A good doctor and a medicine that works! What else can be better for someone complaining of a serious health condition? Through technological advancement, pharmaceutical companies are able to develop many different products, like medicines or drugs, medical devices and surgical supplies that can effectively remedy general and specific health issues. But, before being allowed for public use, these products will first have to be approved by the US Food and Drug Administration (FDA) and one FDA requirement prior to approval is proof, through actual tests of the drug and device, that these are safe and effective rather than possible causes of unexpected harm or injury to patients.

Every year, millions of new pharmaceutical products are presented to the FDA for approval, keeping the hands of this federal branch of the US government always full. This may probably be the reason why some medical products, despite their manufacturers’ claim that these are safe and effective, end up causing adverse effects instead, some even resulting to severe illnesses, while others are linked to patient death.

It is often challenging to pinpoint who the real liable party is whenever a medical product ends up causing injury rather than providing remedy. It can be the pharmaceutical company, which funded and conducted the tests on their own products, but failed to accurately report the products’ possible negative effects, or the doctor who failed to either accurately diagnose the patient’s condition or find out what other health issues the patient has and the medications that he/she is taking which may interact negatively with the drug or product that he/she intends to prescribe; these, however, are just two of the numerous factors that make medical products, which are expected to remedy illnesses, become dangerous medications instead.

A list of some pharmaceutical products that have been (and which are being) linked to serious side-effects is found in the website of Williams Kherkher. Included in this list are the prescription drugs Zofran and Depakote, and Transvaginal mesh, which is a surgical patch.

Zofran, generically named Ondansetron, is an antiemetic agent manufactured by the London-based GlaxoSmithKline. It belongs to the 5-HT3 receptor antagonist drug group, which is known to effectively block serotonin, a natural substance inside the body that can cause vomiting.

Zofran was approved by the FDA to treat vomiting and nausea caused by surgery, radiation therapy and cancer chemotherapy. It definitely must have been effective, otherwise, its manufacturer would not have recommended it for non-label use (for uses not approved by the FDA). This move served as a cue to doctors, who started prescribing the drug to pregnant women to alleviate in them any feeling of discomfort due to severe morning sickness.

The drug, however, was never tested on pregnant women, thus, the absence of notes or proofs of its safety for their use. And, soon enough, the results started to show: babies born to mothers, who took Zofran during their pregnancy, suffered birth defects, such as cleft palate, cleft lip, mouth deformities, musculoskeletal anomalies and heart ailment.

Depakote is another drug that is said to cause severe birth defects if taken by women during their pregnancy. This anticonvulsant drug earned the approval of the FDA three times for three different purposes: for the prevention of severe epileptic seizures (approved in 1983); to treat manic episodes due to bipolar disorder (in 1995); and, prevent migraine attacks (in 1996). It was not approved, however, to be used by pregnant women.

According to the website of Williams Kherkher, Depakote has been linked to the following birth defects, the most serious health conditions caused by this drug:

  • Spina bifida ( a condition wherein the spinal column does not close totally) and other spinal defects
  • Facial dysmorphism or malformation of face or skull
  • Malformation of cardiovascular system
  • Brain defect, which is often fatal.

Besides these, there are other reported side-effects that Depakote has been connected to, such as liver toxicity, pancreatitis, unusual bruising or bleeding, joint weakness, confusion, difficulty swallowing and/or breathing, and so forth.

The most serious health conditions caused by Depakote, though, can be those found in babies, whose mothers were prescribed with the drug during their pregnancy. Women, who took the drug, were in a great chance of delivering dead babies or babies with birth defects, like facial dysmorphism (deformity in a child’s facial structure), spina bifida (a condition wherein the spinal column of an unborn child does not close totally), deformity of the cardiovascular system, and brain defect, which can be fatal.

Prescription drugs are not the only modern threats to patient safety, however; the website of Williams Kherkher also mentions Transvaginal mesh, a surgical patch, as another cause of severe harm.

Through the surgical procedure called Transvaginal/ Vaginal mesh implant, a patch is attached to a vaginal wall to strengthen it due to its insufficient thickness. This is meant to prevent the occurrence of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) which cause women great pain and discomfort.

In 2011 the US FDA’s Center for Devices and Radiological Health stated that transvaginal placement of mesh is dangerous for, besides causing complications, such as mesh erosion, mesh exposure, mesh contraction and mesh migration, it may no longer be possible to remove it once put in place, which means that it may be impossible for the patient, in whom it was implanted, to recover from its side-effects.

Anyone injured by any kind of product, most especially pharmaceutical products, have the right to file a lawsuit against all possible liable parties for the compensation that they are legally allowed to seek and receive. Seeking the help of a seasoned lawyer, however, should be the first step in order to be successful in this legal pursuit.


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