Originally Published January 2001
MEDICAL DEVICE REPORTS
Anthony G. Brazil, Matthew L. Marshall, and Michele L. Abracen
In the normal course of business, medical device manufacturers routinely submit medical device reports (MDRs) to FDA whenever they become aware of the probability that their devices may have caused or contributed to a patient death or serious injury or illness. The forms used by many companies contain language similar to the following: "Submission of this report does not constitute an admission that medical personnel, the user facility, the distributor, the manufacturer, or the product caused or contributed to the event described herein." Some manufacturers also include a statement indicating that MDRs must be submitted before complete information has been obtained by the company and, therefore, do not constitute an admission of fault. For example, one medical device manufacturer includes the following preliminary statement:
This report may be required by medical device reporting regulations contained in 21 CFR section 803. These regulations are vague in a number of respects and subject to different interpretations. Moreover, these regulations require us to make a decision on reporting before having complete information, including our own analysis of returned products. Thus, our decision to file this report does not reflect, nor may it be used to support, a conclusion that the report constitutes an admission that the device, or its components, caused or contributed to the reportable event.
While such statements may appear to limit the use of MDRs in potential product liability lawsuits, these disclaimers often provide little more than a false sense of security. Several courts across the country have already allowed adverse reports to be presented in civil actions, and, as the Internet renders such reports instantly accessible, plaintiffs' attorneys will undoubtedly continue campaigning for their admissibility at the time of trial. (The Manufacturer and User Facility Device Experience—or MAUDE—Web site, enables all interested parties to search for adverse reports pertaining to medical devices by typing in key words, the name of a manufacturer, or the name of a device. All searches are free of charge.)
Given these trends, manufacturers need to stay well-informed regarding their product liability exposure. This article addresses several key issues, including the reasons certain courts have deemed adverse reports admissible, the confidentiality of information contained in MDRs, the possible grounds for courts to exclude MDRs from civil litigation, and the ability of plaintiffs' attorneys to use other documents as evidence of adverse reactions to medical devices. Finally—and perhaps of most importance to manufacturers—methods for limiting liability in lawsuits based upon adverse reports are suggested.
COURT RATIONALES FOR ADMITTING ADVERSE REPORTS
In an effort to sway a jury and obtain a verdict against a medical device company, plaintiffs' attorneys may try to present MDRs submitted by the manufacturer— or other reporters such as user facilities, distributors, etc.— to FDA as evidence in civil litigation. Despite the disclaimers and additional statements often included on MDR forms, some courts have ruled adverse reports are admissible for certain specific purposes: (1) to establish that the company knew its product was associated with a particular risk but failed to provide consumers with a warning of that risk, (2) to assist a jury in assessing punitive damages, and (3) to explain the basis for an expert's opinion presented at the trial.
At this time, there are few existing court rulings on this topic; however, the majority of the published decisions appear to support the admissibility rather than the exclusion of adverse reports. While the case law cited below may not apply in any given jurisdiction, the reasoning contained therein will probably be used by plaintiffs' attorneys to argue for the admissibility of such reports in many future product liability cases.
Reports Admitted to Show Knowledge and a Duty to Warn. In most cases where a court has allowed plaintiffs' counsel to introduce evidence of adverse experience reports, it has done so not because the reports constituted definitive evidence of liability on the part of the manufacturer, but rather because they might show that the company knew there was a particular risk associated with its product but failed to provide a consumer warning. The following examples are illustrative of lawsuits that involved this failure-to-warn theory.
In the case of Worsham v. A.H. Robins Company, Inc. (734 F.2d 676, 1984), the plaintiff, Margaret Worsham, had been wearing a Dalkon Shield intrauterine device (IUD) for five years when she went to an emergency room and was diagnosed with pelvic inflammatory disease. Shortly thereafter, her condition worsened and she had to undergo a complete hysterectomy. Worsham subsequently filed a product liability action in Florida against A.H. Robins, the manufacturer of the IUD.
The contraceptive device featured an exposed string that facilitated its removal and allowed the wearer to verify that it was in place. This string was alleged to have a "wicking tendency" that allowed bodily fluids and bacteria to travel to the wearer's uterus, where they could cause an infection.
The plaintiff's attorney sought to have 10 adverse reports filed by Robins introduced at trial on the grounds that they addressed the issue of whether the manufacturer knew there were problems associated with its product and therefore should have taken action to notify consumers of those risks. In this case, the trial court allowed such evidence to be introduced for this limited purpose. Based in part on the 10 reports, the jury found for the plaintiff and awarded her $2.5 million in compensatory damages and $1 million in punitive damages. Although these monetary amounts were eventually reduced, Worsham was able to obtain a $1 million judgment.
Golod v. Hoffman La Roche (964 F. Supp. 841, 1997), decided in New York state, deemed adverse reports submitted to FDA by a pharmaceutical manufacturer admissible for the purpose of establishing knowledge and a duty to warn. In this case, the plaintiff took a drug called Tegison from 1984 to 1990 to treat her severe psoriasis. Although the package insert began warning of "adverse ocular effects" in 1986, the plaintiff filed suit against Hoffman after she developed permanent blindness in her right eye.
The defendant filed a motion for summary judgment arguing, in part, that it had not breached its duty to warn of known or knowable risks since it had not known of the serious, irreversible, ophthalmic effects associated with Tegison when the plaintiff began taking it. In opposing the motion, the plaintiff's attorney submitted adverse experience reports and an FDA printout summarizing reports of adverse reactions. The reports and the FDA printout were deemed admissible evidence for purposes of opposing the motion for summary judgment. In its ruling, the court explained that although such documents could not be used to establish that the drug actually caused the plaintiff's blindness, the reports were pertinent to establishing that the defendant knew during the relevant time frame that there were serious ophthalmic risks associated with the use of its product and thus should have provided a warning. Although this case concentrated on the admissibility of adverse drug reports for purposes of opposing a motion for summary judgment, it is nevertheless significant because it may be used to argue that comparable evidence should also be admitted during trial and in cases involving devices.
In Palmer v. A.H. Robins Company, Inc. (684 P.2d 187, 1984), the plaintiff filed a lawsuit in Colorado against the manufacturer of the Dalkon Shield IUD after she had experienced a septic abortion. During the trial, Palmer's attorney sought to introduce adverse reaction reports as evidence of the manufacturer's knowledge of adverse consequences associated with the use of its device. A significant component of the plaintiff's claim was that, by failing to eliminate known dangers or to give warnings of them, the manufacturer had prevented the plaintiff and her physician from making an informed decision on the use of the IUD. Even though the MDRs in question involved injuries other than septic abortion, such as pelvic inflammatory disease, the court held that they were admissible because they constituted legally relevant evidence on the issue of the manufacturer's knowledge of the potentially dangerous character of the device. The jury subsequently awarded Palmer $600,000 in compensatory damages and $6.2 million in punitive damages.
Reports Admitted for Purposes of Punitive Damages Assessment. Some courts, while generally unwilling to admit adverse reports as evidence of manufacturer liability, will allow MDRs to be considered for the purpose of determining an appropriate punitive damages award after liability is established. For example, Hern v. Intermedics (U.S. App. Lexis 1630, 2000), a California product liability case, was bifurcated into liability and damages phases. During the liability phase, the plaintiff was prohibited from introducing MDRs to show that the defendant had made submissions to FDA pertaining to its device's susceptibility to failed batteries. The court indicated in that ruling that if liability was established, however, it would entertain a request for admission of the MDRs to assess the amount of punitive damages warranted. Although the plaintiff in this case did not renew the request for admission of the reports during the trial's damages phase, the ruling is important because it establishes the possibility of the admission of adverse reports if liability can be established.
In another case, a court ruling in New York noted, with respect to prescription drugs, that if a manufacturer learns of a danger associated with its product after putting it on the market but does nothing to remedy the situation and "deliberately closes its eyes," punitive damages may be warranted (Roginsky v. Richardson–Merrill Inc. [378 F.2d 832, 1967]). Therefore, plaintiffs' attorneys can be expected to increase their arguments for the admissibility of adverse experience reports once liability is established in order to show that a defendant took insufficient steps to remedy or warn of a risk associated with its product.
Reports Admitted via Expert Testimony. Some courts also have allowed adverse reports to be admitted at trial during expert testimony. Generally, expert witnesses may base their opinions on any and all matters they deem significant, even if such evidence would ordinarily be inadmissible. Thus, even if a court prevents a plaintiff from presenting actual MDRs as evidence, it may allow an expert to testify that his or her opinion is based upon reviewing FDA submissions involving the device in question. For example, in Benedi v. McNeil (66 F.3d 1378, 1995), a Virginia case in which the plaintiff claimed liver damage, an expert testified that he believed the manufacturer of Tylenol should have warned of the danger of mixing its product and alcohol based upon his review of 60 adverse drug reports.
Although these and other cases reveal that some courts will permit adverse event reports to be introduced at trial, medical device manufacturers must not be tempted to respond to these rulings by submitting fewer MDRs to FDA. In addition to regulatory sanctions, underreporting of adverse events can lead to serious obstacles during the course of product liability litigation. For example, in a case where a plaintiff with an alleged device-related injury raises a failure-to-warn claim, one of the strongest defenses the device manufacturer has is that it did not have a duty to warn of the particular risk cited because that risk was unknown. To that end, defense counsel may rely upon the fact that the company had filed no MDRs involving the claimed injury. If it can be shown that the company had been notified of such injuries and did not report them, however, then it will be difficult to argue that it had no duty to warn of the risk associated with its device.
MAINTAINING THE CONFIDENTIALITY OF MDR DATA
Despite the fact that MDRs have become admissible in some civil actions, most courts will protect the confidentiality of some information in the reports, including the names of the reporters, patients, doctors, and hospitals. Motions for protective orders are commonly granted, allowing MDRs to be produced with such information redacted. Relevant cases include York v. American Medical Systems Inc. (U.S. App. Lexis 30105, 1998), Eli Lilly v. The Honorable John Marshall (850 S.W.2d 164, 36 Tex.Sup.J. 683, 1993), and In Re Eli Lilly & Company (142 F.R.D. 454, 1992).
The pertinent Lilly v. Marshall ruling came in a case filed in Texas against Lilly by the family of Michael Biffle, who had committed suicide six days after he began taking Prozac. In pretrial discovery, the plaintiff's counsel sought production of, among other things, various documents that had been submitted to FDA, including adverse reaction and drug experience reports that had been initiated by physicians and other healthcare providers. The trial court ordered Lilly to produce the reports with only the patients' names redacted; however, in Lilly v. Marshall, the Texas Supreme Court reversed that order and required that the names of the reporters also be redacted. Under the Federal Food, Drug, and Cosmetic Act at 21 CFR 314.430 (e)(4)(ii), FDA must keep confidential the identities of the patients who were harmed and of the person or institution that reported an adverse reaction. Thus the state supreme court found that the trial court should have required the plaintiff to show a particular relevance of and need for the reporter data that outweighed the important congressional objective in keeping such information confidential. In so doing, the court referenced cases in several other jurisdictions (Tennessee, Louisiana, New York, Indiana, Kentucky, and Texas) that had required reporters' identities to be redacted, but it also concluded that upon a sufficient showing by plaintiffs, such information might be discoverable.
GROUNDS TO EXCLUDE ADVERSE REPORTS
Although certain courts have permitted plaintiffs to introduce adverse reports in product liability cases, medical device manufacturers have strong grounds to argue that such evidence should be deemed inadmissible at trial based on the adverse event reporting statute. Device manufacturers also can seek to thwart the admission of adverse reports during trial based upon a plaintiff's failure to retain an expert, among other arguments.
Inadmissibility Based on Statutory Language. A viable argument can be made for the exclusion of adverse reports given that the language of the MDR regulation generally prohibits the use of such documents in civil actions. Specifically, 21 USC 360(i)(b)(3) states that:
No report made under paragraph (1) by (A) a device user facility, (B) an individual who is employed by or otherwise formally affiliated with such a facility, or (C) a physician who is not required to make such a report, shall be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report.
In other words, MDRs initiated by user facilities or physicians may not be used in any civil action, including product liability suits, unless it can be shown that the reporter knowingly incorporated false information in the report. The citation of this statutory language has been significant in at least two cases, In Re Medtronic (184 F.3d 807, 1999) and Adcox v. Medtronic (U.S. Dist. Lexis 20277, 1999).
In In Re Medtronic, filed in Arkansas, the plaintiff, who claimed harm from a Medtronic pacemaker, sought the discovery prior to trial of the names of patients, physicians, and facilities involved with other allegedly defective pacemakers made by the manufacturer, and specifically requested the names of physicians who had reported adverse incidents similar to that of the plaintiff. In ruling on that request, the trial court ordered the manufacturer to send letters to 4000 patients whose experiences led to the filing of MDRs to give them the opportunity to waive their attorney-client privilege. Medtronic appealed the ruling, arguing that the proposed letters, which had been drafted by the plaintiff's counsel, were designed to identify potential plaintiffs in violation of 21 CFR 20.63(f), which protects the names of patients and adverse event reporters.
The government, which had been invited to submit a brief on this issue by the court, then introduced the question of the applicability of 21 USC 360(i)(b)(3). The government brief explained that this section generally prohibits the use of adverse reports in civil actions, and on that basis argued that the defendant could not be compelled to write letters to the subjects of the MDRs. Ultimately, the appellate court indicated it "agree[d] with the government's analysis of this legislation" and vacated the trial court's discovery orders.
A similar result was achieved in Adcox v. Medtronic, a product liability suit in which the plaintiff alleged that the design of her pacemaker was defective. The plaintiff's counsel moved for discovery of information contained in adverse reports filed voluntarily by patients and their legal representatives and in voluntary and mandatory MDRs filed by doctors and device user facilities. The court granted the motion only as it related to complaints filed by patients or their legal representatives and stipulated that any information that would have identified these reporters had to be redacted. In denying the other part of the plaintiff's request, the court held that discovery of voluntary reports from doctors and user facilities is explicitly prohibited under 21 CFR 20.63(f), while discovery of mandatory reports is prohibited under 21 USC 360(i)(b)(3). In so ruling, the court explained that section 360(i)(b)(3) explicitly states that mandatory reports "shall not be admissible into evidence or otherwise used in any civil action involving the parties." The court interpreted "used in any civil action" to preclude pretrial discovery of mandatory reports.
Inadmissibility Based on Failure to Retain an Expert. McDaniel v. Merck (367 Pa.Super. 600, 1987) provides another basis to seek the exclusion of adverse reports. This product liability action was filed against Merck after Carol Lee, who had been taking Mefoxin, developed severe anemia and died. Her estate claimed, among other things, that the decedent's anemia was related to her use of Mefoxin. At trial, the plaintiff's counsel attempted to introduce adverse drug reports relating to Mefoxin. The court, excluded such evidence, however, and as a result the case was dismissed via nonsuit before the matter reached the jury. For various reasons, the appellate court ordered a new trial. In its ruling, the appellate court found that the trial court had acted properly in excluding the adverse drug reports because they were "sufficiently technical, [and] complex," but it also stated that should the plaintiff retain an expert to explain the adverse drug reports to the jury at the retrial, the reports should be "deemed admissible." Under this opinion, therefore, defendant companies can seek to exclude evidence of adverse reports at trial if the plaintiff fails to retain an expert to interpret the reports for the jury's benefit.
Other Arguments to Exclude Reports. Another potential basis for a defendant's argument against disclosure of adverse reports is the concept known as the self-critical analysis privilege. This privilege, which is recognized in some states, encourages individuals and businesses to candidly assess their compliance with regulatory and legal requirements without creating evidence that might be used against them by their opponents in future litigation. Thus, manufacturers may claim that MDRs are part of the analysis process and as such are not admissible at trial or subject to discovery.
Another argument in favor of exclusion is the fact that the admission of adverse reports may be more prejudicial to the defendant than the reports are probative to the plaintiff. That is, the existence of a large number of reports may imply that there is a defect in the product even when the reports offer no proof that a defect exists. Finally, because reports submitted by parties other than the manufacturer may be highly unreliable, companies may be able to argue for the exclusion of such reports on the basis that there is no proof establishing the truth of the information contained therein and thus the reports lack the requisite foundation necessary to be admitted into evidence.
The use of MDRs in civil litigation can be quite influential in the subsequent determination of whether a device was a contributing factor to the plaintiff's claimed injuries. Therefore, whenever such reports are sought in pretrial discovery or introduced at trial, the defendant should carefully review the particular circumstances of the case and put forth as many credible arguments as possible to encourage the court to exclude the reports. The circumstances of a given case may give rise to other viable arguments supporting exclusion in addition to those described above.
PLAINTIFFS' ABILITY TO OBTAIN INFORMATION FROM OTHER DOCUMENTS
In some litigation involving medical products, plaintiffs have been able to discover information about potential adverse reactions from documents other than adverse experience reports. For example, in Waelde v. Merck, Sharp, & Dohme (94 F.R.D. 27, 1981), a product liability suit filed in Michigan, the plaintiff specifically requested that the defendant produce its new drug application (NDA) for Clinoril; documents concerning postmarketing adverse reactions, premarketing studies, and animal tests that showed the effects of the drug on blood-forming organs of the body; and correspondence that discussed effects of the drug on persons receiving it with a particular focus on the blistering disease known as Stevens-Johnson syndrome. The defendant objected to the notice to produce, claiming that the contents of NDA files are trade secrets and are so treated by FDA.
In its response, the court held that trade secrets and confidential information in the possession of FDA, whether contained in NDA files or otherwise, are not available for public disclosure based on 21 CFR 20.60, 20.61, 20.100(17), and 314.14, but that not all the data contained in an NDA file are necessarily trade secrets or confidential commercial information. The ruling went on to state that certain categories of information may be disclosed after a drug application has been approved or if the information had been disclosed to the public previously. For example, safety and effectiveness data, which include "all studies and tests of a drug on animal and human subjects and all studies and tests of the drug for identity, stability, purity, potency, and bioavailability," may be released if they had been publicly disclosed previously or if certain other conditions are met. It should be noted that because this case involved a drug, not a device, 21 USC 360(i)(b)(3) was not asserted, leaving device manufacturers to wonder whether the court would have ruled differently had that statutory language been applicable.
METHODS TO LIMIT LIABILITY
Armed with the knowledge that adverse reports may ultimately need to be produced during the pretrial discovery process in civil litigation—or may even be admitted into evidence at trial— device manufacturers must prepare all submissions made to FDA with extreme care. The following suggestions are offered with the aim of limiting a company's liability in subsequent lawsuits.
In preparing MDRs, select the words used and the information contained in the report carefully. Avoid using words that describe the product in a negative manner, and be sure to include any available information that may establish a cause for the patient's problem other than a device-related adverse event. Remember that plaintiffs' attorneys may often cite phrases or sentences from a report out of context.
If additional steps need to be taken to establish the cause of a patient's problem, such as a review of medical records or product retrieval and testing, such steps should be set forth in the MDR so that anyone reviewing the report later will understand that the company had incomplete information at the time the report was filed. Any and all reliable information pertaining to the patient's history and the occurrences leading up to the reportable event should also be included in the report. In addition, if a report is based upon allegations in a consumer complaint or statements made by a plaintiff's attorney, be sure to note the source of the information being reported and make it clear to potential readers whether certain statements are admitted facts or mere claims or allegations.
Once an MDR has been submitted to FDA, make sure to perform the follow-up steps outlined in the report. Follow-up is essential for several reasons. Most importantly, it may reveal that the product was not involved in, or was not the cause of, the patient's problem. In such cases, the company should immediately file a supplemental report with FDA indicating this finding. If a supplemental report is not filed, the company may face the difficult task of explaining away the original report to a jury. Conducting follow-up also may be crucial to avoiding or limiting punitive damages awards. If a plaintiff's attorney is able to show that a company has submitted MDRs for problems associated with a product but has failed to undertake appropriate follow-up, he or she may be able to convince a jury that such conduct amounts to reckless indifference or willful and wanton conduct, which could result in the imposition of substantial punitive damages.
With the growth of the Internet, adverse event reports associated with medical devices have become easily accessible. With a few keyboard strikes, potential plaintiffs in product liability cases and their attorneys can access the FDA MAUDE database and find a profusion of reports pertaining to the product of interest or similar devices made by other manufacturers. At trial, plaintiffs will undoubtedly attempt to introduce such reports in order to influence the jury's perception of the defendant company and convey the not-so-subtle message that the mere existence of adverse reports shows that there must have been something wrong with the device. While grounds exist for defendants to argue that MDRs should be excluded from evidence, it is critical for manufacturers to understand that a growing number of courts are allowing such documents to be presented. Thus, it has become increasingly important to prepare submissions to FDA carefully. MDRs should include any information that may provide an alternative explanation for the adverse event and should outline any necessary follow-up steps. It is also essential that companies perform the follow-up measures needed to determine the cause of the reported problem. By taking these steps, they will be better prepared to face any civil lawsuit that may be filed later.
Anthony G. Brazil, Matthew L. Marshall, and Michele L. Abracen are attorneys with Morris, Polich, and Purdy LLP (Los Angeles).
Illustration by Janusz Kapusta/SIS
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