Mirena Litigation on the Rise

April 28, 2013, by JONES WARD PLC

Women across the country have begun filing lawsuits against the pharmaceutical giant Bayer Healthcare Pharmaceuticals, Inc., alleging they have suffered severe injuries from Bayer's Mirena intrauterine device (IUD).

Mirena is a small, t-shaped plastic device that is inserted into a woman's uterus by a healthcare practitioner. It releases a synthetic hormone called levonorgestrel to prevent pregnancy. It is intended to work for up to five years. After five years the daily dose of the hormone it releases is reduced to half and the IUD should be removed.

Mirena was originally approved by the U.S. Food & Drug Administration (FDA) in 2000 for contraception. In 2009, the FDA approved Mirena for heavy menstrual bleeding. Since its arrival, Mirena is estimated to have been implanted in 2 million women in the U.S. and 15 million women worldwide.

Recently, the Judicial Panel on Multidistrict Litigation agreed to consolidate Mirena cases in the U.S. District Court for the Southern District of New York under Judge Cathy Seibel for coordinated pretrial purposes. The litigation continues to grow as more and more women are filing lawsuits against Bayer.

Many of the lawsuits claim that the device migrated, or moved, from its intended position in the uterus and perforated the uterus, cervix or other internal organs. Women suffering from this type of complication typically have to undergo surgery to remove the IUD. These injuries can also lead to additional types of complications such as sepsis.

Other women claim that the Mirena embedded in their uterus, also requiring surgery to removed the device. Jones Ward is also investigating a possible link between Mirena and pseudotumor cerebri, a serious condition that develops when cerebrospinal fluid builds up the skull and creates increased pressure on the optic nerve.

The legal team at Jones Ward is evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

2 CPSC Recalls of Household Items

April 28, 2013, by JONES WARD PLC

The Consumer Product Safey Commission, which oversees the safety of many products, has issued two recent recalls of household items. Target is recalling nearly 150,000 of its Giada De Laurentiis-branded ceramic lasagna pans (shown right). The cream-colored pans are 9x13 inches and were sold individually and as part of a six-piece set. The bottom of the pan is stamped "Giada de Laurentiis for Target."

TargetGiadaLasagnaPanTopLARGE.jpg

According to the CPSC, the pans or its handles may crack and break during normal use. Target has received at least 39 reports of cracked or broken pans that may pose a laceration hazard to consumers. Of the 39 reports, 6 reported cuts or lacerations due to the problem.

Target is asking consumers to stop using these products and return them to the store for a full refund. The pans were sold between January 2009 to October 2012 exclusively at target.

The CPSC also announced a recall of about 900 of West Elm's floor lamps (shown left). According to the agency, a failure of the lamp's joint locking mechanisms can cause the lamp to collapse and the electrical cord to spark, posing injury and shock hazards to consumers. The recall concerns the industrial Overarching model floor lamps with an iron base and arm in an antique bronze finish, one light socket and a round natural linen shade. They are approximately 78 inches tall and have a swiveling triple-jointed adjustable arm and an ON/OFF foot switch at the base.

LARGE_West Elm Floor Lamp.jpg

West Elm has received 24 reports of the floor lamps failing. Although no injuries have yet been reported, 10 of the reports were for the lamps collapsing and three were for sparking cords.

West Elm is asking consumer to immediately stop using the lamps, to unplug them and return them to the store for a full refund. The lamps were sold nationwide at West Elm from December 2012 to February 2013.

The recall attorneys at Jones Ward PLC are committed to providing you with up to date recall news. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Texting and driving: risk of crashing = 23 times higher

April 28, 2013, by JONES WARD PLC

The lawyers at Jones Ward PLC fight for the rights of people who are injured by all types of product problems, including defective automobile parts and vehicle recalls. The consequences of some of these defective car parts can be deadly for consumers. But there's another safety problem out there that is probably even deadlier: texting while driving.
texting.png
The hazards of distracted driving are reaching epidemic proportions on America's roadways. Nearly one in five people who die in motor vehicle accidents are the victims of some form of distracted driving.

You can learn more about the perils of texting and drivers at this excellent Web site sponsored by the U.S. Department of Transportation. Here are some numbers from the site to keep in mind:

  • In 2011, 3,331 people were killed in crashes involving a distracted driver, compared to 3,267 in 2010.
  • An additional 387,000 people were injured in motor vehicle crashes involving a distracted driver, compared to 416,000 injured in 2010.
  • In the month of June 2011, more than 196 billion text messages were sent or received in the US, up nearly 50% from June 2009.
  • Drivers who use hand-held devices are 4 times more likely to get into crashes serious enough to injure themselves.
As a lawyer who represents people who are injured due to the negligence of distracted drivers, I know first-hand the terrible impact that texting can have on drivers and their families. If you or a loved one are injured due to the negligence of a distracted driver, contact me -- Alex Davis -- for a free case evaluation, or send an email to alex@jonesward.com.

Complaints Mount Over Antifreeze Leaks in the Cabins of Chevy Cruze

April 22, 2013, by JONES WARD PLC

Complaints have skyrocketed after owners of Chevy Cruze sedans began noticing a peculiar smell in the occupants' cabin and film on the windows anytime they ran the heat in their cars. The Cruze, GM's top selling car in 2011, suffers from a defect that allows antifreeze to leak. Anytime the heat in the cars is engaged, the antifreeze fumes blow into the cabin, producing a foul smell and film on the windows. Efforts by drivers to get GM to fix the problem have thus far failed.

GM is certainly aware of the leaking antifreeze, yet has not recalled the cars and has not found a way to correct the defect. Despite these vehicles being nearly brand-new, some Chevrolet dealers have offered a minimal credit to Cruze owners towards the purchase of another new Chevrolet vehicle. Chevy's parent company, General Motors, recognizes the obvious loss of value suffered by Cruze owners due to this defective condition.

The lawyers at Jones Ward PLC are actively investigating class action claims against General Motors related to the antifreeze leaks in the Chevy Cruze.

For more information, contact attorney David G. Bryant at david@jonesward.com

Hip implant lawyer: DePuy wins ASR trial, but loses credibility

April 22, 2013, by JONES WARD PLC

Johnson & Johnson, the maker of baby shampoo and Band-Aids, has long enjoyed a reputation as being safe and responsible. Its products rarely failed, and when they did the company dealt with the problem swiftly and fairly. That approach seems to have changed in recent years.

A prime example is J&J's subsidiary, DePuy, the maker of defective and recalled DePuy ASR metal-on-metal hip implants. The ASR's failure rate is at least 37 percent. Thousands of patients with the ASR have been forced to undergo a costly and painful revision surgery in which the device is ripped out of their bodies. Additional side effects include metallosis, a condition caused by elevated levels of cobalt and chromium in the patient's body.

Given all that trouble, why wouldn't DePuy and J&J simply agree to compensate the estimated 30,000 people in the U.S. who had the ASR? Because sometimes it pays to deny responsibility and fight the claims of these customers in court.

DePuy's denial tactics paid off earlier this month when it won a surprise verdict from a Chicago jury in just the second ASR case to go to trial. In the first trial, the plaintiff earned a verdict worth more than $8 million. The surprise win in the second trial will almost certainly dampen the expectations of plaintiffs whose bodies have been ruined by the ASR. But while DePuy may have protected some of its substantial profits in the process, its reputation in the long run will suffer. Hip Implant Revision

This opinion piece in USA Today does a nice job of explaining the shift in DePuy and J&J's approach to customer safety:

"Hip replacements have become big business, as Baby Boomers age and seek implants with more stability and longer lives. In 2001, DePuy set out to produce a new metal device with those qualities.

But all-metal hip devices shed metallic debris, which can inflame and damage tissue and bone. The ASR implants, according to J&J's own statistics, will fail in about 37% of patients in fewer than five years, forcing a second painful operation to remove and replace the device. Artificial hips are supposed to last 15 years.

J&J isn't the first pharmaceutical company to keep bad news under wraps. But its shift away from more responsible practices is a notable violation of its own policies, which state that the company's "first responsibility" is "to the doctors, nurses and patients ... who use our products and services."

Ultimately, though, makers of medical devices have the best data on whether their products work. Had J&J followed the precedent it set in the Tylenol case, the company would have saved patients a lot of pain and, judging from the lawsuit awards likely to come, saved itself a lot of money."

The lawyers at Jones Ward PLC remain committed to representing DePuy ASR patients who have suffered injuries due to these recalled hip devices. Another several jury trials will be necessary before a fair settlement can be reached with DePuy. Those trials most likely will be unfolding under the umbrella of the plaintiffs' lawyers in MDL 2197 in federal court in Ohio. This MDL group has better funding and more resources than any previous group to go to trial with DePuy. In the end, that means DePuy will be much less likely to get another surprise win.

If you or a loved one have been injured due to a defective metal-on-metal hip implant, contact Attorney Alex Davis at alex@jonesward.com for a free consultation.


FDA Denies Approval of Generic OxyContin

April 21, 2013, by JONES WARD PLC

The U.S. Food & Drug Administration has decided it will not approve generic versions of OxyContin. The decision comes after OxyContin's original patent is set to expire, opening the door to generic manufacturers to produce the drug generically. The FDA's decision, however, blocks generic companies from doing so.

According to reports, the FDA's decision is based on the fact that the original version of OxyContin, which was introduced in 1995, allowed the pills to be easily crushed. When crushed, a drug abuser would be able to obtain all of the drug's narcotic effects at once, rather than the effects being released over time, as intended.

imgres-2.jpeg

In 2010, Purdue Pharma, the manufacturer of OxyContin, released an abuse deterrent formulation for the drug, which makes the pill turn to a gummy substance when attempts are made to crush it. The FDA's decision represents a significant policy move to fight narcotic drug abuse, which has skyrocketed since the introduction of opioid-based painkillers like OxyContin (brand name of Oxycodone).

The FDA also approved a label change for OxyContin stating it was less prone to abuse. According to reports, the FDA's recent decision is the first time the agency has allowed a prescription drug manufacturer to state that a narcotic drug has tamper-resistant properties.

Although the FDA has begun to recognize the devastating prescription drug abuse in this country, it is questionable whether making high-demand, high-abuse drugs tamper resistant will actually work to curb abuse. Statistics show that when one drug is less accessible, drug abusers quickly and easily turn to others.

The dangerous drug lawyers at Jones Ward PLC are dedicated to proving you up-to-date news concerning prescription drugs and medical devices. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Mirena and the Possible Link to Pseudotumor Cerebri

April 21, 2013, by JONES WARD PLC

We have been blogging extensively about Mirena litigation and the injuries women have been suffering due to the IUD. Women across the country have suffered serious injuries due to Mirena migration and perforation, embedment, and other complications.

There may be a connection between Mirena and pseudotumor cerebri--a severe and sometimes debilitating disorder. Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension, is a condition that develops when cerebrospinal fluid in the skull builds up and creates increased pressure.

For many PTC patients, the condition puts pressure on the optic nerve, which results in vision problems such as blurred vision or temporary "black-outs." PTC patients may also start getting severe migraine-like headaches or they may begin to hear "whoosing" sounds. Women who have any of these symptoms should immediately seek medical attention and also see an eye doctor or ophthalmologist.

After a doctor notes the increased pressure, PTC patients will typically undergo an MRI and CT scan to rule out an actual tumor or blood clot, which could lead to stroke. If those results come back negative, a doctor may have a PTC patient undergo a lumbar puncture or spinal tap, to measure the pressure built up in the skull. A spinal tap may give some temporary immediate relief, but it does not "cure" the condition. In severe cases, women may have to undergo shunt surgeries to help the fluid drain from the skull.

The defective medical device attorneys at Jones Ward are investigating whether there is a link between Mirena and PTC. The hormone released by Mirena, levonorgestrel, may have something to do with the development of the condition. Many other FDA-regulated products containing levonorgestrel warn of PTC or papilledema (swollen optic nerve caused by increased intracranial pressure).

230px-MRI_brain.jpg

Mirena's label, however, contains no such warning. After a healthcare provider rules out an actual tumor or stroke, there is nothing in Mirena's label to indicate to a doctor that the device should be removed if a Mirena user develops PTC. Mirena may also cause rapid weight gain, which is a known risk factor for PTC.

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

Mirena Lawsuit Information

April 21, 2013, by JONES WARD PLC

Women across the country have begun filing lawsuits against the pharmaceutical giant Bayer Healthcare Pharmaceuticals, Inc., alleging they have suffered severe injuries from Bayer's Mirena intrauterine device (IUD).

Mirena is a small, t-shaped plastic device that is inserted into a woman's uterus by a healthcare practitioner. It releases a synthetic hormone called levonorgestrel to prevent pregnancy. It is intended to work for up to five years.

Mirena was originally approved by the U.S. Food & Drug Administration (FDA) in 2000 for contraception. In 2009, the FDA approved Mirena for heavy menstrual bleeding. Since its arrival, Mirena is estimated to have been implanted in 2 million women in the U.S. and 15 million women worldwide.

Recently, the Judicial Panel on Multidistrict Litigation agreed to consolidate Mirena cases in the U.S. District Court for the Southern District of New York under Judge Cathy Seibel for coordinated pretrial purposes. The litigation continues to grow as more and more women are filing lawsuits against Bayer.

Many of the lawsuits claim that the device migrated, or moved, from its intended position in the uterus and perforated the uterus, cervix or other internal organs. Women suffering from this type of complication typically have to undergo surgery to remove the IUD. These injuries can also lead to additional types of complications such as sepsis.

Other lawsuits claim that Mirena became embedded in the uterus, also requiring surgery to remove the device. To read more about Mirena's injuries, click here.

The legal team at Jones Ward is evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Mirena Cases Consolidated in the Southern District of New York

April 17, 2013, by JONES WARD PLC

Mirena cases filed across the country have now been consolidated into a Multidistrict Litigation (MDL) in one federal court. On April 8, 2013, the Judicial Panel on Multidistrict Litigation agreed with a group of Mirena plaintiffs that cases involving migration/perforation should be consolidated in one federal court under one federal judge.

The panel agreed to consolidate the cases in the U.S. District Court for the Southern District of New York under Judge Cathy Seibel for coordinated pretrial purposes. An MDL, similar to a class action, allows one judge to oversee all pretrial proceedings. In other words, one judge will preside over all coordinated cases and resources will be shared among the plaintiffs and the parties. The first case management conference in front of Judge Seibel is scheduled for May 16.

The goal of an MDL is to conserve resources and prevent conflicting legal rulings across the country. The panel concluded the cases filed so far have common issues of fact and that it is appropriate to consolidate given that the cases have these issues in common. A case involving lupus, however, was not consolidated into the MDL on the basis that the factual allegations were too different from the migration/perforation cases.

Mirena was introduced in 2000 as a contraceptive intrauterine device. Mirena's manufacturer, Bayer, estimates that over 2 million women in the U.S. and over 15 million women worldwide have used or are using Mirena.

Since its introduction, women have begun experiencing severe adverse events. Many of the cases filed so far allege that the IUD migrated, or moved, from its intended position in the uterus, and perforated the uterus, cervix, or other areas within a woman's abdominal cavity. Women who have suffered from these complications often require surgery to locate and remove the device.

The defective medical device lawyers at Jones Ward are evaluating Mirena cases involving a variety of injuries. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Biomet hip implant lawsuits continue to pile up in federal court

April 15, 2013, by JONES WARD PLC

The federal judge who is supervising a consolidated lawsuit against Biomet metal-on-metal hip implants continues to see more lawsuits filed against the company as patients with the defective device seek help.

Hipimplant.jpg

More than 100 separate lawsuits over the defective Biomet Magnum hip implants are before Judge Robert L. Miller Jr. in U.S. District Court in Northern Indiana.

Like other legal claims involving defective hip implants, the total will probably grow exponentially over the coming months now that the cases are consolidated in a federal court proceeding called multi-district litigation, or MDL. Similar MDL actions involving the DePuy ASR and the DePuy Pinnacle hip implant devices already include thousands of plaintiffs.

The attorneys at Jones Ward PLC are closely involved in both of the DePuy cases, and the firm is taking calls almost daily from clients who have concerns about their Biomet metal-on-metal hip implants. Jones Ward already represents Biomet patients in Kentucky, Indiana, Maryland, Alabama, Washington, New York, and other states.

The problem with the Biomet Magnum M2a is simple: the acetabular cup and other parts of the metal devices can rub against each other inside the patient's body, sending toxic amounts of cobalt and chromium into the patient's bloodstream. It is the position of many scientists and industry observers that these hip devices have an unreasonably high failure rate. In some cases, more than 40 percent of the devices fail within five years.

Unlike a class action lawsuit, these cases will be merged together in Northern Indiana just for the purposes of handling pre-trial testimony and the exchange of evidence, which is called discovery. In theory, each case would return to a local court once the merged case in Indiana is complete. If you or a loved one have been injured by a failed metal-on-metal hip implant made by Biomet, DePuy, Stryker, or another company, call Attorney Alex Davis for a free case evaluation.

Recall lawyer: metal fragments found in potato chips

April 10, 2013, by JONES WARD PLC

Most consumers don't expect to find metal fragments when they bite into a potato chip, but that's exactly what's happening with certain types of chips made by Grippo Foods.

According to the U.S. Food and Drug Administration, Grippo, based in Cincinnati, Ohio, is initiating a nationwide recall of all bags and boxes of their Plain, Bar-B-Q, Cheddar Cheese with Jalapeno, Hot Dill Pickle, Sweet Bermuda Onion and Salt & Vinegar potato chips. You can read more about the FDA statement by clicking here. ucm344013.jpg

The chips may contain metal fragments, which obviously could pose a risk of injury to those who chomp into them. Possible injuries include choking, lacerations, or fractured teeth.

Most of the recalled Grippo chips have an expiration date of May 20 or earlier. A larger 1.5 pound box of chips has an expiration date of April 29 or earlier. The date code is located in the upper right corner of the package.

The chips were distributed to retail markets in Ohio, Kentucky, Indiana and Illinois beginning September 15, 2012 until March 14, 2013. If you or a loved one were injured by metal fragments in these chips, or if you have questions about another recalled or defective product, call Attorney Alex Davis or send an email to alex@jonesward.com.

Kia and Hyundai Recall Nearly 2 Million Vehicles

April 7, 2013, by JONES WARD PLC

Kia and Hyundai are recalling about 1.9 million vehicles in the United States for two reasons, the carmakers said this month. The first involves air bags and the second, faulty brake light switches. The majority of the recall--about 1.7 million vehicles--is due to the faulty brake light switches, which was used in almost all of both auto makers' 2007 to 2009 models. At this stage, it is unknown whether this problem has led to any crashes or injuries.

The air bag problem is specific to 2011 to 1013 Hyundai Elantra compacts. About 194,000 vehicles are being recalled for this problem. At least one injury has been reported. The problem may arise because the vehicle's support bracket may come loose when the side air bags are inflated, which can cause injuries.

The National Highway Safety Administration indicates that the faulty brake light switches could raise several potential safety concerns, including: the brake lights may not work, the cruise control may not turn off when the driver presses the brake pedal, push-to-start buttons may not work on vehicle equipped with them, and a feature that stops the driver from shifting out of park without a foot on the brake may fail.

Hyundai and Kia will begin notifying owners of the brake switch issue over the next two months and will have their dealers replace the switches for free. For the air bag issue, Hyundai will notify owners in the second quarter and dealers will install industrial adhesive strips to keep the brackets in place.

The recall lawyers at Jones Ward PLC are committed to bringing you up-to-date recall news. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Federal Appeals Court Upholds $142 Million Verdict Against Pfizer

April 7, 2013, by JONES WARD PLC

Last week, the First Circuit Court of Appeals upheld a $142 million verdict against the pharmaceutical drug maker Pfizer Inc. to pay for illegal marketing of the epilepsy drug Neurontin for off-label or unapproved uses. Pfizer has also incurred a large criminal fine due to the illegal marketing.

The ruling comes after a Kaiser Foundation Health Plan won at the trial court level against Pfizer. Kaiser claimed Pfizer fraudulently marketed Neurontin, which led to Kaiser prescribing the drug for conditions it did not effectively treat.

Off-label use of a drug refers to uses that it has not been FDA-approved for. It is a common practice for drug makers to seek additional uses for their drug in order to increase use and thus, sales. However, federal regulations make it illegal for a prescription drug manufacturer to engage in active promotion of its products for off-label uses. Although physicians can prescribe medications for unapproved uses, drug makers cannot legally market or promote their products in order to induce doctors to do so.

The First Circuit affirmed the trial court's decision not to grant Pfizer a new trial after a jury verdict found Pfizer was liable for $142 million. The jury concluded Pfizer engaged in illegal marketing of Neurontin to treat bipolar disorder, migraines and neuropathic pain. The FDA did not approve Neurontin for treatment of any of these disorders.

The consequences of the First Circuit's decision may be far reaching. The reason off-label promotion is illegal is because without FDA approval, treatment of a drug for a particular use has not been shown to be safe or effective. Thus, off-label use of a drug may lead to unintended side effects or may not prove to treat the condition at all.

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

Ford Motor Co. hit with lawsuit linked to sudden acceleration

April 2, 2013, by JONES WARD PLC

Ford Motor Co. is the latest automaker to experience legal trouble due to sudden acceleration problems with its vehicles.

A lawsuit was filed last week against Ford on behalf of drivers who are seeking damages for sudden acceleration injuries. The suit comes on the heels of a decision by Toyota Motor Corp. to pay more than $1 billion to settle similar claims. The Toyota settlement was intended to resolve hundreds of lawsuits brought by Toyota owners who claim the value of their vehicles is substantially diminished by a series of Toyota recalls stemming from sudden acceleration claims.

The case against Ford alleges the automaker knew about hundreds of reports of electronic defects tied to sudden acceleration, and that the company nonetheless failed to install brake override systems in some North American vehicles until 2010, even though it knew about problems more than a decade ago.

The attorneys at Jones Ward PLC represent vehicle owners who have been seriously injured by a variety of automotive defects and recalls. If you or a loved one have been injured due to an automotive defect, call Attorney Alex Davis or send an email to alex@jonesward.com.

DePuy on trial again over failed metal-on-metal hip implants

March 28, 2013, by JONES WARD PLC

After a jury returned a verdict of more than $8 million last month, executives at Johnson & Johnson are pushing ahead with a second trial over their faulty DePuy ASR metal-on-metal hip implant.
Metal on Metal Hip Implant
The DePuy ASR was recalled in August 2010 due to concerns about its sky-high failure rate. The problem with the device, among other things, is that the metal parts rub against each other, sending tiny particles of cobalt and chromium into the patient's bloodstream. Those particles can eventually lead to poisoning called metallosis that results in bone and tissue damage, along with destruction of the nervous system and kidneys.

The first trial over the DePuy ASR ended in California last month with a verdict of $8 million for the plaintiff, a former prison guard who endured a horrible revision surgery. More than 10,000 people have filed lawsuits over the ASR, including dozens of people represented by the lawyers at Jones Ward PLC.

The second trial is in Chicago. It is expected to take at least another two weeks before the jury reaches a verdict. One must wonder how many trials DePuy will watch unfold before it begins to fairly compensate patients for the terrible injuries caused by the ASR.

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
DePuy ASR
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, contact Attorney Alex Davis for a free case evaluation or send an email to alex@jonesward.com