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PEDICLE SCREWS -Timeline
Timeline
1960
Harrington Screws
1976
Federal Food, Drug and Cosmetic Act
Medical Device Amendment
1984
510K denied for pedicle screws
Device attachment to spine via pedicles submitted to FDA
1985
IDE Protocols
1990
Safe Medical Device Act of 1990 - established comprehensive system for regulation of medical devices intended for human use
Class I General Controls
Class II Special Controls
Class III Premarket Approval
1992
Breast Implant Settlement
FDA discovered use of pedicle screws outside IDE studies was widespread and that pedicle screw fixation was considered to be standard of care by surgical community
"20/20" Show Broadcast
Philadelphia Court Suit Consolidation
1993
February - FDA requested scientific data
SIMG formed to provide financing for a nationwide study
August - FDA convened Advisory Panel meeting
1994
FDA - Proposed down classing from Class III - II
Class II - Posterior hook - rod fixation devices
Spinal inter laminal fixation
Anterior plate screw cable fixation devices
Bone plates and screws - long bones
Class III - Plates and screws when incorporated into pedicle screw spinal systems
510K granted to Danek - lumbar and sacral fusion using autogenous bone graft in patients with severe spondylolisthesis III/IV with removal of the device after spinal fusion
1995
Physicians' names released to plaintiffs attorneys
1996
NASS & SRS named in numerous law suits
Judges Bechtle & Mazer ruled "a physician is free to use a medical device for an off-label purpose if, in the physician's best medical judgement, he or she believes that the use of the device will benefit the patient."
GAO - "because the pace of medical discovery invariably runs ahead of the FDA's regulatory machinery, off-label use is often on the cutting edge of medical practice and frequently represents 'state-of-the art' treatment."
June: U.S. Supreme Court decides that the federal statute regulating medical devices does not expressly preempt most state law personal injury claims against medical device manufacturers.
September: Judge Bechtle issues the following order:
- dismissed all "omni" complaints without prejudice for lack of subject matter jurisdiction
- dismissed without prejudice all conspiracy and fraud claims on procedural grounds
- gave the plaintiffs until September 30 to re-file
- articulated what any future pleadings must contain to comply with applicable federal procedures
October: Judge DiNubile grants a directed verdict in favor of AcroMed in the first Pennsylvania state bone screw litigation. Judge DiNubile based this decision on the lack of evidence of causation.
December: AcroMed announces that it has entered into an understanding to resolve all product liability claims involving the use of its Variable Screw Placement (VSP) bone screws to achieve pedicle fixation in spinal fusion surgeries. AcroMed creates a $100 million fund to resolve the thousands of claims against AcroMed, its distributors, and all surgeons who have worked with AcroMed in addition to all claims against various medical societies related to the sale and use of AcroMed products.
1997
April: Judge dismissed all claims of conspiracy to defraud the FDA, and dismissed all claims that manufacturers and professional societies committed a tort by conducting the Cohort Study relied upon by the FDA in its proposal to reclassify pedicle screw spinal systems. The Court has: left for federal trial courts around the country consideration of whether, based on each state's law, the manufacturers, professional societies, and certain physicians conspired to fraudulently conceal material information from doctors attending medical seminars, and let stand plaintiffs allegations that physicians with financial ties to, and professional societies involved in seminars supported by, manufacturers are not entitled to First Amendment protection for speech intended to educate other physicians.
May: Judge Bechtle allows defendants to use the Cohort Study in their defense finding no basis in fact for the plaintiffs' charges that surgeons selectively submitted data favorable to pedicle fixation with screws, or that they reported inaccurate information. The course found "that the Cohort Study is based on a methodology that has been generally accepted in the epidemiology community, that had standards controlling its operation and that could be tested".
May: American Association of Neurological Surgeons (AANS) petitions the FDA to issue a final regulation reclassifying pedicle screw systems as Class II devices.
July: AcroMed asks Judge Bechtle to approve its $100 million class action settlement with the plaintiffs; Third Circuit Court of Appeals has agreed to hear appeals relating to Judge Bechtle's refusal to dismiss the so-called "Omni" or conspiracy claims against surgeons, medical societies and manufacturers.
October: Sofamor Danek receives FDA clearance for the CD Spinal System when used as a pedicle screw fixation system with CD screws attached to the non-cervical posterior spine. The CD Spinal System is indicated for degenerative disc disease.
November: Third Circuit Court of Appeals in Philadelphia refuses to review Judge Bechtle's orders declining to dismiss the "Omni" conspiracy claims. The Court said, in essence, that since the federal cases are about to be returned to the districts where they were filed, it would be better to have the remand courts decide the issues.
December: The pedicle screw MDL court has permitted discovery into allegations that a plaintiffs' expert committed perjury or fraud by claiming authorship of reports prepared by an expert witness "broker".
1998
Acromed settlement near completion; Judge Bechtle rules Synthes cannot use statute of limitations as a defense; individual plaintiffs reduced from 3,000 to 2,200
A Houston, Texas jury return a verdict against Sofamor Danek for $414,000. There was no negligence and no punitive damages. The case involved both broken screws and failure of the spine to fuse.
FDA reclassifies Pedicle Screws from Class III to Class II devices.
Federal judge rules that the FDA cannot prevent manufacturers from providing doctors with peer-review journal articles and reference textbooks about off-label uses, or from supporting continuing medical education about off-label uses - as long as certain restrictions are complied with, including that the information is truthful, and both the manufacturer's financial support and the off-label nature of the treatment are disclosed.
