Drug Injury Attorney Blog

Terry L. Damm has a filed a Yaz lawsuit, claiming that the controversial birth control pill caused her to develop gallbladder disease that eventually forced her to have her gallbladder removed.

Damm’s lawsuit was filed on February 3, 2012, in the Superior Court for the State of California — the same day as another woman's, Kristina Bishop’s, who filed her lawsuit for the same reason. Both of the women’s lawsuits are claiming that Bayer, the makers of the controversial birth control pill, failed to properly warn them of the dangers linked to the drug.

In Damm’s complaint, the 37-year-old is claiming she had to undergo surgery on March 8, 2010, to remove her gallbladder, and she is blaming Yaz for her condition. Research has proven that gallbladder disease is directly linked to Yaz use in some patients. Other serious side effects are also caused by Yaz. Those side effects include heart attacks, strokes and blood clots that can lead to pulmonary embolisms and deep vein thrombosis.

For its part, Bayer continues to maintain that its pills are no more dangerous than other birth control pills that don’t contain drospirenone, the main ingredient in Yaz and Yasmin. Because blood clots have been linked to Yaz, the FDA held a panel advisory meeting; however, the panel voted that the benefits outweighed the risks in taking Yaz. This decision by the panel caused a controversy when it was discovered that some of the panelists had financial ties to Bayer. This link has caused many people to call for a new panel meeting to be held, but so far, that announcement hasn’t come. Until it does, patients will continue to file Yaz lawsuits in the hopes of holding Bayer liable for their injuries.

Blood clots and deep vein thrombosis were the subject of a recent Yaz lawsuit that was filed on February 7 in the Minnesota District Court by plaintiff Jamee Schaefer-Oney.

Schaefer-Oney’s complaint states that Bayer, the makers of Yaz, didn’t properly warn her of Yaz's dangers before she started taking the pill. After taking Yaz, Schaefer-Oney developed a pulmonary embolism, which is a commonly known side effect of the drug. Her condition occurred within months of her taking Yaz.

Her complaint specifically says that Bayer Healthcare Pharmaceuticals, “did not provide adequate warnings to doctors, the healthcare community and the general public about the increased risk of serious adverse events.” Bayer has continued to maintain that Yaz, Yasmin and other drospirenone-based pills are no more dangerous to take than older pills that don’t contain drospirenone. This stubbornness by Bayer has caused the FDA to force the company to issue stronger warnings against Yaz and Yasmin, but to the patients that have already suffered from the debilitating conditions caused by the pills, those warnings came too late.

Some of the side effects that have been linked to Yaz include: heart attacks, strokes, gallbladder disease and blood clots that can lead to pulmonary embolisms and deep vein thrombosis. Early in February, two other women filed Yaz lawsuits after they claim that the pills caused them to suffer from gallbladder disease that required surgery to have their gallbladder’s removed. February has been a big month for Yaz lawsuits to be filed and it doesn’t appear to be slowing down anytime soon. If you have suffered from any of the side effects linked to Yaz, you may want to contact an attorney to see what your options are.

While lawsuits can’t correct the damage that these dangerous drugs cause, the can help to hold big name drug companies like Bayer accountable for their irresponsible actions in trying to promote their drug’s off label uses while hiding the dangers from consumers and healthcare professionals.

A woman from Connecticut has filed a Yaz lawsuit after she was hospitalized for eight days because of a Yasmin-related diagnosis of deep vein thrombosis.

Kathleen Benanti began taking Yasmin in 2004. She switched to Yaz in 2007. By February 6, 2010, Benanti stopped taking the pills when she was brought to a hospital for an eight-day stay after she was found to be suffering from injuries that were caused by a massive bilateral pulmonary embolism and deep vein thrombosis. Both of those conditions have been proven to be side effects of the drospirenone-based birth control pills.

Benanti decided to file her lawsuit on January 25, 2012, in the United States District Court (New York Southern). The suit is alleging the same thing that many other Yaz lawsuits claims — that Bayer, the makers of Yaz and Yasmin, “intentionally underplayed serious Yaz side effects by excluding side effects information from marketing and promotional materials.”

Bayer has been accused of keeping the side effects linked to the drugs quiet for quite some time now. Some of the side effects proven to be linked to the pills include heart attacks, strokes, gallbladder disease and blood clots that can lead to pulmonary embolisms and deep vein thrombosis. Many of these side effects have been the subject of articles posted in various medical journals, including the British Medical Journal.

Benanti’s case is just one of the thousands that have been filed against Bayer, but the drug company continues to stand behind its pills by claiming that they are no more dangerous than other birth control pills that don’t contain drospirenone. Clearly with the number of lawsuits against the company, combined with the blizzard of evidential studies backing up plaintiff injury claims, Bayer’s defense is quickly running out of steam. In the end, only verdicts will really decide who’s correct.

I wrote this month as a defective medical device attorney about a lawsuit involving an allegedly defective hip replacement implant. So a recent article about a different implant and its defects caught my eye when it ran in the New York Times this week. The newspaper reported that Johnson & Johnson emails reveal internal discussions about significant numbers of failures of the DePuy ASR artificial hip. That stands in sharp contrast to public statements made by the company that no studies showed signs of problems. The hip was ultimately not approved by the FDA or sold in the United States, but it was sold abroad and implanted in an estimated 93,000 patients before its safety recall. A companion version of the product that was sold in the United States, and was recalled at the same time after use in 30,000 American patients.

The DePuy ASR hip is made entirely of metal, which was one of the novel things about it. Unfortunately, the device sheds metallic debris with use, the newspaper said, leading to injuries to patients. It also failed much faster than conventional hip implants — within a few years, instead of after 15 years or more. As a result, the company now faces more than 5,000 lawsuits over the safety of the recalled hip implant models. In defenses against those cases, and in at least one earlier statement to the Times, Johnson & Johnson had said the FDA had not found any safety issues with the implants, and that its internal studies refuted the concerns raised by independent studies. But in the newly released messages, a company executive reported internally that the FDA planned to not approve the implants due to significant numbers of failures.

As a dangerous medical device lawyer, I’d like to point out that this new information comes from the pending litigation against Johnson & Johnson over the hip implants. Regardless of whether those plaintiffs ultimately prevail, the messages should help them in court because they clearly contradict public statements by the company’s executives. No federal law required Johnson & Johnson to publicize the FDA’s rejection letter, but it’s clear from that letter’s existence that the company has not told the truth to the public — and that’s what matters in lawsuits like these. For example, the Times reports that internal documents say executives did not believe they could overcome the FDA’s objections to the rejected device, even with new data. Nonetheless, the company said in 2009 and recently that its decision not to sell this device in the U.S. was based on declining overseas sales.

At Carey, Danis & Lowe, we focus our practice on patients who have suffered injuries or a loss in the family because of defective or dangerous pharmaceutical products. All manufacturers have a legal duty to ensure that their products are safe when they offer them to the public; if they know of safety risks, they must warn potential users of those risks. When manufacturers seem to be covering up a safety risk by misleading the public into making potentially dangerous medical decisions, people who get hurt have the right to hold them legally and financially liable. Our pharmaceutical liability attorneys based in St. Louis represent clients across the United States who are pursuing individual or class actions against these companies. We help clients win the money they need to get medical treatment, make up for lost income and more.

Continue reading " Internal Messages Show Johnson and Johnson Lied About Safety Studies on Hip Replacement " »

Recently, one North Carolina woman’s Reglan lawsuit was continued despite the fact that there was a motion to dismiss the case filed by the defendant.

This case was filed against the manufacturers of a generic version of Reglan. The original makers of the name brand version of Reglan are Wyeth and Schwarz Pharma. However, it was the generic manufacturers Actavis and PLIVA that have been trying to avoid lawsuits. Defense lawyers have been relying on a Supreme Court ruling made in 2011 that removes generic drug manufacturers from liability from injury claims to have their cases dismissed. But on January 11, 2012, a federal court judge refused the motion.

The continuing case was filed by Mary Cleo Couick, who sued all four of the companies amid claims that their warning labels as well as package inserts did not properly warn the public or healthcare professionals of Reglan’s link to tardive dyskinesia, a common adverse side effect of the drug. Tardive dyskinesia is a movement disorder that is characterized by patients experiencing involuntary movements of the extremities, lip smacking, grimacing, tongue protruding and other Parkinson’s-like symptoms.

Couick’s lawsuit forced the judge to have to decide whether the drug label requirements “preempted Couick’s state law tort claims.” The judge in Couick’s case ruled in favor of a dismissal against her claims against Wyeth and Schwarz Pharma, but would not do the same for PLIVA and Actavis. The judge’s ruling held that “the generic manufacturers had not provided any proof that they used the same labeling information as Wyeth and Schwarz during the period at issue in Couick’s Reglan side effects lawsuit.”

The ruling in this case provides hope for future claimants, who may have been discouraged by a recent ruling to dismiss in another Reglan case. It just goes to show that each case is different and all claims have merit. There is no way to be able to predict the outcome of any trial since all circumstances are different.

A recent Levaquin lawsuit that was filed by a resident of New York is asking for a whopping $90 million in damages after the plaintiff claimed that his tendon injuries (Levaquin-related) caused him to suffer from severe pain, suffering and huge medical expenses.

Frank Annibell’s Levaquin lawsuit was filed on December 29, 2011 in the U.S. District Court for the Eastern District of New York. He is claiming that the controversial antibiotic “caused him severe physical injury due to a tendon rupture.” Annibell’s claim asserts nine causes of action against the makers of Levaquin, Johnson & Johnson and Ortho-McNeil Janssen Pharmaceutical. Of the causes of action, negligence, strict products liability, fraud and breach of implied and express warranties were listed.

Kathleen Annibell, Frank’s wife, is also a plaintiff in the case. Kathleen’s lawsuit is claiming she suffered from a loss of consortium. Each claim that the plaintiffs have made against the defendants was amounted to $10 million each, making the total amount of the lawsuit reach $90 million. However, even with the case having been filed in New York, it has been transferred to the U.S. District Court in Minnesota, which is overseeing the Levaquin MDL.

As for the side effects suffered by Frank, the injuries include “bicep tendonitis, a partial tear of the common forearm extensor, and a right rotator cuff.” Annibell has requested a jury hear the case. This lawsuit is just one in a string of other lawsuits that claim that consumers and healthcare professionals weren’t properly warned of the severe adverse side effects linked to Levaquin, which is used to treat various types of infections including bronchial and sinus infections. One such lawsuit was filed by former plaintiff John Schedin, who won $1.8 million in 2011. That ruling was upheld on appeal and left future plaintiffs hoping to have the same experience Schedin had. That is certainly a possibility since there is plenty of evidence to substantiate the Levaquin side effects claims.

When Sue Swaw filed a Reglan lawsuit on March 24, 2011, in the Circuit Court of the Fourth Judicial Circuit for Duval County, Florida, her claim was originally made against the manufacturers of the generic version of Reglan, which included Teva, PLIVA and Qualitest Pharmaceuticals. However, due to the ruling by the Supreme Court that removed their liability against the side effects linked to the acid reflux medication, Swaw amended her complaint on September 22, 2011. The amendment included the brand name manufacturer of the drug Wyeth Pharmaceuticals. Now Swaw’s complaint will join other similar complaints which will be moving through the U.S. District Court, Middle District of Florida on November 17, 2011.

Swaw’s lawsuit claims that the she developed tardive dyskinesia after taking Reglan from 2006-2009, which far surpasses the FDA-recommended 12 weeks. Like countless other Reglan lawsuits, Swaw says that the company failed to properly warn her of the serious adverse side effects linked to the drug and accuses the company’s warning of being “misleading and inadequate.”

Many former Reglan patients have filed lawsuits just like Swaw’s amid claims that they were not properly warned of their chances of developing tardive dyskinesia if they took the drug for longer than 12 weeks. Many patients developed the condition before the FDA issued a black box warning against Reglan in 2009. Tardive dyskinesia is a condition that is characterized by patients suffering from Parkinson’s-like symptoms, which include involuntary movements of the extremities, twitching of the eye, lip smacking and grimacing. There is no cure for the condition.

As numerous Reglan patients have filed lawsuits against Wyeth, the makers of the brand-name version of Reglan, as well as against the generic makers of the drug, the Supreme Court decision in Mensing v. PLIVA caused many patients to have to do just what Swaw did and amend their complaints. It is likely that many more plaintiffs will be following Swaw’s decision and making sure that these drug companies are held liable for their injuries.

I’ve written here many times before as a dangerous drug attorney about the diabetes drug Actos (pioglitazone). A relative of the now-discredited drug Avandia, Actos has been investigated for some of the same cardiovascular safety flaws Avandia has. However, the most recent research on Actos side effects has identified a different safety flaw: an increased risk of bladder cancer. Studies showing the elevated risk led to withdrawals from the market last year in France and Germany, but no move to take it off the U.S. market. Numerous patients across the U.S. have filed lawsuits, alleging Actos caused their cancer. As the Associated Press reported Feb. 14, those lawsuits have been consolidated in Louisiana federal court, and the first hearing in that case will be held in late March.

Actos is made by drug company Takeda Pharmaceuticals, a Japanese company whose American branch is based in Illinois. Legal observers expect Takeda to face several thousand claims overall that Actos harmed plaintiffs by causing bladder cancer. The FDA’s most recent safety announcements about Actos came in August of 2011, when it announced a black box warning — the most serious warning the FDA has — about the increased risk of bladder cancer. That followed a June announcement that an ongoing study showed the risk increased for patients who have been taking Actos the longest and at the highest doses. This came shortly after a French study found an increased risk of bladder cancer, which also correlated with increased exposure and increased dosage. This led to the French and German withdrawals. In fact, studies dating back before the drug was approved have found an association between Actos and bladder cancer, though the FDA did not start issuing warnings until 2010.

As a defective drug lawyer, I’m disappointed that it took so long for the FDA to issue safety warnings on Actos and bladder cancer. Part of this was because the bladder cancer findings announced in 2010 and 2011 came from a long-term, ten-year study. But those findings echoed findings from animal studies conducted earlier, suggesting that researchers already had some idea of what they might find. It’s easy to see why people who believe Actos caused their cancer, or their loved ones’ cancer, might have preferred a quicker announcement or at least more complete information. Now, Actos has finished its patent, meaning it’s at the end of its profitability for Takeda anyway. All those victims can pursue lawsuits, and many have or will — but it’s likely that none of them would rather have money than their health or their loved ones’ health.

Based in St. Louis, Carey, Danis & Lowe represents clients across the United States who are seeking justice and financial compensation for the harm done by dangerous prescription or over-the-counter drugs. Very often, these are drugs like Actos, that are wildly profitable and new, but have significant red flags for safety that are later confirmed by independent studies. When taking a prescription drug hurts patients instead of making them feel better — and especially when the drug maker knew or should have known about it — patients can and should hold the drug maker legally responsible for the results. Our pharmaceutical liability attorneys help patients recover damages for their disease and serious physical injury as well as lost income, increased medical costs and in many cases, lost quality of life.

Continue reading " Initial Hearing Set in Consolidated Lawsuits Alleging Actos Caused Bladder Cancer " »

William Frank Jr., a New York resident who filed a Levaquin lawsuit on January 24, 2012, is only one plaintiff among a host of others with lawsuits moving in the U.S. District Court, District of Minnesota. This MDL is being presided over by Judge John R. Tunheim and it seems that this MDL will continue to grow as more and more plaintiffs are joining it.

Frank’s lawsuit was filed against Johnson & Johnson and Janssen Pharma, the makers of Levaquin, amid claims that they “actively concealed test results (and) studies and clinical trials showing a statistically high risk of tendon injuries associated with Levaquin.” According to Frank’s claim, he started taking the antibiotic around March 7, 2010, and by April 14, 2010, he had developed a left supraspinatus tendon rupture (rotator cuff tear) in his left shoulder, which is one of the adverse side effects linked to Levaquin.

Cases like Frank's are growing every day despite the fact that the FDA issued a black box warning against Levaquin back in 2008 — a full two years before Frank started taking the drug. Most of the patients are claiming that the manufacturing companies purposely hid the dangerous side effects like tendon ruptures from the public and healthcare professionals. Warnings against the drug also state that the risks of suffering from Levaquin side effects increases in patients who are older than 65 and those who take corticosteroids. Despite these dangers, Levaquin is still among the most popular antibiotic medications on the American market.

However, the drug’s popularity doesn’t protect the drug companies from the numerous lawsuits that have been filed against the manufacturers of Levaquin. At least one of those cases resulted in a $1.8 million award for the plaintiff John Schedin — an award that was upheld on appeal. Lawsuits against Johnson & Johnson will likely continue until the company is fully held liable for the injuries to the patients that take this drug.

As people all across the United States become more and more informed of the dangers associated with Yaz, the group Drug Watchdog has taken up its own initiative against the drospirenone-based birth control pills. This initiative is designed to help locate all of the victims of the drug’s serious adverse side effects, according to group officials.

Drug Watchdog is a private advocacy group located within the United States that was formed to help the victims of various dangerous drugs and medical devices. They keep an eye out for the dangerous medications and the victims of these drugs’ side effects. Right now, the group is in the middle of a hardcore initiative that seeks to find the women who have suffered from severe and potentially life threatening side effects while taking Yaz, Yasmin and the generic version Ocella of those pills.

Ever since the FDA issued a warning letter about Yaz to the drug’s manufacturers, Bayer, about the pills’ side effects, Drug Watchdog has been monitoring the situation.

"The FDA has also strongly criticized the drug maker for failing to highlight the risk factors associated with these birth control pills," the group notes. "These risk factors or severe side effects include heart attacks, strokes, blood clotting, gallbladder issues and other serious medical issues."

The Drug Watchdog takes Yaz and other drospirenone-based side effects very seriously and seeks to reach out to the victims of the drug.

"We want to talk with users of the birth control pills called Yaz, Yasmin, or the generic version Ocella, if they have had any type of severe medical side effects, or who have suddenly developed an unexplained severe medical condition," Drug Watchdog says. "We want to get the word out to all women about these drugs, because of the potential for heart attacks, strokes and or other serious medical conditions.”

With such serious side effects being tied to Yaz and Yasmin, many lawsuits have been filed against Bayer. But the company stubbornly continues to admit that its pills are more dangerous than other non-drospirenone-based birth control pills — despite the many studies that prove otherwise. Most recently, an FDA advisory panel met in December and voted to keep the pills on the market, but after a conflict of interest was discovered regarding some of the panelists who voted, the panel’s decision may not stand. This means that Bayer may still be facing a recall of the dangerous birth control pills, and Drug Watchdog is likely going to be furthering its efforts to have Yaz rebuked by women seeking birth control.

A lawsuit that was filed on January 19, 2012, in California has a lawyer representing a group of different plaintiffs who are all claiming that they developed tardive dyskinesia after taking the controversial acid reflux drug Reglan.

For this lawsuit, at least two of the plaintiffs are minors who have developed tardive dyskinesia after taking Reglan. This side effect forced the FDA to issue a black box warning against the drug back in 2009. Tardive dyskinesia is a debilitating condition that is characterized by patients suffering from Parkinson’s-like symptoms including involuntary movements of the extremities, tongue protrusion, lip smacking, facial grimacing and eye blinking. For many patients, this condition is permanent and requires ongoing medical care.

As with many similar Reglan lawsuits, the plaintiffs are accusing the defendants, Wyeth, the makers of Reglan, of knowing about the tardive dyskinesia side effects and not properly giving warning to patients or healthcare professionals. The plaintiffs in this case are claiming that they will have continuously “experience disfigurement, disability, embarrassment, loss of ability to provide household services for himself or herself, physical pain, mental anguish, potential death and permanently diminished enjoyment of life.”

Drug companies are experiencing a great deal of negative press these days over the side effects of their prescription medications, which has many consumers and experts wondering why drugs like Reglan aren’t simply recalled. This is particularly true in the case of relatively mild medications like Reglan, which is used to treat heartburn and acid reflux conditions. With OTC options out there like Rolaids, Tums and Pepcid AC, it is a wonder that patients need Reglan at all. Even patients suffering from more severe forms of acid reflux can turn to prescription strength medications like Ranitidine. It just doesn’t seem worth it for doctors to continue to prescribe Reglan, when other, safer options are available.

As a defective medical device attorney, I was pleased to read a decision keeping a defective medical device claim alive despite dismissal by the trial court. In Bass v. Stryker Corp. et al., Alton Bass sued several related Stryker entities, alleging that he was injured by a malfunctioning Stryker hip implant. He made both state-law and federal claims, but the district court dismissed his state claims, saying they were barred by the Supreme Court’s 2008 Riegel v. Medtronic, which found that many state-law tort claims in defective medical device lawsuits are preempted by federal law. The Fifth U.S. Circuit Court of Appeals ultimately affirmed the dismissal of his breach of warranty claims; remanded certain other claims for determination of whether they were based on FDA-related laws and rules; and remanded a Texas state Deceptive Trade Practices Act claim for determination of whether it relies on breach of implied warranty.

Bass underwent hip replacement surgery in August of 2007 and received a replacement hip made of four Stryker-manufactured parts. He continued to feel pain in his hip for the next two years despite following his doctor’s instructions. When he underwent a revision of the hip replacement, the surgeon found that the hip replacement was too loose. In his lawsuit, Bass alleges that the looseness was caused by manufacturing residuals that caused his body not to grow over the replacement properly. He sued in the Northern District of Texas, alleging strict liability, negligence, design defects, breach of express warranty, breach of implied warranty and violations of the Deceptive Trade Practices Act. Stryker moved to dismiss, arguing this was preempted by the Medical Device Amendments to the Food, Drugs and Cosmetics Act under Riegel, and the motion was granted. Bass appealed.

Under Riegel, the Fifth Circuit said, a state tort claim is preempted if the federal government has established requirements for the device and the state claims set safety or effectiveness standards different from, or in addition to, federal standards. Bass’s hip replacement satisfied the federal requirements prong of this test, the Fifth said, because of the kind of approval it received. However, it drew fine distinctions among Bass’s tort claims when it came time to decide whether those claims were preempted or merely parallel to FDA requirements, and thus acceptable. Under recent Fifth Circuit decisions — including one in a lawsuit over the same brand of hip replacement — a medical device cause of action may continue if the plaintiff can show that the device manufacturer violated the FDA’s Medical Device Reporting regulations. To the extent that Bass’s claims are based on violations of those regulations — including a safety recall of the product — the court found that they are parallel and can survive a preemption defense. Thus, it remanded many of the claims for determination of their basis.

As a pharmaceutical liability lawyer, I’m pleased to see so much thought put into tort claims for defective medical devices after Riegel. This federal preemption finding was bad news for injured people like Bass, who were initially thought to be without any recompense at all. As the Fifth Circuit noted in its opinion, at least some courts have instead allowed claims that parallel federal requirements, permitting plaintiffs to collect when there has been a violation of an undisputed FDA regulation or federal law. This is fewer rights than plaintiffs had before Riegel, but it’s better than allowing medical device manufacturers to avoid any responsibility for their actions at all. As a dangerous medical device attorney, I frequently see patients who, like Bass, have suffered needlessly because of a device defect they had no way to anticipate or fix.

Continue reading " Fifth Circuit Resurrects Defective Medical Device Claim Involving Hip Replacement – Bass v. Stryker Corp. et al. " »

After word got out about those researchers from Brown, Emery, Harvard and Yale who were accused of signing their names to ghostwritten articles (posted in medical journals), many started questioning the penalties that would be involved. That is perhaps why an article that was recently published in the journal PLoS Medicine has gotten so much attention.

In the article, the authors express what they believe are some of the legal penalties that could (or should) be applied to those academics whose actions have been considered fraudulent at the least. An example of this type of fraud can be found in the case from 2011 wherein a psychology professor from the University of Pennsylvania accused some of his colleagues of signing their names to a ghostwritten article that was written on behalf of the controversial drug Paxil, which has since been the subject of many lawsuits over the drug’s side effects (which include aggressive thoughts and behavior, suicidal thoughts and behavior, birth defects and others).

By many in the medical community, this action by the professors is nothing short of fraud. Bijan Esfandiari, who is one of the authors of the article in PLoS Medicine, says, "By lending his name, the author is contributing to fraud, and the ghostwriter is involved in the conspiracy as well."

Esfandiari’s co-authors include Xavier A. Bosch, who is a professor in the department of medicine at the University of Barcelona, and Leemon McHenry, who is a lecturer and specialist in bioethics in the philosophy department at California State University at Northridge.

Esfandiari believes that because of these ghostwritten articles, doctors are being given potentially dangerous information about the risk-to-benefit ratios of drugs like Paxil that encourages them to prescribe the drugs. The doctors do so believing that the information contained in the articles are written by reputable medical authors. What the doctors don’t realize is that often times, the reputable “authors” of these articles may not have even read it before singing their names to it. This is why Esfandiari and his colleagues believe that these medical academics should be held legally liable for their actions by product liability lawyers.

"We're putting out a novel theory. It hasn't been tested yet. But I'm sure lawyers will, if the practice doesn't stop," Esfandiari says.

Other consequences for these so-called fraudulent actions (which haven’t been pursued in court yet) may be even worse. For example, the real authors and their ‘ghost counterparts’ could be charged by the U.S. government under the federal False Claims Act on the grounds that Medicare uses these journal articles when it decides which drugs will get reimbursements. Finally, authors and their ghost counterparts could also be charged with committing violations against the federal anti-kickback statute, which prevents drug companies from offering doctors and medical researchers money to endorse their products.

Esfandiari and his colleagues are hopeful that these types of penalties and charges could help to prevent the ghostwriting to continue in the future. As in the case against the ghostwriters of the Paxil article, none of these measures has been pursued as of yet, but with any luck, patients who have been given the drugs by doctors who followed the information posted in the ghostwritten article may be able to pursue the matter in the future.

February 6, 2012

St. Louis – St. Louis–based law firm Carey, Danis & Lowe announces the filing of a lawsuit on behalf of 18 plaintiffs against Pfizer (NYSE: PFE), maker of the antidepressant drug Zoloft.

Zoloft (generic name sertraline) belongs to a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs. The U.S. Food and Drug Administration has approved Zoloft for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, acute post–traumatic stress disorder, premenstrual dysphoric disorder and social anxiety disorder.

The lawsuit, Shainyah Lancaster, et al. v. Pfizer, Inc., cause no. 1222-CC00766, was filed on Feb. 2 in St. Louis Circuit Court on behalf of 18 children born with defects after their mothers were prescribed Zoloft while pregnant. The suit was brought on behalf of the plaintiffs by the law firms of Carey, Danis & Lowe; Matthews & Associates; Freese & Goss; and Clark, Burnett, Love & Lee.

The suit notes that SSRIs have been found to cause severe birth defects in the children of women who were prescribed the drug while pregnant and alleges that Pfizer knew or should have known of SSRI studies revealing that children born to mothers who had taken SSRIs during pregnancy had a greater risk of congenital birth defects such as atrial septal defect, multiple holes in the heart and persistent pulmonary hypertension of the newborn. The plaintiffs also allege that Pfizer knew that physicians were prescribing Zoloft to women of childbearing age but failed to adequately warn the medical community and the public of the danger.

The lawsuit asserts state law claims against Pfizer of negligence; negligence of pharmacovigilance, which requires Pfizer to monitor safety data for its drugs; strict liability; negligent design; failure to warn; and fraud. The suit seeks actual and punitive damages.

“Since the 1990s, mounting evidence has shown that SSRIs, including Zoloft, are dangerous for pregnant mothers and their developing babies,” explains Jeffrey J. Lowe of Carey, Danis & Lowe. “Unfortunately, Pfizer hid that information.”

Founded in 1995, St. Louis–based Carey, Danis & Lowe, with offices in Missouri and Illinois, handles personal injury, pharmaceutical liability, product liability, medical malpractice, class action and commercial cases throughout the United States.

The Minnesota Levaquin MDL continues to grow as yet another case has been added to the docket. The MDL, which is being presided over by the Honorable John R. Tunheim, now includes plaintiff Arthur Dement on the list of plaintiffs suing over tendon ruptures.

Dement’s claim is that he developed a tendon rupture after taking the controversial antibiotic Levaquin as a means of treating an upper respiratory infection. While Dement’s claim was originally filed on July 25, 2011, his case was eventually transferred to the Minnesota MDL on January 12 of this year. Dement’s lawsuit claims the same thing that many Levaquin lawsuit claim; that he was unaware of the tendon rupture risks associated with the drug before he started taking it. His complaint states that Johnson & Johnson, the makers of Levaquin, “misrepresented that Levaquin was a safe and effective way to treat bacterial infections.”

Dement’s case joins many other similar cases in the MDL. Research has proven, and continues to prove, that Levaquin tendon rupture risks are unreasonably high. This is particularly true with patients that are older and those patients that take corticosteroids. The tendon ruptures are very painful and debilitating for some patients, and can often require surgery to correct. As this Minnesota MDL continues to add claimants, even more are expected to join in their efforts to hold the drug company liable for their injuries.

One case which made it to a jury was decided in favor of the plaintiff, John Schedin, who suffered from a tendon rupture after taking Levaquin. In his case, the jury awarded him almost $2 million, the appeal of which is currently pending. This certainly gives new plaintiffs a good reason to be optimistic in their own cases. With the research verifying the increased risk of tendon ruptures and the FDA’s issuance of a black box warning against Levaquin, many more favorable verdicts may be handed down. While these verdicts cannot take away from the pain and suffering of a tendon rupture injury, the possibility of holding the manufacturers liable for it can certainly bring a smile back to patients' faces.

While most people associate tendon ruptures with Achilles tendons, an Illinois resident named Margaret A. Frass has recently filed a Levaquin lawsuit on January 3, 2012 that claims that she developed a tendon rupture in her knee after taking the controversial antibiotic back in 2005.

The fourth bellwether trial, which had plaintiffs claiming that they were suffering from Levaquin tendon ruptures, has already beed decided in favor of the defense. Frass’ complaint states that she first started taking Levaquin in April 2005. Soon after starting the antibiotic medication, Frass started experiencing pain and swelling in her knee. Sometime around September 15 of 2005, she was diagnosed with a tendon rupture in her right patellar tendon.

It is the patellar tendon that helps to attach the front of the shinbone to the patella that rests just underneath the knee. Frass’ complaint accuses the defendants in the case, Johnson & Johnson and Ortho-McNeil-Janssen Pharma, of failing to properly warn the public and healthcare professionals about the risks associated with Levaquin. Frass’ complaint also accuses the companies of purposely refusing to keep healthcare professionals up to date on the most recent news regarding tendon rupture risks regardless of the Dear Doctor letters that had been issued throughout Europe that specifically warned of tendon toxicity.

Studies have consistently proven that Levaquin causes tendon ruptures and as many as three tendon cases have already made it into a court room. Of those cases, one plaintiff was awarded almost $2 million after a jury agreed that John Schedin’s tendon damage was caused by Levaquin. Many more Levaquin lawsuits have been filed by numerous people who have been hurt by the antibiotic and who are hoping to hold the manufacturers liable for their injuries.

If you have suffered from a tendon rupture after taking Levaquin, you may want to contact an attorney to see if you are eligible to receive compensation.

As a dangerous drug lawyer, I was pleased to see an appellate victory for a family whose daughter suffered serious birth defects from the use of a drug her mother was advised and permitted to use throughout pregnancy. In Fredericks v. Malouf, Eric and Kristine Malouf sued Kristine’s neurologist and obstetrician over injuries to their daughter, Kimberly. Kristine had been taking the drug Depakote (valproic acid) to treat seizures before her pregnancy, under the supervision of Dr. Ruth Fredericks. They discussed pregnancy with Fredericks and an obstetrician, Dr. Martin Tucker, but neither doctor took Kristine off the Depakote. The Maloufs sued Fredericks in Hinds County and added Tucker to the complaint later, whereupon the defendants moved to change venue to Rankin County. The trial court denied this, finding it had been abandoned, and the Mississippi Supreme Court agreed.

Kristine started taking Depakote in 1994 under Fredericks’s supervision, and went to Fredericks in 1995 to discuss the possibility of pregnancy with Depakote and epilepsy. Fredericks referred them to Tucker, and they conceived in mid-1996. Kristine continued taking Depakote under both doctors’ care, though Fredericks was no longer treating her after November of 1997. In March of 1997, Kristine gave birth to a seemingly healthy Kimberly. However, Kimberly was diagnosed at 22 months with a type of brain injury called periventricular leukomalaca, and at seven years with valproate syndrome, a collection of facial abnormalities. Her parents sued Fredericks in 2002, claiming Fredericks prescribed insufficient Depakote that caused Kristine to have seizures during pregnancy that caused the brain damage. When they added Tucker to the suit in 2006, they changed their case to allege that the brain damage was caused by Depakote itself.

Tucker moved to transfer the venue to Rankin County, arguing that all treatment was performed at his office there. Fredericks joined the motion. However, Tucker did not file a supplemental joint motion for the change of venue for nearly three years. The trial court thus denied the motion, finding the defendants had abandoned it by failing to pursue it for three years, during which time the deadline for pretrial motions passed and discovery continued. Defendants filed an interlocutory appeal.

On appeal, defendants argued that venue cannot be waived, pointing to a state law requiring all lawsuits against doctors to be filed in the county where the treatment took place. The Mississippi Supreme Court disagreed, noting that it has never ruled that defendants cannot waive their rights. All litigants are on notice that they may lose rights by failing to comply with the court, the high court said. Though Tucker submitted evidence that he tried to reschedule the hearing on his motion — and the trial court apparently used rules not permitted by Mississippi’s Rules of Civil Procedure — the Supreme Court found that the trial court’s nonstandard rules didn’t keep Tucker from requesting a hearing. In the time during which he failed to act, the court noted, he otherwise actively participated in the process. Thus, it upheld the lower court’s finding that the venue motion had been abandoned.

As a defective drug attorney, I’m particularly interested in the drug aspect of this case because Depakote is in pregnancy category D. That means it’s known to cause birth defects, but doctors may still prescribe it if they believe the benefits outweigh the risks. In fact, medical literature shows that the first report of harm to a fetus from a mother’s Depakote use was in 1980, sixteen years before Kristine Malouf got pregnant. Over the last three years, the FDA has issued two warnings to pregnant women taking Depakote, saying the drug can increase neural tube defects and lower IQs in their babies. As a result, doctors are now encouraged to find another epilepsy drug to prescribe as an alternative during pregnancy, or reduce dosage of Depakote and add folic acid supplements if there is no alternative. Depakote’s maker, Abbott Laboratories, is also facing allegations by ex-employees that it paid kickbacks to doctors who prescribed it for off-label use in dementia patients. As a pharmaceutical liability lawyer, I believe patients are entitled to the fullest possible information on Depakote’s safety as well as its marketing practices.

Continue reading " Mississippi Supreme Court Permits Drug Lawsuit to Continue in Original Venue – Fredericks v. Malouf " »

When plaintiff Laura Tenorio filed her Yaz lawsuit in the Superior Court of the State of California, County of Los Angeles on September 1, 2011, she likely wasn’t expecting that her case would be joined by many other similar lawsuits. But that is exactly what happened when Tenorio used her lawsuit as a means of holding Bayer, the makers of Yaz, liable for her blood clots. Her case joined several coordinated lawsuits there, with plaintiffs alleging serious side effects like Yaz blood clots, Yaz pulmonary embolism and Yaz gallbladder disease.

When Tenorio filed her case, the case was then removed to the multidistrict litigation (MDL) that is being held in the Southern District of Illinois, which just happens to be the same location that the first bellwether trial was placed on hold pending mediation. Tenorio’s complaint basically states that she developed blood clots after taking Yaz and that Bayer didn’t properly warn her of the dangers linked to the drug before she took it. Because of this failure on the company’s part, Tenorio claims that she suffered from serious physical injuries. Tenorio is suing for “medical expenses, general damage, and loss of earning capacity.”

Tenorio’s case was added to the MDL because “it satisfies both diversity of citizenship and amount in controversy. The court determined that the amount in controversy exceeds the required $75,000.” With Bayer’s stubborn insistence that its dropirenone-based birth control pills (Yaz, Yasmin) are no more dangerous than other non-dropirenone-based pills, despite the studies that prove the opposite, these lawsuits will only continue to magnify. Even the FDA had reviewed the blood clot risks linked to Yaz and decided to strengthen the warnings on the labels, but this effort just isn’t enough for the countless women who have battled debilitating illnesses and even death after taking these dangerous pills.