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In Pursuing an ICD Case, States Outperform FDA

Article-In Pursuing an ICD Case, States Outperform FDA

In seeking redress from big device companies, it seems that state attorneys general can achieve faster results than FDA. Is there a political reason behind that discrepancy?


When it comes to enforcing quality system and GMP regulations, FDA can be vicious. This is especially true when its quarry is a small device firm, as some recent cases (TMJ Implants, Utah Medical, Shelhigh, etc.) seem to indicate.

But when push comes to shove with a big, well-heeled company, maybe state attorneys general can get bigger and quicker results. Case in point: a brief and barely noticed August 30 news release from Boston Scientific.

The news release announced that three of the company's subsidiaries, each acquired last year, will pay $16.75 million and admit no liability to end an investigation by the attorneys general of 35 states and the District of Columbia. Up to $1 million of that total will supplement Guidant's warranty program, in order to compensate consumers.

The subsidiaries, now known as Boston Scientific Cardiac Rhythm Management (formerly Guidant Corp.), Cardiac Pacemakers Inc., and Guidant Sales Corp., were accused of knowingly selling implantable cardioverter-defibrillators (ICDs) that were defective.

In addition to the financial payment, the subsidiaries agreed to extend their supplemental warranty program by six months for three ICD models. The models are the Guidant Ventak Prizm 2DR Model 1681, Contak Renewal Model H135, and Contak Renewal 2 Model H155. The divisions also reaffirmed a commitment to implement changes recommended by an independent panel commissioned by Guidant in 2005. Changes include having a patient safety officer and a patient safety advisory board as well as a commitment to communicating product performance issues more effectively.

Contrast this with FDA's approach. Goaded by Senator Chuck Grassley (R–IA) and a May 2005 New York Times investigative report, CDRH opened an official investigation into Guidant defibrillator problems it had known about since early in 2002. The agency then issued public health advisories, ordered a recall, scheduled meetings and inspections, and issued a warning letter in its efforts to address the ICD devices' electrical problems.

An FDA analysis, kept under wraps until discovered as part of private product liability litigation, found the devices were 10 times more likely to fail than Guidant had projected. In April 2007, 12 months after it acquired the three Guidant divisions, Boston Scientific announced that it had settled all FDA issues with Guidant that had been enumerated in a December 2005 warning letter. The letter, in turn, was the result of an inspection the previous August after 73,000 defibrillators had been recalled.

Of course, the state attorneys general and FDA had different goals. The states wanted Guidant to extend its supplemental warranties on the problematic defibrillators, while FDA wanted the GMP issues addressed.

But whatever the cause of action, the devices in question were mostly the same in both cases, and the problems in both cases were manufacturing defects that injured people.

In one case, FDA proceeded slowly while concealing its own discoveries about the devices' weaknesses, and after about six years, quietly closed its books on the matter. In the other, the state attorneys general coalesced and swiftly emerged victorious—with headlines to prove it—after a 28-month effort.

There's a political reality to all of this that should not be overlooked: State attorneys general are expected to go after big companies that hurt people, and get a lot of credit if they succeed. CDRH, beholden to user fees and those who send them in, gets nothing but angst if it tries the same thing. This might explain why it seems easier to target small companies that have no political clout even if their devices haven't hurt anyone.

Perhaps FDA could outsource its device enforcement to the states?

Spineology Cited for Unapproved Device

CDRH has cited Spineology Inc. (St. Paul, MN) for marketing a product called OptiMesh for use in procedures for which the device did not have agency marketing clearance or approval.

OptiMesh is designed to contain granular bone graft materials. The firm is accused of improperly marketing it for surgical treatment of vertebral compression fractures as well as applications requiring structural support, such as kyphoplasty, vertebroplasty, and spineoplasty.

An August 15 warning letter states that OptiMesh does not have clearance for such uses. A 510(k) cleared on November 26, 2003, did not cover it for those applications, the letter says. The clearance issued was for the device's use in maintaining the relative position of bone graft material within a vertebral body defect that does not affect the stability of the relative position and does not include the vertebral end plates. The device was required to bear a contraindication that it cannot be used in patients with instability and that it does not provide structural support. The device was also required to have a black-box warning that its safety and effectiveness for use in fusing the interbody space had not been established.

OptiMesh is considered a device because “it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the body's structure or function.” The FDA warning letter says a company Web site and DVD promoted OptiMesh for an intended use that requires either an additional 510(k) or premarket approval submission.

Spineology was told to take prompt corrective action and to stop disseminating promotional materials for OptiMesh that included the unapproved intended uses. The company was given 15 days to submit a list of all the promotional materials being discontinued.

Hepatitis C ‘Lookback' Guidance

FDA has issued a guidance for industry with recommendations for complying with regulations for any establishment that collects blood.

The guidance, titled “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV, covers background, definitions, look-back requirements, blood and blood components intended for manufacture into noninjectable products, and references.

It also notes that although multiple layers of safeguards are used to reduce the risk of transmitting infection through blood transfusion, contaminated blood is still a possibility. This is because a person may donate blood early in infection, during the period when the viral marker is not detectable by a screening test (the window period). Although transfusion-transmitted infections account for a very small proportion of HCV infections, it is possible to identify and “look back” at prior donations that might have been collected during that period.

Download the guidance at

FDA Finds Issues at North American Medical

An FDA inspection at North American Medical Corp. (Marietta, GA) last year found quality system, medical device reporting, and premarket submission problems involving the company's manufacture of the Accu-Spina and Da Vinci X10 spinal devices. The inspection revealed that the company had failed or refused to furnish material or information about the devices required under the medical device reporting regulation. The warning letter said the company had failed to conduct an investigation of each device-related adverse event and to evaluate the cause of the events. FDA found that the company's response to its concerns regarding this issue was inadequate.

The warning letter also said that the company had not obtained required marketing clearance or approval for the Da Vinci X10 with a software control or the Accu-Spina with software and a vibrator/heater accessory. FDA said its records indicate that the Da Vinci X10 had a 510(k) clearance without software and the Accu-Spina was cleared without software or the accessory.

The company was told to take prompt action to correct the violations and notify the district office of steps taken, and explain how the firm plans to prevent these or similar violations from occurring again.

Violations at North American Medical

A warning letter issued from FDA's Atlanta district office says quality system violations cited in an FDA-483 at the end of an inspection in 2006 included:

  • Failure to document corrective and preventive action activities. That included investigating causes of nonconformities, verifying or validating corrective actions, implementing corrective and preventive actions, and disseminating information about quality problems or nonconforming product to responsible parties.
  • Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints.
  • Failure to document justification for use of nonconforming product and the signature of individuals authorizing such use.
  • Failure to perform testing of a design using production units under actual or simulated use conditions.
  • Failure to document results of design verification, as well as the method, date, and individuals involved in testing, in the design history file.
  • Failure to document design output in terms that allow an adequate evaluation of conformance to design input requirements.
  • Failure to establish a design and development plan.
  • Failure to document device identification and control numbers in the device history record.
  • Failure to document acceptance test results of in-process product.

FDA said a response from the company dated November 9, 2006, did not adequately address each of these issues.

B. Braun Syringes Recalled

FDA said in September that B. Braun Medical Inc. (Bethlehem, PA) had recalled some of its normal saline flush syringes due to an increase in customer complaints over particulate matter in the saline. A company news release said introducing particulate matter into the bloodstream may result in phlebitis or damage to vital organs. To date, the company said, it had not received any patient injury reports associated with the issue.

The recall involved 33,000 units of normal saline 3-ml-in-12-ml syringes designated by product code 513584 and 1.2 million units of normal saline 10-ml-in-12-ml syringes designated by product code 513587. In each instance, the lot numbers end in “SFR.”

B. Braun said the particulate matter has been identified as a medical-grade silicone. It said that although the silicone is an expected, biocompatible component of the syringes and routinely used in medical devices, the visible silicone particulate matter in these syringe lots may pose a health risk.

Guidance on Analyte-Specific Reagents

FDA has published a guidance for industry and FDA staff titled Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions to clarify regulations covering such reagents.

“FDA is providing this guidance in order to eliminate confusion regarding particular marketing practices among ASR manufacturers,” the guidance says. Companies are being informed through the guidance that FDA views these practices as inconsistent with marketing an ASR:

  • Combining, or promoting for use, a single ASR with another product such as other ASRs, general-purpose reagents, controls, designated laboratory instruments, or software.
  • Promoting an ASR with specific analytical or clinical performance claims, instructions for use in a particular test, or instructions for validation of a specific test using the ASR.

The guidance may be accessed at

Louisiana Fertility Center Cited by FDA

A June FDA inspection of The Fertility Center at Ochsner (Jefferson, LA) discovered significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P), according to a recent warning letter issued by FDA's New Orleans district office. Deviations documented on the FDA-483 included:

  • Failure to test a specimen from an anonymous or directed donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract, including Chlamydia trachomatis and Neisseria gonorrhea.
  • Failure to determine and document eligibility of an anonymous or directed donor of reproductive cells or tissue.
  • Failure to screen an anonymous or directed donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.
  • Failure to collect a donor specimen for testing for relevant communicable diseases within 30 days before oocyte recovery or up to seven days after recovery.
  • Failure to retain documentation associated with communicable disease testing, donor screening for communicable diseases, and donor eligibility determination for donors of reproductive cells or tissue.
  • Failure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other requirements of applicable regulations.

The district office said a new written procedure on accepting egg donors submitted as a corrective measure did not conform to regulatory requirements. The company was told to take prompt action to correct the deviations and prevent their recurrence. A response describing and documenting steps taken to comply and a time frame for steps still to be taken was due within 15 working days.

Copyright ©2007 Medical Device & Diagnostic Industry
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