Risky Pharmaceuticals and Medical Devices

RISPERDAL®

RISPERDAL

Risperdal®, an “atypical antipsychotic” medication indicated for the treatment of autism, bipolar disease and schizophrenia, has been pushed by its manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, for a variety of unapproved uses. Sadly, that marketing effort has included targeting children for the treatment of mood and sleep disorders as well as attention deficit disorder. As a result of their off-label promotion, Johnson & Johnson has been forced to pay $2.2 billion in fines to state and federal agencies.

The real victims of Johnson & Johnson’s conduct – the children – have yet to be compensated. In some users, Risperdal® causes the pituitary gland to increase its production of prolactin. Prolactin causes the development of breasts. For male children, the development of breasts (known as gynecomastia) can be devastating physically and psychologically. Unfortunately, the condition is permanent with many having to resort to surgery as the only means of correction.

If you took Risperdal® as a child, or have a male child who took Risperdal®, and subsequently developed breasts or were diagnosed with gynecomastia, you may have a valuable legal claim. Contact us today for more information about your legal rights.

TESTOSTERONE TREATMENTS

TESTOSTERONE TREATMENTS

A study released in January 2014 found that the use of testosterone supplements doubles the risk of heart
attack and ischemic stroke in men over 65 and men under 65 with a history of heart disease. This study is just the latest in a series of studies finding an association between the use of testosterone supplement and serious cardiovascular injuries including heart attack, stroke, and death.

Testosterone supplements are one of the fastest growing prescription medications in the United States. Sales in 2013 topped two billion dollars. While they were originally marketed for the treatment of serious medical conditions that can result from an imbalance in natural hormone production, testosterone supplements are now being heavily promoted as “lifestyle” drugs designed to increase male energy, stamina, strength and sex drive.

While the science on whether the testosterone supplements really help men achieve these results is inconclusive, the science regarding the increased risk of cardiovascular injury testosterone users face is growing. As a result, on January 31, 2014, the FDA announced it was officially “investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.”

Testosterone supplements are sold under names which include Androgel®, Axiron®, AndroDerm®, Foresta®, Bio-T Gel®, Delastestryl®, and Testim®. The testosterone products are commonly delivered in a roll-on or spray gel but are sometimes applied by removable patch or given through injection. Critically, the testosterone products do not contain any warnings regarding the increased risk of heart attack, stroke and/or death that their users face.

If you or a loved one have used a testosterone supplement and suffered a heart attack, stroke, or death, you may have a valuable legal claim. Contact us today for a free consultation.

IVC FILTER

IVC FILTER

An IVC Filter is frequently provided to patients at risk of developing blood clots who are not able to take anticoagulation therapy. IVC filters are small, cage-like devices inserted into the main vessel returning blood from the lower half of the body to the heart. The device is designed to capture blood clots and prevent them from reaching the lungs.

Unfortunately, some of these filters are defective, causing serious injuries and even death. Since 2005, the FDA has received more than 900 adverse event reports involving IVC filters. The adverse events include incidents of device migration, detachment of device components, perforation of the IVC, and filter fracture. There are also reports of the filters becoming lodged in the blood vessel wall making removal risky or sometimes impossible.

Very recently, settlement discussions with the manufacturer of the IVC filter have started. If you or a loved one have been implanted with an IVC filter and suffered injury as a result, don’t miss the opportunity to have your case included in a settlement. Contact us today for a free consultation.

INFUSE®

INFUSE BONE GRAFT

In 2002, the Food and Drug Administration (FDA) approved the use of INFUSE® Bone Graft (also known as rhBMP or rhBMP-2) for use in single level lumbar spine fusion. INFUSE® Bone Graft (rhBMP-2) is a bioengineered liquid bone protein that promotes bone growth. Historically, bone grafts have come from bone harvested from the patient’s hip, a cadaver, or the like.

After approval, the INFUSE® manufacturer, Medtronic, Inc., launched an extremely aggressive marketing campaign, pushing surgeons to use its product for all sorts of unapproved surgeries. With the unapproved surgeries came a host of adverse effects in patients (depending on the site of the surgery) including: swelling in the neck, blockage and compression of the patient’s airways, significant nerve damage to the lower extremities, dysphagia, male sterility, osteolysis, and the risk of cage migration.

In June of 2011, Congress began looking into allegations that orthopedic surgeons with financial links to Medtronic may not have reported complications during their clinical trials of INFUSE® Bone Graft. In October 2012, the U.S. Senate Committee on Finance issued its report on Medtronic’s influence on INFUSE® clinical studies. The Committee found that Medtronic officials had paid $210 million to physician authors to influence the content of articles published in scientific journals.

If you or a loved one has developed serious health problems following spine surgery involving the use of INFUSE® Bone Graft (rhBMP-2), contact us today for a free consultation.

ACTOS®

ACTOS

Actos®, also called pioglitazone, was marketed to treat those suffering from symptoms of type 2 diabetes. Unfortunately, Actos® has been linked to an increased risk of bladder cancer, with increasing risk at higher doses, and longer duration of use. Takeda Pharmaceuticals, the manufacturer of Actos®, has benefited from flashy marketing and claims that it is safer than other diabetes treatments to the tune of $5 billion in U.S. sales in 2010.

The FDA informed the public in June 2011 of the increased bladder cancer risk. The warning came after the FDA reviewed data from the published five-year results of an ongoing series of epidemiological studies. The FDA then approved labeling changes for Actos® and other drugs containing pioglitazone warning about the risk of bladder cancer, and its common symptom of blood in the urine (hematuria) for the first time.

If you or a loved one has been diagnosed with bladder cancer after ingesting Actos®, please contact us today for a free consultation.

Diabetes drugs in the class known as incretin mimetics, including Byetta®, Januvia® and Victoza®, have been linked to cases of severe pancreatitis, and more recently cases of pancreatic cancer. Studies have revealed that users of these drugs have a greater risk of developing one of these serious conditions than users receiving a
placebo. Unfortunately, pancreatic cancer has one of the highest cancer mortality rates.

A number of lawsuits for Byetta®, Januvia® and/or Victoza® users suffering from severe pancreatitis and/or pancreatic cancer have been filed around the country. Recently, the Judicial Panel for Multi-District Litigation has consolidated cases for pre-trial purposes before a federal district court in San Diego, California.

If you or a loved one developed pancreatic cancer and ingested any of the incretin mimetic drugs, Byetta® (also thyroid cancer), Januvia® or Victoza®, our firm can help. Please call us today for more information about your potentially valuable legal claim.

Lipitor®, the cholesterol lowering drug manufactured by Pfizer, is the most-prescribed medicine in history. But several studies now indicate that it is linked to an increased risk of diabetes, particularly in women. A Women’s Health Initiative study published on January 23, 2012, found a nearly 50% increase in new onset diabetes for menopausal women with statins compared with a placebo. Subsequent studies have found that the risk of diabetes is higher with Lipitor than with other statin (cholesterol lowering) drugs.

In 2012, the FDA required the manufacturer of Lipitor® to change its label to disclose the risk of developing diabetes following the use of Lipitor®.

Despite living healthy and active lifestyles, many women have developed type 2 diabetes after beginning Lipitor® treatment. As a result of developing diabetes, female patients across the country find themselves undergoing regular testing of blood glucose levels, adhering to a restrictive diabetic diet and taking medication to control diabetes.

If you or a loved one developed diabetes after beginning Lipitor® therapy, Contact us today for a free consultation.

PRADAXA®

PRADAXA

Manufacturer Boehringer Ingelheim pushed Pradaxa® as an alternative to the blood thinner Coumadin® (Warfarin) but failed to adequately warn about the risk of potentially deadly bleeding associated with its use. The possibility of serious bleeding events with no known antidote, such as the use of Vitamin K in Coumadin® patients, was not made known to patients or their physicians. The uncontrollable bleeding associated with the use of Pradaxa® can occur in the brain, intestines or internal organs and can lead to lengthy hospital stays or even death.

For more information about the Pradaxa® litigation, Contact us today for a free consultation.

Metal on metal hip replacement systems became very popular beginning in the mid to late 2000’s after being marketed as better for an active lifestyle and having a longer life-span. Not long afterwards, our firm began receiving calls from patients around the country suffering from metallosis or cobaltism. These conditions are caused by wear and/or corrosion between the metal surfaces of the hip replacement devices, sending tiny metal particles into the blood stream. This phenomenon received a lot of media attention in connection with the DePuy Orthopedics ASR™ hip system.

Metallosis, however, is not limited to the ASR™ and our investigation and active litigation now includes claims relating to the following manufacturers’ devices:

Biomet
(M2a 38™ mm and Magnum™ Devices)

DePuy
(ASR™ and Pinnacle®)

Stryker®
(Rejuvenate and ABG II)*

Wright
(Conserve® and Profemur®**)

Zimmer®
(Durom® cup***; M/L and Versys® stems)

* The Stryker® claims arise out of corrosion from the modular neck, not from metal on metal wear. The results, however, are the same – metal toxicity which destroys
tissue and causes pseudotumor formations.

** The Wright ProFemur® claims relate to femoral neck fractures due to weak metals joining the ball and stem causing catastrophic fracture and revision surgery.

*** The Durom® cup claims relate to loose cup/shells due to non-infection related failure of the cup which prevents the patient’s bone to gain boney ingrowth and fixation.

Metallosis Alert

As noted above, metallosis is caused by early wear between the metal ball and metal cup/liner or debris from the metal neck of the femoral stem. This early wear results in the release of metal debris into the hip fluid causing elevations of Cobalt (Co) and Chromium (Cr) ions leading to adverse soft tissue reactions, including pseudotumours and death of surrounding tissues. There may be a long delay from implant of the artificial hip to the onset of metallosis. Signs and symptoms of cobalt/chromium poisoning may include visual impairment, auditory impairment, cognitive impairment, cardiomyopathy, hypothyroidism, peripheral neuropathy, and rashes. Moreover, there are ongoing investigations into the association between metallosis and other dangerous conditions such as kidney failure and bladder cancer. Unfortunately, most patients with metallosis do not have any identifiable symptoms that alert them to this dangerous and potentially life threatening process. Fortunately, a simple blood test can detect metal levels in the body. If you have not already done so, we strongly suggest that you contact your healthcare provider and ask for a blood test to determine whether you have elevated cobalt or chromium levels in your blood – even if your hip system was already replaced. Any medical provider can order a blood test for you. However, the order must specify that the test or panel is to include heavy metal testing (chromium and cobalt).

Hip Litigation History

In 2000, the hip manufacturer Sulzer Orthopedics, Inc. recalled thousands of its Inter-Op hips due to defects in its manufacturing processes. This marked the first large scale hip related national products liability case. In 2007, a similar manufacturing defect was identified relating to Stryker® Orthopedic’s Trident hemispherical and PSL cups.

VOLUVEN

VOLUVEN

When a patient is admitted to an intensive care unit (ICU) following an injury that includes severe blood loss, doctors often use an intravenous solution to increase blood volume and reduce the chance that the patient will go into shock. Doctors have a choice of multiple solutions for this purpose.

One of those solutions, known as HES, has been found to pose such a great risk of death or severe kidney injury that the FDA has put out a warning that Hydroxyethyl starch (HES/HAES) should no longer be used for this purpose, at least not with critically ill adult patients, including patients with sepsis and those admitted to the ICU.

Further, as of June 2013, the FDA is now requiring that these products contain a “black box” warning regarding the risk of death and severe kidney injury – the FDA’s strongest warning.

HES is sold under the trade names Hespan®, by B. Braun Medical Inc. and Voluven® or Volulyte®, by Fresenius Kabi. Both manufacturers were ordered to recall all HES solutions within 48 hours in the United Kingdom on June 27, 2013.

If you or a loved one received an HES IV solution for treatment of blood loss and suffered kidney failure as a result, Contact us today for a free consultation.

Mesh products sold to women to treat pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI), pose significant undisclosed risks and, in some cases, cause devastating injuries. Jury trials in the first three transvaginal mesh cases have resulted in verdicts for the plaintiffs with awards of $5,500,000, $11,100,000, and
$2,000,000, respectively.

If you or a loved one has been suffering in silence from the ill effects of transvaginal mesh, it is time for the silence to end. Transvaginal mesh causes symptoms including pain (localized radiating into lower back or extremities, and/or during urination/intercourse), infection, erosion, and in many cases, the need for corrective surgeries. Unfortunately, for some women these symptoms are permanent. Some victims develop problems shortly after implantation while others may go years before experiencing complications.

The time to make a claim against the manufacturers of transvaginal mesh is now. Contact us if you believe you have been injured as a result of a transvaginal mesh implant even if you have not yet had a revision/removal surgery.

ANTIDEPRESSANTS

ANTIDEPRESSANTS

Selective serotonin and norepinephrine reuptake inhibitor (SSRI & SNRI) drugs such as Zoloft®, Effexor® Prozac®, Paxil®, Topamax® and Celexa®/Lexapro® are the most widely prescribed drugs for depression; millions of women take them during pregnancy. However, recent studies show that these drugs are linked to a potentially increased risk of serious birth defects in children, ranging from skull defects to cleft lip/palate to life threatening heart defects.

Anti-seizure medications such as Topamax® and Depakote® have also been linked to serious birth defects. In particular, Topamax® has been linked to cleft lip/palate and Depokote® has been linked to neural tube defects such as spina bifida.

If you were taking any of these medications while pregnant, there is a possibility that your child’s birth defect was caused by the drug – even if you stopped taking it once you found out you were pregnant. If you or a loved one took SSRI, SNRI and/or seizure medications while pregnant and had a child with a birth defect, you should contact us immediately.

Thousands of women across the country have suffered injuries after being implanted with the Mirena® intrauterine contraceptive device (IUD). In many women, the device migrated or perforated the uterine lining, forcing early removal and, in some cases, damaging other organs. Migration of the device into other parts of the body or perforation of the uterus can have very serious side effects, some of which can be life-threatening.

The Mirena® IUD device is intended to provide contraceptive protection for up to five years after implantation and is manufactured by Bayer Healthcare Pharmaceuticals, Inc., a German corporation. The Mirena® IUD was first approved by the FDA in 2000 and is recommended for birth-control in women who have already had at least one child. Later, in 2009, the device was also approved to treat some women with heavy menstrual bleeding, which was the first time that a medical device of this nature had been approved for that use. On January 14, 2010, Bayer received an FDA warning for improperly sending sales representatives to consumers’ homes to misstate the efficacy and safety of the Mirena® IUD device.

DaVINCI® ROBOTIC SURGERY

DaVINCI ROBOTIC SURGERY

Intuitive Surgical, the embattled manufacturer of the da Vinci® robotic surgical system, warned customers on May 8, 2013, that certain versions of its cautery scissors may develop microcracks that could leak electrical energy and inadvertently burn tissue. The instrument in question, EndoWrist® Hot Shears™ Monopolar Curved Scissors, is used to cut and coagulate tissue in a wide variety of procedures, including hysterectomy, prostatectomy, abdominal sacral colpopexy (bladder prolapse surgery) and gastric bypass. The scissors and other EndoWrist® instruments are made exclusively for use with the da Vinci® Surgical System, consisting of a console from which a surgeon manipulates instruments attached to robotic arms while viewing the procedure in 3 dimensions. Some 2000 systems are installed at US hospitals.

In its “urgent medical device notification”, Intuitive Surgical stated that “certain -09 and -10 versions” of the scissors may develop energy-leaking microcracks near the distal end of the shaft after the instruments are cleaned and sterilized. “These microcracks may not be visible to the user,” the company emphasized. It advised customers to take precautions to minimize the risk for inadvertent burns, such as not applying electrical energy when the instrument tip is not in direct contact with tissue and taking note of any anatomy touching the instrument shaft or wrist.

If you or a loved one has had a surgical procedure wherein the da Vinci® robotic system was used and have suffered a negative outcome, please call our firm to discuss the possibility of making a claim against Intuitive Surgical.

Eye Drop Treatments – Consumer Alert!

Eye Drop Treatments

Certain manufacturers of glaucoma eye drop treatments have designed their droppers to deliver more medicine than the eye can absorb. The resulting waste (more than 50%) of these expensive treatments could be costing our clients thousands of dollars per year.

If you or a loved one have used eye drop glaucoma medications such as Alphagan®, Alphagan®P, Azopt®, Betagan®, Betoptic®, Betoptic®S, Combigan®, Cosopt®, Dorzolamide, Istalol®, Lumigan®, Timolol, Timolol GFS, Travatan®, Travatan®Z, Trusopt® or Xalatan®, please call us right away for more information.

We are also investigating the practice of manufacturers that make eye drops used to treat infection or to aid surgical recovery. Users find that when they take all the medicine their doctor prescribed, they have a lot left over due to companies’ practices of overfilling the bottles.

The products in which we believe this overfilling occurs include:

Acular®
Acular® LS
Acuvail®
Besivance®
Lotemax®
oxeza®
Nevanac®
Vigamox®
Zymar®
Zymaxid™

If you or a loved one has a prescription for any of these products, contact us today for a free consultation.