Two cases decided over the last three months have added California and Massachusetts to the list of minority states that hold brand name manufacturers of drugs (“Brand Manufacturers”) liable under state “failure to warn” laws when sued by patients that exclusively used a generic version of the Brand Manufacturer’s drug. These cases follow the US Supreme Court decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (“PLIVA”), which held that generic drug manufacturers cannot be held liable for failure to update the safety label of a drug or biologic in violation of state “failure to warn” tort law since regulations from the U.S. Food and Drug Administration (“FDA”) prohibit generic manufacturers from unilaterally updating a generic drug’s label . Following PLIVA, the FDA proposed a rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (“Proposed Rule”) meant to allow generic drug or biologic manufacturers (“Generic Manufacturers”), under certain circumstances, to update safety labels without the requirement that the label match the label of the Brand Manufacturer. The Proposed Rule also would have required Generic Manufacturers in certain circumstances to collect post-market safety information. However, after twice delaying publication of a final rule, the FDA withdrew its Proposed Rule last year. Now that the Proposed Rule has been withdrawn, manufacturers holding New Drug Applications or Biological License Applications (collectively herein, “NDAs”) for the drugs or biologics they manufacture are faced with increased uncertainty with regard to the application of state “failure-to-warn” duties and liabilities, especially in light of the recent decisions by the California and Massachusetts supreme courts.
Monthly Archives: March 2018
Recent State Court Decisions and FDA Inaction Leave Brand Name Manufacturers Uncertain about Liability for Updating Safety Labeling: The Impact of the “Sameness” Standard
We’re ending the week on a high note, with a guest post from Lance Godard, of The Godard Group. For over 30 years, Lance has worked with lawyers and law firms to help them craft their messages, so if you’re looking for someone to help you with your content, look no further than The Godard Group. Today, he gives us some solid tips for conducting a quarterly tune-up of our marketing/BD plans.
The first quarter of 2018 has already stirred up an array of legal matters that employers in the hospitality industry should be conscious of, both in their day-to-day operations and long-term planning. In February alone, the U.S. House of Representatives passed legislation to curb lawsuits focused on the inaccessibility of brick-and-mortar business establishments and a federal appeals court ruled that discrimination based on sexual orientation violates Title VII of the Civil Rights Act of 1964 (“Title VII”). Earlier this month, the U.S. Department of Labor announced a pilot program that will allow employers to avoid potential penalties for overtime and minimum wage violations. In addition, the #MeToo movement continues to be top of mind across all industries, and hospitality employers should be vigilant in their training and employee awareness efforts. Due diligence in change-of-ownership transactions should include labor relations issues, especially with unionized employees.
Als je iemand de vraag stelt of het voor een organisatie van belang is dat deze zijn ICT systemen goed beveiligt, zal iedereen die vraag bevestigend beantwoorden. Desondanks gaat het op dit vlak maar al te vaak mis. Dat bleek overduidelijk in 2017 toen organisaties wereldwijd werden lamgelegd door de WannaCry aanval.
On April 1, 2018, the Massachusetts Pregnant Workers Fairness Act (MPWFA) will go into effect, requiring that Massachusetts employers provide, among other things, reasonable accommodations for pregnancy-related conditions.
FJC Publishes New Protocols: Initial Discovery Protocols For Fair Labor Standards Act Cases Not Pleaded As Collective Actions
As More Health Care Employers Adopt Mandatory Vaccine Policies, DOJ and HHS Push Back on Behalf of Individual Workers
In the midst of one of the worst flu seasons to date, many hospitals and other health care organizations enforced mandatory flu vaccine policies for their employees to boost vaccination rates. However, recent litigation and governmental actions should serve as a reminder that health care entities should carefully consider safeguards whenever implementing mandatory vaccine policies and to not categorically deny all requests for religious exemptions based on anti-vaccination beliefs.
DETROIT– Colin M. Battersby has joined McDonald Hopkins, a business advisory and advocacy law firm, as counsel in the firm’s national Data Privacy and Cybersecurity Practice Group. He is based in Detroit.
Section 5 of the Federal Trade Commission Act, 15 U.S.C. § 45(a)(1), provides the Federal Trade Commission (“FTC”) with broad authority to address “unfair methods of competition.” Although Congress chose not to define the specific conduct that constitutes unfair methods of competition, Section 5 provides a green light to the FTC to address acts and practices “that contravene the spirit of the antitrust laws and those that, if allowed to mature or complete, could violate the Sherman or Clayton Act.”