Drug Injury Attorney Blog

Judge David Herndon has decided to seal witness production orders in the Yaz multi-district litigation trial (MDL) he is overseeing. Specifically, Herndon sealed the orders referring to some of Bayer’s European executives who were to give depositions on Bayer's behalf in the Yaz lawsuits. The order came down on Aug. 18. Herndon's decision was made in an effort to solve an argument over whether Bayer had to produce the three Europeans to give the depositions in the first place.

Right now, Judge Herndon presides over the national Yaz lawsuits that have plaintiffs claiming that Yasmin, Yaz and Ocella damaged gall bladders and blood clots. The trials are expected to begin next year. Back on Aug. 12, Bayer asked Herndon to ban the depositions from the Europeans, named van der Werff, Riemann and Trudeau. Bayer's attorneys wrote in the public docket that according to Dutch law, Bayer cannot force van der Werff to testify anyway, writing, "Mr. van der Werff has stated that he will not voluntarily testify in these proceedings."

The attorneys also wrote in the docket that should the plaintiffs really want to depose van der Werff, there are some procedures that could be followed about taking evidence out of the country under the Hague Convention.

"Plaintiffs have a full opportunity to develop evidence on regulatory activity in Europe through other witnesses," Bayer's attorneys wrote. "Plaintiffs are inviting a jurisdictional battle that would take months to resolve and provide a huge drain on the resources of the parties and the court."

Sounds as if Bayer is trying to make it so difficult for the plaintiffs to get the testimony that they simply give up trying.

Much has been blacked out on the public docket, but enough information is provided to show that Bayer is trying to prevent the plaintiffs from getting the depositions that they want. Considering how complicated things have gotten for Herndon and all parties involved when it comes to getting all of the depositions done in the MDL so far, sealing the production orders may help to get the lawyers on both sides to stop wasting the court's time fighting over them. This would be a blessing to everyone involved since the last thing anyone needs is another reason to stay the onset of the trial start date.

A new study published in PLoS One suggests that most prescription drug ads would likely fail to comply with FDA rules regarding their content. That is likely why the FDA instituted its “Bad Ad” program in the first place.

The study, which was conducted by researchers viewing 192 drug ads in November 2008, was done by researchers only counting “unique” ads for various different products. In doing their research, 103 duplicate ads as well as 6 so-called “teaser” ads were found to mention a specific drug but didn’t offer any other information about the drug. The final sample consisted of 83 unique ads, all of which can be found in key U.S. biomedical journals.

The research team found that just 18 percent of the ads were in full compliance to FDA guidelines. A full 49 percent of the ads were not in compliance with FDA guidelines, 41 percent were not in compliance with at least one FDA-described bias and 33 percent did not adhere to the guidelines at all because they omitted information. To make matters worse, almost 60 percent of the ads “did not quantify serious risks needed for safe prescribing of the medications, including death.”

Drug makers have been misleading people in their ads for years. The FDA has issued countless letters to drug makers including Bayer, the makers of the controversial birth control pills Yaz and Yasmin. In fact, the FDA forced Bayer to revise its marketing campaign for Yaz and Yasmin to include the drugs’ links to potentially deadly side effects including blood clots, deep vein thrombosis, heart attacks and strokes. Until the FDA intervened, Bayer was both marketing Yaz and Yasmin’s off-label uses (help clearing up acne and PMS symptoms) just as much as the contraceptive properties and downplaying the drugs' harmful side effects. Because of those ads, many young women took the pills and suffered from life-threatening conditions and even deaths.

While the Bad Ad Program may help to get some of these ads to include the real risks associated with the drugs, they can do little to help patients who have taken the drug and suffered from the side effects. This new study just draws more attention to how much drug companies get away with before the FDA finds out.

U.S. District Court Judge David Herndon has ordered that a previously-dismissed Yasmin lawsuit be reinstated. The case revolves around a mother that sued Bayer, the makers of Yasmin, amid claims that her daughter died after taking the controversial birth control pill.

Paulette Morgan’s daughter Alice died of a blood clot after taking Yasmin. In July of this year, her lawsuit was dismissed when she didn’t finish a questionnaire called a Plaintiff Fact Sheet. Paulette has since completed the fact sheet and filed a motion to have her lawsuit restored. Fortunately Herndon was around, because he ordered her lawsuit to be reinstated on Aug. 5 in U.S. District Court for the Southern District of Illinois. Paulette is just one of thousands of lawsuits that have been filed against Bayer over Yaz and Yasmin, which research has linked to various harmful side effects including blood clots in the veins and lungs. Right now, Herndon currently presides over Yaz multi-district litigation.

Bayer has been defending itself against many claims since Yaz and Yasmin hit the market. The drugs’ ads had even been touting the pills as a practical cure-all for everything from acne to PMS before the real risks became public. Even though evidence came up that showed how dangerous the pills were, Bayer stood by the drugs. The FDA finally intervened, issuing a black box warning against the pills and forcing Bayer to advertise the drugs to that effect.

Paulette is convinced that if Alice had known how dangerous Yasmin was, she wouldn’t have taken the pills at all. Now Paulette is hoping that Bayer will be held liable for her daughter’s death, and thanks to Herndon, Paulette will get to have her day in court.

As a defective drug attorney who also handles medical malpractice cases, I know the two frequently go hand in hand. After all, medical malpractice is nothing more than the legal name for very bad judgment by a medical professional, and knowingly administering a defective drug is very bad judgment. So I was interested to see the Second U.S. Circuit Court of Appeal’s ruling in Brown v. Noxubee General Hospital et al., a case that combines defective drug claims against drug maker Eli Lilly with medical malpractice claims against two hospitals in Mississippi. The claim was brought by Derrick Brown as personal representative of the estate of Dorothy Brown. He alleges Dorothy Brown died because of her use of Zyprexa (olanzapine), an atypical antipsychotic prescribed for her schizophrenia and depression with psychotic features. She also had diabetes, which Zyprexa is known to cause or worsen.

Brown was prescribed Zyprexa when she was under psychiatric care, ending in 2003. In 2005, Brown came to the emergency room at Noxubee General Hospital in Macon, Miss., with trouble breathing and high blood glucose. She was discharged the same day, but showed up the next day at Baptist Memorial Hospital in Flowood, Miss. She was discharged from Baptist the same day, but went back to Noxubee the following day, where she was again discharged. She died at home of cardiac arrest two days after the last discharge. Her estate sued two years later, alleging that Lilly failed to warn patients about the metabolic risks of Zyprexa. It also alleged that the hospitals knew or should have known Brown was unable to care for herself. After some jurisdictional squabbling, the case was ultimately removed to the Eastern District of New York, where other Zyprexa litigation was pending. That court granted summary judgment to Noxubee and eventually Baptist, saying Brown had failed to follow special Mississippi medical malpractice procedures and also, in Noxubee’s case, missed a one-year statute of limitations. It asked Brown to submit an expert witness report connecting Zyprexa with the death, but when Brown missed that deadline, it dismissed the claim against Lilly as well.

Brown appealed the dismissal of all three defendants. The Second Circuit started by noting that the appeal as to Baptist was already decided, and declined to address the issue again. The first appeal was in any case drawn partly from a non-appealable order, the court noted, and the other part was filed past a deadline. That order also dismissed the appeal as to Noxubee, because Noxubee was in the title but had no part of the orders being appealed. A separate appeal as to Noxubee was withdrawn, apparently because Brown’s attorneys believed it was too defective to survive, but this was not the case. Thus, the Second had no jurisdiction over that issue. It also dismissed Brown’s argument that federal jurisdiction was improper, since the Mississippi hospital defendants were dismissed and Lilly was from another state. Finally, it tackled the summary judgment order for Eli Lilly. Under Mississippi law, the Second said, plaintiffs in pharmaceutical liability cases must provide expert opinions connecting the drug to the death. Brown failed to do this, it noted, and even when the court threatened to dismiss the case if no report was filed, continued to not file one. Thus, dismissal was proper and the Second affirmed the lower court.

As a pharmaceutical liability lawyer, I am disappointed that Brown could not pursue his case for reasons that are mostly procedural. Though he seems to have genuinely missed deadlines and other requirements, none of this bears on the merit of the claim that Zyprexa led to Dorothy Brown’s death. Indeed, this case underscores the importance of ensuring that you get legal help as early as possible in your case, preferably as soon as you start considering a lawsuit. By contacting an experienced dangerous drug attorney right away, clients with claims against government entities, like Brown, can make sure not to miss the notoriously short deadlines for government claims. They are also more likely to understand the special procedures required in government claims and medical malpractice claims. Failing to follow these, as this case shows, can be deadly to the claim regardless of its merit.

Continue reading " Second Circuit Upholds Summary Judgment for Eli Lilly in Zyprexa Lawsuit – Brown v. Noxubee General Hospital " »

Today two families from Kamloops in British Columbia are mourning the deaths of their newborns. The families have little in common other than that they believe that Effexor may have killed those babies. To at least one researcher from the University of British Columbia, that is not a surprise.

With the amount of research that has linked SSRI medications like Effexor and Paxil to birth defects in babies born to mothers who took the drugs while pregnant, this shouldn't come as a surprise. Dr. Barbara Mintzes, assistant professor of anesthesiology, pharmacology and therapeutics at the university, has been studying the risks of pregnant women taking antidepressants has said that the data she collected should worry the public because she said that there is evidence of women suffering from more miscarriages when they take antidepressants.

Mintzes has also said that some studies have shown that exposing pregnant women to the drugs can increase the risk of babies suffering from the sometimes fatal condition called persistent pulmonary hypertension of the newborn (PPHN).

PPHN is what one of the families is convinced caused the death of their newborn son. The child’s mother took Effexor while she was pregnant. A spokeswoman for Pfizer, Maureen McConnell, says that the study that was used by Health Canada did not link SSRIs or other antidepressants to a higher risks of PPHN. She also said, “The product monograph and label information distributed with the product addresses the use of Effexor in pregnant women, including that the safety of venlafaxine, has not been established in pregnant women and that venlafaxine must only be administered to pregnant women if the expected benefits outweigh the possible risks.”

However, both the first and second family, whose child also died (at 2 months old) after the mother took Effexor while pregnant, claim that they weren’t warned about the risks associated with Effexor toward babies. Both of the mothers made the mistake of trusting their doctors completely — and their babies paid the price.

Additional plaintiffs have joined a Levaquin lawsuit filed in New York amid claims that they weren’t properly warned of the dangers of taking the antibiotic and developed tendon ruptures as a result. Dozens of plaintiffs now have filed claims against the drug's manufacturer, Ortho-McNeil-Janssen Pharmaceuticals, a division of the troubled Johnson & Johnson.

Levaquin is the controversial fluoroquinolone antibiotic that has been linked to a higher number of tendon ruptures than any other antibiotic medication, especially for patients who are over the age of 60. In addition, if patients are taking corticosteriod therapy, have an even higher chance of suffering from a tendon injury. The lawsuits are based on the complaint that the makers of the drug didn’t properly warn the plaintiffs of the risks associated with it. The attorneys presenting the case against Levaquin also are claiming that the packaging actually hides the worst tendon rupture effects in the middle of the lesser effects just to make it harder to catch.

Finally, the lawsuit claims that Johnson & Johnson downplayed just how much tendon damage occurred in the drug's trial studies. It took a couple of years to have the Levaquin labels changed to include the excessive warnings in a plainly visible manner, which occurred in 2007. However, in 2008, the FDA issued a black box warning against the drug’s tendon rupture side effects and now the warning is included with the severe side effects listed and not hidden with the less serious side effects. If that's not a case of too little too late, nothing is.

Because drug companies have a lot of resources at their disposal — far more than ordinary people dealing with prescription drug injuries — they frequently fight claims brought by pharmaceutical injury attorneys like me on procedural grounds. By claiming the lawsuit was brought too late or in the wrong state, they may be able to delay the case or drive up the costs so much that plaintiffs can’t or decide not to proceed. In Casey et al. v. Merck & Co. Inc., pharmaceutical giant Merck was fighting four lawsuits brought by families in Virginia who suffered serious injuries after a family member took the drug Fosamax (alendronate sodium) for osteoarthritis. The Second U.S. Circuit Court of Appeals ultimately decided that the Virginia Supreme Court should decide whether the families missed their deadline to sue.

All four of the plaintiffs took Fosamax for osteoarthritis and later developed osteonecrosis of the jaw, a condition in which the jawbone literally dies and creates lesions in the mouth that cause pain and sometimes infections. All four sued Merck for their injuries between May of 2007 and November of 2008. Merck moved to dismiss all the claims, arguing that plaintiffs had waited to sue past Virginia’s two-year statute of limitations, because most were injured four years before filing suit. However, a proposed class action on the same topic was filed in 2005; class certification was denied in January of 2008. The plaintiffs argued under American Pipe & Construction Company v. Utah that the statute of limitations should be tolled during the class action, regardless of whether the applicable state law permits it. The district court disagreed, ruling that American Pipe applies only if it applies under Virginia law. The Fourth Circuit, which covers Virginia, had found that the Virginia Supreme Court would not adopt cross-jurisdictional equitable tolling, so the district court declined to apply it here and dismissed the case. The plaintiffs appealed.

The Second Circuit (which covers New York, where the Merck lawsuits were filed) was not so hasty. It sided with several other circuit courts that had decided the law of the relevant state should decide whether a class action tolls a statute of limitations. In this case, the relevant state is Virginia, and the Second found that it lacked enough indications of Virginia state law on the matter. Thus, the court said it was more appropriate to certify a question to the Virginia Supreme Court rather than rely on Fourth Circuit precedent. It therefore certified two questions:
1. Does Virginia law permit equitable tolling of a state statute of limitations due to the pendency of a putative class action in another jurisdiction?
2. Does Va. Code Ann. Sec. 8.01-229(E)(1) permit tolling of a state statute of limitations due to the pendency of a putative class action in another jurisdiction?

As a pharmaceutical liability lawyer, I sympathize with the plaintiffs who were expecting a yes or no answer from the Second Circuit and instead got another delay. But I also think the Virginia Supreme Court’s answer to those questions could be very important to injured Virginians, so it’s good that the court can now choose to address them. When a class action is dismissed, as it is in this case, it doesn’t end the injured plaintiffs’ right to sue; they may still sue as individuals. However, in order to do that, they must be able to file those suits within their states’ statutes of limitations, which can be difficult if the class action was pending for two years or more. Thus, American Pipe guards the right of injured people to sue. As a defective drug attorney, I know that right can be very, very important — not only to serve justice, but also to ensure that seriously injured people have a chance to collect the money they need to support themselves and get medical care.

Continue reading " Second Circuit Punts Tolling Question in Fosamax Injury Case to Virginia Supreme Court – Casey et al. v. Merck " »

Two more plaintiffs have filed Levaquin lawsuits against Johnson & Johnson. Just like many of the others, the plaintiffs are suing Johnson & Johnson, Ortho-McNeil Pharmaceutical and Johnson & Johnson Pharmaceutical Research and Development amid claims that Levaquin caused them to suffer from tendon problems. Levaquin is generally prescribed as an antibiotic treatment for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.

Both of the plaintiffs, Francine Brown and Constance Coffan, are from New York and claim they didn’t know that Levaquin causes patients to suffer from tendon injuries before they started taking the drug. They also didn’t know that the chances of suffering from tendon ruptures was higher for patients older than 60 or if they were using corticosteroid therapy.

"Levaquin-induced tendon injury involves the degradation of the tendon tissue, leading to severe and permanent injuries," the lawsuit states. "More disturbingly, Defendants' promotional campaign was themed on Levaquin's excellent safety profile and failed to disclose the risks of tendon injury."

The plaintiffs in these cases are stating that their tendon injuries are permanent.

Levaquin lawsuits are not new. In fact, thousands of lawsuits have been filed against Johnson & Johnson and Ortho-McNeil. So far, only two of those cases have been ruled on. One case had plaintiff John Schedin winning almost $2 million for his injuries.

Back in July of 2008, Levaquin was issued a black box warning but the new label change that came with it still didn’t list proper warnings about the increased risk of tendon problems in comparison to other antibiotics that are similar. The new plaintiffs have listed 7 counts in their lawsuit, which include “strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Consumer Fraud Act and unjust enrichment.”

Bayer’s Yaz lawyers are facing some confusion over whether the company's generic version of Yaz is exempt from lawsuits. Ocella, the generic version of Yasmin, might be exempt from lawsuits thanks to the Supreme Court’s blanket ruling involving the liability of generic drug makers. Ocella is also just as controversial as the brand name versions of Yaz and Yasmin. Side effects from both birth control pills have been the subject of thousands of lawsuits.

Generic drug companies manufacture drugs of all types, but what makes Ocella different is that is manufactured by Bayer, the same makers of the brand name version. Because of this, Yaz lawyers don’t like the fact that, according to this recent ruling, Bayer is responsible for side effects from the generic version and name brand version, and they want to contest it. They are also just as liable for all of the label inconsistencies that are supposed to warn the public about the pills.

All of this hullaballoo is because of a ruling the Supreme Court made in June of this year. The court ruled on the case Pliva Inc. v. Mensing in a 5-4 judgment that said that generic drug companies aren’t liable for warning label inconsistencies that don’t report on the side effects properly because federal law stipulates that the generic drugs' labels have to be identical to the labels of the brand name versions.

As to how Bayer lawyers think that this isn’t fair is anyone’s guess. The fact is, if the brand name versions of Yaz and Yasmin had listed the warnings properly in the first place, there wouldn’t be as many lawsuits against them today. If Bayer can manufacture dangerous pills and market them (even in their off-label uses) , the company should be held accountable for the suffering of patients taking those drugs. The drug giant should have known that creating a generic version just to make more money off of the drug was going to come back to haunt the company sooner or later. It just wanted to hold on to the drugs' revenue — and in doing so, the company opened itself up to more lawsuits.

The first Levaquin trial in New Jersey is about to get underway as two plaintiffs are combining their lawsuits against the makers of the popular antibiotic. Bob Beare and Paul Gaffney both allege they were not properly warned of the side effects — specifically tendon ruptures — before taking Levaquin. So far, the total number of mass tort New Jersey Levaquin trials has reached an astounding 1,763.

The lawyers have given plaintiff fact sheets to Judge Carol E. Higbee and there have been status conferences already started with the intent of moving the chosen cases to trial. One status conference, which took place August 11, was rescheduled from its previous July 14 date; that conference was expected to address various things such as motions to prevent some evidence from expert witnesses.

As for the plaintiffs themselves, their cases are going to be tried together as a single trial. The start dates are set at late August or early September of this year. Both men are older than 60, and both of them suffered from tendon ruptures after taking Levaquin. Both of the men are from New Jersey and their cases will be tried together because they were filed under the same circumstances.

Levaquin has been the source of thousands of lawsuits because of the drug's link to tendon ruptures and other injuries. Not many of the cases have gone to trial yet; however, at least one case awarded the plaintiff almost $2 million. Still another case was lost. These Jersey cases are expected to help break the "tie." It is hoped that the next trial to reach a decision will help plaintiffs to understand what to expect as far as a verdict is concerned, even though that's nearly impossible to predict. No matter what the decision is in this case, many cases have small differences that can sway the decision for or against a plaintiff.

A new study has found that patients with idiopathic pulmonary fibrosis (IPF) who received treatment for gastroesophageal reflux (GERD) appear to live longer than the IPF patients that didn’t receive the treatment. This study was conducted by Joyce Lee, MD, clinical instructor in the Department of Medicine at the University of California-San Francisco.

Of the findings, Lee says, "While preliminary, these findings support a relationship between GERD, chronic microaspiration and IPF. Microaspiration occurs when gastric droplets reflux into the esophagus and enter the airways.”

This study was published online before it reached the print edition of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine. IPF is an incurable lung disease that is characterized by scarring on the lung tissue; this stops the lungs from giving the body the oxygen that it needs to survive. Most people with this condition live for about 2-3 years from the time of diagnosis.

Dr. Lee’s study looked at 204 patients with IPF who were seen at either UCSF or the Mayo Clinic in Rochester, Minn., between 2001 and 2008. Each of these clinics documented GERD symptoms and the treatment of the patients; the results were reviewed by the treating doctor. The researchers in the study kept track of the “recorded demographic data, radiologic data of the extent of fibrosis and survival time.”

Of the 204 patients, researchers discovered that the symptoms of GERD were found in 34 percent of them, and a reported history of GERD was found in 45 percent. Of the patients that had been diagnosed with IPF, half of those patients said that they were receiving treatments (like Reglan) for it. As many as 11 patients said that they were having surgery to correct their GERD. This was when Lee and her colleagues found out that the patients who were getting treatment had a significantly longer survival time for their condition than the patients that didn’t have treatment for GERD.

That may sound wonderful; however, some GER treatments can cause as much harm as good. One of those drugs is the popular and controversial Reglan. Reglan has been linked to tardive dyskinesia when taken longer than 12 weeks, and many lawsuits have been filed on behalf of patients who have taken the drug. While it may help survival time of the IPF patients who take Reglan, the drug can actually lessen their quality of life.

I’ve written here before as a dangerous drug attorney about the risk of suicidal thoughts from taking any antidepressant. That risk is why every antidepressant sold in the United States carries a “black box” warning, the strongest the FDA has, about the risk to people under 25. A murder-suicide unfortunately underlies the Tenth U.S. Circuit Court of Appeal’s decision in Rimbert v. Eli Lilly & Co., a ruling in a wrongful death lawsuit brought by Mark Rimbert. Rimbert is the adult son of Gilbert John Rimbert and Olivia Acosta Rimbert. Shortly after starting to take Prozac, Gilbert Rimbert killed Olivia Rimbert and himself. Mark Rimbert brought a wrongful death lawsuit against Eli Lilly, the maker of Prozac. In this appeal, the Tenth Circuit rules that even though Rimbert’s expert witness was properly excluded by a trial judge, that judge was wrong to grant summary judgment to Lilly.

Gilbert Rimbert took Prozac for moderate depression. He committed the murder-suicide after the initial dose was increased, and Mark Rimbert alleges that Prozac caused the violence. The first judge assigned to the case told the parties that while he did not think he needed to recuse himself, he did have personal reasons why they might be uncomfortable. Neither party asked him to recuse himself, and he subsequently denied Lilly’s motion to exclude testimony from Rimbert’s expert witness. Later, more personal issues arose and the judge again offered to recuse himself; Lilly took up the offer. When a new judge was assigned, Lilly repeated its motion to exclude the expert witness testimony, and this time, it was granted. In doing this, the new judge held no new hearing, but relied on evidence from a hearing held by the previous judge. Rimbert moved to reschedule so he could find a new witness. Lilly opposed this and moved for summary judgment, arguing that Rimbert had no case without a witness. Summary judgment was granted, and Rimbert appealed the witness ruling and the denial of a new scheduling order.

On appeal, Rimbert argued that the doctrine of the law of the case should bound the second judge to the first judge’s ruling. The court disagreed, pointing out that Tenth Circuit precedent says decisions can be revisited until a final judgment is entered. It declined to revisit issues it said it had already considered. Nor did the appeals court agree that Lilly was estopped from seeking a new ruling after the case was reassigned because it had not asked the first judge to recuse himself. Prior cases agree that parties should act promptly if they want a recusal, but in this case, the Tenth said, the second disclosure from the first judge was very different from the initial disclosure. Indeed, the second disclosure means estoppel cannot be established in this case, the Tenth said, because it represents a material change in circumstances. However, Rimbert had more luck on the scheduling order. The district court “inexplicably” made its ruling on scheduling as if the expert ruling had been entered under the previous judge, the court said. But because the case had been reassigned and then vacated by the new judge, there was no pretrial schedule for Rimbert to disrupt when he asked to delay the case. Thus, the Tenth upheld the ruling on the expert but reversed the scheduling ruling and sent the case back to trial court.

As a pharmaceutical liability attorney, I think this case is a good example of how an adverse ruling on something as small as scheduling can make a big difference to a case’s success. If the court excludes testimony from an expert and then denies the defendant a chance to find a new expert, the court has essentially decided the outcome without actually hearing the case. Without some kind of inaction or wrongdoing by the party whose expert was excluded, this could be an improper use of judicial discretion. This is especially important in defective drug cases, because they depend heavily on expert witnesses to present complex, scientific facts to the jury, who are not necessarily scientists or medical professionals. As a defective prescription drug lawyer, I am pleased that the Tenth Circuit ultimately let this plaintiff have his chance to prove his case.

Continue reading " Tenth Circuit Reverses Summary Judgment Order in Prozac Murder Suicide Lawsuit – Rimbert v. Eli Lilly " »

The controversial antidepressant medication Effexor is widely known at this point as much for its side effects as it is for combatting depression. Some of the side effects include mood swings, aggressive behavior, suicidal thoughts and even suicide. These side effects have many people trying to stop taking the drug, but even that has a side effect associated with it.

Quitting Effexor causes withdrawal symptoms that can be quite debilitating and almost as dangerous as staying on the medication. The reason for this is due to the body’s dependency on it. The drug is highly addictive and many patients don’t successfully come off of it permanently without some help. Now Point of No Return has instituted a program that is meant to help Effexor patients stop taking the drug, while still being at home.

Most drug programs that help people quit a drug or medication are conducted on-site so that doctors can keep a watchful eye on the effects the drug (and lack thereof) is having on the patients. Point of No Return claims to be able to provide patients with a safe-at-home way to quit the drug permanently. All you have to do is visit its website and purchase the program that is associated with the type of drug that you are trying to get off of.

According to information provided about the Point of No Return program, “the primary Effexor withdrawal symptoms include nervousness, dizziness, headache, nausea and insomnia. Withdrawal may also affect the body’s central nervous system including the brain and spinal cord. At Point of No Return, they believe that the natural symphony of chemicals within an individual’s body is injured by sustained intake of medications so they utilize naturally-occurring nutraceuticals and whole food supplements that form an integral part of every program to ease the protracted Effexor withdrawal symptoms.”

The sad part is that Effexor has caused so much damage that patients feel like they have to go to a sort of “rehab” program to avoid suffering from the side effects of quitting the drug. Patients just can't catch a break.

Health Canada is informing health professionals and consumers about changes being made on Reglan labeling. The new labels will warn the public about the drug’s risk of causing tardive dyskinesia.

Tardive dyskinesia symptoms are a lot like Parkinson’s disease in that it causes sufferers to experience uncontrollable movements in the extremities as well as lip smacking, grimacing, uncontrollable eye movements and blinking. The condition also can cause restless leg syndrome.

Reglan has been used in Canada since 1975 and is generally prescribed to treat digestive problems that occur when the stomach empties too slowly. The drug works by speeding up the breakdown of foods in the digestive system. In the U.S., it is mostly used to treat acid reflux (GERD). In 2009, the FDA advised that the drug not be used for a period of longer than 12 weeks because it can increase the chances of patients suffering from adverse side effects like TD.

Right now, Canadian labeling does point out the risks of tardive dyskinesia, but Health Canada is seeking to work with drug manufacturers to make the warning more strenuous. This is likely due to the thousands of lawsuits that have been filed against drug manufacturers amid claims that they were not properly forewarned of the side effects when given the drug for periods longer than the FDA-recommended 12 weeks. For patients that are already suffering from TD, which there is no cure for, this warning came too late.

According to information posted on NewsInferno.com, “Health care professionals are reminded that metoclopramide has not been approved in Canada for the treatment of hiccups, diabetic gastroparesis (partial paralysis of the stomach), nausea and vomiting in pregnancy, or for symptoms of bloating or constipation associated with eating disorders. Metoclopramide is available in various strengths and forms, including as a solution for injection, or as liquid or tablets that can be taken by mouth. It is sold under generic names only.”

The drug Mirapex is prescribed for treatment of Parkinson’s disease, but it has an unusual but frightening unexpected side effect: compulsive gambling. This drug has not been getting the same kind of press attention that drugs like Avandia have, so as a defective drug attorney, I was pleased to see an Eighth U.S. Circuit Court of Appeals decision on the subject. In Gazal v. Boehringer Ingelheim Pharmaceuticals, Inc., Pfizer, Inc., Pharmacia Corporation and Pharmacia & Upjohn, LLC, Nabil Gazal sued the maker of Mirapex for breach of warranty and failure to warn after he developed a serious gambling problem he ascribed to treatment with Mirapex. Gazal, who lived in Australia and Texas, died partway through the legal process, so his widow, Maud Ledhagen Gazal, continued the appeal.

Gazal was diagnosed with Parkinson’s disease in 2002, when doctors at Baylor University prescribed him Mirapex. He began noticing increased urges to gamble shortly thereafter and started losing large amounts of money. Two studies came out in 2005 and 2008 linking Mirapex with gambling, and at least one doctor suggested to him that Mirapex was the problem.Twice, Gazal checked into the hospital for two weeks to try unsuccessfully to quit Mirapex. In early 2006, he wrote to several businesses and acquaintances requesting that they not gamble with him. Nonetheless, he continued to gamble, losing millions and creating problems with his family. His Baylor doctors renewed his prescription in 2007.

Gazal finally succeeded in quitting in May of 2009 and filed this lawsuit against the pharmaceutical corporations. His suit was transferred to Minnesota federal court as part of the Mirapex Pharmaceutical Liability Multidistrict Litigation. The pharmaceutical companies then successfully moved for summary judgment, arguing that Gazal had missed the statute of limitations because his claim started accruing in 2005, when the first study linked Mirapex and gambling. This appeal followed.

On appeal, Maud Gazal argued that the statute of limitations should properly start accruing in 2008, when a stronger study made a causal connection between Mirapex and compulsive gambling. The pharmaceutical companies maintained that 2005 was the proper start date, when the first study linked the two. The Eighth Circuit agreed. Under Texas caselaw, a claim starts accruing when symptoms become so severe or common that a reasonable person would be put on notice that there’s an injury. No scientific studies are required under that standard, the court noted. Thus, Gazal was on notice in 2005, when his symptoms were obvious and a study, a doctor and he himself were all able to connect them with Mirapex. The court also rejected arguments that the statute of limitations should have been tolled. The continuing tort and open courts doctrines both require that plaintiffs not be aware of the injury, which the court had decided Gazan was. Nor was the claim unripe, it said. Finally, it rejected Gazal’s argument that he was of unsound mind in 2005, pointing out that no doctor proposed this and that Gazal remained able to run a profitable company while he was taking Mirapex. Thus, the summary judgment order for the defendants was upheld.

For me, as a dangerous drug lawyer, this decision underscores the importance of taking action quickly. The multidistrict litigation for Mirapex suggests that many people who have similar claims are having their days in court. Gazal may have had a very strong case, but his family will never have their own day in court because the deadline was judged passed. This is why it’s vital to take action early if you plan to pursue a lawsuit, especially a complex one involving serious medical problems or a lawsuit against government agencies. Both of these can be extremely time-consuming, and claims against government agencies generally require plaintiffs to exhaust an administrative process before they can actually sue. As a pharmaceutical liability attorney, I encourage potential clients to get in touch with me as soon as they start considering a legal claim.

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When 18-year-old Sara Carlin's successful suicide was later attributed to her use of the controversial antidepressant Paxil, it caused an outspoken Conservative MP to wage war against Health Canada in a bid to force the organization improve the warnings to doctors against these prescription medications.

Carlin hung herself in her basement in 2007 after taking Paxil for depression. A coroner’s inquest into her death led them to believe that Paxil played a key role in the girl’s death. Now her family is demanding that Health Canada create an independent drug safety board to help improve the way that doctors are warned about drug side effects at a formal inquest. The inquest also suggested that Health Canada force drug companies to submit all clinical trials before they consider approving new medications. This will include clinical trials that show mixed results.

Carlin’s family claims that the girl became depressed after taking Paxil. But Glaxo, the makers of the drug, maintain that she was already depressed when she started Paxil and that the drug made her condition better. The company believes that family issues and school pressure was to blame for her problems.

For its part, Health Canada responded to the inquest demands online by stating that it already was addressing and implementing the suggestions made in the inquest. However, Conservative Parliament member Terence Young, who is an advocate for more vigilance with medication, says that Health Canada has completely ignored the chamber's recommendations for more doctor warnings and it was “misleading” the public into thinking it is making medication safety a priority.

“They are being totally disingenuous," Young says. "They had the audacity to say they’ve already solved this problem. That is blatantly untrue. It’s blatantly misleading.”

Young has stated that the document was an “absolute disgrace” and that it doesn't help Canadians in getting accurate, timely information about the safety of the drugs they are taking. And it certainly doesn't do anything to remove the unsafe drugs from market shelves. With the numbers of lawsuits being filed on behalf of ill and deceased patients growing every day, it is clear that Young has a point.

Now that the Supreme Court has made its ruling with regards to generic drug company liability, many people are now wondering what that will mean insofar as settlements are concerned for the victims of Reglan side effects.

A lot of people were counting on generic drug makers being held liable for needing to post warnings on their medication labels so that patients can be forewarned about possible side effects. However, since the Supreme Court upheld the decision not to hold the companies liable, it has many wondering how that will affect settlements. Right now, that answer is still up in the air as none of the current Reglan lawsuits has gone to trial since the decision was handed down. The only good thing that may have come out about the Supreme Court’s decision is that it was by a vote of 5-4 for the defendant, with many of the justices siding with the plaintiffs.

Actually, the majority Supreme Court Justices have admitted that they think the ruling in favor of Pliva, makers of generic Reglan, is unfair to the people who have taken the generic version and suffered from tardive dyskinesia because of it. Their decision basically removed accountability from the actual makers of the drugs and pushed it onto the brand name drug makers instead. That just seems wrong to many people who think that it gives generic drug companies a “get out of warning label settlement free” card.

The ruling from the justices showed that “the federal law holding brand name drug makers accountable for side effects pre-empts, or trumps, state law that requires generic makers adequately warn about the risk of side effects.” That is just not acceptable. Generic drug makers should have to account for the drugs they push onto the public.

A recent study shows that patients living in nursing homes are more likely to fall down after changes are made to their dosage when taking Effexor. In fact, the study shows that they are 5 times more likely to fall down within two days.

The study, which was published in the Journal of Gerontology: Medical Sciences, suggested that nursing home staff should be more vigilant in keeping an eye on patients that have just been given a dosage change of Effexor. This research was conducted by a Harvard Medical School affiliate. So far, experts believe that the falls could be in relation to acute cognitive or motor effects that have been linked with the drugs.

The lead author of the study, Sarah D. Berry, M.D., conducted the study by observing 1,181 residents of nursing homes in the Boston area who fell. She took that information and compared how often it happened to the frequency of changes made in the dosages of patients taking antidepressants. Berry referred to that time period as a "hazard" period (which was between 1-7 days before a fall). She also did the same thing during a more controlled time period of 8-14 days. What Berry learned was that the chances of patients falling down were a great deal higher within two days of the Effexor dosage change.

Some of Berry’s estimates even suggested that more than a third of the united States’ 1.6 million nursing home residents are actually taking SSRI medications like Effexor, so the rate of injuries is significantly high enough for staff members to pay heed.

That is likely why Berry explains that "nursing home staff should keep a watchful eye on residents in the days following a non-SSRI antidepressant change to prevent falls and clinicians should avoid making changes on weekends or during times when unfamiliar staff is present.”