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German Federal Court: Permission granted - HIV/AIDS drug distribution continued

by Hogan Lovells on

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

Eighth Circuit Affirms Exclusion of Expert in Hip Implant Case

by Reed Smith on

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and...more

Court Dismisses Infringement Theory Premised on Speculated Future Formulation Changes

by McDermott Will & Emery on

The US District Court for the District of New Jersey granted generic manufacturer’s motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement. Par Pharmaceutical, Inc. v. Luitpold...more

The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After

In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more

Class Action and Regulatory Settlements Reflect the Rising Cost of Data Breaches

by Carlton Fields on

As the number of data breaches continues to increase, so too do the costs. After a breach occurs, companies typically expend significant sums conducting investigations, notifying customers and regulators, and engaging in...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Boxed Warnings and Adequacy as a Matter of Law

by Reed Smith on

One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year...more

Personal Jurisdiction Update In Supreme Court’s Bristol-Myers Squibb Co. v. Superior Court

by Weintraub Tobin on

Several weeks ago, the U.S. Supreme Court issued its opinion in Bristol-Myers Squibb Co. v. Superior Court of Cal., No. 16-466, 581 U.S. —, 2017 WL 2621322 (June 19, 2017) (“Bristol-Myers Squibb”). The more than 600...more

California Is At It Again On Personal Jurisdiction

by Reed Smith on

Maybe we should not be surprised when courts within California reach to find personal jurisdiction over out-of-state corporations even when non-Californians sue. That is what BMS v. Superior Court was all about. Right? ...more

PTAB Life Sciences Report - July 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Myriad Genetics, Inc. v. Johns Hopkins University - PTAB Petition: IPR2017-01102; filed March...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

New Mexico Wrongful Conduct Rule Shuts Down Opioid Case Against Pharmacist

by Reed Smith on

New Mexico is called the Land of Enchantment, but when it comes to law it is the Land of You Can’t Make this Up. You might think it weird that New Mexico’s state constitution (Article VII, section 1) specifies that idiots...more

Both Sides Equal Under the First Amendment

by Reed Smith on

There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects,...more

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Eleventh Circuit Gets It Wrong on Preemption

by Reed Smith on

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot...more

Rx IP Update - June 2017

by Smart & Biggar on

Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more

Anthem Settles Data Breach Suit for Record $115 Million

Anthem Inc. has reportedly agreed to pay a settlement of $115 million to its customers that were affected by what is being called one of the largest data breaches in U.S. history....more

Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

by Smart & Biggar on

As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations...more

Supreme Court Says “No” to “Litigation Tourism”

There has been a lot said already about the effect on product liability (especially drug) cases and “mass actions” as a result of the United States Supreme Court’s June 17, 2017 decision in Bristol-Myers Squibb Co. v....more

Failure To Contraindicate Claims and Preemption

by Reed Smith on

We were recently asked the question, “are failure to contraindicate claims preempted?” Our immediate response was, “How could they not be”? However, it’s not helpful to answer a question with a question, and as with all...more

Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer’s Negligence Claims But Denies Summary...

by Reed Smith on

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

Breaking News - Bristol-Myers Squibb Slams The Door On Litigation Tourism

by Reed Smith on

The Supreme Court decided “the big one” today – and not to keep anyone in suspense [the big one is a major earthquake in California mass tort litigation], the result is that the California Supreme Court finding of personal...more

Fourth Circuit Punts West Virginia Innovator Liability Issue

by Reed Smith on

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when...more

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