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2021 New Developments

Chief Judge of Florida’s Seventh Judicial Circuit issues new Administrative Order regarding Covid-19 related procedures at Courthouses in Flagler, Putnam, St. Johns and Volusia Counties

On October 28, 2021, Chief Judge James R. Clayton of Florida’s Seventh Judicial Circuit covering Flagler, Putnam, St. Johns and Volusia Counties issued an Administrative Order titled Resumption of Court Operations (Order C-2021-056),rescinding prior Covid-19 related Orders and conforming Seventh Judicial Circuit procedures to the procedures set forth in the Florida Supreme Court’s July 29, 2021, Administrative Order, No. AOSC21-17. Under the new rules, unless required by federal, state, or local laws, rules, or regulations, a court may not require the wearing of face masks or physical distancing in a courthouse. Any person entering a courthouse may choose to wear a face mask and a face mask will be provided upon request. Any person entering the courthouse may request to be physically distanced, and the presiding official shall address such request as appropriate under the circumstances at the time of the request. Jury selection and trial proceedings in personal injury cases must be conducted in-person unless all parties consent and the presiding Judge approves remote proceedings. Other proceedings in personal injury cases can be conducted in-person, remotely or by a hybrid method in the presiding Judge’s discretion. All court facilities in the Seventh Judicial Circuit are open to participants, the media and public, all court proceedings conducted by a judicial or quasi-judicial officer, even those where all or part of a proceeding is to be conducted remotely, shall be conducted from the judicial or quasi-judicial officer's courtroom or hearing room.

Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene

On October 1, 2021, Bayer U.S., LLC, announced it is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. The company indicated in its risk statement that benzene is classified as a human carcinogen that, depending on duration and level of exposure, can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening. The company noted that to date it has no known reports of adverse events related to this recall.

Aligned Medical Solutions initiates nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits

On October 20, 2021, Allied Medical Solutions announced that it had initiated a nationwide recall on August 19, 2021,of 9,378 kits of its Monoject™ Flush Prefilled Saline Syringes. According to an FDA alert on October 27, 2021, these convenience kits have been found to contain part # 8881570121, which has been recalled for the potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe. If a clinician is not aware of air being introduced into the syringe, the clinician could inadvertently push air into the vascular system creating the potential for an air embolism. Injection of air into the vascular system can cause air embolism which can result in serious adverse health consequences or death.

Teligent Pharma, Inc. Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

On October 12, 2021, Telligent Pharma, Inc. announced that it was voluntarily recalling five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle, consisting of lot numbers 13262, 14217, 13058, 13768 and 16306. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. According to the company’s Risk Statement, use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. The company reported that as of the date of the announcement it had not received any reports of adverse events related to this recall.

Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

On October 19, 2021, Merck announced that it was voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022.CUBICIN is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age), and Staphylococcus aureus bloodstream infections (bacteremia) in adult patients including those with right-sided infective endocarditis, and Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). According to the company announcement, approximately 22,000 vials are affected by the recall and the recall was initiated by a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution.

Cook Medical Issues Voluntary Recall of Transseptal Needle and Transseptal Needle with Catheter

On October 18, 2021, Cook Medical issued a global, voluntary recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. According to the announcement, the needles were recalled due to complaints of rust on the products anduse of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.Cook Medical states it had received no reports of injury or illness related to this recall but had received four complaints where the presence of rust was identified prior to patient contact.

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

On October 14, 2021, Lupin Pharmaceuticals, Inc. voluntarily recalled certain batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets. Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021. The company is now recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US. Analysis reportedly revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan, a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

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.