News Blog

Popularity of Yaz Comes With a Dangerous Price

March 13th, 2014

Yaz is a birth control pill that has been prescribed to as many as 100 million women since its release in 2006. Bayer, the maker of Yaz, initially marketed the drug as a safe birth control alternative with limited premenstrual syndrome (PMS) bloating and acne, as compared to traditional oral contraceptives. Once the most popular birth control pill in the U.S., Yaz has come under fire in the last few years for causing dangerous and even fatal side effects.

What is Yaz Used For?

Yaz is used as a contraceptive to prevent pregnancy by causing changes in the cervical and uterine lining, making it harder for sperm to reach the uterus and harder for the fertilized egg to attach to the uterus.

It is also used to treat moderate acne in women over the age of 14 who have started their period and want to use birth control pills to prevent pregnancy, and for the symptoms of premenstrual dysphoric disorder (PMDD).

Early testing revealed that Yaz produced a variety of side effects common to birth control bills in general, including:

  • High blood pressure
  • Liver disruption
  • Allergic reactions
  • Upper respiratory infections
  • Headaches
  • Yeast infections
  • Irregular non-menstrual bleeding
  • Stomach cramps
  • Hair loss
  • Weight gain

Yaz and Blood Clots

In recent years, researchers have found that drospirenone, the fourth-generation progestin contained in Yaz, raises the levels of potassium in the blood, which increases the risk of blood clots and clot-related events such as:

  • Strokes
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism (PE)
  • Blood Clotting Events

Many medical groups, including the Institute for Safe Medication Practices, the FDA, and publications such as the New England Journal of Medicine, and the British Medical Journal, have issued blood clot warnings associated with taking Yaz. According to the FDA, 22,000 women who have taken Yaz have reported adverse side effects, including over 3,500 reports of pulmonary embolism and nearly 3,000 cases of deep vein thrombosis.

Yaz Lawsuits

Yaz recently announced that it has reached settlement in over 17,000 cases brought by women who say that they have suffered blood clots and other injuries as a result of taking the drug. Bayer still faces thousands of lawsuits across the country, and reportedly has spent nearly $1 billion to settle Yaz claims. The Yaz Lawyers at Childers, Schlueter & Smith continue to review and file Yaz Lawsuits on behalf of victims nationwide. If you have questions about your injuries or your rights, give us a call to learn how we can help.

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Dietary Supplement OxyElite Pro Believed To Cause Liver Damage

March 12th, 2014

Approximately 180 million Americans use diet supplements every day, but it is extremely difficult for the FDA to oversee their use. Manufacturers do not need FDA approval before selling dietary supplements, although they are required to prove that any new ingredients are safe for consumption. The burden is on the FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or take it off the market.

Aegeline Though to be the Culprit

OxyElite Pro contains aegeline, an extract from the Bael tree native to India and Southeast Asia. According to the FDA, aegeline is relatively untested and its side affects are largely unknown, but doctors say they are relatively certain that aegeline was the harmful ingredient in OxyElite Pro that caused serious side effects, including hepatitis and liver damage.

According to WebMD, one person has died, numerous people have been hospitalized, and others have received or are awaiting liver transplants due to the dangerous side effects of OxyElite Pro. After nearly 60 cases of liver damage were linked to the supplement, the FDA required the supplement’s maker, USPLabs, to remove the product from the market in November 2013.

OxyElite Pro Lawsuits

OxyElite Pro was recalled, but not in time to stop a growing number of product liability lawsuits brought by victims alleging that the supplement caused them to suffer hepatitis or liver damage severe enough to require liver transplants.

Concerns about OxyElite Pro began in September 2013 when health officials in Hawaii noticed a growing number of hepatitis and liver injury claims from those who had taken the supplement, which is designed to help lose weight and increase muscle mass. Although most of the OxyElite Pro liver injury cases have occurred in Hawaii, since the recall the adverse side effects of the supplement have begun to spread across the continental U.S., and numerous federal lawsuits have been filed.

The lawsuits raise allegations that USPLabs placed unsafe ingredients in OxyElite and then failed to adequately warn consumers about the risk of liver damage. The U.S. Judicial Panel on Multidistrict Litigation (JPML) will consider a motion later this month on whether to consolidate and centralize all the OxyElite Pro lawsuits filed nationwide in federal court.

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Surgical Mesh Implant Cases Are Moving Forward In 2014

March 6th, 2014

Endo Health Solutions Inc. anticipates it will cost at least $520 million to settle or otherwise exit the vaginal mesh product liability litigation it now faces. In 2013, Endo recorded an incremental pretax charge of about $316 million, increasing its liability reserve to about $520 million as of the end of last year, according to a securities filing. A loss in excess of that figure remains a “reasonable possibility,” Endo said.

The pharmaceutical company’s American Medical Systems Inc. (AMS) unit faces about 22,000 lawsuits claiming its vaginal mesh products are defective and have caused chronic pain, incontinence and other injuries. The suits are consolidated in multidistrict litigation in West Virginia, as well as other state courts.

“The increase in our reserve reflects management’s ongoing assessment of our product liability portfolio, including the vaginal mesh cases, the status of the company’s ongoing settlement discussions related to vaginal mesh litigation and the inherent uncertainty as to the ultimate costs of resolving this litigation,” Endo said. “AMS and the company intend to contest vigorously all currently pending cases and any future cases… and to explore other options as appropriate in the best interests of the company.”

Endo said it believed the settlements, judgments and legal defense costs related to the mesh litigation may be covered, in full or in part, by its product liability insurance policies. Endo has not recovered any insurance money as of the end of 2013, however according to reports.

AMS vaginal mesh trials were scheduled to begin last December but were delayed due to ongoing obligations. AMS previously agreed to settle a small number of cases, and the company is expected to attempt a global settlement of the cases pending in federal court in West Virginia before Judge Joseph R. Goodwin at some point in the future. The first AMS bellwether trial is now scheduled to begin on April 7, 2014 and the second trial is set for May 5, 2014.

Johnson & Johnson, Boston Scientific Corp and C.R. Bard Inc. also face thousands of vaginal mesh injury lawsuits.  Bard is the furthest along in litigation. Bard was hit with a $3.6 million verdict in a California state court trial in July 2012.

In addition, at least two Bard mesh bellwether trials in the West Virginia MDL have resulted in victories for the plaintiff. In August 2013, a jury awarded plaintiff Donna Cisson $2 million in damages, and plaintiff Wanda Queen settled her mesh case on the eve of trial for an undisclosed sum.

The transvaginal mesh implant lawyers of Childers, Schlueter & Smith continue to review and investigate new potential claims for victims across the U.S. If you have questions, please contact us for a free evaluation of your potential case.

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Pradaxa Maker On Legal Hot Seat in United States

March 1st, 2014

Since it hit the market in 2010, the blood-thinning drug Pradaxa has definitely been making waves. According to the New York Times, although Pradaxa has generated more than $2 billion in sales in the U.S. and has been prescribed to 850,000 patients, it has been found to cause fatal bleeding and been linked to more than 1,000 deaths reported through the end of 2012. As a result, the drug’s maker, German company Boehringer Ingelheim, is currently facing more than 2,000 lawsuits in the U.S. Boehringer Ingelheim is standing by the drug, insisting that it is safe according to clinical trials.

Pradaxa is a drug that keeps the platelets in blood from clotting. It is used to prevent blood clots and reduce the risk of stroke in people with a specific type of heart rhythm disorder. But because Pradaxa keeps blood from clotting, it also makes it easier for someone to bleed, even after a minor injury. There is currently no antidote for Pradaxa to reverse its blood thinning effects, so consequently patients who take the drug run the risk of bleeding to death since there is no medical remedy currently available to prevent it.

One of Pradaxa’s main selling points to consumers is that the drug does not require regular blood tests to ensure that it is working properly. But that precise point has been the subject of intense debate among heart and stroke specialists for several reasons:

  • Not all people metabolize the drug in the same way
  • Few dose options are available
  • There are no tests available in the U.S. to monitor those who might be at a higher risk for bleeding

Pradaxa is approved in the U.S. in a 150-milligram dose and a 75-milligram dose for those with low kidney function, but the FDA did not approve a 110-milligram dose because it was believed that the lower dose would not be beneficial to the majority of patients. In Europe, where Pradaxa was approved in 2008, an additional dose and a test are available. Despite the numerous patient bleeding deaths and the absence of an antidote, Pradaxa remains on the market, although the FDA has announced plans to perform a large new safety assessment of the drug.

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J&J Wins “Defense Pick” TVT Mesh Case

February 28th, 2014

On February 18, 2014, Johnson & Johnson won the first MDL bellwether trial against their company Ethicon Inc. in the litigation over alleged transvaginal mesh injuries. The five-day trial over the TVT product used to treat stress urinary incontinence concluded when U.S. District Judge Joseph R. Goodwin granted a motion for judgment as a matter of law in favor of Johnson & Johnson and its unit, according to Court filings that Tuesday.

The case involved a plaintiff by the name of Carolyn Lewis ( 59 years old) that had to endure a revision/repair surgery of her TVT mesh product implanted 3 years prior due to complications. This result, although disappointing, was complicated by numerous factors that played out in the trial that is not likely to be the case in the thousands of tvm cases to follow. It is important to note however that this tvm bellwether was a defense selected case which are typically problematic cases for plaintiffs based on the initial fact and circumstances of each.

Ethicon said in a statement Tuesday that Judge Goodwin found that plaintiff Carolyn Lewis had not shown enough evidence to back her claim about defects in Ethicon’s TVT pelvic mesh product, commonly used to treat stress urinary incontinence in women. The defendants argued in their motion that Lewis could not prove that the product caused chronic pain. Defendants argued that Lewis, who received the mesh in 2009 and began her suit in July 2012, overshot the two-year limitations period since the time when she should have discovered her injury.

The negligent design claims were all that Lewis had left after the Court dismissed her failure-to-warn claims in January as well as her breach of warranty and manufacturing defect claims on legal grounds.

Before the trial began on February 10, 2014 U.S. Magistrate Judge Cheryl Eifert found that Johnson & Johnson had failed to preserve documents related to the litigation. But on the Friday before the trial, she granted a motion to exclude the spoliation allegations from the trial because they were not germane to the remaining legal theories in Mrs. Lewis’ case. Johnson & Johnson argued in that motion that it no longer mattered what information a sales representative had told Lewis’ physician, because her claim that Johnson & Johnson had failed to warn her physician of the product’s risks was no longer at issue.

One Ethicon spokesman claims that “TVT continues to be a safe and effective option for women suffering from the debilitating effects of stress urinary incontinence.” Considering Lewis’s case is just one of thousands, we aren’t so sure about that.

As we progress into 2014, many more TVM cases will be tried. To date, this is the only trial that the defense has won as the other 4 tvm trials thus far have resulted in verdicts for the plaintiffs in each of those cases.

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CSS Attorneys Featured in Atlanta Magazine and Georgia Super Lawyers

February 28th, 2014

Childers, Schlueter & Smith, L.L.C. is pleased to announce that multiple lawyers from the firm have been selected as Georgia Super Lawyers for 2014.  Only the top 5% of all attorneys in the State of Georgia are selected for inclusion as Super Lawyers each year.  Childers, Schlueter & Smith’s selection as Super Lawyers in the Mass Torts category is based on the firm’s work on behalf of individuals injured by dangerous and defective drugs and medical devices.  All of us at Childers, Schlueter & Smith look forward to continuing to work tirelessly in representing such injured individuals.

Super Lawyers is a rating service that uses strict criteria, including peer recognition, to select attorneys with the highest levels of ethical standards and professional achievements.  Childers, Schlueter & Smith’s attorneys have been repeatedly honored by Georgia Super Lawyers since 2007.

Keeping Pharmaceutical Companies in Check

Founded in 2001, Atlanta-based Childers, Schlueter & Smith is recognized nationwide for the exceptional results they have achieved for thousands of clients over the past 13 years.

Childers, Schlueter & Smith is proud of its role as a champion for Americans harmed by dangerous and defective drugs, medical devices, and other products.  They fight day in and day out to hold the corporations responsible for these dangerous products accountable, and to force them to make consumer safety their top priority.

Click here to read the 2014 Super Lawyers feature.

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Georgia Car Accident Basics

February 26th, 2014

When a vehicle collides with another vehicle, pedestrian, or other obstruction, a car accident results. Car collisions can cause minor or more serious injuries, vehicle damage, property damage, and even death.

Factors Affecting the Risk of Car Accidents

Many factors contribute to the risk of car accidents, including the design of a vehicle, road conditions, debris, as well as driver skill, behavior, reaction time, and impairment. Some common types of impairments that may contribute to a higher frequency of car accidents include alcohol, physical impairments, sleep deprivation, drug and alcohol use, and driver distraction.

According to the Georgia Governor’s Office of Highway Safety, the top contributing factors of all crashes and fatal accidents in the state include:

  • Following too close
  • Failure to yield
  • Changed lanes inappropriately
  • Driver lost control
  • Object or animal in roadway
  • Improper backing
  • Disregard of stop sign or traffic signal
  • Driving under the influence of alcohol or drugs
  • Improper turn

I’ve Been in an Accident – What Should I Do? 

If the accident resulted in injury or death of any person or property damage over $500, you are required to report the accident to the authorities immediately.

Georgia law requires the driver of any vehicle involved in an accident to do certain things, including:

  • Stop and remain at the accident scene.
  • Render reasonable assistance to anyone injured, including transporting or making arrangements to transport them to the hospital if necessary.
  • Exchange information with the other driver, including name, address, driver’s license information, and vehicle registration number.
  • Move the vehicle off the roadway onto the shoulder, emergency lane, or median if it can be safely driven and does not require towing.

You will also need to notify your insurance company of the accident, and if possible, take photographs of the accident scene, the damage to the vehicles, and any physical injuries. Always be careful about what you say after an accident. Although you have an obligation to cooperate with law enforcement and your own insurance company, you are not required to give a statement to the other driver or his insurance company – the best way to proceed is to seek legal advice first.

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Risperdal: An Antipsychotic Drug Linked To Gynecomastia

February 21st, 2014

Risperdal is an antipsychotic drug used to treat bipolar disorder and schizophrenia in adults and adolescents ages 10-17. After receiving FDA approval in 1993, in 2005 the FDA required that Risperdal and other antipsychotic drugs include a black-box warning on the package insert to emphasize the increased risk of death in patients who take the drugs for dementia-related psychosis. Johnson & Johnson, whose subsidiary Janssen Pharmaceuticals manufactures Risperdal, is currently facing a number of lawsuits from Risperdal patients who claim to have been physically, emotionally, and socially harmed by the drug.

Risperdal Side Effects

Side effects reported by some patients taking Risperdal include:

  • Diabetes
  • Bone loss
  • Pancreatitis
  • Tardive Dyskinesia, an involuntary movement disorder
  • Pituitary tumors
  • Headaches and eye problems
  • Risperdal gynecomastia, the growth of male breast tissue

Risperdal Gynecomastia: Causes, Symptoms, and Treatment

Experts believe that Risperdal gynecomastia develops because Risperdal works to block dopamine and as a result, the pituitary gland releases prolactin, a hormone that stimulates breast development and milk production in women. In women, excess prolactin levels can cause spontaneous milk production; in men, prolactin can cause gynecomastia.

The symptoms of Risperdal gynecomastia include breast pain, tenderness, swelling, and nipple discharge in one or both breasts. Although Risperdal gynecomastia does not cause severe health complications, the condition can be psychologically and emotionally damaging, especially to male patients.

Surgery is often required to correct Risperdal gynecomastia, although liposuction may be used to remove breast tissue in mild to moderate cases. In more severe cases, the patient may need a breast reduction procedure or even a mastectomy to remove breast tissue and excess breast skin.

Litigation

A number of lawsuits are being brought by patients who have suffered adverse side effects from taking Risperdal, roughly one-quarter of them pertaining to the development of gynecomastia.  According to Market Watch, Risperdal is the subject of dozens of lawsuits filed on behalf of alleged victims of Risperdal gynecomastia, alleging that Johnson & Johnson and Janssen Pharmaceuticals concealed Risperdal’s risks from patients and doctors, and improperly marketed the drug for use in children before it was cleared for pediatric use in 2006.

Childers, Schlueter & Smith is still reviewing Risperdal cases where a patient has been diagnosed with gynecomastia. If you have questions or concerns, contact one of our Risperdal Lawyers today for a free evaluation of your potential claim.

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Pradaxa Under Further Scrunity By The FDA Due To Fatal Health Risks

February 7th, 2014

As of December 2013, the U.S. Food & Drug Administration (FDA) has planned a large scale-assessment to compare the bleeding rates of the anti-stroke drug Pradaxa to those associated with Coumadin. The announcement comes as thousands of lawsuits alleging that use of the drug may cause life-threatening episodes of internal bleeding move through U.S. courts. According to a notice posted on the FDA website on December 30, 2013, the new Pradaxa study will examine selected safety outcomes in adults with atrial fibrillation (AFib) who are new users of dabigatran or warfarin, generics of Pradaxa and Coumadin.

First introduced in 2010 as an effective warfarin alternative, Pradaxa is meant to prevent strokes in atrial fibrillation patients. Both of these drugs are blood thinners meant to keep new blood clots from forming and stop existing blood clots from getting bigger. Late last year, it was reported that the FDA received approximately 3,300 notifications of adverse Pradaxa side effects in 2012, more than any other drug it monitors. Most of the reports involved cases of internal bleeding and hundreds of cases proved fatal. Whereas warfarin side effect reports resulted in a fatal outcome just 6.5% of the time that year, Pradaxa’s rate was about 18%.

According to court documents, at least 2,100 Pradaxa lawsuits have been filed so far. Obviously, that number is still far less than the number of victims affected by this drug and therefore many more lawsuits are expected in the days ahead. The existing lawsuits say that Pradaxa was improperly marketed as a safe alternative to warfarin, an anti-stroke medicine that has been widely prescribed since the 1950s. Pradaxa lawsuits further allege that the manufacturer of Pradaxa failed to disclose its risk and the severity of potential Pradaxa bleeding.

According to the New York Times:

“The one-size-fits-all was a mistake for a drug with this kind of risk,” said Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices, which keeps track of safety reports submitted to the F.D.A. He rated anticoagulants — including warfarin and Pradaxa — as the most serious safety problem in 2011 and 2012. He said Pradaxa has been cited in more than 1,000 deaths reported to the agency through the end of 2012.

The Pradaxa lawyers at Childers, Schlueter & Smith, LLC plan on keeping you informed on the FDA findings as well as the lawsuits currently filed against the drug’s makers. The Federal Court faced with the lawsuits has already taken considerable legal action though the official trials are not set to begin until August 2014. For now, if either you or a love one is using Pradaxa to treat atrial fibrillation, and experienced an uncontrolled bleeding event, we invite you to give us a call to explore your legal options.

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Stryker Hip Implant Dangers And Complaints Continue To Surface

February 6th, 2014

The 2012 recall of Stryker’s Rejuvenate and ABG II hip implants came too late for people who had already experienced painful complications, failed joints and revision surgeries associated with the defective devices. Many patients
were led to believe that these implants would be safe, only to have Stryker recall the devices less than 3 years after they hit the market because it failed to properly test the devices and assess the potential risks and side
effects.  Their Risks and side effects should have been assessed before they were even approved.

This is why Stryker is facing hundreds of lawsuits, with more likely to come. The Wall Street Journal reported in October 2013 that Stryker expects to spend between $700 million and $1.13 billion to resolve these suits.

Sadly, there has been an epidemic of dangerous and defective hip implant products being sold in the US over the past 10 years, with the dangers of these products coming to light over the last few years.  In March 2013, a Montana man was awarded more than $8.3 million after a trial for injuries he sustained from a hip implant made by DePuy, a division of Johnson & Johnson. People injured by Stryker’s hip implants should seek similar justice with the help of an experienced attorney.

Our attorneys have been fighting to hold drug and device companies like Stryker accountable for the injuries they cause for more than fifteen years. Thanks to our thorough understanding of the laws governing drugs, medical devices and product liability, we have consistently achieved great results for our clients. If a Stryker Rejuvenate or ABG II hip system has harmed you or someone you love, we will fight to get you the compensation you deserve.

At a minimum, if you’ve been implanted with a Stryker hip product, please see your doctor as soon as possible to assess your health.

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