The precedents which have emerged in mass tort litigation over the past several years have conditioned the plaintiffs bar to hungrily scan every new medical device for chinks in the proverbial armor, sometimes regardless of the therapeutic indications, safety or efficacy of the product. In chronicling the past national lawsuits which have aspired to vilify and obliterate various advances in medical technology, the Dalkon Shield, Norplant devices and breast implant cases come immediately to mind.
Thinking ahead, no one can dispute that fen-phen and Redux are to be the future focus of profitable multidistrict litigation. Where there is medical or technologic advancement, and at least one human subject to cast in the role of damaged figurehead for the inevitable trials and errors that accompany all progress, we can be assured that "some" lawyers will always seek a way to capitalize (and cash in) on the controversy.
Thus it came as no surprise to learn that a similar fate awaited those who endeavored to research and develop improved spinal fixation implant devices for the treatment of orthopedic patients suffering from chronic pain and instability of the spine. The onset of investigational, surgical trials to examine the safety and efficacy of these exciting new devices elicited an immediate corresponding response, in the form of lawsuits which began on one side of the country and quickly proliferated to the other, creating a morass of state and federal issues which have yet to be fully sorted out.
The current group of trial lawyers ordained to prosecute spinal implant cases has benefited from the historical lessons learned in prior mass tort litigation. They have cultivated every possible liability theory at both the state and federal level, sued every physician, hospital and manufacturer even remotely connected with the devices, and they have directed a massive advertising campaign toward the growing alumni of spinal patients in an effort to recruit suitable victims to support their lawsuits. They have even amassed their brethren across the country into a distinctive cult known as the "PLC" (Plaintiffs' Legal Committee), in order to pool their collective resources, experience and evidence.
The same time-honored themes which drove prior mass tort litigation involving medical products have been revisited in the current spinal implant device litigation: lack of informed consent, improper human experimentation, medical negligence and strict products liability. However, those now waging war against spinal fixation devices have added two relatively novel legal theories to their arsenal, with their obvious purpose being to construct a basis for punitive damages: physician-manufacturer conspiracy through off-label use, and intent to defraud the FDA.
To understand why there is currently more emphasis on these issues than on the more traditional arguments concerning lack of informed consent and medical causation of harm, one need only examine the differences between the populations of "victims."
In stark contrast to the unfortunate recipients of faulty contraceptives and leaky silicone breast implants, some of whom suffered from the use of the medical device in question, many of the current spinal implant litigants can offer no empirical evidence of harm from the device, other than perhaps a disappointing lack of improvement from their preoperative condition. It is indeed significant to note how many cases have been filed by plaintiffs who are, for all practical purposes, relatively uninjured but who have been talked into righteous indignation.
In order to succeed with a clientele unable to boast that the device in question left them with heart-wrenching illnesses or grotesque injuries, spinal implant antagonists have been forced to devise a way to arouse the ire of the average American jury without the usual parade of grisly "Kodak moments" at trial.
Thus evolved arguments targeting the alleged unethical and insidious conduct of the orthopedic surgeon and his partner-in-crime, the spinal fixation implant manufacturer. That a physician could intentionally dupe his unsuspecting patient into accepting an experimental device, merely to increase the value of his stock in the implant company, would surely devastate the average juror who places blind faith in his doctor. That a manufacturer would knowingly allow and privately encourage physicians to use its FDA approved devices in off-label, unapproved ways, for the purpose of circumventing FDA regulations and increasing its profits, would certainly incite even the most temperate fact finder to outrage.
The new argument goes, if a jury can be trained to focus on these sexy, provocative issues at trial, then perhaps they will overlook the absence of a truly injured plaintiff. If they can be convinced that all medical progress is basically conceived from the avarice of physicians and inventors, and that no patient is capable of giving a truly informed consent to a new procedure in the presence of such conspirators, then they will surely award punitive damages, which will offset the lack of objective general and special damages that the plaintiff can prove at trial.
To borrow a phrase, this type of thinking may seriously underestimate the intelligence of the average American jury. A recent jury trial we were involved in Ventura, Calif. offers a poignant illustration of how the plaintiff's counsel failed to ignite the jury's sensibilities, despite having had the benefit of full access to the PLC's vast reservoir of information, and the trial court's latitude in allowing plaintiff to present extensive FDA regulations and communication, which had routinely been excluded by other state trial courts.
In Dolan v. Advanced Spine Fixation Systems, Inc. et. al., No. 150677, (Calif. Super., Ventura Co.), the plaintiff, Robert Dolan, was a Naval electrician in his mid-thirties who underwent a laminectomy and fusion at L4-5 which involved the insertion of a spinal fixation implant device. He later required removal of the hardware and sued the orthopedic surgeon and the manufacturer of the device for compensatory and punitive damages.
FACTS
On May 24, 1989 and February 19, 1990, plaintiff Robert Dolan, suffered injuries to his lower back while in the course and scope of his employment for the Navy at Port Hueneme Naval Base, Oxnard, Calif. He was first evaluated by board certified orthopedic surgeon Dr. Russell Nelson of the Channel Islands Orthopedic Group on June 14, 1989 for his lower back complaints. Mr. Dolan was diagnosed as having grade 1 to 2 spondylolisthesis of L5, and moderate to severe degenerative disc disease at L4/L5 and L5/S1. He initially underwent conservative treatment, which did not relieve his pain complaints. He therefore eventually underwent back surgery on August 20, 1990.
The procedure involved an L4-S1 posterior spinal fusion using Selby 1 spinal instrumentation, manufactured by Advanced Spine Fixation Systems, Inc. He also underwent an L5 laminectomy with bilateral L5 nerve root decompression, and right posterior iliac crest bone grafting. The Selby 1 device had been approved by the FDA for marketing and distribution, and involved the placement of bone screws in the sacrum. However, during the Aug. 20, 1990 surgery, Dr. Nelson elected to modify the configuration of the device, placing the bone screws in the lumbar vertebrae at L4 and the sacrum along with the insertion of a cross-bracing rod. The resultant design was one similar to the Wiltse System, in investigational device, also manufactured by Advanced Spine, which had not been approved by the FDA for commercial distribution. (The Selby 1 kit contained various components which, if the surgeon was so inclined, could be used to configure the device into either a Selby 1 configuration or modify in into a Wiltse configuration.)
Mr. Dolan claimed that, as a result of the surgery, his lower back complaints worsened. On March 23, 1992, he underwent a second surgery to explore the fusion and remove the spinal fixation instrumentation. In the operative report, it was noted that there was a solid fusion from L4 to S1. However, Mr. Dolan continued to have back problems after the second surgery and removal of the hardware.
He was subsequently diagnosed with failed back syndrome. After a short course of pain management treatment at St. John's Regional Medical Center, he was referred to Dr. David Moll, who essentially allowed Mr. Dolan to become addicted to narcotics to control his pain, including morphine and methadone. As of the time of trial, Mr. Dolan was continuing to work at the Naval Base, maintaining a light duty status while taking a daily regimen of morphine and methadone.
Mr. Dolan claimed that he now suffers from extreme lower back pain due to failed back syndrome caused by the implant surgery. He maintains that he can only work by using methadone and morphine. He further claimed that he required a bilateral mastectomy due to the enlargement of his breasts caused by the long-term use of narcotics. Dolan sought past and future medical expense of approximately $125,000, loss of earning capacity of approximately $350,000, general damages of $2.4 million, and punitive damages in the "millions."
THE PLAINTIFF'S ATTACK
The attorneys for plaintiff attempted to ignite the jury's sensibilities in this case by making the following contentions, which mirrored the PLC's manual on "How to prosecute a case against Advanced Spine." The court permitted into evidence virtually every letter written by the FDA to Advanced Spine from 1986 onward including letters suggesting violations of the Federal Regulations. Plaintiff was allowed to use the letters as evidence of statutory violations in support of his negligence per se and punitive damage claims.
- Plaintiff first argued that the Selby System spinal implant device used by Dr. Nelson in Plaintiff's surgery was investigational and, therefore, its distribution by Advanced Spine was a violation of State and Federal regulations, and constituted an unauthorized clinical investigation and experiment for which the company had been previously cited by the FDA (i.e., 500 unauthorized experimental surgeries).
- Then plaintiff argued that Advanced Spine defrauded the FDA by obtaining clearance to market a spinal implant device, the Selby System, which was in reality designed for surgeons to easily modify into an "investigational implant" (that is, experimental use of bone screws in the lumbar pedicles); had the FDA known this, it would never have given clearance to promote and distribute the Selby system.
- Under the guise of clinical investigations, plaintiff claimed that Advanced Spine trained surgeons how to use the spinal implant device in an investigational manner, and then illegally promoted that unlawful use by encouraging the doctors, in their private practices, to modify the Selby System into an investigational implant.
- Plaintiff then asserted that Advanced Spine failed to adequately warn "the use" of the risks associated with implantation of the device, especially in connection with off-label modifications where bone screws were used in the lumbar pedicles.
- Plaintiff next argued that the product warnings issued by Advanced Spine were nullified by its illegal promotion and marketing activities, which abrogated the learned intermediary doctrine concept and resulted in the absence of any effective warning being given.
- The next attack was that the Selby System implant device was shipped with non-approved component parts, which were used by Dr. Nelson in Plaintiff's surgery. The distribution of the system with these non-approved component parts violated Federal regulations, was beyond the scope of Advanced Spine's authorization to distribute, and constituted illegal marketing of an investigational device for which the manufacturer was cited by the FDA.
- As to the co-defendant surgeon, plaintiff contended that the laminectomy and fusion surgery was not medically indicated; Dr. Nelson should not have recommended it and plaintiff should have been continued on a conservative course of treatment.
- Plaintiff also asserted that defendant Dr. Nelson failed to fully disclose to plaintiff all of the risks and benefits of the surgery, including the fact that the procedure was experimental and investigational.
- Plaintiff then urged the jury to find Advanced Spine responsible because it failed to ensure (1) that Dr. Nelson disclosed the experimental and investigational nature of the surgery and (2) that the plaintiff signed a comprehensive written consent, setting forth all of the risks and benefits.
- Plaintiff pointed out that defendant Dr. Nelson failed to disclose to plaintiff that his medical partner James Thomas, M.D., owned stock in Advanced Spine and was on the Board of Directors, and that Dr. Nelson's group had failed in its attempt to purchase stock in the company several months before plaintiff's surgery.
- Finally, using these contentions along with the implication of greed and avarice, plaintiff accused Advanced Spine and Dr. Nelson of being in a conspiracy to implant patients with investigational devices without disclosing the fact to them, so that the company would profit and issue stock options to the doctor and his group. With righteous indignation, plaintiff contended that Advance Spine's fraud and deceit was malicious and in conscious disregard of the rights and safety of plaintiff and others, and therefore, punitive damages were warranted.
DEFENDANT'S COUNTER-STRIKE
Banking on the jury's common sense and the belief that they want to see the advancement of medicine and science utilized in medical care and treatment, the defense contended that:
- Advanced Spine first argued that the Selby System, the spinal implant device utilized in Plaintiff's surgery, was not investigational and its distribution was in conformity with State and Federal regulations; its use by Dr. Nelson was thus not investigational or experimental.
- Advanced Spine then showed it had submitted to the FDA a comprehensive application, with a lengthy history about pedicle screw fixation and a detailed description of the Selby device and its component parts, in support of its request to distribute the Selby System and the FDA's subsequent clearance to commercially market the Selby System was with full knowledge of its intended uses and possible modifications by the surgeons.
- With their regulatory experts, the doctor and the manufacturer asserted that at the time it gave market clearance, the FDA knew the "kit" for the Selby System contained multiple screws and rods in different sizes which could be modified by the surgeons into a construct similar to an investigational implant; the FDA considered this possible use by the surgeons as a permissible off-label application pursuant to its own internal policy memoranda.
- Advanced Spine denied it used clinical investigations or "product champion" surgeons to illegally train doctors or to promote and market the Selby System as a device to the "off-labeled" by modifying it into an investigational implant by the physicians in their private practices; rather the spinal surgery standard of care for the last several years called for such modifications (viz. The implantation of bone screws in the lumbar pedicles in back fusion surgeries).
- It was then pointed out to the jury that spine surgeons routinely modified all of the available spinal implant devices by placing bone screws in the lumbar pedicles because such use greatly enhanced the device's safety and effectiveness and improved the success rate of back fusion surgery. Therefore, Advanced Spine was under no duty to recall or restrict the distribution of the Selby System despite its awareness that the modifications resulted in an allegedly "investigational implant" similar to the Wiltse System.
- Advanced Spine showed that the product warnings strictly complied with FDA protocol which specifically prescribed the language to be used and thus these warnings were not nullified by marketing or promotional activities and the learned intermediary defense was not abrogated.
- The manufacturer admitted that cross-bracing parts, which improved the safety and effectiveness of the device, were included in the Selby System used in plaintiff's surgery. Advanced Spine argued that such components were lawfully used because they had been identified in the original application to the FDA for clearance to distribute and other systems included similar componentry.
- Dr. Nelson claimed that he and other spine surgeons could lawfully modify spinal implant devices, because the FDA does not regulate the practice of medicine, including "off-label" practices by physicians. The laminectomy and back fusion surgery with spinal instrumentation were indicted and medically justified.
- Dr. Nelson, who was well-versed in the risks and benefits of spinal implant devices and the ramifications of modification off-label use, then acknowledged he was responsible for consenting the plaintiff, not Advanced Spine.
- Both defendants contended, apart from the fact that Dr. Nelson properly consented Plaintiff for surgery, that plaintiff would have consented to the surgery regardless of whether or not he knew the investigational status of the device when bone screws were used in the pedicles and/or regardless of the ownership interest in and official position held by Dr. Nelson's partner in Advanced Spine, Dr. James Thomas.
- Finally, the defendants maintained that Mr. Dolan's failed back syndrome and narcotic addition were not caused by the Advanced Spine implant device and Advanced Spine defiantly contended that there was no basis whatsoever for punitive damages.
It is quite possible that had the defendant Dr. Nelson obtained a written consent which disclosed the investigational issues involving pedicle screws, or for that matter had the hospital obtained such a consent, this particular lawsuit may never have come to trial.
COMMENTS
The trial lasted 23 days. After deliberating for eight hours, the jury returned defense verdicts in favor of both defendants. As to defendant Dr. Nelson ---negligence: 10-2 and informed consent: 9-3. For defendant Advanced Spine---negligence: 10-2; fraud: 11-1; and negligence per se: 11-1.
After speaking with the jurors, we think the Dolan jury rejected the suggestion by plaintiff (and the PLC) that he was an unwitting victim of unapproved human experimentation. The jury was also unwilling to subscribe to the PLC's notion that, because the physician held stock in the company that manufactured the device, he recommended the surgery for other than legitimate medical reasons.
According to the jurors, they did not interpret the manufacturer's occasional lapses in regulatory compliance as a basis to assume a conspiracy to defraud the FDA; to the contrary, they seemed to feel that the FDA contributed to those lapses by its own internal, administrative deficiencies.
Their verdict seemed to demonstrate a measure of public skepticism as to the FDA's proficiency in regulating drugs and medical devices. This is significant because it suggests that: juries still believe in medicine and science; they respect medical progress and, when it is explained to them, they understand and accept it; they are open to promotion of medical products which aid in the healing process; they want to see the performance of advanced surgical procedures by capable surgeons; and, they feel that the FDA may, at times, impede this process.
Thus, in this case, the PLC's plan of targeting the unethical orthopedic surgeon and his partner-in-crime, the greedy and deceitful spinal implant manufacturer, was an unsuccessful tactic. For this verdict suggests that, even in the face of sexy and provocative issues, an intelligent jury will ultimately focus on the objective medical and factual evidence. In light of this, we submit that the PLC's philosophy for prosecuting spinal implant litigation may seriously underestimate common sense and values of the jury.
*article courtesy of Stephen L. Hewett of Hewett & Prout.