Harmful Prescription Drugs and Defective Medical Devices
When a doctor prescribes medication or the need for a medical device, we trust it will be safe and effective. We presume the drug or device has been thoroughly tested and wouldn’t be on the market if it put us at risk. It’s the job of the U.S. Food and Drug Administration to govern the pharmaceutical industry and in turn ensure consumers’ safety. But the reality is that there are thousands of cases in which defective drugs and medical devices have caused serious harm or even death. In many of these cases, the pharmaceutical company has been proven negligent due to:
- Failure to adequately test product
- Occurrence of unsuspected side effects
- Inaccurate labeling information
- Manufacturing error
The attorneys of Kitrick, Lewis & Harris are experienced at handling defective drug and medical device cases. We can ensure your rights are protected and you receive fair compensation for any harm you have suffered.
Fentanyl is widely used in patch form to control chronic aches and pains. The fentanyl patch was originally marketed under the name of the “Duragesic Patch” manufactured by Johnson & Johnson subsidiaries, the Alza Corporation and Janssen Pharmaceutica. Other brands of Fentanyl patches include Sandoz (an Alza Product), Mylan and Watson.
On Tuesday, February 12, 2008 Johnson and Johnson recalled 32 million patches because of a defect that could possibly cause leakage and severe injury or death.
Less than a week later (February 18, 2008), a major pharmaceutical manufacturer, Actavis Inc., recalled several lots of a transdermal patch that contains the powerful pain medication known as Fentanyl. These patches were marketed in the United States with labels as “Abrika” or “Actavis.”
Fentanyl Patch Defects
The FDA has investigated reports of problems associated with these patches over the years, including a defect known as the “stringer leaker” defect. These fentanyl patches have been shown to have several potential defects including a fold over defect that can cause leakage and expose the patient, as well as caregivers, nurses, and medical doctors and professionals directly to the gel form of fentanyl. This can lead to serious side effects including overdose, respiratory distress, and in some cases wrongful death. Several hundred deaths related to a lethal dose from fentanyl patches have been reported to the FDA. In most of these cases, patients are receiving extremely high doses of the drug without even realizing it. There is virtually no forewarning before a patient dies due to the effects of a fentanyl overdose.
Inferior Vena Cava (IVC) Filters
Inferior vena cava (IVC) filters are surgical implants that resemble a metal cage and are inserted into the vein that takes blood back to the heart and lungs (the inferior vena cava). The IVC is supposed to prevent fatal blood clots from travelling to the lungs after accidents and surgeries when the risk of developing clots is increased. They are more commonly used in people who can’t take blood thinners.
These devices can be life saving, but some are less effective than others and can create severe and even deadly complications. Filters have been known to come loose, moving away from the insertion site. Then the IVC is ineffective, or it can even puncture veins and causing bleeding and other complications, including:
- Heart and lung Injury
- Wrongful death
- Pain and suffering
The FDA has issued a statement recommending “implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.”
Which IVC Filters are more prone to failure?
Studies show that the following IVC filters are more prone to failure than others:
- Bard’s Recovery
- Bard’s G2
- Bard’s G2 Express
- Cook’s Gunther Tulip
- Cook’s Celect
Testosterone Replacement Therapy (TRT)
The findings of an observational study prompted the U.S. Food and Drug Administration to reassess the safety of testosterone products, a steroidal hormone which has been heavily promoted and has become increasingly popular in recent years. This study found that there was an increased risk of heart attack in the first 90 days following testosterone treatment for men over the age of 65 and in younger men with pre-existing heart disease.
This is on the heels of a November 2013 study, published in the Journal of the American Medical Association, which found a link between testosterone therapy and an increased rate of heart attack, stroke and death. The research focused on a group of 9,000 male veterans. The average age of the participants was 60, and they all had undergone coronary angiography and had low testosterone levels. About 15% of them started testosterone therapy; 26% of that group had a heart attack or a stroke or died from another cause within about three years. Comparing this rate to that of the group not on testosterone therapy, the researchers concluded that those on such medications have a 30% higher risk of serious, even deadly, heart issues.
We’ve all seen the television commercials: A man is distressed because he’s “not the man he used to be,” but through the miracles of modern medicine his youthful vigor is returned and he’s once again able to attract and please beautiful women. The pharmaceutical companies promise to rectify “Low T” through testosterone therapy; that message comes through loud and clear. What you may not be aware of are the warnings that such medications can have serious side effects and consequences.
We anticipate that more research will be conducted, no doubt funded in part by pharmaceutical companies hoping that the data can be refuted. It’s no wonder: Prescriptions for Low-T therapy have more than doubled since 2006, with 5.3 million prescriptions for testosterone being written in the United States in 2011. Already, estimates are that 13.8 million American men experience the effects of declining levels of testosterone; our aging population is likely to provide a ready market for hormone replacement – in fact, pharmaceutical companies are counting on it.
Testosterone is the predominant male sex hormone, responsible for sexual maturation and function as well as for muscle and bone growth. The failure of the testes to produce an adequate level of testosterone is called hypogonadism. Not all cases of Low-T, however, are the result of this kind of medical condition. A decrease in testosterone level is also a natural function of aging. The Mayo Clinic advises that for each year over age 30, a man’s testosterone level can be expected to drop by about 1 percent.
The Uses of Testosterone Replacement Therapy (TRT)
Men with lower than normal testosterone levels typically experience one or more of the following symptoms:
- Lack of libido (low interest in sex)
- Muscle weakness
- Erectile dysfunction (ED)
- Weight gain around the waist
- Reduction in bone density
Testosterone treatments can combat these issues, but they’re not without risks.
As the VA study showed, potentially serious risks may be linked to testosterone therapy, including heart attack, stroke, and death. Other risks are enlarged prostate or breasts, blood clots, sleep apnea, liver disease, high cholesterol, and blocked arteries.
Testosterone replacement therapy (TRT) can be administered orally, by injection, or in a patch or topical gel to be absorbed through the skin.
Oral testosterone is sold under the brand names Android, Androxy and Testred.
Intramuscular injection products are Depo-Testosterone, Andro LA 200, Delatestryl, Depandro 100, Testosterone Cypionate, and Testosterone Enanthate.
Transdermal (patch or gel) testosterone products include AndroGel, Fortesta, Testim, Androderm, Axiron, Testoderm, and Fortesta.
Striant is a product that is placed between the cheek and gum for absorption.
Trasylol is the brand name for a drug called aprotinin. Bayer developed and marketed Trasylol as an anti-fibrinolytic, which is essentially a drug used to reduce bleeding during complicated surgeries such as transplants and heart surgery. Like other anti-fibrinolytics, Trasylol decreases organ damage during surgery due to low blood pressure and reduces a patient’s need for blood transfusions. However, in 2007, the Food and Drug Administration (FDA) and Bayer recalled Trasylol due to potentially fatal side effects. If you or someone in your family has suffered an injury due to Trasylol, you may be able to seek compensation for your injuries through a product liability lawsuit. However, going up against pharmaceutical giants in court is not easy.
Trasylol Side Effects
The FDA and other organizations performed many different studies on Trasylol and found a number of serious side effects, including:
- Acute kidney failure
- Myocardial infarction (heart attack)
- Encephalopathy (global brain damage)
- Heart failure
Any one of these side effects can be deadly. Some studies conducted in 2008 indicate that mortality for patients receiving Trasylol is increased by somewhere between 32% and 64% when compared to patients receiving other anti-fibrinolytics. The FDA has since completely barred Trasylol for patient treatment.
An announcement from the FDA on July 13, 2011 confirms that manufacturers of surgical mesh to repair pelvic organ prolapse (POP) have put many women at great risk of serious injury because the surgical mesh products can cause unnecessary erosion, pain, urinary problems and other complications. Companies marketing these dangerous products include Bard, Tyco, and Mentor.
The FDA is alerting doctors and the public that the vaginal surgical mesh products, also known as TVM or transvaginal mesh, provide no benefits to justify the serious, unnecessary risks and problems the mesh creates. The FDA’s warning is especially troubling for patients, because other, safer, products have long been available to treat the same conditions for which the surgical mesh is marketed.
The FDA convened a panel of experts to consider just how serious the problems are and what steps must be taken to protect the public from the dangers of these surgical mesh implants when used to treat POP and stress urinary incontinence (SUI). The panel of obstetrics and gynecology experts will meet in September.
In addition to Bard, Tyco, and Mentor, plaintiffs’ lawyers are also investigating Ethicon, AMS, and Boston Scientific, to determine if they sold surgical mesh products with insufficient warnings or defective designs.