Articles Posted in Defective Drugs

Nashville Attorneys, The Higgins Firm, are closely looking into Abilify lawsuits and claims which have raised concern amongst professionals after a number of people were said to have developed a gambling disorder, diabetes or other potentially harmful uncontrollable urges while taking the drug. These urges, the Abilify lawyers go on to say, appeared to have ceased once the medication was discontinued.

The antipsychotic drug Abilify, also known as aripiprazole, is manufactured by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Lawsuits against these companies state that they failed to provide sufficient warnings on the label of the drug and neglected to properly educate the prescribing doctors of Abilify’s’ side effects.

In this case, Andrew Yount grew breasts after taking Risperdal since he was five. He was awarded 70 million in damages for physical disfigurement and emotional distress by a jury in Philadelphia. The award is 28 times greater than the highest jury verdict previously decided against Janssen, a Johnson & Johnson subsidiary, in Philadelphia-based Risperdal litigation. That former highest verdict award was $2.5 million.

Austin Pledger, who was prescribed Risperdal in 2002 as a teenager for treatment of mood swings related to his autism, developed size 46 DD breasts, allegedly as a result of taking the drug.

Like Yount, Pledger asserted Janssen did not disclose or properly warn of such side effects before he was prescribed Risperdal. A Philadelphia jury awarded Pledger $2.5 million in February of last year. Only one case thus far, featuring Pennsylvania plaintiff William Cirba, has ended with a ruling in Janssen’s favor.

Gloria Ristesund used Johnson & Johnson’s talc powder products on her genitals for years and she was later diagnosed with ovarian cancer as a result. She had to have a hysterectomy and several other surgeries because of the cancer. The cancer is now in remission. Ristesund was awarded awarded $5 million in compensatory damages and $50 million in punitive damages for Johnson & Johnson’s failure to properly warn consumers about the cancer risks associated with talc powder.

J&J spokeswoman Carol Goodrich stated that the verdict contradicted 30 years of research supporting the safety of cosmetic talc. The company intends to appeal and will keep defending its products’ safety.  This is however, the second trial loss for Johnson & Johnson over their talc powder products. The company is facing one thousand two hundred lawsuits that allege the company failed to properly warn people about these cancer risks.

Deane Berg’s doctor called her the day after Christmas in 2006 to tell her the news of her cancer diagnosis. She had her ovaries removed and the results came back Deane Berg had stage three ovarian cancer and her prognosis was poor. She had twenty-five years of experience has a physician’s assistant but knew almost nothing about ovarian cancer. When she looked up the risks, she had only one; regular use of talcum powder for feminine hygiene.

Berg learned that since the early 1980s, several studies had discovered that women who regularly used talc powder for feminine hygiene had higher than average rates of ovarian cancer. Yet the evidence which fell short of proving that it caused the cancer, was mostly confined to medical journals and had barely been made known to the public. For millions of women including Berg using powder on the the genitals or underwear was a daily ritual, like brushing teeth. Since her teens, Berg had used Johnson’s Baby Powder and Shower to Shower, another Johnson & Johnson powder marketed to women. “A sprinkle a day keeps odor away,” the ads stated. “Your body perspires in more places than just under your arms.”

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.

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.
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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.
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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.
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