Product Liability Attorney Blog

According to an article in the Madison Record, there has been a breakdown in cooperation between federal and state courts over the birth control pills Yaz and Yasmin. All of the hubbub apparently is being caused by the depositions, says U.S. district court Judge David Herndon, who is presiding over all of the Yaz cases.

Herndon wants the giving of depositions to stop while he changes the protocol and gives his written copy to judges in the states of California, New Jersey and Pennsylvania. He wasn't satisfied with the way the depositions were being handled, saying that it is not efficient and that too much time has been wasted with people being uncooperative during the process.

All of this happened after a recent hearing from a Yaz lawsuit where the lawyers in Herndon's court refused to give details to each other. Instead, the lawyers were bickering back and fourth.

"We've got to get back to practicing good law and quit this bickering for heaven's sake,” Herndon reportedly said. “I can't enter an order until the state judges are on board. If they are not on board, then my order doesn't mean anything. If one of those judges bucks on me, then we've got a problem."

Most of this bickering was the result of the experts from Germany that were to give depositions. The plaintiffs wanted the experts — recently ordered to the U.S. on Bayer's dime — to come back to the U.S. after already giving their depositions, but Herndon refused, stating that it was not in his jurisdiction to order their return. Herndon went on to say that he did everything possible to ensure that state court judges were included in the hearings and that he tried to get them to agree to have joint hearings when it came to discussing the qualifications of experts.

However, lawyers on both sides did manage to get some things accomplished during the actual hearing. They were able to resolve their arguments regarding foreign documents. Although the lawyers on both sides are uncomfortable with how fast Herndon's court process is moving, Herndon says, "It's not my job to make people comfortable. It's my job to move this litigation along."

Journalist Terri Rimmer's daughter has an eating disorder that is much like anorexia in that the girl has “an aversion” to food. Rimmer believes that this is directly due to Rimmer taking Effexor while she was pregnant with her daughter.

Effexor and other SSRI antidepressants have been known to cause birth defects in the babies of women that have taken the drug while pregnant. However, this case is slightly different from those that you usually hear about. In Rimmer's case, she is claiming that after doing some research on the effects of Effexor on an unborn fetus, the drug is directly responsible for the fact that her daughter has been hooked up to an IV since she was two years old because she will not eat.

According to Rimmer, she at first didn't want to take Effexor for fears of the effects the drug would have on her baby (she was already on Depakote). After her doctor assured her that Effexor would not harm the baby and that the benefits of taking Effexor outweighed the risks, she went off of Depakote and took Effexor instead. At the time, Rimmer was suffering from a severe case of depression.

"I didn't know that Wyeth, the drug company who makes Effexor, knew as far back as 1993, along with the Food and Drug Administration (FDA), that the medication had a 30 percent chance of causing respiratory and heart problems for newborns as well as feeding difficulties,” Rimmer says. “But neither the pharmaceutical company nor the FDA bothered telling the doctors who were assuring pregnant women as recently as until 2006 that it was perfectly safe to take Effexor while expecting."

While anorexia has been listed as a side effect of Effexor in patients for a while now, this may be the first time it has publicly been associated with an aversion to food in an unborn child. Rimmer goes on to explain her story in her blog on Yahoo! Associated Content. Rimmer's story may be another cause for lawsuits against Wyeth in the future, but only time will tell.

When the news got out in December that Pfizer’s chairman and CEO was receiving $9.6 million dollars as part of his retirement package, the question on everyone’s mind was whether he was being forced out.

Jeff Kindler was, after all, only CEO of Pfizer for 4-and-a-half years; that seems like a large payout for such a short time period. According to a filing at the Securities and Exchange Commission, Kindler received "a bonus payment of approximately $3.3 million in cash, a short-term incentive award of $1.8 million, as well as severance pay in the amount of $4.5 million." This retirement package was including a pre-existing retirement benefit that gave him about $6.9 million on top of a generous stock portfolio.

In 2009 alone, Kindler was reported to have earned $13.7 million, according to the Associated Press, so it makes one wonder why, with such high earnings, he would choose to retire. Then again, Pfizer's declining share prices and the constant failures of its new drugs may be the culprit. Although I doubt that the long list of lawsuits being filed against one of the company's biggest sellers, Effexor XR, is be helping matters. Now that the controversial antidepressant's patent has expired, along with that of its $13-billion-a-year cholesterol drug Lipitor, Kindler's replacement Ian Read has his work cut out for him.

With the failures of new drugs coupled with the patent expiration of Lipitor and Effexor happening on Kindler's watch, it is a wonder that his retirement package would be so large. However, since lawsuits filed against Pfizer on behalf of Effexor are claiming that they failed to properly warn the public of Effexor's adverse side effects, Kindler's retirement package seems like the least of the company’s problems. It may be worth the money just to get a fresh start.

As Ian Read looks to take over as CEO of Pfizer, he is saddled with various complications right from the get-go. Some of the issues that Read will have to deal with include share profits declining, the absolute failures of some of the company's new drugs as well as the patents expiring of two of its most popular drugs: Effexor XR and Lipitor.

Lipitor will lose its patent in late 2011, but Effexor's patent has already expired, which will dry up sales on the drug now that generic versions will be widely available. This could prove to be disastrous for the company since Pfizer's newest drugs can't seem to get off the ground properly after continuous failed attempts to pass clinical testing stages. This has happened to at least 12 of the company's newest drugs.

Analyst Les Funtledeyer of Miller Tabak & Co. certainly didn't agree with Kindler's decision to buy Wyeth, whose controversial Effexor has since caused many lawsuits to be filed against charges that Wyeth hid test data that linked the drug to various life-threatening conditions. Pfizer, in turn, has suffered from the losses of Effexor profits as well as its own best seller Lipitor.

Funtledeyer defends the addition of Read, saying, "One of the knocks on Jeff Kindler was that he really didn't have a lot of pharma experience before coming to Pfizer — that won't be a criticism here." He also states that while Kindler was responsible for some of the company's problems, he wasn't responsible for all of them. With this is mind, perhaps, Read will be able to help dig Pfizer out of its slump. With more than 30 years of knowledge of the company behind him, he certainly knows Pfizer well.

The whistleblower in the case made against GlaxoSmithKline says she warned the company about potentially-contaminated drugs shipped from its Puerto Rico plant, but Glaxo officials ignored her and shipped the drugs anyway.

On January 2, 2011, the news show 60 Minutes aired an interview with Cheryle Eckard, the former quality control manager for Glaxo, the manufacturer of the controversial antidepressant Paxil. In the interview, Eckard stated that the survey that she conducted on the plant was the worst one that she had seen during her career. According to Eckard, the plant used tainted water in the production of the pills and she personally witnessed the contamination of products that were being manufactured there. She even saw incorrect dosages.

She stated that with the packaging of Paxil and Avandia, the pills were being mixed together in the packages. However, Eckard said that when she told Glaxo what was going on, company officials shipped those products out anyway. As far as the dosages being wrong, Eckard stated that the Paxil doses were too strong.

Glaxo has defended its plant, with officials saying that no one got hurt from the mistakes that were made there and that they didn't lie to the FDA about plant conditions. However, since then, the plant has been shut down. Glaxo says it wasn't due to the manufacturing conditions at the plant; rather, the production was moved for commercial purposes.

When Glaxo spokespeople replied to what was shown on the program, they stated that they “strongly disagree with 60 Minutes’ implication that patients suffered harm as a result.” They also stated that the manufacturing problems at this plant took place back in 2001 and 2005 and that these errors only occurred in only one plant. Back in October 2010, Glaxo agreed to pay out criminal fines of $150 million and $600 million to the federal government and states as a means of resolving any claims that would be made. Out of this fund, Eckard was awarded $96 million.

Some doctors in Canada fear that with all of the controversy regarding the dangerous side effects of taking controversial birth control pills like Yaz/Yasmin, women will be too afraid of these pills to take the steps necessary to prevent unwanted pregnancies.

Yaz/Yasmin are popular birth control pills that have been suffering from a lot of controversy since they were discovered to cause various side effects such as heart attacks, pulmonary embolisms, strokes and blood clots in some of the women who take the pills. The pills were the highest-selling birth control in the United States until the side effects started affecting women and their unborn children.

Bayer, the makers of Yaz and Yasmin, recently introduced a new pill named Beyaz. It has been accused of being no more than a dressed-up version of the original Yaz pill; Beyaz has the same ingredients as Yaz (including drosperinone, which is the active ingredient believed to cause the adverse side effects in the original Yaz) but with an addition of folate (folic acid). There have been a great number of class action lawsuits filed because of the negative side effects associated with Yaz and Yasmin.

With the high quantity of lawsuits that have been filed, naturally this has caused a media frenzy around these popular birth control pills. Since Bayer was accused of not properly listing all of the negative side effects of Yaz and Yasmin on its label as well as in its advertising campaigns, some doctors now fear the bad press will scare women off of using birth control pills. This, in turn, could lead to a lot more unwanted pregnancies.

While the fears women may have in taking Yaz or Yasmin may be understandable, there are other methods of birth control out there, including different contraceptives in pill form. These fears, while warranted, likely will prove unnecessary in the end.

Bayer, the makers of the popular yet controversial Yaz/Yasmin birth control pills, has just rolled out a new pill that is essentially exactly the same as Yaz but with one new feature — and a new name.

Yaz/Yasmin has come under fire a lot because of the increased risks the drug poses to women who take it. These risks include heart attacks, strokes and blood clots. Yaz also is one of the birth control pills that contain drospirenone, which is said to be the cause of the adverse side effects. With many lawsuits being filed against Bayer because of Yaz and Yasmin's adverse affects, many thought that the popular drug would be pulled from the market the same way that GlaxoSmithKline's Avandia was. However, Bayer stubbornly refused to take Yaz/Yasmin off the shelves. Instead, the company came up with something else.

Bayer's new birth control pill, called Beyaz, recently was approved by the FDA. The new pill contains a folate (folic acid) supplement, which is a nutrient that many foods contain naturally (vitamin B9). Vitamin B9 is a drug that helps prevent birth defects like spina bifida and preeclampsia in pregnant women. Adding folate to the new birth control pill is designed to help the mother stock up on the much-needed nutrient so that she has a head start should she become pregnant since birth control pills can't be 100 percent effective.

While this new addition to the Beyaz pill seems wonderful, it has many people wondering if this is just Bayer's effort to get everyone's mind off of the extreme danger that Yaz/Yasmin has proven to put women in. What must be understood, however, is that while Beyaz does have a few changes in it, the drug is still just a dressed-up version of Yaz. This means that the drug still has the potential to pose the same adverse side effects as the original Yaz. In the end, only time will tell, but women should pause before taking this "new" Beyaz, since it is just Yaz with B9 in it.

When 60 Minutes aired an interview with the whistleblower in the GlaxoSmithKline class action lawsuit that alleged bad practices in the manufacturing procedures at the company's Puerto Rico plant, company officials had a lot to say in Glaxo’s defense.

The plant's former quality control manager, Cheryl Eckard, appeared on the news show to talk about what she saw at the plant that led to a plague of problems for Glaxo afterward. She stated that while she conducted a survey of the Puerto Rico plant, she saw that they were using tainted water in the making of drugs like Paxil and Avandia. In addition, she saw that the pills were getting mixed up together in the packages and that the dosages were wrong. She also stated during her interview that she warned Glaxo officials of these problems but that they shipped the drugs anyway, and that one 8-year-old boy may have gotten one of the packages that contained 2.5 times the dose of Paxil that he was supposed to get.

In a press release that was issued, Glaxo responded to Eckard’s comments.

"GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality,” Glaxo officials wrote. “It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past — between 2001 and early 2005 — and related to one manufacturing facility. GSK had been working with the U.S. Food and Drug Administration to improve the plant’s performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address the issues cited by the FDA."

The press release also stated that Glaxo disagreed with the statements made that anyone that may have been taking Paxil or Avandia suffered injury because of the problems at the Cidra plant. They cited a statement that was issued by Massachusetts U.S. Attorney Carmen Ortiz who said that her office did not uncover any evidence that patients were harmed from the adulterated batches.

Glaxo also focused on the company’s good track record with Good Manufacturing Practice requirements and noted that they fixed the manufacturing problems at the Cidra plant to ensure that the plant procedures met with both Glaxo's and the FDA standards before closing it down due to a lack of demand for the drugs sold at that plant in 2009.

Federal Court Judge Jayne Jagot recently ruled in Wyeth’s favor related to its patent on an extended release version of the popular drug Effexor. Generic drug manufacturers in Australia had challenged the patent, but Jagot wrote in November 2010 that “the applicants have not established any ground” that would justify taking Wyeth's patent away.

Sigma Pharmaceuticals Ltd., Generic Health Ltd., originally mounted the challenge and Alphapharm Ltd. Sigma posed the challenge because it had lost a net amount of $221 million during the period of six months that ended on July 31, 2010. The other generic drug makers are no longer allowed to sell any copies of Effexor, according to the new ruling.

Wyeth, a unit of Pfizer Inc., had great success with Effexor before the major side effects claims starting coming in. In fact, it was Wyeth's top-selling antidepressant. Effexor brought in as much as $3.9 billion in sales in 2008. But when the generic versions started coming out in the United States in 2010, sales for Effexor had plummeted to $175 million by the third quarter.

As another part of her ruling against the generic drug makers, Jagot also demanded that Sigma and the other generic drug makers destroy any copies of Effexor that they might still have. She then decided to suspend her order for two weeks to make sure that her ruling holds to the appeal that is sure to come. When Sigma started selling the copy of Effexor in May of 2009, they called it Evelexa. Within a month, however, Wyeth had managed to win a court order against Sigma that prevented the company from selling the drug until the matter went to trial.

It's a good thing for Wyeth that there is something good that is coming out of all of the problems it is having with Effexor. Whether Effexor is a good drug or a bad one, it's all Wyeth's now.

The birth defects lawsuit filed against GlaxoSmithKline by Anna Blyth and her family took an unexpected detour recently when their lawyer Rosemary Pinto decided to try and get their case's summary judgment reversed by the Superior Court in Philadelphia.

Anna Blyth, now 14, was born with heart defects and has had at least one surgery because of it. Her parents believe that the Paxil was the direct cause of her heart defects. The case originally was ruled in favor of a dismissal for the defense because of a lack of evidence by the plaintiffs, which some thought was due to the death of the prescribing doctor. While the case originally was expected to go to a jury, Glaxo lawyers later changed their minds and argued that since the doctor that prescribed the Paxil to Anna's mother while she was pregnant was long since dead, there was no one to testify in the case for the plaintiff which left them no evidence in their birth defects case. The presiding judge apparently agreed and the case was thrown out.

"With all due respect, I think the judge was mistaken,” Pinto stated. “I think what a doctor would say can be proven through the evidence of other like-minded physicians that know what the standard of care is. In most cases, the prescriber is alive and this decision is not going to have far-reaching effects because this is limited."

Right now Pinto is convinced that the Blyths have a good birth defects case and she says that "the standard of liability isn't whether or not the doctors knew about the risks, but whether or not they should have known about it." While the case likely will be delayed for a little while longer, Pinto is certain that the case will go to a full trial and that they can win.

Paul Cahan is a prime example of what can happen when it takes too long for the FDA to issue a recall on popular drugs like Levaquin. He has suffered from permanent nerve and tendon damage that was caused by taking Floxin. Ever since then, he has decided to fight the good fight to have Levaquin withdrawn from the market. He has even gone so far as to file a shareholder proxy for the next annual meeting for Johnson & Johnson.

Back in 2007, Cahan decided to buy 1 share of Johnson & Johnson just so that he could go to shareholder meetings. At one meeting, he appealed to shareholders to stop offering incentives to pharmacies that are selling Floxin and Levaquin. In addition, Cahan asked Johnson & Johnson to change the labels to include that since permanent reactions to the drug can be delayed, patients should discontinue the drug if they experience any of the earliest signs of trouble.

When he was done talking, Cahan (who is now in a wheelchair because of his injuries) received a standing ovation. At the reception afterward, the chairman of their pharmaceutical group even went so far as to say that she wanted to help him out and offered him to sign up as a research candidate. According to Cahan, she said, "My people will get back to you; these drugs should never be used for common infections." Cahan wrote to the board of directors and even called them many times but never heard a word about it from anyone after that.

All Cahan wanted was to make sure that doctors don't prescribe the drugs Floxin and Levaquin or other antibiotic quinolones unless it is a last resort. However, Cahan did recognize why Johnson & Johnson may be less than eager to do so, commenting, "Once a label is changed, it opens up the statute of limitations. People who have fallen through the cracks like me could be eligible for compensation."

A class action suit that is being filed in Canada centering on side effects from the popular birth control pill Yasmin is being promoted to potential filers in a way that can only be classified as “extremely modern.” Attorneys are turning to social networking sites as a way to get possible plaintiffs, citing a most natural reason — “that's where the people are."

These days a lot of law firms are advertising their services on YouTube. But Matt Baer, an attorney for the London, Ontario-based Siskinds LLP law firm, has decided to take it a step further by posting his services on Facebook. Basically, Baer created a Facebook page en titled "Take Your Body Back." The clever ploy has worked. So far the firm has 1,842 fans and the tally keeps growing.

Baer has stated that he went to Facebook to advertise his class action lawsuit against Yasmin because he figured that many of the women that may be eligible to participate in the class action will likely be using Facebook. It was a good way to reach them and get their attention, he asserts.

Baer's class action lawsuit alleges that Bayer, the makers of Yaz/Yasmin, didn't properly warn women about the potential side effects of the drugs like blood clots.

“Bayer did not provide adequate safety data to Health Canada with respect to Yasmin and Yaz,” a statement made by Siskinds notes. "Bayer knew or should have known that Yasmin and Yaz were unsafe, defective, unreasonably dangerous and not fit for their intended purposes."

The lawsuit also is inclusive of young women who have suffered from heart complications, strokes, gall bladder and kidney stones — not just the blood clots mentioned earlier. The experiment with the social networking site has given these young women a place to go to for updates on news about Yaz/Yasmin news and side effects, to share photos and even just to talk about their own stories. Baer's class action hasn't been certified yet, and the case itself likely will not start until sometime next year. There is still plenty of time for these young women in Canada to check their eligibility to file as a plaintiff in the suit.