Lawsuits you should know about

Byetta is a prescription drug from Amylin Pharmaceuticals, Inc. It is an injectible drug used to treat Type 2 diabetes and was approved for use by the FDA in 2005. This drug has been potentially linked to a significant side effect known as acute hemorrhagic or necrotizing pancreatitis. Pancreatitis is an inflammation of the pancreas that can cause problems such as infection, bleeding, tissue damage and even in some cases death.

In October 2007 the FDA warned health care providers of the risk of acute hemorrhagic or necrotizing pancreatitis with the use of Byetta.

On August 18, 2008 the FDA announced that it was working with the makers of the diabetes drug Byetta (Amylin Pharmaceuticals) to add a stronger and more prominent warning on the packaging of this prescription drug about the danger of pancreatitis.

Most recently a lawsuit was filed in California in San Diego Superior Court.

The prescription drug Quetiapine is marketed by AstraZeneca under the name of Seroquel. It is part of a class of drugs known as “atypical antipsychotics” which are used to treat bipolar disorders and schizophrenia. It was approved by the FDA in 1997 for use.

Seroquel was initially approved for the treatment of schizophrenia but has been used “off label” to treat other disorders including insomnia, anxiety, autism, depression, dementia and other sleep disorders. In 2006 the FDA issued a “black box” warning on Seroquel, stating that the use of this prescription drug in the treatment of dementia could cause serious side effects that possibly would result in death.

Several lawsuits and a class action lawsuit have been filed on behalf of patients who have taken the drug Seroquel and who have developed diabetes. Several of the lawsuits state that the company marketed and promoted the prescription drug Seroquel while minimizing, down playing or even concealing the potentially dangerous risks and side effects of the drub.

The Durom Cup is manufactured by Zimmer Inc. This medical device was created in 2006 and has been used in more than 12,000 U.S. patients as a part of hip replacement surgeries.

On July 22, 2008, Zimmer Inc. ceased the sales of their Durom Cup hip replacement parts in the United States after doctors reported having to do revisions and further hip surgery after the using the Zimmer products.

However, some experts feel that suspension of sales came far too late for many patients. Dr. Lawrence D. Dorr, an orthopedic surgeon and medical director of the Dorr Institute for Arthritis Research and Education said in April 2008 that the failure rate of the Durom Cup is with the first two years of implant. He noted that after the first year, the x-rays looked perfect, but followed that up with “These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance.” He didn’t feel that the fixation surface is good on the Durom cup and that circular cutting surface on the edge of the cup prevented the cup from fully seating. He said he and his staff of doctors stopped using the cup after the first revisions.

Zimmer finally agreed to start an investigation into the allegations of problems with the cup in May 2008 after numerous complaints by surgeons. The company reviewed over 3,100 patient cases before deciding that the technology and design of the Durom cup required additional instructions and training. They plan to develop instructions which will help the surgeon reduce the risk of problems when the implant is performed. Zimmer also stated that it planned to put into practice a surgical training program in the U.S. and only allow surgeons who had completed the training to perform hip replacements using the Durom cup.

Rather than issue a recall, Zimmer merely suspended sales of the product in the United States until the new procedures could be put in place, feeling that it was lack of proper training and not a manufacturing defect that caused all the additional surgeries.

But, is Zimmer at fault for not providing adequate instructions and trainings from the beginning? It appears that perhaps even the shareholders of Zimmer stock believe the product is faulty and was left on the market too long. Shareholders who purchased stock between January 28, 2008 and July 21, 2008 recently filed a class action lawsuit against Zimmer. The lawsuit, filed in the Southern District of Indiana, says that Zimmer failed to disclose that a disproportionate number of patients receiving the implant then having to undergo corrective surgeries. The day after the suspension of sales was announced, the Zimmer stock declined from $70.88 per share to $66.01.

If you or someone you know has had the Zimmer Durom cup hip replacement and experienced unexplained hip pain three months or more after the original surgery or loosening of the parts which required additional surgeries, you may want to seek legal advice. Many lawyers will offer a free consultation to find out if you have a case against Zimmer or not due to faulty parts.

Cipro (also known as ciprofloxacin, ciproxin, and ciprobay) is a synthetic antibiotic manufactured by Bayer A.G. Like Levaquin, Cipro is in the group of drugs known as fluoroquinolones. Cipro is used to treat lower respirator tract infections (including pneumonia and acute bronchitis), certain STDs, skin infections, soft tissue infections, septicemia, legionellosis, and anthrax. It was approved by the FDA in the fall of 1987. Since then, it has become the best selling antibiotic in the world. The gross sales for Cipro alone in 1999 were $1.04 billion.

There is a list of side effects that could occur as a result of taking Cipro. The most commonly seen side effect of taking Cipro is gastrointestinal irritation, but some users may find themselves sensitive to light (photosensitivity), suffering from constipation, or sensitive to caffeine. However, an alarming number of Cipro users have reported swelling of joints and cartilage, chronic pain, and even tendon rupture in the Achilles tendon, the rotator cuff, the biceps, the hand, and the thumb.

It was the tendon ruptures that caused the Food and Drug Administration (FDA) to change the packaging of Cipro in 2005 to include the possibility of tendon ruptures and permanent neurological conditions. This past July, Public Citizen, a consumer advocacy group founded by Ralph Nader and Alan Morrison, finally pressured the FDA into adding a “black box” warning to Cipro and other fluoroquinolones labeling, stating that taking Cipro increases the risk of tendonitis and tendon rupture. However, the FDA has not recalled Cipro, due to the fact it feels the advantages of the drug far outweigh the possibility of tendon rupture and most physicians agree. The FDA has said “The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart and lung transplant recipients.” Doctors have advised patients to stop taking Cipro at the first sign of any tendon pain or inflammation, avoid exercise, and contact them immediately.

Despite the new label warnings, Public Citizen feels that Cipro has been unsafe for a while now. Between November 1997 and December 2005, the FDA received reports of 262 patients taking fluoroquinolone suffering from tendon ruptures. There were another 258 reported cases of tendonitis and 274 cases of other tendon disorders by Cipro patients during that time frame. Public Citizen feels that there are more cases that have not actually been reported to the FDA. The nonprofit organization filed a petition with the FDA in 1996 to have a warning label addressing the rupture issue. The FDA granted the petition, but the warning was all but hidden in the list of other side effects of Cipro.

Now that the FDA has finally put the “black box” warning on the label, the question is – was it too late for some patients? If you or someone you know suffered tendon problems such as a rupture or tendonitis while taking Cipro before the warning was added, you may want to contact a lawyer to find out more about a lawsuit and see if you are entitled to compensation for your pain and suffering.

Levaquin, also known as Levofloxacin, is a fluoroquinolone antibiotic made by Orth-McNeil. It is used to treat a multitude of infections including pneumonia, skin infections, and urinary tract infections. In fact, it is the only respiratory fluoroquinolone that the Food and Drug Administration approves for use in cases of nosocomial pneumonia. It was released in 1993 after fifteen years of testing proved it to be safe.

As with most medication, Levaquin has some side effects, although it is believed to be generally well tolerated. Some of the more common side effects are nausea, diarrhea, itching, abdominal pain, dizziness, flatulence, rashes, and vaginitis (in women). Some patients may experience blistering sunburns after being exposed to sunlight or the ultraviolet light from tanning salons. Your doctor will suggest that if you suffer any severe side effects, that you immediately quit taking Levaquin and contact him or her.

Now, some groups think that Levaquin may cause serious tendon damage as one of the side effects. Ortho-McNeil has stated that taking Levaquin may cause ruptures of the shoulder, hand, thumb, or Achilles tendon. They suggest in their literature that if you develop pain, swelling, or rupture of a tendon, that you quit taking Levaquin and immediately contact your doctor. Scientists are not sure why some patients taking this drug suffer ruptures, but believe it may be because the drug is toxic to tendons and decreased the blood supply to areas that are already receiving a limited amount of blood.

On July 8, 2008, the Food and Drug Administration (FDA) ordered Ortho-McNeil to put a “black box” warning on Levaquin warning patients of the potential risks as well as creating literature that stresses the risks associated with taking Levaquin. But, the FDA allowed the drug to remain on the market and did not issue a recall.

But, is the warning too late for some? The Public Citizen and Illinois Attorney General tried to get the FDA to add the “black box” warning on Levaquin in August 2006. An earlier petition had been filed in 1996 by a nonprofit group, asking for the same warnings. While the FDA did grant the 1996 petition, the chance of ruptures was merely added to the list of possible side effects and not emphasized as a serious risk. The FDA has stated that the benefits of the class of fluoroquinolone drugs like Levaquin outweigh any potential risks.

While it is believed that patients and doctors may be able to prevent the tendon ruptures with awareness of early warning signals such as tendon pain, there are still a large number of patients taking Levaquin who are reporting this problem. An FDA database shows reports of 262 cases of tendon ruptures, 259 cases of tendonitis, and 272 cases of additional tendon disorders. Of the cases reported to the FDA, 61% of the patients were taking Levaquin.

If you have been taking Levaquin and feel you have suffered tendon damage due to the drug, you may want to contact a lawyer to see what legal recourse you have.

Commission Junction, which was founded in 1998, is an online advertising company aimed at the affiliate marketing industry. It is the world’s largest affiliate network with over 1,500 customers which include Buy.com, Home Depot, Circuit City, and Yahoo! It was acquired by ValueClick in October 2003.

However there is a class action settlement against ValueClick, Inc. If you were a member of the Commission Junction or Be Free affiliate marketing networks, you may be a class member of this settlement.

The settlement claims that ValueClick, Inc. filed to monitor the use of third party software on Commission Junction that violated their publisher Code of Conduct. The fact that ValueClick allowed adware/theftware provides in their network may have stole commissions from other legitimate network publishers.

There has been $1,000,000 set aside to settle the case out of court. ValueClick is offering to pay eligible publishers a share that would equal their share of revenue generated during the time frame mentioned in the lawsuit. Publishers who do not take action will be automatically assigned a credit. Those wishing to take further legal action will have to opt out of the settlement and pursue their claims through the court on their own.

ValueClick has put aside $1,000,000 as a fund to settle the case out of court and is offering to pay all eligible publishers a share of that fund commensurate with their share of the revenue generated across the network at the time. By not taking action, publishers are automatically going to be assigned a credit. Those who do want to take further action can opt out of the settlement and pursue their claims through the court system individually.

The proposed settlement will resolve claims that Defendants failed to adequately monitor Commission Junction’s Network for the use by third parties of software that does not comply with Commission Junction’s (“CJ”) Publisher Code of Conduct and that is intended to steal or divert commissions from publishers on CJ’s network (“Non-compliant Software”), failed to adequately monitor or prevent third parties from engaging in the theft or “hijacking” of commissions from Advertisers and Publishers on CJ’s Network, and failed to make sufficient disclosures regarding the existence of Non-compliant Software and commission theft, resulting in losses to both advertisers and publishers on the CJ Network.

The proposed settlement will provide a monetary recovery to eligible class members. For class members that currently maintain an account on the CJ Network will receive payment through payments or credits deposited or applied to their CJ accounts; eligible class members that no longer have accounts on the Commission Junction Network will receive a check for an equal amount.
If you are a member of the class, your legal rights are affected by whether you act or do not act. You should review the Settlement Notice as soon as possible as there are several important deadlines that you must meet to take certain actions in connection with this proposed settlement. In particular, the deadline for filing an objection or excluding yourself from the proposed settlement is September 30, 2008. For further information, please refer to the Settlement Notice.

Singulair is a prescription drug manufactured by Merck & Co. that is used as maintenance treatment for those suffering from asthma, but also used to relieve symptoms of those suffering from seasonal allergies. With millions of asthma sufferers worldwide, Singulair has been touted as a drug that can help prevent the symptoms of asthma before they even start. Over 50 million Americans alone suffer from nasal allergies and Singulair has been helpful in preventing those symptoms as well. It was approved for treating asthma in 1998 and for seasonal allergies in 2003. Singulair is used by millions and resulted in $4.3 billion in sales last year for Merck. It has been prescribed by physicians to both adults and children over the age of two.

However, the Food and Drug Administration (FDA) is looking into a connection between Singulair and suicidal behavior. The FDA called the possible connection an “emerging safety issue” after it was reported to them that “3 or 4” patients who were taking Singulair committed suicide. Currently, the FDA is doing an investigation to see if there is a link between taking Singulair and experiencing extreme mood or behavior changes, including suicidal behavior.

Within the past year, Merck has told physicians that possible side effects of Singulair could be tremors, depression, suicidal thinking or behavior and anxiety. The FDA has asked Merck to look at study data for more information on the patients who experienced depression, suicidal thinking or behavior, but it may take up to nine months for such an evaluation to be completed.

Until the study is complete, the FDA is not recommending that patients stop taking Singulair, but rather talk to their physicians if they have concerns. The FDA also advised physicians to monitor all patients taking this medication as well as Zyflo and Dey, two other drugs in the same class as Singulair. Merck officials issued a statement saying that the FDA based its concerns about Singulair on reports, not clinical findings, which is what is normally used to test drug safety. Of the 11,000 patients that have enrolled in 40 Singulair trials, Merck points out that none have committed suicide.

Avandia (rosiglitzaone) is a drug that has been used to treat type 2 diabetes. Avandia, the brand name drug manufactured and marketed by GlaxoSmithKline, is used along with diet and exercise to help lower blood sugar levels. Since 1999, Avandia has been prescribed to over 4 million people with type 2 diabetes. Avandia was intended as a safer alternative to Rezulin, which was recalled in 2000 for being linked to fatal liver diseases.

However, in May 2007, the Food and Drug Administration (FDA) issued a safety alert on Avandia. The FDA said that data from controlled clinical trials showed that there is an increased chance of heart attack or heart-related illnesses for patients taking Avandia. The reason that the drug was not immediately removed from the market is that other long-term clinical trials showed contradictory evidence about the risks of taking Avandia. The FDA did said in it’s safety alert that patients who have heart disease or are at a higher risk for heart attack should talk to their physician about these clinical trial findings to decide if they should proceed with taking Avandia to treat their diabetes.

Dr. Steven Galson, the director of the FDA’s Center for Drug Evaluation and Research department, said, “FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia. We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened.”

GlaxoSmithKline provided the FDA with a pooled analysis of 42 randomized, controlled clinical trial results. Those showed that Avandia used for six months by patients could have raised their risk of heart attack or other heart illnesses by as much as 30-40 percent.

Avandia lawsuits are starting to pop up as some patients who have taken it are suffering from heart attacks, congestive heart failure, hepatitis, and liver failure. A new study was reported in the September 9, 2007 issue of Mayo Clinic Proceedings that suggested that Avandia could cause fluid accumulation that results in congestive heart failure. In the study, six men between the ages of 66 and 78 who were taking Avandia had to go to the Dallas Veterans Affairs Medical Center for congestive heart failure.

Since being approved, many FDA officials have questioned whether Avandia should stay on the market or not, but put off a ban on the medication until the results of further research are established. If you or someone you know has been taking Avandia and suffered liver failure, hepatitis, congestive heart failure, a heart attack, or any other type of heart ailment, you should contact a lawyer to find out your legal rights.

When going through menopause, women often suffer many side effects such as hot flashes, night sweats, and vaginal itching and dryness. Prempro is a hormone therapy made by Wyeth Pharmaceuticals that will help lessen those symptoms. Women who are going through a natural menopause can benefit from Prempro’s hormone replacement therapy, which is a combination of estrogens and a progestin.

Since 1995, millions of women have taken Prempro, making it one of the leading hormone replacement therapy drugs on the market. In 2001 alone, Prempro resulted in $890 million dollars in sales for Wyeth Pharmaceuticals.

However, there have been studies that have shown that while Prempro does relieve the symptoms of menopause, it can also increase the risk of stroke, blood clots, ovarian cancer, endometrial cancer, and breast cancer. A study of the drug’s usage began in 1991 and it was conducted by the Women’s Health Initiative (WHI). It started as a 15-year study to find a way to prevent heart disease, breast cancer, colorectal cancer, and osteoporosis. Over 161,000 postmenopausal women were involved in the study. One part of the study involved almost 17.000 women taking an estrogen plus progestin therapy (Prempro) or a placebo. The idea was to determine if Prempro would help prevent heart disease but also determine if the benefits of using Prempro outweighed the risks.

After only 5 years, the study was stopped. So risky was this study that the National Institute of Health (NIH) decided to cancel it to protect the participants. A result showed that not only was Prempro not helpful in preventing heart disease, but it increased the chances of breast cancer. It is believed that women who have taken Prempro have a 29% higher chance of having a heart attack, are 41% more likely to suffer a stroke, and have a 26% higher chance of getting breast cancer.

As a result of this study, there are now lawsuits being filed against Wyeth Pharmaceuticals. The lawsuits claim that Wyeth knew that Prempro had hazardous side effects and failed to describe them in their packaging. In addition, Wyeth failed to remove the drug from the market after the study results became known.

In July 2002, a class action suit was filed against Wyeth Pharmaceuticals by women who were prescribed Prempro. The lawsuit seeks not only compensation for women who suffered side effects such as heart attacks or breast cancer due to Prempro use, but also to get medical monitoring to screen for breast cancer and dementia for all patients who have taken the drug. The lawsuit also hopes to make the risks of taking Prempro known to the public as it has yet to be taken off the market. In May 2005, a woman from Baltimore filed a multi-million dollar lawsuit against Wyeth, claiming that her breast cancer resulted from having taken Prempro. She is asking for $30 million in damages.

If you, a family member, or a friend has taken Prempro, you may be eligible to get in on the class action suit. Even if you have not suffered any side effects from the drug, you will still want to get future medical monitoring for potential side effects. Contact a lawyer for more information about the Prempro class action lawsuit.

Trasylol is the brand name used by Bayer to sell the drug Aprotinin. Also known as bovine pancreatic trypsin inhibitor or BPTI, Trasylol is a protein that is used in medication to reduce bleeding during a complicated surgery. It works by slowing down the process fibrinolysis, which leads to the breakdown of blood clots. Trasylol is used to keep down the number of blood transfusions need while also decrease end-organ damage due to low blood pressure that can result due to major blood loss. Initial studies showed that in the case of cardiac surgery that might cause a great loss of blood, Trasylol significantly reduced the bleeding.

However, during the fourteen years it was on the market, there was controversy surrounding the use of Trasylol. In September 2006, the Food and Drug Administration (FDA) found the Bayer did not reveal during testimony that one of their studies showed the use of Trasylol carried great risks. The study showed that the use of Trasylol could increase the risk of death due to heart attack, strokes, kidney or renal failure and encephalopathy. The FDA was tipped off to these findings by one of the study researchers. On October 3, 2006, the FDA issued a statement of concern and asked physicians consider limiting use of Trasylol, especially in cases where the associated risks would outweigh any benefits.

On October 25, 2006, the FDA said that the use of Trasylol may increase the risk of death and on October 29, 2006, the FDA issued a warning that Trasylol may have serious kidney or cardiovascular toxicity. Bayer reported to the FDA that additional studies showed that using Trasylol might increase the chances of death, serious kidney damage, congestive heart failure, and strokes. On November 5, 2007, Bayer decided to withdraw Trasylol from the market after a Canadian study showed that the use increased the risk of death during heart surgery. Studies published in early 2008 showed that the increased risk of death could be between 32% and 64% higher.

On February 17, 2008, “60 Minutes” aired an episode that showed that as far back as the early 1980s, there were concerns about the use of Trasylol. Dr. Nicholas Kouchoukos, a top heart surgeon, conducted his own study of 20 patients given Trasylol and found that of those, 13 patients experienced problems with their kidney function after being give the medication. It is believed that as many as 22,000 deaths may have occurred due to the use of Trasylol.

Approximately 4.5 million people worldwide were given Trasylol during the fourteen years the drug was on the market, with a third of those patients residing in the United States. The widow of open-heart surgery patient Joseph Randone filed suit against Bayer after her husband died from the effects of Trasylol only eight months after his surgery. It was after this first lawsuit that Bayer finally decided to pull Trasylol off the market. Since then, there have been many more lawsuits filed by people who have lost loved ones due to the use of Trasylol and also by people who survived being given Trasylol, but have suffered kidney or renal failure or had a heart attack or stroke.

If you have undergone heart surgery and were given Trasylol then later developed kidney or renal failure and now require dialysis treatment or suffered from a heart attack or stroke, you should contact a lawyer to see if you have a suit against Bayer. If a loved one passed away after being given Trasylol before heart surgery, you may want to talk to a lawyer about the specifics to see if you have a case against Bayer.