Product Liability Lawyer Blog

October 7, 2015

Endocrinologists’ Association Responds to FDA Testosterone Theory

According to a recent news article from Medscape Multispecialty, the American Associate of Clinical Endocrinologists (AACE) has just issued a position statement on the use testosterone replacement therapy. This is in direct response to United States Food and Drug Administration (FDA) warning about how testosterone replacement therapy can have serious cardiovascular effects on patients.

AACE is agreement with FDA that more safety and efficacy trials are needed with respect to hormone replacement therapy. The association also has concerns with how studies in the past have been performed. Specifically, they are concerned that studies have not been sufficiently randomized and controlled to accurately determine causality between testosterone replacement therapy use and increased risks for cardiovascular disease. Continue reading

October 2, 2015

A Look at Recent Study Data on Transvaginal Mesh Complications

by Jeffrey S. Glassman

Stress Urinary Incontinence is a disease that causes pain, discomfort, and embarrassment to thousands of women in the United States each year. There are a variety of things than can lead to this condition, including childbirth, being overweight, and aging. The pelvic muscles become weak and urethral sphincter no longer functions properly. When this happens, the patient will often urinate without warning whenever there is pressure applied to the abdomen. This pressure can cause by sneezing, coughing, lifting, running, or a multitude of other normal everyday activities.

Doctors have some non-surgical methods to treat stress urinary incontinence, but they are generally not effective, and surgery is normally the option of choice. Surgery involves implanting a sling that holds surgical mesh in a manner that supports the urethra. It is important the mesh, which is actually a form of surgical tape, is tension free, so that is the reason the sling is used, rather than attaching the mesh directly to the area in need of support. Continue reading

September 30, 2015

Cowboys Owner Jerry Jones Had Two Hip Replacement Surgeries in a Six-Week Span

by Jeffrey S. Glassman

There has been a lot of coverage about injuries and medical treatments on the roster of the Dallas Cowboys. The team suffered two significant losses to injury when wide receiver Dez Bryant broke his foot and quarterback Tony Romo broke his clavicle (collarbone). The team is left with downfield problems and Bradon Weeden as the quarterback. While New England Patriots fans might not care too much, this is obviously not a position any preseason Super Bowl hopeful wanted to find itself in.

In addition to the players on the roster, long-time Cowboys owner, Jerry Brown also underwent some significant medical procedures right before the season started. According to a recent report from NBC Sports, Jones had two hips replaced in a six-week period this summer. Continue reading

September 25, 2015

Warning on Savaysa Is Hurting Sales

by Jeffrey S. Glassman

For several years, Pradaxa, Elliquis, and Xarelto have had the market cornered on sales of New Oral Anticoagulants (NOACs) as treatment for patients who suffer from a serious medical condition known as atrial fibrillation (Afib). NOACs are an entirely new class of drugs designed to replace conventional blood thinners, such as Coumadin (Warfarin).

However, Daiichi Sankyo has recently entered the market with its own NOAC product under the name Savaysa. The company has high hopes for Savaysa sales, given that it recently lost its patent for Benicar, according to a recent news article from Fierce Pharma. Benicar, which will soon be available as a generic, is responsible for around 27 percent of Daiichi sales, so this loss will hurt. The company is hoping to make up for that loss with sales of their new drug, Savaysa, but they are running into some stumbling blocks. Continue reading

September 20, 2015

Massachusetts-Based 3D Printed Knee Replacement Used for First Time on Patients

by Jeffrey S. Glassman

Three dimensional, or 3D, printing is much more impressive than most people realized when they first heard of the process. A 3D printer can function in one of two main ways. In one type of 3D printer, the printer takes a computer rendered image and then cuts out a design from a block of material, usually made out of some type of polymer. This design works similar to high priced C&C routers and is known as a destructive construction process. The reason it is called a destructive process is because, much a like a sculptor working with a block of marble, material is chipped away until the intended design is formed.

The really impressive form of 3D printing involves a process where the print heads create the item through emitting layer after layer of material until the design is complete. Not only can these designs be completely customized one at a time, because no construction run is required, they can also create interlocking pieces at the same time. For example, a 3D printer can print a series of interlocking rings without the need for any break in the metal or joint to link the rings, since they were constructed that way. Continue reading

September 15, 2015

Eliquis Sales Linked to Company Future

by Jeffrey S. Glassman

New Oral Anticoagulants (NOACs) are big money for drug companies and marketing partners pushing four different medications currently on the market. One of the four drugs is Eliquis, manufactured by Bristol-Myers Squibb (BMS), and, according to recent article from Forbes, the drugmaker has a lot riding on Eliquis sales.

Specifically, Forbes estimates that around a quarter of BMS’s total value is directly tied to Eliquis. In other words, the future of Eliquis can make or break the economic viability of the company. Continue reading

September 9, 2015

IVC Filter Safety Questioned by NBC News Investigation

by Jeffrey S. Glassman

NBC Nightly News recently aired a report that has raised significant questions regarding the safety of a medical device known as an IVC filter. Specifically, the Recovery IVC filters made by BARD have been connected to at least 300 adverse events, including 27 deaths.

The report was just the first in a series the station plans to air in the coming days on these medical devices, which are implanted in thousands of Americans to reduce the risk of blood clots. It’s a 1.5-inch piece of metal that is inserted into the vena cava, a major vein, and has the ability to block blood clots from traveling to the heart or the lungs, where they have the potential to be fatal.

Journalists disclosed a 2004 confidential study commissioned by the maker of the product, C.R. Bard, in which it reveals this particular product had a higher rate of injury and fatalities when compared to those who used competitor product. These devices appear to be perforating, migrating, breaking or, in some cases, actually causing clogs rather than preventing clots. Despite this, Bard, a multinational product manufacturer, did not recall its product.

Despite the fact that researchers who conducted the study clearly stated further investigation of this matter was “urgently warranted.” Continue reading

September 7, 2015

House Committee Investigating Safety of Warfarin

by Jeffrey S. Glassman

For decades, Warfarin (Coumadin) has been the gold standard drug for atrial fibrillation (Afib) patients to avoid being at a higher risk for stroke and other potentially deadly medical conditions like a pulmonary embolism (PE).

While Warfarin is considered relatively safe, it does require patients to have frequent monitoring by their physicians to make sure the dosage is correct. This means the patients need to regularly have blood taken to determine how the blood thinner is working. If the dosage is off, it can result in serious medical conditions, including bleeding disorders. While this is a risk, with proper monitoring, it should not occur, and, if it does occur, doctors can often reverse the effects of the drug. Continue reading

September 3, 2015

Eliquis Maker Claims it is Safer than Xarelto in Terms of Major Bleeding Rates

by Jeffrey S. Glassman

Eliquis, manufactured by Bristol-Myers Squibb (BMS) and Pfizer, is now claiming its new oral anticoagulant (NOAC) is safer than other NOACs (Xarelto, Pradaxa, and Savaysa), according to a recent news article from Medpage Today.

Based upon a recent study, paid for by BMS and Pfizer, their drug, Eliquis, was shown to cause less major bleeding cases in patients with non-valvular atrial fibrillation (Afib) that patients taking Pradaxa, or Xarelto. Savaysa was not specifically included in this study because the United States Food and Drug Administration (FDA) only recently approved it for sale on the market. Continue reading

August 31, 2015

Xarelto and Eliquis Makers Fighting for Market Share Despite Safety Risks

by Jeffrey S. Glassman

Xarelto, Eliquis, Pradaxa, and the newly-marketed Savaysa are all members of a class of drugs known as New Oral Anticoagulants (NOACs). They are all advertised as a safer and easier to use alternative to Warfarin (Coumadin), which has been the long-standing drug prescribed to patients who suffer from an irregular heartbeat condition known as atrial fibrillation (Afib).

Afib patients require either a blood thinner like Warfarin or an oral anticoagulant like Xarelto to decrease the risk they will develop a serious clotting disorder. If patient develops clots deep within the veins of his or her legs, which is known as deep vein thrombosis (DVT), the clots can break loose and travel to the lungs, where they can puncture the tissue, causing a potentially deadly condition known as pulmonary embolism (PE). The clots can also block blood flow to the brain, which results in a stroke. Continue reading