Brown v. Depuy Spine, Inc.
| Citation | 2007 MBAR 041 |
| Decision Date | 09 April 2007 |
| Docket Number | BRCV200600208 |
| Parties | David Brown v. DePuy Spine, Inc.; Richard Greenwood et al.[1] v. DePuy Spine, Inc.; Mary Anne Rogerio et al.[2] v. DePuy Spine, Inc.; Allyson Fried-Cain et al.[3] v. DePuy Spine, Inc. |
| Court | Superior Court of Massachusetts |
As-is Docket Number: BRCV2006-00208
Other Docket Numbers: BRCV200600209, BRCV200600210, BRCV200600630
As-is Other Docket Numbers: BRCV2006-00209, BRCV2006-00210 BRCV2006-00630
Judge (with first initial, no space for Sullivan, Dorsey, and Walsh): Garsh, E. Susan, J.
Each of the plaintiffs has filed a products liability action against DePuy Spine, Inc. ("DePuy") seeking to recover damages for injuries allegedly caused by the Charité artificial spinal disc manufactured by DePuy. This matter is before the court on DePuy's motions for summary judgment predicated upon the position that all of the plaintiffs' state law claims are preempted by the Medical Device Amendments, 21 U.S.C. §§360c et seq. to the Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq. For the reasons discussed below, DePuy's motions for summary judgment are DENIED.
Viewed in the light most favorable to the plaintiffs as the non-moving parties, the undisputed facts revealed by the summary judgment record are as follows.
DePuy is the manufacturer of the Charité disc, an artificial intervertebral disc implanted in patients to replace a diseased or damaged intervertebral disc. The Charité disc is classified as a Class III medical device by the United States Food and Drug Administration ("FDA") pursuant to the Medical Device Amendments, 21 U.S.C. §§360c et seq., to the Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq. The first generation Charité disc was developed in the 1980s by professors at the Orthopaedic University Charité Hospital in Berlin, Germany. A German manufacturer, Waldemar Link GmbH & Co. ("Link"), began the lengthy process of bringing the Charité disc to market in the United States under the FDA's regulatory oversight by submitting an Investigational Device Exemption ("IDE") application to the FDA on December 2, 1999, to develop clinical data to support an application for Premarket Approval ("PMA"). Only through an FDA-approved IDE can a manufacturer conduct clinical testing on a Class III medical device in the United States. 21 Code Fed. Regs §§812.1-812.150. Link's IDE application consisted of more than one thousand pages, which included the Charité disc's proposed design, an investigational plan for testing the device, the results of pre-clinical trials conducted abroad, specifics about the device's manufacture and labeling, monitoring for the proposed trials, information about Independent Review Board and investigators who would oversee the investigation, and samples of informed consent forms for potential patients in the clinical trials. The plaintiffs vigorously dispute whether the IDE application accurately and fully disclosed material information from the pre-clinical trials and clinical studies.
On December 29, 1999, the FDA conditionally approved the IDE application, notifying Link that it needed to submit information correcting certain deficiencies. On October 5, 2000, Link submitted the last of its supplemental responses to correct the identified deficiencies. On October 30, 2000, the FDA issued final approval for the Charité disc IDE. Investigational testing of the disc then commenced at fifteen approved institutions. On December 11, 2000, an Institutional Review Board approved a "Consent Form for Research" regarding the Charité disc. The Consent Form advised prospective patients that they had been selected to participate in the study because they had been suffering from lower back pain related to a disc in their back. The Consent Form further advised patients that they would be randomly assigned to receive either the "investigational" Charité disc implant or the FDA-approved spinal fusion BAK Cage, and that they could withdraw from the study at any time without penalty. The Consent Form stated that the Charité disc might not be of any benefit and set forth possible risks associated with the study, also noting that there were risks that could not be predicted and such risks might be unpredictable in both nature and severity.
Near the end of the IDE testing, Link submitted a PMA application to the FDA to obtain authorization to market the Charité disc in the United States. Link submitted Module 1, covering bench testing, on March 12, 2003. Link submitted Module 2, covering manufacturing processes, on April 17, 2003. On June 3, 2003, DePuy acquired all product rights to the Charité disc, including Link's submissions to the FDA, and rewrote and resubmitted Module 2.
On February 13, 2004, following four years of clinical study in the United States, DePuy filed the final module to its PMA application, covering clinical studies, safety and effectiveness data, bibliography, and proposed labeling. DePuy's complete PMA application consisted of more than 7,000 pages and included descriptions of the design of the device; technical drawings; manufacturing processes and procedures for the device; quality control procedures; and analysis of data from clinical studies. The PMA application also included a draft package insert to accompany the device after sale and to be available to the implanting surgeon. The draft package insert contained a description of the Charité disc; indications for use, precautions, information on adverse events, warnings, and contraindications; data from the clinical studies and device retrieval; and instructions concerning the proper placement of the disc during surgery, correct and stable joining of the device components, correct selection of proper implant size, and proper care of the device prior to implantation. The draft package insert also provided warnings and precautions related to the performance of the surgical procedure with regard to the risks of serious hemorrhage and neurological damage. The plaintiffs vigorously dispute whether DePuy's PMA application satisfied FDA regulations and whether it fully and accurately described all material information concerning the Charité disc. On March 29, 2004, the FDA accepted DePuy's PMA application for filing after determining that it was sufficiently complete to permit substantive review.
The FDA began a lengthy scientific review of DePuy's PMA application, assigning a biomechanical engineer as lead reviewer, to be assisted by an orthopedic surgeon and statisticians from the Officer of Science and Technology. Their work was further reviewed by FDA's Deputy Division Director, who is a mechanical engineer; the Division Director, who is a doctor; and the Director of the Office of Device Evaluation, a Ph.D. As part of the FDA review process, DePuy had numerous exchanges of correspondence with the FDA, including matters such as requests for additional information, supplemental data analyses, and updates of clinical information. Again, the plaintiffs vigorously dispute whether DePuy accurately, completely, and candidly responded to FDA requests for information. FDA then utilized an advisory panel of independent medical, scientific, and engineering experts to study DePuy's PMA application. The FDA advisory panel held an extensive public hearing on the Charité disc PMA application, which included discussion on the disc's clinical history in Europe and issues such as efficacy, durability, post-operative range of motion, and side effects. The advisory panel voted to recommend the PMA be approved with conditions.
The FDA then required DePuy to update the IDE clinical data submission based on all patients seen between the database closure date of January 2004 and August 2004. The plaintiffs dispute that DePuy completely and accurately updated this data. The FDA instructed DePuy on certain conditions of approval, including reviewing the content of an FDA-required surgeon training program and finalizing the requirements of a post-approval study to collect long-term safety and effectiveness data. With respect to product labeling, DePuy prepared a draft text for the package insert, surgical technique brochure, and patient information brochure. The FDA required changes in the wording, content, and format of all three, which DePuy made, and FDA then approved the text of each component of the Charité disc's final labeling. The FDA conducted multi-day plant inspections at each of DePuy's contract manufacturing facilities in the United States and Germany in the summer of 2004 and again in 2005. The FDA found DePuy's manufacturing facilities to be in compliance with the Quality System Regulation, 21 Code Fed. Regs. §§820.1-820.250.
On October 26, 2004, the FDA's Office of Device Evaluation in the Center for Devices and Radiological Health provided notice of approval of DePuy's PMA application. The Notice of Approval states that the sale, distribution, and use of the Charité disc are restricted to prescription use in accordance with 21 Code Fed. Regs. §801.109. The Notice of Approval also imposes certain post-approval conditions on DePuy, including a post-approval study to collect long-term safety and effectiveness data. The Notice of Approval requires DePuy to submit annual reports with data obtained from all subjects enrolled in the post-approval study, and it requires DePuy to retrieve implants, when possible, for failure analysis of any patient implant that fails or is removed. The Notice of Approval states:
CDRH does not evaluate information related to contract liability warranties, however you should be aware that any such warranty statements must be...
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