Articles Posted in Drug Recalls

Each time a patient is prescribed prescription medication, a physician has determined that the medicine is medically necessary for the plaintiff’s health. However, when a doctor prescribes a prescription, the doctor assumes that the medication that will ultimately be provided to the patient is exactly what they specified.

In the case of a Maryland pharmacy error, or a situation in which a medication is recalled, the medicine that a patient is provided is not what their doctor intended. As a result, there can be serious and potentially life-threatening consequences. If a patient is not given the medication that they were prescribed, the existing condition that necessitated the prescription will not be treated. This often leads to the worsening of symptoms.

Compounding the potential for injury is the fact that whatever medication the patient is provided may have been adulterated, contaminated, or contain other substances that can cause the patient injury or harm. Such a reaction may be due to an allergy, an adverse drug interaction, or an inadvertent overdose if too high a dose is provided.

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Companies that manufacture and market prescription medication are under the same duty that all manufacturers are under to make sure that their product is safe. Of course, some medications, especially prescription medications, present the risk of serious adverse side effects, even when the drug is taken according to a physician’s instructions. Thus, a manufacturer must clear about the potential side effects that a medication could cause when marketing the drug. A failure to clearly warn patients about a known risk may result in the drug manufacturer being liable in a Maryland product liability case.

While a drug manufacturer may be able to avoid liability by warning of a drug’s dangerous side effects, there is no excuse for medication that is contaminated during the manufacturing process. Late last month, the U.S. Food and Drug Administration (FDA) announced the latest in a series of recalls affecting blood-pressure medication. According to the FDA, two lots of Losartan potassium tablets contain an ingredient that was discovered to contain an unexpected impurity called N-nitrosodiethylamine (NDEA). The FDA notes that NDEA “is a substance that occurs naturally in certain foods, drinking water, air pollution” however, it is also a known carcinogenic in animals and a suspected carcinogenic in humans according to its classification by the International Agency for Research on Cancer.

Losartan potassium tablets are used to treat hypertension (high blood pressure) as well as neuropathy (nerve pain) in patients who have Type II diabetes. The FDA recommends that patients who are currently taking Losartan continue to take the medication, as the risks involved with suddenly stopping the drug without an alternative treatment are high. The FDA advised patients taking Losartan to contact their pharmacist or physician to discuss alternatives to Losartan, at least until the manufacturing problem has been resolved.

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Last week, the Food and Drug Administration announced that the manufacturer of a popular blood-pressure medication would be recalling thousands of bottles of the medication after what appears to have been a medication mix-up. According to one news source covering the recall, Accord Healthcare announced that it would be recalling one lot of its Hydrochlorothiazide tablets in the 12.5mg dosage.

The recall was announced after a pharmacist at a local drugstore discovered that a bottle marked as containing the 12.5mg tablets of Hydrochlorothiazide tablets actually contained another medication. None of the medication was provided to patients, and the manufacturer’s initial investigation into the error did not cause them to believe that any other lots suffered from a similar error. However, out of precaution, the manufacturer recalled the entire lot that contained the bottle with the wrong medication.

The Hydrochlorothiazide tablets are round orange pills that have the letter “H” on one side, and the number “1” on the other side.

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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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