Product Liability Lawyer Blog

January 16, 2015

Xarelto Antidote in Development

It is hard to watch TV these days without seeing ads for Xarelto. Xarelto is a member of a class of drugs known as New Oral Anticoagulants (NOACs). Other members of this class include Eliquis and Pradaxa. Xarelto is the brand name in the United States for rivaroxaban manufactured by Bayer AG. Janssen, a subsidiary of Johnson & Johnson, markets Xarelto.

The company claims Xarelto can help patients suffering from a condition known as atrial fibrillation (Afib). Afib patients are a higher risk for serious diseases such as stroke and will typically be treated with a blood thinner to prevent serious clots from forming. Blood clots can cause strokes and other dangerous conditions such as a pulmonary embolism (PE).

Until the development of NAOCs, doctors would prescribe medications such as Warfarin to Afib patients. While effective, Warfarin patients need to have regular blood tests to make sure they are getting the correct dosage. If the dosage is no longer correct, a patient’s doctor can adjust the dose. If a patient fails to have his or her blood checked and is taking an improper dose, they can suffer serious side effects.
Continue reading

January 14, 2015

Soldiers Twice as Likely to Need Total Knee Replacement Surgery

by Jeffrey S. Glassman

If you ever watch a documentary or reality show about military training, it seems like the men and women are being pushed to the limits of their physical ability. In reality, they are often being pushed far beyond what the human body was designed to do. This is evident in that military veterans over the age of 40 are more than twice as likely to need a total knee replacement as civilians of the same age.

The military calls this wear and tear on soldiers’ joints. One of the problems for soldiers is, after performing their jobs and suffering debilitating injury, they are often forced to leave the military due to a medical discharge. According to a recent feature from FOX News, many soldiers with knee troubles are now able to have a total knee replacement and remain on active duty.

With new knee replacement technology, military studies show over 85 percent of veterans who undergo total arthroplasty of the knee are able to return to active duty. Of those returning to active duty after having a total knee replacement, nearly two-thirds of them were able to be deployed to a combat zone and complete full tours of duty.
Continue reading

January 12, 2015

Drugmakers Hope New Antidote to Eliquis Dangers Will Push Sales

by Jeffrey S. Glassman

Eliquis, like Xarelto and Pradaxa, is part of a class of drugs known as New Oral Anticoagulants (NOACs). NOACs have entered the United States market in the past few years and have earned their respective manufacturers billions of dollars in sales in that short period of time.

The reason for windfall sales is that patients who take conventional blood thinners like warfarin to reduce the risk of stroke and systemic embolism need to go their doctors frequently to have a blood test performed. This is needed because, while warfarin has been proven effective at treating patients at risk for these conditions, if medication levels are not checked often and adjusted when needed, serious side effects can occur.

Eliquis was marketed as new kind of treatment that does not require frequent monitoring and will let patients lead a normal life without the fear of developing serious side effects. While this is true for many patients, others will experience a severe internal bleeding condition, which can cause intracranial bleeding and hemorrhaging. If a patient develops one of these deadly conditions, there is not an approved cure to help those suffering from a bleeding disorder. In other words there is no antidote for the poisonous effects of Eliquis.
Continue reading

January 9, 2015

Researchers Examine Problems with “Low-T” Diagnosis

by Jeffrey S. Glassman

Over the past decade, more and more people have started taking testosterone replacement therapy (TRT) drugs to treat the alleged symptoms of having a “low-t” count. Low-T is a term created by the marketing arm of drug companies intended to mean a person has a lower than average testosterone count. The symptoms of having a lower than average testosterone level, according to TRT drug manufacturers, are weight gain, tiredness, depression, loss of muscle definition, and other symptoms that are essentially the characteristics of normal male aging.

According to a recent article from HCP Live, the American Urological Association has released a white paper warning physicians about problems with current practices in testosterone evaluation techniques. The first problem, as noted by the paper’s author, is there is no consensus among urologists and clinical pathologists as to what a low testosterone level is or means.

Many of the studies performed on testosterone levels involved research subjects who were over the age of 65. There is very little research on average testosterone levels of men with normal sexual and reproductive function. The definition of low testosterone levels used by the United States Food and Drug Administration (FDA) is a level below 300 ng/dl. However this is a definition used to establish when a patient suffers from hypogonadism.
Continue reading

January 8, 2015

New Total Hip Replacement Surgery Technique

by Jeffrey S. Glassman

Each year over 330,000 hip replacement surgeries are performed in the United States. A total hip replacement surgery, known to doctors as arthroplasty, traditionally involves cutting through most of the patient’s muscle tissue, tendons, and bone surrounding the original hip joint. An artificial hip is then anchored to the bone using a long metal spike and possibly medical-grade cement.

While elderly Americans and athletes may require a new hip due to their natural hip being broken, most patients are undergoing hip replacement surgery to alleviate the pain of arthritis. Doctors are telling prospective patients a new hip will allow them to essentially live as they did when they were years younger before experiencing any hip trouble.

The problem is many patients who undergo total hip replacement surgery will experience significant pain and suffering as result of defective artificial hip devices, which can loosen, deteriorate or completely fail within a short period of time following surgery.
Continue reading

January 6, 2015

New Test Finds Dangers in Antidepressants in Early Development Phase

by Jeffrey S. Glassman

New drugs can yield billions of dollars for pharmaceutical companies. Because it takes many years to develop a drug, undergo clinical trials, and get it to market, drug companies will do virtually anything to get as much profit as possible for each new drug. This is especially true when considering that many proposed drugs will never make it through development, past clinical trials, or ever receive FDA approval. Some drugs are later found to be toxic or otherwise harmful to patients after being put on the market and then have to be withdrawn, while the manufacturer may be subjected to numerous lawsuits.
Continue reading

January 3, 2015

Xarelto Sued Over Clotting Problems

by Jeffrey S. Glassman

Xarelto is a member of a class of drugs known as New Oral Anticoagulants (NOACs), along with Eliquis, and Pradaxa. These drugs were designed to replace older blood-thinning drugs such as warfarin, which requires frequent monitoring of a patient’s blood to prevent dangerous side effects. The problem with Xarelto and these other NOACs is they have been shown to cause serious bleeding disorders, including internal bleeding, intracranial bleeding, and hemorrhaging.

If patient experiences a bleeding disorder after taking Xarelto, there is no approved cure for the disease, and the condition can be fatal. In other words, when a patient comes into the emergency with serious internal bleeding caused by Xarelto, there is not much doctors can do besides transfuse blood and try to make the patient comfortable.

According to a recent news article from the Madison Record, the makers of Xarelto now are being sued over the drug’s inability to clot in a timely manner. Bayer AG is the manufacturer of Xarelto and Janssen Pharmacutica (a subsidiary of Johnson & Johnson) is the marketing partner in the United States.
Continue reading

December 29, 2014

What Does the Arrest of NECC Executives Mean For Victims of Meningitis Outbreak?

by Jeffrey S. Glassman

Our Boston product liability lawyers recently discussed the arrest of NECC owners and employees in connection with the meningitis outbreak that occurred in 2012. The outbreak, which left 64 dead and caused more than 750 people to contract meningitis, was traced to contaminated steroids from the New England Compounding Center. The contamination occurred because basic safety protocols were not followed when the drugs were being compounded and packaged.

Following the public health crisis due to the contaminated steroids, NECC went bankrupt. This left many victims turning to suing sister companies of NECC to try to recover compensation for their monetary and non-economic damages. It also left the NECC owners and employees without any consequences to face for what they had done. Now, however, the arrest of the owners and of some high level employees at the pharmacy could change things.
Continue reading

December 26, 2014

Artificial Knee Manufacturer Pleads Guilty to Fraud

by Jeffrey S. Glassman

According to a recent news article from NJ.com, the president and founder of OtisMed Corp. recently admitted to shipping hundreds of artificial knee products without FDA approval and pleaded guilty to criminal charges.

Authorities are reporting defendant pleaded to guilty to three misdemeanor fraud counts related to a shipment of over 200 artificial knee devices to surgeons throughout the United States with full knowledge the United States Food and Drug Administration had not approved them. Prosecutors stated defendant will be sentenced in March of 2015 and faces up to three years in prison.

OtisMed, which has since been acquired by Stryker Corporation, plead guilty to felony charge of distributing an adulterated medical device into interstate commerce and must pay approximately $40 million in fines and restitution. The company will also be required to pay an additional $41.2 million in civil settlements related to false claims litigation.
Continue reading

December 23, 2014

Brinkley v. Pliva, Inc.: Defective Generic Drug Lawsuits

by Jeffrey S. Glassman

Brinkley v. Pliva, Inc., a defective drugs case from the United States Court of Appeals for the Eighth Circuit, involved plaintiff whose doctor prescribed the brand-name drug Reglan to treat her Gastro Esophageal Reflux Disease (GERD). Plaintiff’s pharmacist substituted the generic drug metoclopramide, which was manufactured by defendant. This occurred in 2002.

Pursuant to Federal Food Drug, and Cosmetic Act (FDCA), manufacturers of generic medications are required to prove their drugs are the same as the brand-name equivalent in design and labeling. Generic drug makers are not permitted to add any additional warnings.

In 2004, the United States Food and Drug Administration (FDA) approved the Reglan maker’s request to add two additional bold statements to the labeling warning the product should not be taken for more than 12 weeks. Defendant did not add these additional warnings to its generic product.
Continue reading