Posted on August 5, 2009 by Michelle H. Lyu

Senate Committee Meets To Hear From Witnesses Regarding "The Medical Device Safety Act of 2009"

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. 

S. 150 and H.R. 1346 seek to overturn the Supreme Court's important ruling in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that the PMA approval process for Class III devices imposes federal requirements that preempt state tort claims which would impose additional or different "requirements" regarding the safety and efficacy of the device, pursuant to the express preemption clause found in the Medical Devices Amendment of 1976.

Speaking in support of the bill were William Maisel, Director of the Medical Device Safety Institute, Thomas McGarity, Professor at the University of Texas School of Law, and Michael Mulvihill, a patient who was formerly implanted with a medical device. The arguments they presented echoed those of preemption opponents.

Dr. Maisel's testimony came from the perspective of a medical practitioner, and while he praised the work of the FDA as a "preeminent medical regulatory system," it was his opinion that the FDA nevertheless could not regulate all safety and effectiveness issues that arise regarding PMA approved devices. Dr. Maisel also was of the opinion that medical device manufacturers fail to properly report medical device adverse events that in turn allegedly restricted the FDA's ability to properly regulate the industry, and in his view tort liability was an additional safeguard that Congress should restore. Professor McGarity echoed this perspective from a legal standpoint and suggested that innovation would not suffer (although he did not offer any objective support for this theory). Patient Mulvihil provided his thoughts about an allegedly defective lead he received. 

Speaking in opposition to the bill were former Chief Counsel for the FDA, Peter Barton Hutt, and medical device patient Michael G. Roman. Mr. Hutt gave a historical account of how the Medical Devices Amendments of 1976, which included the express preemption clause in question, came to fruition. As Chief Counsel during 1971-1975, he came before the House Subcommittee on Public Health and Environment of the Committee on Interstate and Foreign Commerce at that time to support national uniform standards for medical devices in order to "strengthen[] the integrity, credibility, and primary jurisdiction of the agency." From this sub-committee hearing, "all medical device legislation considered in the House and Senate included some form of national uniformity requirement." Mr. Hutt warned that if the current Senate reverses the standards put in place through the 1976 Medical Device Amendments, judges and juries in product liability cases would make decisions inconsistent with FDA decisions to approve devices for market. Mr. Hutt also went on to describe the rigor of the PMA approval process that is applicable only for less than 1/2 of 1% of medical devices on the market.

The last witness of the day was patient Michael Roman, who testified about the importance of medical device innovation and availability from his personal experience. After multiple surgeries to repair a torn knee ligament that resulted in a staph infection and later progressive amputations of his right leg, Mr. Roam testified that prior to his medical device, he was under so much pain that he could not remember ten years of his children's' lives. Mr. Roman also testified that he was only able to live with large amounts of pain medication, radiation and injections to no avail. It was only after the implantation of a spinal cord stimulator (which delivers certain electrical impulses through leads to his spinal cord) that his pain has been managed effectively. He currently works with Boston Scientific in speaking out about the debilitating nature of pain and how medical technologies could assist patients in living full lives. His focus was that safe, innovative products should be approved through a more robust FDA, not through the vagaries of litigation that would result from the passage of the bill.

The limited time available during these hearings means that the witnesses often can only scratch the surface, and there is so much more to be said about why the Medical Device Safety Act of 2009 is a bad idea. For a more detailed perspective, it is worth reading “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.

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Posted on July 29, 2009 by Lisa Baird

Next Congressional Hearing About Medical Device Safety Announced

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.

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Posted on May 13, 2009 by Michelle H. Lyu

House Subcommittee Holds Hearing To Overturn Riegel: H.R. 1346, the "Medical Device Safety Act of 2009"

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 Dingell, 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.

Most of the invited witnesses were repeat appearances from last year's hearing. David Vladeck, J.D., Professor of Law, Georgetown University Law Center presented his case in support of the bill, and repeated his concerns about the Riegel court's alleged deviation from congressional intent as reflected in legislative history. He also argued that manufacturers brought the express preemption defense to fore and that it was a more recent phenomena since the mid 1990s, after the Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517, 112 S.Ct. 2608, 2618 (1992) decision.

William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston also testified, as both a practicing cardiologist and as a consultant and advisory committee member for the FDA. He provided anecdotal background with what he represented as an example of a man who was implanted with a St. Jude pacemaker that allegedly was subjected to a recall and resulted in additional surgical procedures.  In making this example, Dr. Maisel argued that the self-interest of companies are at odds with the congressional goal of ensuring public safety. Gregory Curfman, M.D., Executive Editor, New England Journal of Medicine also echoed similar sentiments, and discounted the arguments made about innovation and safety for consumers being mutually exclusive.

Richard Cooper of the law firm Williams & Connolly LLP provided a big-picture review of what it would mean to have 50 state juries take the place of the FDA and seasoned clinicians when determining what constitutes a "defect" meriting liability. Mr. Cooper also emphasized that innovation would be hampered should preemption be denied to medical device companies, noting how many smaller companies that are focused on under-served areas of practice would be litigated out of their market share.

Bridget Robb of Pennsylvania and Michael Kinsley of Washington both presented anecdotal history with medical devices. Ms. Robb testified about her experience with a cardiac lead that she claimed unnecessarily shocked her and caused grievous subsequent emotional and physical injury, while Mr. Kinsley presented his story of how deep brain stimulation and other implanted medical devices has allowed him to lead a productive life despite a Parkinson's Disease diagnosis. Both presented different takes on the limits of how much risk a patient should face when balanced with the potential benefits offered by their medical devices.

Prior to the hearing, the Energy & Commerce Committee also published a letter asking the FDA to reexamine its decision to approve a medical device called the "collagen scaffold" that is used to reinforce and repair the meniscus, which is a natural cushion in the knee. This letter, as addressed to the FDA Principal Deputy Commissioner, seeks reexamination of the approval decision that the authors argue was made over the objection of FDA scientists.

For more information, please see the previous post "Will The May 12 Hearing On The "Medical Device Safety Act of 2009" Recognize The Costs Of Eliminating Preemption?"

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Posted on May 8, 2009 by Lisa Baird

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

The House Committee on Energy and Commerce's Subcommittee on Health will hold a hearing on Tuesday, May 12, 2009, at 2:00 p.m. regarding a bill to overturn medical device preemption (H.R. 1346 /S. 540), called the "The Medical Device Safety Act of 2009.” Although the hearing is not yet listed on the Subcomittee's website, hearing materials should become available here. (If you are interested, video and transcripts also are available from last year's lopsided 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.)

Those in the industry will find H.R.1346/ S. 540 ironically named, as patient access to critical new devices and public health would suffer if this bill passes. These ill effects are detailed in 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. As the authors state in the executive summary to their article,

"Eliminating preemption protection for medical devices—as some currently advocate—will impact:

1. Patient access and public health
2. Medical technology innovation rates
3. Industry employment
4. Government expenses as a healthcare payer, regulator and judicial funder

The results from eliminating preemption are likely broad and generally negative across this host of categories."

The article is thoughtful and well worth reading.

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Posted on December 29, 2008 by Lisa Baird

Class II Special Controls Preemption

The FDA last 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).

UPDATE: Mark Hermann and Jim Beck at druganddevicelaw.blogspot.com have posted some interesting commentary on this proposed rule, noting - among other things - that even without reference to preemption, "both a 1998 regulation applicable to latex gloves, and a 1997 regulation applicable to contact lens care products, have likewise been accorded preemptive effect due to their specificity. See Morgan v. Abco Dealers, Inc., 2007 WL 4358392 (S.D.N.Y. Dec. 11, 2007) (latex gloves); Tuttle v. Ciba Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007) (contact lens care products)."

Their Top 10 lists of the good and bad drug and device cases from 2008 also are not to be missed.

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