Daytona Beach Personal Injury Lawyers
Free Consultations 386.258.1622

2021 New Developments

Warning for Covid-19 Lawsuits: Beware of Shortened SOL and Gross Negligence Standard

Effective March 21, 2021, the Florida Legislature enacted two statutes dealing specifically with lawsuits claiming damages related to Covid-19. Fla. Stat. § 768.381 applies to claims against health care providers. Fla. Stat § 768.38 applies to other types of defendants, such as educational and religious institutions, business and governmental entities, persons other than health care providers, as well as health care providers that do not otherwise fall within the ambit of § 768.381. Both statutes define Covid-19 related claims falling within their ambit very broadly. For example, § 768.38 provides that the term “Covid-19 related claim” applies to any claim that “arises from or is related to Covid-19.” In addition to other requirements, the statutes impose a heightened liability requirement that requires the plaintiff to prove that the defendant was grossly negligent. Finally, both statutes create a shortened limitations period for filing Covid-19 related cases. Section 768.38 requires cases to be filed within one year after the cause of action accrues or within one year after the effective date of the statute (3/29/2021) if the cause of action accrued before the effective date of the statute.Section768.381 provides that an action for a COVID-19-related claim against a health care provider (a) which arises out of the transmission, diagnosis, or treatment of COVID-19 must commence within one year after the later of the date of death due to COVID-19, hospitalization related to COVID-19, or the first diagnosis of COVID-19 which forms the basis of the action; (b) which does not arise out of the transmission, diagnosis, or treatment of COVID-19, such as a claim arising out of a delayed or canceled procedure, must commence within one year after the cause of action accrues; and (c) notwithstanding clause (a) or (b) above, an action that accrued before the effective date of the statute (3/19/2021) must commence within one year after the effective date of the statute.

FDA Issues Drug Safety Communication regarding arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib)

On September 1, 2021, the FDA issued a Drug Safety Communication concluding that there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). The FDA’s conclusion was based on a review of a randomized safety clinical trial that compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior FDA Drug Safety Communication based upon earlier results from this trial reported an increased risk of blood clots and death only seen at the higher dose. The FDA is requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant (baricitinib) and Rinvoq (upadacitinib). The FDA reports that Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action withXeljanz, the FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.

If you believe that you suffered an injury due to the above medications and are seeking advice regarding your legal remedies, please contact us for more information.

Coppertone recalls specific lots of five Coppertone aerosol sunscreen spray products

On September 30, 2021, Coppertone, owned by the Beiersdorf company, voluntarily recalledspecific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level. Coppertone has identified the presence of benzene in these lots of products. Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life threatening. Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies. Coppertone indicates that “out of an abundance of caution” it is recalling the lots although it has not received any reports of adverse incidents related to this recall.

The voluntary recall follows the disclosure that a laboratory testing facility, Valisure, reportedly found that samples from dozens of sunscreen and after-sun care products contained benzene, including products fromNeutrogena, Sun Bum, CVS Health, Fruit of the Earth, Raw Elements, Goodsense, Banana Boat, TopCare, Everyday and EltaMD.

If you believe that you have been harmed by exposure to benzene in sunscreen products and are seeking advice regarding your legal remedies, please contact our office.

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets

On September 16, 2021, the drug company Pfizer announced that it is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. This expands a July 16, 2021, voluntary recall announcement which applied only to ten specific lots, and an August 16, 2021, voluntary recall which added four more lots. Pfizer indicates that it is doing so as a precautionary measure.Chantix is a treatment to help patients quit smoking and is intended for short term use. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but Pfizer maintains there is no immediate risk to patients taking this medication and that the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.For more information regarding the affected lots, please consult the public announcement.

If you believe that you have been harmed by exposure to a nitrosamine, N-nitroso-varenicline in Chantix®and are seeking advice regarding your legal remedies, please contact our office.

FDA Approves First COVID-19 Vaccine

On August 23, 2021, the FDA announced that it has approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication

According to an August 20, 2021, announcement by the FDA on their website, the FDA is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.

The FDA noted that RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. These clearances are based on short-term (30 day) patient follow up. The FDA has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.

Before you have surgery to prevent or treat breast cancer, The FDA recommends that you ask whether the surgeon expects to use robotically-assisted surgery. If so, you should:

  • Be aware that the safety and effectiveness of using RAS devices in mastectomy procedures or in the prevention or treatment of breast cancer have not been established.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your health care provider to make the most informed treatment decisions.
  • Before choosing a surgeon for robotically-assisted surgery, the FDA recommends you ask the surgeon about:
    • Their training, experience, and patient outcomes with RAS device procedures.
    • The number of robotically-assisted surgical procedures like yours they have performed.
    • Potential short-term and long-term complications, and whether they are due to the mastectomy procedure, cancer prevention, cancer treatment, or an associated breast reconstruction-and how often they happen.
Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart

According to an August 12, 2021, announcement by the FDA on their website, the product involved in this recall are certain model numbers of components of the HeartWare HVAD System with distribution dates of August 30, 2016 to June 3, 2021. The number of devices recalled in the in the U.S. are 4,620. The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned. Medtronic, the manufacturer, is stopping the distribution and sale of the Heartware HVAD System because there (1) there is an increased risk of neurological adverse events and mortality associated with the internal pump; and (2) if the internal pump stops, it may delay restarting or fail to restart. Both problems may lead to death or serious patient harm including stroke, heart attack, worsening heart failure, the need for additional procedures and hospitalizations. There is a growing body of observational clinical comparisons showing a higher frequency of neurological adverse events and mortality among HVAD System patients as compared to those who receive other commercially available durable left ventricular assist devices (LVAD). Medtronic reports there are over 100 complaints involving a delay or failure to restart of the HVAD internal pump, which led to a total of 14 deaths and 13 pump removals.

If you believe that you suffered an injury due to the above device and are seeking advice regarding your legal remedies, please contact us for more information.

Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen

According to an August 3, 2021, announcement by the FDA on their website, the products involved in this recall are V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10) with distribution dates of May 1, 2009 to June 2, 2021. The number of devices recalled in the in the U.S. are 16,535. V60 and V60 Plus ventilators equipped with high flow therapy are used to provide patients with breathing assistance at high concentration of oxygen at a higher flow than typical oxygen therapy. These devices include a design safety mechanism limiting the amount of flow that can be delivered to a patient in situations where the system pressure reaches a default maximum pressure limit, due to a partial obstruction in the breathing circuit. As of June 18, 2021, Philips Respironics is recalling the V60 and V60 Plus ventilators that provide High Flow Therapy (Software Version 3.00 and Software Version 3.10) due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit. This can occur if the oxygen flow is partially blocked for any reason. If the issue causing maximum system pressure is not resolved by the health care provider, the ventilator will continue to provide the patient with lower oxygen flow rate and issue a low priority alarm. This could lead to serious adverse events, including death. There have been 61 incidents, 25 injuries, and no deaths reported for this issue.

If you believe that you suffered an injury due to the above device and are seeking advice regarding your legal remedies, please contact us for more information.