News Blog

GI Bleeding Risk Higher in Pradaxa Users Per New Data

May 21st, 2014

According to Medscape, the FDA announced on May 13 that based on the results of a study of 134,000 Medicare patients, Pradaxa was associated with a reduced risk for some conditions compared to warfarin, but an increased risk for major gastrointestinal bleeding resulting from the use of the anticoagulant. The risk of bleeding is typically higher among:

  • Patients 75 years old or older
  • Those who have had kidney problems
  • Patients who suffer from recurrent stomach or intestinal bleeding or stomach ulcers
  • Those who take other medications that increase their risk of bleeding (aspirin products and anti-inflammatory drugs) and blood thinners
  • Those who have kidney problems and take dronedarone or ketoconazole tablets

What is Pradaxa?

Pradaxa is a prescription blood thinner medication prescribed to lower the risk of blood clots forming in the body. It is used to reduce the risk of stroke and blood clots in people who suffer from atrial fibrillation, a condition in which part of the heart does not beat the way it should, leading to blood clots and an increased risk of stroke. Pradaxa is also used to treat deep vein thrombosis and pulmonary embolism and reduce their risk of occurrence. People should not take Pradaxa if they:

  • Currently suffer from abnormal bleeding
  • Have ever had an allergic reaction to it
  • Have or plan to have a valve in their heart replaced

You should call your doctor immediately if you are experiencing any of the following signs or symptoms:

  • Unexpected, severe, uncontrollable, or long-term bleeding
  • Unusual or unexpected bruising
  • Coughing up or vomiting blood
  • Vomit that resembles coffee grounds
  • Pink or brown urine
  • Red or black stools resembling tar
  • Unexpected pain or swelling
  • Joint pain
  • Headaches
  • Dizziness
  • Weakness

Since its approval in 2010, Pradaxa has been the subject of numerous safety questions and inquiries. According to the FDA, since Pradaxa’s approval, U.S. pharmacies have dispensed about 6.2 million prescriptions of the medication for 934,000 patients. The FDA warns that patients should not stop taking Pradaxa or warfarin without first talking with their healthcare professionals, as abruptly discontinuing use can increase the risk of stroke and lead to permanent disability and death.

According to the German drug maker Boehringer Ingelheim, the manufacturer of Pradaxa, the company is currently facing more than 2,000 lawsuits in the U.S. filed by individuals alleging that the drug caused severe or fatal bleeding.

Contact Us

If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Pradaxa we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight for the maximum compensation for your injuries.

Tags: , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Richard Schlueter Discusses Metal-on-Metal Risks With Atlanta Journal Constitution

May 11th, 2014

Founding Partner, Richard Schlueter,  discusses the continued risks and concerns over metal-on-metal hip and knee implants in the Atlanta Journal Constitution today.

A short excerpt from the article is as follows:

Recalls and lawsuits have plagued most of the large companies that manufacture artificial hips. Many of the failures have been tied to all-metal joints that were once marketed as the best option for patients.

“There is so much competition and desire from companies to gain market share, a lot of devices have not gone through rigorous clinical trials,” said Richard Schlueter, an Atlanta attorney who has represented hundreds of clients from across the country whose artificial joints have failed.

While “metal-on-metal” joints have been the subject of most of the recalls and suits, Schlueter said failures have been associated with other joints too.

The common problem with the defective joints is that tiny pieces of metal break away from the artificial joint. That can cause damage to the nearby bone or tissue. Particles can also enter the bloodstream.

The U.S. Food and Drug Administration cautions hip replacement patients who experience pain, swelling or noise from the hip joint to contact their surgeon for evaluation.

While some doctors and hospitals may be closely watching their patients with artificial joints associated with failures, others may not, Schlueter said.

Patients who have filed lawsuits often had to undergo complicated and expensive surgeries to remove and replace defective joints.

“When these things fail,” Schlueter said, “they fail really badly.”

The insightful article written by Carrie Teegardin can be found in its entirety on

Outcomes mixed for joint replacements at Georgia hospitals-New data show risk of complications

Tags: , , , , , , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Avaulta Mesh Products Causing Complications for Many Women

April 30th, 2014

Although vaginal mesh devices like Avaulta were intended to help women with weakened vaginal muscles suffering from conditions like stress urinary incontinence (SUI) and pelvic organ prolapse (POP), thousands have sustained permanent injuries due to the surgical implant of such devices. Over $20 million has already been awarded to women injured by vaginal mesh implants, and Avaulta manufacturer C.R. Bard faces thousands of lawsuits over complications allegedly caused by the devices.

What is Avaulta?

Avaulta is a synthetic or biosynthetic vaginal mesh device, including the Avaulta Biosynthetic and Avaulta Plus Biosynthetic Support Systems that are intended to help hold pelvic organs in place. Avaulta’s design was based upon a type of surgical mesh that has been used to strengthen the abdominal muscles of patients who suffer from hernias. Vaginal mesh devices like Avaulta are surgically inserted by implanting the device through an incision in the vaginal wall.


During insertion, complications including bowel, bladder, and blood vessel perforation may occur, along with discomfort and pain due to vaginal scarring. Unfortunately, because of questionable design, incompatibility with the pelvic region of a woman’s body, and the potential for surgical mesh erosion, Avaulta devices have caused patients to experience serious injuries, including:

  • Erosion
  • Significant Pain During Intercourse
  • Organ perforation
  • Internal bleeding
  • Infection
  • Nerve damage
  • Chronic pelvic pain

Many women have undergone multiple surgeries to remove vaginal mesh devices from their bodies (also known as “revision procedures”), only to discover that the device cannot be completely removed. Further surgical complications have worsened the original incontinence or organ prolapse present before the initial procedure. Although there have been proposals to ban the use of pelvic mesh due to these and other post-operative complications, to date, no pelvic mesh ban is in effect.

FDA Warnings

The U.S. Food and Drug Administration issued a health alert in 2008 stating that in the last three years, it had received more than 1,000 reports from nine surgical mesh manufacturers regarding complications associated with surgical mesh devices used to repair SUI and POP, among them Avaulta surgical mesh products. But that same notice indicated these injuries were “rare” and not common in most patients.

In 2011, the FDA issued an update regarding additional data it has received linking pelvic and transvaginal mesh implants to serious complications, and questioning the effectiveness of transvaginal mesh in treating POP. The FDA advises that patients and healthcare providers consider non-mesh options and only consider pelvic or transvaginal mesh after a careful consideration of the risks versus the benefits.

Tags: , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

First Pradaxa Trial Set for September 2014

April 28th, 2014

Of the approximate 2000 lawsuits currently on file relating to the anticoagulant drug Pradaxa, the first case set for trial begins on September 8, 2014 and relates to a wrongful death action brought by a daughter, Suzanne Mackiewicz, on behalf of her father, Malachy Higgins. The Higgins case is one of four specific Pradaxa cases that were chosen to move forward as bellwether trials in the federal multidistrict litigation (MDL) established in August 2012 under the direction of U.S. District Judge David r. Herndon in the Southern District of Illinois.

All the Pradaxa MDL product liability lawsuits involve similar allegations, including:

  • Pradaxa use caused patients to suffer severe and/or sometimes fatal uncontrolled bleeding;
  • The makers of Pradaxa, Boehringer Ingelheim, did not offer sufficient warning of potentially fatal bleeding events and also failed to disclose that there was no conventional way to stop bleeding while using the drug or
  • Prescribing doctors were not provided with an antidote to reverse and stop the blood thinning effects of the drug

What is Pradaxa? Pradaxa

Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. It received U.S. Food and Drug Administration approval in October 2010, and is characterized as an anticoagulant, a substance that prevents the clotting of blood. Pradaxa is the first new treatment alternative to warfarin, which is sold under the brand name Coumadin, in almost 60 years. On April 7, 2014, Pradaxa was approved by the FDA for treatment of Deep Venous Thrombosis and Pulmonary Embolism.

Problems with Pradaxa

From October 2010 through the end of March 2011, approximately 272,119 prescriptions were written for Pradaxa in the U.S., and during this same time period, 932 serious adverse event Medwatch reports were filed with the FDA, including at least 120 deaths and more 500 reports of severe, life-threatening bleeding. In April 2013, the FDA required that the Pradaxa label contain a boxed warning advising patients that discontinuing treatment with the drug increases the risk of stroke.

Studies have shown that although the chances of bleeding may be similar with Pradaxa and warfarin, Pradaxa may pose a more serious health risk. The reason why: although the effects of warfarin can easily be reversed with a dose of vitamin K and plasma, there is no known reversal agent for Pradaxa.

The Pradaxa Lawyers at Childers, Schlueter & Smith, LLC continue to review and file new Pradaxa Lawsuits on a rolling basis. If you have questions and need answers, please give us a call today at 1-800-641-0098 to learn how we can help.

Tags: , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Risperdal Settlement of $5.9 Million in Montana

April 18th, 2014

In 2008, Montana’s attorney general filed a lawsuit against Johnson & Johnson, claiming that it heavily promoted its antipsychotic drug Risperdal despite the fact that the tablets have been linked to the development of diabetes. Risperdal, the trade name of the drug risperidone, is used to treat schizophrenia as well as certain symptoms of bipolar disorder and autism.


Just this month, a Johnson & Johnson subsidiary agreed to pay $5.9 million to resolve the suit. Janssen Pharmaceutical Inc. agreed to the settlement without admitting to any wrongdoing, as part of a deal that prevents it from misleading consumers about its drugs in the future.

Risperdal has been involved with a number of lawsuits. In 2012, Johnson & Johnson settled a lawsuit claiming that Risperdal caused hundreds of male patients to grow breast tissue and another claiming that it had promoted Risperdal for non-approved uses including dementia, anger management and anxiety. In November 2013, Johnson and Johnson settled out of court for $2.2 billion in response to allegations that they encouraged the overmedication of children as well as the elderly and disabled by showering doctors with kickbacks.

The settlement funds Montana is now set to receive will be divided among courts, hospitals and the state’s newly formed awareness groups. Roughly $1.5 million of the settlement funds will go towards a new program in the state to prevent prescription drug abuse, while another $1.5 million will go towards funding mental health services and programs in Montana, according to the statement.

This settlement is not only significant in terms of the amount of money Montana will receive, but also in that it protects citizens from being prescribed Risperdal based on the types of false statements Janssen previously made to health care providers. If you have been wrongfully prescribed Risperdal or taken Risperdal and experienced some symptoms of diabetes, you should contact a health care provider as soon as possible then consider whether or not you should make a claim against its manufacturer.

Tags: ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Transvaginal Mesh Manufacturer Sets Aside $520 Million For Future Settlements

April 15th, 2014

Johnson & Johnson, Boston Scientific Corp, C.R. Bard Inc. and Endo Health Solutions Inc. all face large vaginal mesh injury lawsuits and a multidistrict litigation in West Virginia and various state courts around the Country. Of those four medical supply companies, Bard is the furthest along in litigation. Throughout these trials, we want to provide continual updates including both the corporations’ and the plaintiffs’ product liability arguments and the final outcomes. If you happen to know anyone harmed by a vaginal mesh product, made by one of these manufacturers or not, there is still time to file a complaint.

Endo Health Solutions Inc. (Parent Corporation to American Medical Systems) anticipates it will cost at least $520 million to settle or otherwise exit the product liability litigation it faces, which primarily consists of thousands of vaginal mesh injury cases relating to the following products:

Elevate: Anterior/Apical &Apical/Posterior Pro



Monarc Subfascial Hammock

Sparc Sling

Mini-Arc Precise Single Incision Sling

Mini-Arc Single Incision Sling

In-Fast Ultra Transvaginal Sling


In 2013, Endo recorded an incremental pretax charge of about $316 million, increasing its product 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 more than 20,000 lawsuits claiming its vaginal mesh products are defective and have caused chronic pain, incontinence and other injuries or relapses of previous conditions.

“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.”

It 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. It had not recovered any insurance money as of the end of 2013, however.

AMS transvaginal mesh jury trials are currently set for June 2, 2014 and July 7, 2014. AMS previously agreed to settle a small number of cases last year 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 in 2014 or 2015.

If You Have Questions

If you or someone you love has questions, please contact the law firm of Childers, Schlueter and Smith, LLC based in Atlanta, Georgia.  Childers, Schlueter & Smith, LLC  attorneys will speak with you free of charge.  All inquiries are strictly confidential and will be handled with discretion.  Our trained transvaginal mesh implant lawyers are accustomed to handling personal matters like this.

Tags: , , , , , , , , , , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Alli Recall Voluntary but Significant

April 15th, 2014

Alli maker GlaxoSmithKline Consumer Healthcare is voluntarily recalling all Alli weight loss products from U.S. and Puerto Rican retailers because some product packages were allegedly tampered with and may contain a product that is not the authentic, FDA-approved weight loss product Alli.

According to a March 2014 report in USA TODAY, GlaxoSmithKline Consumer Healthcare has received inquiries from 12 consumers in seven states about packages of Alli purchased in retail stores that contained tablets and capsules that were not the weight-loss product. The affected states included Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas. The tablets and capsules were various shapes and colors, and some bottles were missing labels and had tamper-evident seals that were not genuine.

Alli has had similar problems before. Back in 2010, the FDA warned that a counterfeit version of Alli potentially harmful to consumers was being sold online, although no reports of serious illness related to the recent tampering and recall have been received. GlaxoSmithKline is unsure about how or where the bottles had been tampered with and is conducting an investigation, and also working with the FDA on the recall.

Alli is an over-the-counter fat-blocking pill meant to be taken in conjunction with exercise and a healthy diet. The active ingredient in Alli is orlistat, which was linked to an increased risk of rectal bleeding as well as kidney, liver, and thyroid problems by a 2009 Consumer Reports article. Following the article, the FDA changed the label on products containing orlistat, including Alli, to include new information about cases of severe liver injury. Alli’s new label contained a warning about “rare reports of severe liver injury.”

Consumers should confirm that the Alli they have matches this description: Turquoise blue capsule with a dark blue bank imprinted with the text “60 Orlistat.” Alli is packaged in a labeled bottle that has an inner foil seal imprinted with the words, “Sealed for Your Protection.” Pictures of the product are available on

The diet supplement injury lawyers at Childers, Schlueter & Smith, LLC continue to investigate and review new potential diet supplement cases all over the United States. If you have questions about a potential diet supplement injury, give us a call. All initial case reviews are free of charge and are kept completely confidential.

Tags: , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Wheel Separation Accidents: Usually Not Just Freak Episodes

April 14th, 2014

It may seem highly unlikely, but wheels suddenly detach from moving cars and trucks more often than most people think. These wheel separations can lead to serious injuries when the driver loses control and collides with another vehicle or pedestrian, or when another vehicle swerves to avoid the debris. When a wheel separation occurs on a highway, the approaching speed between a bouncing wheel and oncoming vehicles can exceed 100 miles per hour.

Why Does a Wheel Separate From A Vehicle?

The most common reason that a wheel separates from a vehicle is failure of the fasteners, either because the lug nuts fall off or because the wheel studs break and release one or two wheels from the vehicle. These failures usually happen two to four weeks after a wheel was taken off and put back on during some type of service, such as tire installation or rotation.

The majority of accidents involving wheel separations occur because of improper maintenance – mechanics not properly torquing lug nuts after changing a tire for one of two reasons:

  • They are not properly trained.
  • They use an air gun to tighten the nuts and do not verify the torque readings with a torque wrench.  The only way to verify proper torque is by using a torque wrench that is set to the specific car/tire specifications.

Even when wheel nuts are properly torqued, they can still lose their clamping force due to wear of paint coatings on brake drums, the breakup of corrosion or dirt present when the wheel was put on, and wear of aluminum wheels. The remedy for lost clamping force is to simply re-torque the wheel nuts to the manufacturer’s specified torque to each wheel after a short amount of driving.

Wheel Separations Still Major Problem

 Wheel separations from trucks, trailers, cars, and buses are still a major problem, although exact numbers are hard to determine because many incidents go unreported. Wheel separations came under scrutiny in 1992 after a rash of such accidents in the fall of 1991 left seven people dead. Although policies and procedures have since been put into place to solve the problem, recurring incidents still happen, possibly because of the industry’s reluctance to put more rigorous maintenance procedures in place.

The wheel separation lawyers at Childers, Schlueter & Smith, LLC continue to investigate and review new potential wheel separation cases all over the State of Georgia. If you have questions about a potential incident, give us a call. All initial case reviews are free of charge and are kept completely confidential.

Tags: , ,
Posted in News & Results, News Blog | No Comments »

Punitive Damages In Georgia: Intended to Punish, Not Compensate

March 31st, 2014

Punitive damages, also known as exemplary or vindictive damages, are not meant to compensate a victim for an injury. Instead, they are typically awarded for three very specific reasons:

  • To punish,
  • To penalize, and
  • To deter a defendant or others from acting in a similar manner.

Punitive damages are commonly allowed for a variety of reasons, including fraud, wantonness, drunk driving, oppression, or other conduct that exhibits a total disregard for the consequences of actions upon others.

Are Punitive Damages Available in Georgia?

In Georgia, a plaintiff must ask for punitive damages when he files a lawsuit, but punitive damages are not allowed under Georgia law unless a jury returns a verdict in favor of the plaintiff on punitive damages. There must be clear and convincing evidence that the defendant’s actions exhibit exceptionally bad behavior. Negligence alone will not support a punitive damage award.

To recover punitive damages in Georgia, a party typically has to show conduct that is extreme and outrageous – the kind of behavior that a reasonable person would not want to encourage or accept.

In Georgia, punitive damages may not be awarded:

  • Against the state of Georgia
  • In breach of contract actions
  • Concerning automobile collision cases where the driver at fault simply violated a rule of the road

Punitive damages are available in Georgia in environmental liability cases, bad faith insurance matters, and professional and product liability claims. We usually see them most often in DUI accidents and Hit and Run Collisions.

Split Recovery and Caps

Numerous states, including Georgia, have enacted split-recovery statutes, which provide for some percentage of every punitive damage award to be paid to the state treasury rather than the plaintiff. In Georgia for products liability actions only, this amount is 75 percent, the largest contributory provision in the country. The remaining 25 percent is generally paid to the plaintiff who was injured as a result of the defendant’s misconduct. This split-recovery statute only allpies to product liability actions. (Ie., not applicable in car collisions, premise liability actions, etc.)

Georgia also has a general punitive damage limit, or cap, of $250,000 except in product liability cases or when the court rules that the defendant intended to harm the plaintiff.

Tags: , , , ,
Posted in News & Results, News Blog | No Comments »

GM’s Recall Problems Continue

March 28th, 2014

Last month, General Motors recalled 1.62 million cars worldwide because of an ignition switch issue in which the switch moves out of the “run” position, resulting in a partial loss of electric power and subsequently turning off the engine. The defect has resulted in 12 deaths and 31 crashes, and federal investigations continue into why GM has known of the switch problem since 2001 but didn’t recall the cars until February 14, 2014

New Recalls

On March 17, 2014 new GM CEO Mary Barra announced three new recalls involving another 1.5 million vehicles that are unrelated to the ignition switch recall. The new recalls involve:

  • Seat-mounted side airbags, front center air bags, and seat belt pretensioners that might not deploy due to a wiring defect in 1.18 million full-size crossover SUVs, including the 2009-2013 Chevrolet Traverse, 2008-2013 Buick Enclave, 2008-2013 GMC Acadia, and the 2008-2010 Saturn Outlook. According to GM, if the air-bag warning light on the instrument panel comes on but the owner ignores it, the wiring eventually will fail and the bags won’t function. No known injuries or accidents linked to the defect have been reported.
  • A plug in the brake system of 63,900 2013 and 2014 Cadillac XTS sedans can potentially get dislodged, allow corrosion, and cause overheating that may increase the risk of an engine-compartment fire. GM says it is aware of two fires at dealerships involving dealer-owned vehicles and two warranty claims, but no fires in customer cars, and no injuries have been reported, according to a report in USA TODAY.
  • Front passengers foregoing seat belts in Chevrolet Express and GMC Savana commercial vans are at risk for head injuries because the material on the instrument panel does not meet federal standards and needs to be reworked, according to GM.  Passengers wearing seat belts are not at risk. This recall involves 303,000 of the 2009-2014 standard and medium-duty models primarily driven by tradesmen and delivery services, and also passenger shuttles used by hotels, airports, and churches. Until a fix is found, GM issued a stop delivery order for vans still at dealerships.

According to the New York Daily News, GM expects to spend approximately $300 million in the first quarter of 2014 to repair the vehicles involved in the new recalls as well as the vehicles in the earlier recall. Barra, who has personally assumed control of GM’s recall response, is scheduled to testify about the recalls before a congressional subcommittee on April 1, 2014.

Tags: , , ,
Posted in News & Results, News Blog | No Comments »

Call us toll-free at (800) 641-0098