Articles Posted in Drug Recalls

If you live in Maryland and a medication you are or were taking has been recalled, what you should do depends on the specifics of the recall. The first thing to do is to determine what to do to keep you safe and healthy. The recall generally will include guidance on what consumers should do with the impacted product and what steps to take. That means that in some cases, consumers may need to stop taking the impacted drug immediately, but in others, continuing to take a drug may be the safest course of action for the short-term. Patients should also speak with their healthcare provider to determine if there are any alternative medications they could take. After addressing that concern, the next step is to consider any legal recourse you can seek through a Maryland product liability or negligence claim.

When a company issues a recall, the FDA then classifies the recall and oversees the company’s strategy for recalling the drug. The most serious class of recall is a class I recall. Those are recalls in which the product could cause serious harm or death. The next serious is a class II recall, which is for products that pose a notable risk and threat. The lowest level recall is a class III recall, which is for products that violate the agency’s labeling or manufacturing laws but are not likely to cause adverse health consequences.

If a Maryland resident has taken a recalled drug, the patient may be able to sue the drug manufacturer to recover damages. However, it is not enough to show that the patient took the drug. The patient must also show that they suffered injuries as a result.

Drug recalls have been on the rise over recent years, affecting an estimated 81% of consumers in the United States. But when the federal Food and Drug Administration (FDA) finds a problem with a drug, what happens when a drug is recalled? And what does it mean for victims who want to file a Maryland product liability claim? A recent industry news source outlined the drug-recall process, which provides a good overview for those unfamiliar with the process.

A drug recall is an action by the manufacturer of the drug to remove a defective or harmful product from the market after the drug is found to be in violation by FDA laws or regulations. The FDA cannot pull a product from the market. It can only request that a drug be recalled, but ultimately the pharmaceutical company must decide whether to pull the drug.

The FDA then assesses whether the recall was appropriate, classifies the recalls, and oversees the recall strategy. A recall is classified by the FDA as a class I, II, or III recall. Class I recalls are the most serious, as they are for products that could cause serious harm or death. Class II recalls are for products that pose a notable risk and threat. Class III recalls are for products that violate the agency’s labeling or manufacturing laws but are not likely to cause adverse health consequences. Once a drug recall has been issued, officials from state health departments and pharmacy boards, drug manufacturers, and others may contact pharmacies to let them know about the drug recall. The pharmacies are then responsible for making sure that the recalled product is removed and dispensed of properly. They also have to help patients by counseling them on their options in light of the recall.

According to a national news report, several retailers and pharmacy chains are suspending the sale of Zantac, a popular heartburn medication. The decision was made after concerns arose that the drug may contain a substance that can cause cancer. The makers of the drug face a potential class-action lawsuit, and other Maryland pharmacy error lawsuits may arise from those suffering the adverse effects of the drug.

According to the United States Food and Drug Administration (FDA), doctors routinely prescribe Zantac to treat heartburn and stomach acidity issues. Potential issues with the medication arose shortly after approval for mass distribution in the 1980s. However, the FDA did not provide medical professionals with the warning until they discovered that the carcinogenic agent ranged from 3,000 to over 25,000 times the approved limit. The agent has been linked to cancers of the lung, kidneys, bladder, and stomach. Additionally, the toxic agent is related to liver scarring, fibrosis and tumors. The FDA has not issued a formal recall notice, nor did they tell patients to stop taking the product, however, many national retailers have pulled the medication and replaced it with generic versions that lack the specific impurity. This, however, has brought up concerns regarding the safety and efficacy of prescription drugs whose generic equivalents are manufactured in foreign counties where the FDA typically lacks adequate oversight.

Although the FDA has not recalled Zantac, several drugstores voluntarily removed the product, likely in an attempt to avoid liability if the product eventually gets recalled. Those injured after taking a dangerous drug may seek damages for injuries in instances where a product has been recalled but a retailer or hospital does not abide by the notice. Patients and consumers may suffer serious injuries such as permanent organ damage, cancer, and even death when a party fails to comply with a recall notice. Moreover, manufacturers cannot escape liability just because they issue a recall. Manufacturers, distributors, and retailers may still face liability if they did not adequately issue the recall, provide appropriate warnings and remedies, or abide by the recall notice. Patients should heed the warnings from the FDA and their doctors about specific medications. If they do not abide by the warnings and suffer injuries, they may face difficulties holding the responsible parties liable for their damages.

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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