Drug Injury Attorney Blog

Antipsychotic medications are supposed to help patients control hallucinations, delusions and various other behavioral problems associated with serious conditions like schizophrenia and bipolar disorder. However, these drugs are also given to thousands of residents in nursing homes across the country who suffer from dementia.

The reason why so many dementia patients take antipsychotics and antidepressants like Paxil is because the drugs help to pacify the paranoid and sometimes aggressive behavior that is often displayed by people with dementia. Dementia patients are generally considered to be a danger to themselves and others. While the drug treatment may seem like a benefit, many of those drugs also hinder the senior’s ability to talk, socialize and simply participate in daily activities. These drugs also come with a series of warnings that have caused many doctors in nursing homes to reduce the use of antipsychotic medications. Doing this has proven to result in many positive changes in the patients.

This new system for reducing these drugs creates a personalized care plan that makes use of exercise, aromatherapy, pets and other methods to help dementia patients. Patients that were at one point sedated and detached are now actively “playing video games, listening to music and playing balloon volleyball.”

The choice to reduce drugs was a no-brainer considering that antipsychotics and antidepressants, which were previously a major part of dementia treatment in nursing homes, have been shown to cause severe adverse side effects. Some of the side effects caused the patients to act out more aggressively, which is a side effect of antidepressant drugs like Paxil. Using SSRI medications like Paxil is an off-label use when used to treat symptoms of dementia.

As for the antipsychotics drugs, the FDA issued warnings about those medications in 2005 that stated that the drugs “could increase the risk of death in patients with dementia due to heart attacks or pneumonia.” While the drug-curbing program has proven itself helpful, some nursing homes are still using dangerous drugs like Paxil to treat their dementia patients. If you have an elderly family member with dementia living in a nursing home, you may want to see what treatments they are receiving.

This year, the U.S. Supreme Court made a ruling that will set back the drug injury victims I represent as a defective drug attorney. In PLIVA v. Mensing, the court ruled that generic drug manufacturers can face no liability for the harm their products do, because state-law tort claims are preempted by federal drug laws. That ruling acknowledged the absurdity of the result, which frees generic drug makers from liability that the name-brand drug makers face, but its decision was final. That decision formed a large part of the rationale behind the Sixth U.S. Circuit Court of Appeals ruling in Morris et al. v. Wyeth et al.. In that case, a group of gastroesophageal reflux disease sufferers who had developed a rare neurological disorder sued the makers of the generic drugs they took, as well as the name-brand manufacturer. Both claims were ultimately dismissed.

Kentucky residents Lala Smith, Alice Wilson and Dennis Morris all developed tardive dyskinesia, a slow-onset disorder causing involuntary and repetitive body movements. Sufferers are disabled by a difficulty holding still, rather than an inability to move. Its main causes are psychiatric drugs and gastrointestinal drugs, and there is no cure, just a series of strategies for treating symptoms. The plaintiffs alleged that their disease was brought on by taking metoclopramide, the generic name for the drug Reglan, for GERD. They sued six generic makers whose drugs they had used for failure to warn. They also sued two companies that had previously made name-brand Reglan for fraud, negligent misrepresentation and fraudulent concealment, arguing that the two companies had played down Reglan’s risks in the Physician’s Desk Reference. The federal district court granted summary judgment to the name-brand defendants, saying they cannot make a misrepresentation claim against a manufacturer whose product was not actually used. It later granted summary judgment to generic defendants on federal preemption grounds.

The plaintiffs fought both decisions on appeal, but to no avail. The Sixth Circuit quickly affirmed the ruling about the generic manufacturers, noting that the facts are actually quite similar to those in PLIVA v. Mensing. The same result is compelled in this case, the appeals court said. It took longer to affirm the ruling on the name-brand manufacturers. Under the Kentucky Product Liability Act, it noted, plaintiffs may sue only those whose products actually caused their injuries. The plaintiffs argued that the regulatory structure surrounding name-brand drugs makes it foreseeable that doctors and patients will use name-brand labels as a guide to generic drugs. This has failed in two other federal appeals courts and a federal district court, the Sixth said; only one court, an intermediate appeals court in California, has accepted the argument. The Sixth sided with the majority. Not only did it decline to find a duty of care by name-brand drug makers to non-customers, but it found it unlikely that Kentucky state courts would do differently. Thus, it upheld the dismissal of the case.

Unfortunately, nothing here tells me, as a pharmaceutical liability attorney, that the decision was legally wrong. It is well-established that lower courts must apply Supreme Court precedent, and both common law and common sense underlie the idea that a defendant must be responsible for the plaintiff’s injuries. The problem, as I noted in July, is with the Supreme Court’s bad precedent. Under that split ruling, generic drug makers were essentially given immunity from any lawsuits, regardless of what they have done. Indeed, in this case, the courts never reached the issue of whether the drug makers knew their products could cause tardive dyskinesia. From a legal standpoint, it wouldn’t even matter whether the generic manufacturers took active steps to give patients the disorder, because they face zero responsibility for their actions. As a dangerous drug lawyer, I’m not at all sure this is the result Congress intended.

Continue reading " Allegations That GERD Drugs Caused Tardive Dyskinesia Dismissed Due to Supreme Court Rulings – Morris et al. v. Wyeth et al. " »

A new Canadian Study, published in the Sept. 26 Canadian Medical Association Journal, has found that heart attack patients that take anti-platelet medications like aspirin or Plavix while also taking an SSRI antidepressant drug like Paxil have an increased chance of bleeding.

The study was conducted by researchers who collected information from more than 27,000 heart attack victims who were 50 years of age or older. They found that the patients taking the anti-platelets with no other drugs had the regular expectancy of bleeding. However, researchers also found that those that took aspirin with an SSRI had a 42 percent higher chance of bleeding and those that took the SSRI (Paxil) with both aspirin and clopidogrel (dual anti-platelet therapy) had a 57 percent higher risk of bleeding.

In a journal news release of the study results, researchers said, "Ultimately, clinicians must weigh the benefits of SSRI therapy against the risk of bleeding in patients with major depression following acute myocardial infarction."

It is already established that many heart attack patients end up developing depression and are prescribed antidepressants as a treatment for it. This new research can go a long way to preventing the mix of drugs like Plavix with SSRIs like Paxil, which will in turn help prevent the bleeding that can lead to more heart attacks in the future.

Dr. Kirk Garrett, clinical director of interventional cardiovascular research at New York's Lenox Hill Hospital, says, "We're always concerned about how other medicines might interact with the medicines we know are essential to heart health and recovery after heart attack. Although SSRIs are used in only a few cardiac patients, learning that SSRIs can increase (the) risk of bleeding complications could have important implications for how we care for patients after stents and other heart procedures."

Advising patients against the use of SSRIs with anti-platelets is not a bad idea anyway, since SSRI drugs like Paxil have also been linked with various other dangerous and potentially fatal side effects when used on their own. It just goes to show that there may not be any healthy way for patients to take medications like Paxil safely, either on its own or with other drugs.

Any parents who have noticed that the FDA warnings and television commercials about Paxil birth defects have started to ebb in the past couple of years may also be interested to know that this doesn’t mean that time has run out for filing Paxil birth defects lawsuits. In fact, experts are saying just the opposite.

If you have considered filing a Paxil birth defects lawsuit, there is still time to do so. According to an article in the Los Angeles Times on December 15, 2002, it is estimated that up to 37 million Paxil prescriptions were written in 2002 alone. FDA estimates show that 19.7 million prescriptions were filed in 2007. This shows that millions of children may have been born with birth defects caused by the mother’s Paxil use.

Health experts from all over the world have conducted research that shows that SSRI medications like Paxil cause severe birth defects when they are taken during pregnancy. The most common birth defects that have been linked to Paxil and other SSRIs include heart defects, lung conditions, skull deformities, club foot, brain and spinal defects as well as abdominal defects. These conditions can alter a child’s quality of life drastically and have even caused death for some.

While many parents have considered filing a lawsuit, some may have been turned away by law firms that are no longer accepting birth defects cases. However, an article in Bloomberg (July 20, 2010) estimates that GlaxoSmithKline has paid an average of $1.2 million per Paxil lawsuit as a means of settling cases that were centered around serious birth defects. The point here is that there are still law firms that are helping families file Paxil birth defects lawsuits, and many are recovering significant amounts of money for their clients. If you have been trying to file a Paxil birth defects lawsuit, there is still time.

Yaz and Yasmin have been associated with various serious side effects and the FDA has acknowledged that hyperkalemia is one of them. Hyperkalemia is a condition that is characterized by patients experiencing a high level of potassium in the bloodstream.

While hyperkalemia is considered to be one of the more dangerous side effects of Yaz and Yasmin, it is believed that the condition on its own is unlikely to be the basis of a Yaz lawsuit. However, that doesn’t get Bayer, the makers of Yaz and Yasmin, off the hook since hyperkalemia can lead to other side effects linked to Yaz use. Hyperkalemia can cause women to suffer from strokes, deep vein thrombosis and pulmonary embolisms, which are also Yaz side effects. These side effects have been the basis of thousands of lawsuits against the drug giant.

Back in 2008, the FDA sent a warning letter to Bayer that Yaz and Yasmin “can lead to hyperkalemia … which may result in potentially serious heart and health problems.” The letter continues to show that adverse event reports that have been submitted by patients to the FDA’s Medwatch program reveal “numerous warnings about Yasmin and Yaz stroke, as well as additional Yasmin and Yaz birth control side effects such as hepatic neoplasia, gallbladder disease, and hypertension, myocardial infarction and thromboembolism.”

When it comes to patients and Yasmin/Yaz birth control side effects, there is often a chain reaction of side effects that occurs. Potassium in the blood is required to help manage the activity of the muscle; it also helps to regulate the electrical rhythms of the heart. When a person’s potassium levels get too high or too low, it can lead to abnormal heart rhythms, which can lead to blood clots. It is these blood clots that can lead to deep vein thrombosis and strokes. DVT can lead to a pulmonary thrombosis, which occurs when the blood clot is carried through the bloodstream and into the lungs. This condition is often fatal.

If you experience hyperkalemia after taking Yaz, you may have grounds for filing a Yaz lawsuit.

As a dangerous medical device attorney, I’ve written several posts in this space about the dangers posed by Triad products. The alcohol wipes, prep pads and other disposable items are intended to be sterile so they can be used to clean and prepare the body for injections, surgery or other actions that increases the risk of infection. Tragically, Triad’s products were not sterile; they turned out to be infected with a bacterium called Bacillus cereus. Before the problem was caught, the ensuing infections killed a little boy in Texas and caused life-threatening illnesses to at least two other people. Worse, investigation showed that the FDA had known about gross safety violations at Triad’s Wisconsin plant for quite a while, but failed to address them. So I was sobered and disappointed to see an MSNBC article suggesting that a second alcohol prep wipes company has recalled potentially infected products.

Professional Disposables International, or PDI, shares a supplier with Triad, the now-defunct Wisconsin company. PDI has recalled all lots of five of its alcohol prep pad products because of positive test results for Bacillus cereus — the same organism in the Triad pads. Both companies bought their pads from Tudor Converted Products Inc. In fact, a Triad company has claimed in litigation that the pads from Tudor were the source of the Bacillus infection, though both Tudor and a spokesperson for PDI deny this. The article did not note whether the FDA has found any problems at PDI’s New York plant. Much of the media attention on Triad focused on gross violations at its plant, including the use of products known not to be sterile, insufficient radiation for sterilization, failure to adequately clean equipment and more. To make matters worse, the FDA let these violations slide, resuming inspections only after a Colorado hospital traced infections back to Triad and notified the agency.

Perhaps the most frightening part of this story is that alcohol prep pads are used to sterilize people’s skin where wounds are or soon will be. By introducing a bacterium into that area, the un-sterile pads do the exact opposite of what they are supposed to do, putting patients at risk of developing a life-threatening infection. That’s exactly what happened to Peyton Armstrong, who was 10 years old and being treated for leukemia when he developed a life-threatening Bacillus infection. It’s also what happened to two-year-old Harrison Kothari, who died of his infection after undergoing what was supposed to be minor surgery. More than 100 others have contacted the Kothari family’s attorney — and in fact, the true number of affected people may be much higher, because the problem extends across many Triad products distributed under multiple brand names across the U.S. As a defective drug lawyer, I hope the FDA is working hard to avoid repeating this terrible experience.

At Carey, Danis & Lowe, we focus our practice on the complex, serious and avoidable injuries caused by defective drugs and medical devices. Patients use the drugs and devices their doctors give them with the belief that their health will improve. When the product is dangerous by design, or contains a major manufacturing flaw like an infection, the product can actually be responsible for making things worse. A lawsuit cannot reverse the injury or illness, unfortunately — but it can help victims deal with the results of their injuries. Our pharmaceutical liability attorneys help victims pass the financial responsibility for the injuries back to the people whose carelessness or greed caused them. Victims can claim all of their financial losses, including lost wages and medical costs, as well as compensation for permanent disability, a loss in the family or more.

Continue reading " Second Maker of Supposedly Sterile Wipes Recalls Products for Possible Contamination " »

The Centers for Disease Control and Prevention recently weighed in on the controversial oral contraceptive Yaz and is warning new mothers not to take it or its sister pill, Yasmin.

The CDC is saying that women should not take estrogen-based birth control pills like Yaz or Yasmin within the first 3-6 weeks after giving birth because their own research has shown that the mothers who take estrogen-filled birth control pills in the first six weeks of giving birth are far more likely to develop potentially deadly blood clots. This risk is even higher if the mother is older than 34 or had a C-section.

Dr. Naomi Tepper, a researcher in the CDC’s Division of Reproductive Health, says “the evidence we looked at showed that the risk was really much higher than we previously thought.” This conclusion reflects some serious backtracking, since older CDC guidelines, which were released only a year ago, were quite reassuring when talking to new mothers about the risks associated with Yaz and Yasmin. In fact, the CDC assured them that they weren’t at a higher risk than anyone else of suffering from Yaz adverse side effects after giving birth.

The fact that the CDC did a complete 180 on the subject has many people wondering if they will file a Yaz lawsuit after developing blood clots. For its part, the CDC report does state that all women are at risk of developing blood clots because of Yaz if they take it immediately after giving birth, but that information is again too late since most of the women being warned have already suffered from the effects.

The CDC may finally be admitting the potential threat of estrogen-filled oral contraceptives like Yaz and Yasmin, but this information is hardly new. Thousands of Yaz lawsuits have been filed already due to the thousands of blood clots that have harmed many women and were fatal for others. This new admission of it by the CDC is years too late for some women, but at least the agency finally caught up.

Paxil has been known to cause some potentially deadly side effects, but there is another side effect that has been getting some attention lately — anal atresia. Until recently, most people associated Paxil and other SSRIs with side effects like aggressive behavior, suicidal thoughts and behavior and other birth defects. However, reports show that anal atresia is yet another potential birth defect that can occur when pregnant women take Paxil.

Anal atresia (also called imperforate anus) is a terribly difficult birth defect because it causes problems with the baby’s rectum and generally requires immediate surgery. In some cases, the condition is so bad that it has to be treated with a perineal anoplasty or a colostomy which will help to divert the stool’s path so that the baby can pass a bowel correctly. The condition causes lesions to form in and around the rectum. This condition makes it hard for the baby to have a hard time controlling their bowel movements and can constipate them. If the lesion in the rectum is low, bowel movement can be corrected; however there is still a chance of the baby becoming constipated.

Anal atresia can be hard on baby’s small body, and it can be devastating on the peace of mind of the parents. The cost of surgeries can also be quite burdensome — and the fact that it can be prevented by avoiding Paxil just makes it worse. This condition is only one of the birth defects that have been linked to Paxil. Others include heart defects (Tetralogy of Fallot, Hypoplastic Left Heart Syndrome and Interrupted Aortic Arch), Gastroschisis and brain defects (Hydrocephalus).

Lawsuits have been filed against the makers of SSRIs like Paxil because of the companies' failure to properly alert doctors and the public of the potentially life-threatening birth defects that can occur when a pregnant woman takes the drug. With the right attorney, many of them will be won.

As a pharmaceutical liability attorney, I know vaccines are somewhat out of fashion these days. Rates of vaccination of schoolchildren have gone down, causing certain diseases to make a reappearance and triggering debates about whether vaccinations should be optional. Into that fray went Lombardi v. Secretary of Health and Human Services, a claim before the United States Court of Appeals for the Federal Circuit for damages from a documented vaccine reaction. Cheryl Lombardi developed chest pain after the third of three shots that constitute the hepatitis B vaccine, but only a year later was she diagnosed with post-vaccine syndrome. In this case, the Federal Circuit upheld a decision by the U.S. Court of Federal Claims that Lombardi failed to prove the vaccine was responsible for her illness.

Lombardi, born in 1946, received the first two shots of the hepatitis B vaccine without incident in 1997. Eleven days after the third shot, however, she went to the emergency room complaining of chest pain, with no symptoms found. The hospital visit and non-diagnosis was repeated less than a week later. In January of 1998, she saw several doctors who considered but ruled out lupus as a cause for her right-side pain, nausea, fatigue and elevated levels of an autoimmune disease marker. Other problems were found, but none that led to a diagnosis until July of 1998, when Lombardi saw a doctor who diagnosed her with chronic fatigue syndrome caused by the hepatitis B vaccine. Various other aspects of Lombardi’s medical and personal history were discussed, including later diagnoses of small kidney stones and pressure on her spine. In 1999, Lombardi filed a claim for damages under the Vaccine Act, eventually claiming she suffered from transverse myelitis, chronic fatigue syndrome and systematic lupus. None of these are in the Vaccine Injury Table, which required Lombardi to prove her claim. At hearings, the government’s experts offered alternative diagnoses, and a special master ruled against her. The Claims Court upheld this decision.

Lombardi had no better results on appeal. She argued to the Federal Circuit that the lower court improperly focused on whether she had the claimed illnesses at all, rather than whether they were caused by the vaccine, and that she had shown causation. However, the Federal Circuit said, under recent caselaw, identifying the injury is a necessary first step toward proving causation. The experts at the original hearings, both for Lombardi and for the government, offered at least eight different diagnoses; the appeals court said this disagreement created a genuine question of what illness Lombardi may have. As for each individual claim, the Federal Circuit rejected the transverse myelitis diagnosis because Lombardi’s treating physicians had never diagnosed it, and her expert diagnosed it using an MRI whose results did not suggest it. The chronic fatigue syndrome may have been diagnosed by Lombardi’s previous treating physicians, the court said — but this is a diagnosis of exclusion, and the government’s experts offered plausible alternative theories of osteoarthritis and vitamin B12 deficiency. The court next rejected the lupus diagnosis, saying no doctor had diagnosed her with it before; indeed, two had ruled it out. Finally, it rejected as irrelevant Lombardi’s contention that the special master in her case is biased against petitioners. The court noted that Lombardi obviously has symptoms, but failed to connect them to the hepatitis B vaccine well enough.

As a dangerous drug lawyer, I’m interested in this case because vaccines have fallen so far out of favor recently. The Vaccine Act was enacted in 1986 to address concerns about vaccines hurting children and litigation over those concerns potentially hurting the supply of vaccines. It’s a no-fault system, similar to workers’ compensation, where petitioners don’t need to prove that the pharmaceutical company did something negligent — merely that they were hurt by the vaccine. However, as this case shows, petitioners still must connect the dots to the satisfaction of the special master. This is not the usual route for people who were injured by a prescription drug; in most cases, victims may file a lawsuit against the manufacturer. This is true only in limited circumstances for vaccines. Nonetheless, as a defective drug attorney, I offer free consultations to families suffering from adverse reactions to vaccines or any other medical product they thought would help them.

Continue reading " Federal Circuit Denies Damages to Woman Claiming Injuries From Vaccine – Lombardi v. Secretary of HHS " »

In a recent ruling handed down by the Supreme Court of British Columbia, the makers of Paxil, GlaxoSmithKline, will not be getting the medical records of the mother who is suing the drug maker after she claims that taking Paxil during pregnancy caused her daughter to be born with a heart defect.

Faith Gibson of Surrey filed her lawsuit against Glaxo in British Columbia three years ago. In it, she claims that Glaxo didn’t properly warn her of the birth defects risks involved when taking Paxil during pregnancy. Because of this her daughter, born six years ago, was born with a hole in her heart that needed surgery and a seven-month stay in the hospital. It wasn’t until three months after the girl was born that the FDA issued a warning on Paxil labels that included the increased risk of cardiovascular defects in newborns.

Gibson is also saying that Glaxo should have known that the drug could cause birth defects as early as June 2003. There are also claims that Glaxo didn’t make the birth defects concerns available for the public and because of that Gibson says that neither she, nor her doctor, knew the birth defects risks when she was prescribed Paxil during her pregnancy. She believes that Paxil should have been recalled once this information was known.

The goal of the lawsuit is to find out how much data Glaxo had on Paxil’s effects before Gibson’s daughter was born. She is hoping to have her lawsuit accepted as a class action, but the court hasn’t heard it yet. The class-action certification application is hoping that Gibson will be the representative plaintiff. The goal is to define the class as "any person in Canada, born with cardiovascular defects, to women who ingested Paxil while pregnant, and the mothers of those persons."

It was when Glaxo applied in court to have copies of Gibson and her daughter’s medical records as well as their pharmaceutical records that the judge decided not to allow it. Glaxo was hoping to get the records from as far back as two years before Gibson’s daughter was born. In its argument, Glaxo said that “their experts require these records in order to fully respond to the issues on the certification application.” It's nice to see that there is a ruling that benefits the plaintiffs before the drug companies.

Reglan cases will still move forward to trial regardless of the Supreme Court’s recent ruling in favor of generic drug makers, as plaintiff Strother Lawson’s case proves.

Lawson, who developed tardive dyskinesia after taking generic Reglan (metoclopramide), has filed a motion to have his lawsuit sent back to state court. U.S. District Judge Rodney W. Sipple has granted the motion, which will give future plaintiffs the motivation they need to proceed with their Reglan lawsuits.

Lawson originally filed a Reglan lawsuit in Missouri state court with eight other plaintiffs; however, the state severed that case and it wound up being nine individual cases. After that happened, the defendants “removed them to federal court, based on federal diversity jurisdiction.”

This move didn’t happen without a glitch, though, because one of the defendants, First Databank, is from Missouri like Lawson. Under normal circumstances, this would mean that the case would fall under the jurisdiction of the state court. However, the defendants claimed that First Databank was added to the case under fraudulent pretences just so they could avoid going to federal court.

Lawson’s lawsuit claims that First Databank gave him the “patient education monograph” that came with his Reglan prescription. He also says that in doing that, the company was negligent and in violation of the Missouri Merchandising Practices Act because they didn’t fully inform him in the monograph about the real dangers of taking Reglan, which caused him to suffer from one of the drug’s most common side effects, tardive dyskinesia, a Parkinson’s-like condition.

In the end, First Databank couldn’t prove that they were not fraudulently joined to the case, and Lawson won the judgment to get his lawsuit remanded back to state court. That may be good news for all of the other plaintiffs involved in generic Reglan lawsuits because it proves that the Supreme Court's ruling didn't completely destroy their chances of seeking justice.

The Public Citizen has issued a plea to the Food and Drug Administration that asks the agency to let generic drug makers make changes to their drug labels to include warnings and risks for patients whenever they learn of new risks the drugs pose.

Public Citizen did this by filing a petition with FDA on August 26 that said the regulators should change the current rules that bar generic drug companies from being able to alter their labels in accordance with new risk information. The group has said that the makers of generic drugs should be forced to update health information on drugs. This is a wonderful idea, and one that generic drug companies likely don’t want any part of because that would allow patients to see just what could happen to them if they take the drugs, and that would interfere with the drug makers’ revenue stream.

There is little doubt that The Public Citizen petition was created as a response to a recent decision handed down by the Supreme Court in a generic Reglan case. The case, PLIVA v. Mensing, was a landmark case that left the plaintiff, Gladys Mensing, unable to file a lawsuit against the generic drug makers after she suffered from tardive dyskinesia as a result of taking the generic Reglan (metoclopramide).

The court made its decision after considering that current FDA regulations state that patients who suffer drug injuries after taking generic medications can’t sue on the basis of a lack of warning as long as the labels are the same as on the brand name equivalent. The reason for this is because state laws and federal laws regarding labels differ. That simply doesn’t make sense to many people, including some of the justices who ruled on the case.

The ruling has also left many people wondering what will happen to the generic cases that have already been filed. It turns out they needn’t worry, as most will likely just have to move their cases to state courts so that they can file their lawsuits against Wyeth, the makers of brand name Reglan, instead. It will take longer to get the trials underway, but it's better than nothing.

The first Levaquin trial in New Jersey has finally begun as plaintiffs Bob Beare and Paul Gaffney begin presenting their case, one that they hope will hold the makers of the controversial antibiotic Levaquin liable for their tendon injuries.

The men’s lawsuits were combined because they are both over age 60, they are from New Jersey and their claims are the same. The men are both claiming that they were not properly warned about how dangerous Levaquin was when it was prescribed to them. The main risk involved with taking the drug is tendon rupture, particularly in older patients using the medication.

With only two other Levaquin lawsuits making it inside a courtroom so far, this third effort is one worth following. In the other two cases, one of the plaintiffs, John Schedin, was awarded nearly $2 million. More cases are on the way, as 1,314 Levaquin lawsuits have been consolidated in a MDL in Minneapolis with Judge John R. Tunheim presiding.

These Levaquin lawsuits are on the heels of the FDA’s black box warning that was issued against Levaquin back in 2008. The warning stated that Levaquin increased the risks of causing older patients (60-plus years of age) to suffer from tendon ruptures. The warning also stated that the risks to older patients increased if the patient was taking steroids, or if they had undergone heart, lung or kidney transplants.

While there are thousands of Levaquin lawsuits being filed all over the country, plaintiffs and their lawyers will all be following this case to see how the plaintiffs fare and making notes on both sides’ arguments. Drug injury cases like these can get complicated, as every case is different in its own way. If you were thinking of filing a Levaquin lawsuit of your own because of a tendon injury, it is best to contact an experienced attorney that can help you understand your own case’s merits rather than waiting to see how this case turns out.

As a Missouri defective drug lawyer, I keep an eye on drug manufacturing issues that affect us here in the Midwest. So I was interested to see an Eighth U.S. Circuit Court of Appeals decision about a man who claims he was fired for blowing the whistle on a company making impure, low-quality drugs. In Bazzi v. Tyco Healthcare Group, Ali Bazzi sued Tyco for wrongful termination that contradicted Missouri public policy. Though the stated reason for his firing had to do with his conduct toward another employee, he contended that he was actually fired either for blowing the whistle or for refusing to validate drugs he felt were not up to quality standards. The Eighth Circuit ultimately upheld the district court’s summary judgment decision in favor of Tyco.

Bazzi had been employed at Tyco for 26 years, and was an organic chemist and manager of quality assurance engineering when he was fired. His job was to oversee production and manufacturing of certain drugs; validating them means checking on their quality, purity and federal compliance. For more than a year prior to the firing, Bazzi had been verbally raising concerns about violations in the manufacturing of a drug called naltrexone hydrochloride, which is used to treat alcohol and opioid dependence. However, he had not brought them up to his supervisees, a hotline or to federal regulators. In the summer of 2007, he asked supervisee Marvin Darling to prepare a report on the last few batches of adulterated naltrexone. Darling aired those concerns at a September meeting at which Bazzi apparently did not speak. Bazzi testified that unnamed Tyco employees warned him that the memo could get Tyco in trouble with the FDA; this was struck as hearsay. In late October of that year, Bazzi was caught on videotape entering a colleague’s office, taking a pay stub from her chair and ripping a notice from her wall; he lied about it when initially confronted. This was the stated reason for letting him go.

About a year later, Bazzi sued Tyco for wrongful termination against Missouri public policy, alleging that he was really fired because he raised concerns about improper validation of naltrexone. Tyco moved for summary judgment, claiming there was no genuine issue of material fact because Bazzi failed to establish whether his belief that Tyco violated FDA rules was objectively reasonable; that he had brought his concerns to a supervisor; or that he refused outright to perform an illegal act. Bazzi appealed to the Eighth Circuit — but applying Missouri law, the appeals court affirmed the summary judgment order. In order to prove a wrongful discharge in Missouri, the court said, employees must show they were fired for refusing to violate the law or clear public policy; or for reporting serious misconduct. The Eighth started by ruling Bazzi had not established whether Tyco was breaking the law or clear public policy. In order to show this, Bazzi needed to submit evidence of what Tyco allegedly did to the naltrexone and how it violated the Food and Drug Act, possibly with expert testimony. That did not happen; the Eighth said Bazzi had offered only his unsubstantiated opinions. This was enough as a threshold issue to get warrant summary judgment, the court said. Thus, it upheld the summary judgment order in Tyco’s favor.

As a southern Illinois dangerous drug attorney, I hope for the sake of the public that Bazzi is wrong about these drugs being adulterated. In my work, I have seen ample evidence that drug manufacturers prefer to cover up mistakes rather than correct them, because correcting them costs money and can lead to a public black eye that costs even more money. That’s how KV Pharmaceutical here in St. Louis ended up in serious criminal trouble and nearly closed, and how sloppy practices at Wisconsin’s Triad Group caused bacterial contamination that allegedly injured several patients and killed a toddler in Texas. If Bazzi did blow the whistle on potentially adulterated drugs, he should be commended for his willingness to do so, not fired. As a St. Louis pharmaceutical liability attorney, I know drug companies caught knowingly selling unsafe drugs tend to pay a lot in financial damages in the end, particularly if their products hurt many people.

Continue reading " Former Employee Alleges Drug Company Fired Him for Refusing to Validate Contaminated Drugs – Bazzi v. Tyco Healthcare Group " »

It may well be that generic drug makers will have to pay millions of dollars annually to have their overseas manufacturing plants inspected. In fact, one of the largest drug makers in the United States is trying to get other manufacturers to help them pay for the annual inspections.

Mylan Pharmaceuticals, the makers of the controversial antidepressant Paxil, is trying to negotiate with the FDA as well as other generic drug manufacturers to pay an astonishing $299 million every year for the inspections of their foreign facilities — this according to reports by ABC News. Mylan would understand how important it is to have foreign plants inspected ever since the company’s plant in Puerto Rico was shut down after a whistleblower talked of adulterated drugs like Paxil being made there. The whistleblower accounts also spoke of Paxil and Avandia being packaged together. The case was even profiled on the TV show 60 Minutes.

There is currently a gigantic amount of drugs that are used in the United States today that come from someplace overseas. In fact, ABC News reports that as much as 40 percent of the drugs that are taken in the United States come from other countries, and an estimated 80 percent of the active ingredients that are in the drugs come from overseas. The report also states that “only about 11 percent of the over 3,700 foreign drug plants were inspected by the FDA in 2009 ... citing the U.S. Government Accountability Office (GAO). U.S. manufacturing facilities in the U.S. must be inspected once every two years.”

The GAO says that the FDA doesn’t keep proper records on any of the overseas facilities. That is why it can’t properly track which facilities need inspections. ABC News also states that American plants only get inspected an average of once every 2.7 years.

Heather Bresch, president of Mylan, wants to increase the inspections in the foreign plants because the foreign standards are different than American standards.

“Every American has the right to know that whenever they go to have a prescription filled, it’s held to the same standard of quality, whether it’s made in the U.S. or overseas," Bresch says.

While many of the Levaquin tendon rupture cases seem to revolve around the Achilles tendon, that is not the only type of tendon that can be adversely affected by Levaquin. In fact, various lawsuits are being filed on behalf of patients who have suffered from ruptures and damage to other tendons, as well.

Levaquin tendon ruptures are extremely painful and can even cripple some sufferers to the point where just doing normal daily activities can make it worse. The problem is that most people seem to think that tendon damage caused by Levaquin is limited to the larger tendons. Below is a list of the types of tendon ruptures that are caused by Levaquin.

Achilles rupture: This is perhaps the most commonly-reported type of Levaquin rupture. Located at the back of the heel, the Achilles tendon was recently linked to a Levaquin lawsuit that had the plaintiff being awarded almost $2 million in damages.

Rotator cuff tear: The rotator cuff is located in the area where the shoulder meets the arm. The tendons here are surrounded by muscles around the ball-and-socket shoulder joint. This type of rupture is extremely painful and hard to live with because the shoulder is the body’s most flexible and often-used joint.

Elbow: Tennis elbow is another Levaquin injury that causes small tears in the tendons that keep the forearm and elbow together. Suffering from this condition makes it nearly impossible for people to stretch out their arms and limits the person’s range of motion.

Adductor tendonitis: This condition is also called a groin pull. Adductor tendonitis is not as common as the above-mentioned Levaquin side effects, but it should be watched for anyway. This condition affects the muscle and tendon group that runs across the inner pelvis all the way to the inner thigh bone.

Patellar tendonitis: This condition is also referred to as “jumper’s knee.” This affects the tendon that is located where the kneecap meets the shin bone. This type of Levaquin tendon injury requires much research before it can be linked to Levaquin, but it is believed to have happened.

Dana A. Martin is the mother of a girl who died after taking Yaz birth control pills. She has filed a lawsuit against the makers of Yaz as well as the pharmacist from whom her daughter got the pills.

Dana’s daughter, Sophia Clair Martin, died July 10, 2009, of a blood clot that went to her lungs after taking Yaz. At the time that Sophia started taking Yaz, she already had a condition known as an arteriovenous malformation of her right lower extremity, a condition which is defined by a circulatory system defect that affects the flow of her blood. That condition put Sophia at an even greater risk of hemorrhaging. This is where the story involves the second defendant in the case, Moody’s Pharmacy.

Before Dana would allow Sophia to take the Yaz, she wanted to talk to the pharmacist to be sure the drug was safe. Dana claims that after talking to defendants Seamus N. Kloos and Leslie Sauzek, pharmacists at Moody’s, she was assured that Yaz was safe for Sophia to take. Neither defendant warned Dana about the risks the drug posed to patients with blood disorders like the one that Sophia had.

It didn’t take long for Sophia to start suffering from the blood clot that would eventually take her life. Sophia was suffering from a shortness of breath and excruciating pain and suffering that lasted right up to the moment that she passed out. Dana’s claim alleges that the pharmacists were negligent when they didn’t tell her about the risks of bleeding and that Yaz posed a higher chance of Sophia suffering from major side effects that outweighed other oral contraceptives that don’t contain drospirenone.

Bayer didn't get off the hook either, as the company also is named in the lawsuit as defendants for not properly warning the public of the adverse side effects of its drug. Bayer also is accused of not conducting proper studies before releasing the drugs on the market.