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November is National Diabetes Month, a time to promote greater awareness for the more than 20 million Americans who are living with this chronic illness that can lead to serious complications, including heart disease, blindness, high blood pressure, and stroke. At Altman & Altman, LLP, our drug injury lawyers are well aware of the health issues that patients suffering from diabetes can develop. One of the reasons for this is that we represent diabetes patients (and their families) that have developed bladder cancer after taking the medication Actos.

Already, numerous plaintiffs have filed Actos injury lawsuits suing Takeda Pharmaceuticals because they believe the diabetes drug caused their bladder cancer. There also have been studies confirming the link between Actos and this type of cancer. (Eli Lilly & Co., which marketed the diabetes drug for Takeda in the US, is also a common defendant.)

It wasn’t until 2011 that the US Food and drug Administration issued a safety communication notifying the public that Actos’s label had finally been modified to come with the warning that using the medication for longer than a year may significantly increase a patient’s chances of getting bladder cancer. The FDA especially wants people already suffering from blood cancer or who have a history of the disease to be very careful when taking Actos, or better yet refrain from taking medications with pioglitazone, which is the generic name of Actos. (On August 17th of this year, the FDA approved its first generic versions of Actos tablets. The manufacturer is Mylan Pharmaceuticals.)

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A jury is ordering Novartis Pharmaceuticals Corp. to pay plaintiff Barbara Davids $10.45 million for osteonecrosis of the jaw injuries she says she sustained because she took the drug Zometa. The award is comprised of $450,000 in compensatory damages and $10 million in punitive damages.

Per her drug injury lawsuit, Davids claims that she developed bone death in her jaw after she took Zometa, which is a bisphosphonate that is used to treat bone complications resulting from cancer. Bisphosphonates, which are supposed to help with certain bone conditions, are now being linked to a greater risk of ONJ.

Davids believes that Novartis has known for some time that Zometa may cause serious jawbone complications. Her products liability lawyers even provided during trial an email from 2003 in which one of the pharmaceutical company’s marketing employees talks about a proposed report connecting the drug to the complications, describing it as very damaging. That employee also sent another email proposing a public relations imitative and other “next steps” in case the paper were to be published-although the ideal scenario appeared to be for it to never see the light of day.

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Marcia and Peter Scherone have filed a hip implant defect lawsuit against Zimmer Holdings Inc. They contend that Marcia sustained femur fractures because she had been fitted with a Zimmer hip implant that was defective, As a result, they claim, she had to undergo over six revision surgeries to fix the damage sustained to her leg and hip. The Scherones are suing for negligence, breach of express and implied warranty, loss of consortium, and strict liability.

Marcia, who was implanted with the Zimmer Trilogy hip device in 2005, suffered a fracture while in the shower in 2008 and dislocated her hip. She blames her injuries on the faulty hip implant device, which had to be removed after its plastic liner split in two.

In the last couple of years, Marcia has been forced to use a walker and wheelchair and continues to experience pain from her injuries. She also has not been able to function normally in her professional and daily lives. The plaintiffs want damages for Marcia’s past and ongoing pain and suffering.

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Another dangerous drug lawsuit has been filed against Takeda Pharmaceuticals claiming that the drug Actos caused 14 plaintiffs to develop bladder cancer. All of the victims said they were diagnosed with this type of cancer after taking popular type 2 diabetes medication. Also named as defendants are the company’s subsidiaries and Eli Lilly.

In their Actos lawsuit, the victims are alleging negligent drug design and marketing. They contend that the defendants knew, or if they didn’t then they should have known, that taking Actos for a prolonged period increases the risk of bladder cancer. The plaintiffs want compensatory damages, including medical expenses and pain and suffering.

Although Actos has been available to diabetes users in the US for a number of years, it was just last year that the Food and Drug Administration put out a Drug Safety Communication giving notification that the medication’s label had been revised to include a warning that use of the drug for over a year dramatically increases the chances that the patient might develop bladder cancer. The federal agency’s safety announcement was issued after an examination of data belonging to a 5-year analysis of an Actos study that was conducted by Takeda. The FDA is now recommending that drugs with pioglitazone not be prescribed to people who already have blood cancer and that those with a history of the disease must be cautious should they choose to take this medication.

Also, there has been more than one study confirming the bladder cancer-Actos link. One of the more recent ones was just published in the Journal of the National Cancer Institute in August. Based on the study, which the National Institutes of Health funded, Researchers from the University of Pennsylvania’s Perelman School of Medicine are cautioning that thiazolidinedione users who take these drugs for five years or longer are at least twice as likely to receive a bladder cancer diagnosis than patients who are taking other diabetes medications. Actos is a thiazolidinedione medication.

Unfortunately this Actos-cancer connection was not revealed early enough for the many drug users who have developed cancer as a result. Consider how common a disease type 2 diabetes is-285 million are afflicted globally-and how many of these people have been prescribed Actos over the years. According to Upenn.edu, some 15 million Actos prescriptions are issued in the US each year.

For a medication to have such a serious side effect makes it a very dangerous drug. Already, hundreds of Actos lawsuits have been filed in US and state courts, with all federal cases consolidated in one court in Louisiana.

Diabetes Drugs Prescribed to More than 15 Million Americans Raises Risk of Bladder Cancer, Penn Medicine Study Shows, Penn Medicine, August 13, 2012

FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines, FDA, August 4, 2011

More Blog Posts:
Actos Lawsuits Allow Diabetes Patients to Pursue Dangerous Drug Compensation from Takeda Pharmaceuticals America, Inc., Drug Injury Lawyers Blog, August 1, 2012

Pradaxa Lawsuits Seek Damages for Bleeding Injuries, Drug Injury Lawyers Blog, July 25, 2012

Use of Ocella Birth Control Pill May Cause Higher Stroke Risk, Drug Injury Lawyers Blog, October 3, 2012 Continue reading

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The recent fungal meningitis outbreak continues to spread, as more innocent patients have been diagnosed over the past week. Experts explain that those affected may suffer from a fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status. Patients are urged to seek medical attention if they experience “visual changes, pain, redness or discharge from the eye, chest pain or drainage from the surgical site.” Doctors are urged to contact patients who have been treated with medications distributed by the New England Compounding Center (“NECC”). The NECC agreed to cooperate with the ongoing investigation to find the specific cause for the outbreaks and the medications affected. Their Massachusetts pharmacy has suspended operations until further notice and recalled all of its products.

Since meningitis is a life-threatening illness, federal authorities are taking this investigation seriously and will continuously update their website with pertinent findings. According to the Centers for Disease Control and Prevention, there have been 15 deaths and 214 illnesses associated with the tainted drugs distributed by the NECC in Framingham, Massachusetts. When the drugs were discovered to be tainted, the Food and Drug Administration (“FDA”) issued a warning, claiming that only people with back injuries who received an injected steroid medication would be adversely affected. New studies indicate, however, that there are several drugs from the NECC that can cause other illnesses. These drugs include another injected steroid as well as medications for heart and eye surgery.
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A little over a year after her death, the estate of Shirley Boles has reached a confidential damage award agreement with pharmaceutical giant Merck & Co. over injuries she sustained from the drug Fosamax. Boles developed osteonecrosis of the jaw after taking the medication for several years. She filed a Fosamax lawsuit, and, after an initial mistrial, a jury awarded her $8 million for her personal injuries. A district judge would go on to lower the award amount to $1.5 million while upholding the verdict. Boles decided to go to trial again. Now, however, her estate as instead consented to the damages agreement.

Boles is just one of hundreds of plaintiffs to sue Merck over claims that their bone injuries are result of taking Fosamax, which is a bisphosphonate and one of the more popular osteoporosis treatment and bone strengthening medications in use-by women, in particular. Fosamax is also used to treat other bone disorders and Paget’s disease. Unfortunately, Fosamax is now linked to very serious side effects, including atypical femur fractures, osteonecrosis of the jaw, serious musculoskeletal pain, esophageal cancer, atrial fibrillation, inflammatory eye disease.

Earlier this year, the US Food and Drug Administration published an analysis in the New England Journal of Medicine that warned about taking bisphosphonates long-term. The worry is that after using them for years, the drugs can cause certain women’s bones to become weaker, potentially leading to the serious side effects. The FDA also found that after conducting its own review of how effective bisphosphonates are after several years of use, beyond three to five years there was little, if any, additional benefit for most patients unless the person was older and had a higher fracture risk and a bone density that was “osteoporotic.”

The reason bisphosphonates are often prescribed to women is that after age 30 it is not uncommon for their bones to begin dissolving faster than they can be rebuilt-especially after menopause. Bisphosphonates are supposed to slow down this process.

Fosamax Lawsuits
For a drug that is supposed to strengthen bones to cause serious bone injuries as a dangerous defect. Not only must the patient contend with the complication, but also, there is the necessary treatment, rehabilitation, and, hopefully, recovery, that can take a toll on one’s physical, mental, emotional, and financial well-being. For example, among the more recent Fosamax cases is one filed by a woman who claims she experienced two femur fractures in her thighs after she started taking the medication. In addition to the thigh breaks, the plaintiff contends that taking Fosamax caused her to suffer other side effects that have necessitated ongoing medical care.

Bisphosphonates for Osteoporosis – Where Do We Go from Here, New England Journal of Medicine, May 31, 2012

FDA: Possible increased risk of thigh bone fracture with bisphosphonates, FDA, October 13, 2010

Bisphosphonates (Osteoporosis Drugs): Label Change – Atypical Fractures Update, FDA, October 13, 2012

More Blog Posts:
New FDA Report Suggests Exercising Caution About Using Fosamax Long-Term, Boston Injury Lawyer Blog, May 11, 2012

Meningitis Outbreak Linked to Massachusetts Pharma Company, Drug Injury Lawyers Blog, October 16, 2012

Use of Ocella Birth Control Pill May Cause Higher Stroke Risk, Drug Injury Lawyers Blog, October 3, 2012 Continue reading

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A pounding headache, uncomfortable fever, and disgusting nausea are just a few of the symptoms that are affecting people across the United States today. They may also have a stiff neck, feel dizzy and have eye discomfort from bright lights. Almost half of the states have citizens who have these symptoms and it’s not because of the common flu. Actually, it is a meningitis outbreak, and the company that may be responsible for it all can be found in our very own state – Massachusetts.

Meningitis is “an inflammation of the membranes (meninges) surrounding your brain and spinal cord, usually due to the spread of an infection.” While some forms of meningitis can be spread to others, the outbreak that will affect thousands of people this week is not contagious and has been categorized as a fungal infection. Meningitis, for some people, can resolve itself in a couple of weeks but for others it has been known to be life-threatening. In fact, there have been eight deaths reported so far this week as a result of the outbreak.

The Centers for Disease Control and Prevention (CDCP) are conducting an ongoing investigation regarding this outbreak, predicting that as many as 13,000 patients might have received products from the New England Compounding Pharmacy, Inc. (also known as New England Compounding Center). The source of the outbreak is believed to be this pharmaceutical company, which is based in Framingham, Massachusetts. Due to the medical alarm among federal and state health officials, the New England Compounding Pharmacy, Inc. announced over the weekend a voluntary “recall of all products currently in circulation that were compounded at and distributed” at its facility. While meningitis is believed to be found in one of its products, the company decided to cease its operations over the weekend and recall all of its products as a precautionary safety measure.
This pharmaceutical company’s theoretical tainted product is an epidural steroid injection, a medication that is injected into the spine. This injection is believed to have fungal meningitis, a form of meningitis that causes gradual symptoms and appear mild at first. Patients from 23 states have received these injections.
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According to the Centers for Disease Control and prevention, a steroid called methylprednisolone acetate that was contaminated by a fungus may have been injected into about 13,000 people in 23 US states. The injectable steroid was made by the New England Compounding Center, which is based in Framingham, Massachusetts. To date, there have been at least 105 related cases of this rare form of meningitis confirmed in 9 states-Virginia, Florida, Tennessee, Indiana, Ohio, Maryland, North Carolina, Minnesota, and Michigan-with the death toll at at least 8. The tainted drug was also sent to California, Georgia, Connecticut, Idaho, New Hampshire, Illinois, Nevada, New Jersey, Rhode Island, New York, Pennsylvania, South Carolina, Texas, and West Virginia.

The steroid is usually applied via injection as a painkiller for the back. The contaminated drugs were made in May of this year or later and through last month they were sent to at least 75 medical facilities. If you believe you contracted fungal meningitis from a steroid injection or any other illness from what may have been a contaminated drug, contact our dangerous drug lawyers at Altman & Altman, LLP right away.

Previous complaints had been filed against the New England Compounding Center before this outbreak. Now, in the wake of this health crisis, the company has suspended its operations while an investigation takes place. Its initial recall of three lots of the steroid-impacting 17,676 vials-has been expanded to now include all products that were distributed and compounded at the Framingham facility.

Compounding Pharmacies Are Subject to Limited Oversight
Per a 2003 Government Accountability Office report, close to 10% of drugs that are administered in this country are processed by compound pharmacies. These facilities take medicines made by pharmaceutical companies and break them up into specific strengths and dosages.

Unfortunately, the US Food and Drug Administration has restricted authority over these pharmacies’ daily operations and it is mainly up to the state boards to monitor the licensing, practices, and the certification of pharmacists and pharmacies. Also, compounded products don’t require FDA approval in order to be sold in the US, and the federal agency has no oversight over how the products are labeled or made.

Fungal Meningitis
While fungal meningitis is not contagious, it can lead to serious neurological problems, small strokes, and other health complications. Symptoms may include chills, fever, stiff neck, and headaches. The sooner someone is treated, the better his/her prognosis for survival. An anti-fungal medication that is administered intravenously is given to initially combat this affliction, but some patients may require months of treatment.

Meningitis-linked steroid may have affected 13,000 people in U.S., CDC, Reuters, October 8, 2012

More patients linked to fungal meningitis infections, CDC says, CNN, October 6, 2012

More Blog Posts:
Use of Ocella Birth Control Pill May Cause Higher Stroke Risk, Drug Injury Lawyers Blog, October 3, 2012

Birth Control Depo-Provera Associated with An Increased Risk of Breast Cancer in Young Women, Drug Injury Lawyers Blog, September 25, 2012

Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyers Blog, June 19, 2012 Continue reading

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If you or someone you love suffered a stroke or other serious health complications while taking the birth control pill Ocella, please contact our drug injury law firm right away. This generic version of the popular Yasmin drug has been linked to a higher risk of stroke by a number of studies-especially in women over the age 35 and those with a history high blood pressure, diabetes, or high cholesterol, or who smoke or drink regularly.

One likely reason for this higher stroke risk is that taking Ocella ups how much of the hormone estrogen a woman has in her body. That said, Ocella also contains drospirenone, a synthetic progestin, which the Food and Drug Administration has said may be a cause of heart issues and other health problems, including stroke, heart attack, and blood clots.

Blood clots are a leading cause of strokes. Should a blood clot make its way through the bloodstream to obstruct the flow of blood to the brain, brain cells may be damaged, even destroyed. Common stroke symptoms include:

• Coordination loss • Weakness in one or both sides of the body • Facial muscle weakness, dizziness • Speech difficulties • Loss of consciousness • Irregular or rapid heartbeat
• Vision problems • Headaches • Balance problems • Chest pains • Breathing problems • Cerebral swelling • Seizures • Intracranial hemorrhaging or pressure

While a certain level of blood clotting is normal, for clots to develop because someone is taking Ocella is not. Ocella use might also lead to other health issues, such as deep vein thrombosis (which can cause permanent organ damage), heart attack, pulmonary embolism, gall bladder injury, pancreatitis, abnormal heart rhythm, kidney failure, venous thromboembolism, hepatic adenoma, cardiac arrhythmia, and death.

Already, a number of Ocella lawsuits have been filed against manufacturer Barr Laboratories over serious health complications. Also, Ocella isn’t only used by people seeking to prevent pregnancy. Off-label uses for this medication include treatment of premenstrual dysphoric disorder and moderate acne.

Ocella Lawsuits
Drug manufacturers and pharmaceutical companies must make sure that their medications are safe for use and don’t lead to deadly health complications. They must also warn of possible adverse reactions and risks and do this in a way that there is no doubt in the minds of medical professionals and their patients of what are the possible serious side effects.

Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots, FDA
Stroke Fact Sheet, Women’s Health
Ocella, Drugs.com

More Blog Posts:
Birth Control Depo-Provera Associated with An Increased Risk of Breast Cancer in Young Women, Drug Injury Lawyers Blog, September 25, 2012

Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyers Blog, June 19, 2012
Pradaxa Lawsuit Claims Drug’s Side Effects Caused Woman to Bleed to Death, Boston Injury Lawyers Blog, April 30, 2012 Continue reading

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At Altman & Altman, LLP our dangerous drug lawyers represent clients that have suffered serious health complications from a medication. One med of concern to us is Depo-Provera, an injectable form of birth control that may be upping the risk of breast cancer in young women. Depo-Provera only has progestin.

Researchers looked at over 1,000 women in the 20-44 age group that received breast cancer diagnoses and over 900 who were breast cancer-free. All of the women are from the Seattle area, and approximately 3% had used the injectable contraception in the last five years.

According to the study, which was led by epidemiologist Dr. Christopher Li at the Fred Hutchinson Cancer Research Center, recent use of the contraceptive for a year or more is linked to a 2.2-fold greater risk of invasive breast cancer. Obesity, family history, pregnancy history, and age didn’t seem to be factors to this risk. (The higher cancer risk, however, appeared to go away within months after cessation of use, while women who only used Depo-Provera for less than year or who had stopped using it for more than a year didn’t show this increased cancer risk. Also, no causal connection was proven.

Li and his colleagues noted that even though the risk connected to Depo-Provera seemed to abate after discontinued use, it is still important to note whenever there possible risks involved with certain kinds of birth controls, especially as there are many alternatives to choose from. For example, a woman who has a history of breast cancer in her family may want to consider other contraception choices besides this one.

However, in US News & World Report, NY Clinical Cancer Center breast surgery director Dr. Freya Schnabel noted that there are limits to this study and more research needs to be done to shed more light on the connection between Depo-Provera and breast cancer.

Depo-Provera is made by Pfizer. The contraception is injected every three months and is used by approximately 1.2 million in this country-that’s 3.2% of contraception users, reports Guttmacher institute. Depo-Provera is the only contraceptive in this country that contains Prempro, the same progestin as the postmenopausal hormone therapy bill.

Other serious side effects linked to Depo-Provera include bone loss, delayed fertility, serious allergic reactions, a higher risk of premature deliveries, osteoporosis, and fractures. It also may be linked to a higher infant and neonatal death rates.

Depo-Provera Birth Control Might Raise Breast Cancer Risk, US News, April 4, 2012

Birth control shots tied to breast cancer risk, study says, NBC News, April 5, 2012

Cancer Research

More Blog Posts:
Severe Skin Reactions Caused by Stevens-Johnson Syndrome are Linked to Different Prescription and OTC Medications, Drug Injury Lawyers Blog, August 29, 2012
Despite Actos Lawsuits, FDA Approves Type 2 Diabetes Drug’s Generic Version, Drug Injury Lawyers Blog, September 5, 2012
Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyers Blog, June 19, 2012 Continue reading

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