Product Liability Lawyer Blog

March 14, 2015

Lawsuits for Transvaginal Mesh Injuries Move Forward

In the greater Boston area and across the United States, women have been filing lawsuits against makers of defective transvaginal mesh (TVM) medical devices in large numbers.

According to a recent news article from WBUR, there has been no slowdown of victims coming forward to file cases. Transvaginal mesh implants are used to support sagging pelvic organs and hold them in place. They have been market as a way for women with bladder control issues and other pelvic issues to lead a normal life again, but this is not how it worked out for many victims.

Defectively designed tranvaginal mesh implants have led to serious, painful and often embarrassing medical conditions known as pelvic organ prolapse (POP) and stress urinary incontinence. To make matters worse, doctors have found removing a defective transvaginal mesh implant may not help to fix the damage, because much of it was due to erosion of the vaginal wall while the device was implanted.
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March 13, 2015

RomneyCare Increases Hip and Knee Replacements in Massachusetts

by Jeffrey S. Glassman

According to a recent report from the Boston Business Journal, total knee replacement and hip replacement numbers are on the rise across the Commonwealth of Massachusetts due in large part to the government health program better known as “RomneyCare.”

With more people having access to better healthcare coverage, researchers have found almost a 5 percent increase in total joint replacement procedures throughout the Commonwealth of Massachusetts since 2006, when the state legislature enacted the healthcare reform program.

Among ethnic demographics, the greatest increase was seen in black and Hispanic patients, who historically had the least access to healthcare in the greater Boston area. Researchers believe there was always a demand for total joint replacement procedures among these patients, but they lacked access to health insurance necessary to the cover the high costs of surgery and recovery.
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March 11, 2015

Total Knee Replacement Alternatives: Artificial Cartilage

by Jeffrey S. Glassman

Total knee replacement surgery involves a surgeon removing a patient’s deteriorating natural knee, cutting bone and tissues, and implanting an artificial knee. This is a highly invasive surgery with a considerably lengthy and painful recovery, even if everything goes according to plan.

Traditionally, total knee replacement was largely reserved for the elderly and those suffering a serious, debilitating knee injury. One of the reasons for avoiding total knee replacement on younger patients is most artificial knees have a useful life of around 10 years. When an artificial knee is implanted into a person who is expected to far outlive the artificial knee, the new knee will eventually break down, cause a patient pain, and require a second surgery to replace it with a newer model artificial knee. Again, this is when everything goes correctly.
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March 10, 2015

Boehringer Ingelheim Files for FDA Approval for Pradaxa Antidote

by Jeffrey S. Glassman

Pradaxa is an oral anticoagulant similar to Xarelto and Eliquis, which has been prescribed to patients with a serious medical condition known as atrial fibrillation (Afib) as an alternative to Warfarin and other traditional blood thinning agents. Afib patients are higher risk for serious clotting disorders that can lead to stroke, heart disease, pulmonary embolism (PE), and other serious medical conditions.

Traditionally, doctors prescribed these patients Warfarin or even aspirin to thin the blood and help prevent issues. One major concern for Warfarin patients is that it requires constant monitoring and dosage changes to make sure a patient is taking the correct amount. There are also foods that can affect Warfarin absorption rates. Patients on Warfarin must have frequent blood tests, follow-up visits, and watch their diets closely to prevent problems, including serious bleeding disorders.

Drug companies marketed Pradaxa and its fellow class members as a safe and effective alternative that did not require constant monitoring. The problem, as we now know, is taking Pradaxa can lead to serious interal bleeding disorders, including intracranial bleeding. If a patient presents at the emergency room with an internal bleeding disorder due to a new oral anticoagulant (NAOC) such as Pradaxa, there is no FDA approved treatment, and many patients have died as a result.
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March 8, 2015

Testosterone Replacement Therapy: Risks and Benefits

by Jeffrey S. Glassman

Anyone who has ever watched a football game or a NASCAR race has probably seen his share of testosterone replacement therapy (TRT) advertisements. This is not an accident. Drug makers are spending millions of dollars on advertising testosterone hormone therapy (HRT) supplements to men of all ages.

Drug companies are working to convince men that weight gain, erectile dysfunction (ED), muscle fatigue, mild depression, tiredness and loss of sex drive are not just signs of getting older, as we all once believed. Rather these are all “symptoms” of having a low testosterone (low T) count.

Marketing divisions of drug companies want us to believe the lower your testosterone levels become, the more of these symptoms you will suffer, and, more importantly, taking hormone replacement therapy drugs will not only increase your testosterone level, but will reverse these negative effects, so you can feel and act younger again.
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March 5, 2015

Xarelto Makers Set Sights on Warfarin Despite Bleeding Risk

by Jeffrey S. Glassman

Xarelto, like Eliquis and Pradaxa, is a blood thinner known as a New Oral Anticoagulant (NOAC) or Factor Xa Inhibitor. Patients at risk for heart disease or with clotting disorders are often required to take an anticoagulant to prevent stroke and other serious medical conditions.

The traditional therapy used by millions of Americans is aspirin or Warfarin. While Warfarin is generally effective, patients must have frequent blood tests, so their doctors can closely monitor their dose. They must also watch their diets carefully and avoid foods that can change the rate of Warfarin absorption. If the dose if off even slightly, patients can have serious adverse events (side effects), and this is a problem on which Xarelto makers are trying to capitalize.
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March 3, 2015

Pradaxa Maker Cuts Workforce Due to Lawsuits and Decreased Sales

by Jeffrey S. Glassman

Pradaxa maker, Boehringer Ingelheim, has announced it will be reducing its workforce in New England as well as internationally as it faces defective products lawsuits and declining sales of its blood-thinning medication.

Pradaxa is a member of a class of drugs known as New Oral Anticoagulants (NOACs) that is marketed as being a safe, effective and convenient course of treatment for patients needing anticoagulants.

Patients who suffer from a heat condition known as atrial fibrillation (AFib) are common users of Warfarin, a traditional blood-thinning medication.

Drugs such as Warfarin will thin a patient’s blood to reduce risk of stroke and heart disease, but require constant monitoring of the dose. This is done by getting frequent blood tests and watching their diets. If the dose is off, Warfarin can lead to serious bleeding disorders, so patients and doctors must be ever vigilant to prevent this from occurring.
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February 28, 2015

Federal Judge Pushes Parties to Settle 70,000 Transvaginal Mesh Lawsuits

by Jeffrey S. Glassman

Many women who suffered from urinary incontinence and other medical conditions were told transvaginal mesh (TVM) could solve these problems. Essentially, doctors insert a medical device consisting of a surgical grade mesh, and a suspension system such as sling, into patients in an effort to provide additional support to the vaginal walls and pelvic floor.

Medical device companies advertised their products as being safe and effective at treating these conditions, and would have patients leading normal lives in virtually no time at all.

Unfortunately, many of these devices were defectively designed and not properly tested for efficacy and safety. The result has been many patients now suffer from painful medical conditions such as pelvic erosion, tissue destruction, pelvic organ prolapse (POP), and other serious issues.
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February 25, 2015

Sexual Dysfunction May Cause Low T, Rather Than Be Result of It

by Jeffrey S. Glassman

Of the many claims made by drug companies regarding testosterone replacement therapy (TRT) products is they can help patients with decreased sexual desire or performance caused by low testosterone levels.

While doctors do not know what a testosterone level should be in “normal” patients, and also do not know whether having a lower than average testosterone level is a medical problem for most adults, drug companies created the term “Low T” and push for use of testosterone replacement therapy drugs to fix what they consider a problem.

However, new research shows a decreased desire to have sex may actually cause lower testosterone levels rather than lower testosterone levels resulting in a decrease in one’s desire to have sex or erectile dysfunction (ED), according to a recent article from Scientific American.
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February 22, 2015

Unapproved Knee Replacement Device Used in Surgery

by Jeffrey S. Glassman

When we go to the doctor for a major surgical procedure such as a total knee replacement, we assume our doctor will use the latest devices and techniques. However, we also assume any equipment used will have been subject to clinical trials and approved by the United States Food and Drug Administration (FDA).

Unfortunately, according to a recent news article from the New York Times, things don’t always work out so well. One patient interviewed for a story was scheduled to undergo a total knee replacement procedure.

When a surgeon performs a total knee replacement, he or she relies on a medical device known as a cutting guide. Much like a carpenter’s jig, a surgical cutting guide is placed on the bone to be cut so the surgeon knows where to apply his or her bone saw. Cuts must be made in the precision location to increase the chances of a proper fit and alignment. If alignment is off, even slightly, patients can have a longer recovery, increased pain, decreased range of movement, and in worst cases, the artificial knee may fail and become loose or dislodged.
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