Cynthia Diaz Shephard

FDA Reviews Hepatitis A Tied to Frozen Tuna

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Contaminated Tuna Originated in Vietnam and the Philippines

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), are collaborating with state and local officials to assess the risk of exposure to the hepatitis A virus tied to contaminated frozen tuna sourced from the Sustainable Seafood Company, Vietnam and the Santa Cruz Seafood Inc., Philippines. If unvaccinated consumers have consumed the recalled product in June 2017, post-exposure prophylaxis (action taken to prevent disease) may help prevent contracting the hepatitis A virus infection.

Prior to release of the FDA’s announcement, Hilo Fish Company sent out a direct alert to its customers and distribution partners on May18, 2017 to advise about the company’s recall of certain tuna products. The FDA indicated it had received records from the company or its distribution partners indicating that frozen tuna was sold to the establishments listed on the FDA’s website here.

The FDA indicated that it continues to work with Hilo and other distributors to ensure that the companies remove the contaminated tuna from the market. The FDA notes that it is Hilo Fish Company’s responsibility to advise its customers about the recall. Also, any company that received a recall notice from Hilo Fish Company is responsible to advise its customers. The establishments identified on the FDA’s website should have received a notice from Hilo Fish Company or their direct supplier. If not, they should reach out to their suppliers for additional information.

The first recall took place in Hawaii and involved imported raw frozen ahi tuna cubes sourced from PT Deho Canning Co. (JL. Raya Madidir, Bitung, Indonesia). That recall, by Tropic Fish, includes lot codes 609149 and 609187. No products are believed to remain on the market. The current recall resulted from follow-up after the Hawaii Department of Health advised the FDA of a frozen tuna sample, sourced from PT Deho Canning Co., which tested positive for hepatitis A on May 1, 2017. The initially recalled product has been removed from circulation and the newly recalled frozen tuna lots were not shipped to Hawaii; however, they were shipped to mainland United States.

The current recall, which began May 18, involves frozen yellowfin tuna steaks from Sustainable Seafood Company and yellowfin tuna cubes from Santa Cruz Seafood. The recall, implemented by Hilo Fish Company, includes Tuna Steaks in eight-ounce individually vacuum packed bags with production date code: 627152, lot number: 166623; expiration date: 2018-10-01. Frozen Yellowfin tuna cubes, random, were individually vacuum packed in 15-pound cases with the date code: 705342; lot number: 173448; and expiration date: 2019-04-01.

Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in food poisoning lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a contaminated food lawsuit.

What is Hepatitis A?

Hepatitis A is a contagious liver disease that is the result of an infection with the hepatitis A virus. The virus may range in severity from a mild illness that lasts a few weeks, to a severe illness that lasts several months. Hepatitis A may be spread when a person ingests the virus from contaminated food or water. The virus may also be easily passed from an infected person to other unvaccinated family members, sexual partners, and close contacts, according to the FDA.

The FDA points out that, symptoms of hepatitis A in adults include fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine, and pale stool; individuals with hepatitis A may not have symptoms until 15 to 50 days after consuming a contaminated food or drink. The CDC reports that, while the hepatitis A vaccine is recommended for all children, vaccination rates are lower than for other recommended childhood vaccines. Unvaccinated children may become ill and not have symptoms. Any unvaccinated person who consumed recalled frozen tuna is at risk of contracting the hepatitis A virus, noted the FDA.

The CDC recommends providing post exposure prophylaxis (PEP) for any unvaccinated people who have recently eaten any of the recalled raw or undercooked tuna products. People who have consumed this fish fully cooked are at reduced risk of exposure, but consultation with medical professionals is suggested.

PEP involves receiving the hepatitis A vaccine for people between the ages of one and 40 years or the hepatitis A virus-specific immunoglobulin (IG) for people outside of this age range. The hepatitis A vaccine may be substituted if the IG is not available. Those with evidence of previous vaccination do not require PEP

If you have never received the hepatitis A vaccine, getting a single dose within two weeks of exposure may protect against illness. If you are unable to determine if you have been vaccinated, receiving an additional dose of the vaccine is not harmful.

In the event that retailers and/or other retail locations are found to have handled recalled or other potentially contaminated food in their facilities, wash and sanitize display cases and refrigerators where potentially contaminated products are stored; wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products; and wash hands with hot water and soap following the cleaning and sanitation process. Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products must be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated products, according to the FDA.

The FDA notes that contaminated shellfish, fruit (berries), and salads are the most frequent foodborne sources of hepatitis A. Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Consumers should thoroughly wash their hands after using the bathroom and changing diapers to help protect themselves from contracting hepatitis A.

Filing a Food Poisoning Injury Lawsuit

If you or someone you know suffered injuries due to a contaminated food, you may have valuable legal rights. Our food poisoning lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/fda-reviews-hepatitis-tied-frozen-tuna/

IVC Filters May Fracture If Not Removed In Established Time Frames

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C.R. Bard May Have Known About Issues with Recovery and G2 Filters

At least 27 deaths have been tied to a C.R. Bard blood clot filter named the Recovery. Allegedly, C.R. Bard replaced the device with a modified version. Soon after the modified medical device was approved, C.R. Bard allegedly knew that it had similar problems to the initial version of the device, according to NBC News.

Despite that C.R. Bard was aware of complications associated with its blood clot filter, the device maker continued to sell the medical devices. According to NBC News, just four months after C.R. Bard released the G2 Bard blood clot filter, the device maker was concerned about failure reports. The G2 was created to replace the Recovery Bard blood clot filter and, since that time, the device has been tied to more than one dozen deaths and many injury reports.

Dr. William Kuo, a specialist in removing blood clot filters that have failed, told NBC, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications.” The Stanford radiologist also said that, “[t]he number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

The attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.

C.R. Bard Recovery Filter Background

According to a prior NBC News report, IVC filters—sometimes known as blood clot filters—are implanted in approximately 250,000 Americans annually. In the last decade or so, millions of filters have been implanted in Americans.

C.R. Bard is one of 11 makers of IVC filters and had hoped to gain traction in the profitable filter market when it introduced the Recovery filter, receiving FDA clearance to market the device in 2002. It was then that reports of deaths and injuries tied to the device moving and breaking steadily mounted, according to NBC News. A confidential study commissioned by C.R. Bard revealed that the Recovery filter had increased rates of relative risk for death, filter fracture, and movement when compared to its competitors. An outside doctor hired to conduct the study wrote that “further investigation … is urgently warranted.”

C.R. Bard opted against recalling the Recovery from the market and, in 2005, after the device had been sold for three years, Bard finally replaced the Recovery with a similar device, the G2 series of filters. Internal Bard records and hundreds of reports to the U.S. Food and Drug Administration (FDA) reveal that that the G2 series did not resolve the IVC device’s issues.

A confidential memo written in December 2005 by a Bard vice president after the G2 was cleared by the FDA reveals his concern about “problems with … migration,” “tilting,” and “perforation.” He noted that Bard had another filter on the market with virtually no complaints. “Why shouldn’t doctors be using that one rather than the G2?” he questioned. Another later document includes data through 2010 that reveals that the G2 series filters experienced even more fractures, migrations, and reported problems than any of its competitors, according to NBC News. The C.R. Bard G2 series filters remained on the market until 2010.

In 2010, a man underwent implantation with the Bard G2 Express due to his body’s propensity to develop blood clots. The patient, 69, asked his physician in October 2015 to check on how the filter was doing and learned it had moved. His physician told him that the Bard filter was “dangerously close to your heart,’” according to NBC News. Two surgeons declined to remove the filter given its precarious position. The patient asked Dr. Kuo, whose team developed an advanced technique to remove failed filters and filter pieces. During emergency surgery, Dr. Kuo found that three legs broke off the filter, traveling to the patient’s lungs. Dr. Kuo said that two partially broken legs completely broke away during the operation. One, he said, could have killed the patient. “It floated off right in front of our eyes,” said Dr. Kuo. “First into the right atrium and then into the right ventricle. He’s very lucky.”

Kuo told NBC News that, in the prior 10 years he has removed 1,000 failed filters and noted that he has removed more Bard filters than any other single make of filter. Dr. Kuo said that, the Recovery and G2 series filters should have been pulled from the market and that, “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.” In addition with device companies, the FDA must take stronger action to protect patients. “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices,” he said, according to NBC News.

What is an IVC Filter?

The FDA approved inferior vena cava (IVC) filters in 1979. The human body has large veins known as inferior vena cavas; these veins carry deoxygenated blood from the legs to the heart. The filters are “spider shaped” medical devices that look similar to a small cage, are approximately one-and-a-half-inches, are constructed of metal, and are inserted into the IVC. Once inserted, the filters are meant to capture blood clots that may travel to the heart, lungs, and brain.

IVC filters are typically prescribed for patients unable to take anticoagulants; when a patient is diagnosed with a recurrent pulmonary embolism (PE); a blood clot, especially a clot that may travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT); or if a patient suffered a significant accident or injury. Blood clots from the lower body may take place after knee or hip replacement surgeries.

For the most part, IVC filters are only meant to remain in the body on a temporary basis and should be removed when the threat of clots is over. Previously, some IVC filters were left in patients’ bodies permanently or for extended time periods, which may lead to life-threatening complications.

In 2010, the FDA warned that long-term use of IVC filters should be discontinued given risk of IVC filter damage, noted that IVC filters are intended as a temporary measure, and warned physicians to consider risks when discussing removal of these devices with their patients. The agency updated its warning in 2014, recommending that retrievable IVC filters be removed 29 – 54 days following implantation. Research shows that IVC filter risks outweigh their benefits when the filter remains in the body for more than two months. In one FDA warnings, it indicated that IVC implants may break in a patient’s body, potentially traveling through the bloodstream and into vital body areas with fragments potentially puncturing veins and organs. Pieces may become lodged in high-risk areas, according to NBC News.

Filing an IVC Filter Lawsuit

If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations. For more information, call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/ivc-filters-may-fracture-not-removed-established-time-frames/

Recalls and Lawsuits Continue Over Metal-on-Metal Hip Devices

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Examples of Recent Recalls, Lawsuits, and Settlements

A number of device makers are having issues with their hip devices such as Accolade, Smith and Nephew, DePuy Orthopaedics, Zimmer Biomet, and Stryker. Over the past year, Stryker has been named as a defendant in another round of hip implant lawsuits. Also, its device, the LFIT Anatomic Cobalt-Chromium V40 Femoral Head, was recalled in October 2016 for the third time in five years. The device maker’s hip settlement expanded.

The latest Stryker lawsuit was filed in April 2017 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiffs, a couple, allege that injuries over failure of the implant in which the head of the stem was displaced and began to corrode. The plaintiffs are holding Stryker Orthopaedics responsible for failure to warn of the implant’s possible corrosion.

Another lawsuit was brought against Zimmer Biomet last spring. The plaintiff alleges that her Trilogy hip implant is defective and was unable to bond with her hip bone over an “improper pore size and/or porosity,” according to the lawsuit. The lawsuit was filed four years following implantation with the device. She underwent the surgery just prior to the device’s being recalled in June 2012. Federal Judge Wendy Beetlestone, in Pennsylvania, granted one strict liability claim to a plaintiff who brought a lawsuit against Stryker. The judge also allowed the plaintiff’s strict liability manufacturing defect, breach of warranty and loss of consortium claims to progress after Stryker’s motion to dismiss the plaintiff’s strict liability design defect and negligence claims.

According to The Legal Intelligencer, Judge Beetlestone ruled that the plaintiff’s allegations were sufficient to argue that the Stryker Gamma3 Nail System was defectively manufactured. The plaintiff was implanted with the device in March 2015. X-rays later revealed a broken nail in the implant. The plaintiff underwent a total hip replacement and suffered an infection following that surgery.

In another case, five patients implanted with metal-on-metal hips manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, were awarded $502 million. Because of a cap on punitive damages, the award was reduced to $150 million. According to Law360, the plaintiffs have complained to the Fifth Circuit that the cap is unconstitutional.

The nationwide attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip implant lawsuit.

New DePuy Orthopaedic Hip Implant Lawsuit

In May 2917, a new lawsuit was brought against DePuy Orthopaedics over its Pinnacle hip implant. The lawsuit was filed by a couple who alleged significant hip implant complications that required additional procedures to correct.

The plaintiff underwent a total right hip replacement on December 9, 2005, with a Pinnacle Device with an Ultamet liner. Soon after the procedure, the patient allegedly began experiencing severe pain, inflammation, and discomfort in the implant area. Testing revealed that the Pinnacle Device was experiencing wear and friction and was allegedly causing metal ions to be shed into the patient’s bloodstream, causing metallosis (blood metal poisoning), which compounded the damage in the area tissue and bone of the hip implant. The patient was left with no alternative but to undergo revision surgery on June 7, 2016, to explant and replace the Pinnacle Device. The woman chose to file her DePuy Pinnacle hip implant lawsuit after learning the manufacturing company may have been aware of potential complications tied to metal-on-metal hip implants.

As with other patients who opted for the DePuy Pinnacle device, the Pinnacle was recommended to the patient by her physician after reviewing the product’s packaging. All metal hip implants have been marketed to be overtly superior to ceramic and plastic models because of their durability and customizable features. The metal hip implants are particularly popular with younger orthopedic patients who live a more active lifestyle.

Metal-on-metal hip implants are composed of all metal components with no ceramic or plastic parts to prevent fretting. When the implant surfaces rub together, even during normal activities such as walking, the devices may release metal debris, leading to complications. When an implant fails due to complications, patients typically undergo a revision surgery to remove the device.

Specifically, when the ball and socket joint of the metal device interact, nothing prevents metal ions from entering the patient’s bloodstream, which may ultimately lead to metallosis. This may impair the patient’s condition by potentially leading to infection, fretting, corrosion, tissue death, and the formation of pseudotumors. When this occurs, patients are generally forced to undergo revision surgery to explant the defective device and undergo implantation with a different device. Revision surgeries are considered risker, costlier, and more complex than the original surgeries and call for more intense and long physical therapy. In some cases, insurers do not cover revision surgeries. Despite the devastation to patients, DePuy allegedly failed to warn patients and physicians of these risks.

Signs of the hip failure include unexpected pain, limited mobility, and/or loss of range-of-motion.

According to this DePuy Pinnacle hip implant lawsuit, the company either knew or should have known about the risks associated with its metal hip implants. At all times relevant, the woman involved in the lawsuit alleges that she only used the device for its intended purpose and did not deviate from medical instruction. She also noted that she would never have chosen the DePuy Pinnacle device if she had been aware of the potential complications associated with the DePuy Pinnacle metal hip. The woman’s husband joined her DePuy Pinnacle hip implant lawsuit with a claim for loss of consortium.

This DePuy Pinnacle Hip Implant Lawsuit is being heard in the U.S. District Court for the Northern District of Texas, Dallas Division.

Filing Defective Medical Device Lawsuit

If you or someone you know suffered injuries related to the use of defective medical device or device component, including metal-on-metal hip replacement device, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/recalls-lawsuits-continue-metal-metal-hip-devices/

Eliquis Focus of Mounting Lawsuits

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Plaintiffs Allege Drug Makers Misrepresented Eliquis Safety

Bristol-Myers Squibb Co. and Pfizer Inc. are the creators of the anticoagulant (blood thinner) Eliquis (apixaban). Eliquis has been found to cause irreversible bleeding events and the drug makers are accused of misrepresenting the safety of the treatment, according to three recent, lawsuits filed in New York state court and brought on behalf of patients who suffered significant blood loss after taking Eliquis, according to Law360.

The three plaintiffs allege that the drug maker and marketer misrepresented the risks of the Eliquis anticoagulant by hiding their knowledge of the treatment’s deficiencies, including a lack of a reversal agent for those patients who start bleeding after taking Eliquis, Law360 reported.

The complaint indicated that, “Upon information and belief, defendants concealed and failed to completely disclose their knowledge that Eliquis was associated with, or could cause, life-threatening bleeding in specific patient populations, and failed to fully identify and convey the risks of use of Eliquis at the same time as other blood-thinning agents, such as aspirin,” the complaint indicated.

The plaintiffs also allege that the U.S. Food and Drug Administration (FDA) approved Eliquis in 2012. Approval was largely based on a clinical trial entitled “Aristotle” that was allegedly conducted by “incompetent and untrustworthy” parties in China in which certain side effects, a death, loss of subjects to follow up, dispensing errors, poor quality control, and falsified records were hidden, wrote Law360.

When Bristol-Myers Squibb Co. and Pfizer Inc. began to market Eliquis in the United States, its label did not disclose the lack of a reversal agent that competing treatments such as Coumadin (warfarin) have, according to the filing. Yet, the drug makers proceeded with an “aggressive marketing campaign” for the treatment, claiming that, unlike Coumadin, patients taking Eliquis do not require blood level monitoring, do not need to limit their diets, and would be able to take a set dose of the Eliquis treatment, according to the complaint, according to Law360.

“In the course of these direct-to-consumer advertisements, defendants overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Eliquis, and that such irreversibility would have life-threatening and fatal consequences,” the filing further alleged.

Even after the drug makers became aware of “serious hemorrhaging” in patients, they did not publicize the complete details of the Aristotle study, the patients allege. The patients seek compensatory, economic, and punitive damages; prejudgment and post-judgment interest; and costs. The cases are being heard in the Supreme Court of the State of New York, County of New York.

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving alleged drug injuries, including excessive, deadly bleeding associated with Eliquis. The firm continues to offer free legal consultations to individuals with questions about filing a drug injury lawsuit.

Prior Eliquis Lawsuits Filed

In September 2016, another Eliquis uncontrollable bleeding lawsuit was filed in the Superior Court of the State of California, County of San Diego. The lawsuit was brought by a couple who allege that the Eliquis drug makers and marketers did not warn consumers and the medical community of the adverse bleeding effects associated with Eliquis. The plaintiffs also alleged that taking Eliquis caused uncontrollable, near-fatal bleeding.

The lawsuit also includes allegations that the wife was prescribed Eliquis to treat her atrial fibrillation, a condition caused by an abnormal heart rhythm. Atrial fibrillation may lead to an increased risk of blood clots and related injuries, including stroke. Eliquis was meant to minimize the risk of blood clot injuries; however, the woman suffered internal bleeding complications.

The woman and her physician reviewed various anticoagulants to treat her condition and chose Eliquis based on the marketing materials presented by Pfizer and Bristol-Myers Squibb. Eliquis is one of the new-generation anticoagulants meant to compete against warfarin, which is sold under the brand, Coumadin, the original blood thinner. Warfarin has been on the market for decades and requires routine and ongoing blood monitoring and dietary restrictions. Patients who take Eliquis or other newer anticoagulants do not have these limitations; however, they present different risks because there is no antidote to stop bleeding events.

Anticoagulants are prescribed to reduce the risk of a life-threatening blood clot; however, the mechanism that reduces life-threatening blood counts may also lead to risks that the blood will not clot when necessary.

A prior lawsuit was filed over allegations that Eliquis led fatal hemorrhaging. The wrongful death lawsuit was filed against Pfizer and Bristol-Myers Squibb alleging that Eliquis was to blame for a Mississippi man’s fatal injuries. The lawsuit was filed on behalf of the man’s surviving spouse. The plaintiff’s husband began taking Eliquis in June 2015 to treat his atrial fibrillation. The lawsuit alleges that the drug makers neglected to warn about the lack of an antidote for Eliquis and the risk of uncontrollable bleeding.

According to lawsuit allegations, the plaintiff’s husband suffered from internal bleeding less than three months after starting Eliquis; he died in September 2015. The plaintiff alleges that these injuries were caused by Eliquis and that Pfizer and Bristol-Myers Squibb were aware of the risks, but continued to sell the medication and failed to warn consumers.

Eliquis is among a newer generation of anticoagulants that include Pradaxa and Xarelto. When these drugs were released, according to the lawsuit, they were marketed as being far superior to warfarin as they do not require blood monitoring or dietary restrictions.

Anticoagulants reduce the risk of life-threatening blood clots, but that may also mean that it is more difficult for blood to clot when necessary. One of the most important aspects of drug safety is assessing a drugs risks versus its benefits. When doctors prescribe a drug to a patient, they need to have all current information to help make the best decision for their patients. The lawsuit alleges that Eliquis did not adequately warn about the lack of an antidote for Eliquis, meaning there is no way to stop the bleeding once it starts. Warfarin, on the other hand, may be reversed with vitamin K. The Cleveland Clinic Journal of Medicine published an article placing Pradaxa, Xarelto, and Eliquis in the same risk category, writing that doctors had serious difficulty managing bleeding that occurs in patients taking these drugs.

Questions about Filing an Eliquis Drug injury Lawsuit

If you or someone you know is interested in filing a lawsuit involving serious bleeding injury or death associated Eliquis. Parker Waichman LLP offers free, no-obligation case evaluations. For more information call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/eliquis-focus-mounting-lawsuits/

Obstructive Sleep Apnea Medication, Nubigil, Leads to SJS

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Patient Taking Nubigil (armodafinil) Diagnosed with SJS

A case report that was presented at the 2017 Annual Meeting of the Associated Professional Sleep Societies in Boston, Massachusetts discussed a patient who developed Stevens-Johnson Syndrome (SJS) within two weeks of taking Nubigil (armodafinil).

Armodafinil is the so-called “R-enantiomer of modafinil” and is indicated to improve wakefulness in patients diagnosed with obstructive sleep apnea, narcolepsy, or shift work disorder. How armodafinil impacts wakefulness remains unclear; however, the drug is an indirect dopamine receptor agonist with wake-promoting activity similar to sympathomimetics (stimulant compounds which mimic endogenous agonists of the sympathetic nervous systems), according to Psychiatry Advisor. Armodafinil is sold under the brand Nubigil.

In this case, the patient is a 21-year-old woman who was diagnosed with daytime sleepiness that had been persisting since she was a child and occurred even if she had nine hours of sleep nightly. The woman also has a history of maintenance immunotherapy for allergies. She tested with significantly shortened sleep latencies without REM (rapid eye movement) sleep and idiopathic hypersomnia and was initially treated with a 150 mg dose of armodafinil each morning, wrote Psychiatry Advisor. Idiopathic hypersomnia is a sleep disorder in which a person is extremely sleepy (hypersomnia) during the day and is very difficult to awaken. Idiopathic means there is not a clear cause, according to Medline Plus.

The patient experienced mild subjective fevers (feeling feverish with no confirmed fever) while being treated with armodafinil and was diagnosed with cervical lymphadenopathy (enlargement of the lymph nodes) on the ninth day of medication. Treatment was stopped on the 13th day of treatment and, within 12 hours of discontinuation, she developed mouth and lip ulcers and a generalized rash over her body. According to Psychiatry Advisor, the woman was hospitalized and when the biopsy revealed Stevens Johnson Syndrome (SJS), she received supportive care. After armodafinil was stopped, no alternative was provided and the woman remained symptomatic with daytime sleepiness.

Psychiatry Advisor noted that serious rash, including SJS, is a reported adverse event in the prescribing information for both modafinil and armodafinil and that the risk is based on a clinical trial of modafinil in which 13 cases in patients younger than 17 years of age reported non-specific rash, which led to discontinuation of the drugs. Of the cases, one was reported as a possible case of SJS.

There are no established risk factors for the development of rash, or clinical features to predict its severity, according to Psychiatry Advisor; however, the study authors recommend immediate discontinuation of modafinil or armodafinil when symptoms occur. The research was published in the journal SLEEP in 2017 and is entitled “Stevens-Johnsons Syndrome After Armodafinil Use.”

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving alleged drug injuries, including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. The firm continues to offer free legal consultations to individuals with questions about filing a drug injury lawsuit.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Some medications may trigger a severe skin reaction that may cause serious, sometimes deadly, reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). A study published in the Journal of the American Medical Association (JAMA) revealed that people who suffered from one episode of SJS or TEN are significantly likelier to experience a second episode. There is no test to determine if a patient is likely to suffer from SJS/TEN.

Patient advocates have long argued that current drug allergy alert label information on many over-the-counter and prescription medications does not contain sufficient user warnings concerning the risk of the very serious SJS and TEN reactions. SJS may be caused by a number of drugs and leaves the patient with blistering of mucous membranes, especially of the mouth, eyes, and genitals. The syndrome also causes patchy rashes that lead to severe skin peeling that may spread to internal organs. SJS may also lead to significant scarring and blindness. When over 30 percent of the body is involved, SJS is known as Toxic Epidermal Necrolysis (TEN); TEN is a very aggressive form of SJS.

Both SJS and TEN may be deadly and often call for intensive care or hospital burn unit treatment. SJS is typically characterized by red or purple skin lesions on the body that peel off in what many describe as “melting.” SJS may cause large areas of the skin to blister and peel, leading to open sores and infection. When this skin peeling or sloughing of skin occurs, tissue or muscle infection may occur. Symptoms may include swelling of mucus membranes, organ damage, and throat swelling. TEN causes large areas of the skin to detach from the body, which may lead to lesions developing in the mucous membranes. Symptoms of both SJS and TEN may include blisters on the skin and the mucous membranes of the mouth, nose, eyes, and genitals; facial swelling; flu-like symptoms, including fever, sore throat, cough, and burning eyes; hives; open sores; serious skin shedding and sloughing; skin pain; skin rash that is often red or purple and that occurs within hours to days; and tongue swelling. Surviving patients may need skin grafts and some may be left with vision issues or blindness and severe skin damage.

While SJS lesions may cover up to 30 percent of a patient’s skin surface, TEN may cover up to 90 percent and progresses much more rapidly. SJS and TEN may became deadly if emergency intervention is not rapidly implemented.

The rate of death associated with SJS and TEN is 30-40 percent and those patients who do survive are generally left with permanent injuries such as vision problems, difficulty eating, and scarring.

Stopping SJS requires early diagnosis and intervention and stopping the medication that caused the condition. Because the warnings on many medications are vague, most people do not recognize that SJS has developed when they experience the syndrome in its initial stages. Also, because the syndrome and its symptoms are not widely known, people may ignore what initially appears to be a minor blister or rash, even though this is a significant indication of SJS and TEN.

Patients who suddenly develop flu-like symptoms after taking medication should visit their physicians immediately as these symptoms are early signs of SJS, as well. Experts advise not using medications unless absolutely necessary and informing treating physicians if flu-like symptoms or a blistering and rash occur while using any drug.

Questions about Filing an SJS/TEN Drug injury Lawsuit

If you or someone you know is interested in filing a lawsuit involving injury or death associated SJS/TEN and the drug that caused this serious and deadly reaction, including Nubigil. Parker Waichman LLP offers free, no-obligation case evaluations. For more information call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/obstructive-sleep-apnea-medication-nubigil-leads-sjs/

Obstructive Sleep Apnea Medication, Nubigil, Leads to SJS

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Patient Taking Nubigil (armodafinil) Diagnosed with SJS

A case report that was presented at the 2017 Annual Meeting of the Associated Professional Sleep Societies in Boston, Massachusetts discussed a patient who developed Stevens-Johnson Syndrome (SJS) within two weeks of taking Nubigil (armodafinil).

Armodafinil is the so-called “R-enantiomer of modafinil” and is indicated to improve wakefulness in patients diagnosed with obstructive sleep apnea, narcolepsy, or shift work disorder. How armodafinil impacts wakefulness remains unclear; however, the drug is an indirect dopamine receptor agonist with wake-promoting activity similar to sympathomimetics (stimulant compounds which mimic endogenous agonists of the sympathetic nervous systems), according to Psychiatry Advisor. Armodafinil is sold under the brand Nubigil.

In this case, the patient is a 21-year-old woman who was diagnosed with daytime sleepiness that had been persisting since she was a child and occurred even if she had nine hours of sleep nightly. The woman also has a history of maintenance immunotherapy for allergies. She tested with significantly shortened sleep latencies without REM (rapid eye movement) sleep and idiopathic hypersomnia and was initially treated with a 150 mg dose of armodafinil each morning, wrote Psychiatry Advisor. Idiopathic hypersomnia is a sleep disorder in which a person is extremely sleepy (hypersomnia) during the day and is very difficult to awaken. Idiopathic means there is not a clear cause, according to Medline Plus.

The patient experienced mild subjective fevers (feeling feverish with no confirmed fever) while being treated with armodafinil and was diagnosed with cervical lymphadenopathy (enlargement of the lymph nodes) on the ninth day of medication. Treatment was stopped on the 13th day of treatment and, within 12 hours of discontinuation, she developed mouth and lip ulcers and a generalized rash over her body. According to Psychiatry Advisor, the woman was hospitalized and when the biopsy revealed Stevens Johnson Syndrome (SJS), she received supportive care. After armodafinil was stopped, no alternative was provided and the woman remained symptomatic with daytime sleepiness.

Psychiatry Advisor noted that serious rash, including SJS, is a reported adverse event in the prescribing information for both modafinil and armodafinil and that the risk is based on a clinical trial of modafinil in which 13 cases in patients younger than 17 years of age reported non-specific rash, which led to discontinuation of the drugs. Of the cases, one was reported as a possible case of SJS.

There are no established risk factors for the development of rash, or clinical features to predict its severity, according to Psychiatry Advisor; however, the study authors recommend immediate discontinuation of modafinil or armodafinil when symptoms occur. The research was published in the journal SLEEP in 2017 and is entitled “Stevens-Johnsons Syndrome After Armodafinil Use.”

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving alleged drug injuries, including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. The firm continues to offer free legal consultations to individuals with questions about filing a drug injury lawsuit.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Some medications may trigger a severe skin reaction that may cause serious, sometimes deadly, reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). A study published in the Journal of the American Medical Association (JAMA) revealed that people who suffered from one episode of SJS or TEN are significantly likelier to experience a second episode. There is no test to determine if a patient is likely to suffer from SJS/TEN.

Patient advocates have long argued that current drug allergy alert label information on many over-the-counter and prescription medications does not contain sufficient user warnings concerning the risk of the very serious SJS and TEN reactions. SJS may be caused by a number of drugs and leaves the patient with blistering of mucous membranes, especially of the mouth, eyes, and genitals. The syndrome also causes patchy rashes that lead to severe skin peeling that may spread to internal organs. SJS may also lead to significant scarring and blindness. When over 30 percent of the body is involved, SJS is known as Toxic Epidermal Necrolysis (TEN); TEN is a very aggressive form of SJS.

Both SJS and TEN may be deadly and often call for intensive care or hospital burn unit treatment. SJS is typically characterized by red or purple skin lesions on the body that peel off in what many describe as “melting.” SJS may cause large areas of the skin to blister and peel, leading to open sores and infection. When this skin peeling or sloughing of skin occurs, tissue or muscle infection may occur. Symptoms may include swelling of mucus membranes, organ damage, and throat swelling. TEN causes large areas of the skin to detach from the body, which may lead to lesions developing in the mucous membranes. Symptoms of both SJS and TEN may include blisters on the skin and the mucous membranes of the mouth, nose, eyes, and genitals; facial swelling; flu-like symptoms, including fever, sore throat, cough, and burning eyes; hives; open sores; serious skin shedding and sloughing; skin pain; skin rash that is often red or purple and that occurs within hours to days; and tongue swelling. Surviving patients may need skin grafts and some may be left with vision issues or blindness and severe skin damage.

While SJS lesions may cover up to 30 percent of a patient’s skin surface, TEN may cover up to 90 percent and progresses much more rapidly. SJS and TEN may became deadly if emergency intervention is not rapidly implemented.

The rate of death associated with SJS and TEN is 30-40 percent and those patients who do survive are generally left with permanent injuries such as vision problems, difficulty eating, and scarring.

Stopping SJS requires early diagnosis and intervention and stopping the medication that caused the condition. Because the warnings on many medications are vague, most people do not recognize that SJS has developed when they experience the syndrome in its initial stages. Also, because the syndrome and its symptoms are not widely known, people may ignore what initially appears to be a minor blister or rash, even though this is a significant indication of SJS and TEN.

Patients who suddenly develop flu-like symptoms after taking medication should visit their physicians immediately as these symptoms are early signs of SJS, as well. Experts advise not using medications unless absolutely necessary and informing treating physicians if flu-like symptoms or a blistering and rash occur while using any drug.

Questions about Filing an SJS/TEN Drug injury Lawsuit

If you or someone you know is interested in filing a lawsuit involving injury or death associated SJS/TEN and the drug that caused this serious and deadly reaction, including Nubigil. Parker Waichman LLP offers free, no-obligation case evaluations. For more information call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/obstructive-sleep-apnea-medication-nubigil-leads-sjs/

Class Action Lawsuits Against Financial Firms may be Possible

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The Consumer Financial Protection Bureau Seeks to Prohibit Certain Forced Arbitration

United States Consumer watchdog, the Consumer Financial Protection Bureau, recently adopted a proposed rule that would prohibit banks and other financial firms from forcing consumers into arbitration in disputes over their bank and credit card accounts. This would enable consumers to join in class action lawsuits, which may lead to significant costs for financial institutions.

“A cherished tenet of our justice system is that no one, no matter how big or how powerful, should escape accountability if they break the law,” Richard Cordray, the director of the Consumer Financial Protection Bureau, said in a statement to The New York Times.

The new rule may take effect next year and is expected to be met with some strong reactions, specifically as the Trump administration and the House Republicans have pushed to temper the consumer finance agency as part of a broader effort to minimize regulation on the financial industry. The rule “should be thoroughly rejected by Congress under the Congressional Review Act,” said Representative Jeb Hensarling, the Texas Republican who led the move to weaken the agency. “In the last election, the American people voted to drain the D.C. swamp of capricious, unaccountable bureaucrats who wish to control their lives,” he added, according to The New York Times.

The Congressional Review Act is a law from 1996 that has been rarely utilized prior to the current Congress when it used the Act to reverse 14 rules from the Obama administration. According to The New York Times, lawmakers have 60 legislative days to overturn the rule blocking mandatory arbitrations.

Despite Republicans apparent dislike of the Consumer Financial Protection Bureau, they may face challenges in killing a rule with such broad public appeal;nationwide, judges, prosecutors, and regulators have criticized arbitration clauses given that they enable corporations to skirt the courts and for taking away consumer tools needed to fight abusive business practices, The New York Times noted.

The new rule would, as The New York Times wrote “unwind a series of legal maneuvers undertaken by major American companies to block customers from going to court to fight potentially harmful business practices.” The rule is a key effort of the Consumer Financial Protection Bureau, which was created in 2010 as part of the Dodd-Frank regulatory overhaul meant to protect the rights of millions of Americans following the mortgage crisis.

Representative Hensarling recently sent a letter that threatened contempt proceedings against Mr. Cordray, the agency’s director. He also blamed faulting the agency for not complying with a subpoena related to its work on the arbitration issue. The Chamber of Commerce indicated that, “The CFPB’s brazen finalization of the arbitration rule is a prime example of an agency gone rogue.” For their parts, the chamber, along with other pro-business groups have minimized the rule as nothing more than a present to class action attorney who, wrote The New York Times, are often Democratic donors.

In May, the Treasury Department issued a report that recommended the Consumer Financial Protection Bureau be held in check, also accusing the agency of regulatory overreach. The Treasury Department called for the president to be able to remove its director.

National law firm Parker Waichman LLP has years of experience and success representing clients in class action lawsuits. Attorneys at the firm are available to answer questions for any individuals seeking legal information concerning arbitration issues.

How the New Proposed Rule Will Help Consumers

Agency supporters argue that arbitration is the type of issue that mandates independence from corporate interests. Meanwhile, for decades, financial institutions led by credit card companies discovered how to use the fine print in their contract to coerce consumers into private arbitration, a secret process in which borrowers must face rich, powerful companies on their own. With consumers unable to join in a class action in which they would be able to pool their resources, most abandon their fights, to the benefit of the large financial companies, The New York Times explained.

The new rule could change how consumer finance issues are handled. Although the protections would not apply to existing accounts, consumers could pay old loans and open new accounts that would fall under the new rule, which would take effect 60 days after its publication in the Federal Register. The rule does not specifically outlaw arbitration, but industry lawyers say it will help stop the practice.

Although there are arguments concerning the pros and cons of arbitration, there is no federal database that tracks arbitrations, and the process is very guarded; however, The New York Times put together a database of arbitrations in a series of articles in 2015 that revealed that few people ever go to arbitration. In financial disputes, The New York Times found that from 2010 to 2014, just 505 consumers—just a tiny percentage of the tens of millions of Americans whose financial contracts have arbitration clauses—reached arbitration over disputes of $2,500 or less.

In fact, it is this consumer reluctance that led to one federal judge remarking in an opinion that “only a lunatic or a fanatic sues for $30.” By banning class actions, companies have effectively crushed any challenges to practices, including predatory lending, wage theft, sexual discrimination, and medical malpractice. Among class actions quashed by arbitration are one a case “brought by Citigroup customers who accused the bank of tricking them into insurance that they were never eligible to use. In another, a group of merchants challenged American Express over high processing fees,” according to The New York Times.

The Consumer Financial Protection Bureau rule would only be applicable to the financial companies regulated by the agency, not arbitration clauses in nursing home or employment contracts. Those clauses have hidden disputes concerning elder abuse, sexual harassment, and wrongful deaths. Recognizing that issue, the federal agency that controls more than $1 trillion in Medicare and Medicaid funding proposed a rule in September 2016 that would have stopped any nursing home that receives federal funding from mandating residents to resolve disputes in arbitration. The protection was brief and soon after Mr. Trump took office, his administration moved to get rid of it.

The “nursing home rule adds urgency to the efforts by the consumer bureau,” according to The New York Times. Meanwhile, the agency’s action is the first serious setback to arbitration since two Supreme Court decisions, in 2011 and 2013.

Today, it is just about impossible to apply for a credit card, to rent a car, to receive cable or internet service, or to shop online without agreeing to private arbitration; however, “law professors and judges, including some appointed by conservative presidents, say the amount of money an individual obtains in a class action is beside the point,” according to The New York Times. They note that class actions are meant to help large groups of individuals receive back smaller amounts of money, such as overdraft fees. Also, class actions lawsuits may drive companies to cease questionable business practices.

Legal Information and Advice Concerning Arbitration Issues

If you or someone you know is having problems pursuing a lawsuit due to an arbitration clause, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/class-action-lawsuits-financial-firms-may-possible/