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Elmiron Lawsuit

Elmiron is a medication used to treat people for interstitial cystitis, known as “painful bladder syndrome.” It has been used to treat osteoarthritis in humans, dogs, and horses. But Elmiron has been linked to some very severe side effects that can cause vision problems and even blindness.

Lawsuits against the manufacturer of Elmiron claim that long-term exposure to the medication can cause maculopathy, which is an eye disorder. It affects the macula, or the central portion of the retina, and can result in blindness.

In 2018, an article was published in the American Academy of Ophthalmology that outlined how a number of people experienced pigmentary maculopathy after being exposed to Elmiron. Between the years 2015 and 2017, six patients were treated for these eye problems at the Emory Eye Center in Georgia. By 2019, the number went up to ten people.

Elmiron and Maculopathy

Maculopathy is a generalized term that refers to pathological conditions that affect the central part of the retina, the macula. This is where visual acuity and sensitivity occur There are certain types of maculopathy:

Age-related Macular Degeneration – this is an age-related condition that occurs over time.

Cellophan Maculopathy – known as a “macular pucker” this condition causes a transparent layer of scar tissue to pull on the light-receptive nerves of the macula.

Malattia Leventinese – known as “Doyne Honeycomb Retinal Dystrophy” (DHRD) and is prompted by small, pale spots that grow on the macula, eventually creating a honeycomb pattern.

Pigmentary macular degeneration associated with Elmiron is an injury with no known cause. Each person presents the signs and symptoms differently. Some other Elmiron side effects many people have filed lawsuits over are:

  • Alopecia (hair loss)
  • Bruising
  • Diarrhea
  • Gastroesophageal reflux
  • Headaches
  • Skin rash
  • Sleep disorders

None of the product labeling of Elmiron describes symptoms or side effects related to pigmentary maculopathy, or any other kind. It only references vision disorders such as conjunctivities, optim neuritis, retinal hemmorhage, etc. Yet, pigmentary maculopathy is exactly one of the side effects Elmiron has had on others, and probably many others.

Is an Elmiron lawsuit right for you?

Have you had any of the above side effects after taking Elmiron? Is so, you should contact a lawyer who is knowledgeable about filing a lawsuit for prescription medications. You may be entitled to financial compensation for your losses, including time off from work for doctor’s appointments, medical bills, stress, and more.

focus on concerned surgeon in operating room with nurses around them

Surgical Stapler Lawsuit

Surgeons rely on many instruments in the operating room to successfully and safely take care of their patients. Many of them use surgical staplers, which are a very common instrument to use during surgery. However, if a surgical stapler misfires or fails to work as intended, the consequences can be catastrophic.

A report outlined the Food and Drug Administration may have made it possible for the manufacturers of surgical staplers to “hide” adverse reports of their devices failing from the public.

An article issued in Kaiser Health News startled the healthcare industry in 2019 when it alleged the Food and Drug Administration has been hiding millions of adverse reports from the public.

A doctor by the name of Douglas Kwazneski was interviewed by Kaiser Health News, as he was the first to break the news about an adverse reporting system embedded within the FDA. He explained the surprise and shock he experienced when his surgical stapler locked up in the midst of a procedure.

Nearly two-thirds of surgeons he spoke to had experienced the same problem with the stapler. Yet when Dr. Kwazneski went to the FDA reporting system, he found no such reports of stapler failure incidents.

“Going into something without data is dangerous,” he said. “If the information exists, we should have access to it.”

This was only the beginning of a much larger problem with the FDA reporting system and medical device failures.

FDA Alternative Reporting

The “alternative summary reporting repository” was where Kwazneski could have found millions of reports on surgical stapler failure. Yet the FDA had these reports embedded within other device failure reports; meaning the user would have no way of accessing or even searching for the correct data.

How did the alternative summary reporting even happen in the first place? It all began nearly 20 years ago and was intended to help cut down on paperwork that was often backlogged with the agency.

It was intended for “well-known and well-documented” reports. Devices that had complaints against them would be carried over into similar reports.

But doctors were unaware of this method of reporting, and many still are today.

Shortly after the initial Kaiser Health News article ran, the FDA acknowledged there are more than 56,000 surgical stapler files that were never disclosed before. These surgical stapler reports occurred and were subsequently quietly reported to the agency between 2011 and 2018.

FDA to address the problem

In March, the FDA addressed a letter to doctors that “many more device malfunction reports” had been reported to the agency that health care physicians were most likely unaware of.

Even as of 2016, in the FDA database called MAUDE, only 100 stapler-related injuries were available to the public. Yet, the alternative summary reporting system had roughly 10,000 reports files away. As such, these nonpublic records were taken into account when looking at the large scope of stapler injuries and provided a total of 110,000 malfunctions and/or injuries between 2011 and 2018.

Surgical staplers are responsible for sealing tissues inside the body. They are mainly used to save time during surgery; they lessen the risk of anesthesia complications. But if something goes wrong, it can be catastrophic for both the patient and the surgeon. For example, Mark Levering of Ohio suffered a severe brain injury after a malfunctioning stapler caused massive bleeding.

According to the FDA, there have been 366 deaths because of surgical staplers. Other complications from faulty staplers include:

  • Opening of the staple line or malformation of staples
  • Misfiring
  • Difficulty in firing
  • Failure of the stapler to fire the staple
  • Misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

Surgical stapler lawsuit

Fortunately, surgical staplers are no longer eligible to be reported in the alternative summary program. The FDA said it would end the program in 2019. However, if you or someone you know has been injured by a malfunctioning or faulty surgical stapler, you should find a lawyer immediately. Many people have filed lawsuits against the manufacturers of surgical staplers, such as Ethicon (a subsidiary of Johnson & Johnson) or Medtronic.

 

middle-aged white male sitting on couch with hand on stomach, clearly distraught and in pain

Zantac Lawsuit

Zantac is a popular medication used to treat millions of people each year for a multitude of gastrointestinal conditions. The generic name of the drug is ranitidine and is used in antihistamine and antacid products.

In 2019, many recalls were initiated due to the medication containing a human carcinogen. Read more to find out about filing a Zantac or ranitidine lawsuit, and how to keep yourself safe.

NMDA found in Zantac, ranitidine

Zantac is an over-the-counter (OTC) drug known as an H2 (histamine-2) blocker. This helps to decrease problematic and uncomfortable stomach acid in the body. It can be used to treat many conditions such as ulcers in the stomach or intestines; gastroesophageal reflux disease; duodenal ulcer; reflux esophagitis; post-operative peptic ulcers; Zollinger-Ellison Syndrome; benign gastric ulcer, and many others.

The concern over Zantac aren’t because of any specific side effects– it’s because of a human carcinogen. N-Nitrosodimethylamine (NMDA) was recently detected in Zantac and ranitidine medications.

A routine testing conducted by New Haven, Connecticut online pharmacy, Valisure, initially discovered the presence of NMDA. Valisant immediately alerted the Food and Drug Administration and has adamantly been calling for a recall.

FDA cautious about NDMA in drugs

The FDA has been concerned about NDMA being detected in other medications as well. A press announcement from the agency recently said, “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.”

“In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

According to the International Agency for Research on Cancer (IARC), the environmental contaminant NMDA “has been classified as probably carcinogenic to humans.” It is typically found as a byproduct of cooked or cured meats, such as bacon, or in water, dairy products, or vegetables.

Certain blood pressure medications last year and made quite the controversy as they contained 17 micrograms of NDMA. Many people are concerned about their exposure because Valisure detected NDMA levels as high as 3,000 micrograms in batches of Zantac and other generic medications.

(Sept. 23, 2019) Sandoz Inc. recalled its ranitidine hydrochloride capsules in 150mg and 300mg. The medications were sold in 30, 60, and 500 count bottles.

This story will be updated.

Filing a Zantac lawsuit

If you or someone in your family were diagnosed with cancer after taking Zantac, you should speak to a Zantac lawyer as soon as possible. You may be awarded financial compensation by filing a lawsuit. Be sure to evaluate a law firm on their experience with handling class action lawsuits, or involvement in multidistrict litigation (MDL).

oval yellow pill on white background, no inscription

Valsartan Lawsuit

Valsartan is a medication used to regulate those with high blood pressure that was recalled from the worldwide market in 2018. Products containing valsartan were recalled because certain impurities in the pills were found to be carcinogenic.

Valsartan has been sold under various brand names such as Amlodipine, Azilsartan, Byvalson, Candesartan, Diovan, Entresto, Eposartan, Exforge, Irbesartan, Losartan, Olmesartan, Prexxartan, Telmisartan.

Valsartan History

Valsartan was first introduced to the consumer market in 1996 by Novartis, which originally developed the drug. After the patent was lost, many other companies began manufacturing it in their own generic formulations.

For those with high blood pressure, the blood vessels often narrow and become restricted due to a chemical presence of angiotensin. Valsartan does the opposite; it blocks the chemical restrictor which then allows the blood vessels to remain open and relaxed.

High blood pressure causes the heart to work overtime. This can cause a variety of secondary health complications such as stroke, heart attack, kidney or heart disease. Many people rely on valsartan-type products to keep their heart functioning at a normal pace.

Valsartan Side Effects and Human Carcinogen Detected

Some of the reported side effects of Valsartan have been dizziness, headache, and nausea. There have been some reported allergic reactions as well. Pregnant women, those with a history of kidney, liver, heart disease, or dehydration are not advised to take valsartan products.

The problem with some valsartan products is certain manufacturing facilities introduced the pills to high levels of a human carcinogen known as N-nitrosodimethylamine (NDMA). Due to this issue, 22 other countries issued a recall as well.

The Food and Drug Administration provided a list of companies that manufactured valsartan with high levels of NMDA, however the entire list can be accessed here.

  • Bryant Ranch Prepack Inc.
  • H. J. Harkins Company Inc.
  • Lake Erie Medical, doing business as Quality Care Products LLC
  • NuCare Pharmaceuticals Inc.
  • Northwind Pharmaceuticals
  • Proficient Rx
  • Camber Pharmaceuticals (not all its valsartan products)
  • Major Pharmaceuticals (Teva Pharmaceuticals USA)
  • Solco Healthcare (Prinson Pharmaceuticals
  • Actavis (Teva Pharmaceuticals Industries Ltd.)

Filing a valsartan lawsuit

You may have a valsartan lawsuit if you have been taking the medication that was contaminated with NMDA. It would be important to find a lawyer who is experienced in taking on pharmaceutical companies. Many people find the task daunting, but with the right lawyer, you shouldn’t have to worry too much.

older woman sitting in chair next to table with hand on her head

Amiodarone Lawsuit

Amiodarone is the name of a medication used to treat certain heart conditions such as ventricular tachycardia (VT) and ventricular fibrillation (VF). Essentially it works by toning down the electrical signals of the heart that can sometimes cause an erratic heartbeat. Yet the side effects can be severe, if not deadly for those on the medication. Read more to find out about amiodarone side effects and filing an amiodarone lawsuit.

Amiodarone History

The healing properties of amiodarone were derived from the Khella plant (Ammi visnaga). A physiologist working in Cairo, Egypt observed how it treated angina in people of the region back in the 1940a. It was then brought back to Europe and used to treat angina in the 60’s.

The United States became interested in its later-discovered anti-arrhythmic properties and it became of interest to be put on the pharmaceutical market. In 1985, the Food and Drug Administration approved amiodarone hydrochloride (Cordarone) to treat irregular heartbeats associated with VF and VT. It was only approved as a last line of defense, and not for first-line use.

Concerns Over Amiodarone Use

Cordarone is manufactured by Wyeth (which is a subsidiary of Pfizer, Inc.). Around its original release, Cordarone was marketed as a first-line anti-arrhythmia medication. Yet, the FDA never approved that use; and a pharmaceutical company is unable to promote drugs for use other than what has been approved by the FDA.

This led many physicians to believe amiodarone medications were in the safe zone for treating arrhythmia’s. Yet, this was a contradictory move on the drug manufacturers part–and has been a hard habit to shake ever since.

Amiodarone has been sold under the names Cordarone, Pacerone, and Nexterone. It has been sold by various pharmaceutical companies such as:

  • Par Pharmaceutical
  • Taro Pharmaceuticals
  • Zydus Pharmaceuticals
  • Teva Pharmaceuticals
  • Barr Laboratories
  • EON Labs
  • Wyeth-Ayerst Laboratories

Amiodarone Side Effects

After over thirty years on the market, the FDA indicated amiodarone should only be used as a last resort. That’s because the medication has been linked to causing lung damage, breathing problems, and more.

Amiodarone is so serious, many patients have to be hospitalized during the first week of treatment to monitor their reaction to the medication. Many doctors like to start their patients with a high dose of amiodarone, then taper the dosage down. If the patient is showing signs of adverse side effects, they will immediately be removed from treatment with amiodarone.

However, one study indicated amiodarone may stay in the system; even after a patient has stopped taking it. The British Pharmaceutical Society said, “excessive accumulation in tissues is suspected as ta possible cause of some of its adverse events.”

Many of amiodarone side effects are listed below. If you suspect you may be suffering from any of the following, it’s important to speak with your health care provider immediately.

  • Death
  • Pulmonary fibrosis (scarring of lung tissue)
  • Lung damage
  • Hepatic failure (chronic liver failure)
  • Neurotoxicity (central nervous system damage)
  • Peripheral neuropathy (damage to the nerves in the spinal cord)
  • Neonatal hypothyroidism
  • Optic neuritis
  • Blindness
  • Exacerbation of arrhythmias
  • Congestive heart failure
  • Hepatitis
  • Cirrhosis (late-stage scarring of the liver)
  • Kidney failure / Rhabdomyolysis (especially when combined with Simvastatin)

Amiodarone can effect the liver, especially if someone has had previous liver damage or liver disease. Some of the symptoms of liver damage to look out for while taking amiodarone are:

  • Nausea
  • Vomiting
  • Dark colored urine
  • Excessive fatigue
  • Yellowing of the skin or eyes (jaundice)
  • Itching
  • Pain in the upper right stomach

Amiodarone can actually worsen an irregular heartbeat or cause new arrhythmias. Signs include feeling dizzy, fainting due to a slow heartbeat, low levels of potassium or magnesium in the blood, heart or thyroid disease.

Amiodarone Lawsuit

It’s important to monitor your symptoms or any side effects while taking a medication like amiodarone. If you have been injured by this drug, you should speak with a lawyer that has handled similar cases against pharmaceutical companies.

By filing a lawsuit against the manufacturer, you may be able to recover financial losses you endured during the time you were negatively effected by the drug.

Man opening white tube in hands

AndroGel Lawsuit

AndroGel is a type of hormone used for increasing low testosterone levels in men that has been linked to causing serious cardiovascular side effects and more.

It’s one of many forms of testosterone replacement therapy (TRT) that has been used since the 1930s. TRT can be administered at home via patches, injections, or gels.

AndroGel is the topical gel version that comes in a pump and meant to be applied on clean, dry shoulders or upper arms. It can sometimes be applied to the stomach area as well. AndroGel was first approved in 2000 to treat hypogonadism, a testosterone deficiency that can occur from a genetic defect, illness, or trauma.

AndroGel is manufactured by AbbVie, a major brand-name pharmaceutical company. AbbVie has been responsible for conducting aggressive marketing tactics to increase sales of its product. That sounds about normal, so what’s the problem?

These marketing campaigns by AbbVie failed to address the increased risk of heart attack, liver disease, stroke, blood clots, pulmonary embolism, transient ischemic attacks (TIA), and sudden death. Some of these side effects are more prevalent in older individuals as well.

Many men have been prescribed AndroGel to treat hypogonadism, unknowingly being subjected to side effects their doctors may not have even known about.

Furthermore, many of AbbVie’s marketing tactics included suggestive messaging that AndroGel could increase one’s sex drive, which has yet to be effective with testosterone.

There have been over 4,200 lawsuits filed by men across the country seeking justice for the injuries they experienced while taking AndroGel. Many of them were prescribed AndroGel by their doctors under the assumption it could treat off-label conditions such as fatigue or increased body fat.

Furthermore, AndroGel is not the only testosterone replacement therapy drug on the market that has been responsible for causing severe side effects.

Actavis, the manufacturer of Androderm; Endo International (a subsidiary of Auxilium Pharmaceuticals), the manufacturer of Testim; Eli Lilly, manufacturer of Axiron, have all been embedded with lawsuits from men claiming the same complications as AndroGel.

If you or a male in your life has been injured by AndroGel or any of the above mentioned testosterone replacement therapies, it’s important to find a law firm skilled in the area of drug injuries. Many people have been able to seek financial compensation by filing a lawsuit against the manufacturer of medications that caused them serious health complications.

Biocell Breast Implant Lawsuit

If you or someone you love have textured breast implants and experienced unusual side effects, you may be at risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Read more to find out about recent breast implant recalls and why you should consider filing a breast implant lawsuit.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a serious but rare form of non-Hodgkins lymphoma. This kind of cancer affects the immune system and originates in the lymph nodes. It’s important to note, BIA-ALCL is not breast cancer.

BIA-ALCL can appear between the capsule and the implant, in the fluid surrounding the implant. The symptoms include swelling years after the surgery, of which a healthy implant should never swell. It’s imperative you speak with your plastic surgeon or healthcare provider if you experience any unusual symptoms of breast swelling.

National Comprehensive Cancer Network is recognized for its sound research by the Food and Drug Administration, as well as a handful of other research cancer societies. In a recent study, the most common demonstration of BIA-ALCL was built-up fluid around the breast implant (also known as a large spontaneous periprosthetic fluid).

In the report issued by the NCCN, the symptoms occurred anywhere from one, to an average of seven to ten years following cosmetic or reconstructive implantation.

The FDA has issued safety warnings about the unusual cancer that’s popping up both in the United States, and around the globe. As of July 6, 2019, the FDA received 573 medical device reports (MDR) of BIA-ALCL worldwide. Of that total, there have been 33 deaths. 

Additionally, 481 out of 573 reports indicated they had Allergan breast implants at the time of their diagnosis – and 12 out of 13 deaths (where the manufacturer was known) included Allergan breast implants. The other 20 deaths did not indicate who the manufacturer was.

“In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body,” the FDA announcement said.

Cases reported in the United States showed no difference in likelihood for BIA-ALCL to occur for those with reconstructive surgery or those who had cosmetic breast enhancement. Of those diagnosed with BIA-ALCL, 56% had them implanted for cosmetic purposed, and 44% had them implanted for reconstructive purposes.

FDA Biocell Breast Implant Update

Health Canada initially issued a recall in May 2019 of Allergan textured breast implants from the Canadian market due to the high incidence of lymphoma. The specific textured implant was once again reported in a high incidence of BIA-ALCL diagnoses.

The Health Canada statement read: “..because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licenses for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).”

In 2019, at the request of the FDA, the major breast implant manufacturer recalled its entire line of textured breast implants and tissue expanders from the US and worldwide markets. In a press release from July, Allergan announced its textured implants and tissue expanders would no longer be distributed or sold in any market where they’re currently available.

Additionally, healthcare providers should no longer be performing cosmetic or reconstructive surgery with the Biocell saline-filled and silicone-filled textured implants and tissue expanders.

“..at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.” 

-FDA update, 07/25/19

Post-BIA-ALCL Diagnosis

Textured breast implants only account for roughly 10% of implants in the United States. However, the numbers indicate there is a high risk of developing BIA-ALCL. 

One of the tests for BIA-ALCL is checking for a fluid collected around the breast implant called CD30. It is a type of protein in cell membranes that abnormally shows up in cases of the lymphoma. If the patient tests positive for CD30, they will need to undergo surgery to remove the ‘capsule’ (or scar tissue) around the implant, as well as the implant itself.

According to the FDA, this is a more extensive and time-consuming operation than a standard implant removal.

As with any cancer or serious ailment, the earlier the better when it comes to treating BIA-ALCL – but this also means coming up with the funds for surgery. Many people have to contend with their insurance companies to cover breast implant removal surgery, even when they are diagnosed with BIA-ALCL.

According to the American Society of Plastic Surgeons, the average out-of-pocket cost of breast removal is $2,566. This does not include anesthesia, operating room facilities, x-rays and medical tests, prescriptions for medication, and other expenses.

When filing a breast implant lawsuit, your attorney will take this into consideration for holding the manufacturer accountable for your BIA-ALCL diagnosis.

The following is a list of the Allergan breast implants and tissue expanders that have been recalled from the market.

Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant). Approved under P990074.

  • Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
  • Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
  • Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
  • Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants

Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:

  • Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
  • Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
  • Style 120 – BIOCELL Textured Round High Projection Gel Filled Breast Implants
  • Style TRL – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRLP – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRM – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRF – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRX – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone

Filled Breast Implants approved under P040046. The following are the textured styles:

  • Style 410FM
  • Style 410FF
  • Style 410MM
  • Style 410 MF
  • Style 410 FL
  • Style 410 ML
  • Style 410 LL
  • Style 410 LM
  • Style 410 LF
  • Style 410 FX
  • Style 410 MX
  • Style 410 LX

Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:

  • Natrelle 133 Plus Tissue Expander (K143354)
  • Natrelle 133 Tissue Expander with Suture Tabs (K102806)

Filing a Biocell Breast Implant Lawsuit

Any adverse health conditions or complications can be incredibly nerve-wracking. It’s important you find a lawyer who is skilled in compassion for your situation. When filing a Biocell breast implant lawsuit, your attorney will not only hold the manufacturer accountable for a defective and dangerous product– they will look for ways to win financial compensation for the emotional labor behind a BIA-ALCL diagnosis. This includes time spent away from work and family before, during, and after surgery, medical costs incurred, etc. 

Uloric Lawsuit

Uloric (febuxostat) is a medication used to treat gout in adults. Manufactured by Takeda Pharmaceuticals, it was first approved by the Food and Drug Administration in 2009.

Uloric was designed to lower uric acid levels, thus decreasing the likelihood of gout. It is in a class of medications called xanthine oxidase inhibitors. It’s important to note there are very few medicines to treat gout.

In 2019, only ten years after it was first approved, the FDA issued a Boxed Warning for Uloric because there is an increased risk of death while taking the medication.

The FDA said it would be limiting the approved use of Uloric only to patients who experience severe side effects to the alternative gout medication, allopurinol (Aloprim, Lopurin, Zyloprim).

Have you or someone you love experienced an adverse reaction to Uloric (febuxostat)? Read more to find out if a Uloric lawsuit is right for you.

Gout treatment and causes explained

Gout is a form of arthritis that affects nearly 8.3 adults in the United States. It is considered a gout “attack” when there are sudden, severe attacks of pain, redness, swelling and tenderness in the joints. It usually occurs in the the base of the big toe.

The body naturally produces uric acid when it breaks down natural substances found in the body. Uric acid dissolves into your blood, passes through the kidneys, and then into your urine to be eliminated.

However, a gout happens because urate crystals build up in the joints and cause inflammation. This is due to high levels of uric acid in your blood.

Therefore, it’s important to consider certain factors that may increase uric acid levels in your body:

Diet: Alcohol consumption (especially beer), a heavy rotation of meat and seafood, beverages sweetened with fructose (fruit sugar) all contribute to increasing uric acid levels.
Medications: Those used to treat hypertension (thiazide diuretics) and low-dose aspring can increase uric acid levels. Anti-rejection drugs used for those who have had an organ transplant may also contribute to increased uric acid levels.
Family history of gout: You’re more likely to develop gout if members of your family have been diagnosed.
Age and sex: Women tend to have lower uric acid levels than men. However, after menopause, the levels start to compete with those found in men. Men are likely to develop gout earlier between the ages of 30 and 50.
Recent surgery or trauma: These factors have been associated with an increased risk of a gout attack.
Medical conditions: There are diseases and conditions that increase the risk of gout, those include diabetes, metabolic syndrome, heart, and kidney diseases.
Obesity: Uric acid is produced more with those considered obese. Additionally, the kidneys have a harder time eliminating uric acid from the body.

Uloric test study reveals risk of death

When Uloric (febuxostat) was first approved by the FDA, it included a Warning and Precaution over possible cardiovascular events while taking the drug. The agency required Takeda Pharmaceuticals to conduct a postmarket safety clinical trial. Those details are outlined below.

This trial study included over 6,000 patients who were under treatment for gout with Uloric, or the alternative medication, allopurinol. The outcome of the trial concluded there was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and unstable angina in patients taking Uloric.

Compared to allopurinol, Uloric didn’t indicate any differences in an increased risk. However, it was when evaluating the outcomes separately that Uloric was found to increase the risk of heart-related deaths and death from all causes.

Side effects of Uloric

Below are a list of Uloric side effects that can indicate serious health risks and lead to complications if not attended to by a doctor.

  • Joint pain
  • Rash
  • Skin redness or pain
  • Blistering of the lips, eyes, mouth
  • Skin peeling
  • Fever, or flu-like symptoms
  • Swollen face, lips, mouth, tongue or throat
  • Yellowing of the eyes or skin
  • Dark urine
  • Pain or discomfort in upper right stomach area

Consult your doctor IMMEDIATELY if you experience chest pain, rapid or irregular heartbeat, shortness of breath, numbness or weakness on one side of your body, dizziness, fainting, slurred speech, blurry vision, or sudden severe headaches.

Filing a Uloric lawsuit

If you or someone you love have experienced any of the devastating side effects of Uloric, including cardiovascular complications, it’s important to speak with a lawyer skilled in representing clients for drug injury lawsuits.

A law firm that has experience in this area can help determine the best course of action and protect your rights. They will make every attempt to make sure the drug manufacturer is held legally liable for your injuries, and that you receive financial compensation.

While you cannot go back in time and undo the devastating impact this medication has had on your life, you may be able to get compensation to help with medical bills and other expenses you incur as a result of the side effects associated with Uloric.

To contact a compassionate lawyer handling these lawsuits, please fill out the form below for a Free Case Evaluation.

Hernia Mesh Lawsuit

Hernia mesh has been the source of controversy in recent years due to the severity of side effects and complications it can cause. Read more to find out if mesh has been causing trouble after surgery.

Hernia mesh goes by a variety of names, such as plugs or patches. It is oftentimes called surgical mesh as well. It is a small, woven “sheet” used in surgical procedures. It helps by providing support to tissue or organs– working as a sort of “sling” to keep the compromised site stable and in place.

Types of hernia mesh

Mesh can be made out of inorganic or organic materials, depending on the reason for its use. Biological and organic materials are meant to be absorbed by the body over time, stimulating new tissue growth intended to support the repair. Inorganic mesh is a more permanent and stable remedy.

There are some animal-derived mesh products, which are constructed out of animal tissue (such as intestine or skin). It has been sterilized and disinfected for use in the human body. This type of mesh is considered absorbable and will degrade over time.

Non-absorbable mesh is intended to stay in the body indefinitely. Medically, it is considered a permanent implant and hernia reinforcement.

As simple as hernia mesh sounds, it is actually quite dangerous. Read more to find out some of the devastating complications mesh can cause, and if a hernia mesh lawsuit is right for you.

What causes a hernia in the first place?

To understand the need for mesh, you have to understand the health conditions that may prompt the use of it in the first place. A hernia is the medical terminology for an organ or tissue that protrudes or exits from its intended place in the body. The hernia usually happens due to straining, pulling, coughing, exercise, or strain from using the toilet.

According to the FDA, the most common types of hernias are:

  • Inguinal: occurs in the inner groin
  • Femoral: occurs in the upper thigh/outer groin
  • Incisional: occurs through an incision or scar in the abdomen
  • Ventral: occurs in the general abdominal/ventral wall
  • Umbilical: occurs at the belly button
  • Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm

A hernia can flare up throughout the day and is sometimes visible from outside of the skin. It may look like a reddened, bulging protrusion that increases in size when strained. The purpose of hernia mesh is to hold the protruding organ or tissue back in its original place; thus eliminating the strain.

Hernia symptoms

Symptoms of a hernia vary depending on the severity, but remember that only a doctor can diagnose.

The symptoms of a hernia include pain that intensifies with movement, bulging red or purple protrusion, inability to have a BM or pass gas, nausea and/or vomiting, of fever. A health care provider is usually detected by an ultrasound or a CT scan, and sometimes an x-ray is needed if there is blockage in the bowel.

Some people have certain medical or health conditions that make it easier for a hernia to occur. There are also activities that increase the likelihood of getting a hernia. Such problems include:

  • Increased pressure in the abdominal area
  • A pre-existing weak spot in the abdominal wall
  • Straining during bowel movements or urination
  • Strenuous activity such as exercise or lifting weights
  • Pregnancy
  • Chronic coughing or sneezing
  • Cystic fibrosis
  • Enlarged prostate
  • Smoking
  • Overexertion
  • Poor nutrition
  • Fluid in the abdomen (ascites)
  • Undescended testicles
  • Overweight
  • A combination of any of the above

Hernia Mesh Complications and Symptoms

It’s important to understand the anatomical context of a hernia to better understand the risk of hernia mesh and its associated complications. Though you can take preventative measures to stop a hernia from happening, surgery is really the only remedy to permanently fix a hernia. But what happens if the device used in surgery is unreliable?

The FDA has long been concerned about the effectiveness and safety of hernia mesh. According to the agency, “Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh.”

Furthermore, the most common adverse events reported to the FDA which have prompted recalls of certain mesh were due to bowel perforation and obstructions complications.

There are more complications (outlined below) and conditions that may occur after surgery that involves mesh.

  • Localized or general pain
  • Infections
  • Abscesses
  • Scar-like tissue that sticks tissues together (adhesion)
  • Blockage of the intestines
  • Abnormal connection between organs
  • Organ perforation
  • Allergic reaction
  • Body rejection
  • Mesh migration or erosion
  • Mesh shrinkage (contraction)
  • Fluid build-up at the surgical site (seroma)

Many people who have experienced the devastating and painful complications from hernia mesh have had to undergo follow-up surgery to repair or remove the mesh. Sometimes the mesh has become so engrained in the surrounding tissue, that the process of removing the mesh is even more painful than the hernia before.

Hernia mesh removal surgery can be the cause of many problems, some of them include sexual dysfunction in both men and women. This may result in a lack of arousal, issues with pregnancy, pain during intercourse, lack of sexual desire, inability to maintain an erection and/or orgasm. 

One of the side effects of defective hernia mesh is organ perforation and damage. Depending on the severity of the situation, some organs may even have to be removed during the mesh removal surgery. That’s because the mesh adheres itself to the tissue lining the hernia repair site. 

There is also a risk that comes after hernia repair surgery: painkillers. Many doctors prescribe their patient’s medications such as Oxycontin (oxycodone), Vicodin (hydrocodone), Fentanyl, Carfentanil, Morphine, and others. While this seems like an easy way to control the pain, opioid painkillers are also a nationwide epidemic, as outlined by the Centers for Disease Control. These drugs are addictive and dangerous, and many doctors have overprescribed these medications to their patients. 

Contact a Lawyer Handling Hernia Mesh Lawsuits

The pain from hernia mesh failure is debilitating and can severely alter your quality of life. If you or somebody you know has suffered from hernia mesh complications, you should contact a lawyer handling hernia mesh lawsuits.

Xeljanz Lawsuit

Xeljanz (tofacitinib) is a medication used to treat certain types of arthritis or ulcerative colitis. It was issued the serious Boxed Warning by the Food and Drug Administration in 2019.

On July 26, 2019, the FDA updated and approved a Boxed Warning for the Xeljanz because it puts patients at risk of blood clots in the lungs and death. This information was gathered after a postmarketing study that monitored how the 10mg dosage interacts with those taking it.

Xeljanz History

Xeljanz was developed by Pfizer and approved in 2012 to treat adults with rheumatoid arthritis. Additionally, it is used to treat active psoriatic arthritis and ulcerative colitis.

Rheumatoid arthritis is a condition that causes the body to attack its own joints. This causes pain, swelling, and a loss of function in the affected areas.

In 2017, Xeljanz was approved to treat psoriatic arthritis (another condition that causes joint pain and swelling) as an alternative to using methotrexate and similar medications.

Finally, in 2018, Xeljanz was approved to treat ulcerative colitis. That is a condition which causes a chronic, inflammatory disease that affects the colon.

Xeljanz helps to decrease the immune systems activity which is what causes arthritic problems. It was mainly developed as an alternative medication for those who didn’t respond well to other immune system suppressants. Xeljanz is currently prescribed in 5mg doses (including extended release, “XR”), but once increased to 10mg has some very controversial side effects.

Xeljanz Post-Marketing Study and Side Effects

The FDA required the postmarketing study to be conducted by Pfizer, and evaluated patients with ulcerative colitis for a risk of cardiovascular events, cancer, and infections. This was to make sure it was safe to use in elevated doses.

The Data Safety Monitoring Board initially identified the dangerous side effects of an increased dosage of Xeljanz, including death and pulmonary embolism (blood clot in the lungs).

Xeljanz is linked to an increase in blood clots and death when used at 10mg compared to patients taking it at 5mg doses.

The symptoms of a blood clot from Xeljanz may include:
If you or someone you love is experiencing any of these conditions, go to a doctor or emergency room immediately.

  • Sudden shortness of breath
  • Difficulty breathing
  • Chest and back pain
  • Coughing up blood,
  • Excessive sweating
  • Swelling of the legs or arms
  • Leg pain or tenderness
  • Unusually red or discolored skin that is painful to the touch

Other Xeljanz (tofacitinib) side effects include:

  • Pneumonia
  • Cellulitis
  • Herpes zoster
  • Urinary tract infection (UTI)
  • Diverticulitis
  • Appendicitis

The FDA warns healthcare providers to avoid prescribing Xeljanz to patients with a history of thrombosis. Additionally, it indicates heavily limiting Xeljanz at 10mg to the shortest duration needed.

Filing a Xeljanz Lawsuit

If you or somebody you know has suffered from a blood clot, other serious side effects, or even death from taking Xeljanz, you should contact a lawyer that handles Xeljanz lawsuits.

Health complications from medications can severely affect your quality of life, take time away from work and family, and contribute to other major health episodes later in life. A lawyer skilled in handling a Xeljanz lawsuit will do everything they can to hold the manufacturer accountable.