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In December of 2008, the Food and Drug Administration made requirements for drug companies and manufacturers to conduct studies to show that new diabetes drugs do not increase cardiovascular risk compared with current treatments. The guidance was developed amid growing concern about the safety of many diabetes drugs. AstraZeneca sponsored a trial of over sixteen thousand patients known as SAVOR previously showed patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalization due to heart failure. The company claims that it conducted the SAVOR study in accordance with the 2008 guidance and that the results met the objective of showing that patients taking Onglyza were not at greater risk as measured by a composite benchmark comprising cardiovascular death, non-fatal heart attack and non-fatal ischemic stroke.

The Food and Drug Administration’s analysis revealed that the heart failure was valid. It also showed a possible increased risk of death from all causes. The Food and Drug Administration’s review stated that, “The overall trial results did not reveal a higher death risk, but a more detailed analysis examining only patients who took the drug suggests a significantly increased risk of all-cause mortality.” The agency stated that the causes of death were often multifactorial and some patients may have had several serious medical conditions in the days and weeks prior to death. The agency state that it is not reassured by the risk, however, and does not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.

An analyst for Leerink stated that the Food and Drug Administration’s concerns over all-cause mortality were unexpected and could lead to a cut of up to 50 percent in his $1.8 billion peak annual sales estimate, if Merck & Co’s rival drug Januvia does not show similar problems.

According to the ruling, the Tennessee Supreme Court decided to set aside the decision made last March by  Hamilton County Judge, Neil Thomas, who ruled a 2011 state law, which was a “tort reform” initiative of Republican Gov. Bill Haslam, capping certain personal injury damages at $750,000 is unconstitutional. Judge Thomas had issued a well reasoned decision explaining how the law violates Tennessee’s Constitutional Right to have a jury decided all issues at trial. Regardless, the Supreme Court set the decision aside because they stated that the case did not proceed far enough yet to warrant such a ruling. A move that will simply delay a ruling that will have to be decided at some point.

The case in which the first decision was made involved ruling by Circuit Judge W. Neil Thomas III on a $25 million-plus negligence lawsuit filed by Donald and Beverly Clark against several divisions of AT&T and one of its employees, Aimee Cain. The suit also named then-Tennessee Attorney General Robert Cooper because of the constitutional issues being raised. The couple filed a lawsuit against AT&T because of an automobile accident that injured Clark. The lawsuit sought a ruling on the constitutionality of the state law that caps non-economic damages at $750,000 for certain personal injury cases. Non-economic damages are applicable when pain and suffering is involved or there is a physical impairment or other similar injury.

When we go to the hospital for surgery or any other type of care we expect that we will be well taken care of and at least healthier when we leave. Unfortunately, some medical devices that are used during surgery to keep patients’ body temperatures normal are also leading to some serious and life-threatening infections. If you or someone you know has developed a serious infection or other dangerous medical condition after having a surgical procedure in the hospital, you should speak to a dangerous medical device and Bair Hugger injury lawyer at the Higgins Firm. We will listen to your case and help you to receive the compensation you need for what you have been through.

According to this case, Rosie Bartel went into the hospital for knee replacement surgery years ago and left the hospital with a MRSA infection which led to the need for twenty-seven more surgeries and the amputation of right leg just below the hip. She blamed the use of a Bair Hugger forced-air patient warming system during her surgery, eventually filed a Bair Hugger lawsuit. In her lawsuit, she claimed that the MRSA infection took more than her leg. It also led to the loss of her job and eventually her home. Bartel has now become an advocate against the forced-air surgical warming systems that were employed during no fewer than twenty-two million surgical procedures in 2012 alone.

The Bair Hugger warming blanket was approved by the US Food and Drug Administration in 1988 . A blanket dotted with a myriad of tiny holes connects to a forced-air heating unit that rests on the floor near the operating table. The unit carries heat via forced air to the blanket, with the warm air transferred to the patient through the blanket. While the heat and air unit remained a constant, single-use blankets meant a revenue source for the manufacturer. After several years in use, infections were becoming a problem, and especially for joint replacement surgery where a single germ could have devastating consequences.

When we hand over the care of our loved ones to a nursing home, we expect them to be well taken care and looked after. Unfortunately sometimes nursing home are understaffed and overworked and this can lead to health concerns for many of the nursing home patients. The misuse of antibiotics making elderly residents more likely to get serious medical conditions is one of these concerns. According to Centers for Disease Control, nursing home residents are prescribed antibiotics incorrectly up to seventy-five percent of the time. If you feel that someone you care about may be at risk due to the misuse of antibiotics, then you should speak to a nursing home abuse and neglect lawyer right away. We will listen to your case and help make sure you get the compensation you need for what your loved one has suffered.

The Centers for Disease Control recently advised all nursing homes to do more to help protect over four million nursing home residents from hard to treat super bugs that are increasing becoming resistant to many antibiotics. Elderly people in nursing homes are at a higher risk of these infections because their bodies do not fight off infections well. The Centers for Disease Control counts 18 top antibiotic-resistant infections that sicken more than two million people per year and kill twenty-three thousand. Those infections contribute to deaths in many more cases.

The worry is that every time someone takes antibiotics, sensitive bacteria get killed but resistant bacteria multiples and grows and this makes them easier to spread to other people. If antibiotics are used repeatedly it can make this resistant bacteria continue to grow. Also, taking antibiotics for things such as a cold or the flu when they are not intended for these illnesses leads to more resistance of antibiotics. Antibiotics can also eliminate good bacteria while also eliminating the bad. This can cause serious infections to spread and hospitalize thousands of people. It is important that measures be taken to prevent these infections from spreading in hospitals and nursing homes.

According to this case, Doris Racher and her two sisters installed cameras into their mother, Eryetha Mayberry’s room at the Quail Creek Nursing Home and Rehabilitation Center after they suspected someone at the nursing home of stealing from her. The video revealed that nursing home employees Lucy Waithira Gakunga and Caroline Kaseke forced Mayberry to lie down by pushing on her head and preventing her breathing. Gakunga was also shown shoving latex gloves into Mayberry’s mouth while Kaseke watched.

A lawsuit was filed against Quail Creek Nursing Home and Rehabilitation Center for the abuse and the case went to federal court and the judge announced the verdict on February 13. Mayberry passed away in July 2012, a few months after the video was released. Gakunga and Kaseke were fired and now face criminal charges. The jury found the nursing home guilty of negligence and abuse. The family stated that, “All in the memory of our mother. All of us fought hard and are just happy that now we can relax a little bit, and mother’s probably smiling. I’m so grateful for the outcome, because we told the truth and the truth always prevails.”

Cases just like this one occur all too often in nursing homes all across the United States and even right here in Tennessee. It is crucial that if you have a loved one or someone you care about in a nursing home that you visit them as often as possible. If you notice that your loved one has bruises, cuts, marks, or any other injuries you should notify the nursing home staff right away. It is also recommended that you talk with the staff or the director of the nursing home about their training procedures and what they do to prevent injuries or neglect. These are simple things you can do to help prevent abuse or neglect.

Many people by now have probably heard that Volkswagen put software on their vehicles that would help them pass emissions tests but when the vehicle is out on the road it actually releases a high amount of nitrogen oxide into the air. The company plans to fix the problem, but right now it is unclear when or how this will happen. If you are a Volkswagen owner then you may be confused as to what you should do now. Here are some things for you to consider while you wait for the company’s solution to the problem. If you have questions or concerns, you should speak to a Volkswagen emissions fraud lawyer with the Higgins Firm about your case. We will help to answer any questions you may have and discuss any legal options you may have.

The Volkswagen company has not yet stated how they will fix the problem. Many owners are worried that any repairs will lower the fuel economy and performance which are the reasons many people purchased the vehicles to begin with. The Environmental Protection Agency has told Volkswagen to correct the problem and to follow pollution regulations, but so far there is no news on how or when the problem will be fixed. So what should owners do now?

Many people as we age might need special devices to help improve our quality of life. One of these devices might include a hip implant. When we go to the doctor to have these kinds of procedures done, we expect that these devices are safe and will help improve our lives and help to make our pain and problems greatly decrease. Unfortunately, many hip implants have defects and problems that can lead to additional injuries and the need for revision surgery to fix the problem. If you or someone you know has had a hip implant and then experienced severe pain or needed more surgery to correct the problem, then you should talk to one of our experienced defective hip implant lawyers with the Higgins Firm. We will review your case and help you to get the compensation you need for what you have suffered.

According to this case, the Profemur R used in Alan Warner snapped in 2010 while he stood in his kitchen due to a laser orientation mark that was burned too deeply into the device. The lawsuit argued that laser engravings deeper than 35 microns can cause the titanium in metal implants to become brittle, and that the crack in the Profemur R emanated from a laser mark over 100 microns deep. After only almost three years of having the Profemur R implanted it broke and the fracture caused Warner to have to have fourteen major surgeries after experiencing a number of dislocations and prolonged infections.

The Wright Company argued during the trial that the Profemur R snapped because the top of of the implant wasn’t properly affixed to Warner’s existing bone, and that the device shouldn’t have been used in patients like Warner whose bone structure was compromised. They also said Warner’s surgeon, Brad Penenberg, selected a stem piece that was too narrow. As the top of the implant shifted it placed stress on the narrow stem piece and caused it to break. Wright Company’s own findings initially showed the crack in Warner’s implant emanated from a laser guidance mark, but that once they were faced with a lawsuit, the company began using the argument that the Profemur R wasn’t meant for use in patients like Warner who had degraded bone structures, despite distributing marketing materials that indicated otherwise.

Many of you may have heard about a superbug going around that is resistant to antibiotics. What you may not know about it has been linked to medical scopes known as duodenoscopes. According to this case, 500,000 Americans undergo a procedure known as Endoscopic Retrograde Cholangiopancreatography or ERCP every year using these medical scopes and this procedure has been linked to the superbug outbreak also known as carbapenem-resistant Enterobacteriaceae or CRE.

Earlier this week, Carla Warner provided emotional testimony to a U.S. Food and Drug Administration Advisory Panel about the devastating impact that as carbapenem-resistant Enterobacteriaceae or CRE had on her husband, Willie “Bill” Warner. He developed CRE after having an Endoscopic Retrograde Cholangiopancreatography procedure. Warner’s procedure used a widely sold TJF-Q180V duodenoscope, which was produced and sold by Olympus America, Inc. Carla Warner’s testimony about the death of her husband due to CRE was highlighted on the panel.

Beginning in 2010, Olympus redesigned and replaced its TJF-Q160V duodenoscope with the TJF-Q180V duodenoscope. The new 180V model had a sealed section on the device known as the “elevator wire channel.” In lawsuits that have been brought against the Olympus America Corporation after family members have died from infections using the TJF-Q180V duodenoscope, it was complained that bacteria can become trapped in the device’s sealed elevator wire channel. The elevator wire channel on the device is not easily accessed for proper cleaning so it becomes the source for the outbreak of the deadly superbug CRE infections that patients are developing.

 We all know that when you work in certain jobs such as factories or around oil or gasoline you may be exposed to certain risks and injuries due to the chemicals you work with. However, companies and businesses are supposed to make sure that these chemicals and products are within safe levels for their employees as well as their customers. Unfortunately, sometimes this is not the case. If you or someone you work with has developed acute myeloid leukemia or another serious medical condition while working around benzene or another toxic chemical or product, then you need to speak to one of our benzene exposure and dangerous product lawyers at the Higgins Firm. We will review your case and help you to get any compensation you may be entitled to for what you have been through.
According to this case, David Johnson filed a lawsuit against the United States Steel Corporation along with other defendants in 2013 after he was diagnosed with acute myeloid leukemia. Johnson claims that his cancer was caused by being exposed to to products that contained a cancer causing compound while working as a service station attendant or auto mechanic throughout the 1970s and from 1994 until he received his cancer diagnosis.
The United States Steel Corporation acknowledged that it had sold coal raffinate which contains a toxic chemical known as benzene to Radiator Specialty Company, which formulates the solvent  known as Liquid Wrench. During the case,  Johnson testified that he used the product on a regular basis  to loosen rusted belts and machine parts ,at times, he stated that, it would get “all over” him while he worked under cars. The  defendants all supplied, made, or sold paints, solvents, or other products containing benzene.   The lawsuit has been revisited by the Federal District Court of Appeal. The First Appellate District ruled that the United States Steel Corporation was not protected from liability under the component parts doctrine, since there was a factual question about whether the benzene in the company’s coal raffinate which is  a byproduct of turning coal into coke for steel production  made Liquid Wrench unreasonably dangerous. The United States Steel Corporations bares the burden have failing to test their product for a design defect.

Some of you may have heard news reports or read an article online about “Saturday Night Live” comedian Tracy Morgan’s accident. Morgan was in a limo bus with several other people on the New Jersey Turnpike when a truck rear-ended their vehicle. Morgan and three other people were seriously injured. The driver of the truck had been up for twenty-four hours and did not see that the traffic in front of him was slowing down. The driver was charged with vehicular homicide and assault by automobile.

This accident has recently started a debate about truck driving safety. If you or someone you care about was injured in an accident and you believe that driving regulations might have been violated, then you should speak to a truck accident and personal injury lawyer with the Higgins Firm. We will help answer any questions you may have and make sure you receive compensation for what you have suffered.

The main issue in the case was whether or not the driver was complying with federal rest regulations for truck drivers. Beginning in July of 2013, truck drivers have had restrictions of fourteen hour work days with a minimum of eleven hours of driving. Truck drivers also must have at the very least ten hours off to sleep between their shifts. According to reports, Wal-mart, the truck driver’s employer at the time of the accident, stated that even though it is claimed that the driver was awake for twenty-four hours it was not specified whether the driver was working when he is alleged to have been awake for 24 hours. The debate is about if he was working, were the hours he worked logged properly and if he was not working why was he up for twenty-four hours.

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