Dallas Pharmaceutical and Medical Device Lawyer

The U.S. Food and Drug Administration (FDA) is responsible for overseeing all newly-released market drugs and medical devices in the US. Manufacturers have an obligation to undergo a meticulous and thorough testing process prior to usage approval. In most cases, these drugs and devices provide patients with safe and effective treatment options for severe medical conditions. However, occasionally drugs and devices fail to meet the proper requirements, resulting in significant side effects, irremediable health ramifications, or in worst cases, death.

Despite the anguish caused by these drugs or devices, they can remain on the market for an extended period of time before being recalled, leading to a substantial amount of injuries of deaths. Drug manufacturers are held accountable to warn users of the risks correlated with each medication. If they fail to meet this requirement, they are liable for any suffering endured by the consumer. If you or a loved one has suffered from the ill effects of a pharmaceutical drug or a defective medical device, it is imperative to seek legal representation with a Dallas pharmaceutical lawyer at our firm.

Actos® Drug Injury Lawyer

The ninth best-selling drug in the US in 2010, Actos (pioglitazone hydrochloride) is a Type 2 diabetes drug commonly used with a diet and exercise program. However, the FDA warns that the consistent use of the drug for more than one year has been associated with 40% increases in risk for bladder cancer.

The FDA recommends patients to contact a medical professional immediately if they experience the following:

  • Blood or red color in urine
  • Urgent need to urinate or pain while urinating
  • Pain in back or lower abdomen

Information about the risk of bladder cancer associated with Actos has been added to the Warnings and Precautions section of the label for pioglitazone-containing medicines as well as the patient Medication Guide. The active ingredient in Actos (pioglitazone) is also sold in combination with metformin (Actoplus Met®, Actoplus Met XR®) and glimepiride (Duetact®). From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.

Never stop taking any medication without first consulting your doctor. Actos®, Actoplus Met®, Actoplus Met XR®, and Duetact® are registered trademarks of Takeda Pharmaceutical Company Limited and are used here only for the purpose of identifying the products in question. This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration or Takeda Pharmaceutical Company Limited.

SSRI Birth Defect Lawyer

Selective Serotonin Reuptake Inhibitors (SSRIs) are widely prescribed for the treatment of depression, anxiety, panic disorder, post-traumatic stress disorder and social phobia in order to correct chemical imbalances in the brain. In regards to normal body function, chemicals called neurotransmitters send signals from one nerve cell to another. SSRIs act on one particular neurotransmitter, serotonin, reducing its reentry into nerve cells in order to develop an increase in serotonin.

Recent studies determined mothers who used SSRIs during pregnancy has been linked to babies born with birth defects which can be severe and life-threatening. Due to the similar way SSRIs interact with our brains, the entire class of drugs has correlated with birth defects.

Specific products include, but are not limited to, the following:

  • Celexa® (citalopram)
  • Lexapro® (escitalopram)
  • Luvox® (fluvoxamine)
  • Paxil® (paroxetine)
  • Prozac® (fluoxetine)
  • Symbyax® (olanzapine/fluoxetine)
  • Zoloft® (sertraline)

Celexa® and Lexapro® are registered trademarks of Forest Pharmaceuticals, Inc. Luvox® is a registered trademark of Solvay Pharmaceuticals. Paxil® is a registered trademark of GlaxoSmithKline. Prozac® and Symbyax® are registered trademarks of Eli Lilly and Company. Zoloft® is a registered trademark of Pfizer Inc. All trademarks are used to identify the products in question.

Birth Defects Caused By SSRIs Taken During Pregnancy

The FDA reported that one study showed infants born to mothers who took SSRIs after the 20th week of pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy. A mother who takes an SSRI drug may have a child born with this serious condition, which occurs when a newborn is unable to adapt to breathing outside the womb. This results in the child suffering from abnormal blood flow through the heart and lungs, leading to a lack of oxygen supplied to the rest of the body. Babies with PPHN can become very sick and may die.

Such birth defects could include:

  • Omphalocele
  • Spina bifida
  • Anencephaly
  • Limb malformation (ex: club foot)
  • Heart defects such as atrial septal defects (ASD) or ventricular septal defects (VSD)
  • Persistent pulmonary hypertension in a newborn (PPHN)
  • Craniosynostosis (premature closing of the skull bones)
  • Craniofacial defects, including cleft lip or cleft palate

Vaginal Mesh Failure Lawyer

Recently, many women have turned to transvaginal mesh as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) by inserting the transvaginal mesh to help hold the woman's internal organs in place. Rather than simply stitching tissue of the vaginal wall together, the transvaginal mesh is used to keep the organs—namely the urethra, cervix, and rectum—from falling out of place and "sagging" inside the body cavity. For many, the treatment is effective. Unfortunately in some instances, the mesh results in a number of serious and painful side effects.

In 2010, more than 75,000 women had transvaginal mesh surgery to repair pelvic organ prolapse.

A recent study published in the New England Journal of Medicine revealed troubling results with these procedures: women who had a transvaginal mesh inserted suffered higher rates of serious complications, including bladder perforation and pelvic hemorrhage and an increased number of adverse events after the surgery, such as urinary incontinence and pain during intercourse.

The FDA wanted the following in a 2008 public health notification:

"The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain."

Furthermore, these problems can result in additional complications, such as the need for a second, "revision surgery," IV therapy, blood transfusions, and the treatment of hematomas or abscesses. The FDA later issued an urgent safety communication advising patients and their healthcare providers to consider alternatives to transvaginal mesh. The FDA met to discuss a potential ban on the mesh, after receiving more than 3,875 injury reports associated with the mesh, 3 of which involved fatalities, from 2005 to 2010.

  • Is pelvic organ prolapse common?
    • Some estimates suggest that nearly half of all women between the ages of 50 and 79 have some degree of prolapse. The risk that a woman will need a surgical procedure to correct prolapse is about 11%, and about 33% of these women will need a second surgery to correct problems stemming from the condition or initial surgery.
  • What causes this condition?
    • Pelvic organ prolapse is a result of predisposition, race, and injury. Caucasian women are more likely to suffer the condition than African American women, and injury, childbirth, heavy lifting, and even smoking are also contributing factors.
  • What should I do if I had a problem with a transvaginal mesh?
    • If you or someone you care about has a transvaginal mesh used to correct pelvic organ prolapse and suffered any of the above symptoms, our law firm may be able to help. Contact us today to learn more.

Seek Legal Representation With Our Trusted & Experienced Pharmaceutical Lawyer

At Gresham, P.C., our staff is dedicated to fighting for the justice of our clients who have been severely injured taking life-threatening pharmaceutical drugs or using defective medical devices. Don’t let the negligent of medical manufacturers cause more damage to your life, let us protect your rights and help you get your life back on track.

Let our firm help you through the legal process. Call us today and fight for the justice that you deserve.

Begin Your Injury Claim

Take the First Step Towards Justice

Get In Touch