Drug Injury Lawyer Blog

JUDGE OKS CLAIMS OF STRICT LIABILITY AGAINST DRUGMAKER

2013-05-07T21:15:46Z

A federal judge has opened a window for plaintiffs to make a claim for strict liability against prescription drugmakers on a manufacturing defect theory. Despite developing case law in the opposite direction, U.S. District Judge Malachy Mannion of the Middle District of Pennsylvania ruled that Ryan Bergstresser could bring a manufacturing-defect claim against Bristol-Myers Squibb over its antipsychotic drug, Abilify. Bergstresser alleges he suffered from dystonia, which is characterized by involuntary muscle contractions, after his psychiatrist increased his dosage of the drug.

Liver Toxicity Risks with Samsca

2013-05-07T20:22:29Z

On April 30, 2013, the Food and Drug Administration (FDA) issued their second alert to patients and health care providers concerning the drug tolvaptan (SAMSCA). The warning had two main points: Tolvaptan use should be limited to no more than 30 days, and it should not be used at all in patients who have liver disease.

]]> Tolvaptan was originally approved in 2009 for treating low blood sodium levels that don’t respond to simple fluid restriction or discontinuation of medication that may be causing the problem. Because correcting a low blood sodium level too quickly can be dangerous, patients starting tolvaptan should be hospitalized for monitoring. The drug must not be used for more than 30 days. Also, it affects blood levels when it interacts with some other commonly used drugs (for example, when given along with the drug ketoconazole, a drug to treat fungal infections, the level of tolvaptan increase 5-fold).

The initial letter to health care providers from the manufacturer, Otsuka America Pharmaceutical, Inc., was sent January 22, 2013, followed by an FDA Safety Alert on January 25, 2013. A second set of warnings was issued by both the FDA and Otsuka (the latter on May 1, 2013). These warnings resulted from a recent trial in which three patients developed liver injury as indicated by increased levels of liver enzymes in their blood. The findings are being taken very seriously to warn that patients taking tolvaptan “are at a potential increased risk for irreversible and potentially fatal liver injury.”

Read the complete safety alerts:

April 30 FDA alert:
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM350084.pdf
January 25 FDA alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336669.htm

If you are taking tolvaptan, talk to your health care provider about another treatment option, especially if you have taken it for more than 30 days.

Be alert for signs of liver toxicity, including loss of appetite, nausea or vomiting, fever, feeling unwell, unusual tiredness, itching, jaundice, unusual darkening of the urine, and pain or discomfort in the right upper stomach area.

Report any adverse effects related to tolvaptan to the FDA MedWatch program.

More Bad Press for Fresenius Medical

2013-03-15T21:13:02Z

On March 14, 2013, Fresenius Medical Care North America (FMCNA), announced that it has received yet another reprimand from the FDA, indicating that the agency found that the company failed to properly study artificial kidneys being used in its dialysis machines. The letter is not a formal recall, but it comes in the wake of the mid-2012 GranuFlo and NaturaLyte dialysis product recalls. These products were recalled when it was revealed that there is a serious and high risk of sudden cardiac arrest or death due to elevated bicarbonate levels in these dialysis additives

Prolia May Cause Sudden Femur Fractures

2013-03-14T21:48:30Z

Prolia, a drug used to treat osteoporosis, received FDA approval in June of 2010. Prolia is administered by injection every six months to postmenopausal women and to men, who have either low bone mass or osteoporosis, and are susceptible to fractures.

]]> Prolia, manufactured by Amgen, issued a November 16, 2012 warning letter to Canadian health officials, about the potential risk for sudden femur fractures. This letter warns users of Prolia that atypical femur fractures can occur with little or no trauma to the thigh bone. These sudden fractures appear to be similar to those associated the side effects of Bisphosphonates, another family of bone strengthening drugs.

Health Canada and Amgen warn that if a patient experiences new pain in the hip, pelvic area, or thigh they should immediately contact their health care provider. While Prolia is sold in the United States, no similar warning has been issued by the FDA. However, there have been warning for bisphosphonate bone drugs.

If you or a loved one has experienced a fracture due to Prolia usage, please contact Pogust Braslow & Millrood for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com

Heart Warning for Popular Z-Pack Antibiotic

2013-03-14T14:07:17Z

The FDA issued a warning for the popular antibiotic (azithromycin) commonly known as a Z-Pack and sold under the brand names Zithromax and Zmax. This common antibiotic is widely used to treat sinus infections and bronchitis. In 2011 alone, there were over 50 million prescriptions for the Z-pack with sales in excess of 464 million dollars.

]]> The FDA’s warning comes after a Vanderbilt study published in the New England Journal of Medicine in May 2012 which found a 2.5 fold higher risk of death from cardiac arrhythmia in the first five days of taking azithromycin when compared with another common antibiotic or no antibiotics at all. About 348,000 recorded prescriptions of azithromycin were compared with millions of similar records from people who were not treated with antibiotics or were treated with other antibiotics.

Specifically, the FDA safety announcement warned that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. According to the FDA, the warning was a result of their review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.

Pfizer, the manufacturer of Zithromax, issued a statement that “the majority of patients treated with Zithromax are not affected by this label update.” However, serious questions remain as to how long Pfizer has been aware of these deadly risks. Prior to the Vanderbilt study, the researchers noted well-documented reports in the published literature as FDA database reports linking azithromycin with serious arrhythmias. Based on this evidence, the Vanderbilt researchers sought to examine cardiovascular deaths in patients who were taking the antibiotic.

If you or a loved one was taking the antibiotic Zithromax or Zmax and suffered an abnormal heart rhythm, you may have a legal claim against Pfizer. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com

PBM Files First Cymbalta Personal Injury Suit

2013-03-07T20:47:49Z

On March 5, 2013, Pogust Braslow & Millrood, LLC filed its first personal injury suit against Eli Lily and Company over Cymbalta withdrawal symptoms. The case, Carnes v. Eli Lilly and Co., was filed in the United States District Court for the District of South Carolina. Cymbalta withdrawal symptoms can be severe, long-lasting, and debilitating. The complaint details that Mr. Carnes suffered from severe brain zaps and aggression, and alleges that the company should have known about the likelihood, extent, and severity of experiencing withdrawal symptoms and yet failed to adequately warn doctors and patients about the risk.

]]> Other symptoms typically associated with Cymbalta withdrawal include headaches, dizziness, nausea, fatigue, nightmares, insomnia, and suicidal ideation and actions. If you have experienced withdrawal symptoms or other related injuries in attempting to stop or taper off Cymbalta, you may have a legal claim against the manufacturer of the drug. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com

FDA recalls Johnson & Johnson Orthopedic Device

2013-02-26T21:08:23Z

The Food and Drug Administration issued a Class 1 Recall of the orthopedic device known as the LPA Diaphyseal Sleeve. Manufactured by Depuy, Johnson & Johnson’s orthopedic unit, the LPA Diaphyseal Sleeve is used in reconstructive knee surgery.

]]> Made between 2008 and July 20, 2012 the LPS Diaphyseal Sleeve is a component of DePuy’s LPS knee replacement system. According to the recall, the LPS Sleeve Base taper connection might not be sufficiently stable to tolerate patients’ weight as they walk, thus resulting in an increased potential for fracture. A fracture with the LPA Diaphyseal Sleeve can lead to:

• Loss of function
• Loss of limb
• Infection
• Compromised soft tissue
• Death

According to Reuters, the FDA has received 10 reports of incidents in which the device has malfunctioned. The FDA reports that “Depuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device.”

If you or a loved one received an LPA Diaphyseal Sleeve, while having knee replacement surgery, and suffered a fracture, you may have a legal claim against Depuy. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com

Does Actos increase the risk for heart attacks?

2013-02-26T19:10:52Z

A 2010 study, published in the American Heart Association’s journal Circulation, found that the risk for heart attacks was the same for Actos as it was for Avandia. According to the study, patients taking Actos or Avandia were 4 percent more likely to experience heart attacks. The study included over 36,000 patients with an average age of 54. This study was conducted over 33 months, including 14 months of treatment on either medication. Among the patients, 602 Avandia users and 599 Actos users suffered a heart attack, heart failure, or died. Even more concerning, there were 217 deaths in each group. Despite these alarming numbers, some found the results of this study to be inconclusive.

]]> Following the study, Takeda was quick to reject the Actos-heart attack link. A Takeda spokesperson, Hisahi Tokinoya, explained “Actos studies, conducted over the past 11 years in more than 20,000 patients, show no evidence that Actos was associated with an increased risk of heart attack, stroke, or death.”

Although there has been a black box warning for heart failure since 2007, Actos has never updated its warnings as it relates to the risk of heart attacks.

Questions regarding increased risk for heart attacks for Actos users once again re-emerged in a 2012 lawsuit by whistleblower Dr. Helen Ge. Dr. Ge was a former medical reviewer for Takeda. The Actos whistleblower lawsuit (U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston)) alleged that Takeda knew about instances of Actos heart attacks, but failed to report these events due to financial motives. Dr. Ge further alleged that on multiple occasions, Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” According to Dr. Ge, her contract was terminated as she continued to protest this alleged practice. Unfortunately, in November 2012, Dr. Ge’s lawsuit was dismissed due to a pleading technicality before the merits of Dr. Ge’s claims were determined. Many questions remain as to whether Takeda continues to underplay the risk of heart attacks for Actos users.

If you or a loved one was taking Actos and suffered a heart attack, you may have a legal claim against Takeda. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com

Risk of Dementia from Benzodiazepine Use

2013-02-20T15:16:41Z

Benzodiazepines, such as Valium, Ativan, Librium and Xanax (and their generic versions), have been around for a long time. They are the most popular drugs the world, selling an estimated $880 billion in 2011 alone. They are commonly prescribed for generalized anxiety and to help with insomnia. They also come with many dangerous known side effects, including the potential to cause drug-induced addiction.

]]> Last fall, a study published in the British Medical Journal, concluded that new use of benzodiazepines was associated with an increased risk of dementia. The study’s authors cautioned against “indiscriminate widespread use.” It found that benzodiazepine use by elderly patients increased the risk of developing dementia by an incredible 50%. As dementia becomes more and more prevalent in our elderly population, one has to wonder whether the millions of prescriptions for these addictive drugs is contributing in some way to the rise in dementia, where there are few treatments that can make a significant difference.

Over a decade ago, researchers followed approximately 3700 elderly subjects for approximately 8 years to determine the relationship between benzodiazepines and the elderly. They concluded in the Journal of Clinical Epidemiology that “use of benzodiazepines could be a risk factor for dementia, but more detailed investigation are needed.” Not surprisingly, as far as I am aware, none of the manufacturers of these drugs spent the time or money to study this potential long term association or found it appropriate to warn physicians about this long term risk.

Now, following the publication of this latest study, it is critical that the manufacturers of these drugs directly warn physicians about the risk of dementia. As the BMJ concluded - “Considering the extent to which benzodiazepines are now prescribed, physicians and regulatory agencies should consider the increasing evidence of the potential adverse effects of this drug class for the general population.”

Cymbalta Withdrawal: Affects Approximately Half of Users and Can be Both Severe and Persistent

2012-11-10T17:15:18Z

Last month, the Institute for Safe Medication Practices (ISMP), an independent, non-profit FDA watchdog agency, issued its quarterly report, detailing the 90% increase in adverse events (AEs) reported to the FDA since 2008. Included in the report are findings from a specific investigation aimed at Cymbalta and withdrawal symptoms.

]]> Just last week, the law firms of Keller Rohrback, the Deskin Law Firm, and our firm, Pogust Braslow & Millrood, LLC, filed a class action complaint relating to Cymbalta withdrawal symptoms in the federal district court for the Central District of California. The complaint alleges deceptive marketing, consumer protection act violations, and negligence and strict products liability on the part of Eli Lilly & Co., the maker of Cymbalta.

In its October report, the ISMP concludes that for Cymbalta there are "major shortcomings in the official information for both patients and health care professionals." The report explains:

[W]ithdrawal symptoms were reported in 44-50% of patients abruptly discontinuing duloxetine at the end of clinical studies for depression, and more than half of this total did not resolve within a week or two. In addition, we identified a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage this common adverse effect.

Significantly, the ISMP points out that the only information conveyed to patients in Lilly's official patient guide is to "never stop an antidepressant medicine without first talking to a healthcare provider." The report goes on:

This FDA-approved patient guide is materially deficient. It gives no hint of the persistence or severity of the symptoms known to occur. It does not address basic questions: What kinds of symptoms are most common? Should patients taper off the dose, and if so, how slowly? What should a patient do if depression or other symptoms recur? Is there a way to tell whether these are withdrawal symptoms or the previous illness returning?

ISMP concludes that a likely result of Cymbalta withdrawal symptoms without adequate warnings and physician instructions is "excessive and unnecessary long-term use" of the drug.

If you have experienced withdrawal symptoms or other related injuries in attempting to stop or taper off Cymbalta, you may have a legal claim against the manufacturer of the drug. You can contact our law firm for a free consultationa at (610) 941-4204 or on our website: www.pbmattorneys.com.

Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC File a Class Action Lawsuit Against Eli Lilly and Company Regarding Cymbalta

2012-11-01T14:29:33Z

Seattle, WA, October 31, 2012 (GLOBE NEWSWIRE) – Attorney Advertisement Material. Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC filed a class action lawsuit today against Eli Lilly and Company (“Lilly”) (NYSE:LLY). Lilly, an Indiana based pharmaceutical company, is the maker of Cymbalta. The class action complaint was filed in the United States District Court for the Central District of California, in Los Angeles, on behalf of all consumers who purchased Cymbalta at any time since the product’s launch in August 2004 to the present.

]]> Cymbalta is prescribed to individuals that have been diagnosed with generalized anxiety disorder, fibromyalgia, and musculoskeletal pain. Plaintiff alleges that Lilly misrepresented the risks associated with taking Cymbalta and misled consumers about the frequency, severity, and duration of “Cymbalta withdrawal.” Withdrawal symptoms include, among others, headaches, dizziness, nausea, fatigue, nightmares, insomnia, anxiety, and suicidal ideation. Cymbalta withdrawal symptoms can range from mild to severe—the latter consisting of debilitating and painful symptoms that last several months.

If you used Cymbalta or you would like more information regarding the Cymbalta class action, please contact one of the following attorneys: Michael Woerner or Mark Samson, Keller Rohrback at 800-776-6044 or via e-mail at consumer@kellerrohrback.com.

If you used Cymbalta, suffered serious side effects, and want more information about pursuing an individual personal injury claim, please contact Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC via the contact form on the website: http://cymbaltasideeffects.com or at 800-897-8930 or via email at cymbalta@deskinlawfirm.com.

CONTACT:
Keller Rohrback L.L.P.
Michael Woerner, Attorney
1201 Third Ave., Ste. 3200
Seattle, WA 98101
Keller Rohrback P.L.C.
Mark Samson, Attorney
3101 North Central Ave., Ste. 1400
Phoenix, AZ 85012
800-776-6044
consumer@kellerrohrback.com
www.krcomplexlit.com

Pogust Braslow Millrood LLC
Harris Pogust, Attorney
8 Tower Bridge, Suite 1520
161 Washington Street
Conshohocken, PA 19428
888-348-6787
http://cymbaltasideeffects.com

Deskin Law Firm, a PLC
Samuel Deskin, Attorney
16944 Ventura Blvd., Office
Encino, CA 91316
800-709-8978
consumer@deskinlawfirm.com
http://cymbaltasideeffects.com

Meningitis Outbreak Linked to Steroid Injections

2012-10-10T13:57:34Z

A rare outbreak of fungal meningitis linked to steroid injections has sickened 119 and caused 11 deaths nationwide according to CNN. The FDA has linked the meningitis outbreak to a contaminated methylprednisolone acetate injection that is produced by the New England Compounding Center (NECC). This steroid injection, which is injected directly into the spine, is said to be contaminated with a potentially lethal fungus.

]]> Fungal meningitis is very rare and, unlike bacterial meningitis, is not contagious. Soon after receiving the contaminated injection, patients began experiencing symptoms of meningitis such as headache, fever, nausea, stiff neck and a sensitivity to light.

According the Center for Disease Control (CDC), 76 facilities in 23 states have received products from NECC. Patients started to receive these potentially contamination injections on May 21, 2012. NECC issued a statement announcing a recall of “all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.”

The FDA's statement cautions health care professionals and consumers not to use any product produced by the NECC and requested that all NECC products be retained and secured until the FDA provides instructions for disposition. The FDA is also encouraging any user of these products to notify the FDA MedWatch immediately about any complaints or problems related to these products.

If you or a loved one experiences any symptoms of meningitis after receiving a steroid injection, please go to the hospital immediately. The attorneys at PBM are also here to answer any questions that you may have about your rights related to these contaminated injections if you've received one.

Mirena IUD has Significant Risks

2012-09-18T21:24:46Z

The Mirena IUD (Intra-Uterine Device) was given FDA approval as a long acting form of birth control and for treatment of heavy menstrual bleeding. It is a T-shaped device that is inserted into a woman’s uterus in order to prevent fertilization. In addition, the device also releases a synthetic form of progesterone known as levonorgestrel, to stop a woman from producing and releasing an egg.

]]> Manufactured by Bayer, Mirena has been promoted as a safe and long-term reversible form of birth control. However, Bayer may have sold the device without properly warning women about the potential risks associated with Mirena. Major complications are linked to the IUD’s potential to move inside the body resulting in numerous side effects, including the following: perforation of the uterine wall; migration of the IUD to outside the uterus; infection; infertility; pelvic inflammatory disease; and expulsion of the IUD.

On January 14, 2010, an FDA warning letter was sent to Bayer concerning its live consumer directed program. The letter states that Bayer “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”

As lawsuits from women who were injured while using the Mirena IUD grow in New Jersey state court, Bayer Pharmaceuticals has recently sought to consolidate the lawsuit in a New Jersey court.

If you or a loved one has experienced complications as a result of Mirena please contact the attorneys at Pogust Braslow & Millrood immediately.

Dialysis Treatment Drugs Contributing to Patient Heart Attacks

2012-09-12T19:07:59Z

Millions of patients suffering from kidney disease rely on dialysis and hemodialysis in order to have toxins removed from their body. Dialysis treatment is critical in keeping patients alive and assisting many who may be awaiting a life-saving kidney transplant. And critically important to this life-saving dialysis process is ensuring that the drug products given to dialysis patients neutralize the acid that builds up in their blood.

]]> Fresenius Medical Care North America manufactures some of these dialysis drug products and is the largest dialysis medical care related company in America. Doctors have trusted Fresenius for years with providing safe and effective drug products for their dialysis patients. Two of the drug products used by nephrologists and manufactured by Fresenius are NaturaLyte and Granuflo.

These products were the subject of a March 2012 FDA Class I recall because of a significantly increased risk of a fatal heart attack to patients undergoing dialysis. It seems that physicians were not made fully aware of the chemical nature of NaturaLyte and Granuflo, causing them to prescribe inaccurate amounts of these drugs.

It was not until March 2012, at the time of the recall, that Fresenius began warning all health care providers of the significance of prescribing accurate units of acids in preparing final buffer solutions.

Incredibly, in November 2011, Fresenius issued an internal memo warning its own clinics of the increased risk of heart problems for patients undergoing dialysis treatment with GranuFlo and NaturaLyte, but failed to warn any doctors who worked outside of its own dialysis treatment centers. According to the memo about 941 patients suffered from cardiac arrests and concluded that patients with elevated levels of bicarbonate had about a six times greater chance of having a heart related episode than those with lower bicarbonate levels. Now, the FDA is apparently investigating whether Fresenius failed to comply with federal regulations by concealing the risks of its products

If you or a loved one had a heart attack while undergoing dialysis treatment with GranuFlo and NaturaLyte, please contact the attorneys at Pogust Braslow & Millrood immediately.

The Hidden and Deadly Risks of IVC Filters

2012-09-06T21:22:15Z

Retrievable inferior vena cava (IVC) filters are a type of vascular filter that is implanted in the heart in order to help prevent life threatening pulmonary embolisms and can be removed when they are no longer necessary. According to the FDA, approximately 200,000 of these devices are implanted into patients each year – many of which – were either most likely not medically necessary in the first place or should have been removed when they were no longer necessary.

]]> And these devices were approved under the FDA’s 510(k) process, which as you may know, is approved under much less scrutiny than pre-market approved devices. Unfortunately, it has been reported that perhaps as many as one out of four of these filters may fracture and migrate to other parts of the body – causing serious injury and death. These IVC filters include C.R. Bard’s Recovery® and G2®.

Almost two years ago, on August 9, 2010, the FDA issued an initial advisory communication regarding all retrievable IVC filters, due to risk of perforation, fracture, and migration within the human body. If the IVC filter does travel, these fragments can cause severe pain, disruption in heart rate, hemorrhaging, puncturing of internal organs, veins and arteries and possible death. The FDA believes these issues could be related to the retrievable filter remaining in the place, long after the risk of pulmonary embolisms have passed and recommends removal as soon as doctors feel it is safe to do so.

According to a study by the Archives of Internal Medicine, the Recovery® IVC filter was reported to have a 25% fracture rate whereas the second generation the G2® IVC filter only had a 12% fracture rate. While the G2® IVC filter had a lower fracture rate, according to researchers, the G2® IVC filter failed after just 717 days whereas the Recovery® IVC filter averaged 1498 days before failure.

If you or a loved one has experienced injuries resulting from a Retrievable IVC Filter, please contact Pogust Braslow & Millrood for a free consultation to make sure that you rights are protected.