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.
There are many medical devices and products on the market that are used to reduce medical complications for people and to help improve their quality of life. Unfortunately, sometimes these devices or products can have defects and cause additional complications or medical problems for many people. If you or someone you know had an IVC Filter implanted and are now experiencing serious side effects or more medical problems as a result, then it is important that you speak to a IVC Filter and dangerous device lawyer with the Higgins Firm. We will listen to your case and determine if you may be eligible for compensation for what you have been through.
IVC Filters are implanted in people who have problems with blood clots. They are used to trap the clots in order to help prevent them from becoming pulmonary emboli. When they were originally marketed, they were permanent implants. However, over the last ten years, they were redesigned so that they could be retrievable, which means that the doctor could implant them and take them out at a later date. These retrievable filters were marketed first in 2003. One of the makers of these filters that is now facing lawsuits is C.R. Bard, maker of the Recovery, G2 Filter and Eclipse; and Cook, which makes the Celect and the Gunther Tulip.
According to a study from the Journal of Vascular Interventional Radiology, after five and a half years, forty percent of people who have a retrievable filter have experienced some type of fracture in the filter. Other side effects could include the filter moving, titling or perforating and these side effects can cause perforation of organs or vessels next to the filter. A fracture in the filter could travel to the patient’s heart, which can result in death of the patient or the need for open heart surgery to remove the fractured filter. Another study in the JAMA Internal Medicine discovered that many retrievable filters are actually left implanted permanently . That study discovered that of six hundred and seventy-nine retrievable filters implanted from August 1, 2003 to February 28, 2011, at Boston Medical Center, only fifty-eight were s removed with success and seventy-four people suffered a thrombotic event after filter placement.
Our firm is currently reviewing Zofran Birth Injury Cases. Zofran is an anti-nausea drug that was originally developed to help chemotherapy patients combat nausea. However, the drug has also often been prescribed to help with morning sickness during pregnancy. Unfortunately, the drug was never approved for this type of use and multiple lawsuits have been filed alleging that unborn children exposed to Zofran during pregnancy have an increased risk of heart defects, cleft palate, cleft lip and other congenital injuries. The suits also state that the manufacture of the drug failed to warn the medical providers and mothers about these side effects. As part of a federal civil and criminal complaint investigation, it was alleged that the manufacturer, GlaxoSmithKline, promoted this “off-label” use despite there being no FDA approval and paid kickbacks to physicians to prescribe the drug. GlaxoSmithKline never admitted wrongdoing in its promotion of the off label use of Zofran. However, GlaxoSmithKline entered into a civil and criminal settlement in 2012 with the government which included resolution of civil claims related to the use of Zofran as well as many other allegations related to marketing of other pharmaceutical products. As part of this settlement, the largest health care fraud settlement in U.S. History, GlaxoSmithKline agreed to pay over 3 billion ($3,000,000,000.00) dollars in fines, forfeiture and civil claim settlements and plead guilty to a three-count criminal information regarding counts of introducing misbranded drugs, Paxil and Wellbutrin, into commerce and the failure to report saftey data regarding another one of its drugs, Avandia, to the FDA. If you have taken Zofran during pregnancy, please feel free to call our office to discuss your options. We have also put some frequently asked questions below to give you a little more information about the claims surrounding Zofran.
I TOOK ZOFRAN WHILE PREGNANT WHAT SHOULD I DO?
Don’t panic. If you are still pregnant you should discuss any concerns you have with your doctor. He or she can explain the risks and help you with any concerns. If you had an uncomplicated birth and a healthy child then you really shouldn’t worry. I would suggest talking to your pediatrician to make sure there are no health issues such as an undiagnosed heart defect. However, if you took Zofran for morning sickness and your child was born with heart issues, a cleft lip or cleft palate we would suggest you contact our office. You should also go to your pharmacist and obtain any records you have of medications taken during pregnancy. If you have trouble getting these records we can help.
WHAT ARE THE LAWSUITS INVOLVING ZOFRAN CLAIMING?
The lawsuits against the manufacturer of Zofran, GlaxoSmithKline, set forth allegations that go far beyond just unintended injuries from the drug. The allegations include claims that GlaxoSmithKline decided to illegally market this drug while at the same time they withheld important warnings about the link between Zofran and birth defects.
WHAT IF I TOOK THE DRUG SEVERAL YEARS AGO?
As most everyone knows each state has a time limit to file a lawsuit. However, in Tennessee, the statute of limitations is tolled if the injured person is under eighteen (18) years old. As such, if your child has one of these injuries and they are nineteen (19) years old or younger, it is possible they still have a claim. As with any case, the longer you wait, the more difficult it is to put evidence together so we suggest you contact a Nashville Zofran lawyer as soon as possible.
WHAT DOES IT COST TO HIRE A ZOFRAN LAWYER
We take these cases on a contingent fee basis. This means that you don’t have to pay anything unless a recovery is made. If a recovery is made, our fee will be based upon a percentage of the money obtained plus costs incurred. Continue Reading
Residents in Tennessee and people all across the country have heard about serious side effects and complications occurring after taking certain medicines such as Xarelto. We count on our medications to make us better and help our lives to be better. Unfortunately, sometimes some medications such as Xarelto can cause dangerous side effects like uncontrollable bleeding and this can lead to serious health problems or even death. If you or someone you care about has suffered serious complications or died after using Xarelto, then you should speak to a Tennessee Xarelto lawyer as soon as possible. They will hear your case and help you get the compensation that is rightfully yours for what you have been through.
In this case, plaintiffs who have filed lawsuits due to Xarelto complications have requested that a panel of federal judges consolidate all of the lawsuits in the U.S. District Court. The plaintiffs stated that the Xarelto complaints have the same or similar complaints and claim that people who used the blood thinning medication in order to help prevent a stroke or a blood clot have suffered uncontrollable bleeding or death. These lawsuits also claim that Bayer AG and Janssen Pharmaceuticals Inc., a part of the Johnson & Johnson Company failed to warn doctors and their patients that Xarelto has no antidote to reverse bleeding should significant bleeding events occur in patients. The Johnson & Johnson Company filed their own response urging the court to reject the plaintiffs’ request to consolidate all of the lawsuits.
Representatives for those who previously used Xarelto and their families have asked the panel to assign the fifty cases filed in fifteen different federal courts to U.S. District Judge David Herndon. If panel goes ahead with the request, Judge Herndon would manage pretrial proceedings of the Xarelto multidistrict litigation. . Bayer recommended that the judicial panel assign the Xarelto litigation to U.S. District Judge Freda Wolfson who is already managing two Xarelto cases.
Xarelto is an oral medication that has been prescribed as a blood thinner and was approved by the U.S. Food and Drug Administration to help treat deep vein thrombosis and pulmonary embolism. The FDA initially approved Xarelto in July 2011 to reduce the risk of blood clots in patients who had knee or hip replacement surgery. In November 2011, the FDA expanded the use of Xarelto to reduce the risk of stroke and blood clots in patients with atrial fibrillation. As it announced the expanded approval of the drug, the FDA also stated that Xarelto was the first drug since warfarin was approved 60 years ago to treat and prevent the recurrence of blood clots. The FDA approved the use of warfarin also known as Coumadin and Jantoven as a blood thinner in 1954. However, warfarin has vitamin K as an antidote; Xarelto does not have an antidote to stop bleeding should a significant bleeding event occur in patients using Xarelto.
The plaintiffs in this case stated that the aggressive marketing and promotion efforts of Bayer and Janssen helped to increase the sales of Xarelto. The plaintiffs, however, claim that the increased sales also contributed to the mounting number of serious adverse events associated with Xarelto. The plaintiffs’ motion stated that there were 1,080 serious Xarelto-related events, which included 65 deaths, reported to the FDA in the year leading up to June 30, 2012. By the end of 2012, there were 2,081 new serious adverse Xarelto events reported to the FDA. Of those reported, 151 resulted in death, compared to only 56 deaths associated with warfarin. Continue Reading
Xarelto is one of the latest drugs on the market to come under attack due to its potentially harmful and even life-threatening side effects. The first lawsuit involving Xarelto was filed last August by a Kentucky resident who claims she was hospitalized due to severe internal bleeding caused by taking the medication. The lawsuit was filed in the U.S. District Court of the Eastern District of Pennsylvania and names Bayer Health Care as a defendant. In her Complaint, the plaintiff alleges that the manufacturer knew about the drug’s dangerous side effects and continued to sell it without informing consumers of the risks.
Xarelto (rivaroxaban) is an anticoagulant, or blood thinner, that was introduced in 2011 after receiving its U.S Food and Drug Administration approval. It was approved for use by patients (1) who have had hip replacement surgery or knee replacement surgery to reduce the risk of blood clots, or (2) who have atrial fibrillation for reducing the risk of stroke. It was also approved for treatment of pulmonary embolism and deep vein thrombosis. The drug is manufactured by Bayer Health Care and marketed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. It is intended to prevent blood clots from forming which can obstruct vital organs. The benefit of Xarelto over other anticoagulants on the market is that it can be prescribed in one uniform dose instead of requiring specific doses for each individual patient.
Unfortunately, there are many side effects associated with the drug. These side effects include internal bleeding, blood clots, embolism, and hemorrhaging. Essentially, the drug can cause uncontrolled bleeding to occur inside a patient’s body; and if that bleeding occurs near a major organ, the blood flow to that particular organ becomes interrupted and can cause it to lose some functionality. These are the same side effects associated with the anticoagulant Pradaxa, which has been on the market since 2010 and has similarly come under attack. Boehringer Ingelheim-the manufacturer of Pradaxa-has paid close to $650 million to resolve the thousands of cases brought against it due to the drug’s harmful bleeding side effects. Continue Reading
Glenn Adam Chin has become the first person to face criminal charges in connection with the federal investigation into the 2012 fungal meningitis outbreak caused by the New England Compounding Center. Yesterday, Chin was arrested at Logan International Airport in Boston, Massachusetts as he was about to board a flight destined for Hong Kong. He has been charged with one count of mail fraud related to the outbreak at the facility. While it is unclear whether or not Chin was attempting to flee the country to avoid prosecution, Paul Shaw, Chin’s lawyer, has stated that Mr. Chin was merely going to Hong Kong to attend the wedding of family friend.
Glenn Chin, 46, was the supervising pharmacist at the New England Compounding Center during 2012. He was in charge of the sterile rooms at the facility and making sure that the facility’s rooms and equipment were properly cleaned, sterilized and tested. It was during Chin’s tenure as supervising pharmacist that NECC manufactured and distributed steroid shots that were contaminated with black mold. As a result, countless patients across twenty three states-including Tennessee-were exposed to fungal meningitis. To date, 750 patients have contracted the illness, 64 of whom have died.
The U.S. Attorney’s Office has not yet filed any other charges in the matter, but continues to mount an investigation into the outbreak and additional charges against Chin and others are expected. Additionally, hundreds of people have filed civil suits against the NECC over the last two years. In late 2013, a preliminary settlement in the amount of $100 million was reached; however, this has not been approved by the courts as of yet.
In a statement made Thursday, the U.S. Attorney’s Office explained that Chin is being charged with “participating in a scheme to fraudulently cause on lot of [the steroids] to be labeled as injectable, meaning that it was sterile and fit for human use, and shipped to one of NECC’s customers.” At Chin’s arraignment Thursday, the prosecutor explained that Chin was aware that he was a suspect in a criminal investigation and failed to notify the authorities of his trip out of the country. Chin has been placed on home confinement for the time being and has been ordered to surrender his passport, as has his family. A probable cause hearing will be held on September 11, 2014. Continue Reading
We are currently reviewing Low T cases in Tennessee. These cases involve clients that suffered a stroke or heart attack after receiving testosterone therapy. We recently gave an interview on these cases and you can learn more by watching it here:
Litigation involving the drug Risperdal is gaining traction in many states across the country. Risperdal is a drug that is intended to treat schizophrenia, bipolar disorder and symptoms of autism, and is often prescribed to children. It contains the antipsychotic drug risperidone and is considered to be an “atypical antipsychotic.” The designation “atypical” generally denotes a safer medication with fewer side effects; however, there are many known side effects associated with this drug. The most common side effects include lightheadedness, drowsiness, dizziness, tiredness, impaired cognitive functioning, nausea, and weight gain.
Unfortunately, a new and much more abnormal side effect is being seen in many of those who take the medicine. Boys and young men who take Risperdal have reported the development and growth of male breast tissue-a condition known as gynecomastia. Gynecomastia results when levels of prolactin-a hormone in the body that facilitates human reproductive health-increase significantly beyond normal. Interestingly, the potential for increased prolactin in those who took Rispedal was a known consequence of the drug. In 2006, the Journal of Clinical Psychopharmacology published a study that linked Risperdal to increases in prolactin levels and gynecomastia. The study explained: “Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects . . . are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.”
It is this specific side effect that has prompted the onslaught of litigation over the drug. The development of breast tissue in males, especially young boys, can cause severe and lasting emotional and psychological consequences. Furthermore, surgery is often required to fix the effects that Risperdal can have on the body (procedures range from liposuction to mastectomies). Over 400 lawsuits have been filed against Johnson & Johnson, the drug’s manufacturer, regarding the development of gynecomastia in those who have taken the medication. The company has come under attack for allowing the marketing of off-label uses for Risperdal; specifically, for allowing the drug to be prescribed to young children.
Additionally, Johnson & Johnson is facing attacks from the U.S. Food and Drug Administration and the U.S. Department of Justice for its allegedly illegal marketing practices. Recently, Johnson & Johnson and one of its subsidiaries, Janssen Pharmaceuticals, settled with the Department of Justice for $2.2 million to resolve all criminal and civil charges related to their marketing of Risperdal. Our Risperdal lawyers are looking into these cases today.
It is unfortunate how common new reports about defective drugs are becoming. With a profit driving system it seems that these giant drug companies will often place profits over the safety of the public. It makes you wonder if the leaders of these companies would take these drugs themselves or even allow their family members to take these drugs. One thing is certain; the only way to change this reckless behavior is to have the companies realize that the litigation and judgments against them will costs them more than the any profits they can make from these drugs. Continue Reading
Our office represents several families that were greatly impacted by the DePuy Metal on Metal Hip Recall. Currently there are about 11,000 hip lawsuits pending. Many of the cases involve hip patients right here in Tennessee. As the cases have progressed we have learned more about the alleged problems with these hips and how a jury may view these cases. Currently, two cases have gone to trial and several others are scheduled. The first hip recall case resulted in a verdict of several million dollars. There has also been a recent confidential settlement of another case that was about to go to trial. Is this a good sign that a global settlement may be in the works. Many of us believe so.
I recently gave an interview on the current state of the hip recall litigation. You can watch the interview below:
Last year, hundreds of people were affected by an outbreak of spinal meningitis resulting from tainted steroid injections coming from New England Compounding Center, a compounding agency in Massachusetts. In the wake of this preventable tragedy, Congress has begun looking into further regulating compounding pharmacies. Recently, the U.S. House of Representatives passed a bill that would allow the U.S Food and Drug Administration to have some oversight with compounding pharmacies. To hear attorney Jim Higgins talk about the new bill and provide an update on the status of current meningitis cases, click the video below.