Product Liability Attorney Blog

A man has filed a new Yasmin lawsuit on December 23, 2011 and joined a current consolidated proceeding in California. The man’s complaint was filed on behalf of his deceased wife against Bayer, the makers of Yasmin, a sister drug to Yaz.

This new lawsuit was filed in California Superior Court (County of Los Angeles) on behalf of plaintiff Marc Hersh, his wife Dayna Hersh and their son, Shane Hersh. In Marc’s complaint, he states that Dayna suffered a massive cerebral infarct (which is a brain stroke) that eventually caused her death on January 26, 2011. Marc’s lawsuit is alleging that his wife’s stroke was caused by a Yaz blood clot that occurred after she started taking the controversial oral contraceptives.

This new lawsuit will be joining other similar cases that have all been consolidated in a statewide coordinated proceeding with Judge Elihu M. Berle presiding. All of these cases are making the same basic complaint in that Yaz is being blamed for causing blood clots and that Bayer didn’t properly warn them of the dangers before Yaz was taken.

Bayer has steadfastly stuck to its claims that Yaz and Yasmin are no more dangerous than other birth control pills that don’t contain drospirenone, which is the main ingredient in Yaz and Yasmin. Studies have shown that drospirenone caused various major side effects including gallbladder disease and blood clots that can lead to pulmonary embolisms, heart attacks, strokes and deep vein thrombosis. It is for this reason that as many as 10,000 lawsuits have already been filed against Bayer, and other makers of Yaz and other drospirenone-based pills.

As manufacturers continue to stand by these pills, plaintiffs will continue to file lawsuits. With the FDA doing little about the dangers (other than recommending clearer and stronger warning labels) many more women will take the birth control pills and possibly suffer from serious adverse side effects as well.

Now that the FDA advisory panel hearing about Yaz side effects has been marred by controversy, a public advocacy group is trying to get the regulators to host a new advisory panel hearing to discuss the blood clot risks associated with Yaz.

The drospirenone-based pills have long been linked to various adverse side effects, including blood clots. This is what caused the original advisory panel to convene on December 8, 2011 to discuss the matter. The problem with that hearing was that some of the panel members, it was later discovered, had financial ties to the manufacturers of Yaz and Yasmin. This naturally led many to criticize the panel’s original findings (in a vote of 15-11) that Yaz, Yasmin and other drospirenone-based pills’ benefits outweighed the risks.

Of the questionable panelists, three of them (who voted in favor of Bayer’s drugs) were directly tied to Bayer. Another panelist, it has been reported, had ties to Barr Labs, which makes a generic version of Yaz. This news created an obvious conflict of interest in the matter that forced the advocacy group to write a letter to FDA Commissioner Margaret Hamburg. In this letter, the group says: “Because of the industry ties of these members, the joint committee’s conclusion — which amounted to an endorsement of the safety of these oral contraceptives — should be disregarded. A new advisory committee — without questionable impartiality or any conflicts of interest — should re-evaluate the safety of Yaz and Yasmin.”

The letter continues to point out that “if a reasonable person would have questions about the impartiality of any member of an advisory committee regarding a matter before the committee, the FDA should not allow that member to participate in the matter and should make public the relevant information about that committee member.”

So far, it is not known if the FDA plans on convening a new panel hearing, but it is clear that many people disagree with the original panel’s findings because of this controversy over the impartiality.

The much-anticipated first Yaz bellwether trial has been postponed. FiercePharma has written a report which states that U.S. District Court Judge David Herndon, who is presiding over the bellwether trial, has ordered the lawsuits into mediation.

The first of the bellwether test trials over Yaz and Yasmin birth control pills was supposed to start January 9. However, on December 31, and order by Judge Herndon appointed a mediator to the preceding. That master’s name is Stephen Saltzburg, a law professor at George Washington. Herndon basically told Saltzburg to think about getting both sides to agree to potential “settlements in this litigation.” Herndon also ordered lawyers for both sides to meet with him “without delay” so that they could to negotiate in good faith.

FiercePharma says that this type of mediation is not new to Saltzburg, who has already handled mediation in more than 20,000 Seroquel lawsuits. Herndon’s current order in the bellwether cases could jeopardize the other Yaz bellwether trials by leaving them up in the air. For its part, FiercePharma promised to work toward settlements last year, but Herndon wants something done about the Yaz lawsuits sooner.

Bayer, along with all of the makers of generic forms of Yaz and Yasmin, has been listed as a defendant in over 10,000 lawsuits involving the serious adverse side effects that have been linked to the drug. Some of those side effects include blood clots, gallbladder disease, heart attacks, strokes and pulmonary embolisms. Yaz blood clots have been the subject of much controversy as it has been reported that women taking Yaz are 75 percent more likely to develop blood clots than the women that are taking other birth control pills. Only a month ago, an FDA advisory panel recommended that the Yaz labels be updated to include stronger warnings about the risks of blood clots, but considering the serious nature of the side effects, many feel that the drug should be recalled from the market altogether.

Another Yaz lawsuit was filed on November 17, 2011, in California. This time the plaintiff is Allison Zelinski; she has joined an ongoing coordinated litigation that is taking place in California Superior Court, Los Angeles. Defendants in the litigation include Bayer Corporation, Berlix Laboratories and various others that have been linked to the manufacturing and distribution of Yaz and Yasmin oral contraceptives.

Zelinski’s case has been coordinated as a tag along case to the larger proceeding that has various lawsuit plaintiffs claiming that they weren’t properly warned about the serious adverse side effects linked to the drospirenone-based birth control pills. Many of the plaintiffs have developed blood clots after taking Yaz. Blood clots are serious side effects that can lead to other potentially fatal conditions, such as heart attacks, strokes, pulmonary embolisms and deep vein thrombosis.

Yaz lawsuits against Bayer are nothing new. In fact, up to 10,000 lawsuits have been filed against the company with no end in sight yet. In those lawsuits, Bayer has been the defendant in the majority of them. The company has been accused of hiding the negative side effects of Yaz from the public and healthcare professionals alike. The FDA even ordered Bayer to change its marketing campaign to include stronger mention of the blood clot risks after various studies have proven how dangerous Yaz and Yasmin are. But still the company refuses to admit that Yaz increases the chances of women developing dangerous blood clots more than older, non-drospirenone-based pills do.

Bayer claims that their own study shows that Yaz and Yasmin aren’t any more likely to cause blood clots than pills that are composed of levonorgestrel. However, the thousands of plaintiffs in various Yaz lawsuits would strongly disagree. So far, there is no telling how long it will take before the many lawsuits are over, especially since the bellwether trials (which were supposed to begin next week) have been postponed. However, Bayer is likely going to suffer major financial losses before all the court dates are finished.

According to information discovered in a new study, SSRI medications like Prozac, Paxil and Celexa may help to lessen to the symptoms of autism spectrum disorder in adults. ASD is characterized by the repetitive and compulsive behavior that is often exhibited in autistic patients.

This newly-published study suggests that half of the autistic adults who took the SSRI Prozac showed a huge decline in their repetitive behavior. This study is claiming that SSRI medications (Paxil, Prozac) can do the same for adults that it does for kids with ASD. While Paxil wasn’t used for the purposes of this trial, it is an antidepressant medication that is much like Prozac.

“This medication improves one of the core symptoms of autism in adults, and this can make a big difference in their lives and the lives of their families," says Eric Hollander, MD, of the Albert Einstein College of Medicine and Montefiore Medical Center in Bronx, N.Y.

An older study (that was also monitoring SSRI use in treating autism), which was conducted by the same researchers who did this study, showed that SSRI antidepressant medications like Prozac or Paxil may help to reduce the repetitive behavior in kids, too. Some doctors are prescribing various SSRIs like Prozac and Paxil to autistic patients, but it may have some parents and caregivers worried since some of the side effects linked to those drugs include aggressive and even homicidal behavior in some patients. SSRIs like Paxil have also been known to be addictive and very difficult to be weaned off of, which could cause some behaviors in autistic patients to get worse.

In the end, the use of SSRIs like Paxil, Prozac or Celexa may prove to be more damaging than beneficial for some patients. For this reason, doctors should think more than twice before prescribing SSRIs.

If you were wondering why the FDA advisory panel on Yaz blood clot risks still refuses to recall the controversial oral contraceptive from the market, you may be interested to know that it was recently discovered that at least four of the panelists that reviewed the drug had previous financial ties to the drug’s manufacturer.

According to court documents, which were reviewed by the BMJ and Washington Monthly, four of the advisers that had conducted the research for Bayer and the other makers of pills containing drospirenone (a synthetic progestin) were financially tied to the drug company in that they were being paid by Bayer to render opinions, conduct research, to act as consultants and/or speak on behalf of the company and its drospirenone-based pills. While all of the panelists claim to have disclosed their ties to Bayer to the FDA beforehand, the conflict of interest remains obvious to the rest of us. For its part, the FDA refuses to release the advisers’ “financial conflict of interest forms” because they claim that the information is confidential. However, the FDA’s spokeswoman, Morgan Liscinsky, has said that no waivers had been issued.

Julia Johnson, who is the acting chairperson of the FDA and a professor of obstetrics and gynaecology at the University of Massachusetts Medical School, has said in an email, “The FDA is very vigilant on examining potential conflicts of interest.” She declined to be interviewed by claiming that she can’t speak about the meeting.

When the panel met to discuss the potential dangers of Yaz, they voted 15 to 11 that the benefits of using Yaz outweighed the risks. This new information could cause many Yaz lawsuit plaintiffs to claim include the conflict of interest in their filings. When this potential conflict of interest arose, it appeared in the form of a court filing by the FDA's former commissioner, David Kessler, who found the payments from Bayer by sifting through internal documents that aren’t available to the public.

Another Yaz lawsuit plaintiff has agreed to join the current coordinated proceedings in Los Angeles County, California. While Grace Santamaria’s suit will maintain its individual purpose, her case will join other cases when it comes down to the pretrial proceedings that will take place in the Superior Court of the State of California for the County of Los Angeles. For the pre-trial proceedings, Judge Carolyn B. Kuhl will preside.

Santamaria’s Yaz lawsuit claims that she was diagnosed with portal vein thrombosis on May 7, 2008. Portal vein thrombosis is caused by a blood clot that forms in the hepatic portal vein. Yaz blood clots are a well-known side effect of taking the controversial birth control pills Yaz and Yasmin (and other drospirenone-based oral contraceptive). Yaz blood clots can lead to other severe and life-threatening conditions, including heart attacks, strokes, pulmonary embolisms and deep vein thrombosis.

While class action lawsuits and coordinated proceedings are very different, they also have some similarities. For example, both proceedings both occur in one courtroom and consist of many plaintiffs. A difference between the two, however, is that class action cases have one lawyer filing a single lawsuit on behalf of many plaintiffs, all of whom will share in the award, if any. Coordinated proceedings, on the other hand, involve a single lawsuit that “joins coordinated proceedings [and shares] in the pretrial processes like discovery and witness testimony amongst plaintiffs that have all filed separate lawsuits, but when it comes time for trial, each case returns to the court where it was filed [in the first place].” That only changes if a settlement is reached beforehand.

Yaz blood clots like the one suffered by Sanatamaria have been the subject of much controversy lately as more and more studies are finding drospirenone to be directly linked to the condition. The fact that Bayer, the maker of Yaz, refuses to acknowledge that their drospirenone-based oral contraceptives are more dangerous than other non-drospirenone-based pills is helping to fuel thousands of lawsuits against them.

Adopting a baby can be the most fulfilling decision a woman can make; however, the desire to forge an early bond may have some women putting themselves — and their babies — in danger. While it is common knowledge that breastfeeding helps mothers and their babies bond, it seems adoptive mothers hoping for the same opportunity are turning to drugs like Reglan to help them do it.

Reglan is an acid reflux drug that is also used as a means of helping some women with their production of breast milk. This ability has adoptive mothers using the drug to help them create breast milk despite having not carried the baby. According to information from a recent report on the Today show, it is getting more common for adoptive mothers to use a combination of hormonal therapy and prescription drugs like Reglan as a means of stimulating the lactation process so that they can breast feed their babies.

While there is an upside to breast feeding the babies (both nutritionally and psychologically), a good deal of these women aren’t acknowledging the dangers of these drugs that they are using to accomplish these goals. This process works by women using birth control pills to trick their bodies into thinking that they are pregnant. Next, the women start taking drugs like domperidone, or metoclopramide (Reglan), which are both gastrointestinal medications.

These drugs help produce breast milk as a side effect. But it’s not that side effect that has doctors worried — it is the other side effects of Reglan that are a cause for concern. Reglan also causes a condition called tardive dyskinesia, which is characterized by patients developing Parkinson’s-like symptoms. Symptoms of tardive dyskinesia include involuntary movements of the extremities, twitching eyes, lip smacking and grimacing. The condition is permanent, and can be very debilitating. There is currently no news on whether the condition can be transferred to babies through breast milk.

A recent decision in a generic Reglan lawsuit has caused a fury among other potential plaintiffs looking to be compensated for injuries they suffered after taking the controversial acid reflux medication because they may feel that this decision could affect their own cases.

This particular generic Reglan lawsuit was originally filed on April 30, 2008, by Susan Schrock, and was recently dismissed by Chief Judge Vicki Miles-LaGrange of the U.S. District Court for the Western District of Oklahoma. Defending her decision, LaGrange cited a Supreme Court ruling made earlier this year, which basically ruled that generic drug manufacturers could not be held liable for injuries caused by generic versions of their name-brand counterparts.

This decision may not affect other generic Reglan lawsuits, since another, earlier decision in a Philadelphia case had Court Judge Sandra Mazer Moss denying a dismissal request filed by the generic manufacturers in a mass tort. As for this recent case, Schrock filed her lawsuit after she was diagnosed with tardive dystonia, which is another movement disorder similar to tardive dyskinesia (a common adverse side effect known to be caused by Reglan).

Conditions like cervical dystonia, tardive dyskinesia and tardive dystonia have long been linked to Reglan use, and have caused thousands of lawsuits against manufacturers. These movement disorders are characterized by patients suffering from Parkinson’s-like symptoms including involuntary movements of the extremities, lip smacking, grimacing and eye twitching. The condition is often permanent.

While this dismissal may have some plaintiffs worried about their own generic cases, it is unnecessary since each case is decided upon on its own merit, and there are many judges that disagreed with the Supreme Court’s ruling in the “Pliva V. Mensing” case that allowed generic drug companies to potentially escape liability in the first place. In fact, when the high court handed down its ruling, it was clear at the time that some of the justices disagreed with the decision; some even made public statements against the decision at the time. So far, judges in the states of Alabama, South Carolina, Iowa, Nevada and Vermont have already issued decisions that were in favor of the plaintiffs in their cases against generic drug makers. This shows that this one dismissal doesn’t necessarily mean much in regards to future generic Reglan cases.

The Minnesota-based Levaquin MDL — you know, the one that was previously reported as adding another plaintiff — has just added another one, and a jury trial has been demanded.

Plaintiff Thomas Lutsch’s lawsuit, which was filed on December 13, 2011, is claiming that drug giants Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc., the makers of Levaquin, did not properly warn the public and healthcare professionals of the dangers linked to the drug. Levaquin is known to cause patients to suffer from tendon injuries and ruptures. Thomas Lutsch is a Missouri resident who was prescribed Levaquin by his doctor and has suffered from painful tendon ruptures as a result of it.

According to Lutsch’s complaint, Levaquin has been linked to tendonitis ever since 1983, but the FDA didn’t require a warning about the drug until 1997. The complaint continues to claim that even on the warning label for Levaquin, the side effects are hidden inside of the lengthy list of other side effects. Lutsch’s claim also points out how the manufacturers didn’t make an effort to highlight the serious risks of tendonitis in their other communications to doctors and patients. In fact, Lutsch is claiming that the manufacturers marketed the drug as an antibiotic for common ailments like bronchitis, even though the FDA approved it only as a means of treating serious infections.

This newest lawsuit now has been added to the thousands that have been filed across the country. Not many Levaquin cases have made it to a jury yet, though. To date, three cases have been decided on; one of those cases resulted in an almost $2 million award for the plaintiff, John Schedin, who also suffered from tendon ruptures after taking Levaquin.

A new study has discovered that a hormone called DHEA should be considered to be used to treat menopausal woman and offer a boost to their sex drives. This finding could help to turn women off of using antidepressants like Paxil instead.

The Italian study, which the researchers wrote about in the journal of the International Menopause Society, Climacteric, has the researchers explaining that they had found the first real evidence that small doses of DHEA can assist with sexual function as well as the symptoms of menopause. This could mean that DHEA will replace antidepressants and hormone replacement therapy (HRT). However this study was small, so larger studies have to be done in order to substantiate their findings.

"We must bear in mind that this is a pilot study with a small sample," says Anna Fenton, co-editor of Climacteric. "We can't yet say that this study means that DHEA is a viable alternative to HRT, but ... we should be looking to do larger studies to confirm these initial results."

DHEA (dehydroepiandrosterone) is a natural steroid hormone that is created in the adrenal glands. HRT is basically just a combination of estrogen and progesterone, and is FDA-approved as a treatment for menopausal symptoms like hot flashes, lack of sex drive and mood swings. However, an old study from 2002 found that the drugs were linked to higher risks of ovarian cancer, which made the drugs a good deal less popular.

American studies had discovered that SSRI antidepressant medications like Paxil, Effexor and Prozac worked at treating the hot flashes and mood swings, but the drugs are known to cause just as much harm as good. Paxil and Effexor have been linked to various adverse side effects including aggressive thoughts and behavior, suicidal thoughts and behavior and birth defects in babies born to women who take the drug while pregnant. This new DHEA treatment may provide a safer alternative treatment for menopausal symptoms — and if the larger studies prove this one to be true, many patients will be better off.

As if the dangerous side effects experienced by antidepressants (like Paxil) weren’t bad enough, the FDA has decided to backtrack on data that supported that fact. At one time, the FDA issued a warning that taking SSRI antidepressants like Paxil during pregnancy could cause babies to suffer from a rare heart and lung birth defect that is commonly referred to as persistent pulmonary hypertension in newborns (PPHN). But now the regulators are backtracking on that by claiming that conflicting studies have stymied the agency's ability to reach any real conclusions to that effect.

The announcement came down on December 14 in an SSRI drug safety communication, which concerned the labels for SSRI medications like Paxil, Zoloft, Prozac, Celexa and Lexapro. In the communication, the FDA said, “The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.”

Due to this new opinion, the FDA is planning on updating warning labels on the link between SSRIs and PPHN to reflect this about face. The FDA also has explained to doctors that they have to use their own discretion in weighing the risks-to-benefits ratio when prescribing SSRIs to pregnant women.

This newfound opinion by the FDA seems like a serious backtracking for medical practitioners and patients alike. There are also many women who would sincerely disagree with the decision, namely those whose babies have been born with PPHN after they took SSRIs like Paxil while pregnant.

PPHN is a birth defect that causes newborns to have difficulty learning to breathe outside of the womb. The FDA's new position on PPHN and its connection to SSRIs is in stark contrast to its previous warnings, which most believe should still be in effect. Regardless of this decision, women and their families will continue to suffer and file lawsuits since there is ample studies to verify their claims that the drugs may be directly responsible for their babies’ afflictions.

While it may seem astonishing, another generic version of the controversial birth control pill Yaz has been approved. This one is made by Watson Pharmaceuticals. The FDA decided to approve the generic drug even after it has been reviewing Yaz for its links to blood clots.

The newest generic Yaz is called Vestura, and will be the newest generic version of Yaz birth control pill to hit the market. Vestura will also be comprised of ethinyl estradiol and drospirenone, which is a synthetic progestin that research has shown to cause various adverse side effects including blood clots that can lead to strokes, heart attacks, pulmonary embolisms and deep vein thrombosis. Regardless of the dangers linked to drospirenone, Yaz and its sister pill, Yasmin, are still the most popular birth control pills on the market.

Generic versions of the pills have been spawned from various companies, including Bayer. Bayer’s generic version is called Beyaz, which the company promotes by stating that the pill also contains folic acid. Other generic versions include Ocella and Gianvi. Due to the safety risks linked to Yaz, the FDA is conducting an advisory panel meeting this month to evaluate the dangers. This is why it's so strange that the drug regulators would go ahead and approve another version of the drug.

Thousands of lawsuits have been filed against Bayer amid claims that the company not only failed to properly warn consumers of the dangers, but that the company blatantly advertised the pills as a cure-all for everything from acne to PMS while knowing how dangerous the pills were. In fact, the FDA forced Bayer to change its advertising campaign to include the dangers linked to the drug, but the pill’s popularity continued anyway.