Articles Posted in Pharmaceutical Injuries

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1156714_26816887.jpgOn November 18, 2013, a Philadelphia jury awarded over $10 million to a family whose son was born with a cleft palate and other birth defects after being exposed to the drug Topamax during his mother’s pregnancy. More specifically, in Gurley, et al. v. Ortho-McNeil Janssen Pharmaceutical, Haley Powell was prescribed Topamax for treatment of epilepsy and migraines. More than a year after she began taking the drug, she became pregnant and continued to take it throughout her pregnancy after being told by doctors that the drug was safe.

After their son, now five years old, was born with birth defects that will require at least five surgeries before turning age 21, the South Carolina couple sued the drug manufacturer, Janssen Pharmaceuticals, Inc. (formerly Ortho-McNeil-Janssen Pharmaceutical) in a Pennsylvania state court. The couple alleged that the company failed to warn the Powells doctor that Topamax taken during pregnancy could cause birth defects, despite the company allegedly being aware of the serious risks as early as 1997. Even though the judge threw out most of plaintiffs’ claims against the drug manufacturer, including strict liability-design defect, negligent design, gross negligence and express breach of warranty, and also barred a bid for punitive damages, the jury ultimately found that Janssen negligently failed to warn the patient and the doctor of the risks associated with Topamax when used by patients during pregnancy and awarded the family over $10 million in damages.

The Gurley case was the second of approximately 134 cases pending in Philadelphia relating to Topamax tried in court. Notably, it is also the second largest verdict in recent months against Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. In October 2013, a Philadelphia jury in Czimmer v. Janssen Pharmaceuticals, Inc. issued a $4.02 million verdict in favor of April Czimmer, a Virginia woman who took Topamax from August 2006 through February 2007 to treat migraines. Czimmer subsequently gave birth to a boy born with a cleft lip in September 2007. She alleged that she would not have taken the drug for more than six months had she known the risks associated with it. The jury ultimately found that Janssen was negligent when it failed to warn healthcare providers of the extent of the risk of birth defects from Topamax, and awarded approximately $562,000 in future health care costs to Czimmer’s son and an estimated $3.4 million for pain and suffering.

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syringe.jpgLess than one year after the U.S. Food and Drug Administration (“FDA”) approved the Omontys (peginesatide) injection, pharmaceutical company Affymax, Inc. (“Affymax”) and its partner, Takeda Pharmaceutical Co. (“Takeda”), voluntarily recalled the anemia treatment for kidney dialysis patients after reports of fatal allergic reactions.

Since its approval by the FDA in March 2012, more than 25,000 kidney dialysis patients have used Omontys to treat anemia stemming from chronic kidney disease. Omontys was favored over other similar drugs because it only had to be infused once a month as opposed to other anemia drugs that often must be given more than a dozen times per month. Omontys also broke the previous monopoly that Amgen’s Epogen and Aranesp had on treating anemia in dialysis clinics. Notably, Epogen and Aranesp have also run into their own safety problems, including an increased risk of heart attacks and strokes associated with the overuse of the drugs.

Unfortunately, on February 23, 2013, the FDA revealed that it had received nineteen reports of anaphylaxis, three to five of which resulted in death. Other patients required prompt medical attention, including resuscitation, or hospitalization. Anaphylaxis is a severe allergic reaction. While the severity of the reaction varies from person to person, symptoms include flushing of the skin, hives, swelling of the tongue and throat, and difficult swallowing and breathing. Symptoms can be life-threatening or fatal.

According to the New York Times, approximately 0.02% of patients treated with Omontys have experience a fatal reaction following the first intravenous administration. Overall, approximately 2 out of every 1,000 patients had a hypersensitivity reaction. These reactions were surprising given that no cases of hypersensitivity were recorded in any of the clinical trials. As a result, the original Omontys warning label contained no warning of possible allergic reactions. By August 2012, however, the FDA was receiving reports about severe allergic reactions to the drug. Additionally, by Fall 2012, Affymax contacted the FDA about adding an updated warning label, cautioning of the risk of severe allergic reaction.

Notably, both the FDA and the drug companies reported that the serious allergic reactions occur within 30 minutes of the drug being administered for the first time. There have been no reports of such allergic reactions in subsequent doses or in patients that completed their dialysis sessions. In fact, according to the press release issued by the drug companies, the most common adverse reactions in clinical studies of patients treated with Omontys were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.

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durgs.jpgAlmost ten years after a young girl suffered a life-threatening reaction to the children’s pain reliever, Motrin, that caused her to lose most of her skin and left her legally blind, Johnson & Johnson was ordered to pay $63 million to the girl and her parents.

In 2003, when the then-7-year-old girl from Plymouth, Massachusetts, had a fever, her parents gave her Children’s Motrin. The girl had previously taken Motrin without suffering any side effects. However, this time, instead of her condition improving, she got worse, and ended up in the hospital for months. More specifically, the disease inflamed the girl’s throat, mouth, eyes, esophagus, intestinal tract, respiratory system, and reproductive system, forcing physicians to put her in a coma. Unbeknownst to her parents, ibuprofen, a common painkiller found in Motrin, can cause a rare, and potentially fatal, skin disease known as toxic epidermal necrolysis or “TEN” that eats away at your skin.

The young girl was not only forced to undergo surgery to drill through her skull to relieve some pressure, but she also lost 90% of her skin and is now legally blind. In addition, the girl suffered severe permanent lung and liver damage, and now has only 20% lung capacity. Although she also suffered brain damage, it caused only short-term memory loss.

Following this grueling experience, in 2007, the girl’s parents sued Johnson & Johnson, the maker of Motrin, and its subsidiary, McNeil PPC, Inc., for failing to provide proper warning of the possible side effects. The key issue in the lawsuit was the warning label Johnson & Johnson used for Children’s Motrin, made by McNeil-PPC, Inc. Notably, even though the prescription version of adult Motrin briefly mentions Stevens-Johnson Syndrome, a more common version of TEN, the over-the-counter children’s version of Motrin that was provided to the young girl, contained no such warning at all.

A manufacturer can be sued under one of three theories for injuries caused by a product or drug, including: (1) defective design, (2) defective manufacturing, or (3) defective warning and labeling. Here, the family sued the health care company under the third theory, alleging that the company failed to meet its labeling requirement. When dealing with warning labels, courts can find a product defective because of an inaccurate or inadequate warning label. Importantly, by law, the manufacturer is required to warn consumers of hidden dangers, and instruct users how to use a product in a way that will avoid the dangers.

In this case, the jury agreed that Johnson & Johnson failed to provide adequate warnings about ibuprofen’s potential side effects and awarded the girl, now 16, $50 million, and awarded an additional $6.5 million to each of her parents. With interest, the award totals $109 million.

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woman in hospital.jpgOne key product liability issue to watch for in 2013 is reportedly the continued adoption of the learned intermediary doctrine by states. In June 2012, Texas joined 35 other states in holding that a sufficient warning to a treating doctor (the “learned intermediary”) satisfies a manufacturer’s duty to warn in product liability cases involving medicine and medical devices. Adoption of this rule essentially means that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drug makers advertise their products directly to consumers.

With the Texas Supreme Court’s decision in Centocor, Inc. v. Hamilton, Texas became the largest remaining state where the Supreme Court had not adopted the learned intermediary rule, which requires warnings only to prescribing physicians–not to any health care provider with which the plaintiff may happen to come into contact. Unfortunately for future victims of negligent misbranding, negligent marketing, and fraud in drug/medical device product liability cases, the court all but did away with the direct-to-consumer exception to the rule, making it more difficult for plaintiffs to successfully bring suit against drug manufacturers.

In Centocor, Inc. v. Hamilton, the product at issue was Remicade, a prescription drug manufactured by Centocor, Inc. Patricia Hamilton suffered from Crohn’s disease and sought treatment from her physician, who informed her that her only treatment options were steroids or Remicade intravenous infusions. After her physician informed her of the risks and benefits of each approach, Patricia opted for the Remicade infusions. Following the treatment, Patricia claimed that the Remicade infusions caused her to suffer a serious drug-induced side effect called lupus-like syndrome.

Patricia and Thomas Hamilton brought suit, contending that the informational video shown to Hamilton by her physician in the course of her prescribed treatments provided “inadequate and inappropriate warnings and instruction for use” of its prescription drug Remicade, which made Remicade “defective and unreasonably dangerous.” More specifically, the couple alleged that Centocor’s video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade’s potential risks and side effects, thereby making Centocor liable for Patricia’s injuries.

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Pradaxa was first released into the market in 2010 by German pharmaceutical giant Boehringer-Ingelheim. The drug immediately reached blockbuster status by notching over $1 billion dollars in sales. In its initial stages, Pradaxa was thought to be a next generation drug that would replace the most common drug used to prevent strokes and blood clots, Coumadin, better known as Warfarin.

Coumadin is a blood thinner that has been the primary drug of choice for nearly 60 years to treat atrial fibrillation, or irregular heart rate, and prevent strokes that are associated with atrial fibrillation. One of the disadvantages of Coumadin is that it requires patients to undergo continual blood tests so that dosage adjustments can be made, if necessary.

The optimum dosage will serve to prevent strokes by thinning the blood but not thinning it so much as to cause a bleed. If the dosage is too high and a bleed results, Vitamin K and fresh frozen blood plasma can be given to the patient to reverse the effects and slow the bleeding.

Pradaxa was supposed to be more effective than Coumadin, safer and easier for patients to use. It would also not require the continual blood work regime. Unfortunately, that proved not to be the case. Pradaxa turned out to be a more dangerous substitute for Coumadin.

If a bleed occurs while using Pradaxa, there is no reversal. Simply put, traumatic bleeding cannot be stopped. Often it is even impossible to perform life-saving surgery because excessive bleeding during the procedure might prove to be worse than the initial trauma. Tthe widespread use of Pradaxa is filled with high risk for the patients who use it.

Initially the health risks of using Pradaxa were not provided to the public, specifically that traumatic bleeding cannot be stopped since there is no available reversal agent. This was documented in an issue of the Journal of Neurosurgery in March of 2012, which concluded that once the internal bleeding begins there is not much that can be done to stop it.

The FDA launched an investigation regarding the safety of Pradaxa in December 2011. There was no recall of the drug mandated. However, in September 2012, the Journal for the American Medical Association initiated new demands for a Pradaxa recall, due to the fact that perhaps the FDA overlooked the side effects of internal bleeding as it rushed to approve the drug.

Unfortunately the many patients taking Pradaxa for their atrial fibrillation are exposed to this danger of internal bleeding. The safety of Pradaxa was called into question shortly after usage began in the U.S. Some 542 deaths and 3,781 side effect problems were linked to the drug in 2011.

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743246_pills sxchu username ice26.jpgThe United States Food and Drug Administration recently announced it was investigating whether codeine was safe for post-surgery use in children. The investigation began after the agency was notified of at least three deaths and one life-threatening adverse event in children between the ages of two and five who were allegedly given the drug following a tonsillectomy. Although each child reportedly received a medically acceptable dose of codeine prior to their reaction, doctors believe all of the children may have developed toxic drug levels due to a specific genetic trait.

According to Dr. Joseph R. Tobin, Professor and Chairman of Anesthesiology at Wake Forest University School of Medicine, codeine requires additional processing by the liver before it begins to work in the body. Codeine is reportedly transformed into morphine by liver enzymes in the patient. In about one-third of the population, codeine allegedly takes so long to metabolize it has little or no effect on pain. In others, codeine may metabolize very quickly and lead to toxic drug levels that can ultimately kill a patient. Dr. Tobin stated this is especially true in children who have anesthesia remaining in their system following surgery. When this occurs, a child may stop breathing without warning.

Most people are unaware of how quickly their bodies will metabolize codeine and there is no way to alter the metabolizing process. Still, the use of narcotics following surgery is reportedly risky in patients who are prone to respiratory depression. Dr. Peter Pronovost, a Professor at Johns Hopkins Medical Institution, stated underlying diseases such as sleep apnea and existing airway obstructions may have been a factor in the children’s deaths. He also said consumers should be aware that all pharmaceuticals can carry risks.

Many physicians reportedly believe codeine should not be used to manage post-operative pain. Safer and more effective drug alternatives reportedly include prescription drugs hydrocodone and oxycodone, as well as over-the-counter pain medications such as acetaminophen and ibuprofen. According to Dr. Alan Greene, Clinical Professor of Pediatrics at Stanford University School of Medicine, there is no demonstrated benefit to administering acetaminophen with codeine in lieu of simply administering acetaminophen to children following surgery.

Potential lawsuits are being evaluated throughout the United States for health risks that may be associated with the post-surgery use of codeine in children. If your child stopped breathing after being given codeine by a health care provider, you should contact an experienced personal injury lawyer to discuss your right to recovery.

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818437_injection_1 sxchu.jpgAccording to the nation’s Centers for Disease Control and Prevention (CDC), nearly 200 people in at least 13 states including Texas have contracted fungal meningitis likely as a result of receiving tainted steroid injections in their neck or spine. The rare outbreak has claimed at least 15 lives. CDC investigators have purportedly linked a preservative-free steroid called methylprednisolone created at the New England Compounding Center (NECC) to the fungal meningitis outbreak. Prior to the outbreak, methylprednisolone manufactured at NECC was reportedly shipped to at least 75 medical facilities in 23 states. All drugs created at the Massachusetts company, including three lots of the allegedly tainted steroid, were recently recalled. NECC and its sister company, Ameridose, have allegedly stopped all manufacturing operations.

According to the CDC, two different types of mold have been detected in fungal meningitis patients who were administered shots created at NECC’s compounding facility. Because both molds normally grow slowly and initial fungal meningitis symptoms may be subtle, the CDC stated more cases are likely to be diagnosed in the near future. Symptoms may include a headache, neck stiffness, fever, nausea, and an increased sensitivity to light.

Meningitis causes the membrane that surrounds a victim’s brain and spinal column to swell. Unlike other types of meningitis, the fungal form is not contagious and must be directly introduced into a patient’s central nervous system through a shot or other means. Although the incubation period can vary, fungal meningitis symptoms will generally begin to appear anywhere between one and four weeks after a patient is exposed to the fungus. Once diagnosed, a fungal meningitis patient must be treated with antifungal drugs for several weeks.

Compounding facilities are normally used to create drugs based on an individual patient’s needs. Often, the facilities will adjust the dosage or physical form of a drug before it is administered. Such facilities are also allegedly used to obtain drugs that are not commercially available or are hired to provide pharmaceutical products for medical facilities that seek to cut drug costs. Although the United States Food and Drug Administration (FDA) is tasked with regulating drug manufacturers, the agency’s role in compounding facility oversight is reportedly less clear. Still, the FDA issued a warning letter to NECC in December 2006.

At least 14,000 people across the country are believed to have received possibly tainted steroid injections. Potential fungal meningitis lawsuits are currently being evaluated throughout the nation. If you or a loved one contracted fungal meningitis after receiving a steroid injection, you should contact an experienced personal injury attorney.

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1114174_red_plaster sxchu username barky.jpgOne of the country’s largest dialysis operators, German-based Fresenius Medical Care, was recently investigated by the nation’s Food and Drug Administration (FDA) in response to a number of patient deaths. Following the investigation, the FDA issued a Class I recall for the company’s Naturalyte GranuFlo Acid Concentrate and Naturalyte Liquid Acid Concentrate products. The products are used to aid in the elimination of waste during the hemodialysis procedure. According to the FDA, they may also potentially raise serum bicarbonate levels in patients undergoing dialysis. A higher serum bicarbonate level can lead to cardiac arrest and death in some patients.

Fresenius Medical Care treats more than one-third of the approximately 400,000 dialysis patients across the United States. The company also reportedly supplies many of the dialysis machines and pharmaceutical products used at other dialysis centers nationwide. In fact, an estimated 125,000 patients are treated using GranuFlo or Naturalyte in non-company medical care centers every year.

According to an FDA official, Fresenius Medical Care is accused of failing to warn dialysis patients of the potentially fatal risks associated with use of its GranuFlo and Naturalyte products. In 2010, 941 dialysis patients who were treated with GranuFlo or Naturalyte experienced cardiac events inside of a Fresenius Medical Care clinic. Despite that the company sent an internal memorandum to warn of the heart risks associated with its products to its own dialysis center doctors, Fresenius Medical Care allegedly failed to notify other dialysis centers or the FDA.

Steven Silverman, the FDA’s Director of Compliance in the Medical Devices Division, stated it was quite troubling that Fresenius Medical Care failed to warn its entire customer base about the health risks associated with the GranuFlo and Naturalyte products. The company’s Chief Medical Officer, Dr. Franklin Maddux responded that the health risks were too preliminary to warrant publication in medical journals and Fresenius Medical Care had no other avenues through which to communicate with outside doctors who were using the product.

In March 2012, Fresenius Medical Care finally issued a warning to customers regarding the alleged increase in heart attack risk associated with use of the company’s products. In May, the FDA issued a safety alert for products such as Granuflo. The following month, a Class I recall was issued for GranuFlo and Naturalyte. A Class I recall is issued when there is a reasonable likelihood that exposure to a drug or medical product will result in a serious health complication or death.

Potential GranuFlo and Naturalyte lawsuits are being evaluated throughout the United States for health risks that may be associated with use of the products. If you or a loved one suffered a cardiac event after being treated with GranuFlo or Naturalyte, you should contact a qualified personal injury lawyer as soon as possible.

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725622_watching sxchu username ngould.jpgNew research published in the Journal of Sexual Medicine this month found that unwanted sexual side effects related to the anti-baldness drug Propecia may continue even after patients stop taking the drug. The study, conducted by researchers from George Washington University, asked 54 men who claimed they experienced side effects such as erectile dysfunction, shrunken genitalia, a lowered sex drive, depression, and anxiety after taking the drug for a period of at least three months about the length of time it took for their condition to improve. The author of the study, Dr. Michael Irwig, found that 96 percent of the men interviewed stated they continued to experience sexual problems more than one year after they stopped taking Propecia. According to Dr. Irwig, the results have led him to believe the drug may have inflicted permanent damage on some patients.

Propecia, or finasteride, was initially developed in 1992 by drug manufacturer Merck to treat men who experience issues related to an enlarged prostate. The drug blocks the body’s ability to create certain hormones that can contribute to hair loss in men and was approved for use in 1997. Although Merck reportedly informed the nation’s Food and Drug Administration (FDA) that some men experienced sexual side effects during clinical trials, the FDA’s website reports those side effects went away after patients stopped using the drug.

In 2011, the FDA required drug giant Merck to place a warning label on Propecia that states some men will experience sexual side effects that continue even after they stop taking the drug. The warning label was reportedly required after the FDA received over 400 reports of sexual side effects, about 60 of which failed to resolve within three months after patients stopped taking the drug. Earlier this year, the FDA required additional label warnings regarding specific sexual dysfunction disorders.

Merck has stated publicly that there is no evidence Propecia causes any sort of long-term sexual dysfunction and the drug’s label effectively warns patients regarding possible side effects related to taking it. According to Dr. Irwig, the number of patients who experience sexual side effects after taking Propecia is likely only around three percent of the overall population. Still, he stated that means thousands of men across the nation are affected because the drug is so commonly prescribed. Additionally, he said there is no way to predict who might be affected by Propecia.

Possible Propecia lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk for sexual side effects such as shrunken genitalia, infertility, erectile dysfunction and neurological problems that lasted for more than three months after the drug was discontinued. If you or your loved one experienced sexual or other long-term side effects after taking Propecia or another prescription drug, you should discuss your case with a knowledgeable personal injury attorney.

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1160103_prescription_drugs_2 sxchu.jpgRecently released emails and other internal documents suggest the Pfizer Corporation intentionally withheld key safety information related to the company’s pain relief drug Celebrex. With annual worldwide sales in excess of $2.5 billion, the drug is one of Pfizer’s best selling products. Last year, Celebrex was prescribed to about 2.4 million people in the United States alone. Celebrex is the last of the COX-2 inhibitor pain relief drugs on the market. Other such pain drugs, including Vioxx, were removed from pharmacy shelves worldwide over reported safety issues and concerns.

The incriminating documents were unsealed by a federal judge in a securities fraud case against Pfizer brought by company shareholders. The documents tend to demonstrate that Pfizer officials decided to withhold important study data from the public. Company executives reportedly began analyzing ways to attack safety study results before at least one research study was completed. The company also allegedly ignored warnings from employees and outside consultants to disclose the fact that Pfizer was relying on incomplete safety data.

As prior studies tended to demonstrate Celebrex was no better at relieving pain than other common drugs such as ibuprofen, Celebrex’s chief benefit was the drug’s purported ability to relieve pain without causing stomach upset. One email from a company research director to a fellow employee expresses happiness after learning attendees at a large medical conference “swallowed” Pfizer’s story that the drug was safer on patient stomachs than other drugs on the market “hook, line, and sinker.” Pfizer, however, reportedly failed to alert the audience that the company only presented the results of a portion of the study.

Internal emails suggest the company chose to massage data and cherry pick results in an effort to make Celebrex look safer. Pfizer officials stated the company had no intent to deceive the public regarding the drug’s safety and claimed the drug’s track record of safety speaks for itself. According to Pfizer, approximately 33 million patients in the U.S. have taken the drug. Still, there is reportedly no clinical proof Celebrex is less likely to harm a patient’s stomach than other pain relief drugs. Pfizer’s decision to withhold safety data was made public in 2001 when the federal Food and Drug Administration released the entire results of the stomach safety study.

In 2004, Vioxx, manufactured by the drug company Merck, was withdrawn from the market after safety studies linked it to an increased risk of heart attacks. Some of the Vioxx safety studies also suggested using Celebrex increased a participant’s risk for heart complications. In response to such concerns, Pfizer began a now six-year-old research study designed to evaluate Celebrex’s effect on the heart. The study is not scheduled to conclude, however, until May 2014. That is the same month the drug’s patent will expire and Celebrex sales are expected to plummet.

Potential Celebrex and Vioxx lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk of heart attacks and other health complications such as Stevens-Johnson Syndrome. If you or a loved one experienced heart, gastrointestinal, or other medical complications while taking a COX-2 inhibitor pain relief drug, you should contact a skilled Texas personal injury attorney as soon as possible.

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