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The da Vinci robot surgical system, manufactured by Intuitive Surgical, is a telesurgical davinci pic.jpgdevice that has been FDA approved for a range of minimally invasive procedures. During these procedures, the patient is on the operating table while the doctor sits several feet away at the control area of the machine, where he or she can maneuver the robotic arms while watching the procedure through a 3-D viewfinder. Many surgeons feel the robot makes it easier to see and navigate places in the body normally difficult to reach with traditional surgical methods. Doctors advocating the use of the da Vinci also point to the potential benefits for patients, such as small incisions, minimal bleeding, minimal scarring, and speeding post-surgery recovery time. As a result, surgical procedures using the da Vinci robot are becoming increasingly popular in the United States, with close to 400,000 of the procedures performed in the United States in 2012, and more than 1.5 million procedures since Intuitive Surgical received its initial FDA approval of the device.

Unfortunately, as the da Vinci procedures have grown in popularity, so have the reports of injuries associated with their use. In the last 5 years, the U.S. Food and Drug administration has received more than 4,600 complaints from patients associated with robotic surgeries, including reports of serious burns, cuts, infections, including 89 deaths. Surgeries performed with the da Vinci have also been connected with damage to organs, harm to body tissue, and bleeding and internal scarring that can lead to chronic pain and dysfunction. Causing even greater concern is the fact many patients have been discharged from the hospital following a da Vinci robotic-assisted surgery only to discover the injury days later, thus requiring a prolonged hospitalization, and in some cases, additional surgery.

Many medical experts worry the high-tech, futuristic nature of the machine is driving surgeons’ decision to use the da Vinci, rather than an actual medical need, and they are not adequately considering the risks associate with its use. This fact, coupled with the lack of adequate training by surgeons using the device, has resulted in patients being subjected to surgical complications that may have been avoided if other safer surgical methods were chosen. Moreover, there is evidence the design of the da Vinci surgical robot is known to lead to injury even without any error on the part of the surgeon. As a result, there have been numerous, serious injuries attributed to the use of the da Vinci surgical robot, and lawsuits are being filed across the country against both Intuitive Surgical and negligent surgeons.

A jury heard opening statements last week in the first Federal Court trial involving manufacturer CR Bard, Inc.’s Avaulta transvaginal mesh products. The case of Sisson v. CR Bard, Inc., in the United States District Court for the Southern District of Virginia, is one of approximately 3,600 cases pending against Bard in which women allege that erosion of the mesh products have caused organ damage, made sexual intercourse painful, and caused women to have to undergo additional surgical procedures to remove the mesh products. Most of the cases against Bard have been consolidated before U.S. District Court Judge Joseph Goodwin in what is known as the Multidistrict Litigation Court in Charleston, West Virginia for pretrial workup and the exchange of evidence. The Sisson trial was expected to last 2 to 3 weeks. However, on July 10, 2013, Judge Goodwin declared a mistrial because of a witness’ testimony. The Federal Judge stopped the trial in its second day after expert witness Lennox Hoyte, a gynecological expert, testified about the vaginal mesh devices’ marketing. Judge Goodwin had ruled previously that the Plaintiffs could not mention the fact that Bard had withdrawn the products from the market last year. After the witness’ testimony, Bard’s attorney moved for a mistrial. Judge Goodwin stated that it would be difficult for the jury to disregard such testimony and as a result, granted the Defendant’s motion for a mistrial. However, the trial on behalf of Donna Sisson and her husband is expected to begin again soon before a new jury, perhaps as early as July 29, 2013.

Donna Sisson was experiencing problems with control of her bladder, a condition known as stress urinary incontinence (SUI). When her problems became worse, she turned to a specialist who diagnosed her as suffering from pelvic organ prolapse (POP), a condition that can cause urinary incontinence and/or pain, including pain during sexual activity. In 2009, a transvaginal mesh product manufactured by Bard was surgically implanted in Ms. Sisson, purportedly to solve her problem of urinary incontinence. Instead of solving the problem, she began experiencing significant bleeding, pain during sex, bladder spasms, and as a result, had to undergo 2 additional surgeries to remove the mesh device. Ms. Sisson and her husband sued the product manufacturer, CR Bard, Inc., claiming that Bard knew about the problems associated with these mesh products but failed to warn doctors and consumers. Plaintiffs’ lead counsel, Henry G. Garrard, told the Federal Court jury last week that Bard officials knew that these transvaginal mesh devices were made of a material that was unsuitable for human implantation, and they covered up that flaw from doctors and women who were being surgically implanted with the products. Garrard told jurors that Bard made these implants, which were designed to shore up pelvic muscles, out of a type of plastic that carried a warning saying it should not be permanently implanted in humans. Bard’s lawyers have denied that these vaginal mesh devices were defective.

The litigation involving these transvaginal mesh products which were designed to treat SUI and POP has expanded and accelerated after the United States Food & Drug Administration issued a safety warning in 2011 stating that “Serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” Other manufacturers of vaginal mesh products, such as Ethicon, a division of Johnson & Johnson, Boston Scientific Corporation, American Medical Systems, Inc., Coloplast Corporation, and Cook Medical, Inc. are facing lawsuits claiming that their vaginal mesh devices are defective. In addition to the cases pending in the MDL Court before Judge Goodwin in Charleston, West Virginia, there are thousands more cases pending in State Courts across the country, 2 of which resulted in jury verdicts for the Plaintiffs within the past year. The outcomes of the Sisson case and other cases scheduled for trial in the MDL Court could put pressure on these manufacturers to try to settle the pending cases.

The Federal Motor Carrier Safety Administration (FMCSA) announced recently that new Federal Regulations, which will hopefully improve safety on the roads by reducing truck driver fatigue, have been enacted. The new, so-called “hours of service” regulations became effective on July 1, 2013. These regulations were first announced in December of 2011 by FMCSA, and trucking companies were given 18 months to adopt the new rules for their truck drivers. The new hours of service rules do the following:

(1) limit the maximum average work week for truck drivers to 70 hours, down from the current maximum allowed of 82 hours;

(2) allow truck drivers who reach the maximum 70 hours of driving within 1 week to resume driving after they have rested for 34 consecutive hours; and (3) require truck drivers to take a 30 minute break during the first 8 hours of a driving shift.

On June 3, 2013, the National Highway Transportation Safety Administration (NHTSA) wrote a letter to Chrysler, stating that a safety-related defect exists in 2.7 million Jeep Grand Cherokee and Jeep Liberty vehicles, and demanding that Chrysler recall them. The model years for the Grand Cherokee were 1993-2004, and the model years for the Jeep Liberty were 2002-2007. The alleged defect is related to the rear fuel tanks, which cause an unreasonable risk of a fire occurring in the event of a rear-impact collision. Specifically, there are concerns about the likelihood that the fuel tanks will leak gasoline and catch fire in rear-impacts, resulting in serious injuries and fire-related deaths.

There is presently a lawsuit pending in the Superior Court of Decatur County, Georgia, involving the death of 4 year old Remi Walden, who was a passenger in a 1999 Jeep Grand Cherokee when it was struck in the rear by a Dodge Dakota truck. The collision occurred in Bainbridge, Georgia. Remi was properly restrained in his booster seat in the backset of the Grand Cherokee when the rear-impact collision occurred. The Grand Cherokee, which had a fuel tank located just inside the rear bumper of the car, ruptured upon impact, causing a fire. The Grand Cherokee was quickly engulfed in flames, witnesses were unable to rescue Remi, and he died from fire-related injuries. Remi Walden’s death was one of the incidents referred to by NHTSA in its recall letter to Chrysler.

In the 1970s, 27 deaths were attributed to Ford Pinto rear-impact fires. There was a 1972 accident which resulted in the famous court case known as Grimshaw v. Ford Motor Company, in which a California appellate court ultimately upheld a compensatory damages award of $2.5 million and punitive damages of $3.5 million against Ford, ostensibly because Ford had been aware of the design defects for several years but had decided against altering the design. It was later discovered that Ford had done a “cost-benefit analysis” to compare the cost of a recall and repairs against the cost of settlements or verdicts for injuries, deaths, and vehicles burning up.

Tylenol Package.jpgA number of victims throughout the United States have filed lawsuits against Johnson & Johnson and its subsidiary, McNeil-PPC, after suffering severe liver damage, liver failure and, in some cases, death after taking Tylenol or Acetaminophen. The lawsuits allege that the Defendant manufacturers failed to provide adequate warnings about the risks associated with the side effects of Acetaminophen, which is the active ingredient in Tylenol. The victims suffered serious and life-threatening injuries, even when the medication was taken as directed. Liver damage can lead to prolonged hospitalizations and potentially, the need for a liver transplant. The average cost for a liver transplant in the United States exceeds $500,000.

In April of 2013, the United States Judicial Panel on Multidistrict Litigation issued an order consolidating and centralizing all of the Tylenol liver damage lawsuits pending in Federal Courts throughout the United States in the U.S. District Court for the Eastern District of Pennsylvania. Any Tylenol liver injury lawsuits filed hereafter in the Federal Court system will be transferred into the Multidistrict Litigation (MDL) Court for the purpose of coordinated pretrial proceedings. This is not a class action. Any case transferred to the MDL Court remains an individual lawsuit throughout the process. The consolidation of such cases is more common in complicated product liability cases, where there are a significant number of lawsuits filed regarding similar injuries allegedly caused by a common medication, medical device or defective product. If a settlement agreement is not reached after the pretrial proceedings are completed in the MDL Court, the individual cases may be sent back to the U.S. District Courts where they were filed or could have been filed originally, and they are assigned dates for trials.

When the Tylenol lawsuits were consolidated in the MDL Court recently, there were only 27 Tylenol lawsuits filed against various manufacturers in Federal Courts throughout the United States. I believe this is only the tip of the iceberg, and that the Tylenol litigation will increase over the next few years as more victims discover that their liver damage or liver failure was caused by Tylenol manufacturers’ failure to provide adequate warnings about the risks associated with this over-the-counter medication. Acetaminophen is the leading cause of acute liver failure in the U.S., and has been for the past ten years. This fact has been reported by the FDA, and is well known to the makers of Tylenol. It has been estimated that more than 50,000 emergency room visits, 25,000 hospitalizations, and between 400 and 600 deaths occur annually as a result of liver damage or liver failure associated with Acetaminophen. Consequently, the FDA and other health organizations have been studying the association between Acetaminophen overdose and liver damage.

The well-known organization, Mothers Against Drunk Driving (MADD), has been leading the fight to save lives and prevent injuries caused by drunk drivers. In 2006, MADD started what it called the Campaign to Eliminate Drunk Driving. The campaign is working, as fatalities caused by drunk drivers have decreased by greater than 25% since the campaign began. 9,878 people were killed and approximately 350,000 were injured by drunk drivers in 2011, according to the National Highway Traffic Safety Administration (NHTSA). This was the first time since NHTSA began collecting data that there were less than 10,000 fatalities. When MADD was first founded, there were more than 22,000 drunk driving fatalities each year.

While we rejoice in the fact that the numbers are going down, the battle is long from being over. 9,878 deaths is still too many, and each death impacts not only the victim, but family, friends, classmates and others. The yearly price tag of drunk driving runs into the billions. Proof that there remains more work to be done can be found in the preliminary statistics regarding the first half of 2012. Regrettably, these statistics showed a 7% increase in traffic deaths related to drunk drivers. While the year-end statistics have not yet been released, if fatalities continued to occur at that rate, that means an additional 700 people will have been killed by drunk drivers last year.

Tragically, approximately 1/3 of all drunk driving incidents, ranging from arrests, car crashes, deaths, and injuries, are caused by repeat offenders. We potentially share the highways with approximately 2 million people who have 3 or more drunk driving offenses. That’s one of the primary reasons that states have attempted to crack down on drunk drivers by enacting stiffer penalties for offenders and especially, for repeat offenders. The State of Georgia can take pride in the fact that it has the 3rd lowest percentage of traffic deaths that are DUI related in the USA according to the 2011 Fatality Analysis Reporting System. The State of South Carolina is one of the worst states when it comes to DUI fatalities, ranking 46th among the 50 states. Taking away the driver’s licenses of repeat offenders isn’t always enough, as more than 50% of them will drive anyway. MADD and other organizations are supporting research into various forms of technology that could help eliminate drunk driving. An example of technology being studied includes a system that can read a driver’s blood alcohol concentration and lock the ignition system, which would stop drunk driving offenders before they repeat their crimes.

Generic drugs comprise 80% of all of the prescriptions filled in the United States. These generic drugs generate approximately $53 billion dollars in revenue. Unlike brand manufacturers, generic drug manufacturers have no duty to disclose new safety risks pertaining to their drugs when such risks become known. Brand manufacturers are required to update their warning labels upon learning of new safety risks or hazards associated with their drugs. Why should generic drug manufacturers be treated any differently?

In 2011, the United States Supreme Court ruled in Pliva v. Mensing that generic drug manufacturers cannot be held responsible for injuries caused by their failure to warn about safety risks associated with their generic drugs. Sometimes, these generic drug manufacturers are the biggest or only manufacturer of a particular drug. The Mensing decision protects generic drug manufacturers from being held accountable for failing to warn about potential hazards associated with the use of their drugs.

A young lady named Kira Gilbert is one of many examples of why generic drug manufacturers should be held accountable. Kira, who was 22 years old at the time, took a generic pain medication prescribed by her doctor for a few days prior to undergoing knee surgery. The drug was the generic version of Darvocet, which was eventually removed from the market because it posed a significant safety hazard. Kira Gilbert died from cardiac failure caused by her taking the generic drug. Unfortunately, her family was unable to hold the manufacturer of the generic drug responsible for Kira’s death because of the Mensing decision.

According to the website Nursing Home Inspect, multiple nursing homes located throughout the States of Georgia and South Carolina lead the country in the amount of fines paid for violations of regulations that govern their operation. Nursing homes are inspected periodically by regulators (sometimes called “surveyors”) as a matter of routine. Additionally, when the Government receives a complaint from a family member about a nursing home, the facility will be inspected as part of the Government’s investigation of the complaint. If it is determined that the nursing home failed to comply with regulations that govern their operation, they are issued what are known as “deficiencies.” Simply stated, these are citations for failing to follow the rules.

Nursing Home Inspect was designed to make it easier for consumers to do research online and compare nursing homes based upon the number of deficiencies and penalties that were issued against them during the past 3 years. A non-profit investigative news organization known as ProPublica continually updates the information on the website. When nursing homes are repeatedly cited for deficiencies, they can face penalties, including fines. According to Nursing Home Inspect, the most fined nursing home in America over the past 3 years is Unihealth Post-Acute Care – North Augusta, a nursing home located in North Augusta, South Carolina. That facility paid a total of $737,000 in fines over the past 3 years. The second most fined nursing home in America is Cobb Healthcare Center, located in Comer, Georgia. That facility paid a total of $592,000 in fines over the past 3 years. Sadly, of the 20 most fined nursing homes in America during this time period, 3 were located in the State of Georgia. In addition to Cobb Healthcare Center, a nursing home known as Willowbrooke Court at Lanier Village Estates in Gainesville, Georgia and a nursing home known as Bethany Nursing Center of Vidalia in Vidalia, Georgia were among the 20 most fined nursing homes. Two nursing homes located in the State of South Carolina were also in the top 20, Unihealth Post-Acute Care – North Augusta and Heartland of Columbia Rehab. and Nursing Center in Columbia, South Carolina.

Not coincidentally, the most fined nursing home in America over the past 3 years, Unihealth Post-Acute Care – North Augusta, was also designated as a “Special Focus Facility,” which is a nursing home cited for having a history of serious quality issues. Of the 20 nursing homes across the U.S. listed as having the most serious deficiencies, 5 of those facilities are located in South Carolina. In addition to Unihealth Post-Acute Care – North Augusta, the other South Carolina nursing homes cited were Magnolia Manor – Columbia in Columbia, Brookeview Healthcare Center in Gaffney, Unihealth Post-Acute Care – Aiken in Aiken, and Camp Care in Inman, South Carolina.

Lawsuits continue to be filed against the manufacturer of the dialysis product known as GranuFlo. This product is the powder form of a solution used to clean and remove waste from the blood during dialysis. Fresenius Medical Care, a German company whose American headquarters is located in Massachusetts, created the product to replace a liquid solution that was previously used for this purpose. The idea was to create a product in powder form, so that dialysis clinics could mix it with water and use it in the facility.

Lawsuits filed against Fresenius Medical Care contend that the product has twice the level of acetate as the liquid solution. When used during dialysis, it can affect the patient’s blood’s pH level and disrupt the patient’s heart rhythm, a condition known as arrhythmia. One of the lawsuits involves a patient who went in for his routine dialysis treatment during which GranuFlo was used. The patient went into cardiac arrest and died while he was still connected to the dialysis machine.

In March of 2012, the United States Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo. The basis for the recall was the FDA’s finding that an excess bicarbonate level in the bloodstream can cause a drop in blood pressure, low blood oxygen, a drop in the potassium levels in the blood, and cardiac arrhythmia, which can result in the patient suffering cardiac arrest. Lawsuits allege that Fresenius Medical Care knew about the inherent risk of elevated bicarbonate levels in the blood, but failed to warn clinics to change the settings on the dialysis machines to account for the elevated bicarbonate levels. Company memos revealed that 941 patients at dialysis clinics owned by Fresenius had experienced cardiac arrest while being treated with GranuFlo. Fresenius warned its clinics to reduce the acetate value when using GranuFlo in its concentrated form. However, the lawsuits allege that the company failed to warn thousands of other dialysis clinics about the increased risk of suffering cardiac arrest while using GranuFlo. It is unknown at present exactly how many patients who were treated with GranuFlo experienced cardiac arrhythmia and/or cardiac arrest. Plaintiffs’ lawyers have estimated that the potential number of injured victims from all dialysis clinics across the U.S. could range between 5,000 and 10,000.

The birth of a child is normally a joyous occasion for families. However, lives can be turned upside down when a newborn is catastrophically injured or dies during childbirth. There are many things that can go wrong during the labor and delivery process, so doctors and nurses alike must have a heightened awareness of any changes that could indicate fetal distress. The failure to react quickly to signs of fetal distress can lead to catastrophic injuries or the death of a newborn child.

Recently, an Atlanta area hospital was sued in three, separate cases involving the alleged wrongful death of babies, all of which occurred during a two month period. The lawsuits allege that doctors and nurses at South Fulton Medical Center were negligent in not recognizing signs of early labor in one of the cases, delaying a C-section delivery in another case, and neglecting to recognize the signs of fetal distress in the third case. None of the three babies survived.

In the first case involving the alleged failure to recognize the signs of early labor, a pregnant mother who was suffering from fever, back and stomach pain, and a decrease in fetal movement by the baby went to the hospital to be evaluated. She was told that she was suffering from the flu, was given Tylenol, and told that she could leave. No testing was done to determine whether she was in labor. Her pain worsened, so she returned to the hospital the same day and delivered a baby that weighed less than two pounds. The baby died shortly after being delivered.

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