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FDA Archives - Carey Danis & Lowe

Over 700 IVC Filter Lawsuits Pending in Federal Court

By | IVC Filters, Uncategorized

inferior vena cavaAs of July 2016, there are over 700 Inferior Vena Cava (IVC) filter lawsuits pending in a federal court in Arizona. The multidistrict litigation (MDL) is IN RE: Bard IVC Filters Products Liability Litigation, MDL No. 2641.

The US Food and Drug Administration (FDA) issued a warning on IVC filters after receiving hundreds of adverse event reports. According to the FDA’s warning from May 2014, the adverse event reports “include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device.”

IVC Filter Study

Carey Danis & Lowe attorneys described an IVC filter study conducted by the Yale School of Medicine, and published in March 2016 in the Journal of the American College of Cardiology. Ultimately, the researchers concluded that IVC filter benefits are still unclear.

IVC Filter Lawsuits

Did you suffer an IVC filter injury? If you did, we encourage you to explore your legal options with one of our attorneys. Carey Danis & Lowe offers free, no obligation case evaluations. Call our law firm today — 1-800-721-2519. You can also reach us online through our confidential personal injury claim form.

Invokana Kidney Failure, FDA Strengthens Warning

By | Invokana, Uncategorized

Invokana diabetic ketoacidosisInvokana has been a familiar subject in US Food and Drug Administration (FDA) safety releases as of late. In the past year, the FDA issued safety updates on Invokana and diabetic ketoacidosis, serious urinary tract infections, amputation, and kidney failure. The latest warning, which the FDA issued in mid-June 2016, is about Invokana kidney failure.

According to the strengthened warning, the kidneys can suddenly stop functioning in people using Invokana, Invokamet, canagliflozin (generic equivalent), and dapagliflozin. If the kidneys stop functioning, the body is unable to flush waste, resulting in a dangerous accumulation of waste in the body.

The FDA’s strengthened warning came after the regulatory agency received just over 100 adverse event reports relating to Invokana and kidney failure. Adverse event reports are submitted to the FDA to report injuries from a drug or medical device.

Invokana Amputation

In May 2016, the Invokana attorneys at Carey Danis & Lowe covered the FDA’s warning on Invokana amputation. The FDA issued the amputation warning after reviewing data from an ongoing study.

Do you have an Invokana lawsuit?

Ask an Invokana attorney at Carey Danis & Lowe about your case. We offer free, no obligation case consultations.

Call 800.721.2519, or complete our confidential online form.

FDA Levaquin Warning: Serious Side Effects Could Become Permanent

By | Levaquin, Uncategorized

In mid-May 2016, the US Food and Drug Administration (FDA) issued a new safety warning about Levaquin (fluoroquinolone). The regulatory agency warned of serious side effects that could become permanent.

Levaquin side effects mentioned in the warning include:

  • Tendon, joint, and muscle pain
  • “Pins and needles” prickling sensation
  • Confusion
  • Hallucinations

According to the FDA, these side effects can occur simultaneously, and can become permanent.

With this new information, the FDA ordered that drug labels for Levaquin and other fluoroquinolone drugs be updated.

We are here to help you.

Do you have a Levaquin case? We can help you determine if filing a Levaquin lawsuit is the right decision. Our law firm offers free, no obligation case evaluations.

Contact Carey Danis & Lowe today. Call 800.721.2519, or complete our confidential online form.

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 Announces Transvaginal Mesh Now Class III High-Risk Device

By | Transvaginal Mesh, Uncategorized

US Food and Drug Administration logoOn January 4, 2016, the US Food and Drug Administration (FDA) announced a big change for transvaginal mesh. Previously classified as a Class II medical device, the FDA reclassified transvaginal mesh as a Class III device.

This means that the regulatory agency considers mesh to be high-risk.

30 months to reapply for FDA approval

And the FDA didn’t stop there.

They called on all vaginal mesh manufacturers with devices already on the market to reapply for approval.

The FDA gave manufacturers 30 months to submit their premarket approval (PMA) applications.

In these applications, manufacturers must prove that their products are safe for patients, and effectively treat pelvic organ prolapse (POP).

Smooth sailing is a thing of the past

The FDA is tightening the reins on new products, too. In the past, many transvaginal mesh devices received approval via the FDA’s 510(k) process.

Through this process, manufacturer’s only needed to link a new product to an older product that had already won FDA approval; drawing a similarity was, in some ways, the only requirement to get a mesh device onto the market.

For POP only

It’s important to note that the Class III, high-risk ranking applies only to vaginal mesh devices used to treat pelvic organ prolapse (POP). It doesn’t apply to those devices used for hernia repair or to treat stress urinary incontinence (SUI).

Ask your doctor, know all of the risks

Consult with your doctor about all of the options available to treat POP, including those that don’t involve surgery.

ASK A LAWYER

If you’ve received a vaginal mesh implant to treat POP, and you’ve experienced injuries, either physical and/or financial, we encourage you to begin exploring your legal options.

Need a lawyer?

Carey Danis & Lowe can help you. Contact us today about our free case evaluations.

Call us at 800.721.2519. You can also reach us online by completing a confidential personal injury claim form.

Zofran Birth Defects Lawsuits: Profit Maximization, Not Health

By | Pharmaceutical litigation, Uncategorized, Zofran

Zofran birth defects lawsuitsProfit maximization—that was the driving force of a pharmaceutical company’s marketing campaign. Not patient health maximization. The primary concern of GlaxoSmithKline (GSK) in one of their sales campaigns rested in money, not healing.

Zofran (ondansetron)

GSK developed Zofran to treat nausea and vomiting in chemotherapy patients. The US Food and Drug Administration (FDA) approved the drug for these purposes. And with approval in hand, GSK moved forward with their marketing efforts.

Making physicians think of money, not health

The pharmaceutical company ran a sales campaign with the tagline “Profit Maximization—It’s in the Bag”, according to Courthouse News in an article from November 2015.

The tagline’s target audience—doctors. With such a tagline, GSK sought to direct physician focus to finances, not health.

Marketing to make Zofran look good

GSK promoted Zofran to the medical community and to consumers as safe for pregnant mothers. This way, doctors could feel good about writing off-label prescriptions for mothers-to-be, while also taking advantage of kickbacks from GSK.

GSK’s marketing efforts made Zofran appear safe and effective for morning sickness, even though the FDA never approved Zofran to treat this pregnancy symptom.

Having constructed a positive, strong reputation for Zofran, GSK could conceal what they knew about Zofran birth defects.

The Brown family’s Zofran birth defect lawsuit

In a Zofran birth defect lawsuit filed on October 29, 2015, the plaintiff alleged that Zofran caused her child to be born with congenital band syndrome and teratological clubfoot.

Congenital band syndrome can cut off circulation, hinder development, and result in amputation.

Teratological clubfoot, a condition where a child is born with feet pointing inward, can be caused by exposure to “toxic substances” in the womb, according to Courthouse News, who cited the National Center for Biotechnology Information.

Zofran lawsuits consolidated

A judicial panel consolidated Zofran lawsuits in a federal court in Boston in October 2015. In early March 2016, there were almost 250 lawsuits pending in that court.

The multidistrict litigation is In re: Zofran (Ondansetron) Products Liability Litigation MDL No. 2657 in the US District Court for the District of Massachusetts.

You aren’t alone

You aren’t alone in your experience with Zofran birth defects. And, you can hold GlaxoSmithKline accountable for their misleading practices.

We can help you

Carey Danis & Lowe currently represents families whose lives have been turned upside down by Zofran. We understand the pain and suffering caused by this drug, and that’s why we want to help you. We offer free, no obligation case evaluations.

Call one of our Zofran lawyers today at 800.721.2519.

You can also reach us online. Please complete a confidential personal injury claim form.

We look forward to offering you any help that we can.

You may also be interested in reading:

Feeling the Heat: At COP 21 & in GSK Zofran Lawsuits

By | Pharmaceutical litigation, Uncategorized, Zofran

zofran-birth-defectsThings are heating up this week. World leaders are talking about climate change in Paris. And on the pharmaceutical litigation front, GlaxoSmithKline is feeling the heat from hundreds of Zofran birth defect lawsuits.

The Daily Beast took on Zofran birth defects in a November 2015 article. They focused on Deana Brown, a mother who took Zofran, a drug manufactured by GlaxoSmithKline (GSK), during her pregnancy. Now, Brown is the plaintiff in a lawsuit targeting GSK over her child’s Zofran birth defects.

Brown’s child was born with “amniotic band constriction and a teratologic clubfoot deformity”.

Illegal off-label advertising

Zofran isn’t FDA-approved to treat morning sickness. However, doctors write off-label prescriptions for pregnant women.

Doctors can recommend the off-label use of a drug, but the drug’s manufacturer isn’t allowed to promote that drug for any use other than those with FDA approval. Still, GSK launched a marketing campaign to promote Zofran as safe for pregnant mothers.

This move resulted in civil and criminal charges.

As a result of their illegal promotion, GSK paid $3 billion to settle charges brought by the US Department of Justice.

More studies needed

In August 2015, the American College of Obstetricians and Gynecologists (ACOG) released new information on morning sickness treatments. According to The Daily Beast, the organization noted that more research is needed to determine the safety of Zofran use during pregnancy.

GSK calls Zofran lawsuits groundless

The Daily Beast reached out to GSK for comment. They responded, and stated that the Zofran lawsuits are “unfounded”.

GSK’s decision-making

The Daily Beast also reached out to Brown’s legal representative, who said that GSK could’ve conducted Zofran clinical trials, but they “just chose not to”.

Do you have a Zofran lawsuit?

Was your child born with Zofran birth defects?

We encourage you to explore your legal options and compensation eligibility. Our law firm offers free case consultations. Share your Zofran story with one of our Zofran lawyers today.

Call Carey Danis & Lowe toll free at 1-800-721-2519. You can also reach us online by completing a confidential personal injury form.

You may be interested in reading:

  1. Zofran Multidistrict Litigation (MDL) Formed in Massachusetts
  2. Zofran Birth Defect Lawsuit Filed in Ohio
  3. Zofran Birth Defect Lawsuits: Carey Danis & Lowe Investigating Cases

Meet our St. Louis class action attorneys.

  1. John Carey — Partner
  2. Joseph Danis — Partner
  3. Jeffrey Lowe — Partner
  4. Andrew Cross — Attorney

$2M Vaginal Mesh Verdict Tied Up in Appeals Court

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginalmeshlawsuitFast-tracking medical device approvals is tying up a $2 million jury verdict. The plaintiff in a transvaginal mesh lawsuit won a $2 million award, but now the award is under question in an appeals court.

Why?

The defendant in the case, transvaginal mesh manufacturer C.R. Bard, argues that the verdict needs to be voided. The company contends that evidence presented to the jury was incomplete.

During the trial, both parties didn’t mention how the transvaginal mesh device under question received its approval from the US Food and Drug Administration (FDA).

With most transvaginal mesh products, companies received approval via the 510(k) process.

What’s a 510(k)?

Think of the 510(k) as a template system. A medical device manufacturer submits their transvaginal mesh device to the FDA for approval. That device wins approval due to its rigorous testing, and it becomes the template for future products.

Future transvaginal mesh devices can apply for FDA approval using the 510(k) process, and can cite similarity to that first device that received FDA approval.

In the case of transvaginal mesh, citing similarity was enough to bring these defective products to consumers.

Too many modifications

However, there comes a point when medical devices have been modified so much, they can no longer be considered similar to the first device with FDA approval. This alone should require the manufacturer of the highly-modified device to conduct rigorous research to determine safety.

This wasn’t the case for most transvaginal mesh devices, and is the reason why women all over the world are stepping forward to hold manufacturers like C.R. Bard, Ethicon, American Medical Systems, and Boston Scientific accountable.

We can help you step forward.

Are you ready to share your transvaginal mesh story? We’re here to listen, and to help you.

Our experienced transvaginal mesh lawyers are available to discuss your case during a free consultation. We’ll guide you through your legal options, compensation eligibility, and whether filing a transvaginal mesh lawsuit is the right decision for you.

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

We look forward to hearing from you soon.

TVM Dallas Case

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Anterior-Vaginal-MeshEthicon, a branch of Johnson & Johnson, failed to disclose the dangers and complications linked to its Prosima vaginal mesh device. These statements were given by experts in Texas State Court in late September.

In the first court case involving Ethicon Inc.’s Prosima product, Dallas County District Court jurors were presented internal Ethicon documents that U.S. FDA specialists and urogynecology experts said showed the company was aware the product showed more risks and potential problems than Ethicon told doctors about.

By not disclosing the vaginal mesh risks, Ethicon is to blame for her pain and suffering, says Plaintiff Carol Cavness.

In heart-wrenching testimony, Ms. Cavness told the court how the agony and limitations caused by the Prosima vaginal mesh device affected her marriage to the point of divorce. The Prosima complications also continue to hinder her relationships with her children and grandchildren because she’s no longer physically able to join in activities with them.

In addition, Carol Cavness fears losing her airline mechanic job because the physical pain impairs her ability to perform heavy physical duties required by the job.

Three of the 6 cases filed against Ethicon over its pelvic mesh products have returned jury awards ranging from $1.2 to $11.1 million.

Carey Danis & Lowe seeks justice in medical product liability cases.

If you or a loved one has suffered complications related to the vaginal mesh Prosima device, compensation for pain and suffering may be due.

Our expert product liability attorneys will guide you through a free consultation and give you details about filing a Prosima mesh lawsuit.

Please contact Carey Danis & Lowe by calling 800.721.2519 or send us an email.

Harvard Study Shows No Improvement with Testosterone Use

By | Pharmaceutical litigation, Testosterone, Uncategorized

testosteronegellawsuitA recent study led by Harvard researchers didn’t show meaningful improvement in men with low testosterone. Results from the study beg the question “Why are men with low testosterone being treated with the drug if it doesn’t fix their issues?”

One of the reason that testosterone use has doubled in 5 years is that drug companies are marketing to the aging baby boomer population. After seeing the persuasive ads from the drug manufacturers, men march into their doctor’s offices and demand the drug.

Shalender Bhasin, one of the study’s main researchers, call the sharp increase in testosterone use an “artificial epidemic.” Bhasin goes on to say that men would be better off asking their doctor to prescribe Viagra or similar drugs that have proved their effectiveness.

Unfortunately, these men are seeking help for fatigue, poor sleep, a flagging libido and other minor symptoms. In March the FDA clamped down on drug makers by requiring labelling changes. Now they need to emphasize that testosterone is only approved for men with severe medical conditions like chemotherapy damage or testicular injury.

Additionally, drug companies are required to include warnings that using testosterone possibly increases the risk of stroke and heart attack.

Have you been injured by using testosterone?

Carey Danis & Lowe represents men who have been harmed by using testosterone. Our personal injury lawyers are currently investigating these types of cases; if you have suffered physical injuries from taking testosterone, we encourage you to contact us for a free legal consultation.

Call us at 800-721-2519 or contact us online to schedule a private consultation. We’ll guide you through your legal options and compensation eligibility; and if applicable, we will walk you through the process of filing a testosterone lawsuit.