Posted on October 08,2017 in Defective Prescription Drugs

Abilify is an antipsychotic drug used to treat bipolar disorder, depression, schizophrenia, and Tourette Syndrome. In certain cases, it can also help autistic individuals manage their irritability. Its generic name is Aripiprazole. It is also sold under the brand names Aristrada and Abilify Maintena.

Any drug can have potentially harmful side effects. Drug manufacturers have the responsibility to disclose these side effects to doctors who might prescribe the drug and patients who might take it. When a patient suffers from these side effects without realizing the risk he or she took by taking the medication, the patient may seek compensation for his or her resulting damage through a defective drug claim.

Abilify can Create Uncontrollable Urges

The main side effect of Abilify is its potential to create uncontrollable urges in patients. These urges can lead to compulsive behaviors like promiscuous sex, gambling, and shopping. A patient who suffers from these urges can lose money, contract STIs, or cause an unintended pregnancy, or if he or she eats compulsively as an effect of taking Abilify, gain weight rapidly and suffer from the effects of obesity.

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 Posted on October 22,2016 in Defective Products

Throughout the 19th and first half of the 20th century, asbestos could be found in nearly everything. Paint, shingles, pipes, certain textiles, household goods, and drywall were just some of the many products that contained the heat-resistant mineral. As more and more scientific evidence linking asbestos exposure to illnesses like mesothelioma was released, governments around the world limited and even banned the use of asbestos. Today, asbestos is banned from being used from most, but not all, consumer products in the United States.

When an individual suffers an illness as the result of asbestos exposure, he or she may seek compensation for damages through an asbestos exposure claim. The compensation amounts secured by claimants can be fairly high, putting a financial strain on the companies responsible for those illnesses and pushing them toward bankruptcy. This is the case with Kaiser Gypsum, a former drywall manufacturer based in North Carolina. The company has faced 13,967 asbestos exposure claims, 1,498 of which were filed by claimants in Illinois. Although the company stopped producing drywall many years ago, it remains in existence to pay out compensation amounts to individuals affected by asbestos exposure.

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 Posted on June 08,2016 in Personal Injury Attorney

The Federal Tort Claims Act (FTCA) is one of the earliest forms of Tort Reform. While today, most FTCA claims are against the Post Office, the FTCA finally came to fruition after a tragic, 1945 event where a United States Military bomber pilot crashed into the Empire State Building. The pilot who was flying service men from Massachutes to Laguardia Airport flew his plane through thick fog, attempted to land in Laguardia Airport without clearance. Flying with near zero visibility, he crashed his plane into the Empire State Building. The crash killed fourteen, including the pilot himself. Following the crash, when family members of those killed and injured attempted to seek recovery, they were barred from suing the government by sovereign immunity as the pilot was acting in his capacity as a government agent. Even though, the United States Government offered the families monetary compensation for their loss, several of the families declined and proceeded with a law suit against the US Government. Those lawsuits seemed to be the final push legislators needed to finalize the contents of the FTCA. While the FTCA wasn't enacted until 1946, it was made retroactive to allow families of the 1945 plane crash to recover under it.

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 Posted on April 28,2015 in FDA

The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt. The decree will remain in force until regulators are convinced that the company has addressed and fixed the identified issues.

The SychroMed II Implantable Infusion Pump System is a device designed to deliver medication necessary for the treatment of cancer, chronic pain, and sever spasticity. Medtronic, the manufacturer of the device, says that more 230,000 patients have used a SynchroMed system since it was developed more than 25 years ago. However, inspections by the FDA in 2006 and 2013 identified “significant violations” of federal regulations, including issues related to handling complaints and corrective actions. A warning letter from the FDA in 2012 noted the devices' propensity to stall and subsequently fail to deliver the needed medication.

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 Posted on April 23,2015 in FDA

Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member. While, to a certain extent, home health providers may be able to offer a degree of training in the proper utilization of a home-use medical device, federal regulators have expressed concern over the lack of a standardized labeling format for the devices.

Home-use medical devices include a wide range of equipment, including more simple things like canes and crutches, to more complicated items such as infusion pumps, glucose monitors, and continuous positive airway pressure (CPAP) machines. According to the U.S. Food and Drug Administration (FDA), there have increasing reports of adverse events related to medical devices used in the home, many of them related to the unavailability of the manufacturers instructions.

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 Posted on April 16,2015 in Arlington Heights Defective Medical Device Attorney

An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing. In particular, the group referenced a medical tool used in performing hysterectomies which, despite being widely available, has been found to contribute to the spread of cancer in patients.

This week, America's Health Insurance Plans, an organization representing nearly 1300 health insurers who provide coverage for over 200 million Americans, sent a letter to United States Senator Bob Casey, D-Pennsylvania, citing the dangers discovered regarding laparoscopic power morcellators. Since the 1990s, morcellators have been used to remove fibroids, or benign uterine growths, frequently during hysterectomies. Last year, the U.S. Food and Drug Administration (FDA) announced that women undergoing such procedures may be at higher risk for a certain type of malignant cancer, and use of the devices can potentially spread the cancerous tissue and worsen the condition.

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 Posted on April 09,2015 in Defective Prescription Drugs

A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down.

Compounded Drug Recall

The NCBOP said in a news release that it was recalling all nonsterile and sterile products that were compounded, repackaged, and distributed by the pharmacy from September 10, 2014 to March 10, 2015. The listing of recalled products includes antidepressants, antibiotics, antiviral medications, immunosupressants, and others which were distributed to all 50 states and Canada. “This recall is due [to] the pharmacy's inability to ensure sterility, stability, and potency for these products,” the Board of Pharmacy said. While no complaints of injuries have been received by the board, the NCBOP and FDA are advising clinicians to quarantine any products from the Prescription Center and not to administer them to human or animal patients.

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 Posted on April 07,2015 in Arlington Heights Defective Medical Device Attorney

When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all. There are various types and levels of recalls, and the action required by each is often dependent on the danger related to the particular device or drug.

Recall Classes

The United States Food and Drug Administration (FDA) maintains three separate classes of recalls to be used appropriately based on the level of risk associated with the recalled item. A recall is categorized by the FDA as one of the following:

Class III Recall: Exposure to the device or drug is unlikely to result in adverse health consequences, but the product does not meet regulatory standards.

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 Posted on March 19,2015 in FDA

In an effort to increase safety and prevent disease, the United States Food and Drug Administration (FDA) released new recommendations regarding reusable medical devices. The announcement from the FDA was made following an outbreak of a bacterial superbug linked to the design of a specific piece of reusable medical equipment.

At least seven patients at Ronald Reagan UCLA Medical Center in Los Angeles were infected over the last several months with carbapanem-resistant enterobacteria, or CRE, while undergoing minor gastrointestinal diagnostic procedures. Two of patients later died from complications of the CRE infections, which antibiotics struggle to combat. The procedures at UCLA all involved a reusable medical device called a duodenoscope.

Hospital officials have determined that the device had been maintained and serviced in accordance with manufacturer guidelines, and claim that design flaws allowed the bacteria to be transmitted between patients despite the efforts of hospital staff. While the manufacturer continues to stand behind its products, the company is currently facing several lawsuits related to the outbreak.

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 Posted on March 10,2015 in Arlington Heights Defective Medical Device Attorney

Defective medical devices are not limited to those implanted in a patient's body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not. According to The Baltimore Sun, it is imperative to maintain wheelchairs and walkers as you would a car, as a lack of proper maintenance can result in unsafe conditions such as broken or bent parts. If the device is broken, it can result in the requirement of extra energy to get around, more pain, or—worst-case scenario—a devastating accident that can result in hospitalization.

The onus of maintaining these devices is not, however, solely the responsibility of the patient. Sometimes these devices, and machinery used in conjunction with them, are not properly built or vetted before it is put on the market. One such incident occurred earlier this year, when a California-based manufacturer was ordered to pay a $1.75 million civil penalty for continuing to sell faulty wheelchair lifts. The lifts were recalled by the National Highway Traffic Safety Administration (NHTSA), according to an agency report, as they had been labeled as potential fire hazards. Even after the recall was announced, the manufacturer, Rincon Corporation, continued selling the lifts to the public.

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