Product Liability Lawyer Blog

February 5, 2015

FDA Intervenes When New Testosterone Drug Causes Side Effects

For most of the past decade, it has become impossible to watch a sporting event on television without being inundated with advertisements for testosterone replacement therapy (TRT) drugs. While the United States Food and Drug Administration (FDA) has only approved testosterone replacement therapy drugs to treat an extremely rare condition known as hypogonadism, drug companies have created a new market for their once seldom used product.

The marketing divisions of several major drug companies have convinced aging men that by taking TRT drugs, it will help them overcome fatigue, mild depression, weight gain, loss of muscle tone, loss of libido and other characteristics of normal male aging. Drug companies claim these characteristics are really symptoms of having a low testosterone level or “Low-T”, as it is called by drug companies. They correctly figured men would be comfortable saying they are concerned about Low-T than they are about having low testosterone.
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February 1, 2015

Philadelphia Judge Certifies Xarelto Lawsuits for Mass Tort Docket

by Jeffrey S. Glassman

Xarelto is a relatively new type of blood-thinning medication in a class of drugs called New Oral Anticoagulants (NOACs).

Xarelto is manufactured by Bayer AG and sold in the United States with Bayer’s marketing partner, Janssen Pharmaceuticals. Janssen is a subsidiary of Johnson & Johnson.

These companies market Xarelto for patients at high risk of developing serious clotting disorders such as stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE). A PE is deadly health condition in which a clot forms and then dislodges itself and travels through the circulatory system until it reaches the lungs. One in a lung, it can tear a hole in the tissues, causing serious illness or death.

Patients at risk for these conditions normally require a blood thinner such as Warfarin. While Warfarin is generally effective, patients must closely watch their diet and have regular blood tests to control their dosage. If the dosage is off, patients can develop life-threatening side effects. Xarelto, on the other hand, is supposed be as effective without requiring constant dose monitoring.
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January 26, 2015

Flyers Defenseman Kimmo Timonen Taking Xarelto to Help Get Back on Ice

by Jeffrey S. Glassman

Philadelphia flyers Defenseman, Kimmo Timonen hopes to recover from a serious clotting disorder to a point, which will allow him to get back on the ice. According to a recent news article from Courier-Post, Timonen has been unable to play this season after being diagnosed with blood clots in his lungs and legs.

As part of his treatment for his serious clotting disorder, Timonen has been taking Xarelto. Xarelto is a member of a class of drugs known as New Oral Anticoagulants (NOACs). NOACs are a newer alternative to traditional blood thinners such as Warfarin. Those with clotting disease are at a high risk for stroke if one of the clots breaks free from a vein and block an artery providing blood to patient’s brain. Clots can also travel to patient’s lungs and tear a hole known as a pulmonary embolism (PE). Both of these can result in serious personal injury or death.

One advantage touted by makers of Xarelto is patients are not required to have frequent blood tests, and closely monitor their diets to keep their dosage in check. If Warfarin is administered in an incorrect dosage, it can cause life-threatening side effects. Doctors will use results of frequent blood tests to adjust a patient’s dosage from time to time.
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January 24, 2015

New Injection May help Reduce Pain of Total Knee Replacement Surgery

by Jeffrey S. Glassman

Even a completely successful knee replacement surgery procedure will involve a great deal of pain and suffering as the patient heals from his or her wound and builds up strength.

According to a recent news article from HCP Live, a new injectable medication administered during total knee replacement surgery may help alleviate much of the pain following surgery.

The new drug being studied is called liposomal bupivacaine, and is injected into tissue surrounding the knee during total knee replacement surgery. Researchers hope it will provide considerable relief from pain expected to follow surgery.

Researchers note pain from the injection is comparable to pain from knee replacement surgery and has been shown in studies to provide patients with up to two days of pain relief following surgery. These two days of pain relief have allowed patients to use their new knee sooner, which can greatly decrease recovery time.
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January 22, 2015

Pirates Manager to be “Hippest Cat in Town” After Second Surgery

by Jeffrey S. Glassman

It was previously reported after the end of baseball season, Pirates manager, Clint Hurdle, had a total hip replacement. His struggles with arthritis were well known to baseball fans as the beloved manager could barely stand in the dugout for the length of a ballgame last season.

This painful arthritis in left right hip led him to undergo a total hip replacement less than three months ago. Now Hurdle says the pain in his right hip has gotten so unbearable he has elected to have a total hip replacement in his right leg.

57-year-old Hurdle, who says he will soon be the “hippest cat in town,” knew he would someday need to have his other hip replaced, but did not know when. After speaking with his surgeon, he decided to go ahead and get it over with before the upcoming season.
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January 21, 2015

Big Pharma Paying Speakers to Discuss Xarelto and Eliquis

by Jeffrey S. Glassman

One of the main ways drug companies get patients to take their drugs is through direct marketing to potential patients through television, Internet, and magazine advertisements. There was a time when the United States Food and Drug Administration (FDA) did not allow drug companies to direct market to individual users, but that ban was lifted a long time ago.

These days, it is typical for a patient to say to their doctor they want to take a particular medication. This is different from the past, when a patient would explain his or her symptoms and a doctor would tell the patient what drugs were available. However, today it is necessary to get doctors on board with prescribing a particular drug as well as having patients ask for the drug by name.
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January 16, 2015

Xarelto Antidote in Development

by Jeffrey S. Glassman

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.
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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.
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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.
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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.
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