Metformin Lawsuit Investigation

Thornton Law Firm LLP is actively investigating metformin claims against drug makers on behalf of patients injured by these potentially defective drugs. If you have taken metformin and been diagnosed with a cancer of the digestive tract, call the metformin lawyers at Thornton Law Firm 888-341-1405 for a free consultation to assess your potential claim.

What is Metformin?

Metformin is a drug used to control blood sugar in adults and children over the age of 10 with Type 2 diabetes. It is the most popular oral diabetes medication in the world, and can be taken alone or in conjunction with other drugs. Metformin is also used in the treatment of polycystic ovary syndrome (PCOS), gestational diabetes, and to manage antipsychotic-induced weight gain.

The U.S. Food and Drug Administration (FDA) approved metformin in 1994 under the brand name Glucophage. The generic drug metformin is produced by numerous manufacturers, and it is still sold under several brand names, including:

  • Fortamet
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Riomet

Numerous manufacturers also make drugs that combine metformin with some other diabetes drug. Some examples are Byetta, Januvia, Janumet, and Victoza.

Metformin and NDMA

In 2020, the online pharmacy Valisure reported to the FDA that generic forms of metformin – particularly extended-release metformin – contained high levels of NDMA in 16 of 38 batches it had tested. Amneal Pharmaceutical’s metformin contained the highest levels, in some cases as much as 16 times the FDA’s recommended daily limit. Other companies’ metformin contained more than 10 times the FDA limit.

What is NDMA? NDMA stands for N-Nitrosodimethylamine, a chemical that has been linked to cancer. The U.S. Centers for Disease Control’s Agency for Toxic Substances and Disease Registry (ATSDR), states that it is “reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.” In addition. the U.S. Environmental Protection Agency (EPA) has designated NDMA a probable human carcinogen.

Metformin FDA Recalls

In May of 2020, the FDA announced that 5 companies announced voluntary recalls for certain lots of extended-release metformin. The manufacturers included in the recall were

  • Apotex
  • Amneal Pharmaceuticals LLC
  • Marksans Pharma Limited
  • Lupin Pharmaceuticals Inc.
  • Teva Pharmaceuticals USA, Inc.

Since then, several companies have also recalled lots of extended release metformin. To see the most recent recall updates, check the FDA’s website.

The FDA recommends that patients continue to take their extended-release metformin until a doctor or health care professional has prescribed an alternate form of treatment. It could be dangerous for a person with Type 2 diabetes to discontinue their medication without speaking with a medical professional first, so please contact your doctor if you are taking an extended-release form of metformin. Testing has not shown the presence of NDMA in immediate release (IR) metformin products. IR metformin is the most commonly prescribed type of metformin.

What Can You Do?

If you or a loved one has been diagnosed with cancer after taking extended-release metformin, you may have a claim for damages. Contact the metformin lawyers at Thornton Law Firm by calling 1-888-341-1405 or telling us your story here. Thornton Law Firm’s experienced drug and medical device attorneys can help you assess your potential claims. The consultation is free and will be held in complete confidence.

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Surgical Stapler Lawsuits

If you or a loved one has been seriously injured by the use of a surgical stapler, call our surgical stapler attorneys at 1-888-341-1405 for a free, no-obligation consultation to discuss your legal rights. Or contact us online to tell us your story

What Are Surgical Staplers?

A surgical stapler is a device used by doctors to close wounds or surgical incisions, instead of stitches or sutures. The patient is literally being stapled back together. Surgical staplers are used in many kinds of surgeries, and their use has been increasing.

Surgical staples do not dissolve. They must be removed by a doctor after the wound or surgical area has fully healed. Staples may need to stay in the body for up to 21 days before they are removed.

Gastric bypass surgeries – including the surgery known as having your stomach stapled – are one surgery where staples are not usually removed. If there is a failure of the staples used in a gastric bypass, this can allow gastric contents to leak out into the abdominal cavity.

Most of the surgical staplers used in this country are manufactured by either Ethicon, a subsidiary of Johnson & Johnson, or Covidien, a subsidiary of Medtronic.

Surgical stapler manufacturers

  • 3M
  • B. Braun Melsungen AG
  • Cardica
  • Care Fusion Corporation
  • CONMED
  • Covidien (subsidiary of Medtronic)
  • Ethicon (subsidiary of Johnson and Johnson)
  • Frankenman International
  • Meril Life Sciences
  • Purple Surgical
  • Reach Surgical
  • Smith & Nephew
  • Stryker
  • U.S. Surgical Corp.
  • Welfare Medical Ltd.
  • Zimmer Biomet

What Kind of Post-Op Complications Can Surgical Staplers Cause?

Like the staplers we use at home or at work, sometimes surgical staplers can misfire, jam, or fail to properly close the staples. When deployed near delicate tissues and critical organs – like the heart, lungs, kidneys, and gastrointestinal tract – this can be a deadly failure. Complications from a surgical stapler failure can include:

  • Internal bleeding,
  • Hemorrhagic shock,
  • Nutritional and digestive issues,
  • Need for permanent ostomy bag,
  • Leak in the closures (anastomotic leak)
  • Needing additional closures (anastomoses)
  • Fistula formation,
  • Sepsis,
  • Damage to internal organs,
  • Additional surgeries,
  • Death.

Ethicon Surgical Stapler Recalls 2019

The FDA announced two Class I recalls  of Johnson & Johnson subsidiary Ethicon’s Endo-Surgery surgical staplers in 2019.

A Class 1 recall is the most serious type of FDA recall and is issued when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the FDA.

Ethicon Circular Stapler Recall May 2019

The circular staplers were recalled for insufficient firing and failure to completely form staples.  Products included in the circular stapler recall are:

  • Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
  • Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples

Ethicon Surgical Stapler Recall October 2019

Ethicon announced a Class I recall in October 2019 for the Echelon Flex™ Endopath® stapler due to a defective component which is out of specification and that may cause malformed staples.

Echelon Flex™ Endopath® recalled staplers:

  • Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
  • Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
  • Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
  • Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)

Trust Our Massachusetts Surgical Stapler Attorneys To Help

If you or a loved one has experienced surgical complications from the use of  a surgical stapler, you may be eligible to file a personal injury claim for damages. You may be compensated for medical expenses and  money damages for the pain, suffering, physical injuries, and any other losses, such as lost income,  that you suffered as a result of your injuries.

Call Attorney Marilyn McGoldrick at 1-888-341-1405  or contact the Boston law firm of Thornton Law Firm LLP online or for a confidential, no-cost consultation with an experienced Massachusetts defective drug and medical device attorney. If you have have had complications from a surgical stapler,  you should seek legal advice as soon as possible, as courts apply strict time limits to all legal claims. Contact us today for a fair and thorough consideration of your case.

 

Paragard IUD Lawsuits

Paragard IUD Lawsuits

If you believe you have experienced complications while using a Paragard IUD, you may have a claim for money damages. Please call Attorney Marilyn McGoldrick at 800-404-1150, or tell us your story online.

What is a Paragard IUD?

Paragard is a method of contraception; an intrauterine birth control device (IUD) implanted in the uterus to prevent pregnancy. It is a flexible T-shaped plastic device with copper wrapped around the arms and the stem. It can be implanted non-surgically by a healthcare provider. The Paragard IUD is advertised to be 99% effective in preventing pregnancy, and will last up to 10 years. Approved by the FDA in 1984, it was originally manufactured by Teva Pharmaceutical Industries, Ltd. The Paragard IUD was acquired by The Cooper Companies, Inc., in 2017 for $1.1 billion dollars.

How does a Paragard IUD work?

While other IUDs use hormones to prevent pregnancy (the hormonal IUDs on the U.S. market are Mirena, Kyleena, Liletta and Skyla), the Paragard IUD emits small amounts of copper. Copper ions are associated with an inflammatory response in the uterus. The inflammation in the uterus prevents the sperm from reaching the egg. Researchers also believe the copper ions have a spermicidal, or sperm-killing, effect.

Paragard IUD history with FDA.

The Paragard IUD was originally approved in 1984 for use by women in a monogamous relationship who had at least one child. Revisiting the prescribing label in 2005, the recommendation was expanded to include all women over the age of 16 to menopausal.

More than 40,000 reports of adverse reactions have been made to the FDA since the Paragard IUD device was approved in 1984, including more than 15,000 serious complications and at least 15 deaths.

What severe injuries are associated with the Paragard IUD?

  • Breakage during removal
  • Device embedded in the uterus
  • Device expulsion
  • Inflammation caused by copper left in the body
  • Device migration
  • Device migration leading to organ damage
  • Perforation of the uterine wall
  • Infection or abscess
  • Scarring of the uterus
  • Scarring and damage to other organs
  • Hysterectomy
  • Death

What can you do?

If you or a loved one has suffered complications while using the Paragard IUD form of birth control, you may have a claim for damages. Contact Attorney Marilyn McGoldrick and her team of defective drug lawyers at Thornton Law Firm for a free, confidential evaluation of your legal rights at 1-888-341-1405. Or tell us your story using our contact form for a free and thorough evaluation of your legal rights.

Trust our defective drug attorneys to help.

Contact us online or at 1-800-404-1150 for a free consultation with a recognized leader in Massachusetts and around the country in defective drug litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.

Belviq Weight Loss Drug Lawsuits

What is Belviq?

Belviq, generic name lorcaserin, is a prescription weight loss drug for treating obesity. Belviq was first marketed in the United States in 2012 after FDA approval. It came in a regular version, 10 mg tablets taken twice a day, and as a once-a-day extended-release 20 mg tablet, called Belviq XR.

Developed by Arena Pharmaceuticals, it was distributed in the United States by Eisai Inc. Belviq was the first weight-loss drug approved in the United States in 13 years. As part of the approval, Eisai was required to perform a long-term clinical trial into the cardiovascular effects of Belviq.

Belviq and Belviq XR Recalled

On January 14, 2020, the FDA alerted the public that the clinical study of Belviq showed “a possible increased risk of cancer.”

On February 13, 2020, the FDA and Eisai Inc. announced Belviq and Belviq XR were being removed from the market at the request of the FDA because the safety clinical trial showed an increased occurrence of cancer. The risk of cancer outweighed any weight loss benefit from taking the drug.

While Eisai pulled the drug from the market at the request of the FDA, it disputed the FDA’s interpretation of the data from the clinical trial.

Belviq and Cancer

The clinical trial of Belviq followed 12,000 participants for more than 5 years. Those who took Belviq had an elevated overall cancer rate compared to those who took a placebo.

Pancreatic, colorectal, and lung cancers occurred more frequently, although a range of cancer types was reported by participants in the study.

Because of the elevated cancer risk, the FDA recommended patients stop taking Belviq immediately, and talk to their health care providers about alternative weight loss medicines and weight management programs.

What Can You Do?

If you or a loved one took Belviq and were diagnosed with any form of cancer, you may have a legal claim for damages. Contact the Belviq cancer lawyers at Thornton Law Firm by calling 1-888-341-1405 or telling us your story here. Please contact us as soon as possible if you believe you have a claim. Courts enforce the time limits for filing lawsuits very strictly. Do not delay seeking legal advice.

 

Elmiron and Eye Damage Lawsuits

If you believe you have experienced vision loss or other eye damage after taking Elmiron, you may have a claim for money damages. Please call Attorney Marilyn McGoldrick at 888-809-3937. or tell us your story online 

What is Elmiron?

Elmiron is a medication prescribed to relieve the pain and discomfort of interstitial cystitis (IC). IC is also known as Painful Bladder Syndrome (PBS).  It was originally approved by the FDA in 1996 and is supplied in 100 mg white opaque hard gelatin capsules.  The generic name for Elmiron is polysulfate sodium.

IC is a chronic condition in which the patient may experience bladder pressure, bladder pain, pelvic pain, bladder frequency, urge incontinence, and painful sex. Women are much more likely to experience IC than men. The pain caused by IC can range from mild to severe.

Elmiron is the only drug approved by the FDA specifically for the treatment of interstitial cystitis.

FDA Adds New Warning to Elmiron Label

In June, the U.S. Food and Drug Administration (FDA) approved a new warning label for Elmiron after the medication had been linked to cases of eye damage and vision-related injuries.  Despite receiving reports of pigmentary changes in the retina, also referred to as “pigmentary maculopathy” and several studies indicating a link between Elmiron use and eye damage, the label for Elmiron did not contain any warning about the potential for eye damage.   Pigmentary maculopathy is progressive and permanent.  It cannot be reversed.

The new warning label warns that use of Elmiron may cause “retinal pigmentary changes”. Because of the potential eye damage which may be caused by regular use of Elmiron, the FDA recommends doctors obtain a detailed ophthalmologic history in every patient prior to beginning a course of the drug.

What is retinal maculopathy and what are the symptoms?

In May of 2018 a team of opthalmologists at Emory University in Atlanta identified six patients who had been taking Elmiron with a newly discovered retinal disorder they named “retinal maculopathy”.  Nearly all the patients in this study showed hyperpigmentation of the “subtle paracentral hyperpigmentation at the level of the reginal pigment epithelium (RPE)”. They describe retinal maculopathy as novel – and possibly avoidable.

The following retinal maculopathy symptoms may be related to the use of Elmiron:

  • Difficulty reading
  • Slow adjustment to low or dim lighting
  • Blurred vision
  • Night blindness
  • Difficulty reading
  • Dark spots in vision
  • Loss of detailed vision
  • Blurry vision
  • Seeing dark spots
  • Color blindness
  • A change in eye color
  • Blindness

What can you do?

If you are taking Elmiron and have experienced any changes in vision that may be related to the use of the drug should speak with a doctor about getting the appropriate eye exams. The FDA recommends all patients who have a pre-existing ophthalmologic condition and all patients who have taken Elmiron for more than six (6) months receive a comprehensive retinal examination.

Patients who have been diagnosed with age-related macular degeneration, retinal deterioration, and pattern dystrophy – all diseases related to pigmentary maculopathy – who are taking Elmiron may actually be experiencing retinal maculopathy.

Trust our Massachusetts Elmiron attorneys to help

If you believe you have experienced vision loss or other eye damage after taking Elmiron, you may have a legal claim for the damage you suffered. Please call Attorney Marilyn McGoldrick at 888-809-3937 or tell us your story online for a free consultation with a recognized leader in personal injury and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case. All consultations are held in the strictest confidence.

TDF and Truvada Lawsuits

What are TDF and Truvada?

The HIV drug tenofovir disoproxil fumarate (TDF) is a pharmaceutical that is prescribed (along with other drugs) to patients with human immunodeficiency virus (HIV).

The branded drugs Truvada, Viread, Atripla, Complera, and Stribild all contain TDF. Viread was the first anti-HIV TDF drug on the market, in 2001.

TDF’s ingredients work to decrease the amount of HIV virus in the system, thereby boosting the immune system.

Truvada, a drug combinating emtricitabine and tenofovir disoproxil fumarate, was originally prescribed to treat HIV when it was released in 2004. In 2012 it was also approved as a pre-exposure prophylaxis (PrEP) treatment to reduce the risk of acquiring HIV for sexually active at-risk adults, along with safe sex practices.

TDF and the other TDF-containing drugs are manufactured by Gilead Sciences, Inc., an American pharmaceutical company headquartered in Foster City, California.

What are the side effects of  TDF and Truvada?

Patients taking TDF/Truvada have reported serious side effects including bone deterioration, kidney problems, and lactic acidosis.

Symptoms of bone deterioration in patients taking TDF or Truvada may include:

  • Pain or discomfort;
  • Osteopenia (loss of bone mass);
  • Osteoporosis (porous bone – the bone looks like a honeycomb under a microscope)
  • Fractures

TDF or Truvada may also cause severe kidney problems including:

  • Acute renal failure;
  • Chronic kidney disease;
  • Kidney tubular dysfunction; or
  • Fanconi’s syndrome.

Patients may experience the following symptoms of kidney damage while taking TDF or Truvada:

  • Weakness;
  • Headaches;
  • Fatigue;
  • Confusion;
  • Breathing difficulty;
  • Bruising;
  • Nausea;
  • Vomiting;
  • Thirst;
  • Decreased urine output;
  • Numbness;
  • Muscle cramps;
  • Swelling;
  • Anemia; and/or
  • Yellow skin color

Finally, a patient taking TDF or Truvada may develop lactic acidosis, which is difficulty removing excess acid from the body. Lactic acidosis makes the blood too acidic, as blood is normally slightly alkaline. These symptoms may indicate lactic acidosis:

  • Abdominal or stomach discomfort;
  • Muscle pain or cramping;
  • Decreased appetite;
  • Diarrhea;
  • Fast, shallow breathing;
  • Fatigue;
  • Weakness;
  • Cold and clammy skin;
  • Sweating;
  • Unusual anxiety or confusion;
  • Unusual sleepiness.

What should I do?

If you are experiencing any symptoms you believe may be related to a TDF-containing drug such as Truvada, you should seek medical attention from a physician immediately. In particular, lactic acidosis is a very serious condition. Lactic acidosis can cause death if not treated immediately on an emergency basis.

How we can help

Thornton Law Firm LLP has been a leader in investigating and pursuing financial compensation on behalf of individuals who have been injured by defective drugs for more than 30 years. We have a team of attorneys dedicated to this complex area of law. We understand your rights, what is at stake, and how to handle drug claims from beginning to end. For a free evaluation of your TDF/Truvada case, please call Attorney Marilyn McGoldrick at our toll-free number 1-888-341-1405 or tell us your story here. You have nothing to risk. We offer a fair and accurate assessment of your case.

 

Hernia Mesh Lawsuits

Patients who have been implanted with hernia mesh and subsequently suffered complications have filed lawsuits against the various manufacturers for design defects, manufacturing defects, negligence, and failure to warn patients and their doctors of known problems. The lawsuits request compensation for pain and suffering, lost wages and medical costs.

If you are concerned that your hernia mesh has failed, that you have suffered injury because of failed hernia mesh, or have any questions about your mesh implant, contact attorney Marilyn McGoldrick at 1-(866) 469-6374, or tell us your story HERE. The consultation is free and completely confidential.  The time limits for filing claims hernia mesh manufacturers and distributors are short and strictly enforced. Call now for a consultation with an attorney with years of experience litigating hernia mesh cases.

What is a Hernia?

A hernia occurs when a piece of tissue that should be inside the body begins to protrude outside the body. Hernias can be caused by a weakness in a part of the body, by overexertion, or because of certain medical conditions, like obesity.  Common hernia sites include at the bellybutton (umbilical), inner groin (inguinal), outer groin or thigh (femoral), the diaphragm or upper stomach (hiatal) or at a surgical or incision site (ventral). Each type of hernia requires medical intervention to put, and hold, the protruding tissue back where it should be.

What is Hernia Mesh?

Surgeries to repair hernias often involve hernia mesh, a piece of material that is placed to hold the protruding tissue in place. Hernia mesh sometimes comes in what is called a plug, shaped like a little umbrella, or in larger sheets. Mesh can be woven or unwoven. It can be inserted using a laparascopic method, or in a traditional surgical manner using a large incision. Hernia mesh can be made out of synthetic materials, or actual tissue (from humans, pigs, or cows).

Do I Have A Hernia Mesh Lawsuit?

Synthetic hernia mesh is the basis of most hernia mesh lawsuits. There are many ways in which hernia mesh can be defective. It can migrate, erode, shrink or contract, harden, fold, extrude, fail to adhere to the hernia site or the abdominal wall, obstruct the bowel, or perforate an organ. 

Have Any Hernia Meshes Been Recalled?

Yes.

C-QUR Mesh was recalled by Atrium in 2013. More than 145,000 units were recalled for packaging problems.  In 2015, when the problems were not resolved by Atrium, the court issued a permanent injunction stopping the distribution of all products, except those not deemed medically necessary.  The product is still on the market.

Physiomesh was recalled by Ethicon (a subsidiary of Johnson & Johnson) in 2016. The product had a higher rate of failure and risk of revision surgery compared with other hernia mesh products.

There are several other hernia mesh products on the market that are the subject of litigation.  Synthetic hernia mesh continues to be used in hernia repair surgeries.

What are the symptoms of hernia mesh failure?

  • Infection
  • Fever
  • Nausea
  • Vomiting
  • Heat, soreness around surgery site
  • Severe, chronic pain
  • Allergic reactions
  • Cramping
  • Protrusion of mesh
  • Lump near surgery site
  • Bloating 
  • Inability to pass stool
  • Hernia recurrence

What complications can hernia mesh cause?

  • Internal injuries
  • Mesh adhesion
  • Mesh failure
  • Allergic reactions
  • Rejection
  • Organ perforation

Revision surgery

Seek medical attention immediately if you believe your hernia mesh implant is causing you problems. If your original hernia mesh has failed, revision surgery may be required. It can be more complicated than the original surgery, because the hernia mesh must be dealt with as well as the hernia, and it may have eroded, migrated, perforated a nearby organ, become infected, or your body may have rejected the mesh entirely. The first step in evaluating your claim, is obtaining the necessary medical records.

Trust Our Hernia Mesh Attorneys to Help

Thornton Law Firm litigates hernia mesh lawsuits against manufacturers and distributors of defective hernia mesh throughout the country. 

If you are concerned that your hernia mesh has failed, that you have suffered injury because of failed hernia mesh, or have any questions about your mesh implant, contact attorney Marilyn McGoldrick at 1-(866) 469-6374, or tell us your story HERE. The consultation is free and completely confidential.  The time limits for filing claims hernia mesh manufacturers and distributors are short and strictly enforced. Call now for a consultation with an attorney with years of experience litigating hernia mesh cases.

DePuy Attune Knee Replacement

DePuy Attune Knee Replacement Lawsuit

DePuy Attune Knee Problems

The DePuy Synthes Attune total knee arthroplasty (TKA) system has been the subject of hundreds of complaints to the FDA about the knee device’s problems. The DePuy Attune Knee was introduced in 2010 and a recent study finds a higher than normal device failure rate. The failure seems to be related to the cement which holds the device in place.

Study of Attune Knee Replacement FDA Reports

The study,  published by the Journal of Knee Surgery, examined Manufacturer and User Facility Device Experience reports (MAUDEs) made to the FDA by manufacturers, hospitals,  doctors, patients, and consumers.  In particular, it studied patients who received a DePuy Attune TKA, and later required revision surgery. In looking at three hospitals, the study found 15 cases of tibial loosening of the cement on the implant.  Further, the study authors noted that there were 21 cases of tibial loosening reported to the FDA within the last two months alone. “Numerous other tibial failures” were reported without specifying how the failure occurred.

510(k) Fast Track Approval – Without Product Testing

The DePuy Attune knee system was fast-tracked by the FDA as DePuy represented to the FDA that the Attune knee system was “substantially similar” to  devices on the market. The 510(k) FDA approval process allows manufacturers to skip doing clinical trials on a product because it is so close to a product already on the market. DePuy submitted to the FDA that the Attune knee system was substantially equivalent to the following existing knee system devices:

  • PFC Sigma© Knee System (cleared as the Darwin Knee System), K943462
  • Sigma Patella (cleared s the Darwin Knee System), K950010
  • PFC Cruciate Retaining System, Size 1.5, K961685
  • Sigma Co-Cr Tibial Trays, K032151
  • Sigma XLK Tibial Inserts, K040166
  • Sigma CR 150 Femoral Components, K082500
  • Zimmer NexGen CR Knee System, K933785
  • AMK© Fixed Stem Tibial Tray, K922620

Attune Knee Problems

Despite DePuy’s claim  to the FDA that the Attune knee system was an improvement over existing knee replacement devices, Attune implant recipients began complaining about problems with their Attune knee systems. Problems reported by DePuy Attune knee implant recipients include:

  1.  Pain in the joint especially when weight bearing
  2.  Loosening of the joint
  3.  Heat or warmth in the knee
  4.  Joint instability
  5.  Grinding in the knee joint
  6.  Joint swelling
  7.  Water on the knee (effusion)
  8.  Dislocation of the device
  9.  Debonding of the device’s cement
  10.  Decreased range of motion (ROM)
  11.  Attune knee joint out of alignment
  12.  Nerve damage
  13.  Fracture of knee system components
  14.  Debris release from knee
  15.  Fracture of femur or tibia

FDA Attune Component Recall 2015

The Attune device was subject to a Class II FDA recall in 2015. The Attune  Knee Tibial Articulation Surface Instruments – tools used to implant the Attune knee implant – were recalled. One component of these, called a Balseal, contained a wire spring coil that could break off inside the patient without the doctor’s knowledge. That DePuy knee recall was terminated by the FDA on November 12, 2015.

Trust Our Massachusetts Attune Knee Implant Attorneys To Help

If you have experienced problems with an Attune knee replacement system, or with any other knee replacement, you may be eligible to file a personal injury claim for damages. You may be compensated for medical expenses from surgery to revise and replace your implant, and money damages for the pain, suffering, physical injuries, and any other losses, such as lost income,  that you suffered as a result of your injuries.

Call Attorney Marilyn McGoldrick at 1-888-341-1405  or contact the Boston law firm of Thornton Law Firm LLP online or for a confidential, no-cost consultation with a specialist in Massachusetts drug and medical device litigation. If you have had problems with an Attune knee implant,  you should seek legal advice as soon as possible, as courts apply strict time limits to all claims. Contact us today for a thorough, fair consideration of your legal claim.

Actemra (Tocilizumab)

What Is Actemra?

Actemra is prescribed for rheumatoid arthritis. It is a biologic drug, known as a monoclonal antibody. It is administered by injection every 1 to 2 weeks, or by intravenous infusion once a month. It is manufactured by Genentech, a subsidiary of Roche.

Why Is It Prescribed?

The FDA has approved Actemra as a medication for the following conditions:

  • Rheumatoid arthritis (moderate to severe)
  • Giant Cell Arteritis (GCA)
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA)
  • Systemic Juvenile Idiopathic Arthritis (SJIA)

How Does Actemra Work?

In rheumatoid artrhtis and other auto-immune diseases, the body’s own immune system begins to attack and destroy joints and tissue. Actemra works to suppress the immune system by blocking the protein interleukin-6, thereby preventing chronic inflammation.

Actemra, Heart Failure, and Pancreatitis

When Actemra was first approved, Genentech advertised the drug as “unique”, a breakthrough medication that didn’t carry a lot of the risks of other rheumatoid arthritis drugs. But a recent study published by STAT found over 1100 reports of deaths from heart or lung complications after using Actemra.

STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.

However, neither the manufacturer or the FDA has moved to inform patients of these serious health risks by adding them to the label of Actemra.

Actemra Side Effects and Injuries

The STAT investigators analyzed more then 500,000 side effect reports to the FDA and found that the risks of heart attacks, strokes, heart failure, and other conditions were higher for patients taking Actemra than for patients taking other rheumatoid arthritis drugs. Experts who examined the STAT data said the FDA should consider immediately adding warnings of the risk of heart failure and pancreatitis, an inflammation of the pancreas that has a high risk of death.

A 2016 study released by the  American College of Rheumatology in 2016 found that Actemra users had a 1.5 times greater risk of heart attack than patients taking Enbrel, a competing rheumatoid arthritis drug.

The FDA has also received reports of interstitial lung disease (lung scarring), strokes, gastrointestinal holes and tears, tachycardia (rapid heartbeat), tremors, and other side effects of Actemra.

What Can You Do?

If you or someone you love has taken Actemra and suffered heart failure and/or pancreatitis, you may have a legal claim for damages against the manufacturer. Call our Massachusetts Actemra lawyers toll free at 1-888-341-1405, or tell us your story using our online contact form.

Trust Our Massachusetts Actemra Lawyers to Help

Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.

Talcum Powder and Ovarian Cancer

Ovarian cancer linked to talcum powder

Use of talcum powder on the genitals and perineal area, including on sanitary napkins, may raise a woman’s risk of developing ovarian cancer, according to scientific studies conducted since 1982. Millions of women have used Johnson & Johnson’s baby powder and Shower to Shower talc powders for years because J&J advertised them as safe for feminine hygiene use. Despite being aware of the studies linking talcum powder use and ovarian cancer, Johnson & Johnson has never placed warning labels on its talc powder products, even today. And they have failed to take the easy step of removing the talc powder from the market and selling the cornstarch powder they already produce.

What is talcum powder?

Talcum powder contains talc, a naturally-occurring, very soft mineral made up mainly of magnesium, silicon, and oxygen. Talcum powder has been sold for many years for use on babies and marketed to adults as a cosmetic and hygienic product.

How does talcum powder cause ovarian cancer?

Scientists are not sure exactly how talcum powder causes ovarian cancer. However, in many cases of ovarian cancer, talc is found in the ovarian tumor itself. Through its advertising, Johnson and Johnson advised that women sprinkle talcum powder in their genital area, and on underwear and sanitary pads. This was recommended to keep the vaginal area dry, to prevent chafing, and to cover up any odor of the vaginal area. Used in these areas, talcum powder can travel into the vagina, uterus, fallopian tubes and the ovaries.

Is it safe to use talcum powder?

Many pediatricians recommend against using talcum powder on babies. The American Pediatric Association recommends against using any powder on a baby, no matter the ingredients because inhaling powder can cause an inflammatory reaction in the lungs. The American Cancer Society advised in 1999 that women use cornstarch powder, rather than talcum powder, in the genital area.

Lawsuits against Johnson and Johnson and its talc suppliers

May, 2016:  A St. Louis jury awarded $72 million dollars to the family of a woman who developed ovarian cancer after using Johnson & Johnson’s talcum powder for many years. The jury awarded $10 million dollars in compensatory damages and $62 million dollars to the family of an Alabama woman. Plaintiff Jackie Fox died of ovarian cancer on October 6th. She had used Johnson & Johnson baby powder and “Shower to Shower” talcum powder for 35 years.

Fox’s family submitted expert medical testimony that talcum powder causes ovarian cancer. Statistical evidence presented at trial also showed that 1,500 women per year die from the association between talcum powder and ovarian cancer.

May, 2016: A South Dakota woman was awarded $55 million dollars against Johnson & Johnson for developing ovarian cancer after decades of using J&J talcum powder products. The jury awarded $5 million dollars in compensatory damages and $50 million dollars in punitive damages.

The plaintiff, Gloria Ristesund, was diagnosed with ovarian cancer in 2011 after using J&J Baby Powder and Shower to Shower powder as advertised, on her genital area, for almost 39 years. She is in remission after undergoing a full hysterectomy. Her lawsuit charged Johnson & Johnson of failing to warn of the cancer risk of using talcum powder or failing to remove talc from the powder and replace it with cornstarch which has similar soothing properties. The jury found in her favor after one day of deliberations following a three-week trial.

October, 2016:  A St. Louis jury awarded a California woman $70 million dollars in her lawsuit claiming that years of using Johnson & Johnson’s talc baby powder caused her ovarian cancer.

The 63-year-old plaintiff, Deborah Giannecchini, used Johnson & Johnson’s baby powder for feminine hygiene for four decades before she was diagnosed with Stage IV ovarian cancer in 2012. She has undergone multiple surgeries, radiation, and chemotherapy to treat cancer. Evidence was introduced that she has an 80% chance of dying in the next two years.

What can you do?

If you or a loved one has been diagnosed with ovarian cancer after using talcum powder, you may have a claim for damages. Contact the defective product lawyers at Thornton Law Firm for a free, confidential evaluation of your legal rights at 1-888-341-1405. Or tell us your story here for a free and thorough evaluation of your legal rights.

Trust our Massachusetts defective product attorneys to help

Contact Attorney Marilyn McGoldrick and tell her your story online or call her at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective product litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.

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