Thousands of lawsuits have been filed over the past six years against various manufacturers of surgical mesh products used to treat conditions such as pelvic organ prolapse and stress urinary incontinence in women.  These lawsuits challenged the safety and effectiveness of these products, after years of reports of women experiencing pain, bleeding, infection and other complications caused by the mesh implants.  Often, the complications resulted in women having to undergo multiple surgeries to repair or remove the mesh product.  Now, the United States Food & Drug Administration (FDA) is finally getting on board with those of us who have been stating for years that these products are neither safe nor effective.

In July of 2011, the FDA concluded that women who were surgically implanted with vaginal mesh products had more complications than those who underwent traditional surgery involving stitches.  At that time, the FDA issued an update on serious complications associated with the transvaginal placement of mesh for the condition known as pelvic organ prolapse (POP).  This condition occurs when the tissue that holds the pelvic organs in place becomes weakened or stretched, resulting in the organs prolapse or bulge into the vaginal area, causing various and serious complications.  In its 2011 update, the FDA informed doctors and patients that serious complications associated with the use of transvaginal mesh products for repair of pelvic organ prolapse were “not rare.”

This week, the FDA took a stronger stand against the use of surgical mesh products to repair POP in women, classifying transvaginal mesh products as “high-risk” medical products and subjecting them to additional regulatory scrutiny.  Previously, these products were considered “moderate-risk” products.  Now, the manufacturers of pelvic mesh products will have to submit new applications to the FDA, demonstrating both the safety and effectiveness of these mesh devices.

While trial lawyers commend the FDA for taking this stronger position, the litigation that has been ongoing over the past six years has been the real driving force behind getting doctors to stop implanting these products and manufacturers to stop making them.  Juries have rendered substantial damages awards against manufacturers, such as Johnson & Johnson (J&J), Boston Scientific Corporation, and others, leading to large-scale settlements of thousands of these lawsuits.  For example, in 2014, Endo International, an Ireland-based company, settled approximately 20,000 lawsuits involving mesh products for $830 million.  In April of 2015, Boston Scientific Corporation settled approximately 3,000 cases for $119 million.  By the end of 2015, Boston Scientific had settled a total of approximately 6,000 cases.  Interestingly, J&J, who still has thousands of lawsuits pending against it, stopped selling transvaginal mesh products in 2012.  However, the company claimed that its decision to stop selling its products was not related to the pending lawsuits.  This has not insulated J&J from liability.  In December of 2015, after deliberating for less than 24 hours, a Philadelphia jury awarded a woman implanted with a J&J Prolift pelvic mesh product $5.5 million in compensatory damages and $7 million in punitive damages, resulting in a total jury award of $12.5 million.

The pelvic mesh litigation is another example of the civil justice system being able to bring about changes that benefit the public.  While the FDA was taking years to classify and reclassify the risks associated with pelvic mesh products, trial lawyers have produced evidence of the products’ danger and obtained jury verdicts to prove the point.  The defective medical product attorneys at Suthers Law Firm are proud to have represented numerous women in successful cases against the manufacturers of these unsafe and ineffective products.

Zofran

Suthers Law Firm is actively investigating cases of birth defects caused by the drug Zofran.  Recently, several medical studies have identified an association between Zofran (ondansetron) and birth defects.  The manufacturer, GlaxoSmithKline (GSK), promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and surgery.  However, Zofran was never approved for use during pregnancy, but GSK chose to market the drug to doctors treating pregnant women with morning sickness.  Although it is not illegal for doctors to prescribe medications off-label, it is illegal for drug companies to market drugs for off-label uses. In 2012, GSK agreed to pay more than $1 billion to settle allegations that it illegally marketed medications – including Zofran – for off-label use

The results of studies done on Zofran’s risks to a developing fetus are very troubling.  Because morning sickness most often occurs during the first trimester, the pregnant mother is taking Zofran at the infant’s most critical and fragile stage of development, when drugs can do the most damage. Birth defects that have been linked to Zofran include the following:

  • Cleft lip
  • Cleft palate
  • Heart problems such as septal defects (holes in the heart)
  • Kidney malformations
  • Club foot
  • Craniosynostosis: a condition characterized by an abnormally shaped skull that sometimes may not leave enough space for the brain, leading to mental impairment and vision problems
  • Jaundice
  • Fetal death

If you took Zofran during your pregnancy and your child suffered any of the above listed injuries call the Suthers Law firm at 1-800-320-3284, or fill out a contact form at the firm’s website, www.sutherslaw.com, to discuss your potential Zofran birth defect lawsuit.  The firm has represented many victims injured by dangerous drugs and defective medical products. Such lawsuits are pursued under a contingency fee basis, meaning that there are no attorney fees unless a recovery is obtained.  If your child has suffered one of the serious injuries listed above, you should not delay in consulting with an attorney who is experienced in handling dangerous drug cases.

A recent study performed by researchers at Florida State University found that receiving cell phone notifications, such as a ringtones, vibrations or alarm bells, while operating an automobile can be just as distracting and dangerous as talking or texting while driving.  This is the first study to examine the relationship between of cell phone notifications and mental performance.

The researchers, who published their findings in the Journal of Experimental Psychology: Human Perception and Performance, determined that when your cell phone sends out an alert, your mind starts to wander and lose concentration.  “The level of how much it affected the task at hand was really shocking,” FSU researcher Courtney Yehnert said.  “Although these notifications are generally short in duration, they can prompt task-irrelevant thoughts, or mind-wandering, which has been shown to damage task performance.  Cellular phone notifications alone significantly disrupt performance on an attention-demanding task, even when participants do not directly interact with a mobile device during the task.”

The National Highway Traffic and Safety Administration reported in April 2013 that an estimated 660 thousand drivers use cell phones or electronic devices while driving at any given daylight moment in spite of the fact that 44 states and the District of Columbia have outlawed texting while driving. Unsurprisingly, the National Safety Council has found that twenty five percent of all traffic accidents are caused by distracted driving, specifically cell phone use while driving.

“Even a slight distraction can have severe, potentially life-threatening effects if that distraction occurs at the wrong time,” researcher Cary Stothart said. “When driving, it’s impossible to know when ‘the wrong time’ will occur. Our results suggest that it is safest for people to mute or turn off their phones and put them out of sight while driving.”

As attorneys who represent victims involved in automobile collisions, we have seen far too many people seriously injured as a result avoidable accidents due to cell phone use. If you or a loved one have been injured as a result of the negligence of another driver, contact the attorneys at The Suthers Law Firm. Call toll free 1-800-320-2384 or visit our website www.sutherslaw.com for a free consultation.

Federal and state laws require that nursing homes maintain or attain the highest practicable mental, physical, and psychosocial well-being for their patients.  These laws provide that nursing homes must ensure that their patients’ nutrition and hydration needs are met, as proper nutrition and hydration are two critical components for nursing home residents to maintain their overall health and well-being inside the facility.

The elderly are particularly at risk for both malnutrition and dehydration.  Due to decreased body reserves and other diminished capacities, the elderly are much more susceptible to malnourishment than younger adults. Moreover, many aging patients have dental problems or experience loss of appetite caused by health problems or medications. Thus, they need to be monitored by nursing home staff carefully for any signs of malnutrition. Often times this is not done.

Another reason patients become malnourished while residing in nursing homes is that many cannot feed themselves without assistance, and are not properly fed by nursing home staff. Each year thousands of nursing homes across the country receive citations for inappropriate feeding tube insertions or improper feeding methods.

Recognizing the symptoms of malnutrition and dehydration in your loved ones can often times be very difficult. However, it is extremely important to recognize these signs and symptoms as dehydration and malnutrition can lead to very serious health complications and skin breakdown. The following are signs that you should monitor closely, as these may indicate serious malnutrition or dehydration problems in a nursing home patient:

  • Easily bruising
  • Diminished energy
  • Lowered mental sharpness
  • Hair loss
  • Rapid weight loss
  • Wounds that heal poorly
  • Dental issues
  • Inflamed and red eyes
  • Yellow skin
  • Chills
  • Dry mouth or skin
  • Flushing skin –

If you see any of the above signs, you should make your concerns known to the nursing home staff immediately.  Nursing home residents should not be allowed to become malnourished. Even residents who refuse to eat because of depression or other health problems can be provided nutritional supplements.  Often times, a malnourished nursing home resident is a victim of neglect.

If you believe a loved one has suffered serious injuries as result of malnutrition or dehydration while a resident of a nursing home, contact the experienced Nursing Home Attorneys at The Suthers Law Firm. The Suthers Law Firm, which practices throughout the States of Georgia and South Carolina, regularly represents victims who have been abused or neglected and their families in cases against nursing homes and assisted living facilities. For more information on nursing home abuse and neglect, see the page entitled “Nursing Home Resource Center” at the website of the Suthers Law Firm, www.sutherslaw.com.

Talc is a naturally occurring mineral that is one of the primary ingredients in products like Johnson & Johnson’s Baby Powder and Shower-to-Shower body powder.  Manufacturers of products containing talc have promoted these products for decades, claiming that talcum powder eliminates friction, is gentle on the skin, and provides a fresh scent.  They created ads with smiling, bare-bottomed babies, promoting the use of baby powder to reduce diaper rash, and other ads, promoting the use of talcum powder by women as a personal hygiene product.  However, a large number of studies published in scientific and medical journals concluded that the use of talcum powder in the genital area increases a woman’s risk of developing ovarian cancer.  This alarming information has been known by the manufacturers of products for many years, but the manufacturers chose not to put warnings on their products or in their ads.

Talc is a mineral that shares some similarities with asbestos, another mineral that causes deadly cancers.  Just as asbestos fibers were found in the lungs of workers who breathed them, talc particles have been found in the ovaries of women who used baby powder containing talc in the vaginal area and developed ovarian cancer.  When baby powder containing talc is applied to the genital area, talc particles can move up the vagina, into the fallopian tubes, and into the ovaries, where the talc particles can remain for decades.  Scientific studies have shown that talc causes inflammation in healthy tissue.  This inflammation may, in turn, contribute to the development of cancer.

Dr. Daniel Cramer is a gynecologic oncologist and Harvard Medical School professor.  In 1982, Dr. Cramer published the first study that linked talcum powder use in a woman’s genital area with an increased risk of ovarian cancer.  In a recent interview, Dr. Cramer said “I have always advised gynecologists that if they examine a woman and see that she is using talc in the vaginal area, tell her to stop.”  The association between talcum powder use and ovarian cancer was the subject of numerous epidemiological studies published throughout the 1980s and 1990s, which reinforced Dr. Cramer’s findings.  As early as 1992, manufacturers were urged to put warning labels on talcum powder products because of this serious health threat to women.

In 2003, scientists analyzed 16 of the studies that had been done linking baby powder containing talc to ovarian cancer.  They found that women using baby powder containing talc were 33% more likely to develop ovarian cancer.  Dr. Margaret Gates, a Harvard epidemiologist, and other scientists published a study in 2010 entitled “Perineal Use of Talcum Powder and Endometrial Cancer Risk.”  They found that perineal talcum powder use increased the risk of endometrial cancer, especially among post-menopausal women.  More recently, a 2013 Cancer Prevention Research article analyzed 8,525 cases of ovarian cancer.  That study concluded that genital talcum powder use was associated with an increased risk of ovarian cancer relative to women who had never used talcum powder.

Lawsuits have been filed against Johnson & Johnson on behalf of women who developed ovarian cancer after long-term, frequent use of baby powder containing talc.  These lawsuits allege that Johnson & Johnson promoted its Baby Powder as being “safe, gentle and mild,” despite knowing for decades that its product posed an increased risk of ovarian cancer among women who used it on their genital area.

If you, a loved one, or someone you know has been diagnosed with ovarian cancer after frequent use of baby powder containing talc, you may be entitled to compensation.  Contact the defective product attorneys at Suthers Law Firm, www.sutherslaw.com, or call toll free 1-800-320-2384 for a free consultation.  

Medical device manufacturer, C.R. Bard, Inc., is back in the news and back in Federal Court.  On August 18, 2015, the Judicial Panel on Multidistrict Litigation (JPMDL) announced that the lawsuits pending currently against C.R. Bard, Inc. and Bard Peripheral Vascular involving the IVC filter will be consolidated and transferred to the U.S. District Court for the District of Arizona.  More than 200 pending cases will be transferred immediately, and it is believed that many more will follow.

An inferior vena cava (IVC) filter is a small medical device that is surgically implanted inside the body to capture blood clots before they migrate to other areas of the body, causing serious conditions such as a pulmonary embolism or stroke.  However, a number of studies have shown that pieces can break away from the filter and migrate to other areas of the body, causing serious injuries and deaths.  The New England Society for Vascular Surgery conducted a study, which concluded that the IVC filters fractured in 31% of the cases.  These shards or splinters often migrated to the patients’ right ventricles of the heart.  Another study found that in 25% of the patients studied, there were splinters that broke off, many of which migrated to the heart, lungs and the hepatic vein.

Before introducing these filters on the medical market, Bard knew that IVC filters were associated with serious side effects.  However, this information was not conveyed to doctors.  Bard knew the filters were prone to fracture, which could lead to perforations of the vena cava, surrounding vessels and organs, necessitating serious and life-threatening open surgical procedures.  On July 13, 2015, the U.S. Food and Drug Administration (FDA) cited Bard for failing to report adverse events associated with the IVC filters and for illegally selling a device that was designed to retrieve the filters.  It is believed that Bard has sold more than 500,000 IVC filters.  With failure rates approaching 40% after five years of implantation, there are far too many patients with IVC filters who are at risk.

Problems associated with IVC filters include migration, fracture, perforation of vessels and organs, pulmonary embolism (PE), decreased breathing, stroke and death.  Suthers Law Firm is investigating these and other problems associated with Bard IVC filters.  If you or someone you know suffered serious injuries or died as a result of complications from an IVC filter, contact Suthers Law Firm on its toll free number, 1-800-320-2384, or fill out a contact form at the firm’s website, www.sutherslaw.com.

A great injustice is taking place in this country:  the use of pre-dispute binding arbitration clauses in nursing home admissions contracts by the nursing home industry.  These clauses provide that victims of abuse and neglect in nursing homes give up their right to a jury trial. This directly undermines the spirit and intent of the Nursing Home Reform Act of 1987:  to improve the quality of care and clinical outcomes for our most vulnerable citizens.

Elderly nursing home residents and their spouses are being pressured or mislead into signing arbitration clauses, frequently when they lack the mental capacity, authority or true willingness to do so.  If arbitration was a level playing field and fair to both sides without any negative repercussions to the resident or family, does anyone really believe that the nursing home industry would feel the need to so aggressively enforce them and seek to bury these provisions within 50 pages of admissions materials?

Arbitration provisions lead to protracted litigation, not faster results or less expensive resolution of cases.  The nursing home industry uses them to stall cases, take appeals and delay justice.  An elderly surviving spouse may not live long enough to see justice when nursing home corporations take this approach.

In my experience as an attorney who has represented victims of abuse and neglect in nursing homes, arbitration provisions lead to the provision of poor care.  Residents who have not signed arbitration provisions typically receive better care because the facility has a greater incentive to meet their needs.  Arbitration clauses insulate the nursing home industry from liability, and with that protection, nursing home corporations feel free to cut costs, reduce staffing and sacrifice the quality of care.

There is only one way that arbitration can be fair and truly voluntary:  that is to prohibit the use of pre-dispute binding arbitrations altogether.  In other words, if and when a dispute arises, the parties may thereafter choose to arbitrate the case if they so desire.

The Centers for Medicare & Medicaid Services (CMS) is presently considering changes to the Federal Regulations that govern the operation of nursing homes, including a proposal regarding arbitration. There is a 60 day comment period during which citizens can go to www.regulations.gov, and let the government know that arbitration should be prohibited in nursing homes. CMS, in seeking to protect our elders and promote the quality of care in nursing homes, should ban pre-dispute binding arbitration clauses. It is the fair and equitable thing to do.

Invokana is part of a new class of type 2 diabetes drugs known as sodium-glucose-cotransporter-2 (SGLT2) inhibitors.   SGLT2 inhibitors are designed to control diabetes by blocking reabsorption of glucose by the kidneys, impacting normal kidney function and allowing more sugar to be passed from the body through urine.   However, the FDA has recently issued a new warning for a number of SGLT2 inhibitors, including Invokana (canagliflozin). The agency has stated that these diabetes therapies can cause high levels of acid to build up in the blood, causing diabetic ketoacidosis, which can lead to diabetic coma or death.

In the FDA’s announcement, the agency warned patients using SGLT2 inhibitors that they should seek immediate medical attention if they experience any symptoms of ketoacidosis, including:

  • Unusual fatigue or sleepiness
  • Nausea
  • Vomiting
  • Confusion
  • Difficulty breathing
  • Abdominal pain

The Suthers Law Firm is currently investigating claims on behalf of individuals who used Invokana or other SGLT2 inhibitors and suffered serious medical complications. Other SGLT2 inhibitors that have been associated with health complications include Glyxambi (empagliflozin/linagliptin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin/metformin), and Jardiance (empagliflozin).

If you or a loved one has experienced serious medical problems after using one of the products listed above, contact the experienced attorneys at the Suthers Law Firm. The firm has represented many victims injured by dangerous drugs and defective medical products. Such lawsuits are pursued under a contingency fee basis, meaning that there are no attorney fees unless a recovery is obtained. To discuss a potential lawsuit for yourself, a family member or friend, call 1-800-320-2384 or go to www.sutherslaw.com for a FREE consultation.

The Suthers Law Firm is continuing to investigate potential claims on behalf of individuals who purchased laminate wood flooring from Lumber Liquidators.  Problems with the Lumber Liquidators’ flooring was first noted on CBS’ 60 Minutes.  Reporters went undercover to factories in China that produce laminate flooring for Lumber Liquidators that the company says is “CARB 2″ compliant, meaning it complies with California standards (and soon to be federal standards).  However, managers in these Chinese facilities acknowledged that inventory being produced for Lumber Liquidators was being labeled “CARB 2″ compliant, even though everyone in the facility was aware of the fact it was not.  Independent tests performed by CBS News indicated the flooring failed to meet health and safety standards due to the high levels of formaldehyde.  Formaldehyde is a colorless and flammable chemical, and is a common ingredient in the glue used in laminate flooring.  During and after installation, it is released as a gas that causes burning eyes, nose and throat irritation, coughing, headaches, dizziness, joint pain and nausea.  At long-term exposure, formaldehyde is listed as a known cause of cancer in humans by both the federal government and the State of California.

The following models of Lumber Liquidators lumber may contain excessive and illegal amounts of formaldehyde:

  • 8 mm Bristol County Cherry Laminate Flooring
  • 8 mm Dream Home Nirvana French Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Antique Bamboo Laminate Flooring
  • 12 mm Dream Home St. James Oceanside Plank Bamboo Laminate Flooring
  • 12 mm Dream Home Kensington Manor Warm Springs Chestnut Laminate Flooring
  • 15 mm Dream Home St. James Sky Lakes Pine Laminate Flooring
  • 12 mm Dream Home Ispiri Chimney Tops Smoked Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Imperial Teak Laminate Flooring
  • 12 mm Dream Home St. James Vintner’s Reserve Laminate Flooring
  • 12 mm Dream Home Kensington Manor Cape Doctor Laminate Flooring
  • 12 mm Dream Home St. James Cumberland Mountain Oak Laminate Flooring
  • 12 mm Dream Home Ispiri Americas Mission Olive Laminate Flooring
  • 12 mm Dream Home Kensington Manor Glacier Peak Poplar Laminate Flooring
  • 12 mm Dream Home Kensington Manor Golden Teak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Handscraped Imperial Teak Laminate Flooring (SKU 10029601)
  • 12 mm Dream Home Kensington Manor Handscraped Summer Retreat Teak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Sandy Hills Hickory Laminate Flooring
  • 12 mm Dream Home Kensington Manor Tanzanian Wenge Laminate Flooring
  • 8 mm Dream Home Nirvana Royal Mahogany Laminate Flooring
  • 12 mm Dream Home St. James Blacksburg Barn Board Laminate Flooring
  • 12 mm Dream Home St. James Brazilian Koa Laminate Flooring
  • 12 mm Dream Home St. James Golden Acacia Laminate Flooring
  • 12 mm Dream Home Ispiri Poplar Forest Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Fumed African Ironwood Laminate Flooring
  • 12 mm Dream Home St. James African Mahogany Laminate Flooring
  • 12 mm Dream Home St. James Chimney Rock Charcoal Laminate Flooring
  • 12 mm Dream Home St. James Nantucket Beech Laminate Flooring

Other types of Chinese-made laminate sold at Lumber Liquidators may also be affected.

If you have purchased a laminate wood flooring product listed above, or any other laminate flooring from Lumber Liquidators, and are concerned about formaldehyde levels in your home, you may be eligible to participate in a lawsuit. Contact the experienced attorneys at Suthers Law Firm online or call us on our toll free number, 1-800-320-2384, to set up a FREE consultation.

Xarelto bottle

Xarelto (rivaroxaban) is a prescription blood thinner that was developed by pharmaceutical giant Bayer, and marketed by Janssen Pharmaceuticals, a division of another pharmaceutical giant, Johnson & Johnson.  Xarelto is typically prescribed to reduce the risks of suffering a stroke or blood clot in patients who have a heart rhythm disorder known as atrial fibrillation or A-fib.  For example, Xarelto is commonly given to patients with atrial fibrillation who have undergone hip replacement or knee replacement surgery to prevent blood clots from forming after the surgery.  The drug’s manufacturer is attempting to expand the use of Xarelto for patients with another heart condition known as acute coronary syndrome.

There have been multiple reports of Xarelto causing excessive bleeding in patients.  This can result in severe and permanent injuries, or death, if the bleeding is uncontrolled.  As a result, multiple lawsuits have been filed across the U.S. against the manufacturer of Xarelto and the marketer of the drug, alleging these companies failed to warn both patients and physicians of the increased risks of fatal internal bleeding when using Xarelto.  Because of the number of lawsuits filed in federal courts across the U.S., in December 2014, the United States Judicial Panel on Multidistrict Litigation (MDL) created a Xarelto MDL and consolidated all of the cases in the U.S. District Court for the Eastern District of Louisiana.  The Xarelto litigation is in the beginning stages.

Interestingly, litigation against the manufacturer of a similar drug, Pradaxa, was settled in May 2014 for $650 million.  The Institute for Safe Medication Practices issued a report in 2013, stating that more patients had suffered serious, disabling or fatal injuries from taking Xarelto than those who took Pradaxa.  It should come as no surprise that Bayer and Janssen Pharmaceuticals are fighting the litigation, since annual sales of Xarelto in the U.S. were expected to exceed $1 billion for 2014.  The companies believe that the drugs sales could eventually reach $3.5 billion a year.

Suthers Law Firm is investigating claims involving individuals who took Xarelto and suffered from one or more of the following, serious conditions: pulmonary embolism (PE), severe, uncontrolled bleeding that required hospitalization, stroke or death.  Individuals who have suffered after taking Xarelto should not wait to hire an attorney.  Every state has what are known as statutes of limitations, which are laws that specify the time within which an injury claim must be filed, or it will be barred by law.  If you or a loved one has suffered one of the serious injuries listed above after taking Xarelto, you should not delay in consulting with an attorney who is experienced in handling defective medical product cases.