Pharmaceutical Liability - Hardball Personal Injury Lawyers near Baltimore, Maryland

VIAGRA®, the pharmaceutical drug used by men suffering from erectile dysfunction, is currently being investigated after claims that the product, and its competitors, Cialis® and LEVITRA®, may cause blindness.

VIAGRA® and other impotence drugs work by dilating the arteries to increase blood flow to the penis. However, new research shows that these products may also increase blood flow to the optic nerve which may lead to nonarteritic ischemic optic neuropathy (NAION), an eye disorder that can result in permanent vision loss. Pfizer, the manufacturer of VIAGRA®, denies that there is any link between the drug and blindness, but several eye specialists disagree.

VIAGRA® has been known to cause changes in color vision. However, ophthalmologist Dr. Howard Pomeranz was the first to make the connection between VIAGRA® and vision loss in 1998 after recognizing similarities among several patients that experienced vision loss within 36 hours of taking VIAGRA®. Each of these patients suffered from the same initial symptoms, blurred vision and some degree of vision loss, often in both eyes. Pomeranz has since published articles and documented his findings.

Claims Against Pfizer

Among those making claims against VIAGRA® is Jimmy Grant, who was featured on the May 26, 2005 CBS Evening News. Jimmy claims that within 45 minutes of taking VIAGRA® he experienced pressure in his temples and changes in color vision. Before long, Jimmy went blind in his right eye. He continued to take VIAGRA® every so often and eventually lost sight in his left eye. Jimmy, who is now blind, blames VIAGRA® for his vision loss and is suing Pfizer.

It is estimated that more than 23 million men have taken VIAGRA® since the Food and Drug Administration approved the product in 1998. Within that time, nearly 50 cases of blindness, occurring soon after a dose of VIAGRA®, have been reported. Whether or not VIAGRA® affects blood flow to the optic nerve is not yet known and a direct link between VIAGRA® and blindness has not been proven. One reason for this is that VIAGRA® users, those suffering from impotence, are typically men over 50 with diabetes, high blood pressure, or heart disease. Due to their health conditions these individuals are already at a higher risk for vision loss, which makes it more difficult to prove a direct link between VIAGRA® and blindness. Yet, with nearly 50 reports from men that went blind within hours of taking a normal dose of VIAGRA®, it may be a rare, yet potential side effect of the medication.

While it is unlikely that VIAGRA® and products like it will be removed from the market, the FDA may soon require a warning label to inform consumers of the drug's potential dangers. The makers of Cialis® have already taken action to include a warning in the product's insert. Pfizer is currently negotiating with the FDA to update their labels and warn consumers about the rare, yet potential risk of blindness associated with the drug.

If you or a loved one has suffered vision loss after taking VIAGRA® or another impotence drug, contact the law offices of Susan R. Green today. Our attorneys have extensive experience representing clients in pharmaceutical liability and can obtain the best possible results for your case.

Vioxx® and Bextra®

Vioxx® and Bextra® are both COX-2 inhibitor drugs that have been removed from the market due to an increased risk of serious negative side effects. If you or a loved one has suffered as a result of these or other pharmaceutical products, contact the law offices of Susan R. Green today.

Vioxx®

The FDA approved Vioxx® in 1999 to reduce pain and inflammation caused by osteoarthritis and other ailments. However, Merck & Co., the manufacturer of the drug, voluntarily removed Vioxx® from the market in September 2004 after a long-term study showed an increased risk of heart attacks and strokes among patients.

Vioxx® is a non-steroidal anti-inflammatory drug (NSAID), and is classified as a COX-2 inhibitor. Other older NSAID drugs such as ibuprofen and naproxen block both the COX-1 enzyme, which protects the stomach lining, and the COX-2 enzyme to reduce inflammation. Vioxx® is able to block only the COX-2 enzyme to reduce inflammation without stomach irritation. However, studies have shown that there is an increased risk of more serious side effects with Vioxx® than other NSAID drugs, including heart attack, stroke, blood clots, chest pain related to heart disease, and sudden death.

In studies, Vioxx® (rofecoxib) and an inactive placebo were administered to a total of over 48,000 patients. Results showed that patients taking Vioxx® had a higher rate of heart attacks each year than those taking the placebo. Of the patients taking the placebo, 0.52% had a heart attack each year, while 0.74% of patients taking Vioxx® had a heart attack each year.

Although the risk for an individual patient to suffer an adverse side effect such as a heart attack or stroke from Vioxx® is still low, patients taking Vioxx® have an increased risk as compared to those taking other NSAID drugs.

Vioxx® has been linked to heart attacks, blood clots, and strokes as well as stomach problems including internal bleeding that can start without warning or symptoms, kidney problems, kidney failure, liver problems, and severe allergic reactions that may cause swelling of the face, tongue, lips, and/or throat. If you or a loved one experienced any adverse side effects while taking Vioxx®, contact our attorneys in Maryland to find out if you are eligible for compensation.

Bextra®

Bextra®, another COX-2 inhibitor drug, received FDA approval in 2001. This prescription pain reliever, made by Pfizer, was removed from the market in April 2005 after studies showed that it increased the risk of heart attack and stroke. If you or a loved one has suffered as a result of Bextra®, you may be entitled to compensation from Pfizer.

According to a study involving 5,930 patients, some taking Bextra® and some taking an inactive placebo, the patients taking Bextra® were more than twice as likely to suffer heart attacks or stroke. Patients taking Bextra® were also found to be at a higher risk for blood clots.

Bextra® has been used to manage acute pain in adults including menstrual cramps and the symptoms of osteoarthritis and rheumatoid arthritis.

Pfizer denies that there are any problems with the drug, claiming that those who have suffered adverse side effects were already at a high-risk for heart disease. Pfizer claims that in studies involving 8,000 arthritis patients, no heart problems were discovered. However, on October 15, after studies were conducted in certain high-risk surgical settings, Pfizer warned doctors that Bextra® might increase the risk of heart attack or stroke in coronary bypass surgery patients.

If you or a loved one has suffered as a result of Bextra® or another COX-2 inhibitor drug, contact the law firm of Susan R. Green today for effective legal representation.

Guidant Pacemaker

Guidant Corporation is the manufacturer of several medical devices, including pacemakers and implantable cardioverter defibrillators (ICDs). In 2002, Guidant discovered a short circuit defect in some of their product models and proceeded to correct the malfunction. However, they failed to notify doctors that improved devices were available and continued to sell the defective equipment. With the price of a single device averaging $25,000, Guidant made quite a profit from these sales. In fact, in 2004 their defibrillator profits totaled $1.8 billion. Guidant has since begun to focus more on patient safety than profits.

Near the end of January 2006, Guidant sent letters to patients notifying them of several defective pacemaker models created between 1997 and 2000. These defective models have a faulty seal that may wear away over time, allowing moisture to enter the pacemaker case. As a result, patients can lose consciousness and potentially suffer heart failure.

If you or a loved one have a Guidant pacemaker or defibrillator, it is important to determine whether or not it is one of the defective models. Contact your doctor as soon as possible to find out which model you have. If you are affected by the recent safety measures, your doctor can tell you whether your device needs to be replaced or reprogrammed.

If you or a loved one does have a defective model, you may be eligible for compensation for damages including medical bills, pain and suffering, and loss of wages. Contact the lawyers at our Baltimore, Maryland area office today for optimal legal representation.

Risks Associated with Recalled Pacemakers

There are several risks associated with an additional surgical procedure to replace one of Guidant’s recalled pacemakers or defibrillators. Such risks include death, heart attack, stroke, electrical storm, puncture of lung or heart muscle, torn blood vessel, severe bruising or bleeding, air intrusion between the lungs and the chest wall, short circuiting, magnetic switch problems, and computer memory problems.

Other risks include chest pain; shortness of breath, prolonged hiccupping, or difficult breathing; fainting; palpitations; redness, warmth, tenderness, or swelling of the incision site; and liquid draining from the incision site accompanied by a fever.

The Guidant Corporation advises patients in possession of one of these devices to contact their doctor and determine whether or not they have a defective model. You should also contact your physician if you feel an electrical shock from the device or it begins making a beeping noise.

If you or a loved one has suffered due to a defective pacemaker model, our attorneys at the law offices of Susan R. Green can help you to obtain the compensation you are entitled for medical bills, loss of wages, and pain and suffering.

Ortho Evra® Patch

The Ortho Evra® Patch was introduced to the market in August 2002 as an alternative to oral contraceptives. At the time, the Food and Drug Administration (FDA) was aware that the risk of non-fatal blood clots was three times higher with the Patch than with the pill. However, the FDA has recently announced that the Ortho Evra® Patch exposes women to dangerously high levels of estrogen, increasing the risk for blood clots, heart attacks, and strokes.

In November 2005, the manufacturer of the Patch, Ortho-McNeil, sent out a warning to patients. According to the warning, the Ortho Evra® Patch exposes women to 60 percent more estrogen than oral contraceptives, putting patients at a higher risk for adverse side effects.

Four million women have used Ortho Evra® since it was first released. During this time, the FDA has received several reports of adverse side affects attributed to the Patch. In fact, in one 17 month period the FDA received 9,116 reports of patients suffering negative reactions from Ortho Evra®. ORTHO TRI CYCLEN®, a common oral contraceptive which has more than six times the number of users, only had 1,237 reports of adverse side effects within a six year period.

The first publicized report linking the Ortho Evra® Patch to a fatal blood clot occurred in April 2005 when a student in Manhattan collapsed in a subway station and died. The autopsy results showed that the cause of death was a blood clot in the lung, which the medical examiner attributed to the Ortho Evra® Patch.

The Patch has also been linked to 16 other deaths of American women between the ages of 17 and 30 that suffered from fatal heart attacks, blood clots, and possible strokes. A majority of Ortho Evra® users that have suffered adverse side effects from the contraceptive have been in their late teens or early twenties and were otherwise completely healthy.

Side effects associated with the Ortho Evra® Patch include:

If you or a loved one has been using the Ortho Evra® Patch and developed any of these symptoms, you may be eligible for compensation. Contact our attorneys in Maryland today for effective legal representation in your case.

Trasylol®

Aprotinin, marketed under the brand name, Trasylol®, is the only drug approved by the Food and Drug Administration (FDA) to reduce blood loss during heart surgery. Recently, the FDA issued a public health advisory warning that Trasylol® may significantly increase the risk of kidney failure, heart attack, heart failure, and stroke.

In an observational study involving over 4,000 patients that had heart surgery, some patients were given Trasylol® while others were given one of two generic drugs that served the same purpose, or no drugs at all. Patients taking Trasylol® were found to have an increased risk of side effects. The risk of kidney failure more than doubled, while the risk of stroke increased 181 percent, and the risk of heart failure or heart attack increased 55 percent.

Trasylol® is the only one of the three drugs to contain aprotinin, a protein. Since proteins are taken in by the kidney, it is possible that this could account for Trasylol®’s increased risk of kidney damage.

The results of this study are not definitive however, because doctors were given the choice of which drug to administer to each patient. Therefore, it is possible that patients given Trasylol® were in poorer condition than those being prescribed one of the generic drugs.

Trasylol® has been on the market since 1993 and its manufacturer, Bayer Healthcare, claims that the results of this study are not consistent with 15 years of clinical data.

The FDA is currently investigating the safety of Trasylol® to determine what, if any, further action needs to be taken. In the meantime, physicians have been alerted to consider the potential risks and benefits of this drug before administering it to their patients.

If Trasylol® was administered to your loved one during heart bypass surgery and they suffered an adverse side effect including kidney failure, heart failure, heart attack, or stroke, contact the law offices of Susan R. Green today for effective legal representation.