Product Liability Lawyer Blog

November 28, 2016

A Dozen Hospitals Allegedly Failed to Disclose Medical Device Related Injuries and Deaths

The United States Food and Drug Administration (FDA) is not only charged with the task of regulating pharmaceutical drugs, but also medical devices. Medical devices can include anything from a tool used by a surgeon, to an artificial knee, to a hybrid implant that slowly releases a medicine over time as a broken leg heals. While there is a lot of regulation of medical devices by the FDA, the regulations allow the medical device manufacturers a bit more leeway than they do in the case of drugs. There are also certain loopholes in medical device regulation, such as the one that allows a medical device on the market with less testing and data if there is already a similar device on the market.

For this reason, the FDA will conduct follow-up investigations in hospitals around the nation to see if these devices are working as planned. This should be easy for them to do since the hospitals are required to promptly report any injury or death that involved a medical device. However, according to a recent news report form Kaiser Health News, the FDA has just found that Massachusetts General Hospital (MGH) in downtown Boston, as well as 11 other hospitals, have failed to promptly make these reports to the FDA and the medical device makers, as required by federal regulations. Continue reading

November 25, 2016

Hinrichs v. General Motors of Canada, Ltd.: Products Liability Claims

by Jeffrey S. Glassman

In Hinrichs v. General Motors of Canada, Ltd., an appeal before the Supreme Court of Alabama, plaintiff was riding as a passenger in a 2004 GMC pickup truck when he suffered a serious injury to his spinal cord. He was reportedly a victim of a drunk driver.

According to court records, plaintiff was in the pickup truck being driven by his friend when another driver allegedly ran a stop sign and collided with them. That motorist was arrested for driving under the influence of alcohol. When the collision occurred, the pickup truck in which plaintiff was riding flipped over and rolled twice, resulting in substantial damage to the vehicle. The point of the collision was the passenger door where plaintiff was sitting. Fortunately, he was wearing his seatbelt at the time of the serious car accident, so he was not ejected from the vehicle. When not wearing a seat belt, ejections are common and can often result in death. Continue reading

November 21, 2016

Johnson & Johnson Talc Victim Awarded $70 Million

by Jeffrey S. Glassman

According to a recent news article from Fortune, a woman in California has just been awarded $70 million by a jury in what is now the third lost trial for Johnson & Johnson in connection with its liability for cancer-causing baby powder.

This plaintiff, a 62-old-woman from California, had used talcum powder manufactured by the defendant for years for feminine hygiene purposes. She used the baby powder for around 40 years and only stopped when she was diagnosed with ovarian cancer three years ago. The cancer is already in a very advanced stage. She has undergone surgery and extensive cancer treatments, but as her lawyers argued to the jury, she will likely be dead within two years. Continue reading

November 17, 2016

FDA Issues Warnings for Testosterone Supplements

by Jeffrey S. Glassman

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