Harmful Drugs and Defective Medical Devices
Harmful Drugs and medical devices law
The Ferrell Maritime and Mesothelioma Law Group is committed to helping individuals who have suffered injury from prescribed drugs as well as faulty or defective medical devices. We lend a voice to those who have been injured or otherwise harmed and help them obtain the compensation they are entitled.
Our attorneys are highly experienced in pharmaceutical litigation and are here to help. Navigating the complex corporate big pharma machine is a task we take on with great enthusiasm, as it is an industry with two faces and many facets. They exist to bring much-needed help to those in need, but in many cases, it would seem that they are only there to profit from the misery of others.
If you have been harmed, injured or disabled by a prescription medication, The Ferrell Maritime and Mesothelioma Law Group can help.
The desire to act quickly in order to hasten a drug to market occasionally causes drugs to be released before they have been fully evaluated. The FDA approves some drugs before their safety has been proven, hastening their release despite concerning trial results. New, brand-name drugs are often made available and covered on the Medicaid formulary for a short period of time after release, some going on to cause organ failure, serious side effects, and even death for one of our most vulnerable demographics.
Some alarming statistics:
- Adverse reactions to prescription drugs are the fourth leading cause of death in the United States
- New drugs have a 20% chance of causing serious side effects within the first five years after release
- Independent reviews conducted in The Netherlands concluded that only 8% of new drugs were in any way superior, and only 2% represented a medical breakthrough
- The elderly experience more adverse reactions than any other group
In addition, we can conclude that the business model of pseudo-innovation in the pharmaceutical industry has led to more harm done, fewer breakthroughs, and massive profits for the manufacturer.
While the majority of drugs do help those they are prescribed for, there are many cases where the opposite is true. Many doctors choose not to prescribe new drugs until they have been proven in the market for at least five years. Due to pressure, the promise of kickbacks, and other hard-selling techniques on the part of the pharma companies themselves, some doctors may be persuaded to give them an early try.
When a company knowingly sells a drug that has caused adverse reactions, they are misleading the public, doctors, and the patients under their care.
Just some of the brand-name drugs that have brought about major lawsuits include:
- Talcum Powder and Ovarian Cancer
- Testosterone Replacement Therapy
- Proton Pump Inhibitor
- And many more
Some medical devices have also been the subject of litigation. These include devices used for common procedures such as hip replacements, knee replacements, hernias, birth control, and more.
Medical devices currently in litigation include:
- Metal on Metal Hip Replacement
- 3M Bair Hugger
- IVC Filters
- Bone Cement
- And many more
Pharmaceutical companies are often under a great deal of pressure from their shareholders and will put their interests before the welfare of the people they have promised to help.
The Ferrell Maritime and Mesothelioma Law Group represents many clients who have suffered injuries from the medicines they have been prescribed or the devices that they have had surgically implanted. Our team has a wealth of experience standing up to big pharmaceutical companies and will fight to get you the compensation to which you are entitled.
Our firm has successfully challenged big pharma for many of our clients, obtaining significant settlements for damages and/or wrongful death on behalf of their families. The litigation we have undertaken has brought about change in the pharmaceutical and medical device areas. In some cases, it has forced these companies to improve the safety of the drugs and devices at issue and to more clearly articulate the dangers and risks in order to avoid further harm being done.
We also represent companies and institutions that have been misled into unwittingly promoting and providing coverage for such drugs and devices. If there is even one person who has been harmed, in our opinion, it is one too many.
The Ferrell Maritime and Mesothelioma Law Group has decades of experience in complex medical matter litigation. We provide an authoritative voice, standing up for those who cannot due to the nature of their injuries and the scope of the harm that has been done.
If you have been injured, harmed, or otherwise suffered serious side-effects as a result of a drug that you were prescribed or a medical device that has been surgically implanted on the advice of your doctor, you deserve to be compensated. Call The Ferrell Maritime and Mesothelioma Law Group today to schedule a consultation. We will spend all the time it takes getting to know you, your medical history, and your unique perspective in order to determine the best course of action for you.
What is Pradaxa?
Pradaxa, which is the Boehringer Ingelheim brand of Dabigatran, is a direct thrombin inhibitor—in other words, a blood thinner—that was on the market for almost five years before it was pulled due to severe bleeding and deaths that numbered in the hundreds. It was prescribed for patients with arterial fibrillation, for those who were at high risk of a stroke, and also to prevent pulmonary embolism and deep vein thrombosis either in the presence of stroke risk factors or following hip replacement surgery.
Its surge in popularity was primarily due to the fact that unlike its competitors, Warfarin and Coumadin, regular blood testing was not necessary, and there was no need for the patient to change their diet.
Pradaxa was developed as a “next-generation” type of anticoagulant, one whose action inhibits the production of thrombin, an enzyme that helps the blood to clot. In certain types of stroke, the manufacturers were able to show that the drug was much more effective than other drugs in its class. However, patients who took it were at a much higher risk for bleeding incidents, gastrointestinal bleeding, rectal bleeding, and brain bleeding, the worst of which could result in a fatality. Further to that, patients who discontinued the drug had a significantly higher risk of stroke and blood clotting. It can also cause a blood clot in the spinal cord if an epidural or spinal tap is administered, which can lead to paralysis.
It was also discovered that patients who were taking Pradaxa and who had mechanical prosthetic heart valves were at an increased risk for heart attack, stroke, and blood clots.
Since its release in 2010, Pradaxa has been the subject of thousands of lawsuits and hundreds of deaths. The drug was on the market for five years without an antidote and is considered by many consumer safety groups to be one of the most dangerous drugs on the market today.
There is currently an antidote medicine, Praxbind, that is meant to stop bleeding in emergency situations. For the many individuals who took Pradaxa prior to the release of the antidote, it may have seemed like too little, too late.
In 2014, Boehringer Ingelheim settled $650M worth of lawsuits covering 4,000 unique cases. New litigation continues to be filed as the number of people affected grows.
Some of the adverse symptoms of Pradaxa include:
- gastrointestinal issues: heartburn, nausea, abdominal or stomach pain, diarrhea
- bruising and bleeding (wounds that continue to bleed and will not heal)
- unusual bleeding (from the rectum, vagina, mouth or nose)
- heavier than usual menstrual bleeding
- regurgitation of blood
- bloody stool
- heavy internal bleeding
- joint pain and inflammation
- fatigue, generalized weakness
- dark pinpoint spots beneath the skin’s surface
- itching, mild rash
- urine discoloration
- severe headache
New lawsuits continue to roll in as Boehringer Ingelheim is accused of not adequately warning doctors or patients about the extent of the risks involved in taking the drug. In some cases, death has ensued from relatively minor accidents. In one such incident, an elderly gentleman suffered a minor bump on the head, which can then lead to uncontrollable internal bleeding, proving that even the most seemingly insignificant of contusions could snowball into a major medical emergency.
What to do if you or a loved one has been injured as a result of taking Pradaxa?
Attorneys all over the United States continue to file Pradaxa lawsuits on behalf of patients, both on the part of those who were not included in the 2014 settlement, and for those who have been affected since then.
The average compensation per claimant in the first round of lawsuits was approximately $162K. The consensus is that the second round of compensation will exceed the first, as claims in the first round were not tested in a court of law. Claims are currently being tried at the state level, and juries may not be as accepting of a token gesture such as it is.
If you have been injured as a result of taking Pradaxa, or if your family has suffered a death or devastating and permanent bodily injury that is directly related to Pradaxa, there has never been a better time to file.
The Ferrell Maritime and Mesothelioma Law Group is here to help, with caring, empathetic legal advice for those whose lives have been ravaged by Pradaxa. Call today to set up a consultation with one of our attorneys. When we meet, we will go over every detail of your case from your medical history to the procedures or conditions that led to Pradaxa being prescribed for you. Just know that you are not alone and you are not without recourse. Nobody can ever replace what has been lost, but we will do our best to get the compensation you deserve so that you can start getting your life back on track.
Call today: you are under no obligation to continue, but you owe it to yourself to find out what is possible.
Lawsuits filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp. over the blood thinner Xarelto have been consolidated in Louisiana federal court. Xarelto has been linked to serious side effects including internal bleeding, gastrointestinal bleeding, brain bleed and death. The Xarelto lawsuits come on the heels of the recent $650 million Pradaxa settlement. Researchers linked Pradaxa, also a blood thinning medication, to more than 500 deaths. Xarelto blood thinner litigation has been consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, who presided over suits against Merck & Co. over its medication Vioxx. The Vioxx litigation resulted in a $4.85 billion settlement in 2007.
Talcum powder and ovarian cancer
As many as 2,200 cases of ovarian cancer diagnosed each year may have been caused by regular use of talcum powder. Talc is a mineral made of up various elements including magnesium, silicon and oxygen. Talc is ground to make talcum powder which is used to absorb moisture and is widely available in various products including baby powder and adult products including body and facial powder. Talc products used regularly in the genital area increase the risk of ovarian cancer. In February 2016, a jury found Johnson & Johnson knew of the cancer risks associated with its talc products but failed to warn consumers, and awarded the family of our client $72 million. She died of ovarian cancer after using J&J talc-containing products for more than 30 years.
Testosterone Replacement Therapy
(TRT) products for men have been linked to an increased risk of death, heart attack and stroke. Researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use. A second study found that men had a significant increase in risk of heart attack and stroke in just the first 90 days of testosterone therapy use. Furthermore, men who started the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke or die as men who entered the study with established coronary artery disease. Testosterone therapy, such as the prescription topical treatments Androgel, Testim and Axiron, are used to help boost testosterone levels in men who have a deficiency of the male hormone. Symptoms of low testosterone include decreased libido and low energy.
A preliminary study indicates the erectile dysfunction drug Viagra (sildenafil) may increase the risk of developing Melanoma, the deadliest form of skin cancer. The study, published in the JAMA Internal Medicine Journal, analyzed data from nearly 26,000 men, 6 percent of whom had taken Viagra. The men who used Viagra at some point in their lives had about double the risk of developing Melanoma compared to men who had never taken the drug. Men who were currently taking Viagra were at an 84 percent greater risk of developing Melanoma. We are currently looking at cases involving men who are taking or have taken Viagra and were diagnosed with Melanoma.
Risperdal, an atypical antipsychotic drug used to treat schizophrenia and certain problems caused by bipolar disorder, has been linked to the development of gynecomastia in boys and young men. Gynecomastia is a condition that causes boys to grow breasts. The drug is manufactured by Johnson & Johnson.
Approved in March 2013, Invokana (canagliflozin) is an SGLT2 Inhibitor used to treat adults with Type 2 diabetes, manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. SGLT2 inhibitors work by preventing high blood sugar by helping the patient’s kidneys remove excess sugar through their urine. In May 2015, the U.S. Food and Drug Administration (FDA) issued a warning the drug has been linked to cases of ketoacidosis, a serious condition where there is too much acid in the blood. Complications of diabetic ketoacidosis include difficulty breathing, nausea/vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. The condition can lead to diabetic coma and/or death.
Manufactured by GlaxoSmithKline, Zofran (ondansetron) was approved to treat nausea during chemotherapy and following surgery. Zofran (ondansetron) works by blocking serotonin in the areas of the brain that trigger nausea and vomiting. Between 2002 and 2004, GSK began promoting Zofran off-label for the treatment of morning sickness during pregnancy, despite the fact the drug has not been approved for pregnant women and there have been no well controlled studies in pregnant women. The FDA has received nearly 500 reports of birth defects linked to Zofran. Birth defect risks include cleft palate and septal heart defects.
Proton Pump Inhibitors
Proton pump inhibitors (PPIs) were introduced in the late 1980s for the treatment of acid-related disorder of the upper gastrointestinal tract, including peptic ulcers and gastrointestinal reflux disorders, and are available both as prescription and over-the-counter drugs. The Ferrell Maritime and Mesothelioma Law Group is currently investigating PPI-induced Acute Interstitial Nephritis (AIN), which is a condition where the spaces between the tubules of the kidney cells become inflamed. The injury appears to be more profound in individuals older than 60. While individuals who suffer from AIN can recover, most will suffer from some level of permanent kidney function loss. In rare cases, individuals suffering from PPI-induced AIN will require kidney transplant.
Taxotere (docetaxel) is a chemotherapy drug approved in the treatment of breast cancer along with other forms of cancer. It is administered intravenously through a vein, and is a member of a family of drugs called taxanes. In 2007, manufacturer Sanofi-Aventis issued a press release touting the efficacy of Taxotere based on a clinical study. However, Sanofi-Aventis failed to inform the FDA, health care providers, and the public that permanent hair loss was observed in a number of the patients taking Taxotere. In December 2015, the FDA announced it had ordered Sanofi-Aventis to change Taxotere’s label to warn patients of the risk of permanent hair loss. While hair loss during chemotherapy is expected, patients undergoing chemotherapy with Taxotere were not warned they could potentially experience permanent hair loss. Permanent hair loss is an extremely debilitating condition, especially for women. We are currently investigating claims for women who suffered permanent hair loss following chemotherapy with Taxotere for breast cancer.
Metal-on-Metal Hip Replacement parts
The FDA has ordered a review of all metal-on-metal hip implants due to mounting patient complaints. Problems with metal-on-metal include, but are not limited to loosening, metallosis (ie: tissue or bone death), fracturing, and/or corrosion and fretting of these devices, which require revision surgery. Many patients that require revision surgery due to these devices suffer significant post-revision complications. We are investigating all cases involving metal-on-metal hip implants, including the DePuy Orthopaedics ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System, recalled in August 2010; the Stryker Rejuvenate and ABG II modular-neck stems, recalled in July 2012; the DePuy Pinnacle, the Zimmer Durom Cup, the Wright Conserve, and the Biomet M2A “38mm” and M2A-Magnum hip replacement systems, which have not been recalled. Reported problems include pain, swelling and problems walking.
3M Bair Hugger
The 3M Bair Hugger is a force hot air warming blanket, used primarily to help maintain a patient’s body temperature during surgery. The 3M Bair Hugger pushes warm air through a flexible hose into a blanket draped over a patient. However, warming blankets can recirculate contaminated air over a patient’s body, including over an open surgical site. This may result in infections like MRSA or sepsis. In particular, patients undergoing knee or hip replacement surgery are at risk of infections deep in the joint, which is very difficult to treat. Complications from these infections include hospitalization, implant revision surgery, limited mobility, permanent disability, amputation and death.
Retrievable IVC filters are wire devices implanted in the vena cava, the body’s largest vein, to stop blood clots from reaching the heart and lungs. These devices are used when blood thinners are not an option. Manufacturers include Bard, Cook and Johnson & Johnson. While permanent IVC filters have been used since the 1960s with almost no reports of failure, retrievable IVC filters were introduced in 2003, promoted for use in bariatric surgery, trauma surgery and orthopedic surgery. Risks associated with the retrievable IVC filters include migration, fracture and perforation, leading to embolism, organ damage and wrongful death.
Intended for hernia repair, Physiomesh is a flexible polypropylene mesh designed to reinforce the abdominal wall, preventing future hernias from occurring. Though there are several types of hernias, most occur when an organ or tissue protrudes through a weak spot in abdominal muscles. The condition often requires surgery where mesh, like Physiomesh, which is intended for laparoscopic use, is used to fill in a hole in the abdominal muscle or laid over or under it to prevent any further protrusions. Independent studies have found Physiomesh to lead to high rates of complications including hernia reoccurrence, organ perforation, mesh migration, sepsis and even death. In May 2016, Ethicon issued a market withdrawal of Physiomesh in the U.S. and recalled the product in Europe and Australia. We are currently investigating cases involving serious injury or death as a result of Ethicon’s Physiomesh.
The type of bone cement used during knee replacement surgery affects the outcome of that surgery. High viscosity bone cement (HVC) boasts shorter mixing and waiting times and longer working and hardening phases, meaning surgeons can handle and apply the cement earlier than with low- or medium-viscosity cements. Although HVC may be more convenient to use, there is mounting evidence that the bond it produces is not as strong. Researchers have observed more early failures with the use of HVC, even when used in combination with a previously well-performing implant. Complications associated with knee replacements performed with HVC include loosening and debonding (where the implant fails to adhere to the cement interface on the shin or thigh bone), which requires revision surgery. Other reported problems include new onset chronic pain and instability.