Drug Injury Attorney Blog

Back in January 2010, the U.S. Justice Department claimed that Johnson & Johnson, the makers of Levaquin and other drugs, paid millions of dollars in kickbacks as a means of influencing pharmacies to carry a lot of its drugs. Some of the drugs listed were the popular antibiotic Levaquin and Risperdal, which is used to treat schizophrenia and bi-polar disorder.

The complaint against Johnson & Johnson was filed in a Boston court and specifically accused the drug company of illegally paying millions to Omnicare, one of the nation's largest pharmacies. Omnicare specializes in patients in nursing homes. In return for the money, Omnicare almost tripled its yearly purchase of Johnson & Johnson products, which in turn paid the pharmaceutical company more than $280 million.

Omnicare's overlarge purchase of Johnson & Johnson drugs wound up pushing up sales of Levaquin to its all-time high, making the drug sell even better than its chief competitor, Cipro. Sales weren't affected by the negative side effects that were associated with Levaquin, either, including tendon ruptures and tendonitis.

Back in October 2010, Johnson & Johnson went to court, asking the judge to dismiss the complaint and denying that the company ever paid the money to Omnicare. Documents also showed that Johnson & Johnson’s contracts with Omnicare increased how many discounts the pharmaceutical company was receiving for the drugs so long as the drugs kept selling. In addition, Omnicare representatives were accused of going to nursing homes to push the Risperdal personally.

The prosecutor in the case, Greg Shapiro, stated that Johnson & Johnson's contract with Omnicare specifically stated, “In order to get rebates, you have to go out and push our drugs.’’ Johnson & Johnson officials maintain that the discounts are standard practice with drug pharmacies.

According to William Sarraille, one of Johnson & Johnson attorneys, the government has conceded that there isn't any proof that any of the patients were harmed by taking the Levaquin or Risperdal. It still leaves the question of whether or not Johnson & Johnson paid any kickbacks.

A man named Rob has claimed that while he's not the type to sue, the current side effects that he's suffering from taking Levaquin have changed all that. According to him, this time it's different.

Apparently, just before Thanksgiving, a nurse gave him the antibiotic Levaquin to treat a staph infection and everything went downhill from there. Rob claims that, "the very next day, my lower legs, especially my Achilles tendons, started tingling and burning, to the point where I wasn't able to sit or lie down." To this, Rob says that his doctor replied, "It's bad luck that these Levaquin side effects happened to you."

This response by his doctor infuriated Rob since he didn't have any pain and wasn't on any other medications before he started taking the Levaquin. He also didn't suffer from any injuries that would have caused his Achilles tendons to tear. While Rob does admit that the Levaquin cleared up his infection, he says it wasn't worth the pain that the drug caused in return. Once an active man, Rob is now often confined to crutches and sometimes a wheelchair just to get around.

"Now it feels like electric shocks, below the calf muscle and down the length of my tendons," Rob says, adding that he never would have taken Levaquin if he had known beforehand that there was a chance for any of these side effects, let alone the worst of all of them.

He has since gotten an attorney and he will next have to see if he meets the criteria required for him to file suit against the manufacturers. While the lawsuit can't take away his pain, Rob is hoping that in winning a class action against the company, the manufacturers will think twice before letting people take the drug without proper warning first.

While it is common for many people to want to celebrate the holidays and be surrounded by cheer and joy, it is also well known that for a lot of people this just doesn't happen. Doctors call this Seasonal Affective Disorder (SAD).

Seasonal Affective Disorder is what doctors diagnose when someone gets depressed over the holiday season or throughout the winter. For some it is because of money problems and for others it may be caused by problems within the family, job loss or even lack of adequate sunshine. There are many reasons why sufferers will feel sad during the holidays, and some doctors or patients may be tempted to try antidepressants such as Effexor or Paxil to help them cope. And while this may help to ease the symptoms of depression or anxiety during this time, some people wonder if this is a good idea.

Statistically, 10-20 percent of the American population will suffer from SAD; of those, 5 percent will experience the more severe effects of it such as suicidal behavior, according to the National Mental Health Disorders Association. It is well known that suicide rates go up during the holidays. For some people, a little bit of medication might help; however, with all of the harmful side effects that go along with taking SSRIs like Paxil and Effexor, most people are likely better off without it.

Both Paxil and Effexor have been reported to be highly addictive and coming off of those drugs can make a person feel even worse than they did before they started taking the drugs in the first place. There are plenty of examples of patients that were suffering from depression and anxiety who took Paxil or Effexor, only to have the drugs be eventually blamed for the patients' committing suicide or murder. It is for this reason that someone that is diagnosed with SAD should think twice before agreeing to take Paxil or Effexor. In this case, the cure might be worse than the disorder.

According to an online health forum at eHealthMe, in a study that took place over a couple of years and consisted of 6,454 women who had suffered from the more serious side effects of Yaz, more than 3 percent said that they experienced a higher rate of anxiety, and nearly 4 percent claimed that they suffered from depression. Of those women, 24 actually attempted suicide. The question is whether or not Yaz/Yasmin is to blame.

There are a variety of online forums in which women complain of experiencing depression, anxiety and thoughts of suicide due to taking Yaz. If you add these complaints to the ones that already exist, including pulmonary embolism, blood clots, heart attacks and strokes, the warning on the label almost seems vague. While the label on Yaz does warn of mood swings including depression, the effect of the warning seems moot because the focus of Yaz’s side effect discussions generally relate to the more physical problems that are associated with the drug.

What causes the depression is the drospirenone, which is a type of progestine that is used in Yaz/Yasmin. It is the combination of drospirenone and ethinyl estradio that protects women against pregnancy. Thousands of lawsuits have come up because of the physical side effects that patients are suffering from while taking Yaz, but most discussions about the drug focus on the blood clots, heart and strokes when they are talking about patient deaths.

Some patients or their families are coming out and filing wrongful death suits against Bayer, the maker of Yaz, because someone in their family has committed suicide while on the drug. One such patient was a girl from Ohio, Autumn Plevniak, who committed suicide while taking Yaz. Her parents are now suing Bayer for the loss and will likely claim that their daughter wasn't properly warned about taking the drug beforehand. If that case wins at trial, more lawsuits will likely follow.

A recent FDA decision got my attention as a dangerous drug attorney, even before it became a political issue. As the Los Angeles Times reported Dec. 17, the U.S. Food and Drug Administration has started the process to revoke its approval of the drug Avastin (bevacizumab) as a treatment for breast cancer. In a safety alert issued Dec. 16, the agency said four clinical studies showed Avastin had serious side effects but didn’t seem to prolong patients’ lives or slow their diseases. The side effects cited included heart attack and heart failure; development of holes in the intestines, stomach and nose; strokes; and hemorrhage. The drug is not yet withdrawn from the market, but may be after further FDA action and an expected appeal from Genentech, its manufacturer. Avastin is still approved for colon, kidney, brain and lung cancers.

Avastin was approved in 2008 for metastatic breast cancer using the FDA’s “fast-track” approval process, which allows drug manufacturers to skip the testing and approval process if their drugs meet a need not currently being met, or have major advantages over existing treatments. Avastin’s placement in this category was controversial, because the advisory council voted against approval on the grounds that it didn’t improve patients’ survival. In July, another panel came to the same conclusion and recommended on a 12-1 vote that the drug be withdrawn. The FDA’s most recent action came after four clinical trials showed no benefit and significant risks to the drug when used in breast cancer patients. Avastin has also failed to pass muster with the British National Health Service, which found no evidence in its own trials that Avastin extended patients’ lives.

The FDA’s most recent action has become politicized, with conservatives calling it an example of “rationing” health care and breast cancer advocates calling for insurance companies to continue covering the drug off-label for patients it seems to help. As a defective drug lawyer, I sympathize with concerns that a life-prolonging drug could be taken away from patients who desperately need it. However, the scientific evidence doesn’t seem to support the idea that Avastin is a life-prolonging drug. In fact, from the very start, all of the studies on this drug have suggested the opposite -- that Avastin seems to actually hurt other parts of breast cancer patients’ health. The FDA doesn’t save money by taking drugs off the market, and it’s unclear what effect this might have on Medicare, so there’s reason to think the FDA’s action is an attempt to save money. However, Avastin costs about $100,000 per patient in the U.S. and generated $2.7 million in sales for Genentech in 2008, so it’s clear that the manufacturer and its allies have a financial incentive to keep it on the market.

Continue reading " FDA Considers Withdrawing Cancer Drug Avastin for Safety Concerns, Lack of Efficacy " »

A Michigan woman is hoping to participate in a class action lawsuit filed in California for suffering from what she believes is Tardive Dyskinesia, a side effects of taking the popular drug Reglan. However, a problem exists: She has been diagnosed with Parkinson's disease, not TD.

The woman is hoping that she can get a diagnosis of TD before the statute of limitations runs out to file suit against Wyeth, the makers of Reglan. She was told by her old neurologist that she likely has TD but the doctor can't see her to verify it until early 2011 and she needs the diagnosis before time runs out. The woman did explain what happened to her and about her misdiagnosis.

"I have GERD — Gastro-esophageal Reflux,” she says. “My insurance would not cover Nexium to help with this problem because it is too expensive, so I had to take a plethora of other medications until they were sure nothing else would work. Reglan is a med for GERD and ultimately the last one I tried before getting the Nexium. About three months after I started Reglan, I began to have whole body tremors, but it took almost three months to see a neurologist — typical Michigan medical system. I walked in the door and he said, ‘You have Parkinson's disease.' He sent me back to my primary physician who couldn't recognize Parkinson's and I think he is correct — that I don't have Parkinson's disease.”

With Reglan cases running out of time to be filed, the woman may never get her chance in court. While misdiagnoses are common as many disorders and diseases have similar symptoms, patients should always seek second opinions — especially if they disagree with what doctors say. It is so important for patients that are suffering from severe side effects from prescription medications to speak to their doctors immediately when side effects happen. Even the smallest symptoms should be reported so that an early diagnosis can be made. You never know, you might be eligible to be compensated to help cover your medical costs. This story is a tale of caution.

With the statute of limitations quickly running out on people being able to file lawsuits against Wyeth, the makers of Reglan, the number of lawsuits being filed against the company are increasing exponentially in New Jersey.

So far, at least 70 cases have been filed, and more are expected as the February 2011 deadline approaches. Lawsuits against Wyeth have been popping up all over the place since more and more patients are coming out about the adverse side effects that they have suffered. Some of the effects that have users complaining include Reglan-related Tardive Dyskinesia (TD) and various movement disorders.

Reglan is prescribed to treat various gastrointestinal problems such as gastroesphogeal reflux (GERD), diabetic gastroperesis and delayed gastric emptying. In July of this year, the New Jersey Supreme Court decided to centralize all of the suits that were filed in New Jersey. The order came after a petition warned the court that suits were going come flooding in since Wyeth, the makers of the drug, is headquartered there.

This centralization of the lawsuits is supposed to prevent too many rulings that contradict each other as well as to avoid too much court traffic that is unfamiliar with the issues. That sounds simpler than it likely will be, especially considering how many cases can be expected. The problem with this is that it has also drastically upped the statute of limitations on filing the claims.

The goal here is to get the court to create a spreadsheet database that will help keep the cases organized. The judge likely to preside over the cases said that the spreadsheet will help the court handle the large amount of claims that will be expected. In theory, this is a good idea, but only time will tell if this will have a positive or negative impact on the lawsuits to come.

A lawyer for Johnson & Johnson claimed that the company did warn the public about the risks associated with taking Levaquin, the popular antibiotic, during closing statements in a Minneapolis federal court today.

“The information was not concealed,” said John Dames, a member of the J&J legal team. “We provide warnings that give doctors the means to care adequately for their patients.”

He went on to accuse claimant John Schedin's lawyers of manipulating the truth for profit. Schedin's lawsuit was filed in 2008 after he suffered Achilles tendon ruptures or partial ruptures in both heels while he was taking Levaquin during a bout with bronchitis. At the time, he was also taking steroids. Schedin's is the first case to go to trial with the makers of Levaquin.

Schedin also claimed during the trial that Ortho-McNeil went against Minnesota’s consumer fraud act when it purposely hid information and even left some important factors out all together. Schedin's lawyers were seeking actual damages as well as punitive damages.

“There is no proof that Levaquin caused Mr. Schedin’s tendon rupture, and there is no proof that Levaquin has more risk of tendon rupture than similar drugs," Dames went on to say. "Levaquin is a life-saving drug. That opinion was shared by all of the experts who testified in this case.”

In the end, all of Dames' words fell on deaf ears, since the jury, which consisted of 8 men and 4 women, ruled in Schedin's favor. He was awarded $1.8 million in total damages.

“Mr. Schedin is very pleased because he feels his decision to come forward has been vindicated — he came forward so this doesn't happen to others,” co-council for the plaintiff, Rons Goldser, stated. " It was never about the money for him."

I’ve discussed the antibiotic Levaquin and its risks frequently here, from my perspective as a pharmaceutical liability attorney. Levaquin (levofloxacin) is part of a group of antibiotics called fluoroquinolones, which have come under fire for safety reasons in the past decade. The U.S. Food and Drug Administration has added safety warnings to Levaquin’s packaging at least twice since 2004, including a 2008 warning that the drug increases the risk of tendonitis and spontaneous tendon ruptures, which are disabling and painful and take months to heal. This and other Levaquin serious side effects have led to thousands of lawsuits across the U.S. The first of these went to trial in Minnesota last week, Bloomberg News reported Dec. 8, and ended with a $1.1 million jury award to patient John Schedin.

Schedin, 82, received Levaquin for a respiratory infection in 2005. His attorneys said he was active for his age at the time, but that ended when he ruptured not one but both Achilles tendons. These are the tendons connecting the back of the foot with the calf, and they are an especially common site for a Levaquin-related tendon rupture. In his lawsuit, Schedin alleged that manufacturer Johnson & Johnson failed to adequately warn him or his doctor about the high risk of tendon ruptures, something that was fixed after the FDA ordered a black box warning three years later. This risk is higher in people over 60 and people taking steroids -- both of which described Schedin -- and people who are organ transplant recipients. The jury awarded Schedin $700,000 in actual damages, which are compensation for direct losses, and $400,000 more in punitive damages intended to penalize the manufacturer for deliberate disregard for patients’ safety.

As a Levaquin injury lawyer, I’m pleased that the jury decided this way, especially since the decision is likely to affect other Levaquin injury lawsuits. One juror said he and his colleagues talked seriously about the drug manufacturer’s responsibilities, especially responsibilities to warn doctors. Evidence shows that Johnson & Johnson knew about the tendon-related risks of Levaquin at least since 2001, and that those risks were higher in the elderly. Nonetheless, Schedin’s attorneys said the manufacturer didn’t send warning letters to doctors until it had to because of the 2008 black box warning. Meanwhile, Levaquin was prescribed millions of times around the world, for a total of 430 million prescriptions according to the article. In the first nine months of 2010 alone, the article said, its sales totaled $957 million. It’s not hard to imagine that a company might prefer to suppress negative information about a drug to preserve sales that size, but that’s not the right thing to do when people’s health is at risk.

Continue reading " First Lawsuit on Antibiotic Levaquin Ends With $1.1 Million Verdict for Injured Man " »

According to a lawsuit filed in Sacramento, California against Johnson & Johnson, the company is charged with pushing specific medications on elderly people. Levaquin is claimed to be one of those drugs.

The lawsuit alleges that Johnson & Johnson was involved in a conspiracy with the pharmaceutical consultant Omnicare. The companies allegedly conspired together to encourage senior citizens that were living in nursing homes to buy various medications that are made by Johnson & Johnson such as Levaquin. This is in direct violation of Medicare laws, claims the website ConsumerAffairs.com.

One of the alleged consequences of this apparent conspiracy was that "residents were overcharged for their medications, had additional medications administered and were unlawfully switched to Johnson & Johnson drugs." This lawsuit also claims that Johnson & Johnson actually paid Omnicare to claim that their drugs like Levaquin were "preferred." This is what happens when the consultant (like Omnicare) says that the drug in questions is rated highly "for their clinical effectiveness in the geriatric community."

The drugs specifically involved in the lawsuit are Levaquin, Floxin, Risperdal, Ultram, Duragesic, Procrit and Aciphex.

According to several other lawsuits, which also were filed against Johnson & Johnson, Levaquin was proven to be responsible for ruptures of the Achilles tendons. Tendon ruptures have been reported in more than 1,044 reports of the tendon problems from a period of 1997 through 2005.

Levaquin lawsuits are mounting and doctors are even starting to get afraid that the drug Levaquin will also create a condition that is being referred to as SSRI Discontinuation Syndrome. Between that and the fear that patients taking Levaquin over a prolonged period of time will become immune to its positive effects should have Johnson & Johnson worried.

It turns out that taking SSRIs like Paxil can increase DNA fragmentation in sperm. This is according to research presented recently at the 64th annual meeting of the American Society for Reproductive Medicine in San Francisco.

While the research wasn't aimed directly at the study of male fertility, it did reveal that SSRIs caused men to be five times more likely to develop abnormal sperm DNA. The results, which have been called "troubling," suggest an adverse effect on fertility, according to co-investigator Dr. Cigdem Tanrikut from Harvard Medical School in Boston.

She said that during the clinical trial, "the first study to assess the impact of an SSRI on semen parameters in healthy men," 35 participants had taken Paxil for 5 weeks. They took 10 mg once a day the first week, 20 mg for the second, 30 mg for both the third and fourth weeks and then back to 20 mg the fifth week.

They tested the semen samples that were taken before the men began taking the Paxil and then again after four weeks of taking the drug. The tests revealed that the average DNA fragmentation score rose from 13.8 percent before the Paxil to 30.3 percent after four weeks. The study also showed that the number of men that showed a fragmentation score of 30 percent or more before they started treatment increased from 10 percent to 50 percent.

As to how the Paxil affects the semen directly, it seems to slow down the sperm when it is traveling through the body. In some cases, the sperm was so slow that there was practically no sperm at all in the ejaculate. Having discovered this side effect of Paxil, more studies likely will be conducted to further verify these claims.

If you watch television or browse the Internet, you’ve probably seen advertisements for Invisalign, a product that claims to straighten teeth invisibly and without braces. So I was very interested, as a defective medical device attorney, to see that the product’s manufacturer is in trouble with the U.S. Food and Drug Administration for failing to report potentially life-threatening allergic reactions. Makers of drugs and medical devices are required by law to report “adverse events” to the FDA, meaning injuries or illness to people who used the product correctly. As the San Jose Mercury-News reported Dec. 2, an FDA warning letter sent Nov. 18 faulted Align Technologies for failing to do this. The company must provide more information to the FDA or face fines and other penalties.

Invisalign uses a clear plastic casing to “train” teeth straight. That material apparently has caused an allergic reaction in at least three users, which in some cases led to hospitalization. However, the FDA said Align Technologies failed to report these, even though some cases date back as far as 2007 and could lead to serious injury or death. The FDA’s warning letter cited at least three cases of patients with swollen and irritated lips, swollen lymph nodes, burning sensations on the tongue, sore throat and mouth ulcers. One patient received steroids to treat an unspecified reaction. In all cases, Align failed to report the problem within 30 days as required by law. The letter also faulted the company for not responding with documentation adequate to show it’s taking corrective action. Align said it had responded.

As a pharmaceutical liability attorney, I wonder how many more of these Invisalign allergic reaction cases are out there but have not been reported. If Align has not been meeting its legal requirement to disclose allergic reactions, it’s hard to know whether this is a widespread problem or a few isolated incidents. However, the company says 1.3 million people have used devices in the Invisalign family. Even if 5 percent of those people had any kind of reaction, that would still be 65,000 people hurt by Invisalign. To make matters worse, Align has known since at least 2007 that its product can cause life-threatening allergic reactions, but failed in its duty to warn customers and the FDA. That failure to warn makes the company liable for any legal actions filed by people who were hurt by Invisalign products that they trusted -- but that the company knew could send them to the hospital.

Continue reading " Invisalign Maker Gets FDA Warning Letter for Failing to Report Allergic Reactions " »

Research now shows that among other side effects from taking Paxil — including increased birth defects, addiction, mood swings, suicidal behavior and suicide — Paxil may also cause cataracts.

A study conducted by scientists in British Columbia and Quebec looked for a link between cataracts and SSRI medications like Paxil. The researchers took information from about 19,000 people over the age of 65 and had cataracts and compared their information of 190,000 people that were 65 and older who did not have cataracts. In the end, the researchers learned that the ones that were taking SSRIs like Paxil had a 15 percent higher chance of getting cataracts.

The study also showed that there was a difference in seniors developing cataracts depending on what SSRI medication was taken by the patient. Here are the comparisons between patients taking different antidepressants and the chances of them getting cataracts:

• Paxil patients’ chances became 23 percent higher;
• Effexor patients’ chances became 33 percent higher; and
• Luvox was highest at 39 percent higher.

As far as the research information goes, there is no way to completely determine why patients taking antidepressants have a higher chance of getting cataracts vs. those that were not, but one explanation may be because SSRIs increase serotonin levels around any of the cells that need it. This also includes cells that are in the eye's lens, as was stated in an article in the Reporter. This excess serotonin around the eyes may be the reason that the cataracts develop. More research is needed to verify these claims, but one thing is certain: Antidepressants are getting one heck of a bad name.

Between the heavy side effects of taking drugs like Paxil and Effexor, research also has shown that the drugs may not even prove to be any better than a placebo at treating depression, anyway. If the research keeps going this way, antidepressants may just become a thing of the past.

Even though Reglan now has a more severe black box warning imposed by the FDA, concerns remain for those patients who were already taking the defective drug before the warning was issued.

Reglan can cause severe and permanent health problems — problems that have been downplayed by the drug’s manufacturer. In fact, it is now believed that patients are twice as likely to suffer from permanent disorders from taking the drug than was expected. Since many of the patients currently on Reglan were told that the benefits outweighed the risks, they took it not realizing that the risks of patients developing tardive dyskinesia (TD) are actually higher than claimed. TD is a disorder that causes symptoms like grimacing, compulsive blinking, facial ticks and lip smacking. Currently, there is no known treatment for it. The worst part is that TD can last for years after you stop taking Reglan and for some people this situation is permanent.

Reglan is prescribed for gastrointestinal disorders such as diabetic gastroparesis and gastroesophageal reflux. Reglan is given to stop the symptoms that these disorders cause. Since it is well known now that Reglan causes a higher chance of getting TD when it is taken over a long period or when taken in higher dosages, the patients who suffer from the worst cases of gastrointestinal disorders end up being the most likely to get TD from taking Reglan.

The real risks of taking the drug Reglan have been out for some time now, and because of this time is running out for those patients that might want to pursue legal actions if they had actually contracted TD from the defective drug. When prescriptions are supposed to help you better your health but cause more problems in the end than what patients started out with, it is safe to call those drugs defective.

Many feel that the black box warning on Reglan came too late for those that were already taking the drug for other health problems but the time for filing lawsuits has almost run its course.

As if the constant fears and risks that taking antidepressants like Effexor weren't bad enough, studies show that women taking the drug while they are pregnant are twice as likely to suffer from miscarriages than women who don't.

The new study, published by scientists at the University of Montreal in the Canadian Medical Association Journal, has found that expectant mothers who take antidepressants like Effexor in their first trimester of pregnancy were more likely to suffer from a miscarriage than those that didn't. In fact, the chances were 68 percent higher. It also has been reported that women taking Effexor specifically were at a higher risk than if they were taking other antidepressant such as Zoloft, Prozac, Lexapro and Celexa.

This research used information provided in the Quebec Pregnancy Registry and studied all of the pregnancies from 1997 until recently. The study made comparisons in those that miscarried in their 20th week and those that lost their babies earlier in the pregnancy. The results showed that miscarriages were almost double with the women that were taking venlaxafine (Effexor).

The major damage to the babies seemed to be cause by malformations in the babies' vital organs. Some of the birth defects that were common in these cases where the mothers took Effexor were heart defects, craniosynostosis (which is an abnormal skull shape), lung defects, club foot, cleft lip or palate and abdominal wall defects.

“Women who take antidepressants like Effexor while pregnant are unknowingly putting their unborn babies at risk,” says the law firm of Baum, Hedlund, Aristei & Goldman. This firm has handled more client lawsuits on behalf of injuries caused by antidepressant injuries than any other law firm in the United States.

The first bellwether trial regarding gadolinium and causing the fatal disease nephrogenic systemic fibrosis (NSF) is scheduled for January.

Plaintiffs in the first trial are Loralei and Donald Knase. They filed suit against GE Healthcare, claiming that a serious case of NSF was triggered by the MRI contrasting agent Omniscan.

MRI and kidney failure is linked in such a way, it should be noted, that while MRI does not cause kidney failure, the use of an MRI contrast agent can have dire consequences for anyone with kidney disease, due to the inability of someone with weak or malfunctioning kidneys to clear out the contrast agent.

Kidney patients who require MRI with a contrast agent such as gadolinium are recommended to have MRI dialysis (in other words, dialysis immediately following the MRI) in an effort to expedite the eradication of gadolinium from the bloodstream.

Plaintiffs involved in hundreds of lawsuits allege that gadolinium caused them to develop NSF, which causes hardening of the skin and tissue growth along joints, eyes and internal organs.

There is no treatment or cure for NSF, and the disease can be fatal.

Lawsuits were consolidated in late 2008 in US District Court, Northern District of Ohio, after almost 400 cases were filed across the country. Trials were originally set for May of this year, but a number of the suits against Bayer, one of the defendants, settled.

US District Court Judge Dan E. Polster set the trial date for the Knase action as January 24, 2011.

On a related note, MRI health risks also exist for individuals with pacemakers. Due to the intense magnetic fields associated with MRI, patients cannot wear or be near anything metallic. That goes for an implanted pacemaker.

Earlier this year, Medtronic received European approval for its Ensura MRI SureScan pacing system. Medtronic announced in June that European patients with the new device would have access to full MRI scans without positioning restrictions in the MRI scanner.

The system is, so far, not approved in the US—thus continued MRI health risks for individuals with traditional pacemakers remain.

While the birth control drug Yaz/Yasmin has been under a lot of scrutiny lately with the risks it poses (like heart attacks and strokes) and the questionable advertising practices of its makers (Bayer), something else is causing quite a stir. It seems that Yaz/Yasmin also is being associated with causing gallbladder problems in women. What's worse: Treatment for some women even includes painful gallbladder surgery to correct it.

The reason for this discovery is because Yaz/Yasmin contains drospirenone. This is a newer synthetic variety of progestin not currently used in any other birth control drug approved in the United States. According to a study that was published in the British Medical Journal, using Yaz/Yasmin or a generic version (Ocella) could double the chances of getting blood clots.

One South Carolina woman took Yaz/Yasmin to treat her acne problem and ended up with blood clots in her lungs. A month later the woman had gallstones and ended up having to have gallbladder surgery to correct it. She since has filed a lawsuit against Bayer because of it and the other lawsuits started rolling in. While there are warnings against taking Yaz/Yasmin if you already have previous medical conditions like gallbladder disease, Bayer still is being charged with failure to fully disclose all of the warnings to consumers.

Like most pharmaceutical companies, Bayer played up the positive sides of the drugs, including a better complexion and less serious menstrual symptoms. The company also downplayed the more severe side effects such as severe cardiac complications, strokes, pulmonary embolism, breast lumps and even death.

Yaz/Yasmin's gallbladder problems can prevent the gallbladder from doing its job properly, which is to store bile that the liver produces and help digest fats in small intestine. It usually starts with the production of gallstones, but it can easily escalate from there. Once the gallbladder problems reach their peek, often times it requires surgery to fix.

As a dangerous drug attorney, I’ve written multiple posts in this space about recalls of over-the-counter medicines made by McNeil Pharmaceuticals. The company, a division of Johnson & Johnson, makes major over-the-counter drug brands such as Tylenol, Motrin and Benadryl. It hit the news in 2010 because of recurring safety problems at plants in Puerto Rico and Pennsylvania, leading to recalls of hundreds of millions of bottles of medicine. The U.S. Food and Drug Administration and members of Congress are separately investigating the company. Now, the New York Times reported Nov. 27, the U.S. Food and Drug Administration has made public a report showing that at least some of the safety problems at the plant have not been corrected.

The inspection was of a Puerto Rico manufacturing plant that had also been inspected in January of this year and found to have serious safety problems. The newer inspections, which took place between September and early November, show that some of those problems have not been addressed. Among the recurring problems in the November report (PDF) were failure to thoroughly investigate problems with products and failure to detect them in the first place. The report also found inadequate equipment cleaning and controls, which could lead to contamination or confusion of drugs. Procedures intended to prevent these problems were not being followed, the inspection report said. McNeil has reportedly already responded to these inspection reports. The FDA has said it won’t issue another warning letter, suggesting that more stringent enforcement actions may be taken.

Now is the right time for more serious regulatory action, in my opinion as a defective medication lawyer. McNeil has had most of a year to respond to the inspections, and apparently has failed to take steps to solve some serious safety problems. The inadequate procedures cited in the report are important because these procedures are what stands between the public and drugs that are not safe. In fact, because McNeil has had two consumer safety recalls in the last year, the danger is not just theoretical -- failure to correct procedures stands a good chance of failing to stop unsafe drugs from hitting stores. This could put everyone who buys an over-the-counter medicine from McNeil in danger -- and that’s millions of Americans. If McNeil does not make drastic changes quickly, the FDA should step in for the safety of the public.

Consumers trust name-brand over-the-counter drugs to help them feel better when they’re sick. But when companies allow contaminated, ineffective or otherwise flawed drugs to reach the market, consumers can be made sicker by the medicine that’s supposed to help. My firm,

Continue reading " FDA Cites Tylenol Manufacturer Yet Again for Safety Failures at Puerto Rico Plant " »

In a trial in Minnesota that started today, Johnson & Johnson, the makers of the popular antibiotic drug Levaquin, was accused of hiding information about the risks that the drug posed.

The claimant in the case, 82-year-old John Schedin, says that after he started taking Levaquin, he ruptured the Achilles tendons in both of his feet. He decided to sue Johnson & Johnson as well as the company’s Ortho-McNeil-Janssen Pharmaceutical unit two years ago. At the time, both companies tried to act as if the drug didn't carry that much risk for the injury — even though they had already heard about this adverse effect from Europe as far back as 2001.

“The decision they made was to add a single line to the 14-page package insert somewhere on page four or five,” says Schedin’s lawyer, Mikal Watts. “They did not tell the doctors that the use of Levaquin concomitant with corticosteroids will cause an Achilles tendon to rupture.”

This case is the first Levaquin one to go to trial against Johnson & Johnson even though there are currently at least 2,600 claims in the United States that say the same thing: Johnson & Johnson knew of the risks for Achilles tendon injuries related to Levaquin and it failed to warn the public properly.

The FDA insisted on proper warnings for Levaquin and other drugs in 2008, but the plaintiff says that the warnings should have come earlier and still are not good enough. The plaintiff’s legal team also says that Levaquin is Johnson & Johnson's "blockbuster drug" because their marketing team downplayed the risks that the drug really posed.

“The warning has been in the label since December 1996,” argues defense lawyer John Dames. “It’s not hidden. It’s right there where you would expect it to be, in the warnings section.”

With this being the first trial against Levaquin, the results certainly will be interesting to see.