Amber M. Pang Parra is a pharmaceuticals attorney. She served as attorney with the state and federal judiciaries before moving to private practice, where she focuses on pharmaceutical and medical device litigation.

Medtronic’s Preemption Win in the 10th Circuit – With An Interesting Twist

The Tenth Circuit issued an opinion on Tuesday, finding that state law claims asserted against Medtronic, manufacturer of the InFuse bone growth stimulator were preempted by FDA approval of the medical device under the Medical Device Act (“MDA”). Plaintiff in the case alleged that Medtronic representatives promoted an off-label, posterior surgical approach for the device,

Blood Product Donation and Severe Allergies – New Questions Raised

As any subscriber to FDA notifications may be aware,  a great number of warnings issued involve undisclosed allergens  [You can subscribe to these notifications for free here].  Severe allergies may be life-threatening, can develop suddenly, and can even be inexplicable.  But what if you suddenly develop severe allergies that are not even your own?  Can

Mass Torts Plaintiffs and the Federal Courts

With mass torts, plaintiffs and their attorneys have both state and federal options when considering where to pursue their claims.  The conventional wisdom has been that federal courts are “defense friendly”  – with substantive and procedural requirements and rules which may be unfamiliar or appear restrictive to attorneys who practice primarily in state courts. The

JPML Maintains Narrow Focus of Mirena MDL

The orders from the March JPML panel hearing have been posted, and the JPML issued an order denying a motion by a plaintiff to centralize her case in the Mirena IUD device litigation MDL proceeding in the SDNY.  In its order, the JPML indicated that centralization into the pending MDL was denied because the potential

SCOTUS Denies Cert in Generic Preemption Case

Federal preemption of claims against generic drug manufacturers has prevented (or severely limited) the ability of users of generic drugs from bringing products liability claims premised upon the failure to warn.  Certain state courts have indicated that some state tort law claims may not necessarily be barred by federal preemption, but these “baby steps” potentially

Consent Decree Entered in Texas Compounding Pharmacy Suit

U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, a compounding manufacturer who previously had drugs it manufactured recalled for potential contamination. Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination.

Sixth Circuit Revives Breast Implant Suit with Choice of Law Application

The  opinion in Sutherland v. DCC Litigation Center, issued by the Sixth Circuit is a must-read, dealing with issues of choice of law as affected by both tort and bankruptcy law, across decades and multiple courts.  At the heart of this litigation is a case by a woman who sustained injuries after receiving  breast implants

Xarelto MDL has first status conference

The first conference in the Xarelto MDL (In Re: Xarelto (Rivoroxaban) Products Liability Litigation, MDL 2592,  proceeding in the Eastern District of Louisiana, before the Hon. Eldon E. Fallon, took place on January 29, 2015.  Judge Fallon, an experienced MDL presiding judge, has already set up a website for the MDL (, with posts of

Pelvic Mesh MDL Litigation Updates

A flurry of orders have issued from the chambers of the Hon. Joseph R. Goodwin, the United States District Judge presiding over  the pelvic mesh MDLs in the Southern District of West Virginia, Charleston Division.  The Court vacated and reset a bellwether trial set for December 4, 2014 to March 2, 2015, in Bellew v.