The most disturbing news, aside from the risks of taking various drugs, is that most Americans put their trust in physicians and the drugs they prescribe to heal them. They expect these medications to be safe and make them feel better. Unfortunately, ‘feeling better’ on a temporary basis is not a fair trade against the devastating side effects of some of these drugs.

As Portola Pharmaceuticals rushes to gain approval of their drug which they say will help stop internal bleeding in patients taking the popular class of blood thinners which includes Xarelto and Eliquis, patients continue to suffer severe side effects and even wrongful death.

A recent claim was filed by a man who contends that about two months after his wife was given Eliquis to treat atrial fibrillation, she developed gastrointestinal bleeding. Due to the lack of an Eliquis antidote, doctors were unable to stop her internal bleeding, and she ultimately died. The lawsuit seeks to hold Bristol-Myers Squibb and Pfizer responsible for the woman’s death. The plaintiff claims that Bristol-Myer Squibb and Pfizer neglected to adequately research all potential Eliquis side effects before the drug was released and that they deceived doctors and consumers about Eliquis bleeding risks.

Waiting for a fair and equitable settlement or a jury trial in hard fought litigation like this will likely take years. In the meantime, the plaintiff will still need to pay his ordinary bills and expenses, as well as funeral expenses and any outstanding medical bills. During this time, many plaintiffs find it advantageous to seek out wrongful death litigation funding to remove the pressure to settle early and inexpensively and allow their attorney the time he/she needs to get the fairest possible result.

Litigation funding is better described as a non-recourse cash advance; it does not need to be repaid if the case is unsuccessful. The application is free, and there is no need for a credit check or employment verification. Funding is based strictly on the merits of the case. If you suffered or lost a loved one from internal bleeding after using a blood thinner such as Eliquis, you could be entitled to compensation for damages. It is important to consult an experienced attorney to understand your rights. Once the case is filed, Litigation Funding Corporation would be happy to review your case to determine if you are eligible for a lawsuit cash advance.

In some situations, punitive damages may be appropriate. Punitive damages are paid to the patient, but they are intended to punish the defendant for egregious wrongdoing. Punitive damages typically won’t be awarded unless a patient can show the doctor engaged in behavior that was especially reckless or intentional. That can be very difficult to prove in these cases, but it’s not impossible. An example might be a physician with a struggling practice who treats a patient in a way that will require extensive follow-up treatment/ procedures that otherwise would be unnecessary. In that instance, it’s not simply a mistake – it’s intentional harm. Punitive damages send a clear message to other health care providers: They will pay a steep price for being reckless or putting profits before the well-being of patients.

In the recent case of McColl v. Lang, plaintiff sought to hold a health care provider accountable for causing an infected, third-degree burn on her nose after she underwent a treatment that involved use of a black salve to treat a blemish.

According to court records from the Montana Supreme Court, defendant is a licensed naturopathic doctor. Plaintiff visited defendant for a thyroid problem and also to talk about a blemish on her nose and her desire to have it removed. The physician applied a “black salve,” which was an escharotic agent. He sent her back home with instructions for care and to return for a follow-up. At the follow-up visit, defendant applied more of the salve to plaintiff’s nose.

A few days later, she rushed to a local urgent care center for pain, swelling and burning of her nose. She was treated for an infected, third-degree burn on her nose. Because it ultimately left a large, unsightly scar on her nose, she underwent plastic surgery. In order to remain scar-free, plaintiff has to undergo surgical injections every six months.

Plaintiff sued her doctor for medical malpractice, alleging the salve was not an approved drug and its marketing violated federal law and that the U.S. Food & Drug Administration (FDA) had four years earlier identified it as a phony cancer cure. Consumers were warned not to use it. Defendant argued the FDA’s warnings were prejudicial because the allegation in the complaint centered on the practice of medical care – not the marketing, manufacturing or sale of the medical product. What’s more, defendant never claimed he was curing cancer. The court agreed to exclude evidence of the FDA warning.

However, the court did not exclude plaintiff’s expert witness.

At trial, jurors found the doctor had deviated from the applicable standard of care. Jurors awarded $140,000 in damages, plus costs, for a total of $145,000.

Plaintiff appealed on grounds the court improperly denied the FDA evidence, which resulted in a rejection of her punitive damage award request. She asked for a new trial based on the punitive damage award issue.

The Montana Supreme Court affirmed, finding trial court did not abuse its discretion in excluding the FDA evidence and the denial of punitive damages was proper.

If you have been a victim of a traffic accident, call Chalik & Chalik at (954) 476-1000 or 1 (800) 873-9040.

Additional Resources:

McColl v. Lang, Oct. 11, 2016, Montana Supreme Court

More Blog Entries:

In re Estate of Woody v. Big Horn County – State Supreme Court Reverses Rejection of Wrongful Death Lawsuit, Aug. 19, 2016, Miami Medical Malpractice Lawyer Blog

The medications are Brintellix, which is an antidepressant, and Brilinta, which is a blood-thinner medication used to aid in the prevention of death following a heart attack or serious chest pain or to avert a second heart attack. The agency claims it has been the recipient of reports of errors since the approval of Brintellix in September 2013. Each medication is a tablet with the letter T imprinted on it, and each is yellow. In order to avoid any more confusion, the FDA recommends that physicians write out the generic name of the drug in addition to the brand name, and the illness for which it is being prescribed.

Brintellix is an antidepressant that is intended to be taken once a day, and is also known by another name, vortioxetine. Brilinta is a blood thinner that is to be ingested two times a day, and is also referred to as ticagrelor.

Prior to the approval of drugs, companies suggest names for their drugs. The FDA’s Division of Medication Error Prevention and Analysis (DMEPA) reviews those names, and then compares them to drugs that are on the market, and those that are still being reviewed by the FDA.

There have rarely been warnings over confusion of the names of medications. However, they do occur. For example, in 2011, the FDA said it had discovered over 200 medication errors in which the drugs Risperdal and Requip, were involved. Risperdal is an antipsychotic, and Requip is a drug that treats symptoms of Parkinson’s disease and restless legs syndrome. According to the FDA, five patients were hospitalized when they were administered the incorrect drug.

There were similarities between the brand names and generic names of each drug. The generic name for Risperdal is risperidone, and the generic name for Requip is ropinirole. The FDA requested that drug manufacturers Johnson & Johnson and GlaxoSmithKline PLCD modify their packaging to help differentiate one drug from the other. The FDA also advises patients to always check their prescriptions to make certain that they are receiving the correct medication.

The lawsuit was filed against a number of corporations that are part of Bayer Corporation and Johnson & Johnson, the marketers and manufacturers of Xarelto, a blood thinner, on behalf of the family of a man who died in 2013 after a bleeding event allegedly caused by Xarelto.

Xarelto was approved by the FDA for sale in the U.S. in 2011. It is the second in a new class of anticoagulants to be approved, after Pradaxa, which was approved in 2010. The new drugs are marketed as an improvement over warfarin or Coumadin, which is often used in stroke prevention, but may disrupt vitamin K levels and requires frequent blood testing.

In late 2014, litigants sought to establish a multidistrict litigation (MDL) for Xarelto cases. Most plaintiffs requested that the MDL be established under Judge Herndon in East St. Louis, Illinois, but the Judicial Panel on Multidistrict Litigation chose U.S. District Court Judge Eldon Fallon in New Orleans to oversee the MDL.

The Xarelto litigation focuses on the alleged insufficiency of warning labels, including the alleged failure to warn prescribing physicians and patients that some patients are at higher risk for a bleeding event.

Paul Greenberg is a Chicago work accidents and wrongful death lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

A study of 50 pharmacies nationwide found a 1.7 percent error rate. With 4 billion prescriptions filled each year in the United States, that means there could be more than 60 million medication mistakes made annually in retail pharmacies.

In Illinois, accurate statistics on medication mistakes are lacking because the state does not require pharmacies to report them. Fifteen other states do require such reporting. In addition, under national law, as long as pharmacies create an internal review system, they may keep errors confidential. In Illinois, thanks to a court case won by Walgreens, pharmacies can ignore state subpoenas for reports on medication mistakes.

People who suffer injuries due to medication errors may be entitled to compensation through a pharmaceutical negligence lawsuit. Illinois parents Robin and Eda Ahmed filed a lawsuit against Walgreens recently, after their five-year-old son was allegedly given an antipsychotic instead of allergy medication. The antipsychotic was intended for an adult with the same first and last name as the boy, the lawsuit claims.

According to the Ahmeds’ attorney, the pharmacist should have noted that the dosage was ten times the amount that a child should receive. After the child received two doses of the medication, the parents said he could not breathe or talk. The boy’s mother said that doctors told her one more pill would have killed her son.

Paul Greenberg is a Chicago medical malpractice lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

This case is the beginning of over 12,000 federal court claims against TVT Retropublic slings involving allegations that the sling and their other vaginal mesh inserts disintegrated over time, resulting in severe injuries and unrelenting pain. More than 1 million women have had these slings inserted since the device met with FDA approval in 1998. The West Virginia judge found the plaintiff’s lawyer failed to present enough evidence that there was a defect in the device that caused her injuries.

In 2013, the FDA ordered vaginal sling/mesh makers to study the rate of organ damage and any complications that may be related to those implants. In 2010, more than 70,000 of these devices were inserted into women’s vaginas to provide support for sagging pelvic organs. Thousands of women insist they sustained irreparable harm as a result of receiving these devices.
Given the nature of the evidence so far, it is hard to imagine that each case will end with a victory for Big Pharma. That is not a likely scenario for the thousands of other women waiting in the wings to get justice, despite what the FDA says is safe. In practical applications, the vaginal mesh kits may have damaged many women’s health, and they may never be the same again.

Lee, Gober and Reyna – If you need a personal injury lawyer or help with an auto accident, motorcycle accident, wrongful death, or burn injury case, contact Lee, Gober and Reyna by visiting http://www.lgrlawfirm.com or calling 512.478.8080

ISSUE: HeartWare, Inc. received reports where the driveline connector locking mechanism failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death.

BACKGROUND: The HeartWare Ventricular Assist System is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure.  Also known as HeartWare Ventricular Assist Device (HVAD), the system is designed for in-hospital and out-of-hospital settings, including transportation by fix-wing aircraft or helicopter.

Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205.
Serial Numbers: HW001 to HW 11270 and HW20001 to HW 20296.

Affected products were manufactured from March 6, 2006 through October 17, 2013 and distributed from March 17, 2006 through November 29, 2013.

RECOMMENDATION: Health professionals should promptly arrange a follow up visit with patients having the affected HVAD to inspect the driveline connector.

At implant and at each routine clinic visit, inspect the patient’s driveline connector for proper locking and to ensure that the connector assembly remains secure. During the inspection, pull back the protective boot and slide the locking mechanism back and forth to verify free movement of the mechanism. If the locking mechanism of the driveline connector does not move freely or fails to engage, push the connector back into the controller and immediately contact a HeartWare Clinical Engineer to perform a permanent field repair.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395265.htm

By Richard LaGarde

The jury found that the plaintiff suffered compensatory damages of $1.475 million. Compensatory damages are damages meant to compensate an injured party for his loss or injury.  The jury also awarded punitive damages of $9 billion against defendants Takeda Pharmaceuticals USA Inc. and Eli Lilly & Co.  Punitive damages  are damages intended to reform or deter the defendant and others from engaging in conduct similar to that which formed the basis of the lawsuit.

By Richard LaGarde

The U.S. Judicial Panel on Multidistrict Litigation (MDL) said that 9,961 actions were pending in the Yasmin/Yaz MDL as of May 14. The MDL is No. 2100 in U.S. District Court, Southern District of Illinois. Bayer Healthcare Pharmaceuticals is the manufacturer of both Yasmin, which received FDA approval in 2001, and Yaz, which was approved by the FDA in 2006. Both drugs are oral contraceptives that combine a fourth generation progestin, drospirenone, with estrogen to prevent pregnancy.

The lawsuits against Bayer allege that the plaintiffs developed serious medical issues caused by their use of Yasmin or Yaz. The injuries include gall bladder complications, stroke, deep vein thrombosis, heart blockage and blood clots.

Bayer Pharmaceuticals said in its February 28, 2013 annual report that it had reached agreements to settle the claims of about 4,800 U.S. plaintiffs, for a total amount of approximately $1 billion. The settlements do not include an admission of liability.

In March, Reuters reported that Bayer agreed to settle several state lawsuits in New Jersey, California and Pennsylvania that alleged that gall bladder injuries were caused by Yasmin or Yaz. The settlement reportedly called for plaintiffs who suffered gall bladder injuries to be paid $2,000 and plaintiffs who had their gall bladders removed to be paid $3,000.

In June, the Canadian Broadcasting Corporation reported that Health Canada documents showed that Yasmin and Yaz are suspected in the deaths of women who died suddenly from blood clots. Health Canada is the Canadian equivalent of the FDA in the United States. In April of last year, the agency issued a warning informing consumers about blood clotting as a possible side effect of Yaz and Yasmin.

The Health Canada document said that doctors and pharmacists had reported 23 deaths and more than 600 adverse reactions associated with Yasmin or Yaz. The adverse reactions were reported between 2007 and February 2013. More than half of the deaths were of women under the age of 26, with the youngest being 14. The report came shortly after a Canadian judge certified a class-action lawsuit alleging that the drugs caused life-threatening blood clots.

In April 2012 the FDA issued a similar warning, saying that drospirenone-containing birth control drugs may be associated with a higher risk of blood clots.

Bob Briskman is a Chicago malpractice attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

It is alleged that patients have become ill after taking products manufactured at Specialty Compounding, LLC, based in Cedar Park, Texas. Specialty Compounding is in the process of recalling all of the medicines manufactured in that facility dispensed since May 9, 2013 after at least 15 people developed bacterial infections traced back to the medicines.

Patients who received intravenous infusions of calcium gluconate, a drug to treat too much potassium or to correct calcium deficiencies, have reported issues after their treatment at Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional. It is suspected that the medication was not sterile, which caused bloodstream infections; Rhodococcus bacteria was detected, which typically causes symptoms including fever and pain.

The now-recalled batches of calcium gluconate were distributed directly to medical offices and hospitals throughout Texas, and also nationwide to patients, with the exception of North Carolina. Specialty Compounding has announced that is has contacted all customers to notify them of the recall; anyone who is in possession of the product should contact Specialty Compounding at (512) 219-0724 Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT, to find out how to return it.

A spokesperson for Specialty Compounding has announced that the company is voluntarily recalling all sterile products at this time out of concern for patient safety. The Federal Drug Administration inspected the facility in March 2013 and reported “questionable testing practices” and a lack of some procedures to establish drug sterility. Some drug processors were seen wearing improper clothing (i.e., not sterile), according to the findings, and it was noted that there was inadequate drug testing to ensure a lack of unwanted microorganisms.

This April, a new Senate bill was proposed which calls for much tighter regulations for the drug compounding industry. The FDA has called for an increase in its regulatory powers for compounding facilities; the regulatory powers typically fall under state regulations.

In 2012, a compounding facility in Framingham, Mass., The New England Compounding Center, was the center of an investigation after people in 20 states were affected; 750 were sickened, including 63 deaths. Contaminated drugs made at the facility caused an outbreak of fungal infections, including meningitis. More than 17,600 doses of methylprednisolone acetate steroid injections were affected. An investigation by FDA investigators discovered mold and fungal contamination in numerous vials of the drugs, and in areas where the drugs were made.

At The Hale Law Firm, we have helped thousands of clients successfully prosecute their personal injury claims including auto accidents, wrongful death, dangerous products, brain injuries, burn injuries, and defective medical devices. Clients depend on their personal injury lawyers for guidance and legal advice across a broad range of personal injury accidents. To learn more, visit http://www.hale911.com/ or call 972.351.0000.

Patients with chronic pain now have available to them devices that send electrical signals to the brain in order to block the sensation of pain. They have the support of Medicare, the insurance industry, and the FDA. This is critical to ensure patient access.

One such device, a spinal cord stimulator, is implanted in fatty tissue in the lower back near the spine. The system sends electrical signals to the spinal cord that override the brain’s sensation of pain. The patient operates the unit, turning it on or off and controlling the signal frequency with a small remote control.

A report from the SunSentinel covered a patient who was in near-constant agony following surgery on her broken foot. She was scarcely able to walk or drive and depended on her husband for nearly everything. The spinal cord stimulator let her be without pain and regain her mobility almost immediately. The $23,000 procedure was covered entirely by her health insurance. These high-tech therapies are more costly up-front to insurers when compared with medication, but insurers are on board because of the potential for long-term cost savings.

If you need to speak with a personal injury lawyer, Call Joyce & Reyes at 1.888.771.1529 or visit more of http://www.joyceandreyespa.com/.

Copper is necessary for bone and tissue growth, hormone secretion and nerve conduction, but the new research from the University of Rochester Medical Center suggests that too much copper has negative effects on human health. The research was published in the journal PNAS.

The research found that copper, even in amounts that are common and allowable by the FDA, can affect the barrier that keeps toxins from entering the brain. Copper can also fuel the production of beta-amyloid in the brain and keep proteins from clearing it out. Beta-amyloid is a component of amyloid plaques associated with Alzheimer’s disease.

In addition, copper buildup in the brain can cause inflammation. In the short term, inflammation is a sign that brain tissues are responding to excess proteins and attempting to expel them, but in the long term inflammation can damage brain cells.

Copper is found in a wide range of foods, including shellfish, nuts, red meat, and many vegetables and fruits. It is also found in vitamin supplements, and it seeps into drinking water from copper pipes. Suspended in water, copper is in its free form and is more readily absorbed into the body than when it is consumed in food.

Researchers said that the findings could suggest a way to prevent or slow Alzheimer’s disease. A drug currently in trials binds with copper molecules and removes them from the body. However, researchers said that even if such a drug is successful, a balance will have to be found between too much copper in the body and too little.

The research was done with mice and with human brain cells to find ways that copper might initiate or worsen Alzheimer’s disease. They found that the blood-brain barrier breaks down in the elderly, allowing larger toxin molecules to enter the brain. They also found that the concentration of copper in the small blood vessels in the brain increases with age.

The researchers fed mice a normal diet but gave half of them double-distilled water with a very low copper content and half of them water with higher levels of copper, equal to one-tenth of the maximum allowed by the EPA. The mice with a higher copper intake had a level four times lower of a protein that removes beta-amyloid from the brain.

The Hale Law Firm believe the right solution to your estate planning, elder law, or probate needs can be identified in a free initial consultation with one of our attorneys and counselors at law. To learn more or to contact a Dallas estate planning lawyer, visit http://www.thehalelawfirm.com/ or call 972.351.0000

Over the past 20 years, the use of selective serotonin reuptake inhibitors (SSRIs) such as Zoloft, Paxil, Prozac and others has increased 400 percent. During the same period, several medical studies have addressed the risk of birth defects associated with the use of these medications during pregnancy. The research suggests that babies exposed to these drugs are at higher risk of developing birth injuries such as spina bifida, heart malformations and persistent pulmonary hypertension of the newborn (PPHN), among other injuries.

Antidepressants are the most commonly prescribed medication for people between the ages of 18 and 44. The risk of birth injuries has led to Class D medications such as Paxil no longer being recommended for pregnant women, but Class C medications such as Celexa and Zoloft are still prescribed for expectant mothers.

The FDA has issued warnings regarding the dangers of using antidepressants during pregnancy. In 2005, the agency warned of increased risk of heart defects for pregnant women taking Paxil. Research showed that women taking the drug in the first three months of pregnancy were twice as likely to give birth to a baby with a heart defect. The warning label for Paxil was subsequently changed from Class C to Class D. In 2006, the FDA issued another warning regarding SSRIs and an increased risk of neonatal PPHN.

Paul Greenberg is a birth injury attorney with the Chicago law firm of Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

Dabigatran, better known as Pradaxa, marketed by Boehringer Ingelheim, is an anti-coagulant prescribed to millions of patients since its release in 2010. Now patients are coming forward with claims of life-threatening and other serious side effects.

An FDA MedWatch report states that Pradaxa caused at least 542 known deaths in 2011, the year after it was introduced to the public. Other reports include more than 2,350 cases of internal hemorrhaging, 644 strokes and almost 300 cases of acute renal failure. The most often cited side affects patients are claiming were caused by Pradaxa include gastrointestinal bleeding, brain hemorrhage, stroke, and heart attack.

The maker of Pradaxa, Boehringer Ingelheim, has been accused of concealment of risk, negligence, and strict product liability. The company has also been accused of failing to establish an internal bleeding protocol, failing to warn consumers of the high risks associated with taking Pradaxa, and failing to adequately research the medication’s safety and proper dosage.

Pradaxa has been a popular substitute for Warfarin, an anti-coagulant on the market for more than 50 years. Warfarin also increases the risk of internal bleeding, but the bleeding can be stopped with vitamin K. Pradaxa does not have a comparable antidote and there is no standard method to measure its anticoagulant effects.

Pradaxa lawsuits were consolidated in August 2012 to allow multiple litigants; four bellwether trials are scheduled for August 2014. Meanwhile, Pradaxa is still on the market and is considered a viable treatment option for those who need an anticoagulant. Anticoagulants are designed to reduce blood clotting or prevent blood clots. Anticoagulants are commonly prescribed to treat superficial venous thrombosis (SVT), deep vein clots, and deep venous thrombosis DVT. Anticoagulants are also commonly given when there is a risk of stroke.

As of April 2013, the label for Pradaxa contains a boxed warning which advises that discontinuing the medication may increase the risk of stroke.

If you or a loved one has been prescribed Pradaxa and have had any incidences of an adverse reaction, your experience should be immediately reported to the FDA.

At The Hale Law Firm, we have helped thousands of clients successfully prosecute their personal injury claims including auto accidents, wrongful death, dangerous products, brain injuries, burn injuries, and defective medical devices. Clients depend on their personal injury lawyers for guidance and legal advice across a broad range of personal injury accidents. To learn more, visit http://www.hale911.com/ or call 972.351.0000.

The robot, called da Vinci, is manufactured by Intuitive Surgical Inc. and was used in close to 400,000 surgeries in 2012, three times as many as in 2008. Now the FDA is investigating problems that include several deaths and incidents of apparent malfunctions.

The million-dollar device is used in operations including repair of heart valves, organ transplants, and removing prostrates and gallbladders. The operations can be less tiring for surgeons, who sit at a computer screen to control the machine. Movements can be more precise with robot arms that do not shake, and doctors report that there is sometimes less bleeding when the device is used.

However, an FDA survey of doctors using da Vinci reveals at least five deaths linked to the machine since early last year. The device is currently the only robotic surgery tool approved by the FDA for soft-tissue surgery.

Reports of problems linked to the device include a woman who died during a hysterectomy when a blood vessel was allegedly nicked by the robot and a man who allegedly suffered a perforated colon during surgery on his prostate. Other incidents include a robotic arm that would not release tissue during surgery, requiring a system shutdown, and a robotic arm that struck a patient in the face.

The FDA investigation is intended to determine whether surgical mistakes using the device have increased. Nearly 1,400 hospitals in the U.S. have at least one da Vinci system.

Bob Briskman is a Chicago malpractice attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

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