By Richard LaGarde

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.

Johnson & Johnson is being accused of violating patients’ rights in this regard – and flouting federal regulatory procedures – by allowing a subsidiary, Synthes Inc., to market and distribute a type of bone cement to be injected into patients’ spines. This was an off-label use that was not approved by the U.S. Food & Drug Administration (FDA), and the company was well aware of that fact.

And yet, according to a lawsuit underway in Washington state, the company engaged in off-label use marketing to expand its customer base, even though it was understood this product wasn’t approved for use in back surgeries. Patients died on the operating table within minutes of being injected with the compound. 

In the case of Wilson et al. v. Chapman, et al., plaintiffs are the survivors of a 67-year-old woman who was supposed to undergo a routine back surgery to treat chronic pain. Her family now alleges the surgeon and the hospital knowingly engaged in off-label use of the material, known as Norian bone cement, even though it was not approved for back surgery use.

The case against doctors, hospitals and the product manufacturers is not an isolated one. Fortune detailed a number of these cases back in 2012. One of those involved a woman whose 83-year-old mother died unexpectedly in spinal surgery. At the time, her daughter didn’t raise too many questions. After all, it’s not unusual for a woman her age to suffer negative side effects during surgery. It wasn’t until years later that an agent with the U.S. Department of Health and Human Services informed her that as a result of its investigation into the company, it was learned the woman’s mother’s spine had been injected with this bone cement. The material was not approved for that purpose, and officials believed it may have played a role in the woman’s death.

Most people have never heard of the company Synthes, which is based in Pennsylvania. But it was the largest acquisition ever by Johnson & Johnson, which paid $20 billion for the company. Interestingly, Johnson & Johnson executives at the time of purchase were praising the culture and values of the company, even as Synthes’ leaders were facing charges of grievous conduct.

The Wilson case is the first civil lawsuit since company executives were sent to prison and the company itself was ordered to pay $23 million in fines.

Attorneys are arguing that the surgeon and a former CEO of Synthes knew the bone cement could be deadly if used in the spine. The material was designed for use in arm and skull bone surgeries. But there were tests on pigs in which the animals died within seconds of the material being injected into their spines. Yet, rather than going through the lengthy – and expensive – process of gaining regulatory approval,, the company decided instead to simply start trying it on humans. The results, as the Wilson case and others have shown, as disastrous.

Our Miami product liability attorneys understand that these companies are alleged to have taken a huge gamble with people’s lives. If those allegations are legitimate, the company needs to be held to account. Plaintiff attorneys are pursuing a product liability lawsuit against the manufacturer and a medical malpractice lawsuit against the surgeon and hospital. J

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

Additional Resources:

J&J Unit Performed ‘Human Experimentation’ With Deadly Bone Cement, Jury Told, June 28, 2016, By David Siegel, CVN

More Blog Entries:

Tarvin v. CLC of Jackson – Nursing Home Arbitration Agreement Nixed, July 2, 2016, Miami Product Liability Lawyer Blog

That’s the allegation lobbed by plaintiffs in tens of thousands of vaginal mesh lawsuits, and it’s now being echoed by attorneys general in California and Washington, both of whom recently filed lawsuits against one manufacturer, Johnson & Johnson, and its subsidiary Ethicon, Inc.

“For many victims, their health and quality of life were forever changed as a result of this deception,” said Washington state Attorney General Bob Ferguson.

Side effects of these mesh devices, used to treat pelvic prolapse and incontinence in women, include loss of sexual function, urinary dysfunction, severe pain and constipation. For some women, there is no position that is comfortable anymore. It’s not just the loss of intimacy with their partners, but being unable to sit upright, lie on their side or walk a few steps without incredible pain. 

Speaking at a press conference announcing the lawsuits, one woman from Seattle revealed that she had vaginal mesh surgically inserted at the same time as her hysterectomy, per her doctor’s recommendation, as a way to help deal with her ongoing issues with incontinence. But three years later, not only did her incontinence not get better, it got worse. Plus, she’s had to deal with severe pain, numerous urinary tract infections and constant, agitating itch. What was previously a minor incontinence issue is now so serious, she has to either leave work or keep several changes of clothes with her so that she can cope with the constant accidents that occur as a result of the damage done by the mesh.

She is one of tends of thousands of woman who have already filed personal injury lawsuits against manufacturers of these devices. Johnson & Johnson is a major player, as is Endo International, based in Ireland, and Boston Scientific in Massachusetts.

Two years ago, Endo settled 20,000 personal injury lawsuits with $830 million. Johnson & Johnson, however, still faces 35,000 lawsuits – and more by the day.

These allegations from state attorneys general allege Johnson & Johnson violated state consumer laws with false advertising, and deceptive marketing. In Washington state, where some 12,000 Johnson & Johnson meshes were implanted, the attorney general alleges the company never told patients they risked chronic inflammation, long-term risk of infections and erosion, a condition that occurs when mesh protrudes into an organ or through the vaginal wall. And again, the states allege, these were problems about which the company was well aware.

In one case from 2009, a physician sent the company an email just before he was to begin surgery on a mesh patient. He informed the company she was likely to lose all sexual function, as her vaginal length was just 3 cm. Plus, there was mesh “extruding literally everywhere.” As the doctor put it, the patient would suffer, “a permanently destroyed vagina.”

And yet, despite emails like this, the company continued selling these devices – up until 2014, when they finally pulled them from the market. Still, they have never conceded the products aren’t safe.

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

Additional Resources:

State files lawsuit against Johnson & Johnson over pelvic mesh implants, May 25, 2016, Associated Press

More Blog Entries:

Navo v. Bingham Memorial Hospital – Apparent Agency, May 7, 2016, Miami Pelvic Mesh Injury Lawyer Blog

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/.

William Packard was prescribed Xarelto in January 2012 to treat a nonvalvular atrial fibrillation. In June 2012, Packard suffered a subdural hemorrhage, or hematoma. Excess blood collected between the layers of tissue around the brain, causing pressure on the brain. Packard was admitted to the hospital, where doctors attempted to alleviate the pressure by drilling a burr hole through the scalp. However, the procedure was not enough to save Packard’s life.

In her lawsuit against Johnson & Johnson and Bayer AG, the manufacturers of Xarelto, Nancy Packard alleges that the defendants did not provide proper warnings about the risks of taking the drug — particularly about the fact that excessive bleeding could be irreversible. When other anticoagulants, such as warfarin, are used, vitamin K injections can be used to stimulate blood clotting in case of excessive bleeding. However, there is no such antidote for Xarelto.

Packard also alleges that the defendants’ marketing of the drug failed to acknowledge the danger of irreversible bleeding.

The lawsuit was filed in the U.S. District Court for the Southern District of Florida, seeking compensatory and punitive damages in excess of $75,000.

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

The five-year-old boy suffered from cleft lip and other birth injuries after being exposed to Topamax while his mother was pregnant.

The verdict came just weeks after another multi-million dollar verdict against Janssen Pharmaceuticals, also regarding birth injuries suffered after exposure to Topamax.

Attorneys for the plaintiffs said that the verdicts confirmed that Janssen knew of the risks of birth injuries when Topamax was taken by pregnant mothers, but failed to warn physicians of the danger and continued to market the drug.

The plaintiffs’ attorneys also said that the large verdicts were appropriate, as the children’s birth injuries will necessitate numerous surgeries and will have long-lasting effects on their health.

A spokesperson for Johnson & Johnson said the company was disappointed in the verdict and planned to appeal. The drug maker said that the evidence indicated that the mother and her doctor were aware of the side effects of the drug. Johnson & Johnson also said that the jury failed to consider critical factors, including other potential causes of the birth injuries.

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