Two years from the eruption of media, consumer activist, and congressional concern over allegations of corruption and misconduct in FDA’s 510(k) review process, multiple investigations in mid-January produced agency proposals warmly praised by industry and denounced by activists as a sellout.The announcement came less than two weeks after the new Republican majority announced its determination to aggressively investigate the device review process and the agency’s performance in product recalls, long a sore point (see the next story for details).

Jim Dickinson

January 25, 2011

13 Min Read
FDA Taking 25 Steps to Improve 510(k) Process

In the announcement, FDA said it is taking 25 steps to improve the review path for 510(k)s. Seven FDA recommendations on which stakeholders had raised concerns are being forwarded to the Institute of Medicine for review before the agency makes a final decision.

CDRH director Jeffrey Shuren told a news conference that the approved changes include

  • Streamlining the de novo review process for low-risk devices that fall between 510(k) clearance and premarket approval.

  • Issuing guidances on when industry should submit clinical data.

  • Calling on external experts to help FDA with scientific issues associated with new technologies.

  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent decision making.

Shuren said the changes are intended to lead to a smarter medical device program that supports innovation, keeps jobs in the United States, and quickly brings important, safe, and effective technologies to patients.

Reporters participating in the agency teleconference told Shuren that they received comments from patient and safety groups criticizing FDA for caving in to industry. Typical was a statement issued by National Research Center for Women & Families president Diana Zuckerman that said FDA “has backed down on important safety measures that would have saved lives. Today’s FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments. FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results.”

Asked about such criticism, Shuren said that FDA was not backing down. Instead, it is taking the position that if there is so much controversy, it’s useful to continue to discuss the matters and see if some differences can be resolved.
AdvaMed said it is pleased with FDA’s “thoughtful analysis of comments by industry and its willingness to listen to views and concerns expressed by members of Congress, patient and physician groups, and industry.” The association described the plan as a “good first step that will address some of the major problems” with the 510(k) program. It praised the agency for dropping or deferring several proposals for Institute of Medicine review. The organization believes that these proposals would have significantly slowed patient access to new diagnostics and treatments and would have placed significant burdens on industry without corresponding health benefits.

“The critical next step is how FDA implements the plan through guidances and regulations,” AdvaMed cautioned. “Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.”

Republicans Turn Spotlight on Device Issues at FDA

It didn’t take the new Republican majority in the House of Representatives long to turn their investigational spotlight onto long-smoldering regulatory issues in FDA’s embattled CDRH—a prospect that may have helped principal deputy commissioner Joshua Sharfstein decide unexpectedly to resign in January.

As the Obama administration’s chief honcho in the shake-up at CDRH focusing on 510(k) review reforms, Sharfstein could not have been relishing the advent of the new Congress, even as he denied it was a factor in his departure to become Maryland’s new health chief. Scarcely two weeks before Sharfstein’s announcement, incoming House Oversight and Government Reform Committee chairman Darrell Issa (R–CA) vowed to aggressively investigate FDA recalls. Republican members of the Senate HELP (Health, Education, Labor, and Pensions) Committee wrote to FDA commissioner Margaret Hamburg to express concern over proposed 510(k) reforms that Sharfstein supervised.

The senators said that some of the recommendations could undermine efforts to have a regulatory pathway that is well functioning and predictable while fostering innovation and ensuring patient safety. They asked for copies of all internal planning documents on the development of timelines, project milestones, and notice-and-comment procedures that will be used to implement any proposals for change, along with change management plans for the overall project.

The senators said that Shuren had told committee staff that CDRH would implement noncontroversial recommendations and would refer more controversial items to the Institute of Medicine and Congress for further evaluation.

“Based on our review of the reports and discussions with stakeholders, we are concerned that several of the recommendations are controversial and have the potential to disrupt the current regulatory balance under the 510(k) pathway, jeopardizing patients’ timely access to new treatments and cures,” the senators’ letter told Hamburg. “In particular, we believe that the recommendations regarding rescission authority; split and multiple predicates; intended use and indications for use; splitting Class II; and the treatment of proprietary information, including trade secrets, could have significant unintended adverse consequences on the existing regulatory process.”

The letter concluded that it is important that Congress and the full range of stakeholders know the specifics of FDA’s recommendations and assess their full impact. It says the senators “also recognize that the cumulative effect of the changes proposed by the agency could be quite significant.”

Activists Seek New Investigation of CDRH ‘Wrongdoing’

Independent activist watchdog group Project on Government Oversight (POGO), perhaps unlikely allies of the new Republican majority, said in January that the HHS inspector general overlooked serious wrongdoing within CDRH when it rejected whistleblower complaints of the center allowing unsafe medical devices on the market.

A POGO letter to HHS secretary Kathleen Sebelius asked that she open a new investigation of CDRH misconduct. The letter said the inspector general’s 2009 investigation was inadequate because it only focused on possible criminal violations and ignored noncriminal misconduct and retaliation, including violations of federal regulations. POGO said that the CDRH problems raised by whistleblowers were well documented and included several instances of unsafe medical devices being approved for marketing. The group says that one of those instances was a pediatric feeding tube that caused easily avoidable deaths.

“The broad, underlying problem is managerial misconduct,” POGO alleged. “When CDRH managers fail to heed the advice of their own medical and scientific experts within CDRH, they often overrule these experts by circumventing the FDA's regulations. A group of the CDRH experts were concerned about the managers' violations of regulations and the harmful effect of these violations on patients’ health and safety. When they reported their complaints within FDA, they were largely ignored.”

POGO staff scientist Ned Feder charged in a news release that a “failure of leadership in FDA and the Office of Inspector General continues to put the health and safety of countless patients at risk. It is inexcusable that [deputy inspector general for investigations Gerry] Roy could close the book on these serious allegations without interviewing a single whistleblower.”

Appeals Court Finds Against Preemption in Stryker Case

Notwithstanding a 2008 Supreme Court case (Riegel v. Medtronic) affirming FDA preemption of state tort claims against medical device manufacturers, the U.S. Appeals Court for the Seventh Circuit ruled in December that such cases are not preempted when they allege injury was caused by a violation of federal law. Ruling in Bausch v. Stryker Corp., the appellate panel sent the complaint back to the district court, which had dismissed it with prejudice based on the company’s federal preemption defense.

In her complaint, plaintiff Margaret J. Bausch alleged that she was implanted with Stryker’s Trident ceramic-on-ceramic hip replacement system one week after FDA had declared it “adulterated due to manufacturing methods … not in conformity with industry and regulatory standards” in a March 2007 warning letter. The implanted device subsequently failed, the appellate judges wrote, “causing plaintiff to suffer an unstable right hip, pain, suffering, disability, and what is euphemistically called ‘revision’ surgery—in Bausch’s case a second major operation in which the Trident product was removed and replaced with a different product.”

This wasn’t an isolated incident, Bausch alleged. Her complaint charged that by early 2005, Stryker had received several complaints that the Trident was failing after it was implanted. “Defendants recalled a batch of Trident components in March 2006 because of ‘dimensional anomalies.’ FDA conducted an inspection at the defendants’ Ireland manufacturing facility from October 31 to November 3, 2006, and, following the inspection, informed the defendants of ‘numerous deficiencies [in the Trident] manufacturing and inspection processes.’”

After Chicago federal judge Samuel Der-Yeghiayan dismissed her complaint in December 2008, Bausch appealed to the Seventh Circuit and Stryker reasserted its explicit and implied preemption defenses, citing the propreemption Supreme Court decision in Riegel. Deciding for Bausch, the Seventh Circuit judges wrote: “Nothing in Riegel changes our view that state law claims based on violations of federal law are not expressly preempted by Section 360(k) [of the Medical Device Amendments to the Food, Drug & Cosmetic Act].”

That section, the panel said,

provides immunity for manufacturers of new Class III medical devices to the extent that they comply with federal law, but it does not protect them if they have violated federal law. Just as a plaintiff in an auto accident may use the other driver’s speeding violation as evidence of negligence, plaintiff Bausch claims that she was injured by Stryker’s violations of federal law in manufacturing the device implanted in her hip. It remains to be seen whether she can prove those allegations, including causation and damages. But if she can prove those allegations of harm caused by violations of federal law, her claims under state law would not impose on defendants any requirement ‘different from, or in addition to, any requirement’ imposed by federal law. Her claims are not preempted.

Addressing a Stryker argument seeking to invalidate Bausch’s complaint based on a distinction between concrete, product-specific requirements and more general requirements, the panel objected that this “would also leave injured patients without any remedy for a wide range of harmful violations of federal law.” The panel noted that FDA regulations contain many requirements that are not concrete or product-specific, yet they are vital to producing safe and effective medical devices. For example, 21 CFR 820.70(e) requires manufacturers to “establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.” Further, the panel said, if a patient were harmed by a hip replacement system that was contaminated, for example, by a lubricant or abrasive that caused an infection after implantation, “that contamination would present a substantial claim for violating requirements that are not ‘concrete’ and ‘product-specific,’ yet which surely are essential for the manufacture of safe and effective medical devices for implantation in the human body.”

The panel said it

recognize[d] the possibility that there may be some room for interpretation of the applicable federal requirements, and it is at least conceivable that a jury deciding a common law claim might apply those requirements more stringently than the FDA intended. That danger is defendants’ best argument in favor of their distinction between general requirements and concrete, product-specific requirements. We are not persuaded. First, the meaning of the FDA’s requirements will present questions of law for the court to decide, not questions of fact for a jury to decide. Second, those questions of law will be questions of federal law, subject to the usual processes for reconciling conflicting views. Third, the proposed distinction between general requirements and concrete, product-specific requirements seems to us more slippery and less workable than its proponents acknowledge. And fourth, for the reasons we have explained above, we believe the proposed distinction cannot be derived from the language of the statutory preemption provision or from its purpose, to provide preemption for medical device manufacturers to the extent they actually comply with stringent requirements of federal law. Plaintiff Bausch’s claims are not expressly preempted by federal law to the extent they are based on defendants' violations of federal law.

To Stryker’s argument that Bausch’s claim that the medical device was “adulterated” must be impliedly preempted because there is simply no state tort duty to manufacture a product that is not adulterated, the judges said: “We disagree. The MDA defines an ‘adulterated’ device as a device ‘not in conformity with applicable requirements or conditions.’ 21 USC 351(h). While there may not be a ‘traditional state tort law’ claim for an ‘adulterated’ product in so many words, the federal definition of adulterated medical devices is tied directly to the duty of manufacturers to avoid foreseeable dangers with their products by complying with federal law. The evidence showing a violation of federal law shows that the device is adulterated and goes a long way toward showing that the manufacturer breached a duty under state law toward the patient.”

Three Years Probation for Guidant on Defibrillators

A Minnesota federal judge has sentenced Guidant Corp. to three years of probation as part of a $296 million plea deal settling federal charges that it failed to report faulty defibrillators. The judge had rejected a similar deal last April.

Federal prosecutors said the company, now part of Boston Scientific, kept important safety information about implantable defibrillator short circuits from FDA before a widespread 2005 recall. As part of the settlement, Guidant pleaded guilty to making false and misleading statements to FDA and failing to report what prosecutors termed a “stealth recall.” The defects have been associated with at least 13 deaths.

FDA Refuses to Drop Preamendments Device Policy

FDA has denied a 2008 citizen petition asking that it withdraw its 1997 policy on preamendment device determinations. The petition, submitted by Richard Trehane of Memphis, TN, argued that the policy lacks legal authority, its implementation violates the U.S. Constitution, it is being implemented more stringently than it was written, it doesn’t reflect FDA’s historical determinations of the preamendment status of medical devices, and it was not created in accordance with notice-and-comment rulemaking.

The agency’s response says the policy describes the information individuals or entities may provide to FDA to demonstrate that a device is a preamendment device—meaning that was in commercial distribution before enactment of the Medical Device Amendments of 1976. The response outlines reasons why FDA does not agree with any of the petition’s complaints about the policy. It says the petition is denied because the policy is supported by the Medical Device Amendments statutory language and legislative history and by FDA’s longstanding policy on demonstrations of commercial distribution and preamendment status as evidenced in a 1978 compliance program guide.

Dental Devices Seized by U.S. Marshals

Carrying out a court order requested by FDA, U.S. marshals have seized all dental devices from Rite-Dent Manufacturing Corp. of Hialeah, FL. An FDA news release in January said that seizure of the products valued at $208,910 followed an agency inspection that found significant deficiencies in company manufacturing processes that could affect the products’ safety and effectiveness.

Seized products included Alginate Impression Material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin Material, Cavity Varnish, Polycarboxylate Cement, and Zinc Phosphate Cement, all used in the practice of dentistry.

FDA said that its inspections of the Rite-Dent facility, most recently last November, revealed continuing significant deviations from the current good manufacturing practice requirements for the products. The most recent inspection also confirmed that the company had not obtained marketing approval or clearance for its Ultra Impression System and also reportedly failed to notify FDA about a correction it made to its Alginate Impression System.

FDA says it had been made aware of these and similar violations during inspections in 2005, March 2010, and again last summer, and had previously sent the company a warning letter in 2005. The news release said the agency recommended that healthcare professionals stop using the Rite-Dent products.


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