Boston Dangerous Drugs Lawyer
Experienced Attorneys Handling Drug Injury and Defective Medical Device Claims
Our Massachusetts drug recall attorneys know that many medications and drugs have changed people’s lives for the better. But what you might not think about when you are taking a drug that you hope will improve your quality of life is that it contains a side effect. In fact, nearly every drug has some side effect. When the drug causes a serious side effect, it can be considered a dangerous drug and a drug recall might even be announced. And each year, dangerous drugs as well as defective medical devices cause thousands of injuries and deaths, leading to drug injury lawsuits and wrongful death claims.
If you or a loved one was suffered serious side effects after taking a dangerous drug or using a defective medical device, contact the Law Offices of Mark E. Salomone. Call 1-800-WIN-WIN-1 for a free consultation.
Dangerous drugs are any drugs taken without an adequate understanding of their proper dosage, their side effects, their interactions with other drugs, and the like. In addition, some drugs carry greater intrinsic risk than others. Some drugs have been recalled by the U.S. Food and Drug Administration, while others have side effects that might require the manufacturer to add warning labels to the product.
Risks Associated with Taking Over-the-Counter Medications and Prescription Drugs
Prescription drugs as well as over-the-counter medications have benefits and risks. It may not always be clear to the user what the serious risks are, either because the manufacturers fail to provide that information, or because the manufacturers have marketed their drugs for uses not yet approved by the U.S. Food and Drug Administration (FDA). Occasionally, the drugs pose serious or even fatal risks that the manufacturers are unaware of or knew of and failed to warn against.
The following drugs and medical devices that are linked to dangerous side effects:
- GranuFlo / NaturaLyte
- Yaz, Yasmin, or Ocella birth control pills
- Darvon and Darvocet
- Talcum Powder
The following are other drugs linked to adverse side effects:
- Zocor (simvastatin)
Actos, a medication used by people with Type II diabetes, has been linked to a serious and potentially deadly side effect: bladder cancer. If you or someone you love developed bladder cancer after taking Actos for more than a year, talk to an attorney at the Law Offices of Mark E. Salomone, representing Boston, Worcester, Springfield and all of Massachusetts.
You may be entitled to compensation from Actos manufacturer Takeda Pharmaceuticals. Our legal professionals understand how side effects from defective drugs can ruin your life. We are passionate and committed to helping clients pursue the justice they deserve.
Actos (pioglitazone hydrochloride) has been prescribed to about 10 million people since it was approved for use by the FDA in July 1999. Actos is part of a new class of drugs known as thiazolidinediones. These drugs help improve insulin sensitivity, or control blood sugar levels.
Over the past decade, researchers have found an increased risk of bladder cancer among Actos users. The FDA ordered the manufacturer to include a stronger warning label alerting people with active bladder cancer or with a previous history of bladder cancer not to use Actos.
Already, other countries are taking strong action to protect consumers. Health officials in Germany and France stopped sales of the medication in June 2011. Other Actos side effects were noted, including congestive heart failure, heart attacks, stroke and liver failure.
Avandia, another medication used to control Type II diabetes, also has been linked to adverse side effects.
Patients who have used Actos for more than a year may have a higher risk of experiencing adverse side effects. It’s wise to speak with a lawyer to learn about your rights if you have concerns about Actos side effects. You may need to pursue an Actos lawsuit against the manufacturer.
The following are a few side effects of Actos that may require immediate medical attention:
- Irregular breathing or wheezing
- Chest pain
- Irregular heartbeat
- Extreme fatigue
- Weight gain
- Decreased urine output
GranuFlo / NaturaLyte
Experienced Massachusetts attorneys are accepting Fresenius Dialysis Cases
People who have gone through kidney dialysis may have been treated with the drugs GranuFlo and NaturaLyte, which are linked to cardiac arrest and other serious and possibly fatal side effects. At the Law Offices of Mark E. Salomone, we currently are reviewing potential NaturaLyte and GranuFlo lawsuits. If you or a loved one has had a dialysis procedure since 2009 and suffered a cardiac arrest or stroke within 72 hours of the procedure, or if a loved one died, you may be entitled to compensation. Call 1-800-WIN-WIN-1 now for a free consultation. Fresenius Medical Care developed the dialysis drugs NaturaLyte and GranuFlo. The use of these products during dialysis for kidney patients is linked to heart problems and other adverse health issues because the dangerous drugs increase serum bicarbonate levels in the patient’s body. Higher bicarbonate levels may lead to alkalosis, which can cause cardiac arrest, stroke and death.
About Fresenius Medical Care, makers of GranuFlo and NaturaLyte
Fresenius Medical Care, a division of Fresenius SE, is the world’s largest dialysis company. The Food and Drug Administration is investigating the company for failing to warn patients about the risks associated with GranuFlo and NaturaLyte. The FDA announced a recall of the dangerous drugs. According to internal Fresenius memos in 2010, company officials alerted their own medical directors and doctors about the dangerous drug’s risks, but failed to inform patients, the FDA or anyone else outside of the company. GranuFlo and NaturaLyte contain a greater amount of dangerous ingredients than rival dialysis drugs.
A Fresenius lawsuit may be necessary due to the company’s failure to warn all doctors and patients about the dangerous drugs. If you or a loved one experienced GranuFlo or NaturaLyte injury or death, call us today. Our firm can help with your options. A delay may affect your rights. If you or a loved one has had a kidney dialysis procedure and you’re not sure whether you were treated with GranuFlo or NaturaLyte, contact your doctor. It’s important to know if you or a loved one was treated with any dangerous drugs.
Yaz, Yasmin, or Ocella Birth Control Pills
Yaz, Yasmin and Ocella are brand names for birth control pills that combine the estrogen ethinyl estradiol with the progestin drospirenone.
What is the defect?
Federal regulators and medical journals have found inadequate warnings of health risks linked to the birth control pills.
Women taking birth control pills using drospirenone as the progestin compound were more than 600% more likely to suffer blood clots than women who took no oral contraceptive, according to studies. Blood clots in the lungs — or pulmonary embolism — is a potentially fatal condition. Additionally, blood clots in the major veins in the body can lead to Deep Vein Thrombosis (DVT), a condition cited in several lawsuits already filed by users of Yaz, Yasmin and Ocella. Gallbladder Removal can be another result from taking these dangerous drugs.
What are the adverse symptoms caused by Yaz, Yasmin or Ocella?
Serious side effects that may occur in rare cases include:
- Adrenal insufficiency
- Blood clots and deep vein thrombosis (DVT)
- Breast, cervical or uterine cancer
- Gallbladder disease
- Gallbladder removal
- Heart attack
- Kidney problems
- Liver disease or failure
- Severe allergic reaction
The Food and Drug Administration (FDA) has warned Bayer Healthcare Pharmaceuticals, the maker of Yaz and Yasmin, of its potential legal liability in marketing these drugs. (Ocella is distributed by Barr Laboratories, Inc.) Their television advertisements prompted a warning in October 2008. The regulators cited potentially deceptive and dangerous language to explain the products’ uses and risks. They include:
- Understating the health risks they pose
- Stating they could improve symptoms associated with PMS
- Stating that the products could reduce moderate acne symptoms
Bayer recently agreed to terms requested by 27 different state Attorneys General as well as the FDA to air new advertisements. These commercials had the unapproved medical claims removed and the misinformation corrected. They also included more direct language regarding health risks.
Government regulators have looked at more than 50 reports of death from users of Yaz, Yasmin and Ocella from blood-flow-related causes. Some of these deaths were women of minor age who normally are at a low risk of such conditions.
Darvon and Darvocet
Doctors have prescribed Darvon and Darvocet to people coping with mild to moderate pain since 1957. The active ingredient in the prescription painkillers is propoxyphene. Unfortunately, Darvon and Darvocet side effects include potentially fatal heart rhythm abnormalities, which may be fatal in some cases.
If you or someone you know has suffered adverse Darvon and Darvocet side effects, don’t hesitate to contact an experienced Massachusetts attorney. At the Law Offices of Mark E. Salomone, we are prepared to help. A Darvon and Darvocet lawyers can put experience and resources to work and protect the legal rights of those injured due to pain medication exposure.
Darvon, Darvocet removed from the market
The Food & Drug Administration (FDA) recently asked Xanodyne Pharmaceuticals Inc., the manufacturer of Darvon and Darvocet, to remove propoxyphene products from the market. The FDA’s decision came after a study on the effects propoxyphene drugs have on the heart.
Research found that propoxyphene, even when taken in recommended doses, affects the electrical activity in the heart. Xanodyne removed Darvon and Darvocet in 2010 after the FDA concluded the risks outweigh the benefits.
Furthermore, the generic manufacturers of propoxyphene have been told of Xanodyne’s decision.
If you are taking Darvon, Darvocet or other propoxyphene-based products, it’s important to consult with your doctor immediately about an alternative pain-management plan.
Antibiotics linked to peripheral neuropathy, or permanent damage to the nervous system
Levaquin (levofloxacin) is given to people who are fighting bacterial infections in the lung, sinus, skin and urinary tract. Our Massachusetts attorneys know some people who are suffering from “walking pneumonia” or bronchitis have received prescriptions for Lavaquin, which is an antibiotic and part of a class of drugs known as fluoroquinolones.
Another popular antibiotic drug in this class is Cipro (ciprofloxacin). But while these drugs are touted as products that can restore health and save lives, they also are linked to serious side effects, including peripheral neuropathy, or nerve damage to the arms or legs. Already, thousands of lawsuits have been filed on behalf of patients who have experienced severe nerve reactions related to Levaquin and Cipro. Because drugs like Cipro and Levaquin are associated with significant health risks, they should only be used to treat serious bacterial infections when no other treatment works. Patients should be fully aware of the potential for dangerous side effects.
FDA issues safety alert about risks linked to Levaquin, Cipro
In August 2013, the U.S. Food and Drug Administration (FDA) issued a safety announcement stating that all labels for Levaquin, Cipro and other fluoroquinolone antibacterial drugs be updated to better describe that serious nerve damage is a potential side effect. Peripheral neuropathy may occur soon after a patient uses the drug and may be permanent, according to the FDA. Studies have found that users of Levaquin and Cipro face a risk of developing peripheral neuropathy that is two times higher than it is for people not exposed to these drugs.
Symptoms of damage to the nervous system after exposure to Levaquin/Cipro include pain, burning, tingling, numbness, weakness or a change in sensation to light touch, pain or temperature or the sense of body position.
You may develop these systems anytime during use of Levaquin or Cipro. The FDA states the side effects may last months or years or even be a permanent condition.
If you or a loved one has developed any side effects related to the name brands Levaquin or Cipro, contact your doctor right away. We also encourage you to arrange a free consultation with a lawyer to learn about your rights if you or a loved one suffered after exposure to a name brand antibacterial drug. The attorneys at the Law Offices of Mark E. Salomone are assisting victims and families who have questions about Levaquin /Cipro lawsuits, which have been filed in courts throughout the country.
Zofran and the generic version are prescribed to treat morning sickness, but the anti-nausea medication has been linked to the following birth defects when used by pregnant women during the first trimester:
- Congenital heart defects (CHD)
- Hole in heart
- Cleft lip / cleft palate
- Spina bifida
- Limb deformities
The Food and Drug Administration did not approve Zofran to treat morning sickness, but GlaxoSmithKline promoted off-label use of the drug. In 2012, the global pharmaceutical giant agreed to pay $3 billion to settle a variety of allegations, including that it was illegally promoting Zofran for non-approved use.
Zofran and birth defects
A study in 2012, published by the Center for Birth Defects Research and Prevention, found that women who used the drug ondansetron (Zofran or generic) during the first trimester of pregnancy experienced a two-fold increased risk of giving birth to a baby with defects.
The FDA did approve Zofran in 1991 to treat nausea and vomiting caused by chemotherapy and radiation.
In December 2012, the FDA issued a safety alert to medical care providers stating that the 32 mg, single intravenous dose of Zofran should not be used because of the potential for serious cardiac risks.
The Law Offices of Mark E. Salomone is now offering free case evaluations to any woman or family whose child suffered birth defects allegedly as a result of the mother’s use of Zofran during the first trimester of pregnancy. Our attorneys are also reviewing potential cases involving the use of the generic version of Zofran (ondansetron).
Talcum powder has been used on babies for generations to treat diaper rash. Women also have used talcum powder on their bodies for hygiene, which prompted Johnson & Johnson to market talcum-based powders such as the brand Shower to Shower.
Recent studies have found a link between women’s use of talcum powder for feminine hygiene and ovarian cancer. Dr. Daniel Cramer of Harvard University found an increased risk for ovarian cancer when women used talc powder. He estimated that thousands of women each year receive cancer diagnoses that can be traced to use of talc-based baby powder and body powder.
Talcum powder linked to ovarian cancer
If you or a loved one used talcum powder and was diagnosed with ovarian cancer, contact an experienced attorney immediately. Call 1-800-WIN-WIN-1 for a free and confidential consultation. You may be entitled to compensation for medical care, pain and suffering and other losses related to ovarian cancer.
According to talcum powder lawsuits already filed, Johnson & Johnson has known since 1982 about studies linking use of the product by women for genital hygiene and ovarian cancer.
Talcum powder, when used on genitals to keep skin dry and prevent rashes, can travel into the ovaries where the particles can cause inflammation. The irritation can lead to growth of cancer cells.
The public has never received a warning from Johnson & Johnson, despite studies suggesting the link between its product and a higher rate of ovarian cancer.
We believe J&J should be held accountable and encourage you to contact us immediately if you or a loved one was diagnosed with ovarian cancer after using talcum powder.
FDA Drug Recalls
In a drug recall, the manufacturer of a prescription drug or over-the-counter medicine takes its product off the market. Sometimes the U.S. Food and Drug Administration (FDA) requests the recall, while at other times the recall is initiated by the manufacturer. Either way, the FDA plays a key role in the process.
Recent examples of drug recalls include:
- McNeil Consumer Healthcare’s April 2010 recall of certain batches of over-the-counter children’s drugs, including liquid Tylenol, Motrin, and Zyrtec because of possible contaminants.
- The 2008 recall of Baxter Healthcare’s anticoagulant drug, heparin, because the FDA found contaminants in the drug that caused severe injury and death in some people. (For more on the heparin recall, see Nolo’s article Heparin Recall and Litigation.)
Read on to learn how the FDA approves and monitors drugs, when and how recalls occur, and how to notify the FDA if you suspect a serious problem with a drug.
What Is the FDA’s Role in Monitoring Drugs?
The FDA is responsible for making sure that products like drugs, vaccines, and medical devices are safe and effective.
The FDA’s Center for Drug Evaluation and Research evaluates new drugs to ensure they work correctly and that their health benefits outweigh known risks. The Center for Drug Evaluation and Research does not test the drugs itself. Instead, a new drug’s manufacturer tests the product on both animals and humans, and then sends the results to the center. Experts at the Center for Drug Evaluation and Research review the studies and determine whether the drug is safe, effective, and of good quality.
Once a drug is approved by the FDA and on the market, the manufacturer must review and report any problems linked to the drug. Consumers can report problems directly to the FDA through the MedWatch program. (To learn more about how to report a drug problem, see the “Reporting Defective Drugs: MedWatch” section below.) Sometimes, the FDA requires the manufacturer to conduct additional clinical trials involving the drug.
When Are Drugs Recalled?
A recall occurs when a drug manufacturer or the FDA decides that a pharmaceutical drug is not safe and should be removed from the market. Sometimes a recall is necessary because new research shows that the drug is too dangerous for use by consumers. This could be because of any of the following:
- The drug causes dangerous side effects.
- The FDA has discovered a safer alternative to the drug.
- Consumers use the drug improperly and that unauthorized use causes serious injury or death.
Other times, the drug is considered safe if manufactured correctly, but a manufacturing error or contamination incident makes a particular batch of the drug unsafe.
Types of Recalls
Recalls are grouped by the severity of the danger posed by the recalled drug. Here are the different types of recalls.
- Class I recall. There is a reasonable probability that a consumer’s use of or exposure to a drug will cause serious health problems or death.
- Class II recall. Use of or exposure to a drug may cause temporary or medically reversible health problems, or there is a remote risk that the drug will cause serious health problems.
- Class III recall. Use of or exposure to a drug is not likely to cause adverse health consequences.
- Market withdrawal. The drug has a minor problem that the FDA would not normally monitor. For example, the manufacturer removes a drug from the market because of after-manufacturing tampering and not because of a problem with the drug itself.
- Medical device safety alert. A medical device has an unreasonable risk of causing substantial harm. In some case, these situations also are considered recalls.
How Does a Recall Happen?
Recalls come about in one of three ways.
- The manufacturer initiates the recall. This is the most common method of recall.
- The FDA requests that the manufacturer voluntarily recall the drug. In this scenario, the FDA informs the manufacturer that its product is defective and suggests or requests that the manufacturer recall the drug.
- The FDA orders the manufacturer to recall the drug. If the manufacturer refuses to recall the drug, the FDA can go to court to force the manufacturer to recall the drug or to get legal authority to seize the drug.
When a manufacturer initiates a drug recall, it must notify the FDA, submit progress reports on the recall, and follow up to make sure the recall was successful. If the FDA requests a recall, the manufacturer is expected to comply. Rarely does the FDA need to seize the drug itself. The FDA publishes guidelines for manufacturers to follow when recalling drugs. These are found in Title 21 of the Code of Federal Regulations, Part 7. (To view the Code of Federal Regulations, visit Nolo’s Legal Research Center.)
Notice of Recalls
There are several ways that the manufacturer and the FDA notify consumers about a recall.
Direct notification. The drug manufacturer must notify its direct accounts (such as wholesalers or chain drug stores) about the recall. The notification must do all of the following:
- Inform the reseller that the drug has been recalled.
- Request that the reseller stop distributing the drug.
- If appropriate, request that the reseller notify its customers about the recall.
- Instruct the reseller on what to do with the drug.
Public notification. The FDA maintains a list of drug and medical device recalls on its website (www.fda.gov) called Recalls, Market Withdrawals, & Safety Alerts. For the most part, this list includes Class I safety recalls. To find out about Class II and Class III recalls, you can check the FDA’s weekly Enforcement Reports, also found on the FDA website.
Media coverage. Often, if a drug recall affects many people, or the recalled drug causes severe injury or death, the media will report on the recall.
Reporting Defective Drugs: MedWatch
The FDA encourages consumers and healthcare professionals to report problems they suspect are caused by drugs, vaccines, or medical devices, including:
- serious adverse events (death, risk of dying, admission to the hospital, prolonged hospital stay, disability, or other serious health consequences)
- drug quality problems, and
- potential or actual errors in administering the drug.
Consumers can report problems with drugs or medical devices by filling out the MedWatch Online Voluntary Reporting Form (available on the FDA’s website at www.fda.gov). Consumers can report problems with vaccines to the Vaccine Adverse Event Reporting System (on the U.S. Department of Health and Human Services’ website at www.hhs.gov).
by: Kathleen Michon, Attorney
Reprinted with permission from the publisher, Nolo, Copyright 2010, Nolo.com
Contact a Drug Recall Lawyer in Boston today to discuss possible compensation for your case.