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A Tampa Medical Device Attorney Can Make a Difference in Your Claim

Unfortunately, defective medical devices kill or severely injure thousands of people across the U.S. and in Florida each year. Some medical devices have been subject to formal FDA recalls, but not all claims our medical device lawyers litigate involve recalled medical products.

Our Tampa medical device attorneys have successfully represented thousands of plaintiffs in Tampa and throughout the State of Florida in pharmaceutical and medical device claims involving Vioxx, Bextra, hormone replacement therapy drugs, Guidant and Medtronic heart defibrillators, silicone gel breast implants, diet drugs, Baycol, various manufacturers of hip and knee implants, ProteGen bladder slings, and vaginal mesh implants, just to name a few examples. Our law firm is currently involved in litigation on a number of medical device claims including the following projects:

Important Information You Should Know About Florida Medical Device Lawsuits

If you were injured by a defective medical device or drug and your immediate medical needs have been met, it is important to consult with an experienced Tampa medical device attorney so your future legal right to sue can be protected. With every lawsuit, including those involving unsafe medical products, there is a specified time period under Florida law in which a claim must be filed. In claims involving wrongful death, it is a very short period of time. The sooner you contact a Tampa medical device attorney, the better.

Florida Product Liability Law

In Tampa, defective medical device claims are usually resolved under Florida product liability law; however, you might instead have a medical malpractice claim if the harm was caused because a doctor improperly implanted the device. To win a Florida product liability claim, you must prove:

The defendant was in the chain of distribution of the product (manufacturer or distributor)

The device contained an unreasonably dangerous defect

The defect caused your injury

Types of Defects in Medical Devices and Other Products

The three types of defects that can support a product liability personal injury claim are:

A defect in the design of the device

A manufacturing defect

A warning defect

It's important to remember that it's not up to you to apply the law to your case. If you were injured by a medical device, your attorney will evaluate your claim and explain your options.

What is Needed to Win a Defective Medical Device Claim?

A product liability lawsuit can be challenging because product manufacturers and distributors are often willing to devote substantial legal resources to defend such claims, especially if the product remains on the market and is not subject to a formal recall. You may have to hire expert witnesses, gather extensive documentation about the device and your own medical condition and prove that the harm you suffered was actually caused by the medical device.

Because defective medical device claims can be difficult to prove, you should seek the assistance of a skilled Tampa defective medical device attorney.

Contact a Tampa Medical Device Attorney at Our Firm

There is no charge for our legal consultation and there are no upfront costs owed by you. At Alley, Clark & Greiwe, we handle all personal injury cases on a contingency fee basis. That means there are no fees or costs owed unless we are able to successfully resolve your case. Please contact a Tampa medical device attorney from our firm today at 813-222-0977 to schedule your free consultation, or contact us online now.

Our Attorneys are Recognized for Excellence in Mass Tort Injury Claims

On November 2, 2015, U.S. News Media Groupand Best Lawyers ® released the 2016 "Best Law Firms" rankings by state. We are proud to announce that for the sixth consecutive year Alley, Clark & Greiwe has been recognized with a "First Tier" ranking in the Tampa metropolitan area in Medical Malpractice Law, Products Liability Litigation, and Personal Injury Litigation. Achieving a high ranking is a special distinction that signals a unique combination of excellence and breadth of expertise.

Additionally, three attorneys from the Tampa law firm of Alley, Clark & Greiwewere recently selected by their peers for inclusion in The Best Lawyers in America® 2016:C. Todd Alleywas selected in the fields of Personal Injury Litigation, Product Liability Litigation, and Mass Tort Litigation;James D. Clarkwas selected in the fields of Medical Malpractice Law, Mass Tort Litigation, Personal Injury Litigation, and Product Liability Litigation; andDon Greiwewas selected in the fields of Medical Malpractice Law, Mass Tort Litigation, and Personal Injury Litigation. Previously, Don Greiwe was honored with the distinction of Lawyer of the Year for 2013 by Best Lawyers in the area of Plaintiff's Medical Malpractice Law.

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Unfortunately, defective medical devices kill or severely injure thousands of people across the U.S. and in Florida each year. Some medical devices have been subject to formal FDA recalls, but not all claims our medical device lawyers litigate involve recalled medical products.

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10 medtech hazards you need to watch out for in 2021

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10 medtech hazards you need to watch out for in 2021

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6. Hasty deployment of UV disinfection devices

The need to combat the SARS-CoV-2 virus has prompted healthcare facilities, public health officials, private companies, and consumers to consider UV disinfection technologies for a host of new applications. FDA does not typically regulate UV disinfection devices (most are not considered medical devices), and does not require the device makers to demonstrate safety and effectiveness according to any standardized protocol, according to ECRI. Thus, understanding the capabilities and limitations of each device is vital.

If not used properly, UV disinfection devices may not deliver a high enough dose to inactivate microorganisms, leaving individuals at risk of exposure to infectious pathogens. Improper use could also expose operators or bystanders to unsafe levels of UV radiation.

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10 medtech hazards you need to watch out for in 2021 | Page 6 of 11 | Medical Design and Outsourcing

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The need to combat the SARS-CoV-2 virus has prompted healthcare facilities, public health officials, private companies, and consumers to consider UV disinfection technologies for a host of new applications. FDA does not typically regulate UV disinfection devices (most are not considered medical devices), and does not require the device makers to demonstrate safety and effectiveness according to any standardized protocol, according to ECRI.

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Approximately 750,000 women have been implanted with Essure (manufactured by Bayer) for permanent birth control since it was approved by the FDA in 2002. Essure is a permanent birth control device that does not require surgery. Since its release, thousands of women have reported serious complications to the FDA including persistent pain, perforation of the uterus or fallopian tubes from migration of the Essure device, abnormal bleeding, unintended pregnancies, and allergy/hypersensitivity reactions.

If you or someone you love has experienced negative side effects from Essure, you may be entitled to compensation. Alley, Clark & Greiwe can help you recover the damages you deserve. a Tampa Essure lawyer today to discuss your case and legal options during a free consultation.

What isEssure?

Manufactured by Bayer,Essureis a small implantable birth control device. TheEssureprocedure does not require an incision and is implanted in an office setting. TheEssuredevice is a tiny metal spring-like device with synthetic fibers that is implanted by a doctor into the fallopian tubes. Womencan usually go home within an hour after the device is implanted. Then, over a period of about three months, tissue forms around theEssuredevice. Ultimately, the tissue creates a barrier which blocks sperm from reaching the eggs, thus preventing pregnancy.

Essure Manufacturer to STOP Selling Essure By the End of 2018 Following FDA Action in April 2016

On July 20, 2018, Bayer announced it will pull the controversial Essure device from the market by the end of 2018 citing a decline in sales in U.S. and not because of safety issues. Bayer stopped selling Essure outside of the U.S. last year. After Bayer's announcement, FDA Commissioner Dr. Scott Gottlieb said, "The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen."

Only three months prior, in April of 2018, the FDA issued an order restricting the sale and distribution of Essure. The FDA used its authority to require Bayer to provide a reasonable assurance of the device's safety and effectiveness.

Additionally, following the April order, new labeling was legally required when Essure was offered to a patient. A patient and her physician were required to review and sign a document called a "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement" to ensure the patient understood the risks, benefits, and other information about Essure implantation.

In April, FDA Commissioner Scott Gottlieb, M.D. indicated, "We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option." Furthermore, Dr. Gottlieb said, "We take the concerns of all women affected by Essure very seriously. I've personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks."

Essure Complications

Reports of Essure complications reported to the FDA in recent years include the following medical problems:

Additional surgeries, including hysterectomy, to remove the device and repair internal organs

Autoimmune response to the device, including fatigue, rashes, hair loss and weight gain

Chronic pelvic pain

Unintended pregnancy

Life-threatening ectopic pregnancy

Migration of the device or a device component

Abnormal bleeding

Perforation or tear of pelvic organs, including uterus or colon

Severe migraines and allergic reactions

September 2015 Advisory Committee Meeting on Essure Safety

On September 24, 2015, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to examine safety concerns about Essure. The Advisory Committee meeting "Executive Summary" can be read here, and the panel transcript can be read here. The Panel heard from medical experts and from women implanted with the Essure device. Some women reported pain and other health problems after Essure implantation that are not included in the product labeling, were not observed in post-approval studies, or described in the clinical literature. Examples include extreme fatigue, depression, weight gain, allergy/hypersensitivity reactions. Many of these outcomes were discussed at the Advisory Committee meeting and cited in docket comments that you can read in the links above.

Panel members urged the FDA to add a "boxed warning" and "Patient Decision Checklist" to the product labeling for Essure to help ensure that a woman receives and understands information regarding the benefits and risks of the device. Following the Panel meeting, the FDA ordered Bayer to conduct a postmarket surveillance study to obtain more data about Essure's benefits and risks. More information about the Agency's case report form analysis can be found in the Summary and Key Findings document here.

February 2016 FDA Safety Update onEssure

On February 29, 2016, the FDA announced that a new, mandatory clinical study would be required forEssure. This announcement comes after thousands of complaints have been received by the Agency in recent years. The FDA ordered Bayer to conduct a new post-market surveillance study that will provide data to help the FDA better understand the risks associated withEssureand compare them to laparoscopic tubal ligation. This includes the rates of complications including unplanned pregnancy, pelvic painandother symptoms, and surgery to remove theEssuredevice. The study will also evaluate how the side effects impact apatient'squality of life. Additionally, the study will collect information to identify why some patients do not have a follow-up test to confirm thatEssurehas been properly placed three months after insertion. The FDA will use the results of this study to determine if any further actions related toEssureare needed to protect public health.

The FDA also indicated that it will require changes to product labeling to include a "boxed warning" and a "Patient Decision Checklist" so women receive and understand risks of this type of device.

Contact a Tampa Essure Lawyer Today

If you or a loved one underwent the Essure permanent birth control procedure and experienced a severe complication from the medical device, please contact the law firm of Alley, Clark & Greiwe. A knowledgeable Tampa Essure lawyer from our legal team will help you obtain the compensation you rightfully deserve.

Consumer Information on Essure

Click here to read the FDA's Announcement on April 9, 2018

Click here to read the FDA's Announcement from February 2016

Click here to read the transcript of the Advisory Committee meeting in 2015

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Approximately 750,000 women have been implanted with Essure (manufactured by Bayer) for permanent birth control since it was approved by the FDA in 2002. Essure is a permanent birth control device that does not require surgery.

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Dangerous Medical Device Alert and Urgent Recall of Zimmer Biomet Comprehensive Reverse Shoulder Implants

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Dangerous Medical Device Alert and Urgent Recall of Zimmer Biomet Comprehensive Reverse Shoulder Implants

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When the U.S. Food and Drug Administration (FDA) issues a "Class 1" recall of a defective medical advice, it means lives are at risk. A Class 1 recall is the most serious and urgent kind issued by the FDA, indicating "a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA. In February 2017, the FDA issued just such a recall of Zimmer Biomet Comprehensive Reverse Shoulder implants. These implants were discovered to have dangerously high fracture rates. A fracture of the device can lead to revision surgeries which in turn can cause "serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death," the FDA says.

What is a Comprehensive Reverse Shoulder Implant?

Manufactured by Warsaw, Indiana-based Zimmer Biomet, the Comprehensive Reverse Shoulder implant was introduced into the U.S. market in 2008 after an expedited approval process that allowed it to be approved by the FDA without the more rigorous testing usually required for medical devices.

The implant is a shoulder replacement device which is used to help restore arm movement. It was designed to for patients with rotator cuff tears who developed a severe type of shoulder arthritis known as arthropathy and who also had a previously failed shoulder joint replacement.

What Are the Problems With the Shoulder Implant?

Reverse shoulder replacement fractures usually happen during the replacement surgery itself. The problem with the Zimmer Biomet Comprehensive Reverse Shoulder implant is that the fracture rate was significantly higher than what was listed on the label of the device. According to one study, patients who suffered a fracture after shoulder replacement surgery "had a 6 times higher incidence of death within 30 days than the general population."

Given the serious risks posed by these devices, Zimmer Biomet issued an "Urgent Medical Device Recall Notice" to hospitals and other healthcare providers in December 2016 directing them to quarantine all of the effected devices so that company sales representatives could retrieve the implants.

Over 3,600 Comprehensive Reverse Shoulder Implants have been recalled. The effected devices are model number 115340, manufactured between August 25, 2008 and September 27, 2011.

If you recently had shoulder replacement surgery, there is a good chance that you don't know what model or kind of device was implanted during the procedure. You should contact your physician as soon as possible to learn whether or not it was one of the recalled implants. If so, discuss with your doctor what steps you should take to reduce the risk of a potentially serious fracture.

If you learn that you were treated with a Zimmer Biomet Comprehensive Reverse Shoulder implant or have suffered a fracture after replacement surgery, you should also contact a dangerous medical device attorney immediately. Claims are already being filed against Zimmer Biomet for injuries and losses caused by their product, and

you may be entitled to compensation. An experienced unsafe drugs and products attorney is committed to getting help for those hurt by big pharmaceutical or medical device companies, and fight tirelessly to get our clients the relief and resources they need and deserve. Contact an attorney today.

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Alley Clark Greiwe

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Dangerous Medical Device Alert and Urgent Recall of Zimmer Bio... - Storeboard

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When the U.S. Food and Drug Administration (FDA) issues a "Class 1" recall of a defective medical advice, it means lives are at risk. A Class 1 recall is the most serious and urgent kind issued by the FDA, indicating "a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA.

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