Drug Injury Attorney Blog

Drug Company Will Pay $1.6 Billion to Settle Off-Label Marketing Charges for Seizure Drug

Fri, 18 May 2012 09:03:23 -0500

As a pharmaceutical liability attorney, I’ve written about illegal “off-label” marketing for several drugs, including drugs that turned out to have dangerous and serious side effects. A drug is used “off label” when doctors prescribe it for uses other than the use approved by the FDA. This is permissible for doctors, but the pharmaceutical companies that make the drugs are not legally allowed to market the drugs for those purposes. That rule has led to several large settlements between the drug companies and state and federal governments over the past few years, including cases in which the drug at issue carried serious potential risks that the drug maker did not warn about. The latest such settlement appears to be one announced by Abbott Laboratories, the maker of seizure drug Depakote.

Depakote (valproic acid) was approved in the United States to treat seizures, prevent migraine headaches and stabilize the moods of those with bipolar disorder. However, it’s also used off-label in a variety of applications, some experimental. According to the Chicago Tribune, a former saleswoman for Abbott sued in 2007, charging the company with asking her and other salespeople to market the drug for schizophrenia, autism and symptoms of dementia. Even more disturbingly, the Depakote whistleblower lawsuits accused Abbott of paying illegal kickbacks to doctors and pharmacists to talk up these off-label uses. A statement from Abbott said it had been under investigation for at least four years, for behavior stretching as far back as 1998.

The off-label marketing was particularly damaging to the federal and state governments because it took advantage of publicly funded Medicare and Medicaid programs, which have funds readily available for drugs doctors deem necessary for covered patients. Nursing homes in particular provided many potential patients for the off-label use to control agitation in dementia patients – but no science backed up that claim, the Justice Department said. No clinical trials showed benefits to using Depakote in schizophrenia patients, either. The settlement from Abbott totaled $1.6 billion, which included $700 million to settle criminal charges, $800 million to settle civil lawsuits brought by various governments and $100 million to resolve state consumer protection matters. Illinois will receive $20 million and Missouri $15 million.

This settlement continues a trend that I, as a dangerous drug lawyer, think is promising. As the article notes, the federal government and many states have aggressively pursued drug companies accused of defrauding Medicare and Medicaid with off-label marketing, kickbacks and similar illegal marketing practices. These drugs include several with concerning side effects, such as the diabetes drug Avandia – associated with an increased risk of stroke and heart disease – and atypical antipsychotics such as Risperdal and Zyprexa, all of which are federally required to carry a warning about the increased risk of death in elderly dementia patients. That’s why off-label marketing is concerning to me as a defective drug attorney: drug companies are not just breaking the law, but also using the drug in populations that haven’t been studied and may carry unknown risks.

Plaintiff Accuses Johnson & Johnson of Lying About Tendon Risks

Fri, 18 May 2012 04:30:00 -0500

On March 20, 2012, a Mississippi resident named Kathy Stroud filed a Levaquin lawsuit on behalf of Gilbert Stroud’s estate. The lawsuit was filed in the Northern District of Alabama and lists drug giants Johnson & Johnson and Ortho-McNeil as the defendants.

Gilbert Stroud suffered from tendon injuries after taking Levaquin and Kathy Stroud blames the drug for his condition. Kathy states in her lawsuit that although a black box warning was issued against Levaquin in 2008, the warning did not include the information for doctors that the drug was more toxic for patient tendons than all of the other antibiotic medications in its class. It is for that reason that Kathy says that the drug’s manufacturers purposely misled doctors about the injury risks linked to Levaquin. Stroud’s lawsuit was included in the Minnesota Levaquin MDL on April 23.

When Gilbert started taking Levaquin in 2008, he was 73 years old. Soon after he started the medication, he suffered a rotator cuff tear that required extensive physical therapy and treatment. Kathy maintains that his injury caused his quality of life to be severely compromised and diminished. Stroud’s lawsuit is similar to many others that have been filed against the makers of Levaquin. At least one of those lawsuits, filed by plaintiff John Schedin, resulted in a nearly $2 million award that was upheld on appeal.

Levaquin research has proven that the drug causes rotator cuff tears and tendon ruptures, yet it is still prescribed regularly. Part of the drug's warning label includes information that the drug is more dangerous to patients aged 65 or older, like Gilbert, and those patients who are taking corticosteroids. While older patients have an increased risk of developing tendon ruptures after taking Levaquin, younger patients also develop the condition. It is for this reason that so many patients are filing lawsuits against J&J amid charges that the company did not properly warn consumers and healthcare officials of the risks before putting it on the market.

New Yaz Lawsuit Attempts to Hold Generic Drug Maker Liable

Wed, 16 May 2012 04:30:00 -0500

A new lawsuit against Bayer, the makers of brand name Yaz and Yasmin oral contraceptives, is attempting to hold the generic makers of the pills liable for the side effects suffered by the plaintiff, Jeri Atkinson. What makes this case interesting is that the defendant of the generic version of Yaz, Ocella, is none other than Bayer.

A Supreme Court ruling stated that generic drug makers cannot be held liable in failure to warn consumers about the side effects linked to medications they duplicate. Atkinson’s lawsuit is claiming that she took both the generic version of Yaz, called Ocella, and the name brand versions of Yaz and Yasmin. Her lawsuit — which was filed on April 2, 2012 and joins the MDL in the Southern District of Illinois — claims that she developed a pulmonary embolism after taking the pills. In 2010, within a year of taking the pills, Atkinson was hospitalized for her injuries. Due to her condition, Atkinson maintains that she has suffered “physical pain and mental anguish, diminished enjoyment of life and medical, health, incidental and related expenses.”

Atkinson’s lawsuits charges Bayer with “fraudulently concealed and intentionally omitting” the true facts about the dangers of Yaz and Yasmin. She also says that she had no way of knowing how dangerous the pills were until the winter of 2010, which was over a year after she started taking the pills. While Bayer is listed as the main defendant in her case, Atkinson is also naming generic drug makers Barr and Teva Pharmaceuticals. She did that because she took the generic version made by Teva and the name brand version made by Bayer. Of course, Bayer also makes Ocella, too, so her case is more interesting than it at first appears. This case should be an interesting one to watch.

Questions Arise About FDA Committee’s Support of Yaz

Mon, 14 May 2012 04:30:00 -0500

When the FDA’s panel advisory meeting handed down its decision about the fate of Bayer's oral contraceptives Yaz and Yasmin, its decision was met with controversy after it was discovered that four of the panel members had financial ties to Bayer. Now four women’s health groups have decided to band together to show how disappointed they are that the panel opted to keep the pills on the market.

The panel was originally put together to address the concerns that Yaz and Yasmin cause serious side effects, including blood clots, which has been repeatedly proven with research. The four women’s groups assert that the FDA committee's decision was “rife with irregularities that prevented voters from fully evaluating the risks of Yaz side effects.” Those side effects have caused thousands of women and their families to file lawsuits.

On March 9, 2012, the women’s groups mailed a letter to Margaret Hamburg, FDA commissioner, that expressed their concern over the members of the voting panel. Their main point of concern is the fact that practicing OB/GYNs were omitted from being a part of the vote because of a perceived conflict of interest, but other members who had financial ties to Bayer were included. The facts about the questionable panelists were made public soon after the vote was taken, but the FDA opted to follow through with the panel’s recommendations anyway.

As more than 10,000 Yaz lawsuits have been filed already, it looks as if Bayer is finally preparing to concede to the dangers of Yaz dangers; the company recently agreed to settle 500 cases to the tune of $110 million, which amounts to about $220,000 per plaintiff. Bayer is also in settlement negotiations in the Illinois MDL cases being presided over by Judge David R. Herndon, which has caused another stay in the proceedings. RD Legal has even agreed to offer up the settlement funds should an agreement be reached.

So far, there is no knowledge as to how the FDA commissioner will respond to the letter sent by the four groups, but if the past provides any insight, Yaz and Yasmin will stay on the market and the panel's decision will continue to be upheld.

Bayer Marketing Tactics the Subject of New Yaz Lawsuit

Fri, 11 May 2012 04:30:00 -0500

The newest Yaz lawsuit, which was filed on April 10, 2012 by Susan and Stewart Lundstrom, is blaming an old marketing campaign for Susan’s deep vein thrombosis and pulmonary embolism. The lawsuit was filed in U.S. District Court in Illinois.

What is under scrutiny in the Lundstrum lawsuit is Bayer’s marketing campaign for the oral contraceptives. Earlier marketing efforts for Yaz came under fire when the ads focused on the off-label uses of the pills while downplaying the risks. The FDA eventually forced Bayer to include the serious side effects linked to Yaz (blood clots, heart attacks, strokes, pulmonary embolisms and gallbladder disease), but it wasn’t done before many women started taking the pills. Off-label uses that were promoted by Bayer in the ads included acne and PMDD.

Like other lawsuits against Bayer over Yaz and Yasmin, the Lundstrums are accusing the company of negligent and careless marketing practices that they believe Bayer either did or should have known about. The source of all of this danger lies in the pills’ main active ingredient, drospirenone, which is a synthetic progestin. On top of all this, blood clots caused by Yaz have been the source of much controversy lately after an FDA panel advisory meeting voted to keep Yaz and Yasmin on the shelves in favor of stronger warnings on the drug’s labels instead. That decision originally met with a good deal of heat after it was discovered that four of the panel members had financial ties to Bayer. However, the FDA upheld the panel’s recommendation.

One thing that may help plaintiffs in these Yaz lawsuits is that Bayer recently agreed to a $110 million settlement, which covers about 500 lawsuits. This move just goes to show that the company may be acknowledging some sort of guilt in how they failed to properly warn patients about the blood clot dangers linked to Yaz. While this settlement may not be repeated by the drug giant, it certainly gives new and current plaintiffs hope that they will receive compensation for their injuries.

First Circuit Upholds Design Defect Verdict for Woman Burned and Blinded by NSAID – Bartlett v. Mutual Pharmaceutical Co.

Thu, 10 May 2012 09:16:16 -0500

As a pharmaceutical liability attorney, I’ve written here a few times before about the potential for a rare but very serious reaction to nonsteroidal anti-inflammatory drugs, a class of painkillers that includes over-the-counter ibuprofen as well as prescription drugs. So I was saddened to see a case out of New England involving devastating injuries to a woman who took an NSAID as prescribed. Karen Bartlett of New Hampshire was given the drug Clinoril (sulindac) for shoulder pain, but developed a hypersensitivity reaction called toxic epidermal necrolysis, which is related to Stevens-Johnson syndrome. She suffered chemical burns and near-blindness, among other injuries. In Bartlett v. Mutual Pharmaceutical Co. et al, she alleged the drug was defectively designed because its risks outweighed its benefits, and the First U.S. Circuit Court of Appeals upheld a jury verdict in her favor.

Bartlett filled the prescription for generic sulindac in late 2004 and developed TEN in early 2005. She suffered chemical burns to 60 to 65 percent of her body and spent 70 days in the hospital, more than 50 in a specialized burn unit. Among her permanent injuries are near-blindness, disfigurement and loss of the ability to eat normally, have sex, exercise and work. She originally sued drug manufacturer Mutual Pharmaceutical Company in New Hampshire state court, and after removal to federal court and pretrial motions, her core claim became one for defective design. She alleged that sundliac’s risks outweighed its benefits, noting that it had more reports of TEN and SJS than other NSAIDs and that a similar NSAID, valdecoxib, had been withdrawn from the market in 2005. The jury ultimately awarded Bartlett $21.06 million in damages. Mutual appealed on a variety of theories, including mistakes of New Hampshire design defect law, federal preemption, inadmissible expert testimony and excessive damages.

The First Circuit examined each claim in turn, but upheld the verdict. On design defect claims, Mutual argued that New Hampshire law requires a showing that a safer alternative design exists, but the appeals court said no such requirement exists — indeed, the state Supreme Court has rejected such a rule. On federal preemption, a recent issue at the U.S. Supreme Court, the appeals court took more time. The Supreme Court declined to find implied preemption in 2009’s Wyeth v. Levine, and while 2011’s PLIVA v. Mensing did find preemption of failure to warn claims for generic drugs, the court drew a distinction between that case’s logic on generic drug labels and claims for design defects. The First next rejected arguments that the two experts for Bartlett were underqualified or unreliable, noting that their use of FDA adverse event reports could actually strengthen Bartlett’s case. It also found that no misconduct by Bartlett’s counsel was serious enough to create a new trial, and that the jury award, while large, was not unreasonable given the “truly horrific” injuries Bartlett suffered.

As a dangerous drug lawyer, I’m pleased to see the First Circuit deciding for a patient whose injuries were clearly quite severe. TEN and SJS are not common, but when they strike, they can sometimes leave the victim with severe, permanent injuries. In fact, death from infection or respiratory distress is estimated in 30 to 40 percent of cases. I am particularly pleased by the appeals court’s thoughtful analysis of the federal preemption issue, which is a popular defense by drug companies and others that wish to escape the consequences of their actions by hiding behind compliance with inadequate federal laws. While it decided for Bartlett, the First acknowledged that PLIVA may apply before leaving it to the Supreme Court to make that call. As a defective drug attorney, I will be watching for that decision very closely.

Bayer Marketing Tactics the Subject of New Yaz Lawsuit

Wed, 09 May 2012 03:50:58 -0500

Yaz Plaintiff Adopts California Master Complaint

Fri, 04 May 2012 04:30:00 -0500

This month saw another Yaz lawsuit plaintiff added to a California master complaint when Katelyn Martin filed her lawsuit against Bayer on April 2, 2012 in the California Superior Court for the County of Los Angeles.

According to Martin’s complaint, she suffered from deep vein thrombosis and a pulmonary embolism on September 2, 2011. While Martin’s case has been filed separately from the master complaint, her case meets with the requirements that allow her case to be included with the others in terms of the accusations being made by other plaintiffs about the side effects they have suffered after taking Yaz and/or the generic version, Ocella. In joining her case to the master complaint, Martin’s lawsuit should move through the system faster.

Yaz, Yasmin and their generic equivalents have been linked to various side effects, including heart attacks, strokes, gallbladder disease and blood clots that can lead to pulmonary embolisms and deep vein thrombosis. Research has shown that the pills’ primary active ingredient, drospirenone (a synthetic progestin), is responsible for these side effects. At one point, FDA officials had received so many complaints about Yaz that they put together a panel advisory meeting to determine if the blood clot risk warranted a recall of the pills. In the end, the panel recommended that Yaz remain on the shelves, but with the stipulation that the warning labels on the drug show the blood clot risk more predominantly. This decision met with criticism after it was discovered that four of the panel members had financial ties to Bayer, but their recommendation was upheld.

While Bayer continues to maintain that Yaz and other drospirenone-based pills are no more dangerous than other birth control pills that don’t contain drospirenone, the company recently agreed to a financial settlement of around 500 Yaz lawsuits for $110 million. That doesn’t sound like a company that is 100 percent certain that its pills are safe. This move on Bayer’s part may just end up helping the other Yaz lawsuits. Of course, I doubt that was Bayer’s intention when they agreed to the settlement.

Poor Drug Research the Main Complaint by Reglan Plaintiffs

Wed, 02 May 2012 04:30:00 -0500

Despite the sheer volume of plaintiffs filing Reglan lawsuits, the main complaint shared by all of them seems to be the lack of proper research on the part of the drug’s manufacturers when conducting the clinical trials.

Reglan is an acid reflux drug that is used to treat various condition including gastroesophogeal reflux disease (GERD), acid reflux and heartburn. The drug has been linked to various serious side effects which include neuroleptic malignant syndrome and secondary Parkinson’s disease. The most common side effect suffered by Reglan patients is tardive dyskinesia (TD). TD is a condition that causes Parkinson’s-like symptoms, including involuntary movement of the extremities, lip smacking and grimacing. The condition is often permanent and can be very debilitating. Reports of these side effects caused the FDA to force the manufacturers of Reglan to update the drug’s warning labels after research showed that Reglan use increased a patients’ chance of developing the side effects when used for periods longer than 12 weeks.

While the manufacturers complied, the warnings came too late for the patients who were already suffering from tardive dyskinesia and the other side effects. At that point, lawsuits already were being filed against the manufacturers of Reglan which alleged that the manufacturers either knew or should have known how dangerous Reglan was, but refused to properly warn consumers and healthcare professionals for the sake of sales.

One thing that is making things more challenging for lawsuit plaintiffs in cases against generic manufacturers of the drug is the June 2011 Supreme Court’s ruling which removed generic drug maker’s liability in generic Reglan lawsuits. This decision is forcing many plaintiffs that have filed lawsuits over the side effects to have to alter their lawsuits. With the research issues being a primary focal point for the plaintiffs, things may improve for them — especially since there is plenty of research to back up what the plaintiffs are saying.

Bayer Tells Stockholders It Has Already Settled 651 Yasmin and Yaz Blood Clot Lawsuits

Tue, 01 May 2012 16:41:48 -0500

As a dangerous drug attorney who has written extensively on lawsuits alleging injuries from Yaz and Yasmin, I was interested to see an article on a recent disclosure to stockholders by their manufacturer, Bayer. The German drug company told stockholders last week that it has paid a total of $142 million in settlements to women and families who allege they were injured by blood clots triggered by the pills. Yaz and Yasmin are newer birth control pills containing the synthetic progestin drospirenone. The chemical was originally marketed as more safer than older contraceptives, but studies and consumer reports eventually showed that it actually poses a higher blood clot risk. These blood clots can lead to life-threatening strokes or heart attacks, sometimes due to pulmonary embolism. Since then, Bayer has faced an increasing number of lawsuits, numbering in the thousands in the United States alone.

The $142 million number will settle 651 lawsuits, Bloomberg News reports, citing a shareholders’ letter. This is a more precise number than Bayer offered earlier in April, when it said publicly that it would pay at least $110 million to settle at least 500 cases. All of these are blood clot cases. The federal blood clot cases are consolidated in East St. Louis, where a judge suspended trials this year in favor of mediation by a George Washington law professor. No settlement has yet been reached that way, and an attorney for some plaintiffs said he didn’t expect one this year. According to Bloomberg, the company is settling only those U.S. lawsuits that allege deep vein thrombosis or pulmonary embolism, two serious consequences of blood clots. The article says these cases account for fewer than half of the 11,900 lawsuits pending in the U.S., involving about 14,000 plaintiffs.

The article did not specify what injuries the others allege, but the plaintiffs’ lawyer told Bloomberg that Bayer has declined to discuss settling cases alleging Yasmin and Yaz caused gallstones or other gallbladder injury. Though scientists have apparently not yet narrowed down a reason, women taking drospirenone-containing birth control pills have reported an increase in problems with their gallbladders. This includes gallstones, a painful condition in which hard stone-like objects build up inside the gallbladder, and inflammation of the gallbladder. At worst, the condition can cause infection or even bursting of the gallbladder, requiring its removal. No transplant is required for those who have had their gallbladders removed, but of course, the condition is painful, frightening and potentially expensive. Some Yasmin injury attorneys have suggested this could be caused by a cholesterol buildup triggered by the drug.

As a defective drug lawyer, I’m not surprised to see the total number of settlements and the total payout climbing. Yasmin and Yaz have been the focus of blood clot worries for several years, including several highly-publicized cases when seemingly healthy, often young, women suffered fatal or life-threatening blood clot complications. Bayer has also faced other criticisms of the drug. In early 2009, the FDA penalized the drugmaker for television commercials the agency said were misleading because they played up the drug’s benefits and omitted enough mention of risks. It was also cited that year for failing to follow quality control procedures at a hormone manufacturing plant. As a pharmaceutical liability attorney, I expect to see more trouble for Bayer related to drospirenone.

Court Docs Claim Bayer Hid Information About Yaz Blood Clot Risks

Mon, 30 Apr 2012 04:30:00 -0500

When court documents were unsealed in a Yaz MDL Illinois in December 2011, Bayer was said to have hidden important information about how dangerous the drugs are. Side effects linked to Yaz and Yasmin are numerous and potentially life threatening. Some of those side effects include heart attacks, strokes, gallbladder disease and blood clots that can lead to serious conditions like deep vein thrombosis and pulmonary embolisms.

While Bayer was made aware of these side effects, the company has long been claiming that Yaz and Yasmin are no more dangerous than older birth control pills. All of these side effects associated with Yaz and Yasmin have been blamed on drospirenone, a synthetic progestin that is one of the primary active ingredients in the pills. Because of the side effects that Bayer is accused of hiding from the public, the company is facing over 10,000 plaintiffs that have filed Yaz lawsuits.

Bayer has tried everything to downplay Yaz’s side effects, including trying to prevent former FDA commissioner David Kessler from testifying in one of those lawsuits. However, the company failed miserably in that effort. Now Kessler’s report is included in the documents that were unsealed on December 4, 2011.

Kessler has stated that before the FDA approved Yasmin back in 2001 (Yaz didn’t get approval until 2006), Bayer possessed study results that showed the drugs’ links to deep vein thrombosis. The problem here is that Bayer didn’t inform the FDA about the test results before the approval was given. Now the company is going to have to face the thousands of plaintiffs’ claims. For now, Bayer has agreed to settle 70 of the cases filed against them, which could lead to many more; but for the time being, the 70 settled cases is a start.

Bayer Yaz Settlement Amounts Exceed $100 million

Fri, 27 Apr 2012 04:30:00 -0500

As Bayer’s Yaz settlements continue to make headlines in recent weeks, many have wondered exactly how much the drug giant agreed to settle for. It turns out Bayer is going to shell out at least $110 million in settlements to cover 500 Yaz lawsuits which were filed over blood clots.

While 500 settlement agreements sounds like a lot, it is small when compared to the 11,000 lawsuits the company is facing over various side effects caused by the birth control pills Yaz and Yasmin. For years, Yaz, Yasmin and other drospirenone-based contraceptives have been linked to serious side effects including heart attacks, strokes, gallbladder disease and blood clots that can lead to pulmonary embolisms and deep vein thrombosis. While Bayer has refused to concede that the pills are more dangerous than older birth control pills that don’t contain drospirenone, these settlement agreements may put an end to that defense.

As far as the settlements go, the $110 million will amount to an average payout of $220,000 for each lawsuit. For its part, the FDA ordered Bayer to increase the warnings on the pills’ label to include stronger mention of blood clot risks. This is in direct reference to a recent panel advisory decision that voted to allow Yaz and Yasmin to stay on the market but recommended such wording be added to the drugs' labels.

When it comes down to opinions about Bayer’s recent settlement agreements, Carl Tobias, professor of product liability at the University of Richmond in Virginia said [to Bloomberg Business Week], “Sounds to me like mediation is paying off. As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less expensive way to deal with these kinds of cases.”

At the moment, the Yaz settlements have not officially been confirmed by Bayer, says the company’s American spokesperson Rosemarie Yancosek. Still, she did state [in an email to Bloomberg,] “Bayer HealthCare confirms that some cases pending in the current Yaz/Yasmin litigation in the U.S. are being settled.”

Ninth Circuit Rules Medtronic Pain Pump Claims Expressly or Impliedly Preempted – Stengel v. Medtronic

Thu, 26 Apr 2012 09:48:52 -0500

I’ve written here many times before, as a dangerous medical device attorney, about the flaws of the Supreme Court’s decision in Riegel v. Medtronic. That 2008 case found that federal law preempts most state-law cases alleging that a dangerous medical device hurt or killed a patient. Effectively, this means medical device makers face absolutely no accountability for making and selling products they know or should know will hurt patients who trust them, which presents obvious safety problems. Patients and their families can and do still try, but they must find a way in which the device violates federal law, or another exception. Such a case was recently dismissed by the Ninth U.S. Circuit Court of Appeals. In Stengel v. Medtronic Inc., Richard Stengel of Arizona and his wife, Mary Lou Stengel, brought a lawsuit alleging several causes of action against Medtronic after a pain pump implanted in Richard made him permanently paraplegic.

The pain pump at issue, which is called the SynchroMed EL Pump, is surgically implanted in patients’ abdomens and delivers medication to the spinal area to control chronic pain. Stengel had it implanted in 2000 and began feeling paralysis and numbness in his extremities in 2005. Doctors eventually realized the device was causing inflammation in his spine and removed it and the buildup, but were unable to stop his permanent paralysis. The Stengels sued under Arizona law, alleging breach of express and implied warranties, negligence and strict liability. Medtronic removed the case to federal district court, which dismissed the claims as preempted by federal law. While that motion to dismiss was pending, the Stengels asked to amend their claims to add a new allegation that Medtronic violated FDA regulations by failing to evaluate and report complaints about the device, which would have allowed warnings to doctors. This was denied on the grounds that it was impliedly preempted anyway.

The couple appealed the dismissal of their original claims as well as the denial of leave to amend, but the Ninth Circuit’s majority upheld the district court. It agreed that the original claims made by the Stengels are expressly preempted by the Medical Device Amendments to the Food and Drug Act and under Riegel; indeed, the Stengels did not deny that Medtronic complied with federal requirements. However, it examined the proposed amended complaint to determine whether it could survive preemption. To the extent that their failure to warn claim paralleled federal requirements, the appeals court said, it is not expressly preempted — but it is impliedly preempted. Relying on 2001’s Buckman Co. v. Plaintiffs’ Legal Committee, the Ninth said allowing the claims to go forward would interfere with the FDA’s authority to punish noncompliance with its own rules. The Ninth acknowledged a split in the circuits on preemption of state failure to warn claims for medical devices, but disagreed with the logic of the opposing circuit. Judge Noonan, dissenting, pointed out that the court’s conclusion creates a situation where manufacturers of “sensitive devices” are liable for their actions “only in nonexistent cases.”

As a defective medical device lawyer, I couldn’t agree more. In this ruling, the Ninth sides with our own home circuit, the Eighth, in finding that Buckman disallows suits based on express violations of FDA rules. Under this logic, plaintiffs may not sue over anything that violates state law as long as it complies with FDA rules — but they also may not sue over violations of FDA rules, even when they parallel state requirements. This is no doubt welcomed by medical device manufacturers that wish to cut safety corners in order to maximize their profits, but it’s a terrible way to protect the public. In addition, the dissent in this case suggests that the ruling violates Supreme Court precedent. Along with the circuit split, this suggests that this case may ultimately wind up being reheard by the full Ninth Circuit. As a pharmaceutical liability attorney, I look forward to more precedent on the issue from the Ninth and its sister circuits.

Levaquin Lawsuits Exceed 3,600

Wed, 25 Apr 2012 04:30:00 -0500

The controversial antibiotic medication Levaquin has caused many patients to suffer from serious side effects, including tendon ruptures and rotator cuff tears. These side effects have forced some patients to file lawsuits against the makers of Levaquin; so many, in fact, that there are currently over 3,600 plaintiffs currently awaiting trials.

Dating from November 2011, there were 1,678 Levaquin lawsuits filed as a part of an MDL in the U.S. District Court for the District of Minnesota. Another 1,975 cases were filed in the New Jersey Superior Court of Atlantic County as part of a mass tort. All of these lawsuits were filed after patients taking Levaquin started suffering from rotator cuff tears and tendon ruptures. While the chances of patients suffering from these side effects increases with people aged 65 and older, a patient as young as 26 recently filed a lawsuit after a rotator cuff tear was blamed on Levaquin.

The chances of patients suffering from adverse side effects also increase in patients using corticosteroids. All of the lawsuits filed against Levaquin manufacturers claim that these side effects were not properly made public. Levaquin is generally used as a treatment for patients with various bacterial infections, including sinusitis.

Even though there have been thousands of Levaquin lawsuits filed, not all of them have reached a courtroom yet. At least one case resulted in an award for the plaintiff. John Schedin was awarded almost $2 million after he claimed that the makers of Levaquin failed to properly warn him of tendon rupture side effects linked to the drugs. The jury agreed, and his award was upheld on appeal.

If you have taken Levaquin and suffered from a tendon rupture or rotator cuff tear, there is still time to file a lawsuit against Johnson & Johnson and Ortho-McNeil, the makers of the drug.

FDA Approves New Yaz Warning Labels

Mon, 23 Apr 2012 04:30:00 -0500

The FDA announced on April 10, 2012 that Bayer’s birth control pills — including Yaz and Yasmin — may now start carrying higher warnings about the risks of patients developing blood clots while taking the pills.

The regulators have approved new labels for Yaz, Yasmin, Beyaz and Safyral as well as the generic versions of these medications since it has been proven that these drospirenone-based pills cause blood clots that can lead to pulmonary embolisms and deep vein thrombosis. Drospirenone is the main medicinal ingredient that makes these pills so dangerous over other pills that do not contain the synthetic progestin.

So far, the FDA said “the revised drug labels will report that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, while other studies found no additional risk of blood clots with drospirenone-containing products.”

This decision by the FDA is likely the result of recommendations handed to agency officials by a panel advisory decision given in December after a team of medical experts got together to discuss the blood clot risks associated with Yaz. During that meeting, the panel voted 15-11 to keep the pills on the market and instead issue stronger warnings against the pills instead. The panel decided that the benefits outweighed the risks involved in taking the pills. The fact that the panel’s recommendation went under scrutiny after panel members were found to have financial ties to Bayer seems to be moot at this point.

Yaz and Yasmin have long been linked to various serious side effects that also include heart attacks, strokes and gallbladder disease. Many people are hoping that the pills will just be removed from the market all together, but at this point, that is not likely to happen. Instead, patients are filing thousands of lawsuits in the wake of the illnesses that these pills are causing. So far, Bayer has already agreed to settle at least 70 Yaz lawsuits for the plaintiffs. There is no word on if the company will settle any more.