On December 14, 2011 the FDA issued a safety communication regarding Select Serotonin Reuptake Inhibitor (SSRI) Antidepressants and “use during pregnancy and potential risk of Persistent Pulmonary Hypertension of the newborn.” This follows a string of warnings and studies pertaining to the use of antidepressants during pregnancy resulting in complications with the baby.

Antidepressants being investigated are:

• Celexa
• Lexapro
• Paxil
• Prozac
• Wellbutrin
• Zoloft

Injuries being investigated are:

• Anencephaly (neural tube defect)
• Clubfoot
• Craniosynostosis (craniofacial defect)
• Omphalocele (abdominal defect)
• Gastroschisis (abdominal defect)
• Heart Defects
• Lung Defects
• Spina Bifida

If you or someone you know ingested an antidepressant while pregnant and their baby was born with one of the above mentioned defect,

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Benicar was first approved by the FDA in 2002 to help lower blood pressure, but has conversely been known to lead to chronic diarrhea in patients with symptoms similar to celiac disease. Symptoms remain unresolved even with a gluten-free lifestyle for these patients. In July of 2013, the FDA broadened its approval to extend for causing intestinal problems defined as “sprue-like enteropathy.”
Benicar has had an increasing amount of adverse effects reported to the FDA.

Patients using Benicar have suffered:

• Chronic Diarrhea
• Vomiting
• Rapid & Excessive Weight Loss
• Dehydration
• Cardiovascular problems

In many instances, these injuries have resulted in hospitalization. If you or a loved one has ingested Benicar and was subsequently diagnosed with one of the above-mentioned side effects, please contact us.

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DePuy ASR

In August of 2010 DePuy Orthopaedics, Inc. issued a voluntary recall of the DePuy ASR hip implant system.

The DePuy ASR hip implant is a metal on metal implant featuring a “shallow cup design.” Some patients with the ASR hip began experiencing problems such as pain in hip area, squeaking, popping, dislocation of the implant, etc. leading some to undergo painful revision surgery. Additionally, some patients were found to have elevated cobalt and chromium levels as a result of the metal-on-metal implant. Elevated cobalt and chromium levels could lead to a complication known as metallosis. Symptoms of metallosis are pain, pseudo-tumors, rash at the site, loosening of the implant, etc.

Stryker Rejuvenate

In July of 2010, Stryker Orthopaedics issued a voluntary recall on its Rejuvenate hip implant following multiple adverse event reports to the Food and Drug Administration. The recall urges patients to undergo periodic diagnostic testing to ensure they have not been exposed to high levels of metal ions.

The Stryker Rejuvenate hip system is a type of implant known as a modular implant. Although the Stryker Rejuvenate implant is not considered a metal-on-metal implant, the neck of the Stryker Rejuvenate implant is made of cobalt and chromium and when rubbed against the titanium coated stem, can have the same effects as metal-on-metal implants.

Some symptoms patients may be experiencing are:

• Loosening of the implant
• Metallosis
• Necrosis of the tissue surrounding the implant
• Pain or rash at site of implant
• Pseudo-tumors

Often times, patients experiencing these symptoms are required to undergo painful revision surgery resulting in long recovery periods and physical therapy.

Our firm is currently investigating a range of hip implant products with a metal-on-metal design. If you or someone you know underwent a hip implant surgery and has suffered complications following that surgery,

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Mirena is an intrauterine device used for contraception. Mirena is recommended for use in women that have at least one child. It is inserted into the uterus and should be removed after five years. Unlike most contraceptives, it does not contain estrogen. Mirena was first approved for contraception in 2000. In 2009 it was approved for control of menstruation. Recent studies have shown an increased risk for spontaneous migration of the device causing pain and in some cases requiring surgery to remove the device.

WARNINGS

Women using Mirena are at risk for serious injuries such as:

• Spontaneous migration of the implant
• Perforation of the Uterus

Symptoms of these problems include:

• Pelvic and abdominal pain
• Irregular bleeding

Often, women undergo radiological tests to determine where outside of the uterus the device has migrated in order to have it safely removed.

If you or someone you know has used Mirena and was subsequently diagnosed with device migration or perforation of the uterus,

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On July 13, 2011, the FDA issued a safety communication in regards to “serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapsed.” Women suffering from Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP) underwent surgery in which they were treated with a surgical mesh.

On June 4, 2012, one of the manufacturers of the mesh products, Ethicon (a subsidiary of Johnson & Johnson) announced that it would discontinue the Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare Prosima Kit and Gynecare TVT-Secur products.

Post-surgery some women may begin experiencing complications which can lead to debilitating symptoms and at times result in additional surgery(ies). Some symptoms may include:

• Vaginal/Pelvic pain
• Bleeding
• Infection
• Urinary problems
• Pain during sex
• Organ Perforation
• Implant Hardening

If you or someone you know had a pelvic mesh and/or sling implant and have suffered complications following the surgery,

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Morcellators, first approved in 1993, are widely used in surgeries for treatment of uterine fibroids, as they allow for a minimally-invasive procedure that cuts fibroids into small pieces that can then be removed laparoscopically. A study published in March of 2014 in the Journal of American Medical Association (JAMA) evaluated the risks of electric uterine morcellation and found that it can be difficult to prevent small tissue fragments and certain cancers, including uterine sarcomas, carry a risk of being dispersed during the procedure.

On April 17, 2014, the FDA broadened its approval to extend that if laparoscopic power morcellation is performed in women undergoing hysterectomy or myomectomy for fibroids that may have an unsuspected type of uterine cancer, there is a risk that the procedure will spread cancerous tissue within the abdomen and pelvis, “significantly worsening the patient’s likelihood of long-term survival.”

Patients who underwent surgery with a morcellator and subsequently developed cancer suffered:

• Abnormal vaginal bleeding / discharge
• Vaginal lumps
• Frequent urination
• Abdominal pain / feeling full
• Death

If you or a loved one has suffered from cancer as a result of morcellation, please contact us immediately, so that we may evaluate your claim.

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Pradaxa, first approved by the FDA in October of 2010, is used in patients with atrial fibrillation to prevent stroke. It is the first anticoagulant approved for stroke prevention in patients with atrial fibrillation since Warafarin (brand names Coumadin and Jantoven) was made available.

In 2011, reports were released showing Pradaxa having one of the highest ranks of adverse event reports filed with the FDA. In December 2011, the FDA announced it was evaluating reports of serious bleeding events in patients taking Pradaxa.

Patients using Pradaxa have suffered:

• Gastro-intestinal (GI) bleeding
• General unspecified internal bleeding
• Hemorrhagic stroke
• Trauma induced bleed out

In many instances, these injuries resulted in hospitalization, and in some instances resulted in death. If you or someone you know has ingested Pradaxa and was subsequently diagnosed with a serious bleeding event,

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Talcum powder, commonly found in products such as Johnson & Johnson’s baby powder, is used by women for perineal hygiene. Talcum powder ovarian risk has been documented through numerous studies dating back to 1982. In 2010, a study was published in Cancer Epidemiology, Biomarkers and Prevention concerning the role of talc particles and cancer, confirming that talc in baby powder is carcinogenic to humans.

Patients using talc powder who developed ovarian cancer have suffered:

• Abdominal pain/swelling
• Bloating
• Constipation
• Fatigue
• Frequent urination
• Abnormal vaginal bleeding
• Death

While some leading cosmetic companies admit the risk of talc powder, Johnson & Johnson continues to fail to warn consumers of the risk of use of talc powder and developing ovarian cancer. Talcum powder is an unregulated substance in the United States. If you or a loved one has used talc-containing products and subsequently suffered from ovarian issues, contact us as soon as possible.

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Viagra was approved for the U.S. Market in 1998 to treat male sexual function problems such as erectile dysfunction and impotency, but in April of 2014, the Journal of American Medical Association Internal Medicine studied the association between the use of Sildenafil (Viagra) and melanoma. The study found men with a history of Viagra use were twice as likely to develop this form of skin cancer, while men currently taking the drug were at an 84% increased risk. Further, the study revealed identical results when risk factors such as family history of skin cancer and UV ray exposure were taken into account.

Patients taking Viagra who developed melanoma have suffered:

• • Unusual moles
  • Painful biopsies
  • Skin that does not heal
  • Redness/swelling of the skin
  • Change in sensation of the skin
  • Death

If you or a loved one has used Viagra and was subsequently diagnosed with melanoma, please contact us immediately.

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Invokana, a drug used in adults to treat Type II diabetes, was first approved by the Food and Drug Administration (FDA) on March 29, 2013.

Not long after Invokana was release on the market, the FDA began receiving adverse event reports involving acidosis diagnosed as diabetic ketoacidosis (DKA), ketoacidosis or ketosis.

On May 15, 2015 the FDA released a warning of increased risk of ketoacidosis, a condition where the body produces high levels of ketones (blood acids), requiring hospitalization while using Invokana.

Symptoms of ketoacidosis include:

• Difficulty breathing
• Nausea
• Vomiting
• Abdominal pain
• Confusion
• Unusual fatigue/sleepiness

Invokana has also been linked to increased risk of kidney damage/failure and lower limb amputation.

If you or someone you know has been diagnosed with ketoacidosis, kidney failure or lower limb amputation while on Invokana, please contact us to discuss your potential case.