Drug Injury Attorney Blog

A recent lawsuit that focused on Levaquin tendon ruptures is going to continue on as the third bellwether case in the federal MDL in the District of Minnesota. When the defendant in the case, Johnson & Johnson, tried to get a summary judgement on the grounds that a jury is supposed to decide whether Levaquin labels gave enough warning of the tendon rupture risks, Judge John R. Tunheim denied it. The judge also decided that “a jury must hear fraud claims, citing public benefit.”

For this particular lawsuit, the plaintiff, Clifford Straka, says his doctor had the potential to cause the tendon ruptures when she prescribed the drug to her patient. Dr. Baniriah also claimed that she couldn’t remember if she read the warning label when she prescribed it, either. For his part, Straka took his Levaquin as prescribed; in a 10-day regimen, which he took for nine days. It took that long for him to start developing bilateral Achilles tendon ruptures, which is why he wound up filing his Levaquin lawsuit.

While Levaquin-induced tendon rupture risks have been listed on the packaging since 1997, the label had to be modified in 2001 to include the other risks involved with taking the drug. For example; elderly patients aged 65 and older, studies show, are more susceptible to Levaquin tendon risks and so are patients that are taking corticosteroids. As for Straka’s Levaquin lawsuit, Johnson & Johnson tried to get a summary judgement in Straka’s lawsuit because of what it claims are the company's efforts to warn doctors and consumers with the packaging as was required by the FDA. The company claimed that “failure-to-warn claims fail because the doctor admitted she did not read the full label prior to prescribing the drug to Straka."

However, since Straka is claiming in his lawsuit that J&J violated the Minnesota Consumer Fraud Act, the judge wants the jury to hear the case. The judge also stated that this lawsuit “may indirectly cause defendants to redress a public safety hazard, a result that would benefit the public.”

I write on this blog regularly about the dangers posed by the antibiotic Levaquin (levofloxacin), particularly for older patients and those taking certain other drugs. So, as a dangerous drug attorney, I was interested to see an article on the close of a trial in a Levaquin injury lawsuit. The trial in Minneapolis alleges that pharmaceutical company Johnson & Johnson, which makes Levaquin, had an inadequate warning on its label about the risk of tendon rupture. This led to two ruptured Achilles tendons for Clifford Straka, now 78, just nine days after starting a Levaquin prescription for a respiratory infection in 2006. In 2008, the Food and Drug Administration required J&J to add a warning about the risk of tendon ruptures to the label of the drug. No ruling was reported a day after the close of trial.

Straka was an active man when he was injured and had been an athlete when he was younger, even trying out for the Green Bay Packers. But after taking Levaquin for his respiratory infection, he suffered dual tendon ruptures that sidelined him. The Achilles tendon connects the heel to the calf; without it, walking is impossible or extremely painful. The risk of tendon rupture with Levaquin’s class of antibiotics has been known and reported on the label since the 1990s, but the label did not carry a warning highlighting the special risk to older patients until 2007 and again in 2008, when a “black box” warning was added. This was insufficient when Levaquin was prescribed for Straka and may still play down the risks, the lawsuit said. J&J argued that the label had always been sufficient.

Straka’s lawsuit is the third to go to trial in Minnesota and one of more than 3,700 Levaquin injury lawsuits across the United States. The first, decided in 2010, ended in a jury verdict of $1.8 million for the patient. As a Levaquin injury lawyer, I’m pleased to see more cases in the news, because each report helps raise awareness that the drug is not always safe. As this lawsuit outlines in detail, the research on the relationship between Levaquin and tendon ruptures stretches back to before the drug was approved in the United States. Watchdog group Public Citizen petitioned the FDA for any warning at all in the 1990s. Despite evidence of as much as three times the risk of tendon rupture in the elderly, it wasn’t until the early 2000s that the label was updated to mention such a connection — and even then, it subordinated age to corticosteroid use until 2007.

At Carey, Danis & Lowe, we represent clients across the United States who have suffered serious injuries because they took Levaquin or another prescription drug. Most patients believe drugs wouldn’t be sold, and doctors wouldn’t prescribe them, if they weren’t safe. Unfortunately, as Straka and many other patients across the country can testify, that’s frequently not true. Drug makers that want to protect the profits and profit potential of their drugs sometimes not only downplay the risks of their drugs, but take active steps to suppress negative information and research or even plant positive information through ghostwritten medical journal articles and company-sponsored studies. When these flawed drugs hurt or even kill someone, our pharmaceutical liability attorneys help victims hold the drug makers legally liable for their failure to make the risks clear.

Continue reading "Trial Ends in Levaquin Injury Lawsuit Filed by Patient Who Ruptured Both Achilles Tendons" »

There may be some good news in store for Levaquin patients who have suffered from a tendon rupture. According to a study conducted by Assad A. Qureshi, M.Sc., M.R.C.S., of the Leicester Royal Infirmary in the United Kingdom, the gap that forms after a person (like a Levaquin user) who suffers from a ruptured Achilles tendon can be reduced just by repositioning the ankle.

For the study, researchers used a dynamic ultrasound as a means of monitoring 26 patients who suffered from a unilateral acute complete Achilles tendon rupture. The injury revealed that the mean distance of the rupture that started from the calcaneal enthesis was approximately 52 mm (which puts it at a range of 40 to 76 mm). The researchers then used the ultrasound scan as a means of measuring the gap distance between the edges of the tendon while the ankle was resting in a neutral position and with the knee extended. This gap was then measured while the foot was in an extended position, with the foot extended to it max. The researchers learned that the position of the ankle and knee had a significant impact on the gap distance (and maybe the amount of pain patients felt) with the different positioning.

The ultrasound showed that the gap distance decreased by a significant amount when the ankle was moved from one position to another. Research authors wrote that, "Maximum ankle equinus alone significantly reduces the gap distance after acute Achilles tendon rupture. Increasing knee flexion further reduces the gap distance by small increments that, although significant, may not be clinically important.”

This research may be able to help some Levaquin patients who are suffering from tendon ruptures to ease their pain, if only a little bit. Tendon ruptures are a well-documented side effect of using the controversial antibiotic Levaquin. While it is more common for senior patients and those taking corticosteroids to suffer from Levaquin tendon ruptures, patients of any age group are susceptible. This new research may help to give a small amount of comfort to the patients waiting for surgical assistance.

The famous first of the Yaz bellwether trials was postponed by the presiding judge, David R. Herndon, on December 31, 2011.

According to information from a report that was posted by FiercePharma, Herndon ordered the postponement so that the lawsuits can go into mediation. While the first of the bellwether test trials was supposed to begin next week, the postponement order came down on December 31. Herndon chose Stephen Saltzburg to be the mediator. Saltzburg is a law professor at George Washington; Herndon asked him to see if he could get both sides of the litigation to agree to “settlements in this litigation.”

Currently, there are more than 10,000 lawsuits filed over the serious adverse side effects that have been linked to Yaz, Yasmin and other drospirenone-based birth control pills. A variety of side effects have been linked to Yaz, including blood clots, gallbladder disease, heart attacks, strokes and pulmonary embolisms. Yaz blood clots have been the subject of a good deal of controversy, since countless research studies have consistently shown the pills to cause women to be 75 percent more likely to develop blood clots after taking Yaz vs. any other oral contraceptive.

It was only last month that an FDA advisory panel decided that Yaz labels had to be updated to include stricter warnings against Yaz blood clots. The panel’s recommendation left a sour taste in many experts’ mouths, since many of them wanted Yaz to be recalled from the market altogether. Until the pills are recalled, consumers will continue to suffer from illnesses and death. As the plaintiffs, lawyers and defendants await the onset of the bellwether trials, it remains to be seen whether this postponement will affect the other bellwether trials that were slated for later this year.

As a defective drug attorney, I’ve written here many times about the drug Vioxx — both as a dangerous drug itself and as an example of the terrible consequences when powerful pharmaceuticals are lightly regulated. As regular observers of the pharmaceutical liability world know, Vioxx (rofecoxib) was withdrawn from the U.S. market in 2004, after scientific studies showed an increased or even doubled risk of heart attacks and strokes in users. To make matters worse, investigations showed that Merck had known about the risk for at least five years and said nothing to patients or the FDA, with some watchdogs accusing Merck of suppressing negative studies and fabricating positive ones. As a result, Merck has faced lawsuits across the world, including hundreds in Canada that the Associated Press reported Jan. 19 it would settle.

According to the article, Merck has set aside up to $36.9 million in Canadian dollars (US $36.5 million) to settle all lawsuits in Canada. The amount that will actually be paid depends on individual users’ circumstances, but attorneys for both sides expect it to be at least $21.6 million. The settlement covers Canadians who suffered a heart attack or their survivors; stroke victims will be eligible for a lesser amount of money. Canadian provinces and territories that paid for the drug will also be eligible for the money. The settlement follows Merck’s settlement of criminal and civil charges in the U.S. for a combined $950 million and an agreement to plead guilty to marketing Vioxx for off-label use with rheumatoid arthritis. A settlement of U.S. claims by 50,000 patients and their families was reached in 2007 for $4.85 billion.

Though this amount of money might seem staggeringly large to an individual, as a dangerous drug lawyer, I know it’s likely not much of a deterrent to Merck. Vioxx had sales of $2.5 billion in 2003 in the U.S. alone — experts believe up to 80 million people around the world had taken it at some point. Though it’s impossible for an outsider to calculate what kind of profit Merck made on Vioxx, it was clearly good for business for a while. And that “while” was reportedly about five years longer than it should have been. Results suggesting a link between Vioxx and cardiovascular problems began appearing even before the drug was approved by the FDA, and Merck has been criticized for failing to follow up. After approval, the pharmaceutical company allegedly withheld safety information from a medical journal that was submitted to the FDA; that agency also warned Merck for leaving cardiovascular information out of its marketing.

If you believe a dangerous or defective drug is responsible for your family’s injuries, you should call Carey, Danis & Lowe as soon as possible. Our pharmaceutical liability attorneys handle all kinds of lawsuits involving prescription and over-the-counter drugs that are tainted or unsafe to use according to the manufacturer’s directions. Patients are not medical experts; we trust our doctors to prescribe drugs that are safe and free of defects. But when manufacturers fail to warn us about serious risks, especially known risks, our trust is betrayed. Patients in this position and their families can hold the manufacturer legally liable with a defective drug lawsuit. In this kind of case, you can claim compensation for your illness or injury; personal losses; and all kinds of related costs, including lost income from not being able to work.

Continue reading "Manufacturer of Banned Painkiller Vioxx Settles Canadian Lawsuits for Up to C$37 Million" »

Information from a recent federal study is showing that 11 percent of the American population is currently taking some form of antidepressant medication such as Paxil. This information was released by the U.S. Centers for Disease Control and Prevention.

This means that two times more people are taking antidepressants than going to movies. The study also showed that 23 percent of middle-aged women (one in every 4 women) are taking drugs like Paxil and that 11 percent of people aged 12 or older have used either Prozac, Zoloft, Paxil or some other type of antidepressants. According to nationally-conducted surveys, women were prescribed the pills more often than men were and that Caucasian people relied on the drugs more than minorities did. Of those people taking the drugs, it was mostly women aged 40 to 59 that admitted to taking antidepressants. Almost 19 percent of senior women over 60 used them.

“I think it's a disturbing thing that so many people are feeling like things are bad enough that a long-term medication makes sense,” said Dr. Josephine Soliz, a family doctor in Oxnard, Calif. “I think it likely also reflects the fact that sometimes mental health services don't really serve the walking wounded. It's pretty hard to get first-rate mental health services if you're depressed but not suicidal.”

Laura Pratt, lead author of the CDC study, disagrees with Soliz; she feels that underuse of antidepressants is a larger problem than overuse.

“I think that's more undertreatment than overtreatment," Pratt says. "Two-thirds of people with severe depression aren't being treated.”

Considering that recent data have shown a 400 percent rise in antidepressant use since the 1980s, underuse doesn’t appear to be the problem — especially since antidepressant medications like Paxil and Prozac have serious adverse side effects that can be fatal for some patients. Research has shown that SSRI medications like Prozac or Paxil cause patients to behave in suicidal and homicidal ways. The drugs can also cause birth defects in babies whose mothers take the drugs while pregnant. From that perspective, many believe that antidepressants should not be prescribed at all. Studies also have shown that the medications may be no more effective at curing and treating depression than placebos.

Diane K. Eccles is an Oregon resident who has filed a lawsuit against the makers of Levaquin after she developed a tendon rupture while taking the controversial antibiotic. She filed her lawsuit on December 23, 2011 and has joined in the current Levaquin multidistrict litigation (MDL) in the U.S. District Court, District of Minnesota.

Eccles’s case is different in that she is claiming to have developed a tendon rupture in her shoulder. (Most plaintiffs claim ruptures in their feet or legs.) Eccles started taking Levaquin back in May 2008, and within a few months of taking the drug she was diagnosed with a tendon rupture in her shoulder after started experiencing pain and swelling in the area. That diagnosis came on October 24, 2008.

Levaquin has long been linked to tendon ruptures, and there are numerous studies to verify Eccles’ claim. Eccles has agreed to allow her case to be joined with the growing Levaquin MDL that is currently taking place in Minnesota, with Judge John R. Tunheim presiding. This MDL includes more than 1,600 lawsuits that are all claiming that plaintiffs suffered tendon ruptures after taking Levaquin — and this number of plaintiffs rises continually. This MDL lists drug giant Johnson & Johnson as the defendant, along with Ortho-McNeil-Janssen. Both companies have been accused of failing to properly warn the public and healthcare professionals of the tendon rupture dangers linked to Levaquin use.

There have been three Levaquin trials so far with a fourth underway. At least one plaintiff, John Schedin, has been awarded financial compensation for his tendon ruptures. Studies have shown that Levaquin increases a patient’s chances of developing tendon ruptures and that the drug should not be taken by seniors aged 65 and older who are also taking corticosteroids since the likelihood of developing a tendon rupture increases even more. The problem with this is that many plaintiffs have claimed that seniors are the very people at which the manufacturers seem to aim their marketing efforts.

Before the Supreme Court entered a ruling on the liability of generic drug makers in Mensing v. Pliva, many patients had filed Reglan lawsuits against generic drug manufacturers after they developed tardive dyskinesia from taking the acid reflux drug. After the Supreme Court’s ruling, some of those lawsuits have been dismissed. One of the most recent cases to be dismissed was filed by Joshua A. Whitener and his wife.

Whitener and his wife, Lindsey C. Whitener, originally brought a Reglan lawsuit against manufacturer Pliva Inc., the makers of the generic Reglan (metoclopramide). Among other side effects listed in the case, Joshua Whitener has suffered from tardive dyskinesia. The Whiteners accuse Pliva and other manufacturing companies of not properly warning them or healthcare professionals of the side effects linked to Reglan.

Judge Eldon Fallon of the U.S. District Court for the Eastern District of Louisiana issued a ruling in the Whitener’s case on December 6, stating that their lawsuit is “federally preempted because the generic versions of Reglan must follow exactly the warning labels of the brand-name drug.” However, the judge did leave the case in such a way as to allow for the Whiteners to make amendments to their case so that they can show that the manufacturers promoted or marketed the drug for use in off label ways. This, the judge said, would be a federal violation.

This recent dismissal is not the first case that has been forced to be dismissed after the Supreme Court’s ruling and it may not be the last. However, it should be known that not all generic Reglan lawsuits are ruled upon in this manner since not everyone shared the Supreme Court’s opinion on the liability of generic drug manufacturers. If you have filed a generic Reglan lawsuit, or are considering it, these recent dismissals should not deter you in your efforts to get compensation for your injuries because each case is different and each judge presiding over them is different as well.

In a recent Levaquin lawsuit, the plaintiff’s lawyer is claiming that the manufacturer of Levaquin, Johnson & Johnson, did not properly warn the public or healthcare professionals about the increased risk of tendon ruptures and other severe adverse side effects while marketing the controversial antibiotic.

This newer Levaquin suit has been assigned to multidistrict litigation (MDL) in Minnesota, where Yvonne Griffin will join other plaintiffs just like her who have filed lawsuits against Johnson & Johnson after developing tendon ruptures after taking the drug. Griffin’s lawsuit was filed on December 20, 2011, amid claims that she suffered from “a severe and debilitating tendon injury” after using Levaquin as a treatment for a bacterial infection. Because of her condition, Griffin claims that she will be forced to suffer through painful medical treatments for the rest of her life since the after effects of the rupture are permanent.

The FDA originally approved Levaquin as a treatment for bacterial infections in 1996. After about a year, the FDA received so many complaints about tendon ruptures from Levaquin patients that they ordered J&J to revise the Levaquin warning labels to include the tendon rupture risks. According to Griffin’s lawyer, Johnson & Johnson complied with the FDA label changes but hid the serious tendon rupture warnings inside of a lengthy list of less severe side effects so that the information would be hard to find.

Griffin’s complaint also mentions that J&J seemed to be marketing Levaquin specifically to senior patients, who are more susceptible to the tendon rupture risks. Griffin’s complaint further notes that the company's “promotional campaign was themed on Levaquin’s excellent safety profile and failed to disclose the risks of tendon injury.” Griffin’s complaint is just the newest in a long list of plaintiffs suing J&J for failing to properly warn the public about tendon rupture risks associated with Levaquin.

J&J’s efforts to market Levaquin as a safe and popular antibiotic even featured the advertisement stating that Levaquin had an “outstanding record of safety,” and claimed that diarrhea and nausea were the only two adverse side effects that had been reported at that time.

I’ve written here many times from my perspective as a dangerous drug attorney about the problems with atypical antipsychotic drugs. These newer drugs were originally hailed as an improvement over older antipsychotics, but their use has become controversial because they were widely prescribed for “off-label” uses until fairly recently. In fact, drug makers including Janssen, a subsidiary of Johnson & Johnson, have been accused of illegally promoting atypical antipsychotics for off-label uses, particularly dementia. That use has fallen out of favor after studies showed that antipsychotics actually increased dementia patients’ risk of death; Johnson & Johnson announced a $1 billion settlement of related charges this month. Now, according to Bloomberg News, the company is accused of paying kickbacks to a former Texas state official for giving its drugs prescribing preference.

In the lawsuit, the state of Texas accused Janssen of defrauding it paying a mental health official to give its drugs priority in prescribing. As head of the Texas Department of Mental Health and Mental Retardation, Steven Shon helped develop the Texas Medication Algorithm Project, a computer program that provided prescribing guidelines to state doctors. Shon testified that he accepted payments from Janssen to fly to other states to promote the project as a model, once or twice a month over several years. Shon also served on Janssen advisory boards and the board for a Janssen publication, and served as a continuing medical education speaker for the company. Though he testified that these trips happened on his own time, the state cited at least one instance where he stayed on the clock despite being in Arizona. He retired involuntarily in 2006.

Shon and Janssen deny the allegation that they conspired to promote drugs like Risperdal illegally. Texas is also alleging that Janssen’s illegal over-promotions overbilled the state’s Medicare program. That is one of at least 12 similar claims in state and federal lawsuits, according to the Associated Press. Jury verdicts and settlements against the drug manufacturer for its Risperdal marketing practices include a $327 million award in South Carolina in 2011 and a 2010 award of $258 in Louisiana. In addition to alleging that Janssen marketed Risperdal for dementia and, before FDA approval for this purpose, bipolar patients, states also claim that the pharmaceutical company promoted it for use in children despite no approval for that use. The FDA itself ordered Janssen at least three times, in 1994, 1999 and 2004, to stop making false marketing claims about Risperdal.

This is especially concerning to defective drug lawyers like me because Risperdal has serious side effects. In particular, it and other atypical antipsychotics have a known risk of weight gain, diabetes and related metabolic problems such as high blood pressure. In addition, studies over the past decade have revealed that they may also increase the risk of stroke and heart problems in dementia patients or other older people. Those studies that gave rise to the FDA’s decision to include a “black box” warning, the agency’s strongest, advising against their use in dementia patients. More rarely, but also more seriously, antipsychotics like Risperdal can cause life-altering neurological problems including neuroleptic malignant syndrome and tardive dyskinesia. As a pharmaceutical liability attorney, I support these lawsuits and look forward to anything else they may reveal about these apparently widespread illegal marketing practices.

Continue reading "Trial Begins in Texas Lawsuit Alleging Manufacturer Fraudulently Promoted Antipsychotics" »

A recent Reglan lawsuit that was filed against five defendants has been dismissed without prejudice. This will allow the plaintiff to re-file her lawsuit in the future. The case began on May 27, 2011, when Virginia Carswell filed against Wyeth and four other defendant companies that Carswell claims were responsible for the manufacturing and distribution of Reglan (metoclopramide). The woman’s complaint stated that regardless of Reglan's benefits, it also causes some patients to suffer from tardive dyskinesia, which is a movement disorder that is similar to Parkinson’s Disease.

Carswell’s original complaint stated that she was suing because she developed tardive dyskinesia after taking Reglan, an acid reflux medication, from December 2004 to February 2011. That length of time far exceeds the FDA recommended period of 12 weeks, to avoid serious adverse side effects linked to the drug. Carswell also claimed that the defendants failed to properly warn her and a healthcare professional of Reglan’s increased risk of causing tardive dyskinesia when used for more than 12 weeks.

Some of the companies that were named as defendants in Carswell’s case include the generic version's manufacturers, Atavis and Mutual. Another company included in the lawsuit was A.H. Robins Company, which Carswell accuses of poorly wording the proper warnings for its own Reglan products.

Tardive dyskinesia is a movement disorder that causes patients to suffer from debilitating side effects, which include lip smacking, eye twitching, involuntary movements of the extremities and excessive blinking. The condition is permanent and incurable. While there is no word yet on whether Carswell intends on re-filing her lawsuit, the option remains. If she does choose to re-file, she will join thousands of plaintiffs all over the country who are seeking compensation for the injuries they have suffered after taking Reglan.

A Yaz lawsuit that was filed in California on November 17 of this year is headed toward the statewide coordination of lawsuits, are of which all claiming that the controversial birth control pill causes serious adverse side effects like blood clots. The lawsuits all named Bayer, the makers of Yaz and Yasmin, as defendants.

Judge Carolyn B. Kuhl of the Superior Court of the State of California has been assigned to oversee the coordinated case management proceeding. The coordination, which had been established in September of this year, is keeping track of other similar consolidations that will be taking place in Philadelphia and New Jersey. Of these cases, all of them involve plaintiffs that want to be compensated for the injuries they suffered from after taking Yaz or Yasmin. The blood clots that these plaintiffs are complaining about can lead to conditions such as heart attacks, strokes, deep vein thrombosis and pulmonary embolisms.

One such plaintiff is Kristen Salome, who has developed deep vein thrombosis after taking Yaz. She received her diagnosis on June 13, 2007. The deep vein thrombosis is caused by a blood clot, which is one of the more serious side effects linked to Yaz, Yasmin and other drospirenone-based birth control pills. Salome is hoping to receive compensation for the damages she has suffered due to her Yaz use, including “economic, punitive and exemplary damages.”

Salome’s lawsuit is accusing Bayer of various misdeeds when marketing and selling Yaz, including “negligent misrepresentation, fraudulent concealment, and failure to warn.” Bayer has been accused of negligent misrepresentation by other plaintiffs after the company was accused of misrepresenting Yaz’s benefits during a major marketing campaign, which claimed that Yaz was a magic cure-all for everything from acne to PMS. The FDA eventually forced Bayer to change its marketing campaign to include the serious side effects associated with Yaz and Yasmin.