Drug Administration Archives - Carey Danis & Lowe

Invokana Ketoacidosis & Kidney Failure

By | Invokana, Uncategorized

Invokana diabetic ketoacidosisPeople with Type 2 diabetes take Invokana, or the version with metformin—Invokamet, to regulate blood sugar levels. Treating Type 2 diabetes with medication, along with improved diet and exercise, is important; however, in the case of Invokana and Invokamet, the risks may outweigh the benefits.

What is Invokana?

Invokana is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. It is only FDA-approved to treat Type 2 diabetes, not Type 1.

Invokana side effects

Invokana is linked to diabetic ketoacidosis. This occurs when the body overproduces a blood acid, called a ketone. Ketoacidosis is a serious condition that can result in hospitalization.

Ketoacidosis symptoms include:

  • Abdominal pain
  • Confusion
  • Dehydration
  • Fatigue
  • Trouble breathing
  • Vomiting

The US Food and Drug Administration issued a warning about diabetic ketoacidosis in May 2015. And adding to that warning, the FDA mandated that drug makers update warning labels to include information about ketoacidosis.

The FDA also required drug makers to begin postmarketing studies on ketoacidosis and patient health.

Another Invokana side effect is urinary tract infection that can cause kidney failure. People who used Invokana, and suffered kidney failure, ended up being hospitalized for their injuries.

We can help.

Do you have an Invokana case?

We can help you determine if filing an Invokana lawsuit is the right decision. Our law firm offers free, no obligation case evaluations.

Contact Carey Danis & Lowe today. Call 1-800-721-2519, or complete our confidential online form.

FDA Warns about Using Testosterone for Aging

By | Pharmaceutical litigation, Testosterone, Uncategorized

testosterone gel lawsuitOn March 3, 2015, the Food and Drug Administration began requiring drug makers to caution patients that testosterone medications may escalate the risk of heart attacks and strokes.

The FDA originally approved testosterone gel only for men with low testosterone levels due to medical problems, such as effects from chemotherapy or genetic deficiencies. However, doctors and clinics have been prescribing the gels to treat the effects of aging, something the FDA never approved. The safety and benefit of these drugs have not been tested for treating low testosterone (Low T) levels due to aging. Consequently, the FDA is requiring that manufacturers use new labels detailing the exact approved use of these medications.

This new, widespread use of the drug has caused the agency to take a hard look at the possible increased risk of heart attack, stroke, and death associated with the hormone treatment. Some studies with aging men have pointed to the drug’s link with these diseases. As a result, the agency is requiring drug makers to add labeling information about the potential elevated risk of cardiovascular disease in patients. Another FDA stipulation: mandating that drug corporations carry out a study, defining just how risky testosterone treatment is.

Personal Injury Lawsuit Information

Carey Danis & Lowe represents men who have been harmed by testosterone gels. If your health has been impaired by the use of testosterone gels, we suggest that you discuss legal possibilities and compensation eligibility with one of our personal injury lawyers.

Contact Carey Danis & Lowe by phone at 800.721.2519, or complete a confidential personal injury claim form.

Transvaginal Mesh Side Effects Can Last A Lifetime

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsThough medical devices are developed to improve lives, such is not always the case when discussing transvaginal mesh products. Used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), women who have received an implant of a transvaginal mesh product often have not been fully informed of all known health risks associated with mesh.

In an interview for The Globe and Mail, a Canadian news publication, a clinical professor in the urology department at the University of British Columbia was quoted as saying that, due to transvaginal mesh being designed as a permanent implant, removal of the product is challenging, as it is often already fused with surrounding tissues.

Thus, for women who have suffered injuries from transvaginal mesh products, complete removal of the product may not be possible. As a result, severe pain becomes a constant for these women.

The article in The Globe and Mail also describes how the Canadian equivalent of the U.S. Food and Drug Administration, Health Canada, has done little to educate women, as well as healthcare providers, about the health risks posed by transvaginal mesh products.

When making important health decisions, the article states, it is of the utmost importance for women to be able to weigh all of the known risks with the benefits.

Carey Danis & Lowe Represents Mesh Users

A personal injury law firm with headquarters in St. Louis, Carey Danis & Lowe represents women across the U.S. who have been injured by transvaginal mesh products. When you seek legal assistance from Carey Danis & Lowe, you can rest assured that our lawyers work tirelessly to recover losses for you.

If you or someone you love has been injured by transvaginal mesh, we invite you to share your case with us during a free, no-obligation case evaluation.

Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim form.


Carey Danis & Lowe Investigates Bard LifeStent Cases After FDA Class 1 Recall

By | Defective Medical Device litigation, Uncategorized

Published October 30, 2013 by PR Web

St. Louis, Missouri (PRWEB) October 30, 2013

bard_lifestent_solo_vascular_stent_lawsuit_fda_recallThe defective medical device attorneys at Carey Danis & Lowe are currently investigating Bard LifeStent cases following an October 18, 2013 recall announcement made by the U.S. Food and Drug Administration (FDA). As a national law firm representing victims of defective medical devices, Carey Danis & Lowe provides legal assistance to individuals who have experienced injuries from faulty medical products that have been recalled by the FDA.

In mid-October, the FDA announced a class 1 recall of the Bard LifeStent Solo Vascular Stent over faulty deployment.* The Bard LifeStent solo vascular stent, a mesh tube implanted into a blood vessel to treat lesions, is known to deploy partially and with difficulty, and in some cases, the stent entirely fails to deploy.

These deployment problems place patient health and safety at risk. According to the FDA, patients with inadequately deployed Bard LifeStent devices have experienced bleeding, limb loss, heart attacks, stroke, and death. Furthermore, patients have often undergone surgical operations to repair and replace the defective stent to avoid future health complications.

Though the FDA has taken action to recall the Bard LifeStent device due to life-threatening adverse events, claims targeted at Bard’s medical device have not yet been heard in a court of law at the time of writing.

The FDA class 1 recall concerns stents manufactured by Bard between November 2011 to June 2012.

Carey Danis & Lowe is currently investigating Bard LifeStent cases, and invites individuals who believe their injuries stem from defective stent deployment to reach out to the law firm for a gratis legal evaluation. For more information about legal services provided by Carey Danis & Lowe, call 800-721-2519.

About Carey Danis & Lowe

Carey Danis & Lowe is a plaintiff’s litigation firm based in St. Louis, Missouri with law offices across the United States in Illinois, Missouri, and Florida. Carey Danis & Lowe specializes in defective drug and pharmaceutical litigation and class action lawsuits. The Carey Danis & Lowe team is comprised of experienced attorneys working alongside knowledgeable and professional staff that includes medical doctors, nurses, and information technology specialists. Contact Carey Danis & Lowe at 800-721-2519 for more information about our legal services.

*U.S. Food and Drug Administration, Bard LifeStent Solo Vascular Stent: Class 1 Recall – Failure to Deploy:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371415.htm

CBS Denver Profiles Rise in Transvaginal Mesh Lawsuits and Transvaginal Mesh Injuries

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsIn early September, CBS Denver profiled a woman who received a transvaginal mesh implant to treat stress urinary incontinence (SUI). The woman, Rose Lucero, underwent an operation to receive the mesh in 2008, and three years later, she began experiencing severe pain.

According to CBS Denver, Lucero’s pain started in her back, and then became much more severe when the pain moved to her legs and feet. The pain has been so debilitating that it has impacted her life to such a degree that she can no longer engage in day-to-day activities.

Lucero links her pain to the transvaginal mesh implant, and as such, she is currently trying to get the transvaginal mesh removed. Lucero filed a transvaginal mesh lawsuit in order to acquire the funds to do so.

Between 2008 and 2011, the U.S. Food and Drug Administration received 2,874 adverse event reports linking transvaginal mesh to injuries and health complications, according to CBS Denver. These reports link transvaginal mesh to organ damage, mesh erosion, mesh contraction, infection, bleeding, pelvic area pain, and painful intercourse.

Carey Danis & Lowe transvaginal mesh lawyers work with women who claim to have been injured by transvaginal mesh. Our lawyers and on-staff medical experts are familiar with the injury and pain associated with this medical device.

Carey Danis & Lowe is here to help you. Our transvaginal mesh lawyers are currently offering free legal evaluations of transvaginal mesh cases.

Share your story with Carey Danis & Lowe today by calling 800.721.2519, or by submitting a personal injury claim form.

Levaquin Lawsuit News: Antibiotic Drug Levaquin Linked to Tendon Damage and Many Other Serious Side Effects

By | Levaquin, Pharmaceutical litigation, Uncategorized

Levaquin MDL Settlement Update: Phase 1 Plaintiffs Have Signed a Settlement AgreementIn current Levaquin lawsuit news, it has become apparent that fluoroquinolones, like Levaquin (levofloxacin), is the cause of more than just tendon damage, as previously understood. In a recent New York Times article,  fluoroquinolone antibiotics have recently been linked to other serious problems affecting ocular and renal health.

The article goes on to cite the fact that this class of antibiotics has been over-prescribed by doctors. According to one pharmacological epidemiologist, prescribing a drug like Levaquin to treat certain infections is sometimes overkill. It appears that the harm caused by Levaquin and other fluoroquinolone antibiotics could be lessened by exploring other treatment options.

Individuals who have taken Levaquin, and have experienced health complications following use, have most often reported incidences of tendon damage, tendon rupture, and tendonitis. Though, in addition to tendon problems, recent research published in The Journal of the American Medical Association reveals that the use of fluoroquinolones like Levaquin has also played a key role in increasing the risk of retinal detachment and kidney failure.

In 2008, the U.S. Food and Drug Administration ordered manufacturers of fluoroquinolones to include a boxed warning about the risk of developing tendonitis and tendon damage while using these kinds of antibiotics. Following the studies showing a connection between Levaquin and damage to retinal and renal health, the FDA recently updated this order to cover information about the link between fluoroquinolone use and neuromuscular problems.

The manufacturer of Levaquin, Janssen Pharms, faces over 2,000 Levaquin lawsuits.

Carey Danis & Lowe Levaquin lawyers are currently investigating Levaquin cases. If you or someone you love has been injured through the use of Levaquin, contact Carey Danis & Lowe today for a free legal evaluation and for assistance in filing a Levaquin lawsuit.

Contact Carey Danis & Lowe by calling 800.721.2519 or by submitting a personal injury claim form.

Yaz and Yasmin Lawsuit News: Health Canada Notes Higher Blood Clot Risk with Yaz and Yasmin

By | Pharmaceutical litigation, Uncategorized, Yaz/Yasmin

Oral Contraception Yaz & Yasmin Side Effects LawsuitAccording to an article recently published in The Vancouver Sun, the birth control pills Yaz and Yasmin, manufactured by Bayer, have been linked to the deaths of 23 women in Canada. Health Canada, the Canadian version of the U.S. Food and Drug Administration, noted that in addition to the 23 deaths associated with Yaz and Yasmin use, they have received approximately 600 reports over a six year period, starting in 2007, linking Yaz and Yasmin use to health complications.

According to reports submitted by Canadian healthcare providers, most of the women’s deaths were caused by complications associated with Yaz and Yasmin, especially blood clots.

Health Canada has stated that in women taking contraceptive drugs containing drospirenone, which is the primary acting hormone in Yaz and Yasmin, the likelihood of developing a blood clot is three in 10,000, which is considerably higher when compared to other contraceptive drugs.

As in the United States, individuals who have been injured through using either Yaz or Yasmin have filed lawsuits against Bayer in Canada. In the U.S., Yaz and Yasmin lawsuits have been consolidated into a Yaz and Yasmin multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Illinois.

The case is In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation MDL No. 2100. The Yaz and Yasmin MDL contains 11,194 Yaz and Yasmin lawsuits.

Women have filed their Yaz and Yasmin lawsuits claiming a number of injuries, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, brain hemorrhage, and blood clots. Plaintiffs have also alleged that Bayer employed misleading marketing strategies in their Yaz and Yasmin advertisements that made the drug appear to be much safer to use.

Furthermore, plaintiffs have claimed that Bayer did not adequately warn healthcare providers about the serious risks of using either Yaz or Yasmin.

Carey Danis & Lowe Yaz and Yasmin lawyers hear from women almost on a daily basis about their Yaz and Yasmin injuries. Our pharmaceutical product liability lawyers are currently accepting Yaz and Yasmin cases.

If you or someone you love has been injured through the use of Yaz or Yasmin, contact a Yaz and Yasmin lawyer at Carey Danis & Lowe today. In addition to providing a free legal evaluation, our Yaz and Yasmin lawyers can assist in filing a Yaz and Yasmin lawsuit.

Contact Carey Danis & Lowe by calling 800.721.2519 or by submitting a personal injury claim form.

Actos Bladder Cancer Lawsuit News: Pharmacologist Points to Takeda’s Fixation on Profits Over Consumer Safety

By | Actos, Pharmaceutical litigation, Uncategorized

Actos Bladder Cancer Lawsuit News: Pharmacologist Points to Takeda's Fixation on Profits Over Consumer SafetyThe first trial in more than 3,000 Actos lawsuits filed in the U.S. is currently being heard in a Los Angeles court. Lawyers at Carey Danis & Lowe reported last week that the first Actos trial began with revelatory information about Takeda Pharmaceutical’s misleading marketing strategy.

Apparently, the Japanese pharmaceutical company was knowledgeable of the health problems associated with Actos ingestion, but decided to hide that information in order to market the diabetes drug.

Since Carey Danis & Lowe’s update last week, the trial involving plaintiff, Jack Cooper, has convened again for opening arguments from both sides, and expert testimony from a pharmacologist.

Jack Cooper filed a lawsuit against the manufacturer of Actos, Takeda Pharmaceuticals, citing that the pharmaceutical company failed to warn Actos users and healthcare providers about the risks of using the diabetes medicine, especially about the link between Actos and bladder cancer.

A Bloomberg article about the trial states that Cooper developed bladder cancer in 2011. Though Cooper alleges his bladder cancer is a result of ingesting Actos for four years, a lawyer representing Takeda pointed to the plaintiff’s lifestyle to explain his current health condition.

On March 4, Howard Greenberg, a clinical pharamacologist, delivered expert testimony about Takeda’s priorities regarding Actos. Greenberg noted that upon analyzing internal Takeda emails, it became clear that profits from Actos took precedence over consumer safety.

The content of these emails reveals that Takeda executives were concerned about the drug’s viability on the market if pharmaceutical regulators, like the U.S. Food and Drug Administration, ordered that the Actos drug label include information about bladder cancer. These emails go on to express that a bladder cancer warning would be a “worst-case scenario”, according to Bloomberg.

Cooper’s case is being heard in a California Superior Court in Los Angeles, and has been filed as Cooper v. Takeda Pharmaceuticals America Inc.

The worst-case scenario being poor drug sales resulting from a bladder cancer warning illustrates Takeda’s egregious disregard for consumer safety. Lawyers at Carey Danis & Lowe work diligently for our clients to hold pharmaceutical companies accountable for the harm their products cause consumers.

If you or someone you love has been injured by the use of Actos, and as a result, has developed bladder cancer, you and your loved one may be eligible to receive compensation.

For a free legal evaluation and for more information about filing an Actos bladder cancer lawsuit, contact an experienced trial lawyer at Carey Danis & Lowe today by calling 800.721.2519 or by submitting a legal claim form.

UK Health Organizations Conduct Study on Transvaginal Mesh Safety

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

UK Health Organizations Conduct Study on Transvaginal Mesh SafetyIn the United Kingdom, the Department of Health and the Medicines and Healthcare Products Regulatory Agency (MHRA) have been collaborating on a safety review of transvaginal mesh. Their collaborative effort results from an observed need to analyze the safety of these medical devices and to provide UK surgeons, gynecologists, and urologists with the most current and pertinent information regarding transvaginal mesh and transvaginal tape.

One recommendation made by the reviewing body was to create a registry of patients who have received surgical implantation of either transvaginal mesh or transvaginal tape. The UK health officials hope to develop such a registry in order to make the data available to surgeons for review of post-surgery patient health.

In conducting its own analysis of reports and data relating to the safety of transvaginal mesh and transvaginal tape, the U.S. Food and Drug Administration discovered that severe health complications related to the surgical implantation of these vaginal medical devices are not rare. Furthermore, in its scientific literature review, the FDA made the conclusion that there was no significant benefit in using transvaginal mesh versus a non-mesh device in treating patients with pelvic organ prolapse (POP).

Also, the FDA noted that the most commonly reported transvaginal mesh health complication is vaginal mesh erosion.

Transvaginal mesh and transvaginal tape are used to treat women suffering from stress urinary incontinence (SUI) or pelvic organ prolapse (POP). Patients have reported to the MHRA in the UK and the FDA in the U.S. a number of severe health complications resulting from surgical implantation of transvaginal mesh. These serious health complications include vaginal bleeding, vaginal pain, painful intercourse, infection, scarring, transvaginal mesh erosion, and damage to surrounding tissues and organs.

Furthermore, some women must undergo revision or corrective surgeries following the initial implantation of their transvaginal mesh or transvaginal tape.

In the United States, transvaginal mesh and transvaginal tape manufacturers have pulled their defective medical devices off the market. Johnson & Johnson has removed four of its transvaginal mesh and transvaginal tape products from the market following increased reports of severe health complications related to these products. The Johnson & Johnson vaginal mesh recall included the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M.

If you or a loved one has suffered from a transvaginal mesh or transvaginal tape implant, do not suffer in silence, and learn more about filing a defective surgical mesh claim. To file a transvaginal mesh lawsuit, contact an experienced defective medical device lawyer at Carey Danis & Lowe.

Johnson & Johnson Stops Sales of Gynecare Transvaginal Mesh

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

In June 2012, Johnson & Johnson made the decision to remove their defective transvaginal mesh (TVM) medical device from the global market. Though the medical device manufacturer cites future market performance as being the reason for the discontinuation of sales, their decision comes as there is an ever-increasing number of lawsuits citing links between their transvaginal mesh devices and severe health complications.

According to a Reuters report from June 2012, there are currently over 1,000 transvaginal mesh lawsuits  filed against Ethicon Inc., the subsidiary of Johnson & Johnson responsible for the manufacture of the defective transvaginal mesh. The Johnson & Johnson Gynecare vaginal mesh lawsuits are being heard by a federal judge in West Virginia and a state judge in New Jersey.

As a result of surgical implantation of Johnson & Johnson’s Gynecare Prolift transvaginal mesh devices, patients have claimed organ injury, bleeding, infections, and severe pain. Transvaginal mesh is used to treat women suffering from pelvic organ prolapse or stress urinary incontinence, both health conditions resulting from muscle weakening in the pelvic region.

According to a statement made by an Ethicon spokesperson, the medical device manufacturer has made a plan to pull several Gynecare products from the global market, including the Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M, all transvaginal mesh devices.

Back in January 2012, the U.S. Food and Drug Administration ordered transvaginal mesh manufacturers, such as Ethicon and Johnson & Johnson, to begin studying patients with surgically implanted transvaginal mesh to better understand the safety of such products. As Johnson & Johnson has made the decision to pull four of their surgical mesh devices from the global market, the company has stated that it should no longer have to conduct studies of patients with their surgical mesh implants.

If you or someone you love has undergone surgery to receive one of the discontinued Johnson & Johnson transvaginal mesh devices, and as a result, has suffered enormously from physical pain and financial losses, you and your loved one may be entitled to receive compensation. For a free legal consultation about your Johnson & Johnson Gynecare transvaginal mesh case, contact an experienced defective medical device lawyer at Carey Danis & Lowe today by calling 800.721.2519.