Court Docs Claim Bayer Hid Information About Yaz Blood Clot Risks

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

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

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.

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Eighth Circuit Finds Umbrella Insurance Policy Does Not Cover Judgment for Online Harassment – Heacker v. Safeco Insurance Co.

Here in St. Louis, we still remember the sad story of Megan Meier, a 13-year-old girl who committed suicide after cyberbullying by someone who turned out to be her adult neighbor. One result of that case was a series of laws in Missouri making it illegal or civilly actionable to harass someone else online. In the handful of years since, there have been a few cases of people prosecuted or sued under those laws, but this is still a new area of the law, which means legal systems aren’t always set up to handle real-life circumstances as they arise. That’s why, as a St. Louis personal injury attorney, I was interested to see the Eighth U.S. Circuit Court of Appeals decision in Heacker v. Safeco Insurance Co. et al.. Lewis Heacker sued Jessica Wright for a variety of causes of action, all stemming from five years of harassment and defamation that included hacking into his voicemail and online accounts.
Heacker’s Jackson County, Mo., lawsuit accused Wright of sending disparaging letters and emails about him, hacking into his voicemail and Facebook accounts and making anonymous phone calls and texts, all with the intent of defaming and harassing him. The opinion didn’t go into the cause of their dispute, but media reports say Heacker was hired at age 13 as a babysitter to Wright’s kids. Wright reportedly developed a sexual relationship with Heacker that continued until he finished high school and cut off contact, at which time the alleged harassment began. He alleged this caused emotional distress leading to post-traumatic stress disorder and alcoholism, and his lawsuit alleged a variety of tort claims including failure to supervise children, including Heacker as well as Wright’s own children.
Heacker won a $7.3 million judgment in Missouri state court, but was able to collect from only one of Wright’s several insurers and sued the others for equitable garnishment. After removal to federal court, the Missouri district court dismissed, finding no coverage from the policies at issue for the acts and time periods covered.
Heacker’s injuries. Furthermore, the Eighth agreed with the district court that “bodily injury,” under Kansas law, cannot apply to mental illness and alcoholism, even those aspects that are physical. Finally, it rejected arguments that a coverage exclusion for “mental abuse” in the umbrella policy was ambiguous, saying failure to define a term doesn’t necessarily make it ambiguous. Thus, it upheld the district court.
This case underscores a frustration for me and my clients, as a Missouri personal injury lawyer: Just because we win a case doesn’t mean the defendant will pay the full judgment. A case against an individual like Wright can be legally enforced, but Wright is unlikely to have the $7.3 million ordered by the court, so enforcement will simply hurt her credit without getting Heacker any money. The rather large amount of insurance policies Wright carried might have helped if Heacker had been injured by Wright’s dangerous dog or slipped on her front stairs, but they were written to expressly exclude the kind of intentional acts she actually did commit. That’s why, as a southern Illinois personal injury attorney, I start each case by considering what recovery is available, so I can give my clients a realistic assessment of their chances — and plan the litigation.

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More than Expected – The Complexity of Semi Accidents

A recent accident in Chambersburg, PA, may seem very much like any other on the surface. However, it illustrates part of the difficulty caused by semi truck accidents, and why such collisions are not only larger but also more complex than more typical roadway accidents.

The accident, which took place on April 11th, happened at Exit 14 in the southbound lanes of I-81. The tractor-trailer flipped over at the exit ramp at 11:04 a.m., blocking multiple lanes of traffic until several hours later. The reason the accident took so long to clear is the reason that people use semi trucks in the first place — it was transporting a large cargo that had to be cleared away first.

In this case, the truck was carrying several tons of newsprint, large rolls of newspaper stock.

Recovery crews had to raise the truck several feet off the ground on hoists so the cargo could be inspected. Then, the massive rolls of newsprint had to be carted away from the accident on tow trucks. Only after the cargo was removed could crews begin to move the truck itself from the highway and allow traffic to resume. As a result, traffic to that exit was blocked until just after 3:00 p.m.

According to a local man, it took over an hour to travel between two exits following the accident.

Semi trucks are almost always carrying very large cargoes, of course. In some cases, these payloads are hazardous materials such as fuel or chemicals of one sort or another. Many tractor trailer accidents can result in the cargo spilling out onto the highway. But even those that do not spill their cargo, often require it to be secured and transported before the wreck of the vehicle can be dealt with and removed, particularly when the cargo is dangerous or flammable. This is part of what makes semi truck accidents so disruptive, and indeed so very dangerous.

Parents of College Student File Wrongful Death Suit Against Police

In what is sure to be an emotionally-charged motion, the parents of college student Kendrec McDade have filed a wrongful death suit against the Pasadena police department. The same day, they also filed a civil rights violation lawsuit against the city of Pasadena.

The decision came after the death of Kendrec at the hands of police on March 24, around 11 pm.

Kendrec’s parents say that the shooting is the latest in a pattern of unwarranted shootings by the Pasadena police aimed at young black males.

The shooting came as the result of information received from local resident Oscar Carillo, who told the police that two armed men had held him up and stolen his backpack. Officers soon saw Kendrec running, and opened fire. Officers at the time stated that they believed Kendrec had been reaching for a weapon. However, no weapon was found on Kendrec’s body, calling their account into doubt.

Carillo later admitted that the men who allegedly took his backpack from him were not actually armed, despite what he told the police dispatcher who passed the information on to the police. Police tried to bring manslaughter charges against Carillo in connection with the shooting death, but the public prosecutor declined to do so. Carillo is under investigation with an aim toward deportation, but these proceedings have been suspended while the criminal investigation is still ongoing.

Perhaps the most disturbing information about the case is that Kendrec McDade did not die immediately from the gunshots. Instead he was left in the street for some time without medical aid, and according to witnesses attempted to talk to the police as he lay bleeding and dying.

The lawsuits filed by Kendrec’s parents are seeking unspecified amounts of general and personal damages. There is no word yet on any court date, or which judge or judges will hear the respective cases.

Levaquin Lawsuits Exceed 3,600

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

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.

Bayer to Pay $110 Million to Settle Yaz and Yasmin Birth Control Blood Clot Lawsuits

This blog routinely covers the ongoing series of lawsuits over the safety of the birth control pills Yaz and Yasmin (both containing drospirenone). So as a dangerous drug attorney, I was very pleased to see two patient-friendly developments last week. On April 10, the FDA announced it was requiring stronger warning labels for birth control pills containing drospirenone, which include Bayer’s Yaz and Yasmin as well as similar drugs. Then, on April 13, the news broke that Bayer has agreed to settle about 500 of the numerous lawsuits brought by U.S. victims of blood clot side effects from taking Yasmin or Yaz. The pharmaceutical company will pay at least $110 million to settle the cases, an average of about $220,000 per case. Plaintiffs in these cases allege that they developed life-threatening blood clots, leading in some cases to pulmonary embolism, a medical emergency, or even death.
The FDA action came after the agency examined data on 835,000 patients who took drospirenone-containing drugs. Several studies have found that women taking drospirenone, a synthetic progesterone, are as much as three times as likely to develop the life-threatening blood clots as women taking older forms of hormonal birth control. After it reviewed recent studies, the FDA announced it would add information about those studies to the warning label on drugs like Yasmin and Yaz. It also said it would continue to study the issue. Yasmin was the fourth-best-selling birth control pill in the United States in 2011, according to Bloomberg News; contraceptives generated $1.58 billion in sales for Bayer in 2010, behind only a drug for multiple sclerosis. The FDA reports at least 50 deaths connected to the pills between 2004 and 2008.
The Yaz and Yasmin lawsuits allege Bayer and some subsidiaries misled patients about the risks of the drugs in marketing materials. Bloomberg reports that over 11,000 lawsuits have been filed in the United States, most alleging the drugs caused injures from blood clots the manufacturer should have warned about. A February SEC filing by the company said 70 had already been settled, but many more are pending. Federal Yaz and Yasmin injury lawsuits have been consolidated in East St. Louis (not far from our own offices here at Carey, Danis & Lowe), but state cases may be pending across the United States. The judge in the consolidated federal cases postponed the first trial, scheduled for early January, and instead ordered mediation led by George Washington University law professor Stephen Saltzburg. One legal expert interviewed by Bloomberg said the settlements show that mediation may be working.
As a pharmaceutical liability lawyer, I welcome the news that these lawsuits may settle — as long as people injured by the drugs are fairly compensated. This group of victims includes women who suffered serious health problems because they took Yaz and Yasmin, as well as families that lost a loved one due to blood clots and the problems they cause. The main problem with blood clots is that they can enter the bloodstream and travel through the body to the lungs, where they obstruct blood flow and put pressure on the heart. For the patient, the result is difficulty breathing, chest pain, heart palpitations and sometimes collapse. It is considered a medical emergency requiring quick treatment with an anti-clotting drug or, in rare cases, surgery. As a defective prescription drug attorney, I urge patients taking Yaz, Yasmin or other drospirenone-containing birth control pills to talk to their doctors about this newest FDA action.

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Plaintiffs Who Filed Generic Reglan Lawsuits Face New Challenges

Thanks to the June 2011 Supreme Court’s ruling which removed generic drug makers’ liability in generic Reglan lawsuits, plaintiffs who have filed lawsuits over the side effects are being forced to alter their lawsuits. In addition, many of the plaintiffs’ lawyers are encountering specific challenges once the cases reach the courtroom.

Recently, the New York Times mentioned that people who have suffered from Reglan side effects do not have any legal recourse when it comes to pursuing compensation after suffering from side effects. In the Times report, the focus was on two females who suffered from specific injuries after taking a generic version of the medication. One of the women suffered from gangrene and had to have her hand amputated; the second woman had both her hand and forearm amputated after suffering from gangrene. Both women sued the drugmakers of the generic version of the anti-nausea drug they were taking, but there was a difference in how the cases were handled.

One of the women was using a brand name version of the medication, while the other woman used a generic version of the same drug. The woman with the brand name version won her lawsuit, while the other’s lawsuit was thrown out. The main difference in the women’s lawsuits is the version of medication that the plaintiff’s took. That is the difficulty that is currently facing Reglan lawyers today. Even though a couple of generic Reglan lawsuits have been dismissed, they were dismissed in such a way that the plaintiff still has a chance of altering the lawsuit to be re-filed. Most of the time that simply means filing the lawsuit again using the name brand manufacturers as the defendants. Other times, Reglan lawyers just have to be a little bit creative.

Reglan lawsuits have been filed by various plaintiffs who have developed tardive dyskinesia after taking both generic and brand name versions of Reglan, an acid reflux drug. TD is a condition that causes Parkinson’s-like symptoms, including involuntary movement of the extremities, lip smacking and grimacing. Don’t let a few dismissals keep you from seeking the compensation you deserve — just be sure to check out your lawyer’s knowledge of PLIVA v. Mensing when choosing the right one.