New York’s Appellate Division, Second Department recently denied two motions arguing an appeal was untimely where the appellant filed a notice of appeal nine days beyond the standard deadline. The appellant successfully...more
The Supreme Court of the United States recently affirmed two state court judgments that had permitted plaintiffs to assert jurisdiction over Ford Motor Company for injuries stemming from allegedly-defective cars. In an 8-0...more
In a mass tort product liability, class action and consumer fraud consolidated litigation involving Allergan's Biocell textured breast implants and tissue expanders, Allergan moved to dismiss plaintiffs' complaints on...more
The Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures...more
From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more
1/29/2021
/ Bayer ,
Contraceptives ,
Design Defects ,
Failure to Report ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Merck ,
Mirena IUD ,
New York ,
Pfizer ,
Summary Judgment ,
Teva Pharmaceuticals ,
Transvaginal Mesh
Two recent New York Appellate Division Second Department decisions articulated the standards of review for appeal of orders entered upon the default of the appealing party for its failure to oppose a motion in two different...more
The First Department has limited the role of testimony as to custom and practice in establishing what a defendant physician did in a specific instance in medical malpractice cases in Guido v. Fielding, 190 A.D.3d 49 (2020)....more
Recently, the Court of Appeals of New York answered the questions certified to it by the Second Circuit in the affirmative that New York recognizes “American Pipe” (American Pipe v. Constr. Co v. Utah, 414 U.S. 538 (1974))...more
In recent rulings, New York’s Second Department has clarified the standard to strike pleadings for violation of Court Orders. Contrasting the Tolkoff and Onyenwe cases shows how the Court distinguishes between a violation of...more
The Second Department of the Appellate Division, New York State Supreme Court, has limited the role of testimony as to custom and practice in establishing what a defendant physician did in a specific instance in medical...more
In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...more
The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more
A New York Supreme Court allowed a Plaintiff to assert a statutory fraud claim in the context of deceptive business practices under New York General Business Law (“GBL”) § 349 against Plaintiff’s neurologist in conjunction...more
In responding to the question of law certified by the United States Court of Appeals for the Third Circuit pursuant to Rule 2:12A-3, the New Jersey Supreme Court answered in the affirmative that a claim under the New Jersey...more
New York Federal Court granted Defendants’ Daubert motion to exclude design defect expert testimony on a design defect claim for PAM Cooking Spray and dismissed all product liability claims on summary judgment, including...more
MemoryGel silicone breast implants are Class III medical devices, approved by the FDA through the premarket approval (PMA) process in 2006. Premarket approval was a federal requirement imposed on the device. Plaintiff sued in...more
In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and...more
4/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Distributors ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Workers ,
Immunity ,
Manufacturers ,
Masks ,
Personal Protective Equipment ,
Public Readiness and Emergency Preparedness Act (PREP Act)
As concern about availability of personal protective equipment (“PPE”) continues to grow amid the COVID-19 pandemic, the federal government continues to take action aimed at increasing the availability of PPE with important...more
4/17/2020
/ Best Practices ,
Business Continuity Plans ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Management Plans ,
Employer Liability Issues ,
Flexible Work Arrangements ,
Health and Safety ,
Infectious Diseases ,
Medical Equipment ,
NIOSH ,
OSHA ,
Personal Protective Equipment ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Wage and Hour ,
Workplace Safety ,
World Health Organization
In times of national public health crises such as the COVID-19 pandemic, manufacturers and distributors of products are often called to the frontlines of battle to create, supply, and administer the tools necessary to combat...more
A new amendment in New York that restricts the use of judgments by confession will protect debtors and limit the ability of creditors to exploit a loophole.
The change prohibits a creditor from filing a confession of...more
The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more
The Appellate Division of New York, Second Department, recently upheld a lower court’s decision denying a defendant manufacturer’s application to perform destructive testing on a plastic object surgically removed from...more
The Food and Drug Administration (FDA) has announced that data reviewed on the risks associated with textured breast implants and anaplastic large cell lymphoma (BIA-ALCL) does not require a ban of this medical device under...more
The Food and Drug Administration (FDA) has issued a safety warning regarding the use of robotically assisted surgical devices for mastectomies and other cancer surgeries, asserting that "the safety and effectiveness of...more
Harris Beach attorneys Judi Abbott Curry, Victoria A. Graffeo and Marina Plotkin prevailed on plaintiffs’ appeal to the Second Circuit of product liability failure to warn claims against Pioneer Surgical Technology, Inc. and...more
5/9/2018
/ Appeals ,
Breach of Warranty ,
Design Defects ,
Dismissals ,
Expert Testimony ,
Failure To Warn ,
Learned Intermediary ,
Manufacturing Defects ,
Negligence ,
Product Defects ,
Summary Judgment