Parker Waichman LLP

FDA Letter to HCP re Paclitaxel Devices for PAD and Mortality Risk

A recently issued letter to healthcare providers by the United States Food and Drug Administration (FDA) reveals a link between the use of paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of peripheral arterial disease (PAD) and the risk of mortality. The FDA’s letter was released following the publication of data in the Journal of […]

Deaths Linked to Paclitaxel-Coated Balloons & Stents

Paclitaxel coated balloons

A recently issued letter to healthcare providers by the United States Food and Drug Administration (FDA) reveals a link between the use of paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of peripheral arterial disease (PAD) and the risk of mortality. The FDA’s letter was released following the publication of data in the Journal of the American Heart Association (JAHA) that suggests an increased risk of mortality in PAD patients two years after implantation of a paclitaxel-coated balloon and paclitaxel-eluting stent as compared to patients without implantation of such devices. The FDA has not identified a specific cause for the increased risk of mortality and is informing doctors to be aware of the link and to consider alternative treatment options for patients with PAD.

What Are Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents?

Paclitaxel-coated balloons and paclitaxel-eluting stents are Class III medical devices that require premarket approval (PMA) by the FDA. Such devices are considered life-saving, and as such, the FDA has stringent requirements that medical device manufacturers must meet to ensure the devices are safe and effective for their intended use. Paclitaxel-coated balloons and paclitaxel-eluting stents are marketed for the treatment of peripheral arterial disease (PAD), which is narrowing of the arteries that limits blood flow to the limbs. The balloon and stent are implanted to open the arteries and allow blood to flow more easily. The paclitaxel medication is released from the balloon and stent to ensure there is no scar tissue formation which can lead to re-obstruction (or re-narrowing) of the arteries.

The Failure of Life-Saving Medical Devices

When a medical device is used to treat a potentially life-threatening condition, such as PAD, patients and doctors trust that the medical devices will be safe for their intended use. When evidence comes forward that a life-saving device may cause more harm than good, doctors and patients are rightfully concerned. If patients have had a paclitaxel-coated balloon and stent used for treatment, they may be in fear that they will suffer fatal injuries two or more years following implantation of the product, fear that no patient deserves to experience.

Our legal system allows for injured patients and representatives of fatally injured patients to bring forward lawsuits against medical device manufacturers to hold them accountable for defective products they place on the market. After all, these medical device manufacturers are making billions of dollars, and money is often the primary goal. While there are responsible medical device manufacturers that care about safety, many products are pushed to market without safety being a number one concern. When safety falls by the wayside, patients suffer the consequences. The recent FDA letter to healthcare providers should help to ensure patients are fully aware of the risks associated with paclitaxel-coated balloons and paclitaxel-eluting stents, helping them to make an informed decision about whether alternative treatment options would be more beneficial in the long run.

Contact Parker Waichman LLP Today to Schedule a Free Consultation

If you have learned that you have a potential legal claim concerning a paclitaxel-coated balloon or stent for the treatment of PAD, you should consider speaking with a Defective Medical Device Lawyer right away to discuss your situation. At Parker Waichman LLP, our team of legal professionals has extensive experience handling complex defective drug and medical device cases. To schedule a free consultation, contact Parker Waichman LLP today by calling (800) YOUR-LAWYER (968-7529).

[sc name=”post-footers”]
[contact_js_widget content=”Have you lost a loved one due to a paclitaxel-coated balloon or paclitaxel-eluting stent?” button=”Click To Get A Free Case Review” link=”/new-york/contact/”]

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I feel truly blessed to be a client of your firm and can't thank you enough for the concern expressed during this difficult time. I am extremely pleased with all the attention given to my case. If you're in Port Washington, give them a try.
Dwayne Andrews
8 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value Had a great experience here, Cara Feiler especially was a professional Paralegal. Professional helpful and fast acting firm. Will recommend for a friend!
Giovanna DeLoca
3 years ago
5 Star Reviews 150
So grateful for the great team at Parker Waichman. Julie, Maryann and Jorge were there for me from the very beginning treating me like family. They kept full communication with me through the entire process and took all the weight off my shoulders. Thanks again to you all!
Jorbel Mateo
2 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038