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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Motion in Limine regarding other evidence of defective Duragesic patches

Posted in Duragesic / Fentanyl

In every Duragesic or fentanyl lawsuit, two things will happen:

First, the plaintiff will discover evidence of other people injured by the fentanyl patches.  This evidence will come in the form of FDA reports, internal company reports, and perhaps even other lawsuits.

Second, the defendants will file a motion in limine that asks the court not to let the jury see that information.

This is just one of the many tricks that defendants in product liability lawsuits such as this pull.  Thankfully, I know several former defense lawyers who used to represent companies in lawsuits like this one.  Now, they represent injured people and know first hand what they’ll be up against.  If you’d like me to put you in touch with a Duragesic lawyer, just contact me and I will.

Defendants Johnson & Johnson, Janssen Pharmaceutica Products, L.P., and ALZA Corporation hereby move for an Order excluding from trial all evidence relating to other incidents, adverse event reports, and product complaints involving Duragesic, the product at issue in this case. More specifically, Defendants move to exclude Plaintiff's Exhibit Nos. 62-70, 72-73, 84, 87, 103-104, 109, 112, 163, 165, 193, 208-210, 214-215, 217, 220-221, 228-229, 237, 246, 249-250, 257, 269, 272, 309-311, 394-400, 403, 453, 464-465, 468-474, 479-502, 505-509, 514-516, 539-541, 543, 545-557, 562-580, 583-584, 595-596, 602-652, 671-672, and 682-702 and any other document, testimony or argument relating to other incidents, adverse event reports, and product complaints involving Duragesic. Such evidence is inadmissible because these reports and complaints (1) are hearsay within hearsay, (2) reflect incidents that did not occur under reasonably similar conditions to those involved in this case, (3) are not relevant to the determination of the facts at issue in this action, and (4) are unfairly prejudicial to Defendants and confusing to the jury. Such evidence is therefore inadmissible under Federal Rules of Evidence Rules 401, 402, 403, and 802.
I. FACTS

The product at issue in this case is Duragesic, a prescription pain patch that delivers medication through the skin of the user. Duragesic is manufactured by defendant ALZA Corporation and distributed by defendant Janssen Pharmaceutica Products, L.P. Fentanyl, the active ingredient in Duragesic, is a generic opioid analgesic that is contained in a gel mixture inside each patch.

In 1996, Plaintiff's son, Adam Hendelson (“Decedent”), suffered a broken pelvic bone and other injuries from a severe car accident. In the following years, he developed a number of physical problems related to the car accident injuries, including arthritis and degenerative disk disease in his back. As his physical symptoms progressed, Decedent began taking an increasing variety of pain medications and anti-depressants. Decedent was found dead in his apartment in the early morning hours of December 17, 2003, at the age of 28. His death was ruled to be a result of a combined drug overdose. A variety of prescription and over-the-counter medications were found in Decedent's blood, but the medical examiner concluded that Decedent died from excessive amounts of three particular medications: Celexa, (citalopram, an antidepressant), Remeron (mirtazapine, an antidepressant), and fentanyl, the active ingredient in Duragesic. See Broward County Medical Examiner Autopsy Report, attached as Exhibit A.
II. THE PRODUCT REPORTS

As the manufacturers/distributors of Duragesic, a prescription drug, Defendants are required by federal law to record every adverse event and product complaint they receive. See 21 C.F.R. § 314.80. Adverse events (which involve patient injury) and product complaints (which do not involve injury) are reported to Defendants from third parties, generally healthcare providers, plaintiffs' attorneys, patients, and caregivers/family members. When Defendants receive a report of an adverse event from a third party, the information relayed to Defendants is entered onto certain forms that are then forwarded to the relevant departments within the company for follow-up. The forms are also forwarded to the FDA at certain intervals that are regulated by law.

Defendants expect Plaintiffs will attempt to introduce into evidence adverse event forms, MedWatch reports, 15-day Reports, and/or product complaints (collectively, “Reports”) to demonstrate that (1) Defendants' Duragesic patches were defective, and (2) Defendants knew the patches were defective. The Reports are not admissible in support of either theory. First, the reports contain multiple levels of hearsay that does not fall under any hearsay exception. Also, the Reports are anecdotal accounts by third parties, so they are not reliable and therefore not relevant to the determination of the issues in this case. And because the Reports reference incidents other than the one involved in this lawsuit, they are not admissible unless Plaintiff can demonstrate that those incidents occurred under reasonably similar conditions. Plaintiff cannot meet this standard. Even if he could, the Reports are still inadmissible because such evidence would create undue prejudice, confusion, or delay.
III. THE REPORTS ARE INADMISSIBLE UNDER FEDERAL RULES OF EVIDENCE RULES 401, 402, 403, AND 802
A. The Reports are hearsay within hearsay under Rule 802, and they do not fall under any exception in Rule 803.

The Reports are a classic example of multiple hearsay. They contain not only the hearsay statements of the individual employees who prepared the reports, but also the hearsay of the individuals who contacted Defendants to make a complaint or to report an adverse event. Additionally, some Reports have a third layer of hearsay; many Reports are based upon information received by plaintiffs' attorneys handing cases involving Duragesic, and the information relayed by the attorneys to Defendants is based on what they have heard from their clients.

Hearsay is an out-of-court statement offered to prove the truth of the matter asserted. Fed. R. Evid. 801. Hearsay is not admissible unless it falls within a hearsay exception. Fed. R. Evid. 802. Hearsay within hearsay is only admissible if each layer of hearsay falls under a hearsay exception. Fed. R. Evid. 805. The Reports contain multiple hearsay, and they do not fall under any exception in the Rules.

The most likely hearsay exception that would apply to the Reports is the business records exception in Rule 803(6). However, records do not fall under that exception unless they are based on “information transmitted by a person with knowledge,” and they are not admissible if “the source of information… indicate[s] lack of trustworthiness.” Fed. R. Evid. 803(6). The Reports here are not made by people with knowledge; incidents can be reported by anyone – patients, doctors, lawyers, family members, etc. Because the information comes from a variety of sources, including people with no medical training and no understanding of medical causation, the Reports lack the trustworthiness required by Rule 803(6).

This Court has specifically held that such reports are inadmissible hearsay. In Goldstein v. Centocor, 05-21515 CIV (May 5, 2007), Magistrate Stephen Brown held that reports of adverse events regarding Remicade, the prescription drug at issue in that action, were not admissible. The Goldstein Court held that the reports contain multiple hearsay that does not fall under any hearsay exception, and the probative value of the reports was outweighed by their prejudicial nature. See Order on Defendant's Motion to Exclude Evidence of MedWatch Reports, attached hereto as Exhibit B.

Many courts have also recognized that the reported information in customer complaints does not meet the requirements of any hearsay exception. For example, in this District, Judge Middleberg has held that an audit report of customer complaints is not admissible: “[S]ummaries of statements by… customers…are inadmissible hearsay. The audit itself is hearsay….Under the business records and residual exceptions, the [customers'] statements recounted in the audit report would still constitute hearsay within hearsay.” Commodity Futures Trading Com'n v. Wilshire Inv. Management Corp., 407 F.Supp.2d 1304, 1315 (S.D.Fla. 2005). Similarly, the Florida Supreme Court has held that while complaints created by an agency can be construed as business records, “the information contained within the records…[is] not admissible under the business records exception because it was relayed by witnesses, and not based upon the personal knowledge of an agent of the business.” Brooks v. State, 918 So.2d 181, 193-94 (Fla. 2005). The Florida Court of Appeals has held that if statements made in reports are not by agents of a business, the business records exception cannot apply: “A business record includes a statement of a bystander to an accident, the bystander's statement is hearsay and not included within the business records exception because the statement was not made by a person with knowledge who was acting within the regular course of the business activity.” Harris v. Game and Fresh Water Fish Com'n, 495 So.2d 806, 809 (Fla.App. 1 Dist. 1986); see also Wolf by Wolf v. Procter & Gamble Co., 555 F.Supp. 613, 620 (D.C.N.J. 1982) (holding that complaints made over the telephone and incorporated into a written record by employees of the defendant did not fall under any hearsay exception in the Federal Rules); Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 788 P.2d 1293, 1298 (Idaho 1990) (determining that reports submitted to drug companies regarding reactions to particular drugs were unreliable hearsay); Olson v. Ford Motor Co., 410 F. Supp. 2d 855, 861-62 (D.N.D. 2006) (holding that customer complaints contained in a manufacturer's business records are inadmissible hearsay under the Federal Rules).

Furthermore, the Reports are not admissible to show that Defendants had notice of the reported incidents. It is wholly illogical to argue that the Reports cannot be admitted for the truth of the matter asserted, but can be admitted for Defendants' knowledge of the truth of the matter asserted. The Texas Supreme Court, for example, reversed a lower court's decision that had done just that: “[T]he court of appeals indicated that the [customer complaint] database was relevant to show [the defendant's] knowledge of the dangerous condition in its [product]. In other words, the hearsay was admissible not for the truth of the matters asserted, but to show [the defendant's] knowledge of the truth of the matters asserted. The hearsay rules cannot be avoided by this kind of circular reasoning.” Nissan Motor Co. Ltd. v. Armstrong, 145 S.W.3d 131, 141-142 (Tex. 2004).

If the Reports did not contain information from third parties, they could potentially fall under the business records exception set out in Rule 803(6). However, this is not the case. The information in the Reports is from third parties who are not employees or agents of Defendants. The hearsay within the Reports does not fall under any hearsay exception. In sum, the Reports contain multiple levels of hearsay that do not fall under any hearsay exception in Rule 803.
B. The Reports contain unreliable anecdotal information from third parties that is not relevant to the issues in this case.

The Reports consist of anecdotal evidence of individuals' health issues that may or may not have had anything to do with Duragesic. Incidents are reported not only by knowledgeable people in the medical field, but also by caretakers, family members, and attorneys who are not qualified to determine whether any particular incident was actually caused by Duragesic. These third parties are not under oath when they make the reports, and they cannot be cross-examined. More than one person may report a single incident, and Defendants are compelled by law to record each report, even if it is duplicative. Thus not only are Reports unreliable for their content, but the number of Reports received is not an accurate indicator of incidents caused by Duragesic. In short, the Reports are not a reliable source of information.

The Eleventh Circuit has recognized how unreliable such reports are in McClain v. Metabolife Intern., Inc., 401 F.3d 1233 (11th Cir. 2005). The Court described adverse event reports as follows: “[T]hese FDA reports reflect complaints called in by product consumers without any medical controls or scientific assessment. Under the adverse events reporting system, consumers call in to describe medical problems that they think they are experiencing from taking a product.” Id. at 1250. The McClain Court summarized these reports as “uncontrolled anecdotal information” that “lack[ ] the indicia of scientific reliability.” Id.

Only relevant evidence is admissible. Fed. R. Evid. 402. “Relevant evidence” tends to make the existence of any material fact more or less probable. Fed. R. Evid. 401. The Reports at issue do not meet that standard. They are anecdotal accounts of incidents that may or may not have been caused by Duragesic; they have no bearing on whether the patch Decedent had on when he died was defective. The Reports are therefore not admissible under Rules 401 and 402.
C. The Reports do not meet the admissibility standards of the Substantial Similarity Doctrine.

Courts have been clear that evidence of other incidents, such as those in the Reports at issue, may not be introduced into evidence unless there is a “substantial similarity” between the other accidents and the one at issue in the case. The “substantial similarity doctrine” is meant to “protect parties against the admission of unfairly prejudicial evidence, evidence which, because it is not substantially similar to the accident or incident at issue, is apt to confuse or mislead the jury.” Heath v. Suzuki Motor Corp., 126 F.3d 1391, 1396 (11th Cir. 1997). Here, because Plaintiff cannot show that the incidents in the Reports are substantially similar to the facts in this case, the Reports are inadmissible.

Evidence of other accidents “is only admissible if conditions substantially similar to the occurrence caused the prior accidents, and the prior incidents were not too remote in time.” Hessen v. Jaguar Cars, Inc., 915 F.2d 641, 649 (11th Cir. 1990). “As a general rule, evidence of the occurrence or non-occurrence of a prior accident is admissible where it pertains to the use of the same type of appliance or equipment under substantially similar conditions.” Lasar Mfg. Co., Inc. v. Bachanov, 436 So.2d 236, 238-39 (Fla. 1983) (emphasis added). The burden is on Plaintiff to show that the prior incidents were substantially similar: “[B]efore evidence of prior accidents or occurrences is admitted into evidence, the proponent of such evidence must show that conditions substantially similar to the occurrence caused the prior accidents.” Heath v. Suzuki Motor Corp., 126 F.3d 1391, 1396 n.12 (11th Cir. 1997).

The “conditions” surrounding any one patient's use of Duragesic are far too complex to determine whether any incident is “substantially similar” to the conditions at issue here. Decedent was 28 years old, and the cause of his death was determined to be a combined drug overdose from three prescription drugs. Other medications, both prescription and over-the-counter, were also found in Decedent's system. To determine whether other incidents occurred under “substantially similar conditions,” the Court would have to conduct a mini-trial, complete with expert medical causation analysis, for every single report to determine whether the age of the patient, ailments or illnesses, and drug interactions could be considered “similar” to the facts of this case. The variety of patients' medical history, ailments, illnesses, and concurrent medications make it extremely difficult, if not impossible, to determine whether any one situation is “substantially similar” to the issues in this case. Any determination of “similarity” is also complicated by the fact that Duragesic is indicated only for patients who require continuous, around-the-clock analgesia for significant pain – thus every Duragesic patient has underlying medical problems that cause the type of continuous pain that requires Duragesic. The medical complexity of determining whether incidents are “substantially similar” would create an overwhelming burden on the Court and the parties.

Plaintiff cannot meet the exacting requirements of the Substantial Similarity Doctrine. As such, Plaintiff cannot meet his burden to show that the Reports involve incidents that are substantially similar to the incident at issue in this case. The Reports are therefore inadmissible.
D. The Reports are not reliable, thus their admission would confuse the jury, create prejudice against Defendants, and waste time.

The Reports should not be introduced at trial because any potential “probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury.” Fed. R. Evid. 403. Because there is no connection between decedent's patch and the Reports, such evidence has no probative value.

As discussed above, the Reports do not contain scientifically reliable data. Also, Plaintiff cannot show that the Reports involve incidents or circumstances that are similar to the facts of this case. The jurors could easily be confused into thinking that reports of the involvement of Duragesic in other instances somehow indicate that Duragesic patches in general are unsafe, and that the patch at issue was defective. Such a misunderstanding would clearly prejudice Defendants by allowing the evidence to be misconstrued.

Introduction of the Reports would also waste the Court's time. As discussed in section II(C) above, the Court would have to hold a mini-trial to determine whether the incident in each Report occurred under circumstances similar to those in this case. Furthermore, discussion of the Reports by counsel or witnesses would be a waste of time because the information contained within the Reports is not relevant and cannot help the jury decide the facts of this case.
IV. CONCLUSION

Reports of product complaints and adverse events are not admissible under the Federal Rules of Evidence. They are hearsay that does not fall under any hearsay exception, they are not relevant to the issues in this case, Plaintiff cannot show that the circumstances in each report were substantially similar to the circumstances here, and they would waste time and prejudice Defendants. All evidence regarding such Reports should therefore be excluded. More specifically, Defendants move to exclude Plaintiff's Exhibit Nos. 62-70, 72-73, 84, 87, 103-104, 109, 112, 163, 165, 193, 208-210, 214-215, 217, 220-221, 228-229, 237, 246, 249-250, 257, 269, 272, 309-311, 394-400, 403, 453, 464-465, 468-474, 479-502, 505-509, 514-516, 539-541, 543, 545-557, 562-580, 583-584, 595-596, 602-652, 671-672, and 682-702 and any other document, testimony or argument relating to other incidents, adverse event reports, and product complaints involving Duragesic.
V. PRE-FILING CONFERENCE CERTIFICATION

I hereby certify that pursuant to Local Rule 7.1 (A)(3) counsel for Defendants conferred with counsel for Plaintiff in a good faith effort to resolve the issues raised in this Motion and has been unable to so.

DATED: May 21st, 2007