Product Liability Attorney Blog

The Bellwether Yaz trials have seem some action lately as Judge Herndon, who’s overseeing the proceedings, has decided that Bayer cannot ask present or former employees to give testimony regarding the drug’s safety. Herndon gave his ruling on that issue on June 29, 2011.

The testimony in question was about employees telling the court whether they or members of their families have taken the controversial birth control pill Yaz, Yasmin or the generic version, Ocella. Bayer wanted to allow employees to testify to their own use as part of the Bellwether litigation that is focusing on the pills’ side effects, namely that they cause patients to suffer from gallbladder problems and damaged blood circulation.

Roger Denton, the lead lawyer of St. Louis, objected to the idea of Bayer collecting testimony from employees about personal use in an email that the judge didn’t add to the docket posting. Denton argued that if Bayer could ask employees questions about their personal use, the plaintiffs would be able to get all of Bayer’s employees’ patient histories. Denton also argued that the testimony from employees could “invite jurors to draw an improper and prejudicial conclusion that company use equates to product safety.”

"Just as the court would not permit every other allegedly injured plaintiff in this broad-ranging litigation to come to trial and tell the jury her story to bolster another plaintiff's case, it will not let a few employees say they think the product is great," Herndon wrote. "The only evidence that is relevant is the particular plaintiff's evidence and the science that relates to that plaintiff and to the product as a whole."

Herndon believes that the testimony from employees would be highly prejudicial for a jury because it is likely that their testimony would claim that all of these women took the drug without suffering from a side effect. Herndon decided instead to limit the order to multi district pretrial proceedings while in his court because he didn’t want to tie the hands of district judges that are going to be handling the individual trials.

Another generic version of Levaquin has hit the market, and this one is being made by Sagent Pharmaceuticals, which is a specialty pharmaceutical company that places a specific emphasis on injectable products. The company now is selling an injectable form of levofloxacin that is in 5 percent dextrose.

The drug is what is known as a fluoroquinolone antibacterial, and has hit the market in three ready-to-use premix bag strengths. This particular levofloxacin injection is what is known as the generic form of the popular, yet controversial, antibacterial drug Levaquin. This injection is meant to be used on adults that are at least 18 years old and suffering from infections that are caused by bacterias including “nosocomial and community-acquired pneumonia, sinusitis, chronic bronchitis, skin and skin structure infections, prostatitis, urinary tract infection, pyelonephritis.”

Jeffrey Yordon, founder, chairman and CEO of Sagent Pharma, has said that just like with other products in its portfolio of anti-infective drugs, the generic Levaquin injection is used because it works on many different bacterial infections. He also says that aside from its premixed version of levofloxacin injection, the company is including in the drug’s label information that is going to help reduce the number of medication errors.

Brand name Levaquin makers have been subjected to thousands of lawsuits amid claims of tendon ruptures associated with the drug. While only two cases have reached trial, it is expected that more will go to trial later this year. There have even been some warnings against giving people who are older than 60 the drug for fear that they are more susceptible to the tendon ruptures. This new generic injection of Levaquin may feel like a dream come true to the drug makers, but patients are still advised to beware of tendon problems when they begin taking it. Symptoms of tendon ruptures include hearing a snap or pop, severe pain in the area, bruising fast, general weakness, not being able to move the appendage properly and not being able to bear weight.

Bayer, the German company that makes Yaz and Yasmin, is trying to pass off a recent stock market loss on the expiration of the drugs' European patent protection. But analysts are claiming that the drop in shares for GSK was not caused by the revocation — at least, not exactly. Bayer stated that the European Patent Office revoked the patent after a Novartis generic drug unit filed an appeal against a 2006 decision upholding the patent. This move brought Bayer’s shares down to 1.6 percent lower at 9:07 a.m. GMT. The patent, which protects a specific procedure that is meant to lower the size of the particles that have the pill's active ingredient (referred to as micronisation), was supposed to have lasted until 2020. However, the revocation of the patent may now allow generic versions to be released as early as this year.

Analysts from JP Morgan Cazenove expect to see a generic version from Hexal as early as this year. When it comes to Yasmin products, which used to be the best seller for Glaxo before the American patent protection was lost, the pills are not best sellers anymore and have had thousands of lawsuit filed becasue of the harmful and life threatening side effects. In fact, after patent revocation in the U.S., Yasmin and Yaz sales are down 13 percent from just a year before that.

The analysts have said that Europe is likely to cause a smaller financial blow.

"In Germany the pricing is dramatically lower than in the U.S. at 7.5 euros per month compared to the U.S. at 54 euros per month, which could lead to more brand loyalty allowing Bayer to retain more share," a brokerage firm said.

Medical insurance companies in Europe want to prevent patients from buying generic versions of contraceptives like Yaz and Yasmin because most of the women that buy the drugs pay for them out of pocket. While the revocation was not good news for Bayer and some others, it likely was expected following the patent loss in the United States. Unfortunately for the patients that have suffered from Yaz side effects, many are wondering why they don't simply take Yaz and Yasmin off the market all together.

A recent landmark Supreme Court ruling which limited liability for generic drug manufacturers might end up having a significant impact on future Yaz lawsuits. That doesn’t necessarily mean that the impact will be a bad one, though.

Earlier in the month, the Supreme Court ruled against Gladys Mensing’s Yaz lawsuit when she sued the generic drug maker Pliva Inc. Her claim was built mostly on the fact that Pliva didn’t properly warn her against the known side effect of using Yaz which was a permanent neurological condition. In the end, the court ruled in favor of the drug company by stating that they were not “responsible for her health problems because the company accurately reproduced the warning label distributed by the brand name manufacturer.”

While the ruling prevents generic drug makers from being liable for injuries that occur because of the copies of brand name drugs, it doesn’t specify if the brand name drug makers can be held liable for injuries caused by generic versions. That is something that is still to be determined. One thing is certain: Injuries continue to happen because of various prescription drugs like Yaz and someone has to be held liable for it.

Even though generic drug makers may feel like they have won a free pass in selling copies of brand name drugs, there may be some back-end problems that they haven’t thought about yet. For example, brand name drug makers will likely start to tighten their holds on their medications if they are going to be held solely responsible for any side effects that the drugs cause. With some luck, maybe the brand name manufacturers will finally start to be responsible in their marketing and sales of the drugs before they let them out on the market.

The drug-industry’s influence when it comes to medical research writing has been a controversial issue for some time, and another debate erupted on the University of Pennsylvania’s campus this week when a new Paxil study conducted by GlaxoSmithKline was accused of bias and unduly promoting Paxil.

It all started when a psychiatry professor accused several colleagues of letting their names be included in the manuscript even though the controlling party was Glaxo, the makers of the controversial antidepressant Paxil. Professor Jay Amsterdam is also claiming that the manuscript was actually written by a contractor (ghostwriter) that wasn’t mentioned in the credit. The manuscript can be located at C. Nemeroff et al. Am. J. Psychiatr. 158, 906-912; 2001.

"The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil," Amsterdam’s lawyer said in a letter to the Office of Research Integrity (ORI) on July 8. ORI is responsible for investigating any misconduct when it comes to gathering and posting research findings with the U.S. Public Health Service agencies.

Documents in support of Amsterdam’s complaint claim that Glaxo specifically chose which of his colleagues to include in the study to give it some credibility and to ensure that the document would place Paxil in a good light. Karl Rickels, a psychiatrist who was not involved with the study, has said that "apparently ... (academic) participants never had a chance to review or even just see the manuscript before it went to press."

While it is no wonder that Glaxo would want to promote studies that downplay the negative side effects associated with Paxil, the act itself has been condemned. In total, 5 authors were accused by Amsterdam: Dwight Evans, department chair; Charles Nemeroff, chairman of psychiatry at the University of Miami in Florida; Laszlo Gyulai, retired psychiatrist at from the University of Pennsylvania; Gary Sachs, a psychiatrist at Massachusetts General Hospital in Boston; and Charles Bowden, chairman of psychiatry at the University of Texas Health Science Center in San Antonio.

According to information provided by the National Institute of Mental Health, almost 7 percent of adults in America are suffering from depression that lasts a year or longer. Of those people, 30 percent, or 2 percent of the population, are suffering from severe depression. According to a new paper, antidepressants like Paxil and Effexor can have long-term benefits to patients who take them, but should it be believed?

Older studies tracked data which covered periods of weeks or months when looking for benefits. This new study is the first one that claims look at long-term benefits for people using antidepressants. The most common class of drugs prescribed for depression is SSRIs like Paxil, Effexor, Zoloft and Prozac. As with all medications, these drugs have negative side effects associated with them that have caused people to experience symptoms like suicidal thoughts, aggressive behavior and even suicide. Now many people think that the benefits outweighs the risks when they are finally on the right medication — which, admittedly, can take much trial and error to find. It is that trial and error process that is scary. Often, patients suffer from those harsh side effects before the right dosage can be found. By that time, it is too late. It makes you wonder if the guess work is worth it.

This new study claims that it was able to show that only 29 percent of the people who had severe depression took an antidepressant at first. However, with this particular study these people ended up feeling better and functioning better than those who didn’t take medications early in their depression. The study also claimed that those people were less likely to still be taking antidepressants eight years later.

So far, these findings haven’t been confirmed with corroborating studies, making it easy to cast doubt. More studies will have to be conducted and more information has to be considered; any of these could change or affect the outcome in people with depression. Some of those factors could include other mental health issues and anxiety disorders. The difficulty here is that there are always studies that claim a potentially harmful drug is safe. Studies have already been conducted that prove that many patients may in fact, be better off not taking any antidepresants drugs as they are no more effective than a placebo. In the end, it may turn out that the risks will outweigh the benefits with SSRI medications like Paxil.

Two studies are currently suggesting that drugs a woman takes while pregnant may increase her child’s risk of being born with autism.

One of the studies looked at two different groups of women. One of the groups included women whose children had autism. The children of women in the other group didn’t have the condition. The data collected showed that the women in the first group (kids with autism) were twice as likely to have taken some sort of antidepressant like Paxil or Effexor during their pregnancy. All of the medications that were studied were of the group of drugs called selective serotonin reuptake inhibitors (SSRIs).

The researchers did admit that any link that they did find between SSRIs like Paxil and Effexor and autism in children would be limited because more than 93 percent of the women whose kids were autistic weren’t taking any form of antidepressant, SSRI or otherwise. While SSRIs have been linked to heart defects and other birth defects in children, depression that is left untreated also may present risks for both the mother and her baby.

This study was published on July 5 in the journal Archives of General Psychiatry. In that same issue, there was a study that was conducted on 192 sets of twins. In this study, at least one of the twins was autistic. One expert told the Associated Press, “In 77 percent of male and 50 percent of female identical twin pairs, both twins had autism. About one-third of fraternal twin pairs of both sexes also had autism in both twins. This suggests that the womb environment may be a factor as well as genes.”

While the studies don’t prove that Paxil and Effexor or other SSRIs definitely cause autism in babies of pregnant women taking the drugs, the studies did show that it is something worth taking a look at.

Calvin Christensen's recent Levaquin lawsuit has been lost, and this loss has many people wondering just what that will mean for future plaintiffs. Calvin's case was expected to set a precedent in future Levaquin trials; if that remains true, it has many people worrying that it will mean a lot more losses in the future.

He filed his suit against the makers of Levaquin, Johnson & Johnson, amid claims that he wasn't properly warned of the dangers in taking the drug. Levaquin has been proven to increase a patient's risk of developing tendon ruptures. Calvin developed tendon ruptures when he was taking the drug in 2006. His lawyers said that he never would have taken the drug if he knew beforehand that this injury was a possibility.

However, Calvin's own physician likely weighed the risk of tendon injury before he prescribed the drug to him. The defendant's lawyer said that the physician “read the label and he knew (of the risk).” He also said that the doctor gave the drug to Calvin regardless of the risk because he wanted to help get the man back home. Another thing that may have tipped the jury in the opposite direction is that they were given cause to believe that it might not have been the Levaquin alone that caused the tendon rupture since Calvin was also taking a steroid at the time. It was said that the combination of the two medications could have caused the tendon rupture and not just the Levaquin.

With the jury having heard about the possibility of another drug playing a role in Calvin's injury, they were compelled to rule in favor of Johnson & Johnson. This case will not likely set a precedent for future losses for plaintiffs since it is more likely that future plaintiff's won't have combination drugs be a factor. While it is possible that J&J's claims that doctors were given lengthy inserts about the warnings associated with Levaquin, not all doctors received the information. Future claimants can still win.

Pfizer has decided to buy back a manufacturing facility in Rouses Point, New York from Akrimax after the company bought the facility in 2008 from Wyeth. At the time, Wyeth was trying to phase out the plant because of a drop in demand for Premarin, a drug that was used to treat the symptoms associated with menopause. The plant currently manufactures Effexor among other drugs and medications.

When they first made the deal, Akrimax leased some of the facility's manufacturing space back to Wyeth so that it could keep making Premarin and Effexor XR. This deal continued after Pfizer bought Wyeth in 2009. Akrimax used its piece of the facility to make a bunch of over-the-counter medications, creams and ointments. Many reports verify that Pfizer has agreed to buy the facility back after Akrimax’ plan to expand its manufacturing operations fell short thanks to oversaturation in the marketplace. This just means that they can't sell their drugs fast enough because there are simply too many manufacturers out there making the same drugs, causing the medications to be too easy to attain, thereby making it impossible for any one manufacturer to really capitalize.

A spokesman for Pfizer, Chris Loder, told Press Republican that"Akrimax’ departure, which is due to take place in the next few weeks, will see around 60 of the 400 people employed at the facility lose their jobs. While Pfizer intends to continue some manufacturing operations at the facility in the short term, the plan is to seek a buyer for the facility and, if none can be found, close the plant in 2013."

With generic versions of Effexor XR hitting the market, the claim that there are too many versions of similar drugs available certainly holds true. These days it seems that drug manufacturers are popping up with new versions of old drugs all the time. When you couple that with generic versions of blockbuster medications like Effexor hitting the scene, there may not be much money to be made for any company, even the large ones.

A new study conducted by researchers in Finland is reaffirming previous studies’ results linking SSRI medications like Paxil and Effexor to birth defects when taken by pregnant women.

The study, which found that Paxil and Prozac were linked to a small risk of birth defects, was based on data collected in a new analysis of information gathered from national data in Finland. What the researchers found was that women taking fluoxetine (Prozac) and paroxetine (Paxil) had a slightly higher chance of having babies that had heart defects.

This information isn’t new, since research already showed that Paxil babies had a higher chance of suffering from birth defects, but it does continue to show that the results remain steady after deeper analysis of the data.

Study author Dr. Heli Malm is careful to note that “these results do not mean the drugs are never safe in pregnancy.” In fact, Malm says that there may even be some instances where it is safer for a woman to take the drugs if she suffers from depression during her pregnancy.

"The absolute risk for the specific cardiac malformations is small and ensuring the mother's well-being is important," he says, but adds that the drugs should only be taken when absolutely necessary.

Dr. Mette Norgaard at Aarhus University Hospital in Denmark, who reviewed the findings for Reuters Health, says, "To the best of my knowledge, no studies have examined how untreated depression will affect the fetus and the maternal health during pregnancy and most likely it is not safe to have an untreated depression."

Now that Dr. Reddy’s has launched three new drugs, including Effexor XR, onto the American market, the FDA is not taking any chances with the generic drug maker. It has issued a four-item warning letter to the company’s chemical manufacturing facility in Cuernavaca, Mexico.

The warning letter was sent even after the drug maker responded to the FDA’s observation made in November 2010 that listed ways the company could fix things at its Mexico facility.

The facility produces intermediate and active pharmaceutical ingredients, or bulk drugs. Dr. Reddy’s has claimed that it responded to an astounding 483 observations that were made by the FDA by implementing the corrective actions that the FDA recommended. Now the FDA also had wanted more information and corrective actions to the things listed in the letter.

"Dr. Reddy’s looks forward to working collaboratively with the U.S. FDA to resolve the matters contained in the warning letter," a company statement says.

A few weeks ago, Dr. Reddy’s launched generic Effexor XR and some other drugs on the market. The Effexor was released after a settlement was reached with Wyeth, the brand-name drug's manufacturer. That settlement is said to be the last one Wyeth will reach in its bid to keep a tight grip on the worldwide market for venlafaxine. The reason why Wyeth was keen to reach settlements with the generic drug makers like Dr. Reddy’s was because the patents for Effexor will expire in 2017, but generic drug companies have been making offers so that they could sell their versions of the popular antidepressant.

Dr. Reddy’s is sure to be more than willing to adhere to the FDA’s suggestions if it means the company can keep this potential blockbuster medication on the market.

Scott Prewitt, the father of a 15-year-old girl who died from a pulmonary embolism, is devastated because he says his daughter was prescribed Yasmin and Ocella for her acne.

Prewitt says that his daughter was not sexually active when she was given the pills. He claims that the doctor prescribed them because they were "aggressively" marketed as a skin treatment, even though that is considered an off-label use of the pill and is not approved by the FDA. He also claims that the makers of the controversial pills "ignored" the "serious risks associated with the drug."

The distraught father says that when he took his daughter to her pediatrician after she complained about a skin infection in her leg, she was dismissed by the doctor. Scott's daughter, Brittany Nicole, started taking Yasmin at the age of 13 on the advice of a dermatologist who prescribed the drug for acne in 2007. The dermatologist, Dr. Hilary Krueger, hasn't been named as a defendant in Prewitt's case.

Brittany continued to take Yasmin until August 2008 after Dr. Krueger prescribed Ocella instead. Ocella is one of the generic versions of Yasmin. The girl was taking Ocella right up until she died on June 13, 2009. After her death, Prewitt decided to sue the drugs' manufacturers and their distributors, which include Bayer, Barr Laboratories, Teva Pharmaceuticals and Intendis. He filed for wrongful death and product liability. Prewitt also sued Dr. William Bryan III and Kelly Klaaren of Asheville Children's Medical Center amid claims of negligence. The suit was filed in Buncombe County Court.

Of his daughter's death, Prewitt says that the doctors knew that his daughter was at an increased risk of suffering from pulmonary embolisms because she was obese and that they misdiagnosed the signs of the pulmonary embolisms that eventually caused her death.

"Use of the drug Yasmin and its generic counterpart Ocella are associated with increased risks of several serious health conditions, including thromboembolism," Prewitt says. "The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors, including obesity."

He goes on to add that Klaaren, Bryan and ACMC "knew that Brittany Prewitt was taking Yasmin, and subsequently Ocella, on a regular basis as prescribed for her acne condition and made regular notes of same in Brittany Prewitt's medical records maintained at ACMC." And he says they misdiagnosed the signs of the embolism that killed her.

Teva Pharmaceutical Industries has been hearing an earful from Bayer, the makers of name brand Yaz and Yasmin, after it launched a generic version of the drugs early. The Teva version of Yaz is called Gianvi.

Bayer and Teva had struck a deal that allowed Teva to sell generic Yaz as long as they waited until July of 2011 before releasing it. Teva launched Gianvi early, and now Bayer officials are saying that it is in violation of the contract that was reached between the two companies. As a result of that “breech,” Bayer officials filed a lawsuit against them. While all of this was happening, Yaz lawyers have started to name Gianvi in some of the thousands of lawsuits that have been filed against generic versions of Yaz and Yasmin.

As many as 7,000 lawsuits have been filed against the brand name version of Yaz because of the many harmful and potentially deadly side effects like blood clots, and companies are still churning out the generic versions of them. One of the pills that Teva already sells in generic form is Yasmin (Ocella), but Bayer still manufactures it for Teva. Other generic versions of Yasmin are Zarah and Syeda, which are made by Watson Pharmaceuticals and Novartis’s Sandoz division. Bayer tried to sue both of the companies but the case was dismissed back in September 2010.

Bayer's intentions were to manufacture a generic version of Yaz for Teva this July, but Teva jumped the gun by releasing Gianvi last June. That move allowed Teva to be the first company to file for generic rights. That is when Bayer officials claimed that the company's actions were in breach of a contract between them.

The generic drug makers fought back by saying that the contract allowed them to release the pills early under “certain conditions.”

This May, the FDA approved another generic Yaz, Loryna, which is made by Sandoz.