Tag Archives: Riegel

Courts Continue To Get Express Preemption Right In Medical Device Cases

Since last year, a number of courts have interpreted and applied the express preemption holdings of Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Miller v. DePuy Spine, Inc., 07-cv-01639, 2009 US Dist LEXIS 49602 (D. Nev. May 1, 2009), is another example and, although it was decided on May 1, has just recently been picked up by LEXIS. In Miller, the Nevada District Court granted summary judgment for the manufacturer of a PMA approved spinal implant disc called the Charite Artificial Disc. While many courts, including this one, correctly follow Riegel and hold that the state law claims challenging the design, manufacture and labeling claims are expressly preempted, this court also entered judgment for the defendant on warranty and misrepresentation claims that have a received a more mixed reception in some courts...… Continue Reading

Will The May 12 Hearing On The “Medical Device Safety Act of 2009” Recognize The Costs Of Eliminating Preemption?

Recent posts on www.lifescienceslegalupdate.com include: "Objectivity in Research PHS-Funded Research" discussing whether HHS should tighten current regulations for Public Health Service-funded research to provide a more rigorous approach to investigator disclosure, management of conflicts, and federal oversight. View the entire entry: https://www.lifescienceslegalupdate.com/2009/05/articles/regulatory-developments/objectivity-in-research-phsfunded-research/ and "Will The May 12 Hearing On The "Medical Device Safety Act of 2009" Recognize The Costs Of Eliminating Preemption?" regarding a hearing the House Committee on Energy and Commerce's Subcommittee on Health announced for Tuesday, May 12, 2009, at 2:00 p.m. regarding a bill to overturn medical device preemption, and a new economics study ("The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs" by Ernst Berndt, PhD, and Mark Trusheim of the Massachusetts Institute of Technology's Sloan School of Management) regarding the "broad and generally negative" effects likely to result from any effort to eliminate preemption.… Continue Reading

Gerald Masoudi at ACI

Today's posts on lifescienceslegalupdate.com include "Gerald Masoudi at ACI" which includes some notes regarding the presentation by the FDA's Gerald Masoudi today at the ACI Drug and Device Conference, and "EPA Proposes Change in Regulations for Disposal of Unused Pharmaceuticals". View the full blog at https://www.lifescienceslegalupdate.com. View "EPA Proposes Change in Regulations for Disposal of Unused Pharmaceuticals": https://www.lifescienceslegalupdate.com/2008/12/articles/regulatory-developments/epa-proposes-change-in-regulations-for-disposal-of-unused-pharmaceuticals/… Continue Reading

Harvard Law Review Takes Notice of Riegel

In its November 2008 issue, the Harvard Law Review will publish "Preemption of State Common Law Claims," 122 Harv. L. Rev. 405, an article that discusses Riegel v. Medtronic, Inc., 128 S.Ct 999 (2008) and its impact on state law claims.  Of note, the authors state: "Despite criticisms that it leaves tort victims uncompensated, preemption is … Continue Reading

JAMA on Preemption

Tomorrow's JAMA contains an editorial entitled, "Prescription Drugs, Products Liability, and Preemption of Tort Litigation" (subscription) by Catherine D. DeAngelis; Phil B. Fontanarosa (JAMA. 2008;300(16):1939-1941 (doi:10.1001/jama.2008.513)). Suffice it to say, the premise that tort litigation safeguards patient health is faulty. Ensuring patient access to innovative and needed medical options is essential. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1009 (2009) (discussing the express preemption statute for medical devices and stating, "the text of the statute - suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.")… Continue Reading

Recent Post-Riegel and OTC Drug Preemption Cases

In Parker v. Stryker Corp., 2008 WL 4457864 (D. Colo. Oct. 1, 2008), the District of Colorado addressed Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), and the applicability of the express preemption clause of the Medical Device Amendments in a case where the manufacturer sought a discovery stay pending resolution of its motion … Continue Reading

Preemption – It’s Not Just For Product Liability Anymore

Earlier this week, in Uhm v. Humana, Inc., --- F.3d --- , 2008 WL 3891592, No. 06-35672 (9th Cir. Aug. 25, 2008), the Ninth Circuit upheld a lower court ruling that the express preemption provision of the Medicare Prescription Drug Improvement and Modernization Act preempted state law claims arising from the plaintiffs' prescription drug benefits provided by a Medicare supplement insurer.… Continue Reading

Life after Riegel: a Glimpse of the Possible

This case provides an interesting glimpse of what could happen if the plaintiffs are successful in persuading Congress to change the import of Riegel v. Medtronic, Inc.’s, (552 U.S. ___, 128 S.Ct. 999, (Feb. 20, 2008)) holding through legislation. In Lundeen v. Canadian Pacific Railway Company, 532 F.3d 682 (8th Cir. July 2, 2008), the Eighth Circuit addresses … Continue Reading

A PMA Device and a Sales Representative in the Operating Room – The Breadth of Riegel Preemption

A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations … Continue Reading

Pharmaceutical and Medical Device Preemption

Reed Smith partners James W. Wood and James C. Martin recently wrote an article regarding pharmaceutical and medical device preemption for the Washington Legal Foundation, discussing such cases as the Third Circuit’s Colacicco v. Apotex, Inc. case, as well as activity in the U.S. Supreme Court.… Continue Reading

Bi-Annual Update Regarding Pharmaceutical Drug and Medical Device Federal Preemption: The Supreme Court Speaks In Riegel v. Medtronic

This post was also written by Michael K. Brown. In This Issue… U.S. Supreme Court Activity in Medical Device and Drug Preemption Cases Express Preemption in the Lower Courts Preemption and Buckman Implied Preemption in the Lower Courts Recent Legislation Miscellaneous Cases Click here to read more.… Continue Reading
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