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On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more
Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more
Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more
Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more
The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more
On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more
With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more
ECHA raised serious concerns recently about the quality and compliance of 574 companies' registration dossiers, all of which relate to intermediate substances. The companies have been notified via REACH-IT and given 3 months...more
Originally published in Medical Devices Law & Industry Report on 10/03/2012.
FDA’s New Plan -
The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more
Originally published in the American Health Lawyers Association, Washington, D.C. on October 17th, 2012
New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing...more
In This Issue:
*First Circuit Affirms Judgment Against Generic Drug Manufacturer on Plaintiff’s Design Defect Claim, Holding: (i) Product May Be Found “Defective” on Proof It Is “Unreasonably Dangerous”; (ii) Design...more
State and federal courts reject efforts to categorize salmonella as a "communicable disease."
While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more
In an effort to protect children (and, to a lesser extent, adults) from toxic exposure, California has banned the use of the controversial chemical Bisphenol A (BPA) in baby bottles and sippy cups, and has eliminated certain...more
This week the FDA released a plan for fostering innovative science. It is entitled the “Strategic Plan for Regulatory Science,” and it focuses on the agency’s goal to enhance the processes for developing and evaluating new...more
On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more
On March 22, 2011, the U.S. Supreme Court issued its opinion in Matrixx Initiatives, Inc. v. Siracusano, 562 U.S. ___ (2011), an important securities fraud class action with potential implications for pharmaceutical and...more
The growth of the biomaterials market, which analysts expect to reach $58.1 billion by 2014, shows that biomaterials suppliers have flourished by relying on the Biomaterials Access Assurance Act of 1998 (BAAA), 21 U.S.C. §§...more
In a highly anticipated new development, California’s Department of Toxic Substances Control (“DTSC”) submitted its Green Chemistry Proposed Regulation for Safer Consumer Products to the state Office of Administrative Law...more
In a recently released letter to U.S. Sen. Chuck Grassley (R-Iowa), the Government Accountability Office (GAO) reported the results of its study into the Food and Drug Administration's (FDA) criminal investigation of...more
On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the...more
The Supreme Court yesterday decided Wyeth v. Levine, the long-awaited decision on preemption of state court product liability claims against the pharmaceutical manufacturers. In a 6 to 3 decision, the Supreme Court determined...more
IN THIS ISSUE:
*New bills push for better regulations on toxic products sold in California
*Connecticut moves to limit lead in children's toys
*Climate Counts' second annual company scorecard finds food services industry...more
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