Product Liability Lawyer Blog

November 17, 2016

FDA Issues Warnings for Testosterone Supplements

Over the past decade, we have seen a tremendous increase in the number of men taking testosterone replacement therapy (TRT) drugs. These drugs were originally developed for treatment of a relatively rare medical condition known as hypogonadism. That is the condition for which these drugs were approved by the United States Food and Drug Administration (FDA) in the 1970s.

However’ that’s apparently not the reason hundreds of thousands of men are taking these drugs. The real reason these men have been taking TRT medicaitons is because of the many television commercials and magazine ads that tell us that taking testosterone supplements will help with all of the “symptoms” of normal male aging. This includes lowered libido, weight gain, fatigue, mild depression, loss of muscle tone and so on. The FDA has not approved the drug for this use, and doctors and researchers have not seen that taking testosterone will actually help “treat” any of these conditions. Continue reading

November 14, 2016

Tyson Chicken Issues Major Recall Over Plastic Scare

by Jeffrey S. Glassman

According to a recent news article from International Business Times, Tyson Foods, one of the world’s largest producers of poultry products, recently recalled over 130,000 pounds of fully cooked chicken nuggets because they believe these nuggets may contain hard plastic. This was announced after a statement by the U.S. Department of Agricultural (USDA) and its Food Safety and Inspection Service (FSIS).

Consumers who noticed the foreign substance in their fully cooked chicken nuggets first discovered this food contamination. This plastic is believed to have once been part of a rod used in a conveyor belt at the factory that transported the nuggets during the production and packaging process. Continue reading

November 11, 2016

Allegations that Johnson & Johnson and Bayer Hid Knowledge of Faulty Devices During Xarelto Trials

by Jeffrey S. Glassman

Last year, the United States Food and Drug Administration (FDA) became aware that a device used to monitor a patient’s blood in Xarelto clinical trials had problems. Now it has been reported by British Medical Journal, and via FiercePharma, that the two major drug companies (Janssen/Johnson & Johnson and Bayer A.G.) were well aware of this faulty blood monitor during the time it was being used and did not notify any of the study monitors or the FDA.

The device in question is known as the INRatio device, and it was designed to monitor how much Xarelto was being absorbed by patients on a single dose as compared to those who were taking Warfarin (Coumadin). The reason this is very important has to do with why drug makers claim Xarelto and the other New Oral Anticoagulants (NOACs) are safer and more effective than traditional blood thinning medications like Warfarin. Continue reading

November 7, 2016

101-Year-Old Woman Has Hip Replacement – Sets Record

by Jeffrey S. Glassman

A 101-year-old woman now holds the Guinness Book of World Records title for being the oldest person ever to receive a total knee replacement, according to a recent news article from the Preston Citizen. Although it’s probably not a title she would have wished to have, considering it all stemmed from a serious fall in which she broke her hip, the surgery marks a notable feat for the medical community.

Prior to the fall accident, the woman had been dealing with serious knee pain for many years. Doctors felt there was no choice but to do a total hip replacement procedure if she was ever going to walk again, even with the assistance of a walker. After the hip replacement surgery, she was able to move the hip joint again, but she was having a lot of difficulty healing. The reason for this was due to her knee trouble. With the knee also being very week and deteriorated, she was unable to walk normally, and this was causing her to not heal properly following the total hip replacement procedure. Continue reading

November 3, 2016

Report: Xarelto Bleeding Risks Higher that Pradaxa

by Jeffrey S. Glassman

According to a recent report from WebMD News, a recent study, which asserted both Xarelto and Pradaxa were superior to Warfarin, found that Xarelto poses a higher risk of serious internal bleeding disorders than its competitor, Pradaxa. The drugs at issue are part of a new class of anticoagulants known as New Oral Anticoagulants (NOACs). Xarelto, Pradaxa, Eliquis, and Savaysa are the four NOACs approved by the United States Food and Drug Administration (FDA).

The risk of increased internal bleeding disorders for patients taking Xarelto over patients taking Pradaxa was seen in patients who suffer from a serious medical condition known as atrial fibrillation (Afib). Afib, is characterized by an irregular heartbeat not caused by a heart valve defect. If this sounds familiar to you even though you do not suffer from Afib, it might be because Saturday Night Live alumni actor Kevin Nealon appears in a commercial where he discusses his own struggles with Afib and how taking Xarelto has helped him to lead a normal life. Continue reading

October 29, 2016

Eliquis Sales Closing in on Xarelto Market

by Jeffrey S. Glassman

For many years, if someone needed a blood thinner, he or she would take Warfarin (Coumadin). This product is relatively safe and there are not many side effects, so long as a person carefully monitors his or her diet and has regular blood tests so their doctor can check the blood chemistry to see how the drug is being absorbed.

The reason it is important to monitor the absorption level of Warfarin is because if the level is off, it can result in a serious internal bleeding disorders. While this is a serious concern, as this is no minor side effect, it is easy to avoid so long as you are compliant with your medication. In the event a patient has an internal bleeding disorder and goes to the emergency room, the ER doctors will be able to administer a reversal agent (antidote) that will stop the anti-clotting effect, which, in turn, will allow the body to clot again so the internal bleeding will stop. It should be noted that reason it is important for a patient to monitor his or her diet is because certain foods high in vitamin K like dark greens will affect the absorption rate of Warfarin, and that can lead to serious problems. Continue reading

October 26, 2016

More Concerns over Galaxy Note 7 Recalls and Transparency

by Jeffrey S. Glassman

By now, most people have heard that Samsung’s release of the Galaxy Note 7 smartphone did not exactly go as planned. Problems started when users were reporting their phones were spontaneously bursting into flames or completely exploding. As if this was not bad enough, there were reports of them exploding on airplanes, which caused even more concern. The company has claimed there was a problem with the batteries that were made by a third party and has agreed to recall all of the phones sold to consumers to replace them with a device that features a safe battery.

According to a recent news article from NPR, there are now more questions being raised about not only the safety of these products, but also in the transparency of the recall process – or more accurately, the lack of transparency. The problem is the company claimed the issue was not the device itself, which Samsung manufactured, but rather with the batteries, made by a third party. However, that seems to not be the case, considering Samsung has switched battery suppliers and the combustion continues. Continue reading

October 22, 2016

Al Roker Recovers from Total Knee Replacement Surgery

by Jeffrey S. Glassman

According to recent news release from the Today Show, long-time anchor and television personality Al Roker is recovering from his most recent total knee replacement operation. Roker says he is doing great and will stay in the recovery center until he is cleared to go home by his physical therapy team. Footage of Roker moving around with the assistance of a walker was included in the release by the show.

Roker also discussed how this was not the first time he had undergone knee surgery. Around 15 years ago, he had a total knee replacement performed on his other knee after being involved in a car accident, and from general wear and tear on his knee due to being overweight most of his life. He is, of course, much thinner now after his successful bariatric surgery. He said that technology has come a long way since his first total knee replacement procedure, and this time, he was up and walking around in less than a day. Continue reading

October 18, 2016

Study: Talc Cancer Risk Greater for African American Women Than Peers

by Jeffrey S. Glassman

A recent study conducted by the American Association for Cancer Research (AACR) reveals that African American women are at greater risk of developing cancer caused by talc exposure than their peers who did not use the genital powder.

Study authors noted that while regular use of talcum powder was associated with higher rates of ovarian cancer regardless of where it was applied, users who applied the powder to their genitals showed a 40 percent higher risk of cancer, while those who used the powder for non-genital purposes increased the risk by more than 30 percent.

Joellen Schildkraut, an epidemiologist at the University of Virginia and the lead researcher for this study, told Reuters that black women in America were heavily targeted in marketing campaigns for the body powder. Yet it has no real benefit. Still, Schildkraut began her research as a skeptic. She questioned the fiercely debated issue of whether it caused ovarian cancer and other forms of gynecological cancer. She described herself as a cynic. Her latest findings, on top of what has been previously studied by other researchers, have convinced her. Continue reading

October 16, 2016

A Look at Robotic Knee Replacement Surgery

by Jeffrey S. Glassman

A recent news article from Fox News looks at a new procedure that allows doctors to perform a total hip replacement with the assistance of a robot. While we have seen many instances where hospitals across the country are using robots to perform partial knee replacement surgeries, there are only 10 surgeons in the country who are presently certified to use this new technology.

It is a robot in the sense that one might think in that it is self-controlled. Instead, the system uses an advanced scanner that creates a 3D model of the patient’s knee joint and displays that model on a monitor used during surgery. The surgeon then uses a robotic surgical instrument to make the cut, and controls the robot using a series of hand control levers. The surgeon is then able to look at the monitor with the 3D model and see where he or she is cutting. Continue reading