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In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more
In This Issue:
- Massachusetts Supreme Judicial Court Holds Foreign Manufacturer Which Pled Meritorious Personal Jurisdiction Defense in Answer, But Did Not Move to Dismiss, Forfeited Defense By Participating in...more
In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more
Plaintiff’s expert is excluded for relying on a “novel” methodology to support opinion that antidepressant drug causes birth defects. -
On June 27, 2014, in In Re: Zoloft, U.S. District Judge Cynthia Rufe of the...more
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
Last week, the Third District Court of Appeal resolved any questions concerning the applicability of the Daubert standard in Florida following the legislative changes to Florida's evidence code in July 2013. ...more
In This Issue:
- Forum Non Conveniens: How To Avoid The Tide of Lawsuits Brought by Foreign Nationals
- Pro Te Solutio: Product Defense And FDA Compliance
- Health Care Strike Force: Uncovering Fraud In The...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more
A motion to dismiss can be a powerful tool in the hands of medical device companies to eliminate cases that should be dismissed from the outset on preemption grounds, before engaging in costly discovery. Oftentimes, however,...more
Product liability law in Pennsylvania has been fundamentally altered as it relates to the manufacturing and selling of prescription drugs. Manufacturers are now subject to design defect claims following a recent state Supreme...more
In a stunning decision with broad implications for pharmaceutical companies in Pennsylvania and elsewhere, the Supreme Court of Pennsylvania has held that plaintiffs may assert negligence claims against pharmaceutical...more
In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more
Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a...more
Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more
Where product liability actions or government investigators have targeted a prescription drug, class actions follow alleging that patients are entitled to a refund of what they paid for the medicine. The theory of these...more
In a recent decision issuing from the Central District of California, the court evaluated requirements pertaining to federal preemption and pleading, and granted Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.’s...more
Consistent with the U.S. Supreme Court’s opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Eleventh Circuit recently held that generic prescription drug manufacturers cannot be held liable under state-law failure...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
In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more
In most states that use a “risk utility” test to determine whether a product is “not reasonably safe” (i.e. defective) as designed, an alternative design for the product is generally considered to be a critical element of the...more
On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more
My part in a recent presentation to the San Francisco Trial Lawyers Association concerned opening statements, and I wanted to share a highly graphically immersive style of opening that allows an attorney to persuasively...more
Not surprisingly, the Supreme Court reaffirmed the broad preemptive scope of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and further extended the reach of impossibility preemption to design defect claims, in issuing its...more
In a 5-4 decision, the U.S. Supreme Court rejected the notion that a manufacturer’s option to stop selling its product resolves preemption concerns raised by conflicting state and federal laws....more
In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more
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