Product Liability Lawyer Blog

March 10, 2015

Boehringer Ingelheim Files for FDA Approval for Pradaxa Antidote

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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February 19, 2015

McClellan v. I-Flow Corp. – Pain Pump Litigation to Continue

by Jeffrey S. Glassman

In recent years, product liability lawyers have seen a growing number of injuries filed by individuals who developed severe cartilage damage in their shoulders following minimally invasive surgery.

The suspected culprit is a type of shoulder “pain pump” used to deliver medication directly into the joint after surgical joint procedures. Usually, the device is filled with various pain medications, and the idea is to deliver the medication quickly and directly to the site of surgery.

Problematically, this procedure has been linked to the development of a debilitating condition known as chondrolysis. This means there is virtually no cartilage between the bones, and joints can become fused and completely immobile. Usually, by the time the condition is discovered and diagnosed, there is no treatment or cure. The condition is typically discovered between three and 12 months after surgery.
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February 17, 2015

Boston Toy Injuries: 40 Percent Increase in 22 Years

by Jeffrey S. Glassman

The number of toy-related injuries in the U.S. has spiked by a stunning 40 percent over the past 25 years, and researchers say that’s likely a low-ball estimate.

According to a new study published by the journal Clinical Pediatrics, over 3 million children were treated in hospital emergency departments between 1990 and 2011. But what’s especially troubling is the fact the rate at which injuries occurred increased steadily during that time.

Today, a child is treated in a hospital emergency room every three minutes for a toy-related injury. Of those, more than half are younger than the age of six.
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February 15, 2015

2014 Had Highest Auto Recall Numbers in U.S. History

by Jeffrey S. Glassman

With the recent announcement by the National Highway Traffic Safety Administration that another 2.1 million vehicles are recalled due to faulty crash sensors that could result in sudden and unnecessary airbag deployment, we see a continuation of what was an especially awful year for the auto industry – and consumers.

Reports are that 2014 was a record year for auto recalls in the U.S., with 60 million vehicles recalled between Jan. 1 and Dec. 30. That is more than twice as many as the previous annual record number of recalls, which was set in 2004.

With a total of 700 vehicle recall announcements last year, it averaged out to about two every day, with one in five vehicles on the road affected.
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