Product Liability Attorney Blog

Yaz lawsuit plaintiff Cherese Shadwick’s lawyer has dropped her lawsuit against Bayer just five days after the drug maker had the case moved from Madison County, Ill., to federal court.

The attorney decided to drop the case on Aug. 17. He asked for the dismissal from U.S. District Judge David Herndon "without prejudice," meaning Shadwick will have the chance to file her suit again if she wants to. Shadwick’s case began when she developed problems with her gallbladder that required her to have it removed. In the end, Shadwick sued Yaz manufacturer Bayer and Walgreens for those injuries on July 11. Bayer in turn had the lawsuit removed to federal court on Aug. 12, amid claims that Shadwick's attorney had "fraudulently defeated federal jurisdiction by joining Walgreen, an Illinois company, as defendant."

Bayer’s lawyer speculates that Shadwick's attorney did this because he believed he couldn’t win his lawsuit against the pharmacy if it was tried in state court. Shadwick’s complaint didn’t claim that Walgreens filled, dispensed or labeled the prescription wrong, Bayer's lawyer notes. She didn’t claim that the pharmacy knew or should have known how dangerous Yaz was when it filled the prescription. In addition, Shawick didn’t claim that Walgreens was in cahoots with Bayer, either. Bayer's legal team has argued that Bayer’s First Amendment rights protected the company's commercial speech (the right to say what they want to in advertising as long as it’s not found to be untrue) and that Herndon shouldn’t adjudicate claims that have anything to do with warnings and labels and just let the FDA do it.

All that remains in this matter is to see if Shadwick decides to refile her lawsuit.

According to information posted in the Journal of the American Academy of Physician Assistants, birth control pills that contain drospirenone like Yaz and Yasmin should not be taken by women unless they have polycystic ovarian syndrome (PCOS) because of the risk the pills pose to women’s health.

Now that current research shows that oral contraceptives containing levonorgestrel and low-dose estrogen are safer, the report’s author Jennifer Ribowsky suggests that women not take the pills unless absolutely necessary. Ribowsky's report centers around what advice physician assistants should give to patients wondering whether to keep taking a birth control pill that was drospirenone-based.

After Ribowsky reviewed a number of different studies that looked into Yaz and Yasmin side effects, she determined that those pills can actually help women that had PCOS, which is an endocrine disorder that causes “excessive androgenic hormones, which can cause masculine effects like hair growth, as well as acne, irregular menstrual periods and polycystic ovaries. Yaz, Yasmin and similar drugs have androgenic effects that can counter some PCOS symptoms,” according to Ribowsky.

Naturally, the drug treatment that can help with PCOS causes its own damaging effects; namely blood clots, gallbladder problems, heart attacks, strokes and more. It is for that reason that Ribowsky concluded that the pills shouldn’t be prescribed to any women unless they were suffering with PCOS. She bases her opinion on the fact that there are safer birth control pills that are levonorgestrel-based. Many doctors and pharmacists would likely agree with her judgement.

Ribowsky has a good point. Trying to treat one harmful condition with a drug that causes even worse conditions just seems crazy — especially after Yaz and Yasmin have caused quite a few deaths, as well. That is why thousands of lawsuits have been filed against the maker of the pills, Bayer. You don't have to conduct research like Dr. Ribowsky to understand how dangerous the drugs are.

If Merck’s Vioxx lawsuits track record holds any hope for former Paxil users who are filing lawsuits against GlaxoSmithKline, it is that they just might walk away with a large cash settlement.

With Paxil being proven to be of practically no value by recent studies, yet still one of the most prescribed types of medicines in America, the dangers it poses to patients have spawned thousands of lawsuits. GlaxoSmithKline, the makers of Paxil, have been accused of hiding some of the drug’s more dangerous side effects from the public and, naturally, the lawsuits followed.

If you are wondering how this all related to Merck and its arthritis drug Vioxx, let me explain. Vioxx was only on the market for five years before Merck completely had the drug removed from the market in October 2004 after it was discovered that the FDA’s clinical studies showed that it was linked to heart attacks and strokes. The lawsuits against Merck piled up amid claims that the drug makers didn’t properly warn the public about the dangers. So far, 50,000 people have sued Merck and current FDA stats estimate that more than 60,000 Americans have been killed by the drug. Because of these lawsuits, Merck has lost millions in preliminary judgements and has adopted far more aggressive tactics to fight against losing more.

These new tactics are being watched by drug makers like Paxil’s Glaxo to see how they fare, but they are also being monitored by plaintiff’s lawyers. Both sides of Paxil lawsuits will learn what is working and what isn’t by keeping tabs on the difficult precedents that Merck has set in what to expect in future drug lawsuits. In fact, it seems as if Merck’s lawsuit troubles have become a sort of blueprint for future lawsuits. This could prove to be excellent news for Paxil patients because if nothing else, Merck’s tricks will also help lawyers for the plaintiff know exactly what to expect from the defendants to ensure the best possible award for their clients. Merck's tactics didn't just raise the bar for defendants like Glaxo, they have shown just how much effort has to be made if drug makers hope to win their battle against the plaintiffs.

A recent study has shown that more Americans than ever are taking antidepressant medications without even having a mental health diagnosis from a licensed psychiatrist first.

More physicians are prescribing antidepressants like Paxil and Prozac to patients for anxiety and stress relief without even getting a mental health diagnosis from a psychiatrist first. Antidepressants such as Paxil, Prozac and Lexapro are considered the third most oft-prescribed drugs in the U.S. — and many of the people taking them aren’t aware of the potential damage they can cause.

"Both consumers and prescribers of antidepressants should be more knowledgeable about the indications (or symptoms) that antidepressants are better for," the study’s lead author, Dr. Ramin Mojtabai, an associate professor of psychiatry at the Johns Hopkins Bloomberg School of Public Health in Baltimore, says. "Although these drugs do not have many acute side effects, there may be more long-term adverse effects."

The study authors are careful to note that the higher amount of Americans taking antidepressants like Paxil doesn’t necessarily mean that the drugs are not being used properly. But it does bring up a very interesting question: Just how many of these drugs are being prescribed for their off-label, or unofficial, uses? Since the study only looked at information collected from yearly surveys by the U.S. Centers for Disease Control and Prevention, the information doesn’t include why the patients were taking the medication. With the high number of lawsuits stemming from the side effects associated with Paxil and other antidepressants, it seems as if people just aren’t listening to the dangers.

The study was published in the August issue of Health Affairs and doesn't shed any light as to why doctors are still prescribing antidepressants in such high numbers, especially since they have been proven to be dangerous. Not getting a mental health diagnosis from a psychiatrist before writing a prescription just seems irresponsible, since physicians may not be aware of mental health conditions of patients before prescribing the drugs. This could end up being a disaster.

A new review by the Cochrane Collaboration can’t seem to find any reliable research to support teaching men how to control what their bodies do with their minds as a form of treating premature ejaculation. Even though antidepressants like Paxil have been prescribed as an off-label treatment for the condition, that method is proving too dangerous. This is making researchers believe that behavioral therapy may still be the way to go.

Two of the review authors are saying that it is still too early to be able to completely write off the behavioral therapy as a treatment. The review’s co-author, Stanly Althof, executive director of the Center for Marital and Sexual Health in South Florida, says, “We need to do more to prove it works.”

Since doctors and mental health specialists do not know just how many men suffer from premature ejaculation, they have put the number at somewhere around 2 percent to 5 percent of the male population, says Althof. As to what causes the condition, no one really knows that either for certain — but researchers have associated various conditions as possible causes, such as “anxiety, a malfunctioning ejaculation reflex, prostate disease and chemical problems in the brain.” Some researchers even believe that genetics can be a possible cause.

Antidepressants like Paxil and Zoloft have been used as an off-label treatment since doctors note that delayed orgasm has been listed as a side effect of taking the drugs. The review’s lead author, Tamara Melnik, says of the Paxil treatment, “These medications are a simple treatment and cost-effective if not used for a lifetime.”

However, even Melnik admits that while antidepressants like Paxil may work to some extent as a treatment, they are also potentially dangerous. Combined with other treatment that is safer than Paxil, including topical anesthetics like Lidocaine which numbs the penis, behavioral therapy seems like the safest method. As to whether the therapy can work, more research has to be conducted to prove it, but researchers believe that it may all chalk up to a mind over matter situation.

New research is now suggesting that SSRI antidepressants like Effexor and Paxil may not be the right prescription option for seniors because the drugs appear to have more negative side effects associated with them than other types of antidepressants.

Paxil and Effexor are a part of a class of drugs commonly known as selective serotonin reuptake inhibitors (SSRIs), and have been linked to various adverse side effects. A new British study that is currently appearing in the Aug. 2 issue of the BMJ has found that older antidepressants, known as tricyclic antidepressants, may in fact be safer for patients older than 65 years of age. This new research adds to many existing questions about how to choose which type of antidepressant to give seniors.

"The choice of class of antidepressant is a complex decision, and some evidence is still lacking to help with that choice in older patients," says study author Carol Coupland, associate professor of medical statistics at the University of Nottingham. "Low-dose [tricyclic antidepressants] may be more suitable in frail elderly patients at increased risk of falls and fracture."

During the study, Coupland's team evaluated prescription information for more than 60,000 patients between the ages of 65 and 100 who were recently diagnosed with depression. Of those people, 90 percent were given one or more antidepressant prescriptions; 55 percent of those given prescriptions were given SSRIs which may have included Paxil or Effexor and the other 32 percent were given a tricyclic antidepressant. The rest of the patients were given other antidepressants. The results showed that the seniors taking the SSRIs experienced a “higher risk of dying, having a stroke, falling, breaking a bone and seizures compared with those not taking any antidepressant.”

These results are scary because while many seniors say that the SSRIs like Paxil or Effexor work for ebbing their depression symptoms, they seemingly are dangerous, too. While these terrible effects are scary, one thing should be taken into consideration: The SSRIs were proven more dangerous to seniors but the people taking the tricyclics were given smaller doses than those taking the SSRIs. Still, these results, combined with other studies that have proven that the efficacy of antidepressants is the same as those taking placebos. makes one wonder — why risk it at all?

A new study is showing that drugs being prescribed to the troops suffering from Post Traumatic Stress Disorder (PTSD) aren’t working as doctors would have liked. In fact, for some of the soldiers, the medications aren’t working at all.

Right now, PTSD is the most common condition our troops suffer from. For a lot of those troops — and that includes the veterans — their doctors are prescribing medications like Paxil and Zoloft to no avail. The pills simply aren’t working. Current research is showing that even the second line of treatment may not be of any help, either.

Veterans who are battling PTSD generally experience symptoms including flashbacks or nightmares. Many have difficulty readjusting to living at home again. Right now, antidepressants like Paxil and Zoloft are the go-to drugs that doctors run to for treating PTSD, but the soldiers’ symptoms do not seem to improve.

Doctors have started to try a different type of medication besides Paxil or other antidepressants. The new medication is called Risperdal (risperidone). Until now, the drug hasn’t been formally tested as a treatment for PTSD. However, a new six-month study that evaluated more than 250 veterans has discovered that the Risperdal didn’t actually lessen the severity of their PTSD symptoms, anxiety or depression. The study also found that soldiers’ quality of life didn’t improve, either; rather, they were more likely to gain weight and were often tired.

"Sometimes the common wisdom is not accurate, and we really do need to pay attention to what medications have evidence to support their use in our patients," says UCLA psychiatrist Dr. Ian Cook.

So far, the study results are disappointing to the researchers with high hopes for the new drug. But they are saying that the new drug's failure shows some progress, in that at least they know what doesn’t work. All they have to do now is find a drug that actually does.

Judge David Herndon gave a ruling on July 25 that allows Yaz lawsuit defendant Bayer to depose the first 100 plaintiffs of what will be thousands. The goal is to compare their testimony to the fact sheets that Bayer’s lawyers filed.

The plaintiffs in this lawsuit claim that Bayer's Yaz, Yasmin and Ocella have caused damage to their gallbladders. So far, Judge Herndon found defects in at least a third of the sheets that Bayer looked at and compared against previous deposition testimony of 24 plaintiffs in the bellwether trials that will be beginning next year.

In his ruling, Herndon wrote: "In one case, the revisions were reportedly so extensive as to involve identification of additional treating physicians, changes in dates of treatment and hospital admissions, identification of additional pharmacies, identification of additional medical conditions and medications, and new information regarding the use of oral contraceptives. In another case, the plaintiff allegedly misidentified the prescriber of her Yaz prescription on the plaintiff fact sheet and failed to identify the pharmacy at which her Yaz prescriptions were filled.”

So far, the plaintiff fact sheets have been identified as deficient and it brings up many questions that Bayer has to answer to in regard to whether the information given is credible. Herndon goes on to say that the court's goals can’t be reached if both sides think that the information that is gathered in the discovery process isn’t credible. Herndon, however, did defer a decision regarding the deposition of doctors that had actually treated the 100 plaintiffs who were chosen.

The Yaz lawsuits are expected to help set a precedent in future Yaz lawsuit settlements. Many of the plaintiffs have had their cases consolidated into bellwether trials, or trials which help settle mass-lawsuit litigation by showing a variety of potential judgments. These trials' results are highly anticipated by everyone involved.

Research continues to shed more and more light on the reasons why the court system is swamped with Yaz and Yasmin lawsuits. Studies are popping up all over the place that link Yaz and Yasmin to various negative side effects. With the dangers of the drugs getting an increasing amount of attention, Yaz lawyers are desperately awaiting a new FDA study that should be released by the end of August — one which they hope will work to their benefit.

Just how does any of this apply to the current Yaz lawsuits waiting to get to trial? The link revolves around studies like the one being commissioned by the FDA that have yet to be released. The judge presiding over the group of Yaz lawsuits in Illinois has been working with lawyers to coordinate the lawsuits across the federal and state courts. During his pretrial court orders, the judge is debating whether he wants to extend the trial dates while they wait for clinical study results of the side effects to be released.

Chances are the judge is waiting for the release because he wants all information to be available for use by both sides in an effort to be fair and impartial. Not every judge involved in centralized Yaz lawsuits will be this accommodating. In fact, Philadelphia mass tort judge Sandra Maze will not be extending trial dates in her cases.

The FDA study mentioned here was announced earlier in the year. The drug regulators announced they would begin a “large study” of Yasmin and Yaz side effects that were going to “fully assess” all of the risks that were involved with women taking the pills. It should be ready to be released soon, and Yaz lawyers are crossing their fingers that it helps defend the drugs. However, the pills have been proven dangerous already and this fact has never been refuted, so this study likely won’t do them much good regardless of the results.

Antidepressant medications like Paxil and Effexor are now so widely prescribed that many critics are beginning to question why — particularly in light of the fact that no one is completely certain if or how the drugs work.

Most antidepressants in the U.S. work by changing a patient’s neurotransmitter levels called serotonin, a chemical that is released into the brain that causes people to experience feelings of general well-being. These drugs like Paxil and Effexor are in a group of medications called selective serotonin reuptake inhibitors (SSRIs). As to why these drugs work the way they do is a mystery, but one that implies that depression is caused by a chemical imbalance. Currently there is actually little evidence supporting this belief. However, drug companies have chosen to push their prescriptions on the public under that claim.

There are actual studies that refute that claim by stating that “the levels of serotonin in depressed people’s brains are the same as they are in those of non-depressed people.” Many studies have been conducted that will satisfy the critics’ point of view. For example, a recent study claims that drugs like Paxil don’t work any better than placebos. Various other studies show that these pills can cause fatal/violent side effects. There are plenty of studies that can cause critics to try to get these medications off the shelves, but people believe that they work. In essence, it seems to be a mind over matter issue.

With the combination of harmful side effects and research proving that drugs like Paxil and Effexor are not only dangerous, but no better than sugar pills at treating depression, it is only a matter of time before people start demanding the drugs to be less widely used. The thousands of lawsuits haven’t convinced doctors to stop prescribing the pills, but perhaps more research disproving the pills’ efficacy might.

While it is well known that the acid reflux drug Reglan can cause tardive dyskinesia (TD) if it is taken for a period that exceeds 12 weeks, the drug has also been given to aid women in breastfeeding their children.

Reglan has been used to help increase lactation in women who were having problems producing enough milk for their babies. It is an off-label use of the drug. So far, there is no official dose that has been established for this use of the drug in this manner, but mothers have generally been given 30 mgs a day, which is about the same as the 30-40 mgs that are given to heartburn patients. This is where the questions start.

Since the chances of a person developing TD is the same for nursing mothers as it is for everyone else taking the 30-40 mgs of Reglan, it seems that the only variable that is different is the purpose for taking the drug in the first place. The reason for this is because the purpose for taking the drug will likely affect the length of time that the drug is prescribed. Since the FDA stipulated that the drug shouldn’t be used for more than 12 weeks at a time, this likely places nursing women at a higher risk of developing TD. But what about their babies?

Many studies will likely have to be conducted before any real data are available on whether a baby can develop TD or other conditions associated with Reglan use when its mother takes the drug while nursing. It is best that parents of breastfeeding babies that develop conditions such as TD, Parkinson’s Disease, Neuroleptic Malignant Syndrome, blepharaospasm and ocular deviation contact a doctor and then a lawyer, as these conditions may be caused by Reglan.

There are thousands of debilitating conditions. Drug companies have figured out that there is not much that a person won't pay to save themselves from their symptoms. Antidepressants like Paxil and Effexor have come under fire lately because of the harmful side effects that have been associated with them. In some cases, the side effects have proven to be worse than the condition that they were treating.

Effexor and Paxil have been widely used in treating symptoms of depression and anxiety. They are also known to cause side effects like severe mood swings, aggressive behavior, suicidal thoughts and even suicide. These drugs have also been reported to cause physical symptoms such as dizziness, nausea and sexual side effects. Some people have even accused the drug of causing them to hurt themselves and others in what is being dubbed a "Paxil defense." The claims of the drug causing suicide and violent behavior are far worse than the feeling of being sad, and yet the drug is still viewed as a magic cure by many.

When Paxil first came out, it was considered a magic pill that could cure you of depression — and many people still believe that it does. This was considered a good thing because those that have suffered from depression can attest to how debilitating the condition can be. However, research has recently concluded that the drugs don't work any better than placebos. If you ignore the bad research and focus on the people who claim that Paxil or Effexor is their "happy pill," you have to wonder if it is all in their heads.

The fact is, while the drugs may work by controlling the level of serotonin (what makes people feel good) in the brain, they have the potential to cause just as much harm as good. It can leave people wondering "why bother at all?" Why not just go to therapy, which is also proven to work in treating depression and anxiety without the harmful side effects (other than the cost). Until people start properly weighing the drug side effects with the "good" that it can do for you, drug companies will keep selling them more magic pills that claim to cure them of your ails. The only question is, how much danger are people going to put themselves in?

While antidepressants may be helpful with depression symptoms, more research needs to be done to make a drug that offers fewer and/or less dramatic side effects. Until that happens, lawsuits will continue to pop up against drug makers in the hope that they will learn more about their drugs before they put them on the shelves.

Last month’s controversial Supreme Court ruling might have given generic drug makers a “get out of warning label settlements free” card; however, it hasn’t stopped current Reglan lawsuits from pushing on.

All over the United States, Reglan lawsuits in both state and federal courts which claim that the brand name version of Reglan doesn’t properly warn the public of the risks associated with the drug still await trial. The Supreme Court’s ruling did not stop litigation from happening; it merely forced plaintiffs to take their claims to the brand name drug makers instead and in federal court.

Reglan has long been associated with tardive dyskinesia (TD), a condition that is characterized by Parkinson’s-like symptoms. Generic versions of the drug also have been proven to cause TD. Many can’t help wondering what happens to all of the plaintiffs that developed the condition due to the generic version. Can they now sue brand-name drug maker Wyeth instead?

Recent studies have shown that patients who take Reglan for a period of longer than 12 weeks are more likely to develop TD. However, that information was not readily available when many people started taking the acid reflux drug. It is clear that someone should be held responsible for that, and right now, generic drug companies are not. The theory behind this decision is likely because the justices figured that generic drug companies didn’t have to post any warnings on their labels other than what the brand name drug companies wrote on theirs. The Supreme Court just upheld the federal court's rule that doesn’t allow generic drug makers to post different warning labels from their brand name counterparts.

For now, however, a different judicial panel recently decided to reject a motion to have all Reglan lawsuits that are filed in federal court to be consolidated into multidistrict litigation (MDL). That said, all of the lawsuits that are filed in state courts have been centralized to the New Jersey Superior Court. The fight pushes on, and brand name drug makers will be the defendants.

On Tuesday, July 26, 2011, the FDA announced that the drug research company, Cetero Research, faked drug research results in order to manipulate the results. This could prove disastrous for drug makers of controversial drugs like Paxil as there already is a barrage of contradictory studies that debate their safety and efficacy.

This accusation by the FDA came on the heels of an investigation into the research company that involved two inspections of the facility in 2010, an internal probe and a third-party audit. All of this led the FDA to say that the facility was found to have “significant instances of misconduct and violations,” according to information posted by Reuters.

Cetero is hired by drug companies to test medications and then check out the results. Its work is designed to help drug companies understand just how effective — and potentially dangerous — their drugs are. After an intensive set of investigations, the FDA has warned drug companies that information provided by Cetero may not be true and that some medications will have to be reevaluated. The FDA officially states that Cetero is accused of “faking documents and manipulating samples.” This could void any research results provided by Cetero because drug companies use Cetero’s information to support data that is included in drug approval applications with the FDA.

Paxil comes up when thinking of this subject, because GlaxoSmithKline recently was accused of hiring ghostwriters to write articles that doctors took credit for and that helped "prove" Paxil’s efficacy while minimizing the risk associated with the drug.

It sounds like Cetero was telling drug companies what they wanted to hear, rather than what they needed to know. One accusation made against Cetero stated that in some cases, Cetero was said to have conducted studies that could not have been conducted at their locations when they said they did. The FDA also wrote that it is possible that the research company actually “fixed” studies to get the result that its clients needed or just excluded any failed results when posting its findings.

This could be important for drug makers like Paxil’s GSK with all of the lawsuits being filed against them. Whatever happens to Cetero, this information could damning in lawsuits.