Victims and family members who suffered a loss due to the defective dialysis component, GranuFlo, may have their cases transferred to the District of Massachusetts. A panel of federal judges decided today that all of the GranuFlo cases that have been filed in any federal court will be managed by the Honorable Douglas P. Woodlock for pre-trial purposes. Massachusetts is the headquarters for Fresenius the manufacturer of GranuFlo as well as the location in which dozens of GranuFlo victims have already filed suit. Generally, cases filed in state court will not be subject to the transfer order.
The manufacturer of a component of the hemodialysis treatment known as GranuFlo, investigated over 900 reports of cardiac arrest during or immediately following treatment. According to an internal study by the manufacturer, Fresenius, at least 914 patients suffered sudden cardiac arrest in Fresenius clinics in 2010 alone. Alkalosis, too much sodium bicarbonate in the blood is one explanation for the high rate of dialysis patients have suffered cardiac arrest in recent years. That electrolyte imbalance makes patients six to eight times more likely to suffer cardiac arrest.
More than 100 federal lawsuits have been filed across the country as a result of consumers being killed or injured by the side-effects of the anti-coagulant Pradaxa, manufactured by the German company Boehringer Ingelheim.
Those suits have now been consolidated in a "Multi-District Litigation" proceeding, and they have all been sent to a judge in East Saint Louis, Illinois, for handling. That judge, the Honorable David Herndon, is the same judge who is overseeing the thousands of cases filed by those injured by Yaz and Yasmin birth control pills.
The judge has appointed Pradaxa lawyer A.J. De Bartolomeo of Girard Gibbs in San Francisco to the plaintiffs' steering committee. She will be responsible for helping direct the efforts of all the lawyers working on the case for the various Pradaxa plaintiffs. She currently serves on the Yaz Plaintiffs' Steering Committee as well.
Atrial fibrillation is a type of irregular heartbeat that can cause blood clots, heart attacks and strokes. For years, doctors have prescribed blood-thinners like Coumadin, also known as warfarin, to those who suffer from atrial fibrillation. The blood thinners prevent the clots from forming, and so prevent the heart attacks and strokes.
A few years ago a new drug came on the market, Pradaxa. Manufactured and marketed by Boehringer Ingelheim, a German company, Pradaxa has been a huge money maker, accounting for $1 billion in sales in 2011 alone.
Like Coumadin or warfarin, Pradaxa works to prevent strokes and heart attacks, though at least one study found that Pradaxa isn't as good as Coumadin. Only problem is that if someone taking the drug starts to bleed, the bleeding can’t be stopped. Unlike warfarin or Coumadin, there is no antidote (called “reversing agent”) to stop the drug’s blood-thinning effects. A patient who cuts himself or, perhaps falls and begins to bleed internally, may get himself to the hospital, but there often is nothing the doctors can do except make the patient comfortable as he bleeds to death in the ER.
Pradaxa supporters agree that an antidote would be “desirable.” But as one researcher noted, “when prescribing a drug with side effects that include life–threatening hemorrhage, reversal is not ‘desirable,’ it is essential.”
- Generic name: dabigatran
- Manufacturer: Boehringer Ingelheim
- Sales: Approximately $1 Billion per year
- Side Effect: Fatal Hemorrhage
More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human volunteers. Instead, Takeda minimized the risks, pushed through production and sought FDA approval. Takeda claimed “the evidence did not point to a risk in humans.”
Despite the results of the rat study and though Takeda never tested on human volunteers, the FDA approved Actos for sale in the U.S.
As a condition of its approval, the FDA required Takeda to conduct a 10-year observational safety study. In effect, the FDA gave its endorsement to use the entire global population of Actos users as “human lab rats”. When interim data was available in 2010 , it revealed that patients taking Actos for the longest period had an increased risk of developing bladder cancer -- a result consistent with the rat study.
Again, Takeda decided not to warn users. But this time, the FDA disagreed and advised the public that taking Actos for more than a year may indeed carry an increased risk of bladder cancer. The European regulators went even further, banning Actos altogether from the European market.
Takeda’s failure to properly investigate Actos' side effects and the FDA’s lackadaisical approach raises questions: What purpose do investigative studies serve? Why conduct animal studies if the correlation to humans is ultimately ignored? Can a drug manufacture use patients as “lab rats” and get away with it? If Actos had been properly tested before it hit the global market, how many victims might have been spared bladder cancer?
Actos victims are hopeful that their attorneys will find answers through the newly created multi-district litigation, In Re: Actos (Pioglitazone) Products Liability Litigation.
Takeda International is a global pharmaceutical company headquartered in Japan. It’s top selling product, Actos, improves the body's insulin use; while it also reduces blood sugar levels. In 1998 Takeda entered into a marketing partnership with Eli Lilly and Co. to push Actos in the United States and obtain FDA approval. Remarkably, one year later Actos was approved for release in the U.S. market and Takeda set up shop in Deerfield, Illinois, its U.S. corporate headquarters. Actos has been a huge success for Takeda, as Both Takeda and Eli Lilly marketed the drug in Japan, the United States, France and Germany. In 2010, Takeda’s global sales revenue from Actos was an estimated $4.8 billion with an estimated 2.3 million prescriptions filled in the United States. Recently Takeda has been on the defensive. In 2011 researchers determined that users of Actos are at an increased risk of bladder cancer. And , the top-selling drug is now the center of hundreds of lawsuits with Takeda as their target.
Four out of five ads in medical journals targeting doctors fail to follow FDA guidelines. Over half fail to quantify the risks. Dr. Deborah Korenstein, lead author of a recent study and Associate Professor of Medicine at Mount Sinai School of Medicine states:
Marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of five dollars for every dollar spent. . . the current system is not in the best interest of the health of the public.
Drug companies know that the FDA does not have the resources to enforce its advertising "guidelines." In fact, the FDA has asked doctors for help, launching a "Bad Ads" campaign that urges doctors to take it upon themselves to report the drug companies' bad ads to the FDA. As if, doctors have more time and resources than the FDA? And absent independent research, how will the doctors know the ad is bad?
Without enforcement, the drug companies will continue to violate the rules; doctors will not have the relevant information needed for safe prescribing practices and the public will be suffer avoidable harms. Doctors, as well as the public, need to be reminded not to be swayed by flashy ads and to conduct independent investigation about a drugs safety and efficacy.
Beyaz is Bayer Healthcare Phamaceuticals’ newest birth control pill. In its latest marketing ploy, Bayer enriched its Yaz product. The new pill includes levomefolate calcium, which is designed to increase folate levels in women to help prevent neural tube birth defects. Neural tube birth defects include spina bifida and encephalopathy.
Prevention of birth defects is a good thing. But like Yaz, Beyaz contains ethinyl estradiol and drospirenone. With this troubling combination, Beyaz also carries the same increased risk of blood clots, pulmonary emboli, deep vein thrombosis, gallbladder disease and other potentially life-threatening side effects.
Do women need “fortified Yaz“? No. Folate, also known as folic acid, is naturally found in green vegetables such as spinach, asparagus and broccoli. Since the early nineties, the FDA has required adding folic acid to grains and cereals. A U.S. woman can meet her daily requirement of folic acid by eating a bowl of breakfast cereal.
In April, U.S. scientists reported that short term use of the popular diabetes drug, Actos (pioglitazone), posed no risk of bladder cancer, while use for more than two years was only weakly associated with an increased risk.
But last month a French study found diabetics who used Actos for longer than 12 months were exposed to a 40 percent increase in risk for bladder cancer compared to diabetics who had never used Actos.
In a footnote to their study the U.S. scientists admit:
- The study was funded by a grant from Takeda the manufacturer of the Actos.
- Takeda reviewed and commented on the study before it was submitted for publication.
- The scientists are paid consultants of Takeda, as well as, other drug manufacturers GlaxoSmithKline and the Actos distributor Eli Lily.
When the U.S. study was published the U.S. Food and Drug Administration did not take any action against Actos or its manufacturer Takeda.
But, when the French study was published, France and Germany pulled Actos from the market. In response to the French study, the FDA issued a warning to consumers that Actos may increase the risk of bladder cancer when used for more than a year.
Did the funding from the drug manufacturers influence the results of the U.S. study? It sure looks that way. How did the French study uncover such a strong association of risk of bladder cancer, when the U.S. researchers missed it?
Actos has become one of the most popular treatments for type 2 diabetes mellitus. Now the FDA is warning of a link between Actos and bladder cancer. A recent study showed that the risk increases by 40% after 12 months on the drug. That risk is significant enough that the use of the drug has been suspended in France and no new patients are to be started on the drug in Germany. The FDA is suggesting that doctors limit the use of Actos while it continues to study the matter.
According to class action law firm Girard Gibbs, who is investigating the drug, early symptoms include blood in the urine, an urgent need to urinate or pain while urinating, and low back or lower abdomen pain.
The irony is why Actos is so popular:
Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.
More at the Actos lawyers' website.
The Food and Drug Administration approved Yaz and Yasmin based on research that Bayer provided saying that the drugs were safe. We've been saying all along that the research was suspect and that, in fact, the drug is more risky than other birth control pills with no added benefits. The danger, we said, was the drugs' unique ingredient, drospirenone.
In April, two independent studies were published concluding that Yaz and Yasmin are, in fact, two to three times more likely to cause potentially lethal blood clots than competing birth control pills. The studies can be found here and here.
Now the FDA has taken notice. Yesterday, it released a "safety announcement" concerning the drugs. As part of it's "ongoing safety review of birth control pills that contain drospirenone" (Yaz and Yasmin were the first and hold the largest market share), the FDA says it will take another look at the risks the drugs carry. It will look most closely at the risk of death resulting from blood clots:
A blood clot that forms in a deep vein in the body is called a deep vein thrombosis (DVT). A DVT is a rare side effect of taking birth control pills. A blood clot can break loose from the vein, move through the body to the lung, and cause a serious problem in the lung, called a pulmonary embolism (PE). This can lead to death.
The FDA says that it will do two things to see whether Yaz and Yasmin do, in fact, have a higher risk of blood clots and death. First, it will be looking closely at the new studies. Second, it has commissioned its own "large study exploring the association of blood clots with hormonal contraception." It says that the results of that study are "currently being finalized and reviewed."
Depending on what it determines, the FDA could (1) do nothing, (2) work to take the drugs off the market, or (3) order a stronger warning so that women who use the drugs know the risks.
Meanwhile, the 6000 lawsuits brought by women injured after using the drugs march toward trial. The first cases will be tried next year.
Darvon and Darvocet are names for a drug that has been prescribed for many years to manage pain. In 2009, its generic version alone -- Propoxyphene -- was prescribed more than 17 million times.
In November, the FDA determined that the drug can cause serious cardiac problems, including arrhythmias and heart attacks, and recommended that the drug be recalled.
The drug manufacturer didn’t warn consumers about the drug’s risk to the heart. As a result, many people who have suffered heart troubles while on Darvon never linked their problems to the drug.
Fortunately, if a patient stopped taking the drug before he developed cardiac issues, he doesn’t need to worry. But those who have experienced symptoms while taking Darvon, or lost a family member – however long ago -- may want to get more information.
Propoxyphene-containing drugs were sold by various names, including:
- Propacet 100
- SK-65 APAP
More information at Girard Gibbs’ Darvon/Darvocet Lawyers website.
Today a consumer rights group reports on the risks of blood clots, strokes, and heart attacks that Yaz and Yasmin pose to women using these birth control pills. The California-based group, called The Civil Justice Research Project, also reports on the the federal lawsuits that have been filed against Bayer by the hundreds of women who have suffered serious injury after taking Yaz. The story mentions our co-counsel on the Yaz cases, A.J. De Bartolemeo of Girard Gibbs, and quotes Mike Danko:
Bayer just isn't telling women what they need to know. No woman would take Yaz if she knew that it was no more effective than other birth control pills but was more risky.
The article talks about the "corrective" ad campaign the FDA required Bayer to run, noting that -- at least according to some -- Bayer's corrective commercials were "too confusing and jargon-filled to be effective." The article links to one of the commercials.
We're excited to report that The Danko Law Firm has teamed up with the Yaz lawyers at Girard Gibbs LLP in San Francisco to jointly represent the victims of Yaz and Yasmin in lawsuits against Bayer. Girard Gibbs is a nationally known class action firm with a long history of representing those harmed due to the wrongdoing of large corporations.
Together we've launched a new blog to help spread the word about the dangers of these drugs and to provide information about the pending lawsuit.
Follow our Yaz blogging at the new site, Yaz On Trial.
The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expert, Professor James T. O'Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits. Mike talked about the lawsuits while Professor O'Reilly provided his insights on what the FDA does and, more importantly, does not do when approving a drug for the market.
Bayer was invited to come on the show but didn't accept.
It is an interesting discussion that can be heard on line.
I'm hoping to get the word out to other women about how dangerous that drug is. . It devastated my whole life.
As usual, Bayer delined comment about its drug, except to offer the usual lawyer-speak:
Bayer's oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used according to product labeling.
The trendy Yaz and Yasmin birth control pills are unlike any others because they contain a new synthetic hormone, drospirenone. Bayer has aggressively marketed the drugs, especially to young women, as a cure for everything from acne to pre-menstrual syndrome. Unfortunately, Bayer did not adequately test the drug before bringing it to market, and it now ignores two studies on Dutch and Danish women suggesting that the drugs are more dangerous than other birth control pills that don't contain the synthetic hormone.
Women who take Yaz or Yasmin have suffered a list of harmful side effects. One of the most common is blood clots. Blood clots may lead to debilitating strokes, pulmonary emboli and heart attacks. Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.
The Food and Drug Administration has now decided that Bayer's television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. In addition, the consumer protection group Public Citizen warns all women against using either Yaz or Yasmin, and instead suggests sticking to a pill that does not contain drospirenone.
Yaz and Yasmin are no more effective than traditional birth control drugs, but they appear to be more dangerous. Nonetheless, because of Bayer's aggressive and misleading advertising, they are now Bayer's most popular drugs. In fact, the drugs are the most popular birth control pills in the world. Last year alone, Bayer sold $1.8 billion worth of Yaz and Yasmin .
Not surprisingly, with that type of money on the line, Bayer continues to promote the drugs, regardless of their risks.
I admire clients who find the strength to tell their stories on television. It takes guts. When Susan Galinis said she wanted to do just that, I warned her that it would be difficult and, well, embarassing. She said she didn't care. If she could persuade just one woman to switch from Yaz to a traditional birth control pill, it would be worth it.
On Monday, Susan appeared on local Fox, ABC, and NBC stations. She showed to the cameras pictures that, until now, she hadn't shown to anyone outside her family.
After Susan's story aired, I received dozens of calls from Yaz survivors who asked me to thank Susan for getting the word out, or to offer her their help and support. Some called to ask for more information or just to talk about their own experiences. One talked about a friend she lost to Yaz. I appreciate hearing from anyone whose life has been impacted by this drug.
We're working on all of our Yaz and Yasmin cases with a Yaz law firm in San Francisco. We chuckled over the fact that Bayer had no problem speaking to reporters before the first news segment aired. But once Bayer actually saw Susan and heard what she had to say, the company apparently could think of no response and refused to speak with the reporters who produced the later segments.
Susan, you "done good."
Beginning in July 2003, the Food and Drug Adminstration warned Bayer (or more accurately, Bayer's predecessor, Berlex Laboratories ) that its television commercials for Yasmin were misleading and should be corrected. The FDA warned Bayer again in 2008, and again in 2009. Among Bayer's more serious violations, according to the FDA, was that the commercials minimized the risks associated with Yaz while at the same time overstating its benefits -- especially for conditions such as premenstrual syndrome for which the drug was never approved. According to the FDA:
These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.
Yaz and Yasmin cause blood clots that often begin in the deep veins of the legs. A clot, called a Deep Vein Thrombosis (DVT), can break off and move to the brain, where it causes a stroke. If the clot moves to the lung, it causes a pulmonary embolism. If it moves to the heart, it can cause a heart attack.
Within weeks of taking Yaz or Yasmin, women have been stricken by life-changing strokes . For some women, the stroke or heart attack occur without warning. For others, there are warning symptoms. These warning symptoms include:
- Pain in the calf or the back of the leg (Possible DVT)
- Sudden headaches (Possible stroke)
- Unusual swelling in the lower legs (Possible DVT)
- Chest pains or heaviness (Possible heart attack)
- Drooping of the eye or mouth (Possible stroke)
- Weakness in arm or leg or speech problems (Possible stroke)
- Eye problems and loss of vision (Possible eye clot)
Studies show that the risk of clots is higher with Yaz and Yasmin than other birth control drugs that don't contain drospirenone. Drospirenone is believed to cause strokes in a number of different ways. For example, besides causing clots in the legs, it is believed that the drug changes the rhythms of the heart, slowing blood flow to the point that it clots there as well.
Gallbladder disease includes inflammation and infection (cholecystitis), stones (chollithiasis) or other obstructions or narrowing of the ducts. It appears that Yaz increases the cholesterol level in a woman's bile while, at the same time, decreasing gallbladder movement. That leads to gallstones which can block and damage ducts, requiring that the gallbladder be removed.
Some women function well without a gallbladder. But in about 40% percent of the cases, the women will suffer pain or discomfort for months or even years after the surgery. In one out of five cases, the common bile duct will be damaged during the surgery, leading to fever, jaundice, and chronic pain in the shoulders and abdomen. Further surgery may be needed to correct the complications. Even when a second surgery is not required, many patients who have had their gallbladder removed find that they must permanently change their diets after the surgery because without a gall bladder they are unable to digest the foods they used to eat.
The symptoms of gallbladder disease include pain under the lower breastbone, eventually progressing to under the right breast and then onto the back or between the shoulder blades. Other symptoms include fever, heartburn, nausea and vomiting. The symptoms are typically recurrent.
Yaz and Yasmin cause blood clots. When a blood clot finds its way to the lungs, the result is a pulmonary embolism. The blood clot cuts off the flow of oxygen and blood to a portion of the lung. A pulmonary embolism can be fatal. In fact, about 15% of all sudden death is attributable to pulmonary embolisms. In some cases the pulmonary embolism can travel to the brain and cause a stroke. In less severe cases it can lead to lung damage. The symptoms of a pulmonary embolism include:
- Sudden shortness of breath, especially after even slight exertion;
- Rapid breathing;
- Coughing up blood;
- Chest pain that mimics a heart attack. The pain gets worse with exercise but remains even after resting; and
- Rapid heartbeat.
A more complete list of symptoms can be found here.