Prempro Lawsuit

A Brief Guide to Filing a Prempro Lawsuit:

What is Prempro?

Prempro is a prescription medication that alleviates certain conditions and symptoms of menopause. Prempro is the brand name for an oral medication containing medroxyprogesterone acetate and estrogen. It is administered to women who experience severe menopause symptoms including dizziness or hot flashes. Prempro may also be administered to patients with vaginal atrophy and osteoporosis. Despite the drug’s effectiveness with regards to increasing estrogen levels, Prempro poses significant side effects.

Prempro Side Effects:

The most common Prempro side effects include back or abdominal pain; headaches; increased incidences of bacterial infections; pharyngitis; nausea; breast tenderness or pain; and itching. According to various studies conducted by the United States Food and Drug Administration, these Prempro side effects occur in roughly 10-30% of users.

Moreover, according to various reports issued by the Mayo Clinic, using prempro in conjunction with other medications such as isotretinoin (acne medication), felbamate, theophylline (lung disease medication) and.or paclitaxel (chemotherapy drug) increases the risk of Prempro side effects.

Similar to other estrogen supplements, Prempro increases the patient’s risk of developing blood clots, stroke, heart attacks, dementia and the development of estrogen-dependent tumors like endometrial or breast cancers. Additionally, Prempro side effects also include loss of vision, increased blood calcium levels and gallbladder disease.

Because of these side effects, Prempro is not safe for use during pregnancy. If a prospective user has a history of diabetes, epilepsy, asthma, heart problems, lupus, benign liver tumors, kidney disease, blood clots, gallstones, pancreatitis, or vision loss, it is not safe to consume Prempro.

Prempro FDA:

In January of 2003, the FDA and Wyeth (Prempro’s manufacturer) revised the prescribing information to include boxed warnings to aptly reflect that estrogens and estrogens combined with progestin therapies should not be applied for the prevention of cardiovascular disease. This FDA warning includes risk information from the Women’s Health Initiative study, which reported increased risks of stroke, myocardial infarction, pulmonary emboil, invasive breast cancer and deep vein thrombosis in postmenopausal women during a 5-year conjugated equine estrogen treatment plan. Because of these Prempro side effects, estrogens should be prescribed at the lowest effective dosage levels and for the shortest duration possible.

Prempro Lawsuits:

Due to the aforementioned side effects, Pfizer—the drug’s manufacturer—has faced a whirlwind of Prempro lawsuits. The bulk of these Prempro lawsuits allege that use of the drug caused breast cancer.
To elaborate, the Women's Health Initiative in 2002, released a report stating that Prempro side effects included an increased risk of heart attacks, strokes, clots and breast cancer. These disclosures both decreased drug sales and increased the number of women seeking a Prempro lawsuit.

Prempro lawsuits stem from the drug’s chemical makeup; Prempro combines Premarin with progestin—a combination that results in an increased risk of breast cancer. A swarm of Prempro lawsuits were filed in response to the Women’s Health Initiative Report. The number of plaintiffs seeking Prempro lawsuits escalated at roughly 10,000. A large percentage of these Prempro lawsuits; however, were dismissed before reaching formal trial.

The first noteworthy Prempro lawsuit took place in April 2006. Prior to this period, no Prempro lawsuit had come to trial. Although this Prempro lawsuit was ultimately dismissed, the second litigation effort resulted in a $1.5 million settlement for a woman whose Prempro side effects included the development of breast cancer. The number of Prempro lawsuits exponentially grew in the subsequent years, as more and more users were developing breast cancer.

In 2007, a $134.1 million Prempro settlement was awarded to three Nevada women who developed breast cancer. In 2009, in response to similar Prempro lawsuits, the FDA added a warning to elaborate the risks associated with breast cancer.

In 2011, it was reported that the first large-scale Prempro lawsuit was disbursed by Pfizer. Reports stated that roughly 2,200 Prempro lawsuits resulted in a Prempro settlement for the plaintiff. By 2012, it was reported that the company had paid $896 million as remuneration in Prempro lawsuits.

At this time, Pfizer estimates that it has resolved two-thirds of its Prempro lawsuits. It is not known how many cases were dropped before trial or how many plaintiffs received out-of-court compensation; however, a 2009 study published in The Lancet indicated that Prempro side effects might include the development of lung cancer. If further studies determine that this is the case, it is possible that more people will pursue a Prempro lawsuit.

Initially, many cases seeking compensation for Prempro side effects were handled in in an Arkansas federal court as part of consolidated multidistrict litigation.

Sources:

1. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153358.html

2. http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm116295.html