases have been consolidated into mass tort in Atlantic City.

The days of lengthy and expensive clinical trials may be coming to an end, as researchers now believe that virtual research which includes data mining can provide more detailed results in less time, even while spending less money.

Testing a new or existing drug’s efficacy and potential dangers is extremely important. This is particularly true in the case of drugs that are already approved for use because while they may be okay to use on their own, research may prove that the drugs are fatal when used in combination with other drugs. A good example of this is in the cases of the antidepressant drugs Paxil and Pravachol. While Paxil was first approved for use in 1992, and Pravachol was approved for use in 1996 for lowering cholesterol, it was proven that on their own, both drugs work and they were safe. However, researchers from Stanford University eventually discovered that when the drugs are taken together, patients suffered from increased sugar levels. This condition was particularly dangerous for diabetics.

Generally when researchers run clinical tests the process is a lengthy and arduous one. They have to gather the test patients and group them according to various factors including age, sex, weight and medical history. Once the testing is completed, the patients are split into different classes, such as those who reacted well to the drug, those that had a neutral reaction and those that had a bad reaction.

The information collected in the trials is then used to predict how new patients will respond to the drug by following patterns. This method takes up a great deal of time and money. Using data mining to collect data rather than clinical trials is a simpler way to get the information those researchers need when looking for the same patterns in patients. Russ Altman, director of Stanford's Biomedical Informatics Training Program, whose group published the Paxil/Pravachol result in the journal Clinical Pharmacology and Therapeutics, says "you're not constrained by the need to actually get patients lined up in a clinical trial that would be incredibly expensive. We had most of this paper done probably in a month."

Data mining is a research technique where researchers gather information from patient databases (based on the criteria of their research) and search for patterns to answer their questions. These databases are usually drawn from hospitals and medical records. So if a researcher wants to know how Paxil affects the elderly, they will use medical records and hospital files of senior patients using Paxil to gather up their information. Data mining is proving itself to be a significantly faster and cheaper route to clinical trials, and may wind up being the wave of the future when it comes to virtual research.

The U.S. Department of Health and Human Services announced last month that oral contraceptives like Yaz will now be included in its coverage for free. This is all a part of the new health care requirements set by the Obama administration. This will happen in accordance to the new rules that are designed to cover a broad spectrum of preventative coverage for women.

Some of the other things that are now covered include breast pumps for women who are breast-feeding their babies and yearly physicals. One of the ways that insurance companies are expected to be able to regain some of its losses (that will occur by offering these extra services with no co-pay) is to increase their premiums. These new benefits won’t go into effect for another year,

These new guidelines being administered are going to make it a great deal easier for women to get their hands on prescription birth control pills like Yaz and Yasmin. This just points out how much more important it is going to be for women to have access to the most up-to-date risk-related information available for those products. The fact is that many women are not properly informed of the real dangers associated with prescription medications like Yaz before taking it is because drug companies use misleading advertisements to sell the products.

In the case of Yaz and Yasmin, Bayer has been sued by thousands of women and their families over just that. The company’s insistence on advertising the drug as a cure-all while downplaying the risks associated with the drug has left many women suffering from life-threatening conditions such as blood clots, thromboembolism, stroke, heart attacks, gallbladder complications and even death. As many as 50 deaths have been formally reported to the FDA with links to women taking Yaz and that amount is likely higher.

Even though the FDA sought to rectify this by forcing Bayer to include the real warnings of adverse side effects, the damage had already been done. Now that the drug will be available for free, the chances of even more women taking Yaz and Yasmin will likely increase. It is already the most popular oral contraceptive on the market. That is sad because many of those women will suffer from horrible consequences if Bayer doesn't make a bigger effort to make the risks more public.