Product Liability Lawyer Blog

July 2, 2015

OtisMed CEO Sentenced for Shipping Defective Knee Replacement Products

We have seen a variety of different defective artificial knee replacement devices, and many of these defective products have been the result of negligence committed by various medical device manufacturers. We have seen problems with artificial joints manufactured by Stryker, DePuy, OtisMed and others.

What makes things different in the Case of OtisMed is that the CEO pleaded guilty to knowingly shipping knee replacement products after the United States Food and Drug Administration (FDA) denied an approval request to ship the articular product. In other words, the FDA found a particular knee replacement product did not have enough safety data and may be defective, but, as he admitted to in a criminal court in New Jersey, the owner decided to disregard the denial. Continue reading

June 29, 2015

Managing Joint Replacement Risks

by Jeffrey S. Glassman

Over the past decade, we have seen a tremendous increase in the number of patients electing to undergo total joint replacement surgery. This can include total knee replacement surgery, total hip replacement surgery, and even other newer surgical procedures, such as a total ankle replacement surgery. All of these total joint replacement surgeries involve the implantation of an artificial joint to reconstruct or replace the damaged joint through a medical process known as arthroplasty.

Even if the surgeon performs these surgeries flawlessly and the artificial joint implanted was properly designed and functioning, there is still a significant amount of risk a patient will face when electing to undergo total joint replacement surgery.

According to a recent feature article from U.S. News and World Report, it is important to manage joint replacement risks appropriately, so patients can get back on their feet sooner. Continue reading

June 26, 2015

Testosterone Levels Vary Throughout the Day with Hormone Patch

by Jeffrey S. Glassman

Testosterone replacement therapy is clearly a big money maker for the various pharmaceutical companies that manufacture the hormone. It has gotten to the point where you cannot watch a football game or NASCAR race without seeing more than one commercial for testosterone replacement hormone.

Testosterone replacement therapy hormone comes in a variety of forms, including injections, transdermal patches, gels, skin creams, sublingual films, and pills. They are heavily marketed to men who are experiencing the symptoms of normal male aging, including reduced libido, weight gain, loss of muscle tone, fatigue, and mild depression.

While the companies that make testosterone replacement therapy hormone say taking replacement hormone is essentially a quick fix for all of these symptoms or characteristics, many doctors are not so sure. The medical community is not sure what it means to have low testosterone and what is normal for aging men. They also do not know if there is any benefit to raising one’s testosterone level though taking hormone therapy, unless the patient’s levels are so low as to qualify for the rare disease of hypogonadism. Continue reading

June 23, 2015

Robotic Hip Surgery Purports to be Safer, Some Evidence Suggests Otherwise

by Jeffrey S. Glassman

In Minnesota, a local news article touted a new robotic surgery for total hip replacements at a nearby hospital. The article noted surgeons were relying less on the imperfect human eye and fallible human hand and instead leaning on the precision of robots.

The latest investment for the local surgical center costs millions of dollars. It’s an arm-assisted system, and promises to “take the guesswork” out of placement of hip replacement implants, allowing patients to receive fits that are customized. It’s one of two surgical centers in that state to use the robotic arm system, which was manufactured by Stryker – the same company at the center of hip replacement and knee replacement litigation for defective products.

Approximately 400 to 550 hip replacements are done at this surgical center alone each year. The hope is to reduce the number of additional surgeries sometimes needed to correct improper placement of hip replacements, which is largely attributed to “eyeballing techniques” used by surgeons to get the parts in the right place.

June 21, 2015

Study: High Testosterone Linked to Diabetes, Prostate Enlargement

by Jeffrey S. Glassman

Hoards of testosterone products have been heavily marketed to men in recent years, promising increased vigor, stamina and health. Drug manufacturers marketed these to males who reportedly suffered from “Low-T,” or an inadequate level of the hormone.

We are now learning the reality is not only are these drugs ineffective for that purpose, they may actually cause a substantial amount of harm.

A new study conducted by researchers at the University of California Santa Barbara and published in the Journals of Gerontology: Medical Sciences indicates these drugs are linked to a markedly increased risk of diabetes and prostate enlargement.

June 17, 2015

New Procedure for Double Hip Replacement

by Jeffrey S. Glassman

According to a recent news article from the Times-Herald, a patient interviewed was a former college football player at East Tennessee State University and a life long athlete who had developed severe arthritis in both of his hips. His doctors told him there was virtually no chance he would be able to continue walking if he did not have a double hip replacement.

The patient, now 56 years old, said he did not want a double hip replacement. There was no way he wanted to undergo the surgery and did everything he could to avoid the procedure. He said his daily pain level was eight out of ten and sometimes worse. He needed a walker and a cane just to get around.

Finally, after the pain got unbearable, he spoke to a new doctor who had recently relocated to the area and was using a relatively new procedure during surgery known as anterior total hip arthroplasty. Patient listened to what the doctor had to say and also did his own research. He determined the new procedure, which had been around for some time at other hospitals, was as good as advertised, and with this new approach, healing and rehabilitation took two months less on average than when using conventional surgical procedures for total hip replacement.
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June 14, 2015

Report: Testosterone Replacement Injections More Dangerous Than Gels and Patches

by Jeffrey S. Glassman

With the huge marketing effort to get every aging male on testosterone replacement therapy hormones, despite them generally not being medical necessary or even proven to be effective, it should come as no surprise the hormone come in a variety of different forms. Drug companies are aiming to make it more convenient for patients.

Testosterone replacement hormone comes in pills, skin creams, skin gels, transdermal patches, sublingual (under tongue) films, similar to breath freshening strips, and injections. While all forms of testosterone replacement hormone have been linked to an increased risk for heart attack and stroke, according to a recent news article from Medscape Multispecialty, injectable testosterone has been shown to cause a higher risk of cardiovascular problems than other forms of the hormone, such as patches and gels.
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June 10, 2015

Hip Replacement Surgery for Patients of All Ages

by Jeffrey S. Glassman

Total hip replacement surgery is traditionally a procedure performed on older Americans. Female patients were typically around 5 to 10 years younger than the average male patient, but outside of athletes and accident victims, the surgery was generally performed on patients who were over the age of 50.

According to a recent feature from Costal Point, total hip replacement surgery is now becoming more common for patients both young and old. While many total hip replacement patients are aging baby boomers who still desire to lead an active lifestyle, as opposed to spending their golden years in a nursing home facility, there has been a significant increase in the number of hip implants on younger Americans.

People who are in there 20s, 30s, 40s and 50s are more commonly getting the procedures for sports-related trauma and injuries caused by leading a more active lifestyle than people had in the past. With more people playing recreational sports and running than ever before, there has been a reported uptick in cases of severe osteoarthritis at a much younger age than in the past.
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June 6, 2015

Boston Scientific Settles Another Transvaginal Mesh Case

by Jeffrey S. Glassman

According to a recent article from FDA News, Boston Scientific has entered into a private settlement agreement with a plaintiff who was suing the company for injuries she alleged are related their defective transvaginal mesh implant.

This transvaginal mesh lawsuit was being heard before the United States District Court for the Central District of California. Trial has already begun in this case, and there had been about a week of testimony and evidence presented prior to the parties agreeing to settle the matter, rather than letting a jury ultimately decide on the case.
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June 3, 2015

Bayer Hopes for New Market for Xarelto

by Jeffrey S. Glassman

The general public is becoming more aware of the dangers of Xarelto. The problem with Xarelto is it has been shown to cause serious internal bleeding disorders, clotting disorders and other serious heath problems. There is currently an antidote for the irreversible symptoms of Xarelto bleeding disorders, but it is still in the experimental stages, and the company needs to undergo additional testing before the United States Food and Drug Administration (FDA) will approve the drug for general use. The antidote is an injectable medication being developed by another drug company, and it will be available for use in the emergency room if and when it is approved.

To help keep sales up with dangers being made known to atrial fibrillation (Afib) patients, Bayer is hoping to find additional customers for their new drug. According to a recent news feature from RTT News, Bayer is now conducting clinical investigations into using Xarelto to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in cancer patients, in addition to the Afib patients for which is currently approved.
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