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Sometimes prominent drugs are recalled and no one knows about it. This was the case with a 2010 Food and Drug Administration (FDA) recall of the birth control Yaz, a contraceptive approved by the FDA for use among women as young as 14 years old. Yaz and Beyaz—a similar FDA-approved medication made by the same manufacturer, Berlex, Inc.—hit the market when it was approved in 2006, according to Drugs.com. Beyaz is primarily used to treat acne, while Yaz is marketed as the contraceptive. The only warnings on the Yaz website for either drug alert women who smoke and women over the age of 35 to increased risks of blood clot or stroke when taking the drug.

The trouble for the popular contraceptive came in 2010, when lawsuits started to pop up across the country alleging that women who were on the medication experienced a much higher rate of blood clots than the manufacturer had described. Bayer, the parent company for Yaz, was sued in 1,100 lawsuits that year, according to CBSNews.com. When Bayer began to face these lawsuits, Yaz was its best-selling product, according to CBS. As a result, one may think that a recall of the product would have been widely publicized. Not so.

The FDA issued a recall of the drug in November 2009, but it never made consumer headlines. This regardless of the fact that it “involved 32,856 boxes of Yaz, at three packs per box, and 122,208 boxes of Ocella, an identical product,” reports CBS. Despite its magnitude, the recall was hidden in the “Enforcement Report” section of the FDA website, meaning that anyone who wanted to know about the recall would already have had to know to look there.


Xarelto is a blood thinner prescribed to patients at high risk of blood clots or strokes and is widely prescribed by the medical community. It can also be used to treat pulmonary embolism and can be used to reduce the risk of clotting in a person who has just undergone joint replacement surgery. According to the Xarelto website, more than 9 million people worldwide have been prescribed Xarelto for various reasons. The only people not recommended to take the drug, according to the website, are people who have artificial heart valves or abnormal types of bleeding. Yet the drug has come under fire lately after many patients and the loved ones of patients complained that the drug resulted in hemorrhaging in otherwise healthy users of the drug.

According to WebMD.com, hemorrhaging is a common side effect that can accompany the less common side effects of taking Xarelto, which can include, but are not limited to:

  • The collection of clotted blood in an organ;
  • Dizziness or sensations of feeling faint;
  • Brain hemorrhaging;
  • Backache or arthritis;
  • Indigestion; and
  • Low energy or muscle spasms.

Since patients began coming forward with cases indicating that Xarelto was responsible for these side effects, many lawsuits have been filed against the manufacturer of the drug for failing to properly alert the medical community to the risks. According to the U.S. Food and Drug Administration, Xarelto was originally approved for use in 2011, and expanded uses—to treat deep vein thrombosis and pulmonary embolism—were approved in 2012. All blood thinners carry the risk of uncontrollable bleeding, yet the risk is more serious with Xarelto than other approved drugs, especially because of its many approved uses. Lawsuits allege that Xarelto's manufacturer, Bayer, and marketing team (overseen by Johnson & Johnson subsidiary, Janssen Pharmaceuticals), did not fully vet the possibility of severe bleeding before releasing the drug to market, after failing to allow time for proper clinical trials before the drug was release to the public.


Products liability covers a large range of products and can include intangible property such as pets, gas leaks, and real estate. Defective medical products are one of the most damaging types of products liability. Examples of defective medical products include those that were not fully vetted for compatibility with the body, those with side effects more severe than the disease they are supposed to alleviate, and those that cause unexpected additional issues for the patient. Product liability for defective medical products does not only refer to the product itself, but also to the way in which the product was distributed and used.

According to the Legal Information Institute at the Cornell University Law School, there are three main types of product defects. These include design defects, manufacturing defects, and marketing defects. A defect in marketing, in regards to a medical device, includes instructions for patient use.

The U.S.Food and Drug Administration (FDA) has strict labeling requirements for medical products, and they vary depending on product type. General requirements entail all products to include adequate instruction for use, meaning, “directions under which the layman can use a device safely and for the purposes intended.” Conditions for which the product shall be used, quantity of adequate dose, duration of dosage, and method of application are all included in this proviso.


When the antidepressant drug Paxil hit the consumer market in the early 1990s, it was hailed by the medical world as a wonder drug, able to relieve even the most severe cases of mental depression. Like most other antidepressants, Paxil is a selective serotonin reuptake inhibitor (SSRI). There have been widely-publicized side effects about SSRIs for the patient who takes them. However, not as much has been published about the effects SSRIs can have on babies born to women who are taking them.

According to the U.S. Food and Drug Administration (FDA), the first such warning was in fact issued as early as 2005, when the FDA advised the medical community to discontinue the practice of prescribing Paxil to pregnant women. In 2005, however, the FDA maintained that women who were already on Paxil may face a greater risk to the fetus by discontinuing the medication than by continuing to take it.

This has changed. According to a recent article in The New York Times, the risk of taking SSRIs during pregnancy could be far worse for the fetus than the risk of being depressed. Women, reports the The New York Times, go to great lengths to give their baby the best start to life: they often quit smoking, give up drinking, and decline foods like Brie cheese and swordfish. Yet these same women often do not give up SSRIs, “despite an increasing number of studies linking prenatal exposure to birth defects, complications after birth, and even developmental delays and autism.” A recent study out of John Hopkins University found that young boys with autism were more than 30 percent more likely to have been exposed to SSRIs via their mother during prenatal development.


The U.S. Food and Drug Administration (FDA) recently issued a warning to physicians across the country not to use any compounded drugs that were manufactured by Unique Pharmaceuticals because of possible contamination. This action was done in response to an FDA inspection of the company's Temple, Texas manufacturing plant, where inspectors found issues with medication production that may have compromised the sterility of the medication.

Unique Pharmaceutical issued a voluntary recall of all its sterile compounded medications that have not yet expired and are advising that all products be returned to the company. The products were contained in vials, bags and syringes. Non-sterile items manufactured by the company are not affected by the recall. In the warning to consumers, the FDA said that patients who use sterile items that may have been contaminated are at risk of serious and possibly fatal infections.

Compounding pharmacies manufacture customized medications that have been ordered by doctors. According to the International Academy of Compounding Pharmacists (IACP), out of the almost 56,000 compounding pharmacies in the country, approximately 7,500 offer “advanced compounding services.” About 3,000 of them manufacture sterile products.

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