George & Farinas LLP
Asbestos & Mesothelioma

Personal Injury Attorney in Indiana

Drug & Medical Device Defects

George & Farinas, LLP represents individuals harmed by dangerous drugs or defective medical devices. We stand up for patient rights against medical industry giants who are the source of inadequate medical care, corporate wrongdoing, or hasty marketing campaigns for a medical drug or product. We advocate fiercely for those suffering from health problems, injury, or even death. George & Farinas, LLP is currently investigating cases for the following:

Testosterone Therapy Treatments

Contraceptives:

Drugs:

Knee & Hip Devices & Implants:

Testosterone Therapy Treatments

George & Farinas, LLP attorneys are currently investigating claims from men who have taken prescription testosterone therapy drugs and have suffered serious personal injuries including heart attacks and stroke.

In January 2014 the Food & Drug Administration announced it was launching an investigation into testosterone replacement therapy drugs to assess an increased risk for heart attack, stroke, and death.

This announcement came after the Journal of the American Medical Association and the Public Library of Science published findings indicating some men on testosterone therapy demonstrated a 30% increased risk for heart attack and stroke.

In 2011, more than 5 million prescriptions for testosterone were written in the United States according to news reports. Testosterone therapy is most often administered as a gel, patch, or injection. Popular prescription testosterone therapy drugs include:

  • AndroGel - Abbott Labs (AbbVie)
  • Axiron - Eli Lilly
  • Testim/Testopel - Auxilium Pharmaceuticals
  • Androderm - Actavis (formerly Watson Pharmaceuticals)
  • Android - Valeant Pharmaceuticals NA
  • Depo-Testerone - Pfizer Inc.
  • Fortesta - Endo Pharmaceuticals
  • Striant - Auxilium Pharmaceuticals

If you are currently undergoing treatments for low testosterone or testosterone therapy, discuss the increased risk of heart problems with your doctor. Do not stop taking any medication until you have discussed the risks and benefits of doing so with your doctor.

If you have questions about testosterone therapy treatments, please contact us TOLL FREE: at 1-888-277-0500, for a free, no hassle consultation to discuss your potential case. We want to help you understand the warnings and to understand your legal rights if you have been injured.

Potentially Dangerous Contraceptives

Women should be cautious when choosing birth control options. Certain contraceptives have been found to cause serious complications and injury. George & Farinas, LLP is investigating potential lawsuits involving women who have suffered serious injury or died while using the following contraceptives:

Mirena® (IUD)—Mirena is a hormonal intrauterine device (IUD) that serves as a long-term form of birth control. Some of the adverse side effects that have previously been associated with this device include pelvic inflammatory disease (PID), perforation of the uterus, higher risk of ectopic pregnancy, permanent loss of fertility, blood infections, and ovarian cysts, among other side effects.

NuvaRing® (vaginal ring)—Is a vaginal contraceptive medication linked to harmful side effects such as stroke, heart attack, blood clots, pulmonary embolism (blockage in the lungs) and vision problems. As of April, 2013, there were more than 1,000 lawsuits filed against Merck & Co., the maker of this device, for allegedly failing to properly warn the public of the risks of NuvaRing.

Yazmin® and Yaz® (pill) — A popular birth control pill manufactured by Bayer AG, women who took this oral contraceptive may be at risk of experiencing serious heart-related side effects, blood closs, deep vein thrombosis (DVT), pulmonary embolism, stroke, and even death. George & Farinas, LLP is investigating these cases involving women who are non-smokers but experienced adverse side effects possible cause by this oral contraceptive.


Potential Dangerous Drugs

Unsafe drugs and medical devices are potentially dangerous products that may kill or injure those who use them without proper warnings. Although most remain on the market for patient use, many of these drugs are the subject of FDA-mandated changes, industry warnings or voluntary recalls. If you or a loved one have suffered serious health problems, injury or even death caused by a drug or medical device, you may be entitled to recovery.

We are currently looking at cases for the defective drugs and medical devices:

Accutane®—Accutane is a drug for severe acne that has been linked to birth defects, Crohn's disease, suicide and various other harmful side effects. Accutane was taken off the market by manufacturer Hoffman-LaRoche in 2009 after published studies alleged the drug was tied to several incurable diseases. Accutane was also produced under other generic names. Reports estimate that approximately 13 million people were treated with the drug between the early 1980s and 2009.

Actos® — Actos is a medication prescribed for the treatment of Type II Diabetes. The FDA began reviewing studies of individuals who developed bladder cancer at an unusually high rate after taking Actos for a period of more than one year. In 2011 the FDA issued a warning based upon these studies that Actos may be linked to an increased risk of the development of bladder cancer for individuals using the drug for one year or more. Similar studies in France led to the suspended use of pioglitazone. Germany is considering doing the same. The FDA has recommended that physicians not use pioglitazone in patients with active bladder cancers or a history of bladder cancers and urged that the benefits of the drug must be weighed against these risk factors in such patients.

There is current litigation against the manufacturer of Actos, Takeda Pharmaceuticals, filed by people who developed bladder cancer after taking Actos for an extended period of time. When this drug was placed on the market, it is alleged that insufficient warnings existed to inform patients of these potential health risks and concerns.

If you or your loved one has been diagnosed with bladder cancer and has taken the drug Actos for a period of more than one year prior to the diagnosis, contact us today to discuss your rights.

Actos & Other Health Concerns:

In addition to bladder cancer, the drug Actos (pioglitazone) is in a family of drugs called thiazolidinediones which have also been linked to heart and liver diseases and disorders. These drugs have side-affects which may include congestive heart failure (CHF), rare but serious liver conditions, and bone fractures.

It is important to discuss these risk factors as well as the benefits of the medication with your prescribing doctor. Never stop taking prescribed medication without the direction of your physician. It is important that you and your doctor decide what is best for you and your health.

If you have questions about you or your loved one's use of Actos, please contact our office to discuss your potential case. We want to help you understand these warnings and to understand your legal rights if you have been injured.

Share These Symptoms with Your Doctor if You are taking Actos:

  • Bladder Cancer: Dark Urine, Blood in Urine, Frequent Urination, Infection of the Urinary Tract, Abdominal and/or Lower Back Pain
  • Liver Disorders: Dark Urine, Abdominal Pain, Yellowing of Skin or Eyes (Jaundice), Vomiting
  • Heart Disease/Failure: Shortness of Breath, Sudden or Unexplained Weigh Gain, Sweating, Swelling of Feet and Hands, Fatigue

Byetta® and Januvia®—Byetta (exenatide) and is an injectable prescription medication that helps control blood sugar levels in adults with type 2 diabetes. Approved by the FDA in 2005, Byetta is the subject of safety communications linking the drug to acute pancreatitis and, in some patients, pancreatic cancer. It has been alleged that Amylin Pharmaceuticals, the manufacturer, failed to test Byetta properly before bringing to the market and failed to provide adequate information to the FDA about its risks

Januvia (stigaliptin) is a once daily pill also assisting adults with type 2 diabetes to lower their blood sugar level. In 2009, the FDA revised the prescription information for Januvia and alerted healthcare professionals to monitor diabetic patients taking this medication for signs of pancreatitis. It has been alleged that the Merck Pharmaceuticals, the manufacturer of Januvia, failed to adequately test the drug before promoting it to patients and failed to provide adequate risk information to the FDA and health care professionals.

Effexor®—Effexor is a prescription antidepressant drug used to treat depression and mood disorders in adults. Some women prescribed Effecor had a child born with a birth defect such as: cleft lip and palate, club foot, abnormally shaped skulls, congenital heart defects and other serious issues. Women taking the drug may also have higher risk of experiencing miscarriages.

Fosamax®—Fosamax is marketed and sold for the treatment of osteoporosis. Studies have shown that this drug has been linked to higher risk of femur fractures and other abnormal bone diseases. In July 2011, the FDA issued an update to healthcare providers and patients regarding the review of Fosamax studies and continues to evaluate this drug.

Lipitor®—This is a cholesterol-lowering medication that has been associated with higher risks of developing type 2 diabetes in women taking the drug. This is because the drug can lead to elevated blood sugar levels in patients. Lawsuits have already been filed against the drug's manufacturer, Pfizer.

Topamax®— And its generic versions are drugs approved for use in the United States to treat both epilepsy and severe migraine headaches. They have also been prescribed for weight loss treatment, although that is an off-label use of the drug. (An "off label" use is a prescription for using a drug treatment of a condition not included in the FDA approved label).

You may have a claim:

  • If you took Topamax® or one of its generic versions;
  • While in your first or second trimester; and,
  • Your baby was born with a cleft lip and/ or cleft palate or serious fetal or skeletal malformations.

These drugs are still on the market and widely prescribed. If you have questions about a potentially dangerous drug or have experienced adverse symptoms or serious injury after taking prescription drugs, such as these described above, contact us our office and ask to speak to an attorney.

Wellbutrin®—Wellbutrin (also known as bupropion) is a medication that is used for treatment of depression. Studies have shown that this drug may lead to higher risk of congenital heart defects in infants when the infants' mothers took Wellbutrin early on during pregnancy.

Zoloft®—There have been claims that Zoloft, an anti-depressant, causes negative side effects for women who take the drug while they are pregnant—particularly birth defects in their infants. According to a 2007 U.S. News & World Report article, one study showed that women who had taken Zoloft in the early stages of pregnancy were twice as likely to give birth to infants with heart defects. There are also other types of birth defects this drug has been linked to.


Knee & Hip Replacements

The FDA has issued warnings in recent years about the possible dangers of metal-on-metal hip implants. With these types of hip replacements, patients experience excessive friction between the metal ball and metal cup that rub against each other when they walk, run or engage in other physical activities. As a result, corrosion of the device may occur and metal particles may be released into the person's bloodstream. For some patients this has led to pain, soft tissue damage, device failure and other side effects. We are currently investigating the following metal-on-metal hip implants:

Biomet M2a-Magnum™—Hundreds of reports of complications have been submitted to the FDA concerning Biomet's M2a-Magnumhip implant product, both from patients and from doctors, according to a DrugWatch.com article. After suffering from problems such as soft tissue damage, hip pain and dislocation of the device, many patients with these implants have sued Biomet.

DePuy ASR™ and Pinnacle® hip systems— DePuy Orthopedics, division of Johnson & Johnson, recalled its ASR™ HipResurfacing System and ASR™ XL Acetabular Hip System. These implants have been used nationwide since July 2003. Anyone who had a hip implant surgery after that date may be affected by the recall. The team at George & Farinas, LLP can help you find out if your implant was one of these recalled products.

Hip implants should last for over 10 years. Patients with the DePuy products are experiencing loosening of the hip joint as the device fails to stay attached to the bone, fractures of the anchoring hip bone, clicking or popping sounds, problems walking, excessive pain, swelling or discomfort. At least 12% of patients who received the DePuy ASR hip implant were required to have a second revision surgery to remove the failed implant. The ASR™ Hip is made of ball and socket components that move against each other. These metal components wear over time and release tiny metal particles into the patient's hip that can cause pain and swelling around the joint and can lead to permanent damage to the muscles, bones and nerves. The release of metals from the implant causes high levels of cobalt and chromium to enter the blood, which can cause additional and severe side effects.

A UK study showed that about 13% of individuals who received DePuy ASR total hip systems needed revision surgery (second surgery) within five years due to problems with the implants—a percentage that was higher than expected, according to data released by DePuy. Furthermore, 12% of individuals with resurfacing hip implants needed revision surgery within the same timeframe. Following this study and high numbers of complaints about the products, DePuy Orthopaedics recalled its ASR™ XL Acetabular System and ASR™ Hip Resurfacing System. Some of the problems associated with these hip replacements include dislocation or loosening of the implant, bone fractures, and pain and swelling. According to the New York Times, ASR products are expected to fail in 40% of patients within a five-year-period. Complaints that have been made about the Pinnacle hip implants are similar to those made for the ASR implants.

Stryker® Rejuvenate—In 2012, the Stryker Corporation recalled its Rejuvenate Modular hip stem product, according to DrugWatch.com. This is because it was found that the hip implant was linked to problems such as the wearing down of the device (corrosion) and "fretting." Fretting is the process of the metallic particles affecting the bloodstream, tissues, bones, etc. As a result, many people have suffered from pain, tissue inflammation, organ damage and more.

Wright Medical Technology Conserve® Plus and Profemur® hip systems—These are among the various metal-on-metal hip replacement products that have led to complaints and lawsuits by consumers. The problems that have been linked to these systems include metal poisoning, loosening of the implants, tissue damage and more.

Zimmer Durom Cup— Defective knee implants from Zimmer, Inc. are failing and causing needless surgeries andcomplications. Zimmer® knew of problems with parts of its NexGen knee replacement systems yet failed to take adequate steps to reduce the risk of injury or warn patients. George & Farinas, LLP is investigating claims for Zimmer® NexGen Knee Replacement implants, focusing on component parts and specific lots of these implants that have high failure rates.

In September 2010, Zimmer announced a massive recall of over 68,000 NexGen™ MIS Tibial knee replacement components that could have been used in the Zimmer® NexGen™ CR, CR Flex Legacy Posterior Stabilized (LPS) and LPS-Flex Knee replacement systems. This Class 2 recall came only after numerous studies showed early loosening, causing pain, discomfort, and slipping, forcing premature replacement of the failing knee. A study at the July 2010 meeting of the American Academy of Orthopedic Surgeons (AAOS) showed the porous femoral NexGen CR-Flex implant part resulted in 36 % of its recipients showing signs of loosening within 5 years from date of surgery, when these knees should last 8-15 years without problems.

However, not all Zimmer® Knee Systems are subject to this recall. If you or a loved one have a Zimmer® Knee implant and have pain, loosening, difficulty walking, or other problems, call our firm and ask to speak to an attorney. We will help you determine if your Zimmer® Knee is part of one of those recalled.

Dialysis Treatments & Other Products

Thousands of Americans undergo dialysis treatment each year to treat end-stage renal disease (ESRD), commonly known as kidney failure. More than a third of these kidney dialysis patients are given the dialysis products GranuFlo and NaturaLyte – treatments that have recently been linked to hundreds of deaths and serious heart problems.

Fresenius Medical Care, the world's largest dialysis service provider is under investigation for failing to inform customers of potentially deadly risks connected to excessive doses of GranuFlo and NaturaLyte. In Fresenius Medical Care's own 2010 internal survey, results indicated GranuFlo and Natural Lyte had potentially deadly "side effects" including causing extremely low blood pressure, heart problems, strokes, cardiac arrest and death. Despite this, they continued to manufacture GranuFlo and Natural Lyte, as well as administer to patients in the clinics they own. In June 2012 the U.S. Food and Drug Administration (FDA) officially announced an emergency Class I recall on GranuFlo and Natural Lyte manufactured between January 2008 and June 2012.

If you or a loved one were on dialysis and had heart problems, you should be aware that your dialysis treatment may be the cause. Vicitms of GranuFlo and NaturaLyte heart problems may be entitled to compensation. For a free, no hassle legal evaluation of your potential case, please contact the lawyers at George & Farinas, LLP today.

Pelvic/Transvaginal Mesh/Sling Devices—Transvaginal mesh devices are implanted into female patients for the treatment of pelvic organic prolapse (POP) and stress urinary incontinence (SUI). From 2005 through 2010, the FDA received nearly 4,000 complaints from patients who suffered adverse effects from these devices. Harmful side effects reported include: erosion of the device within the body, infection, pain, bleeding, urinary problems, and recurrent prolapse. The FDA has issues Public Health Notifications as well as recalls of some of these devices. If you've suffered side effects from a transvaginal mesh or pelvic sling, legal options may be available to you.


Pradaxa

If you, a family member, or loved one have taken the medication Pradaxa and suffered from uncontrolled and/or excessive bleeding, heart attack, or experienced other serious or fatal side effects you might be entitled to compensation.

Pradaxa (dabigatran) is a blood-thinning medicine approved by the U.S. Federal Drug Administration (FDA) in October 2010 and manufactured by Boehringer Ingelheim Pharmaceuticals Inc. The drug is marketed for stroke prevention associated with atrial fibrillation. People who have atrial fibrillation have occasional "fluttering" in the heart, which increases the risk that blood will pool in the heart, form a clot, and be pumped into the brain (causing stroke).

Pradaxa reduces the risk of strokes by inhibiting thrombin, an enzyme that is necessary for the formation of blood clots. Pradaxa was developed as an alternative to Warfarin and is widely prescribed for off label use as a "new generation" of anti-coagulant medication. However, Warfarin is inactivated by many foods containing Vitamin K and in an emergency, doctors can administer a simple dose of Vitamin K, which allows blood to clot and prevents bleeding to death.

In contrast, when a Pradaxa patient needs emergency treatment, they must undergo dialysis to mechanically remove Pradaxa from the bloodstream. This can take several hours. By the time dialysis takes effect, a person can bleed to death — even from a minor injury. As a result, the FDA is evaluating reports of serious or even fatal bleeding events in patients taking Pradaxa. In 2011, manufacturer Boehringer Ingelheim admitted to knowledge of cases of fatal bleeding yet they continue to market the drug.

Now, Pradaxa warns of side effects of bleeding which can lead to death, as well as:

  • Lethargy
  • Blood in urine
  • Red/black tarry stool
  • Headache
  • Nosebleed
  • Vomiting
  • Dizziness
  • Unusual bruising
  • Brain bleed
  • Stroke or Heart Attack

Topamax

Topamax® and generic versions of topriamate are drugs approved for use in the United States to treat both epilepsy and severe migraine headaches. They have also been prescribed for weight loss treatment, although that is an off-label use of the drug. (An "off label" use is a prescription for using a drug treatment of a condition not included in the FDA approved label).

You may have a claim:

  • If you took Topamax® or one of its generic versions;
  • While in your first or second trimester; and,
  • Your baby was born with a cleft lip and/ or cleft palate or serious fetal or skeletal malformations.

These drugs are still on the market and widely prescribed. If you have questions about a potentially dangerous drug or have experienced adverse symptoms or serious injury after taking prescription drugs, such as these described above, contact us our office and ask to speak to an attorney.


Zimmer

Defective knee implants from Zimmer, Inc. are failing and causing needless surgeries andcomplications. Zimmer® knew of problems with parts of its NexGen knee replacement systems yet failed to take adequate steps to reduce the risk of injury or warn patients. George & Farinas, LLP is investigating claims for Zimmer® NexGen Knee Replacement implants, focusing on component parts and specific lots of these implants that have high failure rates.

In September 2010, Zimmer announced a massive recall of over 68,000 NexGen™ MIS Tibial knee replacement components that could have been used in the Zimmer® NexGen™ CR, CR Flex Legacy Posterior Stabilized (LPS) and LPS-Flex Knee replacement systems. This Class 2 recall came only after numerous studies showed early loosening, causing pain, discomfort, and slipping, forcing premature replacement of the failing knee. A study at the July 2010 meeting of the American Academy of Orthopedic Surgeons (AAOS) showed the porous femoral NexGen CR-Flex implant part resulted in 36 % of its recipients showing signs of loosening within 5 years from date of surgery, when these knees should last 8-15 years without problems.

However, not all Zimmer® Knee Systems are subject to this recall. If you or a loved one have a Zimmer® Knee implant and have pain, loosening, difficulty walking, or other problems, call our firm and ask to speak to an attorney. We will help you determine if your Zimmer® Knee is part of one of those recalled.

If you have questions about you or your loved one's use of any of these drugs or medical devices, please contact our firm toll free at: (888) 277-0500, for a no hassle consultation to discuss your potential case. We want to help you understand the warnings and to understand your legal rights if you have been injured.

George & Farinas, LLP. Commitment You Can Trust.


Bard IVC Filters

IVC filters are supposed to protect patients from dangerous blood clots, but these devices are potentially deadly in themselves. An IVC filter is a wire device that looks something like a spider, set snugly against the walls of the inferior vena cava. When implanted, they were designed to prevent blood clots from forming, preventing stroke and other life-threatening events. Unfortunately, studies show that shards can break from the filter and may be just as deadly.

Retrievable IVC Filters, including C.R. Bard's (unit of Johnson & Johnson) Recovery IVC Filter have reportedly been fracturing and migrating inside patients, leading to serious injuries. It is alleged that as early as 2003, Bard's own research showed that the IVC filters posed an unreasonable danger to patients from splintering. The company did not tell the Food and Drug Administration ("FDA") about their findings, or warn patients or doctors, and continued to sell and market the deadly Recovery IVC filter until it could create a suitable replacement for the market.

Any one of the metal extremities on the device can fracture and be carried away by the blood stream, finding its way to the heart or lungs. The likelihood of splintering increases the longer the device remains in the body.

Warning signs that a Recovery IVC Filter has failed include chest pain and shortness of breath. A CT scan or other test will be used to determine if the IVC filter system has failed. If not caught quickly, this can lead to serious and life-threatening complications including:

  • Death
  • Constant severe pain in the heart, chest or elsewhere
  • Respiratory distress
  • Perforation of tissue, vessels, and organs
  • Pulmonary embolus
  • Emotional distress at the thought of metal shards splintering into organs

Recently, a Motion to centralize the existing Bard IVC filter law suits was granted by the Judicial Panel on Multidistrict Litigation ("MDL"). This will consolidate lawsuits pending in numerous courts around the nation. The time to act is NOW if you or someone you love suffered serious injury or died due to complications from an IVC filter! Contact our office at 1-888-277-0500 for more information.

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George & Farinas, LLP - Indiana Mesothelioma Attorney
Located at 151 North Delaware Street, Suite 1700 Indianapolis, IN 46204. View Map
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