Civil Procedure Health Products Liability

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Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

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

Drop-down Menus: The Pitfalls of Electronic Medical Records, Part II

In an earlier blog post, I discussed the importance of time stamps and signatures in electronic medical records (EMRs). A potential pitfall in using EMRs is the prevalence of drop-down menus....more

Pro Te: Solutio Vol. 6 No. 2

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

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

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

BOOK REVIEW: An Excellent Resource for Litigators Preparing for Depositions

This Book Review by Northeastern Pennsylvania insurance defense attorney of the Scranton, PA law firm of Foley, Comerford & Cummins appeared in the July 2013 edition of the Pennsylvania Lawyer Magazine. The review analyzes...more

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more

Pro Te Solutio - Vol. 5 No. 3 August 2012

In This Issue: - Diversity In Clinical Trials: The Need For Diversity To Ensure Safety And Efficacy - Federal Removal Statutes: A Review Of The Federal Courts Jurisdiction And Venue Clarification Act Of 2011 -...more

Pharmaceutical Law Update -- October 2012: New Jersey Court Grants Summary Judgment Based on Lack of Warning Causation

A New Jersey federal court granted summary judgment to Baxter Healthcare Corporation (Baxter) last month based on a familiar legal concept rarely applied in the Garden State – warning causation. In Baker et al. v. APP...more

The Gap Between Express and Implied Preemption Narrows In The Ninth Circuit

The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v....more

The Dregs - The Ten Worst Drug/Medical Device Decisions of 2011

Here we go again. At the end of every year, we look back over the past twelve months – the highs and the lows – the thrill of victory and the agony of defeat. We always start with the agony, however, and this year’s no...more

Protecting Yourself from Class Action Lawsuits

Over the past few years, the food industry has become the darling of the plaintiffs’ class action bar. Food companies have everything that class action lawyers love: huge numbers of consumers; heavy advertising; products that...more

Presumption-of-Adequacy Defense Is Clarified and Reinforced

On Sept. 29, the Appellate Division took a significant step forward in clarifying and reinforcing the presumption-of-adequacy defense provided to manufacturers of prescription drugs under the New Jersey Product Liability Act...more

New Important Appeal Grant in Pennsylvania

We can't discuss the substance, because Dechert's involved, but recently, the Pennsylvania Supreme Court accepted an appeal in a prescription drug product liability case, Daniel M. v. Wyeth Pharmaceuticals, Inc., (order here)...more

A View from the Bench on MDLs

Last week we attended ACI’s Annual Drug and Medical Device Litigation Conference. As always, it was nice to be in New York City during the holiday season (though the persistent drizzle was less than festive) and even nicer to...more

Tallying TwIqbal

It’s been a while since we’ve taken a comprehensive look at how TwIqbal’s been affecting prescription medical product liability pleading. We’ve done lots of posts about this or that case, but we haven’t synthesized anything...more

Nevada Supreme Court Imposes Duty to Warn on Pharmacists

On November 23, 2011, the Nevada Supreme Court ruled in Klasch v. Walgreen Co., Nev. No. 54805, 1123(11), that a pharmacist who has knowledge that a patient may be at risk with respect to specific prescription drugs may be...more

The Learned Intermediary And Implied Warranties

In a relatively recent case, Currier v. Stryker Corp., 2011 WL 4898501 (E.D. Cal. Oct. 13, 2011), the court stated, with respect to a claim for implied warranty: “Because this is a medical implant case, and the...more

There They Go Again

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more

Successful Class II Medical Device Preemption Decision

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v....more

Too Bad Its Unpublished

A reader recently recommended that we take a look at Rounds v. Genzyme Corp., ___ Fed. Appx. ___, 2011 WL 3925353, slip op. (11th Cir. Sept. 8, 2011) (applying Florida law), even though it’s unpublished. We’d blogged about...more

Court of Appeals Rejects Medical Monitoring Class Action

The Third Circuit last week affirmed a lower court decision denying class certification in a medical monitoring case alleging vinyl chloride exposures. Gates v. Rohm & Haas Co., No. 10-2108 (3d Cir., 8/25/11). Readers...more

One and a Half Learned Intermediary Victories

Not every decision we bring you is a quadruple scoop chocolate peanut butter sundae dripping in hot fudge sitting atop an extra fudgy brownie (OK, maybe we shouldn’t be blogging with the Food Network’s “The Best Thing I Ever...more

Yaz Court in NJ Issues Bellwether Trial CMO

The court overseeing the coordinated litigation in New Jersey state court over the birth control pills Yaz, Yasmin, and Ocella recently issued a case management order. See CMO No. 25 - Bellwether Trial Selection...more

Mirapex - Daubert Inapplicable To Toll Statute of Limitations

We don't generally cover statute of limitations-type issues (except for class action tolling) because they tend to be too state-specific and fact-bound to be of much general use. We're making an exception for today's...more

Pennsylvania District Court Dismisses Class Action Against Pharmaceutical Giant Johnson & Johnson

Judge Mary McLaughlin of the U.S. District Court for the Eastern District of Pennsylvania tossed a class action lawsuit last week after finding that the named plaintiffs lacked standing in In re McNeil Consumer Healthcare...more

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