Drug Injury Attorney Blog

A law firm in Texas, Fitts Zehl LLP, is ready to start the first five cases against GlaxoSmithKline, the makers of the controversial antidepressant Paxil. The birth defects cases will be tried in a Philadelphia State Court in May. These are the first birth defects cases that will tried in the U.S., and the firm is still taking on new cases while its attorneys prepare for the trial to begin.

Ryan Zehl is excited about being the first firm to take Paxil birth defects cases to court.

"We've taken steps to ensure that no other Paxil trials take place before our May trials," Zehl says. "This will be the third time GSK goes to trial over Paxil since the FDA required them to disclose the increased risk of congenital heart defects in babies born to mothers taking Paxil during the first trimester of pregnancy in December 2005."

This Paxil trial includes cases in which the plaintiffs allege that Glaxo didn't properly warn doctors about the adverse side effects of the drug such as birth defects. The suits also claim that Glaxo outright ignored study results that showed Paxil caused birth defects. If these first five cases are won, it could set a precedent for other birth defects cases that make it to trial with the same claims. That is why this trial is so important.

GlaxoSmithKline has been battling lawsuits against Paxil and have paid more than $1 billion to date. The drug giant has even settled a lawsuit for $750 million when a whistleblower came out against the manufacturing process at GSK's plant in Cidra, Puerto Rico. That lawsuit alleged that Glaxo ignored warnings of the plant manufacturing and packaging adulterated drugs, including Paxil.

The birth defects lawsuits against Glaxo have been filed by the thousands, but this trial in May will be the first to make it to court. If your baby was born with birth defects and you took Paxil during the pregnancy, there is still time to file a lawsuit.

With the statute of limitations for filing Reglan lawsuits being reached on February 26, 2011, many potential plaintiffs that can't get their lawsuits filed before that date have a small chance for recovering money.

The second anniversary of the FDA's issuance of a black box warning against Reglan and its generic versions is February 26, 2011. This is important because it also means that the statute of limitations will also be up for filing any new Reglan lawsuits. This doesn't prevent new lawsuits from being filed, but it will severely lower the chances of a lawsuit becoming successful if it goes to trial.

The FDA approved Reglan as a treatment for gastroesophogeal reflux disease (GERD) in 1995. It was meant to be a short-term treatment (12 weeks or less), but many doctors were prescribing Reglan for years at a time. As a result of this long-term use, many patients started developing some severe side effects of the drug. Some of those side effects include Neuroleptic Malignant syndrome, Akathisia, ocular deviation and, most popularly, Tardive Dyskinesia (TD).

TD is characterized by patients suffering from symptoms like uncontrollable movements in the face and extremities, grimacing, tongue protrusion, lip smacking, puckering and pursing of the lips and rapid eye blinking. There is no cure for TD and the condition is often misdiagnosed as Parkinson's Disease, which has similar symptoms.

Lawsuits filed against Wyeth, the makers of Reglan, claim the company hid the dangerous side effects from the public, and knowingly listed only short-term effects on the warning labels.

If you have suffered from any of the adverse side effects after taking Reglan, your time is just about up for filing your lawsuit. After February 26, 2011, your chances of winning any money will likely be over. Talk to a lawyer today as there is no tomorrow!

As a defective medical device attorney, I was interested to see a growing number of stories about contaminated alcohol wipes blamed for the death of a little boy in Texas. MSNBC originally reported Feb. 15 on the lawsuit by Shanoop and Sandra Kothari of Houston, who lost their two-year-old, Harrison, in December. Harrison Kothari was supposed to have surgery to remove a benign cyst from his brain and spinal cord. But as he recovered at a children’s hospital, he was treated with Triad alcohol wipes that were supposed to be sterile. A few days later, he died of bacterial meningitis that was later determined to be caused by the bacterium Bacillus cereus. The Triad wipes were later recalled for possible contamination by Bacillus cereus, and the Kothari family is now suing the manufacturer Triad Group of Wisconsin.

Bacillus cereus is typically found in cases of food poisomning and is an unusual bacterium to find in a hospital. However, MSNBC followed up with a Feb. 22 report showing that the FDA knew there was a problem with the wipes as long ago as July of 2009. Plant visits by FDA inspectors in that month, and later in the spring of 2010, found that Triad couldn’t show that its sterilization process was working, but was continuing to sell its products as sterile anyway. Documents sent to MSNBC anonymously showed that the FDA was concerned about the low levels of radiation used in the sterilization of products, as well as Triad’s failure to address high levels of microbes found in a supposedly sterile lubricating jelly.

The reports show that the president of the company even authorized the shipment of a product that failed tests, only to recall it after some had already been sold. Triad also failed to evaluate and investigate a complaint by a hospital that one of its jellies was not sterile — one of six such complaints. Nonetheless, the FDA took no action to penalize the company or incentivize it to correct its problems. A note in the papers says only that Triad promised to correct the mistakes. In the week since the report, 50 people have contacted the Kothari family’s attorney to report their own health problems blamed on the Triad wipes, which range from skin infections to another death. And Joe Postich of Tennessee has also sued, alleging that contaminated wipes caused him to develop a heart infection that left him too disabled to work.

Visit msnbc.com for breaking news, world news, and news about the economy

As a dangerous medical device lawyer, I’m pleased that these reports have focused public attention on the regulatory lapses at the FDA. The FDA exists to protect us from contaminated, ineffective or otherwise dangerous foods, drugs and medical devices. But when it cannot or will not do that job carefully, Americans can be lulled into a false sense of security that products offered for sale are guaranteed to be safe, and seriously hurt or even killed. The pharmaceutical industry has been complaining in the past months about the FDA’s choice to increase regulatory actions — but this case shows that the agency may not be going far enough.

Continue reading " Complaints About Contaminated Alcohol Wipes Growing After MSNBC Investigation " »

Another two women, Amy Nordone and Lauren Powell, have filed lawsuits against Bayer, the makers of Yaz birth control pills. Both are claiming that if they had known that they were risking their lives taking the pill, they wouldn't have.

Nordone and Powell both suffer from gallstones and blood clots as a result of taking Yaz. Yaz is made with a combination of ethinyl and drosperinone that has been proven to increase the risks of users suffering from various adverse side effects such as heart problems, strokes, blood clots and gallbladder complications. The popular pills quickly became the market's best seller among young women as soon as it was released in the early 2000s, and many are blaming a huge marketing campaign that claimed the pill could help clear up acne and help treat major symptoms of PMS.

The downside to this major marketing campaign, which included commercials, is that it worked. Young women that have taken Yaz have since been diagnosed with various severe and life-threatening conditions including blood clots, pulmonary embolisms, deep vein thrombosis, strokes, heart attacks and damage to their gallbladder that often requires surgery to correct.

The commercials for Yaz successfully downplayed any negative side effects until the FDA caught wind of it and forced Bayer to replay the ads, but include the negative side effects. However, by the time Bayer complied with the FDA's order, thousands of young women like Nordone and Powell were already suffering from the adverse effects of the pills. Thousands of Yaz lawsuits have been filed against Bayer under claims of misleading advertising in Canada and the United States.

Bayer stands stubbornly behind Yaz and its sister pill Yasmin. The first group in the lawsuits is being heard in Bellwether trials which are being presided over by Judge David Herndon.

Dawn Harris of Louisiana filed a lawsuit against the makers of Reglan when her daughter, Coy Callahan, developed the neurological disorder tardive dyskinesia after taking the drug between 2006 and 2008.

Callahan was prescribed Reglan — minor privacy laws prevent listing what for — in a dosage that was already proven at the time to cause young children to contract tardive dyskinesia. The condition causes victims to suffer from involuntary arm and leg movements as well lips smacking, grimacing and eye blinking. As of yet, there is no cure for the disorder. The lawsuit has named Pharmaceutical Associates Inc., its parent company Beach Products Inc. and Morton Grove Pharmaceuticals Inc. as defendants in the lawsuit. These are the companies that make the generic version of Reglan, which is called metoclopramide.

While it is not known what Callahan was taking Reglan for, it is most popularly used for treating gastrointestinal disorders such as gastroesophogeal reflux (GERD) and diabetic gastroparesis. It is even given to women that have a difficult time lactating while breast feeding. However, using it for breastfeeding is not approved by the FDA and is considered an off-label use. Reglan is only approved for use for less than 12 weeks.

Back in February 2009, the FDA made the makers of both generic (metaclopramide) and brand name Reglan carry a “black box” warning that sent doctors and patients an alert to the risks of users developing tardive dyskinesia, but the warning didn't come early enough for some patients like Callahan. While Reglan lawsuits against Wyeth Inc. have been centralized to New Jersey (where Wyeth's headquarters are located), lawsuits against the generic versions have been refused MDL status because there are too many companies that manufacture metroclopramide. However, plaintiffs are filing suits all over the country. Many lawsuits are being filed now since the statute of limitations for filing Reglan suits is going to be up later this month.

The Canadian Broadcast Corporation (CBC) has aired a segment about the side effects of Yaz called "Spinning the Pill." During the broadcast, various young women that were interviewed were telling about their experiences while taking the popular birth control pills.

One of the women interviewed, Jennifer, spoke about experiencing extreme pain while she breathed after taking Yaz for a year. She was first misdiagnosed with the flu and sent home but wound up in the hospital anyway because her breathing pains worsened. Eventually she was diagnosed with a blood clot in her lungs (pulmonary embolism).

Another young woman, Hayley, told interviewer Erica Johnson that she started taking Yaz when she was 15 to help her with her PMS symptoms (as advertisements for the drug claimed Yaz did). Within 3 months, Hayley was experiencing pains in her right side and vomiting. An ultrasound revealed an enlarged gallbladder that eventually had to be removed with painful surgery. As a result of that, Hayley will have problems with her digestive system as long as she lives.

Both of these girls have joined in a class action lawsuit that is being filed in Canada. Bayer has gone under fire recently when it revealed the results of its own studies that claimed that Yaz and Yasmin were no more likely to cause blood clots than any other birth control pills. However, there are various other studies that claim just the opposite. In fact, Susan Jick of Boston University completely disagrees with Bayer's study findings, saying that the company's research was flawed and that the current data reveal that Yaz and Yasmin may cause an even higher risk of blood clots than was previously believed.

The family of Vicky, a young woman that died after taking Yasmin, will agree with Jick's account of the pills. Vicky's brother told CBC that Vicky experienced multiple massive pulmonary embolisms after only 5 weeks of taking the pills. Vicky was 26 at the time of her death.

As a defective prescription drug attorney, I’ve written before about the possible misuse of antipsychotic drugs in patients with dementia. This practice is popular because dementia patients can suffer delusions, paranoia, aggression and agitation, sometimes making them a danger to themselves and others. Starting in the early 2000s, caregivers began responding by giving patients atypical antipsychotics such as Risperdal (risperidone) and Zyprexa (olanzapine), an off-label use of the drug but a common one. However, studies increasingly began showing that these newer antipsychotics carried an increased risk of death in the elderly. In response, the FDA added a black box warning, its strongest, to the packaging of the drugs in 2005. Now, a new study shows that prescribing took a sharp downturn after that black box warning.

Difficult-to-control dementia patients demand a lot of time from caregivers, and thus a lot of money from nursing homes and other facilities. That’s why it was once more popular to prescribe atypical antipsychotics to keep dementia patients calm, even though the FDA hadn’t approved the drugs for this purpose. But after a series of studies in the early 2000s, scientists concluded that patients on those drugs were substantially more likely to die than similar patients not using the drugs – in one Canadian study, 31 to 55 percent more likely. Deaths were particularly blamed on stroke and cardiovascular causes, including diabetes.

The new study in the Archives of General Psychiatry used Veterans Affairs data to conclude that new prescriptions for all types of antipsychotics dropped from 18% of dementia patients in 1999 to 12 percent in 2007. That study found that first-generation antipsychotic use dropped throughout the study period, while atypical antipsychotic use rose until 2003 – when the medical community first reported the risk of death in the elderly. In 2003, atypical antipsychotic use began to drop – and 2005, after the black box warning, it accelerated. Another study of prescribing practices at doctors’ offices found a 50 percent reduction in antipsychotic use between 2004 and 2008.

As a dangerous prescription drug lawyer, I’m pleased to see such a strong correlation between regulatory action and changes in prescribing practices. I am particularly interested in the fact that prescriptions started dropping when the risk of death from atypical antipsychotics first became known – but dropped much faster once the FDA added a black box warning to the drug. That suggests that doctors take the FDA’s warnings seriously. That’s good in itself, and it also shows that regulatory actions likely do matter. Unfortunately, the FDA moves slowly – it frequently waits months for panels to make nonbinding decisions before taking action. Since some scientific decision-making can’t be sped up, it would be best if more doctors were willing to change their prescribing practices as soon as credible scientific evidence about a drug appeared.

Continue reading " Study Finds Drop in Use of Antipsychotics for Dementia After Black Box Warning " »

The decision has finally been made on how much money the State of Vermont will be receiving as its share of the $750 million dollar settlement that GlaxoSmithKline made after the fiasco that happened at the manufacturing plant in Cidra, Puerto Rico, involving the popular drugs Avandia and Paxil CR.

After charges of bad manufacturing practices made by a whistleblower came to light, Glaxo settled a lawsuit by agreeing to pay out $750 million in damages, penalties and fines. Of that settlement, it has been decided that the state of Vermont will receive $136,000, which amounts to double what the state's Medicaid Program paid for drugs like Avandia and Paxil that were deemed to be adulterated and even packaged with wrong dosages.

Other claims that were made against Glaxo in this case included that the drugs were manufactured using water that was tainted, and even that the Paxil and Avandia were packaged together. When the whistleblower in the case, quality control manager Cheryl Eckard, brought these mistakes to the attention of executives at the plant after a routine inspection, she claimed that her warnings went ignored. She was awarded $96 million of the settlement.

In an agreement made with the federal government, Glaxo will keeping a much firmer eye on the manufacturing practices of their other plants. After this, they will want to turn themselves into the model for good practices. Glaxo has since closed down the plant in Cidra, Puerto Rico, but the company maintains that it was not over the situation that occurred at the plant.

So far, Vermont is the first state to receive money from this settlement, but more awards are certain to come out as a result of the mistakes made in Cidra. As for Glaxo, the lawsuits continue to pile up amid claims that the company hid data about the severe and potentially life threatening side effects from its drugs including Paxil and Avandia. The company already paid as much as $1 billion in settlements. The reward to Vermont is just the tip of the iceberg.

As the steadily-rising number of Yaz and Yasmin lawsuits continue to be filed, many people are wondering if there will be a settlement made in any of those cases anytime soon.

While there is no doubt that there is pressure being added to settle some of these lawsuits rather than inundate the courts with more and more lawsuits every day, an actual settlement feels like it's a lifetime away. So far, it is unclear just how many lawsuits will continue to be filed; some are estimating that the toll can be as high as 25,000 by the time new filings finally ebb. This may seem like a huge amount, but if you consider the fact that in 2008, as much as 28 precent of the birth control market was being ruled by women taking Yaz and Yasmin, that sum is relatively small in comparison.

While U.S. District Court Judge David Herndon is already hearing a number of the cases against Yaz in what are called bellwether trials (meant to set the standard for all other Yaz lawsuits), many plaintiffs feel an actual settlement announcement still is aeons away, especially since Bayer filed a protection motion to avoid having to recall German experts to the U.S. to give more depositions in the case.

The bellwether trial process is supposed to help clear up some of the courts' congestion with regards to these Yaz lawsuits, and the pressure continues to mount for a settlement to be reached so that the other trials can get pushed along as well. However, Bayer, the makers of various control drugs including Yaz and Yasmin, is stubbornly refusing to make it easy for the plaintiffs, even though evidence and research is mounting up against the company. Bayer continues to file motions to protect it from having to produce research and data that show that Yaz and Yasmin increases the risks of women experiencing such severe side effects as strokes, heart attacks, pulmonary embolisms and gallbladder disease.

Bayer is also defending itself against claims that the company marketed the pills for off-label purposes including that the pills help clear up acne and PMS symptoms. Bayer continues to stand by the drugs and claim that Yaz doesn't cause any more risk of experiencing the severe side effects than any of the other birth control pills on the market. Bayer officials claim they have their own research to prove it.

As the steadily-rising number of Yaz and Yasmin lawsuits continue to be filed, many people are wondering if there will be a settlement made in any of those cases anytime soon.

While there is no doubt that there is pressure being added to settle some of these lawsuits rather than inundate the courts with more and more lawsuits every day, an actual settlement feels like it's a lifetime away. So far, it is unclear just how many lawsuits will continue to be filed; some are estimating that the toll can be as high as 25,000 by the time new filings finally ebb. This may seem like a huge amount, but if you consider the fact that in 2008, as much as 28 precent of the birth control market was being ruled by women taking Yaz and Yasmin, that sum is relatively small in comparison.

While U.S. District Court Judge David Herndon is already hearing a number of the cases against Yaz in what are called bellwether trials (meant to set the standard for all other Yaz lawsuits), many plaintiffs feel an actual settlement announcement still is aeons away, especially since Bayer filed a protection motion to avoid having to recall German experts to the U.S. to give more depositions in the case.

The bellwether trial process is supposed to help clear up some of the courts' congestion with regards to these Yaz lawsuits, and the pressure continues to mount for a settlement to be reached so that the other trials can get pushed along as well. However, Bayer, the makers of various control drugs including Yaz and Yasmin, is stubbornly refusing to make it easy for the plaintiffs, even though evidence and research is mounting up against the company. Bayer continues to file motions to protect it from having to produce research and data that show that Yaz and Yasmin increases the risks of women experiencing such severe side effects as strokes, heart attacks, pulmonary embolisms and gallbladder disease.

Bayer is also defending itself against claims that the company marketed the pills for off-label purposes including that the pills help clear up acne and PMS symptoms. Bayer continues to stand by the drugs and claim that Yaz doesn't cause any more risk of experiencing the severe side effects than any of the other birth control pills on the market. Bayer officials claim they have their own research to prove it.

As a dangerous drug attorney, I have followed the news about the diabetes drug Avandia closely. Avandia (rosiglitazone) was once a very popular drug for treating Type II diabetes – but at least two studies showed that it actually elevated patients’ risk of heart problems and strokes. Worse, there’s evidence that Avandia’s manufacturer, GlaxoSmithKline, knew about the risks for several years before those studies, but tried to cover them up and even intimidate scientists who made negative conclusions about the drug. In September, European regulators took Avandia off the market altogether, and the FDA ordered a new, very strict warning label limiting who may take Avandia. That label has arrived, as MedPage Today reported Feb. 8, even as GlaxoSmithKline agreed to pay $250 million to settle Avandia injury and death claims.

The new warning label says Avandia may be prescribed only to two groups of patients. One is patients who are already taking it. Those patients should not stop taking it without bringing it up to their doctors. The other group is people who have not been able to control their diabetes with other drugs in the same class and have medical reasons to avoid Actos (pioglitazone). The new label also warns patients about the increased risk of heart attacks, heart failure and related conditions. GlaxoSmithKline is still working on another part of the September order, which asked it to have independent scientists analyze data from its RECORD study of Avandia, after observers raised concerns about bias in the company’s own analysis. And the company is still working on FDA-ordered measures to ensure that patients obey the warning label, which includes a requirement for patients to sign a statement that they understand the risks.

This may not be the total ban that some public health advocates wanted in the United States – but as a defective prescription drug lawyer, I believe this will go a long way toward ending unnecessary deaths, strokes and heart attacks caused by Avandia. Already, NPR reports that only about 100,000 Americans are taking Avandia, down from 600,000 in September and about 1 million in 2007. That was the year that Dr. Steven Nissen of the Cleveland Clinic performed a meta-analysis showing Avandia raised patients’ risk of heart attack by 43 percent. That’s especially troubling because diabetics are already at an increased risk of heart and circulatory problems. Just as troubling was Nissen’s allegation that GlaxoSmithKline tried to discourage him from publishing his results through deception. How many similar actions never made it into the press?

Continue reading " Avandia Manufacturer Implements FDA Requirement to Strictly Control Patient Access " »

As far back as 10 years ago, a paper published by the Journal of the American Academy of Child and Adolescent Psychiatry claimed that the popular antidepressant drug Paxil was “generally well-tolerated and effective for major depression in adolescents.” However, the article's declaration of safety for Paxil since has been discredited, and the manufacturer of the drug, GlaxoSmithKline, has undergone several investigations and numerous lawsuits amid claims that the company hid the adverse side effects that Paxil causes.

In fact, as recently as two years ago, the FDA ordered a black box warning be assigned to Paxil as a result of charges against Glaxo that the company hid side effects. The warning was to include advice that Paxil not be given to children under the age of 18 because it was found to potentially cause youngsters to become suicidal. As early as last June, the journal had been mentioned in as many as 200 other articles attempting to argue that Paxil remains an effective treatment for youngsters under 18 to treat depression.

With this information in mind, two academics, Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, lecturer in philosophy at California State University, have requested that the journal write a retraction to that article.

“The JACAAP was the most important instrument through which the results of Study 329 were misrepresented to physicians,” the professors argue.

All of this does raise an interesting question, however: Once an article has been proven to be false, should it, in fact, be retracted? While some may believe that a retraction is the only recourse if a journal wants to remain a credible source of information, others may believe that the original article lends some historical opinion to the current trends against the drug. This is a good case to measure whether an article should be retracted and, if so, when and how?

So far, requests for a retraction haven't been answered.

As ever, some accidents involving semi trucks are more confusing than they are tragic. Not every collision is fatal, but all of them are serious for a variety of reasons. Still, it's easy to see at least a certain amount of ironic humor in a recent accident between a semi and a much larger train near Louisville, Kentucky.