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Birth Control Recalled Due to Packaging Error

In late May 2018, pharmaceutical manufacturer Allergan voluntarily recalled approximately 170,000 sample packs of its Taytulla birth control pills due to a packaging error. In the recalled packs, lot 5620706 with a May 2019 expiration date, had their placebo pills at the beginning of the packs, rather than the end where they are supposed to be. These four placebo pills contain no hormones and are meant to give users a “break,” during which they experience period-like bleeding, between three-week rounds of pills that contain hormones.

An incorrectly packaged medical product, such as the recalled birth control packages, is a defective medical product that can put patients at risk of suffering the effects of not receiving the medical care they need.

Product Manufacturers are Liable for the Damages Related to Their Products

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When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them. Such is the case with a device that until very recently was used to aid with knee replacement surgery, the OtisKnee, distributed by OtisMed Corporation.

In December, according to The New York Times, the former CEO of OtisMed pled guilty in a New Jersey federal court to criminal charges of distributing adulterated medical devices. The OtisKnee was not cleared by the Food and Drug Administration before OtisMed began to distribute and sell the device to American hospitals, and 18,000 of the adulterated devices were sold and distributed between 2006 and 2009. The device was marketed as one that would speed knee surgery and aid in patient recovery, but many patients experienced the exact opposite. In one case, a woman experienced intense and lasting pain after the surgery, and ended up having to have a second knee replacement. Another patient said that the revelation that the device that had been used was likely at fault for her persisting knee problems made her feel like she “had been a guinea pig.”

The Times reports that had it not been for a whistleblower, presumably at OtisMed, the public may never have been made aware that this device was being distributed without FDA approval. Knee replacements are the most common elective surgery performed in the U.S.—roughly 700,000 such operations are performed annually. The FDA medical device approval process is long and arduous, and can cost thousands of dollars for the company attempting to have a single device approved. According to the Times, OtisMed, a California-based start-up, saw an opening in a crowded market. While doctors and other experts say that the device is a good idea, because it was not fully vetted by the FDA, it was never decided if the device was actually able to perform the function it purported to do.

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With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition. There are several types of biopsies, according to WebMD. A surgical biopsy is one of the most common, and one of the most dangerous. In a surgical biopsy, a surgeon will either remove a part of tissue or a whole lump of tissue.

Because of the sensitive nature of biopsies, especially in cases in which a patient may already be ill or injured, equipment used in the procedure must be painstakingly considered. When biopsy medical devices are recalled, it can be a very serious issue for any patient involved. One such recall issued in 2011 just recently expired, but not before implicating thousands of patients. In 2011, DeRoyal Industries, based in Tennessee, issued a recall of their Geomed Biopsy Tray, an all-inclusive tool kit used by surgeons to perform the invasive procedure. According to the U.S. Food and Drug Administration, there were several products included in the tray that were potentially contaminated, including triad lubricating jelly, alcohol prep pads, and alcohol swabs.

According to the Committee to Reduce Infection Deaths (RID), Center for Disease Control data suggests that 1.7 million people contract infections in U.S. hospitals every year. The RID posits that number is actually seven times higher than that. Contamination from faulty medical equipment, such as the recalled biopsy tray, is one major culprit of such infection. Medical equipment that is not sterilized properly can not only transmit infection borne at the manufacturing site, but also obtained at the hospital itself.

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In recent years, testosterone therapies to help men with erectile dysfunction or low testosterone levels have become more common than ever. With the advances in such medication, however, come advances in risks that accompany such treatment. According to WebMD.com, testosterone replacement therapy (TRT), are not as common as one may think. Part of this could because of the many risks that accompany TRT and the fact that many physicians are not yet familiar with the overall picture of such therapy.

Testosterone gels carry their own set of risks separate from those associated with pill therapy. Pill therapy can have unwanted side effects such as acne, sleep apnea, and breast enlargement, according to WebMD. Yet when a man uses a testosterone cream or gel, it can have unintended side effects for his family. “If a woman or child comes into contact with testosterone gels, it can cause side effects in them, including hair growth and premature puberty,” according to WebMD. Most doctors say that this transference is rare, but men using testosterone gel should take care to wash their hands thoroughly after use to mitigate the possibility of such unwanted side effects.

Yet transference to women and children is not the only highly publicized negative effect of testosterone gels. According to Bloomberg News, earlier this year, Abbott Laboratories (ABT), the manufacturer of AndroGel, a very common brand of TRT gel, was sued by five men claiming that the ABT failed to properly warn patients of severe side effects of the gel on their hearts. One man allegedly had a stroke as a result of AndroGel use.

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Cymbalta is a multi-use prescription drug most commonly used as an anti-depressant. Despite several clinical trials during the approval process of Cymbalta that alleged Cymbalta caused depression in otherwise healthy patients, the U.S. Food and Drug Administration did not recall the drug for use as an anti-depressant, according to the New York Times. Most tellingly, the suicide of 19-year-old drug tester Traci Johnson, who had no other symptoms of depression, brought the issues with Cymbalta to wider attention. Four years after this negative publicity, in 2008, Eli Lilly, the manufacturer of Cymbalta, sought to have the drug approved for treatment for chronic pain, especially in patients suffering from Fibromyalgia. The drug was not approved for such use in 2008. It would eventually be approved for such treatment in 2010, according to another article in the New York Times.

Cymbalta has been back in the news recently, as several lawsuits have been brought against Eli Lilly by patients using Cymbalta as an antidepressant. These patients claim to have experienced “brain zaps and other side effects” when attempting to stop taking the drug, according to Law360.com. Yet Eli Lilly representatives have responded to the claims by saying that medical professionals were made well aware of the risks when prescribing Cymbalta to their patients, and thus the fault does not lie with the drug manufacturer for failing to make patients aware of the risks of use.

According to Law360.com, Lilly earned $18 billion from 2004 to 2011 for the sales of Cymbalta. Like other antidepressants, patients are discouraged from suddenly stopping to take Cymbalta, as this can lead to serious conditions, either physical (ie: nausea, headache) or emotional (ie: irritability, anxiety, nightmares). The complaint alleges that if patients had known how difficult it would be to stop taking Cymbalta, they would never have started to take it in the first place.

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