Drug Injury Attorney Blog

As a dangerous medication lawyer, I was gratified to read that a woman from Peoria, Ill. was awarded $6.3 million in damages after a finding that her breast cancer was caused by hormone replacement therapies. Reuters reported Nov. 20 on the largest Prempro award to date, handed down to Donna Kendall of Decatur, Ill. Kendall, 66, sued pharmaceutical company Pfizer after spending 11 years taking the hormone replacement drugs Prempro and Provera, products of Pfizer corporate units. She was diagnosed with breast cancer in 2002, the same year that new research showed dramatic increases in breast cancer and cardiovascular problems for postmenopausal women taking the drugs. In her lawsuit, Kendall said Pfizer failed to adequately warn her and other patients of these risks. The jury indicated that it planned to award punitive damages as well, suggesting that it felt there was evidence of serious wrongdoing.

Prempro was once widely recommended for post-menopausal women, to treat symptoms of life after menopause. However, that changed after the 2002 study from the Women’s Health Initiative at the National Institutes of Health. That long-term study showed a substantially increased risk of breast cancer, heart attacks and strokes among users of Prempro, Provera and Premarin. In fact, that study was ended early because of concerns for the participants’ health. Later studies confirmed the link and suggested that Prempro may also raise women’s risk of blood clots and dementia. Perhaps most damningly of all, later evidence showed that Wyeth, a unit of Pfizer, paid medical ghostwriters to plant articles in medical journals under doctors’ names. At least some of the articles denied the breast cancer link altogether, triggering multiple lawsuits and a Congressional investigation.

As a pharmaceutical liability attorney, I am pleased to see the justice system doing its job with these drugs. By now, most observers agree that the FDA approval process, while important, is not enough to ensure that drugs are safe. Too many drugs have slipped through the cracks in recent years, including drugs that have since been linked to life-threatening diseases. In a few cases, pharmaceutical companies have also been caught misleading the public, as with Prempro, using deceptive advertising, biased medical studies and unethical corporate policies. In addition to causing unnecessary deaths and lowered quality of life to patients and their families, these drugs can also trigger six or even seven figures in bills for medical care that patients would never have otherwise needed. As the FDA itself once acknowledged, lawsuits like this one help incentivize drug companies to stay honest by generating severe financial costs and negative publicity when the issues are publicly and fully aired.

Continue reading " Jury in Prempro Trial Awards Illinois Woman $6.3 Million for Link to Breast Cancer " »

As a St. Louis defective drug attorney, I was disturbed to read about a new Food and Drug Administration warning of potential irreversible cartilage damage from certain anesthetics and medical devices. According to a Nov. 17 article from the Wall Street Journal, the FDA has called for stronger warnings on the labels of pain pumps and certain anesthetics after 35 reports that they caused permanent cartilage damage (chondrolysis) in patients who received continuous infusions after surgery. In more than half the cases, patients needed additional surgery, including joint replacements for otherwise healthy young adults. The FDA required pain pump and anesthetic makers to update their labels within 30 days to include warnings about the destruction of cartilage.

The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.

Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.

The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them -- and doctors continued to prescribe pain pumps full of anesthesia.

Continue reading " FDA Calls for New Labeling for Anesthetics Used in Post-Surgery Pain Pumps " »

As a defective prescription drug attorney, I am familiar with at least one older study linking a class of anemia drugs to potentially life-threatening blood clots. On Nov. 10, a study to be published in the Dec. 2 Journal of the National Cancer Institute confirmed that link. According to a Nov. 10 article from HealthDay, the study found that a class of drugs called erithropoiesis-stimulating agents (ESAs) doubled the risk of blood clots in cancer patients receiving the drugs during chemotherapy. Of those patients, 14.3% developed thromboembolism (blood clots big enough to block blood flow), while 9.8% of those not receiving an ESA developed it.

ESAs are typically prescribed to people undergoing chemotherapy -- of which anemia can be a side effect -- or people with chronic kidney disease. Common brand names for these drugs include Procrit, Epogen (both epoetin alfa) and Aranesp (darbepoetin alfa). They were approved in the late 1990s to reduce the need among chemotherapy patients for blood transfusions and are now widely prescribed. According to the article, U.S. ESA sales were $10 billion in 2006, and Medicare spent more on ESAs than on any other drug. However, the new study found no difference in number of transfusions between patients receiving ESAs during chemotherapy and chemotherapy patients not taking the drugs. Survival rates were also similar.

However, patients taking ESAs had an higher risk of developing veinous thromboembolism -- blood clots in veins big enough to block at least some blood flow. Specifically, they had a higher rate of pulmonary embolism and deep vein thrombosis, both of which can cause life-threatening complications. When a blood clot passes into the lungs in a pulmonary embolism, it can cause breathing problems, heart palpitations, abnormally low blood pressure, collapse and sometimes death. Deep vein thrombosis that doesn’t result in a pulmonary embolism can still cause swelling, pain and skin problems. Because of the risk of death, both are considered medical emergencies.

As a dangerous medication lawyer, I’m not sure whether it’s more disturbing that these drugs can cause sudden death from pulmonary embolism -- or that they don’t appear to do what they were approved to do. The study’s lead author, Dr. Dawn Hershman of the Herbert Irving Comprehensive Cancer Center in New York, said her results raise questions about the approval process and post-marketing research for ESAs. After the first studies connecting ESAs with blood clots, the Food and Drug Administration added a black box warning to their labels -- the most serious warning available -- disclosing the risk of blood clots and death and suggesting limitations on which patients should receive them. With this new study, I hope doctors and regulators seriously consider whether chemotherapy patients truly need an ESA before prescribing one.

Continue reading " Study Confirms Serious Blood Clot Threat From Anemia Drugs for Cancer Patients " »

General Electric, GE Healthcare AS and other entities, alleging she developed Nephrogenic Systemic Fibrosis (NSF) as a result of being given gadolinium-based contrast agents – or GBCAs – for magnetic resonance imaging (MRI) and magnetic resonance arteriography/angiography (MRA).

According to the complaint, Ms. Crabtree was administered Omniscan, also known as gadodiamide, which is an injectable paramagnetic contrast agent used for MRI and MRA, made by GE. It contains the metal gadolinium, which is a highly toxic substance in its free state. For three additional MRA procedures she was given the GBCA Optimark, which is manufactured by Mallinckrodt.

The lawsuit states that following the administration of the GBCAs she began experiencing symptoms of NSF, including hardened plaques of skin ("orange peel skin"), skin lesions, fibrosis and contractures in her hands, feet, arms, legs and associated joints. She was subsequently diagnosed with NSF.

Consequently, she has suffered serious, progressive, permanent and incurable injuries, together with significant pain, physical insufficiency, disfigurement and scarring.

Ms. Crabtree is suing the manufactures of the GBCAs she was administered, seeking actual and punitive damages, and costs incurred to date for her personal injuries and suffering.

The lawsuit was filed by Jeff Lowe of the Lowe Law Firm located in St. Louis, Missouri with a nationwide personal injury practice. The Lowe Law Firm can be reached at 877-678-3400.

As a pharmaceutical liability attorney, I have noticed several reports of serious safety problems with the newest drugs intended for treatment of Type II diabetes. So I was disappointed, but not entirely surprised, to see a safety alert issued by the Food and Drug Administration Nov. 2 about problems with the diabetes drug Byetta (exenatide). According to a report from U.S. News and World Report, the FDA received 78 reports of kidney function problems in 4.5 years from people taking Byetta. In response, the agency announced major labeling changes for Byetta, including the addition of information on the kidney risks as well as advice to physicians to monitor patients for kidney problems.

Byetta, made by Amylin Pharmaceuticals Inc. of San Diego, is used to control blood sugar levels in Type II diabetes patients already using diet, exercise and some other diabetes medications. The FDA said its reports of problems with Byetta included 62 cases of acute kidney failure as well as 16 cases of renal insufficiency. Some, but not all, of the cases were in patients who already had kidney problems or were at risk for kidney problems. In addition to adding information on those cases to the label, the FDA said it would add information on kidney dysfunction to the prescription information for Byetta, so that patients can identify problems more quickly. It also asked health care professionals not to use the drug in patients with severe kidney problems and to use caution with patients with moderate kidney problems.

This is the second post-marketing report of serious side effects for Byetta. In 2007, the FDA issued a safety alert after receiving reports of acute pancreatitis in patients taking the drug. In 2008, the agency received at least four reports of death from pancreatitis, a sudden and painful inflammation of the pancreas. It can also reduce blood sugar to dangerously low levels (hypoglycemia).

As a dangerous drug lawyer, I am pleased to see the FDA take reasonably quick action on these reports of kidney problems. Renal failure is a type of organ failure with very serious implications for the patient. When the kidneys stop working, patients suffer pain and serious illness, as well as high risk of complications like anemia. Severely affected patients must depend on daily dialysis or hope for a transplant in order to stay healthy. And U.S. News and World Report said there were seven million prescriptions for the drug written during the 4.5-year period the FDA examined, which means millions of Americans are likely exposed to this side effect. When the risk is this serious, patients and their doctors have the right to know as much as possible about it.

Continue reading " Diabetes Drug Prescribing Information Revised to Reflect Reports of Kidney Problems " »