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Reaping the Jurisdictional Whirlwind

by Reed Smith on

Literally for decades plaintiffs in mass torts have employed the business model of flooding jurisdictions seen as friendly to them with more solicited plaintiffs than any court system can possibly handle. They have employed...more

Pro Te: Solutio - Vol. 10 No. 3 – Summer 2017

by Butler Snow LLP on

Every summer vacation (or, at least, the ability to take the weekend off!) should include a good read. Whether your preference runs toward a memoir with words of wisdom, a review of new technical advancements, issues of...more

Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits

by Reed Smith on

If you want to insult and annoy someone, consider suing them under the Racketeering Influenced and Corrupt Organizations Act, 18 U.S.C. section 1964. That law is charmingly known as RICO, in an allusion to the big bad in the...more

Empty Gestures – Pennsylvania’s Right To Try Legislation

by Reed Smith on

For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets...more

Data Privacy + Cybersecurity Insider - October 2017

by Robinson & Cole LLP on

McAfee Report Lists Health Care Sector as Most Targeted Industry for Cyber-Attacks - In its cybersecurity incident report outlining vulnerabilities for the second quarter of 2017, security firm McAfee lists the health care...more

Rx IP Update - September 2017

by Smart & Biggar on

Federal Court of Appeal Applies Supreme Court’s Utility Test to SPRYCEL Patent - In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36...more

Fraud on the FDA? If Not Preempted, It Is Trumpery

by Reed Smith on

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent...more

Off-Label Marketing Case Tossed

by Reed Smith on

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them,...more

Samsung Bioepis Biosimilar Updates

by Goodwin on

We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab...more

N.Y. Court Holds that Manufacturer Cannot be Responsible for Medical Malpractice

by Reed Smith on

We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes). We’ve said before that both Levine and Riegel...more

No Causation, No “Parallel Claim”

by Reed Smith on

The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v....more

Sham Affidavits

by Reed Smith on

We’re quite familiar with people who say one thing, when they think that’s in their interest, and later when circumstances change, say something quite different. For example, as the late, great Molly Ivins pointed out in...more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

Medical Monitoring Class Certification Fails

by Reed Smith on

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Will I Get Sued After a Data Breach? D.C. Circuit Broadens Scope of Data That Gives Rise to Identity Theft in CareFirst

by Orrick - Trust Anchor on

In the latest sign that data breach class actions are here to stay—and, indeed, growing—the D.C. Circuit resuscitated claims against health insurer CareFirst BlueCross and Blue Shield, following a 2015 breach that compromised...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

August 2017: Product Liability Litigation Update

Hot Topic: Plaintiffs’ Efforts to Evade the Burden of Supporting Products Liability Claims with Expert Testimony. The core allegations in many product liability cases are that the manufacturer failed to adequately warn of its...more

Federal Right To Try Legislation – Is It Any Better?

by Reed Smith on

We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute...more

Nixing Discovery on Foreign Regulatory Submissions

by Reed Smith on

The cases we typically write about focus on events after medical products have made their way through the applicable regulatory process and been marketed in the United States. The marketed product is used, people claim to...more

Specialty Pharmacy's Antitrust Claim against Humana Fails

by Baker Ober Health Law on

On August 9, District Judge Susan Wigenton (D. NJ) issued a ruling in Prime Aid Pharmacy v. Humana, Civ. No. 16-2104, granting Humana's motion to dismiss the plaintiff's Second Amended Complaint, finding that the plaintiff...more

Dental Device Class Action Bites The Dust

by Reed Smith on

This is our second post in three weeks on class actions, owing to the filing of two really interesting class action opinions within a couple of weeks of each other. We posted two weeks ago on the Eleventh Circuit’s rejection...more

Guest Post – Before the Flood: Fifth Circuit Oral Argument on Writ of Mandamus From Pinnacle Hip Implant MDL

by Reed Smith on

Today’s guest post is by Reed Smith Houston office associate Curtis Waldo. Given the Noachic weather down there recently, one might ask “where’s Waldo?” The answer is safe and sound, if not quite high and dry. Curt is...more

Rx IP Update - August 2017

by Smart & Biggar on

Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more

Good Risperdal Times, Part Three: Summary Judgment for Janssen in Philadelphia

by Reed Smith on

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday...more

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