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Johnson & Johnson Wants Baby Powder Lawsuit Dismissed

August 26th, 2014

Johnson & Johnson is requesting that a federal judge dismiss a class action lawsuit that alleges that the talcum-based product may increase the risk of ovarian cancer in those who use it in their genital areas.

The suit, filed by Barbara Mihalich, is seeking class action status for all consumers in Illinois who purchased Johnson’s Baby Powder, and alleges that the company failed to disclose that the talc may put women at a 33 percent increased risk for ovarian cancer. According to J&J, the plaintiff does not have ovarian cancer, did not use the product on her genitals, and shows no damages in her claim.

The Link between Talc and Ovarian Cancer

Several studies have found that the use of talcum powder on a woman’s genital area may significantly increase their risk of ovarian cancer because it may migrate from the vagina into the fallopian tubes, uterus, and ovaries. One study, published in the medical journal Cancer Prevention Research in 2013, found that women who use talc on their genital areas may have a 20 – 30 percent higher risk of ovarian cancer than those who do not.

According to, it is not clear if talcum powder use increases cancer risk, but until more information becomes available, the American Cancer Society is recommending that women who are concerned might want to limit their use and consider cornstarch-based products instead.

In October 2013, a South Dakota jury determined that J&J failed to adequately warn consumers about the risk of ovarian cancer from talcum powder in a product liability lawsuit brought by a woman who developed ovarian cancer in 2006 after using Shower to Shower body powder for 30 years. Harvard University doctor Daniel Cramer, who has been studying the link between talc and ovarian cancer for three decades, testified in the case that talcum powder “probably caused 10,000 cases of ovarian cancer every year.”

New cases and causes of action are being investigated now on an individual basis for those who have developed ovarian cancer after prolonged use of Talc. If you have questions about your legal rights we are here to help.

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More Oversight Is Needed To Hold Careless Drugmakers Accountable

August 19th, 2014

At long last, the Food and Drug Administration and our nation’s Congress are beginning to see how important quality control in drug manufacturing facilities is to public health and safety, something we’ve understood at Childers, Schlueter & Smith for quite some time. The FDA is launching a new regimen of quality-control initiatives aimed at overseas drug manufacturing, potentially empowering former and current victims of drug companies with sloppy production techniques.

Because the U.S. imports so many drugs and pharmaceutical ingredients at this point, the FDA now realizes that the demanding standards they place on U.S. production facilities are going to have to be employed elsewhere as well in order to truly protect the American public. About 40 percent of drugs consumed in the U.S. are shipped from abroad, and 80 percent of active ingredient makers are located outside the U.S., according to FDA reports. You can imagine what that means for the scope of the new policies.

FDA officials just launched a pilot project that loosens import restrictions for those drugmakers that the agency respects, freeing up inspectors to focus on less reliable companies. The FDA said its India drug inspection workforce will grow to from 3 positions to 10. There are also plans to create a central U.S. office dedicated to pharmaceutical quality.

Concerns that U.S. regulators were ill-equipped to police globalized drug manufacturing have been simmering for some time. A wake-up call came in 2008 when more than 50 people died after using Baxter Healthcare Corp.’s blood thinner heparin which the FDA found had been contaminated with ingredients made in China.

The flood of new initiatives goes hand in hand with an intense interest from the U.S. Department of Justice in pursuing civil and criminal cases against messy manufacturers. Early last year, one official from the department vowed to take an especially hard look at breaches of good manufacturing practices and bring those companies not up to par to justice. The FDA and Congress have begun to hold drugmakers liable for every step of the supply chain, where multiple companies often play a role in creating a single product. Last year, an important guidance document about contract manufacturing made clear that both drugmakers and their contractors are responsible for ensuring quality.

There is no question that Congress is pushing both the FDA and the Department of Justice to criminally prosecute people in the pharmaceutical industry who do not follow the law. Congress has come to the conclusion that civil fines are no longer effective when up against a massive drug conglomerate.

It’s possible that the additional FDA inspections will lead to more recalls, which can fuel investor suits as well as personal injury suits. Last year, for example, Johnson & Johnson paid $23 million to end a shareholder complaint over an alleged cover-up of production errors linked to a massive recall of medicine.

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M. Brandon Smith Listed In 2015 Best Lawyers® Edition

August 18th, 2014

Childers, Schlueter & Smith L.L.C. is proud to announce that firm partner M. Brandon Smith has been listed in the  2015 Edition of  Best Lawyers® In America. Best Lawyers® is the oldest and most respected peer-review publication in the legal profession. A listing in Best Lawyers® is widely regarded by both clients and legal professionals as a significant honor, conferred on a lawyer by his or her peers. For more than three decades, Best Lawyers® lists have earned the respect of the profession, the media, and the public, as the most reliable, unbiased source of legal referrals anywhere. Its lists of outstanding attorneys are compiled by conducting exhaustive peer-review surveys in which tens of thousands of leading lawyers confidentially evaluate their professional peers.

Smith-Best Lawyers 2015

“It is a great honor just to be nominated in Best Lawyers®, much less make the final selection list. I am very fortunate to have such a great office and family-without them both, none of this would be possible. I am therefore very humbled by this recognition,” says M. Brandon Smith.

Although very appreciative, Mr. Smith is not alone in terms of awards and honors bestowed upon him. The lawyers and team members at Childers, Schlueter & Smith L.L.C. continue to be recognized for their tireless work and efforts on behalf of consumers all over the Country.  With other designations and recognitions in 2014 such as: Super Lawyers, Top 100 Lawyers, Top Lawyers 40 Under 40, Elite Lawyers of America; CSS Firm continues to strive for the highest level of client satisfaction and results. With over $300,000,000 recovered in verdicts and settlements thus far, they certainly appear to be on the right track for both.

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Xarelto Lawsuit Filed Over Bleeding Risks And Injuries

August 13th, 2014

Virginia Stuntebeck sued Johnson & Johnson and Bayer AG in Pennsylvania Court earlier this year, alleging that she suffered severe internal bleeding stemming from use of the blood-thinning drug Xarelto. In the Xarelto lawsuit, which appears to be the first tort suit filed over the medication in Philadelphia, Stuntebeck said the drug should not be sold because of the high risks surrounding its use.

Xarelto-pill_MainStuntebeck confessed that she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding as a result of using the drug. As the manufacturers and distributors of Xarelto, Johnson & Johnson knew or should have known that Xarelto use was associated with irreversible bleeds. Stuntebeck’s lawsuit claims the warning label on Xarelto fails to properly convey the true risks of the drug as it relates to uncontrolled bleeding events and other serious injuries including death.

Xarelto is now being likened to its competitor Pradaxa which is the subject of more than 2,000 injury lawsuits in a multidistrict litigation and occasionally referred to as “the most complained about drug” in the U.S.

Both Pradaxa and Xarelto claim in their marketing that you don’t need to monitor a patient taking the drug to prevent blood clots and stroke. This is supposedly an advantage of these blood thinners since the more well-established anticoagulant warfarin (Coumadin) frequently requires medical monitoring and doctor supervision.

28367The U.S. Food and Drug Administration originally approved Xarelto in July 2011 to reduce the risk of blood clots and pulmonary embolism. They extended the recommendation to include the treatment of abnormal heart rhythm or a-Fib which leads to strokes later that same year. But the subsequent approval was against the recommendation of FDA staff who noted serious safety concerns with Xarelto. Recently, the FDA has refused a third expansion of the Xarelto’s use.

At Childers, Schlueter and Smith LLC, we feel that drug manufacturers and medical professionals should be at fault when their treatments cause serious side effects and put people in danger. If you suffered internal bleeding event or some other injury as a result of Xarelto, you may have a legal claim.

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Xarelto: More Dangerous than Warfarin?

August 11th, 2014

Cases have recently been filed in courts around the U.S. relating to bleeding injuries and death caused by the drug Xarelto.

Xarelto-pill_MainXarelto is an oral anticoagulant manufactured by Bayer Pharmaceuticals and Janssen Pharmaceuticals (a Johnson & Johnson affiliate).  It was brought to market in 2011 and has been extensively promoted as an alternative to warfarin (coumadin).  Xarelto was originally approved to prevent blood clots (and stroke) in patients with atrial fibrillation and in patients undergoing knee or hip replacement surgery.

Until the release of Xarelto and other new oral anticoagulants (“NOACs”), warfarin had long been the standard care for preventing blood clots.  The NOACs, including Xarelto and Pradaxa, have been widely marketed by their manufacturers as better alternatives to warfarin because patients would no longer have to undergo regular blood testing and frequent doctor visits to monitor proper dosage and kidney function.

It has since been demonstrated, however, that the claim of added convenience of Xarelto comes at a steep and often devastating cost to many patients.  Xarelto has been linked to medical complications including intestinal bleeding, rectal bleeding, blood clots, brain hemorrhaging, pulmonary embolism, and deep vein thrombosis.  Many of these conditions can lead to severe disability or death.  Ironically, it appears that these devastating bleeds could often be prevented if the patients on the NOACs underwent regular blood testing – just like patients taking warfarin – to ensure that their dose was appropriate.  Such a recommendation, however, would be in stark contrast to the marketing strategy for Xarelto – that it is more convenient and thus superior to warfarin.  As a result, no such recommendation has been made by the manufacturers of Xarelto.

xarelto 2The failure of manufacturers to recommend blood monitoring in patients taking Xarelto is even more dangerous in light of the fact that, unlike warfarin, there is no known antidote to stop bleeding caused by this medication. If you develop a bleed from taking warfarin, simple vitamin K therapy is generally sufficient to treat the condition and promote clotting.  This is not the case with Xarelto.  Until an effective antidote is created and approved for use in Xarelto patients, there will continue to be an unreasonably high number of uncontrollable bleeds and deaths caused by the drug.

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Risperdal Use May Cause Breast Development in Boys and Men

August 8th, 2014

Risperdal 1Risperdal (risperidone) is a medication used to treat schizophrenia, bipolar disorder, and autism spectrum disorders in children and adults.  Some doctors also prescribe Risperdal off-label (meaning that it is given for a condition other than what has been approved by the FDA) for attention deficit hyperactivity disorder (ADHD), sleep disorders, anxiety, and depression.

ds00850_im02136_m7_gynecomastiathu_jpgA serious side effect of Risperdal is the abnormal growth of breast and glandular tissue in boys and men.  This condition is called gynecomastia, and it is caused by high levels of prolactin (the hormone that stimulates breast growth and lactation in women) that result from use of the medication.

Patients may experience varying levels of growth in one or both breasts, and in some cases may discharge breast milk.  Severe cases may result in significant breast growth, comparable to a women’s cup size D or larger.

Patients suffering from gynecomastia often face considerable social stigma and isolation.  Boys and young men may experience extreme emotional distress as a result of negative reactions from peers (including teasing and bullying).  Mental health conditions such as those the medication is intended to treat – schizophrenia, bipolar disorder, and autism spectrum disorder – are in and of themselves extremely challenging.  A damaging side effect such as this has the potential to increase the level of anxiety and depression that may already accompany these diseases.

In some cases, surgery may be required to resolve gynecomastia.  Options may include liposuction, breast reduction surgery, or mastectomy.

Several hundred lawsuits have been filed against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals due to damages caused by Risperdal

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Mirena IUD Linked to Pseudotumor Cerebri (PTC)

August 7th, 2014

The Mirena intrauterine device (IUD) has been linked to development of pseudotumor cerebri (PTC), a debilitating condition caused by an accumulation of cerebrospinal fluid in the skill. The fluid causes increased pressure on the optic nerve and results in symptoms such as:

  • Migraine-like headaches
  • Vision problems such as blurred or double vision
  • Temporary blackouts

If pseudotumor cerebri goes untreated or is not treated promptly, the pressure and damage to the optic nerve can be irreversible and can even cause permanent blindness. The Mirena IUD contains the synthetic hormone levonorgestrel, which is released daily to prevent pregnancy. This hormone has been linked to PTC and papilledema for many years.

What is Mirena? 

Mirena is a type of long-lasting, reversible birth control known as a hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. The Food and Drug Administration approved Mirena, one of only two hormonal IUDs approved for use in the U.S., in 2000. In 2009, the FDA expanded Mirena’s use to include the treatment of heavy menstrual bleeding in women already using IUDs. 

Globally, the IUD is the most popular form of reversible birth control, with an estimated 150 million users. In the U.S., the popularity of IUDs is growing, and in 2011, the devices made up about 10.4 percent of the contraceptives issued by doctors, up from 1.4 percent in 2002. The reasons for Mirena’s growth in popularity are simple:

  • Mirena can protect against pregnancy for up to five years and is more than 99 percent effective in controlling pregnancy
  • Mirena is more convenient than most oral contraceptives because once implanted, there is no need to take a daily pill
  • Mirena has a failure rate of less than one percent, while oral contraceptives can have a failure rate as high as 30 percent if they are not taken properly

Mirena Lawsuits 

Plaintiffs pursuing Mirena Lawsuits against the device’s maker, Bayer, allege that Bayer failed to warn of the increased chance of developing papilledema and PTC. The lawsuits also charge that Bayer failed to test Mirena properly to learn of the potential risk and the company failed to notify doctors that patients who have PTC and use levonorgestrel-releasing implants like Mirena should consult with their doctors and have the IUDs removed as soon as possible to avoid further injury.

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Stryker Hip Recall Lawsuits Allege Serious Injuries

August 5th, 2014

Rejuvenate, metal hip implant components manufactured by Stryker Corporation, have been linked to a broad range of debilitating injuries, including organ and tissue damage, inflammation, and metal poisoning.

Stryker Lawsuits Patients-Suing-Over-Recalled-Stryker-Hip-Implant

More than 2,000 Stryker hip lawsuits have been filed in U. S. federal court, designated as multidistrict litigation (MDL), and others have been filed in state courts, including hundreds more in New Jersey that have been consolidated into a multicounty litigation (MCL) in the Superior Court of Bergen County, N.J.

With the 2,000 lawsuits having been consolidated into a multidistrict litigation (MDL) in U.S. District Court in Minnesota, the hope is the recall lawsuits will move faster and resolve more quickly.

The hip recall lawsuits share similar claims, alleging that Stryker:

  • Was negligent in designing the hip implant devices and testing their safety
  • Failed to warn consumers about the dangers of the devices
  • Concealed information about the risk of serious injury and death

The plaintiffs seek compensatory damages including reimbursement of lost wages, costs of revision surgery, other medical expenses and some seek punitive damages. Those who still have the Stryker Rejuvenate and ABG II devices implanted in their bodies are also seeking medical monitoring coverage so any adverse effects can be detected as early as possible.

Mediation began in several Rejuvenate lawsuits in the Fall of 2013 in New Jersey, and a small group of cases, known as bellwether cases, are being prepared for early trial dates in June 2015. These bellwether cases will provide some insight into how juries are likely to respond to some of the evidence and testimony that will be offered in the Stryker MDL.

Some of the factors a jury will likely consider in Stryker lawsuits include:

  • The injuries caused by the implant
  • The effect any complications caused by the implant had on the plaintiff’s overall physical and mental condition
  • Lost wages and diminished earning capacity
  • Past and future pain and suffering related to complications caused by the implant
  • Past and future medical expenses relating to the Rejuvenate surgerystryker

Stryker initiated the recall of Rejuvenate and ABG II modular-neck hip stems after the implants showed signs of corroding and fretting in July of 2012. The company has stated that the recall and lawsuits could cost it as much as $1.3 billion to resolve and settlement in the days ahead. As a leader in the Stryker hip implant litigation, our hip implant recall attorneys continue to review and file new claims on behalf of Stryker victims nationwide. If you have questions or concerns about your potential claim, contact us know to learn how we can help.

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Benicar Produces Symptoms Similar to Celiac Disease

August 4th, 2014

On July 4, 2013, the U.S. Food and Drug administration issued a warning that Benicar causes sprue-like enteropathy. The high blood pressure drug has been linked to more than 60 cases of severe Benicar enteropathy that exhibits symptoms similar to those of Celiac Disease, including:

  • Chronic diarrhea
  • Vomiting
  • Rapid and substantial weight loss
  • Stomach pain and discomfort
  • Dehydration
  • Cardiovascular problems


But unlike Celiac Disease, a gluten-free diet will not improve the symptoms of Benicar enteropathy. The only way to do that is to stop taking Benicar.

What is Benicar?

Benicar is a medication developed by Japanese drug maker Daiichi Sankyo, Inc. to treat high blood pressure. The U.S. Food and Drug Administration originally approved Benicar in 2002, and doctors write more than 11 million prescriptions a year for the medication.

Benicar’s active ingredient, olmesartan medoxomil, lowers blood pressure by helping to keep blood vessels open. It can be taken either as a singular blood pressure treatment or as part of a combination of drugs.

FDA Warning

Despite the popularity of Benicar, research linking the drug to severe gastrointestinal side effects led the FDA in April 2014 to issue a mandate that Benicar carry a warning on its label regarding its association with severe gastrointestinal side effects.


The Mayo Clinic contacted the FDA in 2012 after their researchers found a connection between specific gastrointestinal symptoms and olmesartan medoxomil. Between 2008 and 2011, Mayo Clinic saw 22 patients with symptoms similar to those associated with Celiac disease. Although tests for Celiac disease returned negative, all the patients took Benicar.


Benicar Lawsuits

Some people who took Benicar have suffered physically, financially, and may have undergone long and difficult treatments to ease the severe intestinal complications and other health issues triggered by Benicar. Soon after the 2013 FDA warning, former Benicar users filed the first lawsuits in New Jersey against Daiichi Sankyo, Inc. and the cases were moved to federal court. Those lawsuits and others are still pending today with numerous other new cases being filed on a continual basis.

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FDA: Morcellators May Cause the Spread of Sarcoma in Women

August 1st, 2014

Pending a review by the U.S. Food and Drug Administration, Johnson & Johnson plans to ask doctors to return its laparoscopic power morcellators, surgical tools that may inadvertently spread cancer in women being treating for fibroid tumors. The company’s Ethicon unit suspended sales and distribution of the devices in April 2014.

Morcellators are used in hysterectomies, and also to cut up uterine masses in the uterus so that they can be more easily removed through non-invasive procedures. The problem is that uterine cancers commonly known as sarcomas sometimes appear to be benign fibroids and can’t be reliably detected before surgery. When the blade of the morcellators spins, it potentially spreads the cancer and worsens patient outcomes.

Johnson & Johnson is the world’s largest manufacturer of laparoscopic morcellators, holding an estimated 72 percent of the market in 2011, according to iData Research Inc. Smaller manufacturers, including the German companies Karl Storz GmbH and Rich Wolf GmbH, and Danish company LiNA Medical, haven’t responded to requests for comment regarding the morcellator controversy and their market plans.

The risks of cutting up cancer inside a human body have been known for some time, but the risk that a woman with presumed fibroids actually had cancer was always believed to be extremely small, 1 in 10,000, and most gynecologists did not consider it worth mentioning to patients. But in April 2014, the FDA stated that women undergoing surgery for fibroids actually have a 1 in 350 risk that the growths are cancerous, much greater than originally thought. A new study by Columbia University found that 1 in 368 women undergoing hysterectomies actually have hidden uterine cancer that is capable of being spread by a morcellator.

According to the FDA, the tool was being used in approximately 50,000 hysterectomies per year, and very commonly used to remove uterine fibroids as well.

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