The Recall Lawyers

This past Thursday, March 21, 2013, a panel of federal judges, known as the Judicial Panel on Multidistrict Litigation, convened in San Diego to hear plaintiffs' request for consolidation and coordination of Mirena lawsuits.

The dangerous medical device attorneys at Jones Ward PLC were in attendance. The Judges heard from plaintiffs' lawyers across the country regarding whether the cases should be consolidated and if so, which federal court (and judge) they should be coordinated under.

Plaintiffs' attorneys argued that the lawsuits should be consolidated for purposes of cost, efficiency and to avoid inconsistent rulings across jurisdictions determining Mirena cases. Plaintiffs in Ohio argued for consolidation of the cases in the U.S. District Court for the Northern District of Ohio. Others argued for federal courts in Pennsylvania or Rhode Island.

Bayer--the manufacturer of Mirena--opposes the request for consolidation, despite having previously submitted an application to the New Jersey Supreme Court requesting consolidation in the Middlesex Superior Court in New Jersey.

Specifically, Bayer claims it wants to "vindicate its product" and that an individual case in a South Carolina federal court is nearly ready for trial. In other words, Bayer wants to proceed with the South Carolina case and argued coordination of that case, and of others, will prevent it from doing so.

Bayer also claims that perforation injuries caused by its Mirena IUD have been warned about for decades, and that doctors are well-aware of the issue before prescribing Mirena. It is apparent that Bayer will claim that because doctors are warned and educated about perforation, that it cannot be liable for Mirena's injuries.

However, as much as Bayer protests, Mirena's label (that must be provided to doctors and must warn of all clinically significant adverse events) does not warn that Mirena may "spontaneously" migrate from its intended position in the uterus and that this post-insertion migrate often leads to perforation of the uterus, cervix, or other areas within the abdominal cavity.

A multidistrict litigation, or MDL, is similar to a class action in that cases involving similar facts (and in these case, the same IUD) are coordinated under one federal judge. This allows for a streamlined pre-trial process. Plaintiffs may share resources and information. This greatly preserves costs. However, if the cases go to trial, they are generally tried individually. And unlike a class action, if the cases get settled, they are settled based on individual injuries and damages.

Jones Ward has been following the Mirena litigation closely. We will be sure to update you once the panel makes its decision. We are currently evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

A $48 million verdict on behalf of a California mesothelioma patient and his family is being hailed as one of the top 100 legal verdicts in the United States last year.

The decision held that Dow Chemical's subsidiary, Union Carbide, is responsible for the most of the damages in what was the largest mesothelioma verdict in the nation last year.

Up to 3,000 people are diagnosed with mesothelioma each year. The disease affects the linings of the lungs, or pleura. People who have been diagnosed with mesothelioma and lung cancer often were exposed to asbestos years earlier, in settings such as shipyards, barge building companies, public schools, or work as plumbers and electricians.

"The chemical industry spent millions to cover up just how dangerous asbestos exposures were," John Langdoc, one of the lawyers in the California case, told one news source.

To learn more about your legal options related to asbestos and mesothelioma, contact Attorney Alex Davis for a free case evaluation.

A manufacturer of prescription drugs in New Jersey is being voluntarily recalling certain lots of its products after mold was found in bags of ingredients used to make antibiotics and pain relievers.

The U.S. Food and Drug Administration informed doctors and hospitals that the New Jersey-based compounder, Med Prep Consulting Inc., shut down all production and shipping of its products, due to the mold problems. The drugs were packaged in infusion bags, plastic syringes and glass vials.

News media reported this week that the problem surfaced after hospital staff in Connecticut found particles floating in an intravenous medicine. A spokeswoman for the FDA, commenting on the situation, said that "giving a patient a contaminated injectable drug could result in a life-threatening infection."

This is just the latest in a string of problems with contaminated drugs, including recent problems at the New England Compounding Center, and last fall's drug recall by Ranbaxy after glass particles were found in its version of generic Lipitor.

If you or a loved one have been injured by a defective or recalled product, contact Attorney Alex Davis or send him an email at alex@jonesward.com for a free case evaluation.

This past week, the Sixth Circuit Court of Appeals (federal appellate court that reviews appeals from federal district courts in Kentucky, Tennessee, Ohio and Michigan), ruled that a generic drug case involving the drug metoclopramide (generic for Reglan) should go forward. The Sixth Circuit reversed the decision from the Northern District of Ohio, which dismissed claims against the generic drug manufacturing defendant.

Specifically, the Sixth Circuit concluded that a 2011 U.S. Supreme Court case, PLIVA, Inc. v. Mensing, which held that certain state law claims (for failure-to-warn) against generic drug manufacturers are preempted by federal drug regulations, does not preempt claims against generic drug makers when the manufacturers fail to update their drug labels with the FDA-approved labels for the brand-name drug equivalent.

Preemption is a legal theory based on conflicts between state and federal law. In other words, if federal law and state law conflict on the same issue, state law must give way. Mensing found that because federal regulations require a generic drug label to be identical to the brand-name drug label approved by the FDA (U.S. Food & Drug Association), a generic drug manufacturer cannot independently strengthen a drug label (even if stronger labels are needed) because it would violate its duty of "sameness" with respect to the labeling.

Recognizing the obvious difference where a generic drug manufacturer fails to update its drug labels to match the brand-name labels (thus, violating the duty of "sameness"), the Sixth Circuit represents the first federal appellate court to specifically address the issue of failure to update and create precedent. And it ruled unequivocally in the favor of injured plaintiffs. The case is Fulgenzi v. PLIVA, Inc.

Although the Sixth Circuit's opinion may not be that far-reaching, since it is specific to circumstances where the generic drug maker failed to update its label and the injured party took the generic drug during that time period (where the label was not updated), plaintiffs' attorneys across the country argue that the failure to update problem is widespread.

Fulgenzi's lawyer, Louis Bograd, points to a study published in 2012 in the journal Pharmacoepidemiology and Drug Safety, which found that nearly 80% of generic drug labels differ from the brand-name labels.

The dangerous drug lawyers at Jones Ward handle a variety of prescription drug lawsuits. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Next Thursday, March 21, a panel of federal judges, the Judicial Panel on Multidistrict Litigation, meets in San Diego to hear arguments on whether to consolidate Mirena cases into a multidistrict litigation (MDL).

An MDL is similar to a class action in that the cases will be consolidated for pretrial purposes. However, if the cases go to trial, they will likely be tried individually.

If the panel agrees to consolidate Mirena lawsuits, it will also decide where to consolidate them. If they are consolidated, they will be under one federal judge in one federal court. We have been blogging extensively on the status of the litigation. Bayer, the manufacturer of Mirena, is opposing the consolidation, arguing that the cases are too diverse and that consolidating them will lead to the filing of "marginal" cases.

Many of the cases involve women who have been injured by Bayer's Mirena IUD (intrauterine device) when the IUD has migrated from its intended position in the uterus and perforated the uterus, cervix, or other organs within the abdominal cavity. For some women, this migration took place years after Mirena was inserted.

Bayer's label fails to warn that the IUD may spontaneously move or migrate from its position in the uterus. When it does, it often leads to perforation, which can be a severe and even life-threatening complication. Typically, when migration occurs, the IUD must be surgically removed, which also increases the risk of complications.

The hearing will be held March 21 in San Diego, California. The dangerous medical device attorneys at Jones Ward will be in attendance.

The defective medical devices lawyers at JONES WARD PLC are currently evaluating Mirena cases, involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Women who used Yaz or Yasmin birth control medication are still filing lawsuits against Bayer related to side effects from the drugs, including DVT, deep vein thrombosis.

DVT is one of the worst side effects of Yaz, Yasmin and the generic version, Ocella. Thousands of women who took these drugs and experienced a DVT have filed suit against the drug manufacturer Bayer.

A deep vein thrombosis is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other parts of the body such as the heart, brain, or lungs. DVTs are also known as venous thromboembolic events, or VTEs.

The signs and symptoms of a DVT can appear in one or both legs and include:

Pain or tenderness that may only occur while standing or walking
Swelling
Red, discolored or warm skin
Leg fatigue
Visible surface veins

DVTs can be life threatening and women experiencing symptoms of a DVT should seek immediate medical care.

Numerous studies have found a direct link between Yaz, Yasmin and Ocella and DVTs. The strong connection between the ingestion of these drugs and such a serious condition has subjected Bayer to civil liability. Women who experienced a DVT after taking these birth control pills may be entitled to financial compensation.

The attorneys at JONES WARD PLC represent hundreds of women from across the country that have been harmed by Yaz, Yasmin and Ocella. If you would like to speak with someone about a potential case, please contact attorney Alex Davis at JONES WARD PLC.

A retired prison guard with a DePuy ASR metal hip implant will receive more than $8 million after a jury decided that DePuy must pay for its defective product.

It's good to see a small measure of justice for those who have been injured by this awful product. The DePuy ASR, made by a unit of Johnson & Johnson, has a sky-high failure rate and eventually was recalled in August 2010. Many patients with the ASR have been diagnosed with symptoms of metallosis, in which the parts of the ASR rub against each other inside the patient's body, sending particles of cobalt and chromium into the bloodstream.

The $8 million verdict in state court in Los Angeles represents the end of the first trial over the ASR. Another roughly 10,000 trials could unfold over the next few years across the United States, including dozens in which the patient is represented by attorneys at Jones Ward PLC. Here's an excerpt from a news story in the L.A. Times about the trial:

"All-metal hips accounted for an estimated 40% of all U.S. hip replacements in 2008. But since then, they have fallen out of favor as concerns grew about their effectiveness and safety.

Overall, product safety issues have become a major headache in recent years for J&J, long admired by consumers as a trusted medical name. The company has issued more than 30 product recalls since 2009."

Unfortunately, the DePuy ASR is not the only defective metal hip on the market. If you have any of the following types of metal hips, you may have a valid legal claim against the manufacturer.

• DePuy Pinnacle
• Stryker Rejuvenate
• Biomet Magnum
• Zimmer Durom
• Smith & Nephew
• Wright Pro Femur

If you or a loved one have been injured by a defective metal-on-metal hip implant, call Attorney Alex Davis or send him an email at alex@jonesward.com for a free case evaluation.

In 2000, Bayer Healthcare Pharmaceuticals, Inc. released its Mirena intrauterine device (IUD) in the United States. Since that time, an estimated 2 million women in the U.S. and 15 million women worldwide have been implanted with the device. In 2009, the FDA approved it for treatment of heavy menstrual bleeding, in addition to contraception.

Mirena is a t-shaped, plastic IUD intended to be inserted in a women for contraceptive purposes. It is meant to provide long-term birth control for up to five years. A healthcare practitioner must insert Mirena directly into the uterus and women using Mirena should follow up with them after 4-6 weeks for a "string check" to make sure Mirena is still in place.

However, women all over the country (and likely, all over the world) have begun experiencing horrible complications with the device. The device may "spontaneously migrate" from its intended position in the uterus, which may lead to perforation of the uterus, cervix, or other organs. Doctors are not warned of this event and thus, patients have no idea either.

Additionally, Jones Ward is investigating whether a condition known as pseudotumor cerebri (PTC) (or intracranial hypertension) is related to Mirena, and specifically, the hormone released by Mirena called levonorgestrel.

PTC develops when the cerebrospinal fluid in a person's skull builds up and increases pressure in the skull and on a person's optic nerve. The condition typically manifests when a person experiences extreme migraines and blurred or double vision. It is frequently diagnosed by use of a lumbar puncture or spinal tap.

Plaintiffs across the country have begun filing Mirena lawsuits, claiming Bayer failed to warn them of a variety of injuries. Many claim they suffered from spontaneous migration and perforation of the device, requiring surgery, sometimes an emergency hysterectomy. The cases may be consolidated in a Multidistrict Litigation (MDL) in front of one federal judge.

The attorneys at Jones Ward PLC are currently evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

As Mirena litigation continues to rise, many women injured by Bayer's intrauterine device (IUD) are filing lawsuits alleging Bayer failed to warn them of a variety of injuries, including "spontaneous migration" of the device leading to perforation of the uterus and/or other internal organs.

We've recently reported that plaintiffs in Ohio have moved to consolidate Mirena lawsuits into a consolidated, multidistrict litigation (similar to a class action) in a federal court in Ohio. Bayer is vigorously opposing consolidation, claiming the injuries are too varied among the plaintiffs who have already filed suit and that consolidation will encourage the filing of "marginal" cases.

Oral arguments on the consolidation issue will be heard by a panel of federal judges, known as the Judicial Panel on Multidistrict Litigation. Specifically, the panel will hear arguments from plaintiffs and defendants on 1) whether to consolidate the cases, and 2) if consolidated, where the cases will be located.

The hearing will be held March 21 in San Diego, California. The dangerous medical device attorneys at Jones Ward will be in attendance.

A multidistrict litigation is similar to a class action in that a group of plaintiffs' cases claiming similar facts, i.e., injuries by the same drug or device, are consolidated for pre-trial purposes under one federal judge. The procedural device is intended to conserve judicial resources, save money for both parties (by allowing the various cases to share the costs and resources), and prevent conflicting rulings across the country in cases alleging nearly identical facts.

However, if the cases end up settling, each case is evaluated individually in terms of damages. That means that unlike a class action, plaintiffs do not share proportionately in a settlement. Rather, each plaintiff's damages are specific to each plaintiff's individual injuries. If they cases get tried, they are generally tried individually as well, although sometimes several cases are tried at once.

According to the Notice of Hearing by the JPML Panel, at least eight Mirena cases are pending in federal courts throughout the country. Even more have been filed in Morris County, New Jersey (where Bayer is located).

The defective medical devices lawyers at JONES WARD PLC are currently evaluating Mirena cases, involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

The recalled Stryker Rejuvenate hip implant is causing growing concerns about the safety of patients who have received the defective product. Some of them are now being forced to have the Rejuvenate surgically removed in a painful and costly process called revision.

Because of these safety concerns about the Stryker Rejuvenate, the attorneys at Jones Ward PLC are launching a national awareness campaign to offer information about the health hazards of this defective medical device.

In July 2012, Stryker recalled its Rejuvenate and ABG II hip implant components from the market. The metal parts of the Rejuvenate, which is made of cobalt, chromium and titanium, are subject to corrosion and fretting, which can lead to a dangerous disease called metallosis.

The problems with the Stryker Rejuvenate are just the latest health nightmare in the metal-on-metal hip implant industry.

But unlike other hip implant lawsuits, involving brands such as the DePuy ASR, Zimmer Durom, or Biomet Magnum, the recall of the Stryker Rejuvenate involves the device's stem, and not the ball and cup. For patients who have hired Jones Ward PLC to seek compensation for recall injuries, the process of removing this device is often painful and costly. Unlike a revision surgery to replace the ball and cup, an operation to replace the Stryker Rejuvenate involves the removal of the stem itself, which is fused to the patient's femur.

The safety awareness campaign organized by Jones Ward PLC includes the above advertisement that is being published in newspapers across the region, including the Lexington Herald-Leader, the Central Kentucky News Journal in Campbellsville, and the Kentucky Standard in Bardstown.

If you have a Stryker hip implant, or another type of metal-on-metal hip implant, call Attorney Alex Davis or send an email to alex@jonesward.com for a free case evaluation.

Fed up with a string of safety and quality problems, the U.S. Food and Drug Administration has launched a new wave of surprise inspections at compounding pharmacies.

Some recent problems with these pharmacies include glass particles found in generic versions of Lipitor, made by an Indian company called Ranbaxy.

Ranbaxy saw its share of the U.S. market decline sharply after it recalled certain lots of Lipitor, also known as atorvastatin, in November. The recall involved contamination with tiny glass particles.

Another compounding pharmacy nightmare was the spread of a dangerous strain of meningitis linked to tainted drugs.

Here's how a story in The Washington Post describes the new FDA inspection program:

"The actions are part of a new program aimed at the multibillion-dollar compounding industry that has fallen between the regulatory cracks. The inspections were the first targeted enforcement actions against large compounders since the FDA found filthy conditions at a Massachusetts pharmacy that shipped contaminated steroid shots to 23 states. The shots caused the outbreak that has so far killed 48 people and sickened 666 others, making it the country's worst drug disaster in several decades."

The steroid problems stemmed from quality control issues at the now-infamous New England Compounding Center. But the above article in the Post shows that those problems are not isolated, and that the lightly regulated pharmacy compounding industry is in fact riddled with safety issues.

If you or a loved one have been injured by a defective pharmaceutical product, including the Ranbaxy recall or the meningitis outbreak, call Attorney Alex Davis or send an email to alex@jonesward.com for a free consultation.

One of the hottest new trends in health care includes surgical procedures conducted by robots, including those made by Intuitive Surgical Inc. (ISRG), such as its "da Vinci Surgical System." Recently, the U.S. Food & Drug Administration--responsible for overseeing the safety and efficacy of prescription drugs and medical devices--has decided to look into whether these techno-surgeons are safe.

Specifically, the FDA has requested that surgeons at particular hospitals across the country list the complications they have experienced or seen with the technology. According to reports, such surgeries cause about $1.5 million each and were used in nearly 500,000 procedures last year.

The FDA submitted a surgery to the surgeons also asking which surgeries the robots might be best at or worst at to perform. Apparently, the FDA is interested in whether there a rise in incidents may be due to problems with the machines. At this point, regulators have not pinpointed a specific cause of the rise in surgical incidents. Additionally, the results of the investigation will help answer the basic question of whether robotic surgeries (which are marketed as being less invasive) are worth their costs.

The incident reports may be adverse event reports (AERs) submitted to the FDA by doctors, patients or the robot-makers themselves. AERs involving the machines include gynecological surgeries that represent about half of the procedures using Intuitive's robotic machines. The AERs include damage such as when the instruments broke off and fell into patients. They also include instances of user errors and not with the machines themselves.

Intuitive continues to publically state that its products are extremely safe, and that the benefit of the technology far outweighs the risks and costs.

For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

We have been blogging heavily about an increasing number of lawsuits against Bayer Healthcare Pharmaceuticals--maker of the Mirena IUD, a t-shaped plastic device inserted into a woman's uterus intended to provide long term (up to five years) contraception.

In a nutshell, women across the country have experienced severe complications after Mirena has migrated from its intended position in the uterus and perforated the uterus and sometimes other parts of the body. When this occurs, it typically requires surgery to remove the device. Bayer's label warns that perforation may occur upon insertion. However, the label does not warn doctors (who then never have a chance to warn their patients) that sometime after proper insertion, Mirena can "spontaneously" migrate and perforate the uterus and end up somewhere in a woman's abdominal cavity

Recently, we posted that one of Bayer's defenses in a South Carolina case in federal court is that spontaneous migration is "biologically implausible." Thus, Bayer is claiming migration (which, in turn, frequently leads to perforation) simply does not occur.

However, a variety of sources points otherwise. In addition to adverse events reported to the FDA and to Bayer, in June 2010, Bayer wrote letters to inform healthcare practitioners and the public in Canada of important safety information about Mirena. Specifically, the letter to the public warns that "Uterine perforation may occur as MIRENA® is being inserted or after the insertion with limited symptoms." (emphasis added). If Bayer is claiming Mirena does not migrate, or move, after insertion, why would it warn of post-insertion perforation at all?

And if this warning was provided to the public and to doctors in Canada nearly three years ago, why didn't Bayer warn of the same in the United States? Bayer's label currently only warns that perforation may occur upon insertion. The label includes no warning of migration and post-insertion perforation. According to Bayer, nearly 2 million women in the U.S. currently have MIrena.

The attorneys at Jones Ward PLC are currently evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

In 2000, the pharmaceutical giant Bayer Healthcare Pharmaceuticals released its long lasting method of birth control, the Mirena IUD (intrauterine device). In 2009, the FDA additionally approved Mirena to treat heavy menstrual bleeding. Since that time, Mirena has been inserted in an estimated 2 million women in the U.S. and 15 million women worldwide.

Mirena is a t-shaped, plastic device inserted directly into a woman's uterus by a healthcare provider. Mirena releases levonorgestrel at a set daily rate for five years. After five years, the device must be removed because it loses its contraceptive value.

Mirena's label, approved for the heavy menstrual indication by the FDA in 2009, warns that perforation, or "penetration of the uterine wall or cervix," may occur upon insertion although it may not be detected until sometime later. Additionally, "[t]he risk of perforation may be increased in lactating women, in women with fixed retroverted uteri, and during the postpartum period."

In an article in the medical journal The European Journal of Contraception and Reproductive Health Care, published in September 2006, the authors explored the risk of migration and perforation of the Mirena IUD and its association with perforation of the bladder.

The article discusses the case of a woman whose Mirena perforated her bladder. According to the authors,

"One major problem with IUDs is uterine perforation, which can be complete or partial. Uterine perforation was originally thought to occur at the time of insertion but it has now been realised that migration and erosion can occur at any time and into any structure. Migration has been reported into adjacent structures, including the broad ligament, urinary bladder, the peritoneum and more distant structures including the appendix and colon."

The study concludes that uterine perforation may occur 0.2-9.6 per 1000 insertions. Plaintiffs across the country have filed lawsuits alleging Bayer has failed to warn them of spontaneous migration and post-insertion perforation. In one case, redacted testimony of one of Bayer's corporate witnesses may indicate that Bayer denies that spontaneous migration can even occur.

The attorneys at Jones Ward PLC are currently evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Bayer Healthcare Pharmaceuticals, manufacturer of the Mirena intrauterine device (IUD) has fashioned an interesting defense to lawsuits alleging Mirena migrated from its intended position in the uterus and perforated the uterus or other parts of the body. Plaintiffs across the country have brought suit against Bayer claiming Bayer failed to warn of spontaneous migration and perforation, and that although patients were aware the device could perforate upon insertion, they had no idea sometime later--even years later--they could suffer severe complications due to migration and perforation.

Bayer's defense to this is simple: spontaneous migration is "biologically implausible." In a case in South Carolina, the plaintiff claimed Mirena spontaneously migrated and perforated her uterus more than two years after her doctor inserted it. After she went laparoscopic surgery to remove Mirena, which was embedded in her omentum, she suffered post-perforation pain and bleeding, due to adhesions caused by the perforation. Because of the problems she suffered after Mirena perforated her uterus, she eventually had to undergo a hysterectomy for relief.

The case, originally filed in state court in South Carolina was removed to federal court in South Carolina on March 4, 2011. Bayer recently moved for judgment in its favor. In opposition, plaintiffs argue that it is impossible to reconcile Bayer's claims the court that spontaneous migration is "biologically implausible," but that, regardless, Bayer adequately warned of plaintiff's injuries.

Plaintiffs pointed to deposition testimony of Jo-Ann Ruane, Bayer's Associate Director of Global Regulatory Affairs. Although the testimony included in the opposition has been heavily redacted, it is apparent that Bayer is claiming it does not believe spontaneous migration can even occur. This is contrary to other evidence, including numerous adverse event reports submitted to Bayer and to the FDA and a letter that Bayer itself distributed to healthcare providers in Canada.

The defective medical devices lawyers at JONES WARD PLC are currently evaluating Mirena cases, including cases of spontaneous migration and perforation. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.