In February we noted that the perennial "Sunshine in Litigation" bill had been introduced again. The Senate version in S. 623 and the House version is H.R. 592 but there is no real difference. It now is scheduled for consideration in Senate Judiciary on May 5 at 10:00 a.m. A link to the webcast should be available then from the relevant Senate Judiciary Committee hearing and meeting page.… Continue Reading
Law360 is reporting that Rep. Jerrold Nadler (D-NY) is seeking to revive the 2009 "Sunshine in Litigation Act," a bill we covered previously. H.R. 592 would turn around the Supreme Court's Seattle Times Co. v. Rhinehart, 467 U.S. 20, 33 (1984), which concluded that discovery materials are not public components of a civil trial. As a result, litigation protective orders are permissible to protect the confidential and proprietary information of parties to civil litigation, at least until information produced in discovery is filed with the court or introduced into evidence for determination of a merits issue (such as on a motion for summary judgment or at trial.… 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
Congress has been busy and there is no sign it intends to slow down just because it is summer.
In two weeks, the House Energy and Commerce Health Subcommittee will hold a hearing entitled, "Medical Devices: Are Current Regulations Doing Enough for Patients." The hearing will be on June 18th at 9:30 a.m. in 2322 Rayburn House Office Building and access to the webcast and witness list should be available from this page once available. Information about this subcommittee's May 12th hearing about medical device preemption is in this prior post...… 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