Articles Posted in Drug Recalls

Earlier this month, the Food and Drug Administration announced a voluntary recall of several lots of an increasingly popular drug that is designed to combat the effect of an opioid overdose. According to a recent news report discussing the voluntary recall, two specific lots of the drug Naloxone have been recalled based on the “potential presence of embedded and loose particulate matter on the syringe plunger.”

Hospira, the company that manufactures the drug, moved forward with the recall after it discovered that users may experience certain side effects if they inject the affected medication. These side effects include local irritation, an allergic reaction, inflammation of a vein, restriction of blood supply to healthy tissue, pulmonary embolism, and pulmonary infarction.

The FDA explains that users should be sure to check the medication before injecting it. Specifically, users should look for discoloration or particulate matter. The drug’s manufacturer explained that the recalled medication was provided to medical professionals and law enforcement. The company has stressed that none of the recalled lots were distributed to individual patients.

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Whenever a person is injured after using a dangerous product, they are able to file a product liability lawsuit against the manufacturer, and potentially others in the chain of commerce who handled the item. In the case of dangerous medical products, sometimes there are many people who suffer the exact same or very similar injuries. In these cases, a class action lawsuit may be the best option for the injured patients.

Class Action Lawsuits in General

Generally speaking, class action lawsuits are beneficial for plaintiffs because they allow a large group of plaintiffs to argue their case together. Of course, this can save on legal costs, and it can also help the individual plaintiffs in their negotiations with the defendant manufacturer. However, class action lawsuits are not always appropriate.

One of the biggest hurdles to proceeding with a class action lawsuit is “certifying” the class. Before a class of plaintiffs can proceed against a defendant in a single case, the court must certify them as an official class. There are many requirements in order for a class to be certified, but one commonly argued issue is whether the injuries are similar.

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Drug manufacturers make billions of dollars each year from marking up medications that cost mere pennies to make but are often sold for hundreds, if not thousands, of dollars. While the manufacturing cost of most medication is relatively low, the reason consumers end up paying a high price for prescription drugs is based on other behind-the-scenes costs, including research and development as well as the cost of a potential problem with the drug resulting in a recall or significant lawsuit against the manufacturer.

Indeed, all pharmaceutical manufacturers have a duty to ensure that the product they release into the stream of commerce is safe when taken as advised by the company or a physician. Of course, companies may not necessarily always be held liable when an injury results from the abuse of one of their medications. However, when a medicine is taken properly, and an unanticipated adverse effect results due to unsafe manufacturing, the manufacturer may be liable to patients who suffered as a result. These cases are called product liability lawsuits, and they are commonly brought against the manufacturers of dangerous medications.

Proving a Product Liability Lawsuit

As with all personal injury lawsuits, it is the plaintiff’s burden to prove a product liability case. However, pharmaceutical manufacturers may be held to the legal standard of “strict liability” when it comes to a dangerous product. Under a strict liability theory, the plaintiff does not need to show negligence on the part of the manufacturer and must only show that the dangerous drug manufactured by the defendant was the cause of the plaintiff’s injuries. There are several types of product liability lawsuits, however, and an attorney should be consulted for specific advice.

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Earlier last month, the Food and Drug Administration (FDA) issued a “black box” warning for a birth control medication, Essure. According to one local news source reporting on the newly released warnings, there have been over 5,000 women who have reported negative side effects while using Essure. These side effects include unplanned pregnancy, miscarriages, still births, and severe pain and bleeding. There are also some reports of women developing auto-immune disorders after taking the medication.

Despite the negative side effects, the FDA will continue to allow Essure to be marketed and sold in the United States. The FDA decided against a pharmaceutical recall and implemented a high-alert warning instead. The warning, known as a “black box” warning, is the most serious type of warning issued by the FDA. It requires that physicians provide patients with a written waiver prior to prescribing the medication. The waiver outlines the harms that the drug may cause.

According to another news source, the general response to the FDA’s action among women who had used Essure was that it fell far short of doing what needed to be done:  issue a total recall. Support groups of women who have been harmed by Essure claim that the warning will not be taken seriously enough by prospective patients, and also that it fails to include all the potential side effects of using the product.

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When a patient goes to the doctor and is given a prescription, one of the first things the patient is likely to ask is “what are the potential side effects?” Indeed, most pharmaceutical drugs have side effects of some kind, ranging from the mild to the more severe. In some cases, there is even the risk of serious injury or death.

Ultimately, the choice is left up to the patient to weigh the risks of taking the medication against continuing to suffer from their current ailment. However, when a drug company markets its drug in a misleading fashion, the patient cannot make an educated decision about the pros and cons of taking the prescription mediation.

In these types of cases, it is possible that a patient who is hurt after taking a medication can sue the drug manufacturer, alleging one of several available theories. In essence, many personal injury claims based on dangerous pharmaceuticals allege that, had the patient known the real dangers of taking the medication at the time, they would not have taken it. Of course, these cases are quite complex and often rely on medical and scientific expert testimony to prove the necessary causation element.

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Pharmacies are places people go to get better. When a patient walks into a pharmacy with an ailment, they expect that they will be able to obtain the relief they need, either by speaking with a pharmacist about their condition or by selecting the over-the-counter medication that fits their specific needs. However, both prescription and over-the-counter drugs are commonly recalled for causing various side effects, ranging from the uncomfortable to the life-threatening.

Of course, a pharmacy may not know that a medication they are selling to their patients is harmful. However, there is a duty imposed on pharmacy owners and pharmacists to familiarize themselves with the latest recalls and product news about the medications they stock and sell. If someone is injured by a product, the injured patient may be able to seek monetary compensation from not only the manufacturer of the drug but also anyone else in the chain of distribution, including the pharmacy that sold them the medication.

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Earlier this month, a prescription drug designed and marketed for the treatment of some kinds of cancer, including brain cancer, was recalled because a number of the bottles that contained the drug had faulty caps. According to one industry news report, the caps of approximately 1,100 bottles of the prescription drug, Temozolomide, have the potential to crack, nullifying the childproof nature of the cap.

Evidently, the side effects of the medication are potentially severe, even for adults, and can include respiratory failure, terminated pregnancy, infertility, severe vomiting, and nausea. To ensure that the medication is not ingested by curious children, the U.S. government requires that potentially dangerous drugs like Temozolomide are packaged in childproof packaging. However, for an unknown reason, the caps on a significant number of these bottles were defective.

Specifically, the bottles that may be in danger of having cracked lids were sold between July 2013 and August 2015. The bottles at issue are the five- and 14-count brown bottles with black lettering. Merck, the manufacturer of the drug, has told patients to inspect the caps of their medication and to remove the bottles from the reach of children. In addition, Merck has suggested that all pharmacists who handle bottles of Temozolomide double check to ensure that the caps are in good condition. Of course, any bottle that does have a cracked lid should not be distributed to a patient.

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Earlier in May of this year, an Indian-owned pharmaceutical company announced a voluntary recall of over 10,000 bottles of promethazine hydrochloride, a drug used to treat allergies. According to a report by Medical Daily, the recall was initiated when a 25-mg tablet of atenolol was found mixed in with the allergy medication. Atenolol is a medication used to treat high blood pressure. The recall affects those bottles with a September 2015 expiration date.

Potential side effects for atenolol are listed as constipation, memory loss, impotence, numbness, and diarrhea. There has not been any research done to determine what potential side effects may occur from taking the two medications together. However, out of an abundance of caution, the company decided to recall the bottles.

This recall is a Class-II recall, meaning that it “involves a potential health hazard situation where there is remote probability of adverse health consequences from the use of the product.” Evidently, this is the seventh recall that this particular pharmaceutical company has announced this year. Given their track record, the FDA is beginning to crack down on Indian pharmaceutical companies. In fact, the FDA has already placed a ban on the import of medication from two Indian pharmaceutical companies this year. Given this company’s track record for 2014, it may be next.

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Earlier this month, Ranbaxy Laboratories initiated a voluntary drug recall of over 30,000 blister packs of one of the drugs it makes. The drug, which is a generic version of the popular allergy medication Claratin, is called loratadin and is a slow release pill with an added decongestant.

The FDA’s official title for the drugs is “Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only.”

According to a report by Business Insider, the recall affects drugs that were sold in the following five states: Rhode Island, Ohio, California, Pennsylvania, and Texas. Evidently, the expiration on the packaging indicates that it expires in September 2015. The defective drug was sold at the following pharmacies: Rite Aid, CVS, Discount Drug Mart, H-E-B, Kroger, Good Neighbor Pharmacy, and Sunmark.

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