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The Circuit Court Split On 'Fraud On The FDA' Continues
On Feb. 22, 2012, the U.S. Court of Appeals for the Fifth Circuit unanimously affirmed the U.S. District Court for the Northern District of Texas' granting of a defendant drug manufacturer's motion for summary judgment on all claims, including the plaintiffs' failure-to-warn claims, in Lofton v. McNeil Consumer & Specialty Pharmaceuticals Co., No. 10-10956, slip op. (5th Cir. Feb. 22, 2012).
United States
13 Apr 2012
2
The Circuit Court Split On 'Fraud On The FDA' Continues
On Feb. 22, 2012, the U.S. Court of Appeals for the Fifth Circuit unanimously affirmed the U.S. District Court for the Northern District of Texas' granting of a defendant drug manufacturer's motion for summary judgment on all claims, including the plaintiffs' failure-to-warn claims, in Lofton v. McNeil Consumer & Specialty Pharmaceuticals Co., No. 10-10956, slip op. (5th Cir. Feb. 22, 2012).
United States
21 Mar 2012
3
Fifth Circuit Concludes That U.S. Supreme Court's "Fraud-On-The-FDA" Federal Preemption Precedent Has Broad Application
The defendant drug manufacturer asserted as an affirmative defense the rebuttable presumption that it had complied with all U.S. Food and Drug Administration (FDA) requirements governing its product's labeling.
United States
8 Mar 2012
4
U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers
On June 23, 2011, the U.S. Supreme Court issued a decision in Pliva, Inc. v. Mensing, holding that state-law claims against generic drug manufacturers are federally preempted pursuant to the Supremacy Clause of the U.S. Constitution.
United States
27 Jun 2011
5
FDA Food Safety Modernization Act Passes U.S. Senate
On November 30, 2010, the U.S. Senate passed the FDA Food Safety Modernization Act, the goal of which is to keep unsafe foods from reaching American consumers.
United States
7 Dec 2010
6
Federal Government to Provide Its Position on Generic Preemption to the U.S. Supreme Court
Following the U.S. Supreme Court's March 2009 landmark decision in Wyeth v. Levine, state and federal courts have struggled with how to apply "Levine" to failure-to-warn products liability claims against generic pharmaceutical manufacturers.
United States
5 Aug 2010
7
Medicare Secondary Payer Reporting and Repayment Obligations: Is Relief on the Way?
The Medicare Secondary Payer Enhancement Act of 2010 (MSPEA) was introduced in Congress on March 9, 2010, and would amend the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) statute to address many of the concerns raised by counsel for plaintiffs, defendants and others who are likely to be affected by MMSEA's reporting requirements.
United States
27 Apr 2010
8
Medicare Secondary Payer Statute: New Reporting Requirements For Products Liability And Toxic Tort Clients
Beginning January 1, 2010, extensive new Medicare reporting obligations will apply to insurance companies and other businesses, including products liability and toxic tort defendants that make payments to Medicare beneficiaries as a result of verdicts or settlements resolving liability claims.
United States
14 Dec 2009
9
Exception To Pennsylvania´s One-Disease Rule: Pre-1992 Asbestos Plaintiffs May File New Claims
On October 21, 2009, the Pennsylvania Supreme Court issued an opinion in "Abrams v. Pneumo Abex Corp., et. al.," following oral argument almost exactly one year ago.
United States
27 Oct 2009
10
Have You Registered Under MMSEA? New Reporting Obligations And Penalties For Medicare Secondary Payers
Beginning on January 1, 2010, extensive new Medicare reporting obligations will apply to insurance companies and other businesses that make payments to Medicare beneficiaries as a result of litigation claims.
United States
19 Oct 2009
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