Reed Smith is pleased to present a virtual life sciences CLE week from November 9 – 13, covering hot litigation and regulatory topics of interest to our pharmaceutical, biotech, and medical device clients. Sessions include: The ABCs of an MDL: Lessons learned through the lens of a case The benefits of arbitration for life sciences … Continue Reading
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2018” on Wednesday, January 16, 2019 at 12 p.m. ET. Each year since 2007, Reed Smith’s Drug and Device Law blog contributors have compiled and posted … Continue Reading
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2016” on Wednesday, January 18, 2017 at 12 p.m. ET. Each year since 2007, James Beck, Reed Smith’s Senior Life Sciences Policy Analyst and the founder … Continue Reading
Michael Brown and Lisa Baird from our Life Sciences Health Industry Team will be presenting an hour-long AdvaMed Medical Technology Learning Institute webinar on “Top 10 Product Liability Issues” on July 20 at 1 p.m. ET. Product liability litigation is ever-evolving, and the plaintiffs’ bar is continually adapting its business model and litigation strategy against … Continue Reading
Over on the Drug & Device Law blog, Reed Smith partner Eric Alexander calls attention to Booker v. Johnson & Johnson, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014), a recent decision from the Ortho Evra multi-district litigation (MDL) extending the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013) … Continue Reading
As they do every year, authors from the Drug and Device Law blog have published a list of the top 10 best and worst medical device and pharma decisions of the past year. In addition to their standard analysis, this year two of the Reed Smith authors, Eric Alexander and Jim Beck, will be hosting a teleseminar on Wednesday, January 8th at 12 p.m. ET to discuss the decisions in more detail. Information on how to register can be found at www.reedsmith.com/events.… Continue Reading
As reported on Drug and Device Law Blog, in a five-to-four decision by Justice Alito, the Supreme Court has decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, slip op. (U.S. June 24, 2013), a generic drug preemption case out of the First Circuit where that court had permitted the plaintiffs to recover on a “design defect” … Continue Reading
Over at the Drug and Device Law Blog, there are several posts analyzing the meaning of the Second Circuit’s opinion in United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012), including this one and this one. Most Caronia commentary has focused on the court’s First Amendment holding, that the FDCA does not ban … Continue Reading
This post was written by Christopher C. Foster. As many of you no doubt have heard, the United States Supreme Court last week decided that FDA regulations applicable to generic drug manufacturers preempt state law “failure to warn” claims in PLIVA, Inc. v. Mensing, Nos. 09–993, 09–1039, and 09–1501, 564 U.S. ___ (2011). Among other … Continue Reading
One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA’s regulations governing the content of labels for prescription drugs. Essentially, defense lawyers … Continue Reading
On Tuesday, August 4, 2009, the Senate Committee on Health, Education, Labor and Pensions met for a hearing called "Protecting Patients from Defective Medical Devices" regarding Senate Bill 540, a companion bill to the House bill, H.R. 1346, the "Medical Device Safety Act of 2009." The House Subcommittee on Health, of the Committee on Energy and Commerce also met earlier this year on this issue, with some of the same speakers.… Continue Reading
On August 4, 2009 at 2:30 p.m., it will be the Senate’s HELP Committee’s turn to hold a hearing entitled “Protecting Patients from Defective Medical Devices”. No witness list is yet posted. For our coverage on past hearings on this issue, click here.… Continue Reading
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
The White House Press Office just released a Memorandum for the Heads of Executive Departments and Agencies re Preemption. Regarding actions by the executive branch intended to preempt state law, it directs:… Continue Reading
Washington Legal Foundation’s latest Legal Backgrounder, the "Logic of Michigan’s ‘FDA Defense’ Survives Recent Supreme Court Ruling", authored by Thomas J. Foley, explains why the Wyeth v. Levine, 129 S.Ct. 1187 (2009) ruling does not support a rationale to overturn Michigan law that provides a defense against drug product liability suits where the manufacturer obtained … Continue Reading
On May 12, 2009 the Subcommittee on Health, of the Committee on Energy and Commerce, House of Representatives, held a hearing on H.R. 1346, the "Medical Device Safety Act of 2009". If passed, it would overturn the Supreme Court decision, Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that under the express preemption clause of the Medical Devices Amendment of 1976 (MDA), the federal requirements created by the premarket approval process for Class III devices preempted state law tort claims that added or differed from the federal requirements. This hearing comes at the heels of public and media scrutiny of this decision, including last year's House Committee on Oversight and Government Reform preemption hearing held May 14, 2008 and the Senate Judiciary Committee's preemption hearing held June 11, 2008.
Before the invited panel of witnesses spoke, numerous members of the subcommittee provided opening remarks, which reflected the division among those who argued that the Supreme Court's analysis in Riegel departed from the legislative intent of the MDA, and those who agreed that the pending legislation would prevent innovation and access to medical devices that are life-saving. Arguments against the bill also noted that moving against preemption would otherwise place safety concerns in the hands of juries across the country, instead of on the FDA's safety and efficacy evaluations. Some focus was also placed on the FDA's effectiveness in policing the manufacturers, with several congress members such as Representative John Dingle, MI and Henry Waxman, CA arguing that the FDA has not been able to identify and take action on defective products, therefore calling into question their effectiveness in ensuring safety, while other congress members such as Representatives Steve Buyer, IN and Michael Burgess, TX argued that if the FDA is underfunded and without resources, the Committee should focus on the FDA, not on tort reform...… Continue Reading
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:
"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
The Supreme Court had held action on a petition in Colacicco v. Apotex, Inc., No. 08-437, an implied preemption decision out of the Third Circuit involving an anti-depressant, pending the outcome of Wyeth. The docket now reflects that the case has been distributed for the Court’s March 6, 2009 conference. The most likely outcome is that … Continue Reading
As Point of Law pointed out on February 3, a move is afoot to “Revers[e] Preemption, One Bill At A Time,” starting with industries regulated by the FDA. Section 2 of the FDA Globalization Act OF 2009, H.R. 759, merits the attention of the life sciences industry. It provides: This Act and the amendments made … Continue Reading
Although the life sciences industry continues to await the Supreme Court’s decision in the Wyeth v. Levine preemption case, the court already is half-way through this term. The Washington Legal Foundation (WLF) will be holding its annual Midterm Supreme Court Media Briefing event on Wednesday, February 11 at 9:00 a.m. EST: The program will be moderated … Continue Reading
The FDA on Monday issued a proposed rule to classify "tissue expanders" as Class II (special controls) medical devices. These devices are "intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications."
What makes this notice interesting is preemption. In Riegel v. Medtronic, 128 S.Ct. 999 (2008), the Supreme Court upheld preemption in part because it concluded that the premarket approval (or PMA) process for Class III medical devices results in "federal requirements" specific to the approved device. In the tissue expander proposed rule, the FDA explains its view that these special controls also amount to federal requirements that should result in preemption. It states:
"In this proposed rulemaking, FDA has tentatively determined that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and that there is sufficient information to establish special controls to provide such assurance. FDA therefore proposes to establish special controls to address the issues of safety or effectiveness identified in the special controls draft guidance document. If this proposed rule is made final, these special controls would create 'requirements' for specific medical devices under 21 U.S.C. 360k, even though product sponsors would have some flexibility in how they meet those requirements (Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)). In addition, if this rule becomes final, as with any Federal requirement, if a State law requirement makes compliance with both Federal law and State law impossible, or would frustrate Federal objectives, the State requirement would be preempted. (See Geier v. American Honda Co., 529 U.S. 861 (2000); English v. General Electric Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado Growers, Inc., 373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).)"
Although this is the first reference we have seen to Riegel in a proposed rule to establish Class II special rules, the FDA is actually not breaking new ground. In 1997, the Papike upheld preemption in a case involving tampons (a Class II device) and an alleged failure to adequately warn of toxic shock syndrome since the FDA had issued regulations specifying the toxic shock syndrome required for tampon packaging. Other tampon cases have followed Papike, and there have been a few latex glove cases, too. See, e.g., Whitson v. Safeskin Corp., 313 F.Supp.2d 473, 479 (M.D. Pa. 2004); Busch v. Ansell Perry, Inc., 2005 WL 877805 (W.D. Ky. Mar. 8, 2005).… Continue Reading
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
The gap that the Supreme Court’s non-precedential decision, Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168 (2008), left open earlier this year continues to force the lower courts to take sides, as was done in the latest case – Grange v. Mylan Labs., Inc., Case No. 1:07-CV-107 (N.D. Utah Oct. 31, 2008). Specifically, the controversy remains … Continue Reading