Stevens v. Novartis Pharmaceuticals Corp.

DA 10-0029 December 30 2010

IN THE SUPREME COURT OF THE STATE OF MONTANA
2010 MT 282

PEGGY L. STEVENS,

Plaintiff, Cross-Appellant and Appellee,

v.

NOVARTIS PHARMACEUTICALS CORPORATION,

Defendant and Appellant.

APPEAL FROM: District Court of the Fourth Judicial District,
In and For the County of Missoula, Cause No. DV 08-100
Honorable John W. Larson, Presiding Judge

COUNSEL OF RECORD:

For Appellant:

W. Carl Mendenhall; Worden Thane P.C.; Missoula, Montana

Joe G. Hollingsworth, Katharine R. Latimer; Hollingsworth LLP;
Washington, District of Columbia

Rebecca Anne Womeldorf (argued); Washington, District of Columbia

For Appellee/Cross-Appellant:

Terry N. Trieweiler (argued); Trieweiler Law Firm; Whitefish, Montana

James T. Towe; Towe Law Offices; Missoula, Montana

Robert G. Germany; Pittman, Germany, Roberts & Welsh, LLP;
Jackson Mississippi

Bartlett T. Valad; Valad & Vecchione, PLLC; Fairfax, Virginia

Argued and Submitted: September 23, 2010

Decided: December 30, 2010

Filed:

__________________________________________
Clerk
Justice W. William Leaphart delivered the Opinion of the Court.

¶1 A Missoula County jury returned a verdict awarding Peggy Stevens (Stevens)

$3,200,000.00 in compensatory damages in Stevens’ action for negligence against

Novartis Pharmaceuticals Corporation (Novartis). Stevens alleged that Novartis failed to

properly warn that its drug, Zometa, causes osteonecrosis of the jaw (ONJ) in patients

who undergo dental surgery while taking the drug. The District Court denied Novartis’

motions for summary judgment, ruled against Novartis on several evidentiary issues, and

denied post-trial motions for judgment as a matter of law and for a new trial. Novartis

appeals these rulings. Stevens cross-appeals, claiming that the trial court erred in

denying Stevens permission to file an amended complaint, in dismissing a Novartis sales

representative from the action, and in offsetting social security disability benefits against

the jury award.

¶2 We affirm in part and reverse in part.

¶3 We consider the following issues on appeal:

¶4 1. Whether the District Court erred in denying Novartis’ motion for summary

judgment.

¶5 2. Whether the District Court erroneously instructed the jury as to Novartis’

duty to warn.

¶6 3. Whether the District Court erred in refusing Novartis permission to amend its

complaint to include an apportionment defense.

¶7 4. Whether the District Court erred in excluding statements in prior pleadings

that were allegedly inconsistent with Novartis’ liability.

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¶8 5. Whether the District Court erred in admitting testimony regarding a change

to Novartis’ warning label.

¶9 6. Whether Novartis is entitled to judgment as a matter of law because Stevens

failed to prove proximate causation.

¶10 7. Whether the District Court erred in refusing Stevens permission to amend

her complaint to include a claim for punitive damages.

¶11 8. Whether the District Court erred in offsetting social security disability

benefits against the general damages awarded by jury.

¶12 9. Whether the District Court erred in dismissing Stevens’ negligence claims

against Patrick Doyle, a sales representative for Novartis.

FACTUAL AND PROCEDURAL BACKGROUND

¶13 Peggy Stevens was diagnosed with follicular lymphoma in October 2000 by

Dr. Judy Schmidt (Dr. Schmidt), a Missoula oncologist. At the time, Stevens served as

the house supervisor at Community Medical Center, where she had been employed for

nearly 20 years. In April 2002, Dr. Schmidt prescribed Novartis’ drug Zometa to Stevens

after finding lymphoma in Stevens’ spine, pelvis and ribs. Zometa, like other drugs in the

“bisphosphonate” family, is administered intravenously to cancer patients who are at risk

of bone fractures and other bone-related problems due to cancer-weakened skeletal

systems. Zometa works by attacking cells called “osteoclasts” that normally dissolve old

bone, which has the result of hardening bones to make them more resilient. At the time

Dr. Schmidt prescribed Zometa to Stevens in April 2002, the drug had only recently been

3
approved by the Federal Drug Administration (FDA), and no serious reports of any

negative side effects had arisen.

¶14 Experts soon began to take note, however, of the large number of ONJ patients

who were also taking bisphosphonates. Several months after Stevens began taking

Zometa, Dr. Robert Marx, a leading national expert, published an award-winning medical

textbook which first mentioned the possible link between ONJ and bisphosphonates.

Novartis responded in September 2003 by changing the Zometa label to include a

mention of ONJ, stating that “cases of [ONJ], primarily of the jaws, have been reported

since market introduction.” The label also stated, however, that ONJ has “other well-

documented risk factors,” and “it is not possible to determine if [cases of ONJ] are related

to Zometa.” The label pointed to chemotherapy and smoking as the more likely and more

well-established causes of ONJ.

¶15 Dr. Marx continued to sound the alarm, writing of a “growing epidemic” of ONJ

in bisphosphonate patients. In December 2003, Novartis convened an advisory panel on

the subject in coordination with the American Society of Clinical Oncology. The panel

included Dr. Marx and another expert, Dr. Salvatore Ruggiero, who had echoed

Dr. Marx’s reports of ONJ-bisphosphonate linkage. In March 2004, a second panel was

convened at Novartis headquarters, again with Dr. Marx, Dr. Ruggiero, and other leading

national figures present. A main goal of this second panel was to draft a “white paper”

on the topic, which was eventually published in June 2004. The white paper was met

with heavy criticism from Dr. Marx and others. They asserted that the paper failed to

admit the clear causal relationship between bisphosphonates and ONJ, and that it

4
misleadingly identified other factors such as chemotherapy and smoking as the more

likely causes of ONJ in bisphosphonate patients. In the same month the paper was

released, Novartis again changed its Zometa label, adding that the majority of reported

cases of ONJ were “in cancer patients attendant to a dental procedure” and advising that

“although causality cannot be determined, it is prudent to avoid dental surgery as

recovery may be prolonged.”

¶16 Stevens continued visiting Guardian Oncology for treatment, although her

relationship with Dr. Schmidt no longer included active consultation. Instead, Stevens

interacted with the nursing staff and visiting physicians at the clinic. She began having

pain in her jaw in August 2004, and was subsequently advised that her tooth was cracked

and she would need to have surgery to remedy the problem. Stevens called Guardian

Oncology on August 31, 2004, in connection with the upcoming dental procedure. She

advised clinic staff and locum tenens physicians that she needed to have dental work

done and was planning on having her tooth extracted (a much less expensive procedure

than alternative possibilities such as root canal therapy and crown lengthening) in the

near future. No concerns regarding ONJ were raised, and Stevens made an appointment

with Dr. Eugene Morris, an oral surgeon, for the procedure. Dr. Morris was unaware that

Stevens was taking Zometa, but testified that even if he had known, it would not have

made a difference as he was unaware of the relationship between Zometa and ONJ until

2006. Dr. Morris performed the extraction on September 27, 2004.

¶17 Within days, Stevens began having additional pain at the extraction site. She went

on an antibiotic regimen, but the pain failed to abate. Stevens reported the continuing

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problem to Dr. Schmidt, who ordered an MRI in early 2005. The MRI suggested that

Stevens had contracted ONJ, which was confirmed by further testing. Stevens stopped

taking Zometa around this time, although the drug was still present in her body as it has a

half-life of over a decade. While Stevens’ ONJ continued to develop into a serious

problem, her cancer was in remission, as it has been ever since. In October 2006,

exposed bone first became visible at the extraction site. In April 2007, Stevens took what

was intended to be a temporary break from work, but could not return to work without

pain medication. Because Community Hospital requires its employees to abstain from all

narcotics while on duty, however, Stevens was forced to abandon her position. She has

been out of work ever since. ONJ has no cure and is progressive, and thus Stevens’

condition will only deteriorate as more of her jawbone dies. Like all ONJ patients,

Stevens suffers from chronic pain and constant infection, and manages her condition with

antiseptic mouthwash, antibiotics, and powerful narcotics for pain.

¶18 The growing recognition of a link between ONJ and bisphosphonates caused

reverberations in the courtroom as well as the medical community. On September 15,

2005, three class action suits were filed against Novartis in federal court in Tennessee. In

one of these suits, Susan Becker, et al. v. Novartis Pharms. Corp., No. 3:05-0719 (M.D.

Tenn.), counsel for the named plaintiffs sought to represent a worldwide class of

plaintiffs who contracted ONJ after using Zometa. The suit alleged failure to warn,

among other claims, and sought damages for personal injuries. Class certification was

eventually denied and claims were ordered severed on November 14, 2007. During the

pendency of the suit, the linkage between bisphosphonates, dental surgery, and ONJ had

6
become widely accepted. Novartis had long since sent a “Dear Doctor” letter to doctors

regarding Zometa and other bisphosphonates, admitting that the ONJ-bisphosphonate link

was no longer an unproven hypothesis, but rather an established medical conclusion.

¶19 In August 2007, Stevens brought an action against Dr. Schmidt and Dr. Morris

before the Montana Medical Legal Panel (MMLP), alleging failure to warn of the risk of

contracting ONJ as a result of dental surgery while on Zometa. Dr. Schmidt responded

that she did not have knowledge of these risks, and Dr. Morris responded that there were

no other feasible options available to Stevens. In January 2008, after the conclusion of

the MMLP proceedings, Stevens filed suit in Missoula County District Court against

Dr. Schmidt, Guardian Oncology, and several fictitious defendants, claiming that they

knew of the risk of ONJ but negligently failed to warn her. Stevens substituted Novartis

and its sales representative, Patrick Doyle, for the fictitious defendants named in the

complaint in January 2009. Novartis immediately raised a statute of limitations defense

and moved for summary judgment. The District Court denied Novartis’ motion on the

basis that the complaint was timely filed as to the fictitious defendants, and that Novartis

had failed to show that it was not properly substituted. Novartis had failed to show that

the substitution was improper, explained the court, because “the nature of Novartis’

alleged culpability may have been unknown at the time of Plaintiff’s original complaint.”

A protective and confidentiality order was entered in May 2009, and the case proceeded

to discovery. Stevens settled her claims against Dr. Schmidt and Guardian Oncology in

June 2009, and they were dismissed from the case in July. Numerous motions were filed

refining the scope of issues at trial. The parties were both denied leave to amend the

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pleadings, and additional cross-motions seeking to postpone the trial date were denied as

well. Novartis again moved for summary judgment on its statute of limitations defense,

but was again denied. The case proceeded to trial on October 13, 2009, before the Hon.

John Larson.

¶20 Eight days later, a Missoula County jury returned a verdict of $3,200,000.00 in

Stevens’ favor. A hearing on potential offsets was held in January 2010, after which the

District Court entered an order reducing the award to $2,657,257.32. The offsets

included the amount Stevens received in settlement with Dr. Schmidt and Guardian

Oncology, the amount she received in short-term disability for six months in 2007, and

the social security disability benefits she had received and would receive in the future.

Stevens was awarded her costs. Novartis filed post-trial motions for a new trial and for

judgment as a matter of law, which were denied. Novartis timely appealed.

¶21 We held oral argument on September 23, 2010, directing the parties’ attention to

two issues: Stevens’ alleged statute of limitations violation and Novartis’ duty to warn.

STANDARD OF REVIEW

¶22 We review a district court’s grant or denial of a motion for summary judgment de

novo. State v. Butte-Silver Bow Co., 2009 MT 414, ¶ 17, 353 Mont. 497, 220 P.3d 1115;

Goettel v. Est. of Ballard, 2010 MT 140, ¶ 10, 356 Mont. 527, 234 P.3d 99. Applying the

criteria contained in M. R. Civ. P. 56, we determine whether the moving party has

established both the absence of a genuine issue of material fact and entitlement to

judgment as a matter of law. Goettel, ¶ 10 (citing Watson v. Dundas, 2006 MT 104, ¶ 16,

332 Mont. 164, 136 P.3d 973).

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¶23 We review jury instructions for abuse of discretion to determine whether the jury

instructions, as a whole, fully and fairly instructed the jury on the applicable law. State v.

Johnston, 2010 MT 152, ¶ 7, 357 Mont. 46, 237 P.3d 70. We review evidentiary rulings

for an abuse of discretion, and a district court possesses broad discretion to determine the

admissibility of evidence. Malcolm v. Evenflo Co., 2009 MT 285, ¶ 29, 352 Mont. 325,

217 P.3d 514 (citing Sunburst Sch. Dist. No. 2 v. Texaco, Inc., 2007 MT 183, ¶ 74, 338

Mont. 259, 165 P.3d 1079).

¶24 We review a district court’s findings of fact to determine whether they are clearly

erroneous. Emmerson v. Walker, 2010 MT 167, ¶ 20, 357 Mont. 166, 236 P.3d 598. We

review questions of law de novo. In re Fair Hrg. of Hanna, 2010 MT 38, ¶ 13, 355

Mont. 236, 227 P.3d 596. We review a district court’s interpretation of a statute for

correctness. Signal Perfection, Ltd. v. Rocky Mt. Bank-Billings, 2009 MT 365, ¶ 10, 353

Mont. 237, 224 P.3d 604.

DISCUSSION

¶25 1. Whether the District Court erred in denying Novartis’ motion for summary
judgment.

¶26 Novartis has strenuously argued over the life of this litigation that Stevens’ claims

are time-barred. Montana’s three-year statute of limitations for personal injury actions,

§ 27-2-204, MCA, ostensibly began to run on March 18, 2005, when Stevens was first

informed she had ONJ as a result of undergoing dental surgery while taking Zometa.

Stevens filed a timely complaint in January 2008 against Dr. Schmidt, Guardian

Oncology, and John Does one through four. She amended the complaint to substitute

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Novartis for one of the fictitious defendants in January 2009, three years and 10 months

after the statute of limitations began to run. Stevens maintains that Novartis was timely

served because parties who are fictitiously named pursuant to § 25-5-103, MCA, are

considered part of the action from its inception. M. R. Civ. P. 4(E)(2). Novartis counters

that the fictitious name statute applies only when the plaintiff is unaware of the

defendant’s identity. Given that Stevens was fully aware of Novartis’ name and that

Zometa had caused or contributed to her ONJ, Novartis contends, she cannot escape her

failure to timely name Novartis as a defendant.

¶27 In the alternative, Stevens argues that the statute of limitations was tolled by the

Becker class action suit. In this suit, plaintiffs’ counsel sought class certification for a

worldwide class of patients who took Zometa and later contracted ONJ. Becker, No.

3:05-0719 (M.D. Tenn.). The suit contained claims for strict product liability and

negligence for failure to warn doctors and consumers of the danger of Zometa-induced

ONJ. Plaintiffs sought medical monitoring, compensatory damages, and punitive

damages. The suit was pending from September 15, 2005, until November 14, 2007,

when the district court denied class certification and ordered that the claims be severed

and individual amended complaints filed. Stevens asserts that because the Becker class

action contained a request for worldwide class certification, and contained a claim for

failure to warn against the dangers of Zometa-induced ONJ, the statute of limitations was

tolled as to Stevens, along with all other potential class members, under the “class action

tolling” rule. Because the statute of limitations was tolled for over two years during the

pendency of the Becker class action, argues Stevens, the amended complaint was timely

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filed as to Novartis regardless of whether it relates back to the original complaint via the

fictitious name statute. Novartis replies that the class action tolling rule ought not apply

to the current situation for a variety of reasons, most notably that the class action suit in

question was filed in a different jurisdiction than the present suit.

¶28 In reviewing the District Court’s conclusions on whether Stevens’ claims are

barred by the statute of limitations, we are mindful that we will uphold a district court

when it reaches the correct result, regardless of the court’s reasoning. Peterson v.

Eichhorn, 2008 MT 250, ¶ 37, 344 Mont. 540, 189 P.3d 615. Thus, we will uphold the

District Court here if we find that Novartis was properly substituted as a fictitious

defendant or that the limitations period was tolled during the pendency of the Becker

class action suit.

¶29 After careful consideration of the principles at issue, we are persuaded that the

class action tolling rule logically applies here. We thus conclude that Stevens’ amended

complaint was timely filed. We will therefore not reach the issue of whether Novartis

was properly substituted for a fictitious defendant.

¶30 Class action tolling is a matter of first impression in Montana. The doctrine was

first established by the United States Supreme Court in the landmark case American Pipe

& Constr. Co. v. Utah, 414 U.S. 538, 94 S. Ct. 756 (1974). In American Pipe, several

companies were accused of antitrust violations for the alleged price-fixing of steel and

concrete pipe projects, and faced both criminal and civil complaints filed by the federal

government. After the conclusion of the criminal case and the filing of a consent

judgment in the civil case, the State of Utah filed suit, professing to represent a class

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consisting of various state and local governmental bodies damaged by the companies’

price-fixing scheme. Utah’s suit was filed in federal district court within eleven days of

the expiration of the applicable statute of limitations. Seven months later, the court

denied class certification, concluding that the class was not so numerous as to be

impracticable—thus failing the numerosity requirement for class certification under Fed.

R. Civ. P. 23(a). When more than 60 governmental bodies that had been claimed as

members of the original class filed motions to intervene as plaintiffs eight days after class

action status was denied, the court denied their motion on the basis that the statute of

limitations had run.

¶31 The Ninth Circuit reversed. It concluded that “as to the members of the class Utah

purported to represent, and whose claims it tendered to the court, suit was actually

commenced by Utah’s filing,” reasoning that “[t]he claims of appellants were then before

the court and the only question was as to the manner in which they should be entertained

on the merits.” Utah v. American Pipe & Constr. Co., 473 F.2d 580, 584 (9th Cir. 1973).

The United States Supreme Court granted certiorari to “consider a seemingly important

question affecting the administration of justice in the federal courts.” American Pipe,

414 U.S. at 545, 94 S. Ct. at 762.

¶32 The Supreme Court affirmed the Ninth Circuit, holding that “the commencement

of the [class action suit] satisfied the purpose of the limitation provision as to all those

who might subsequently participate in the suit as well as for the named plaintiffs.” The

Court pinned its reasoning on the furtherance of judicial economy. “To hold to the

contrary,” the Court opined, would invite “precisely the multiplicity of activity” that the

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federal rules of procedure were designed to avoid, as individual plaintiffs would be

forced to file preventative motions to join or intervene as parties if the class action status

was still pending at the expiration of the statute of limitations. Id. at 551, 94 S. Ct. at

765. Furthermore, continued the Court, “no different a standard should apply to those

members of the class who did not rely upon the commencement of the class action (or

who were even unaware that such a suit existed),” and who thus “cannot claim that they

refrained from bringing timely motions for individual intervention or joinder because of a

belief that their interests would be represented in the class suit.” Id. The Court reasoned

that “[n]ot until the existence and limits of the class have been established and notice of

membership has been sent does a class member have any duty to take note of the suit or

to exercise any responsibility with respect to it,” and thus, it would be illogical to require

active participation before such point for other purposes such as class action tolling. Id.

at 552, 94 S. Ct. at 765.

¶33 The Court also noted that class action tolling “is in no way inconsistent with the

functional operation of a statute of limitations.” The Court explained that limitation

periods are designed to ensure justice by preventing surprise, but no surprise exists where

defendants are already on notice of the substantive claims being brought against them, as

they may be when a class action suit has been filed. Id. at 554-55, 94 S. Ct. at 766-67.

“Within the period set by the statute of limitations,” the Court concluded, “the defendants

have the essential information necessary to determine both the subject matter and size of

the prospective litigation, whether the actual trial is conducted in the form of a class

action [or not].” Id. at 555, 94 S. Ct. at 767.

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¶34 Recognizing that it was stepping into unknown territory, the Court limited its

holding to instances in which the plaintiffs seek to intervene in a class action where class

certification has been denied. The Court broadened this narrow holding, however, in

Crown, Cork & Seal Co. v. Parker, 462 U.S. 345, 103 S. Ct. 2392 (1983), making clear

that the statute of limitations is tolled not only as to those class members seeking to

intervene in the class action, but also as to individual actions filed by members of the

putative class. 1 The rule established by these two decisions is instructive, but gives little

guidance as to the outer limits of the doctrine, as has been noted by courts and secondary

sources.

¶35 For example, the rule applies to cases filed in federal court, but states are free to

fashion their own class action tolling rules and are not bound by American Pipe. Another

open question is whether the rule should apply equally to all class actions, or whether

distinctions should be recognized, such as between mass tort class actions and securities

class actions. Most importantly for the present case, authorities conflict as to whether the

rule applies when the individual action is filed in a different jurisdiction than the class

action. So called “cross-jurisdictional tolling” has rarely been addressed, and the few

state courts and secondary sources to have considered the doctrine have expressed widely

divergent viewpoints.

1
Crown, Cork & Seal also dispensed with American Pipe’s limitation to instances in which class
certification was denied for failure to satisfy the numerosity requirement of Fed. R. Civ. P. 23(a).
The class in Crown was denied certification for several additional reasons. Other courts
applying class action tolling in the years since then have followed Crown’s lead, and the specific
basis for denial of class certification has rarely been considered a significant factor.
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¶36 Novartis urges this Court not to adopt class action tolling in Montana in the

present case for two principal reasons. First, Novartis argues that the doctrine is

premised on the provision of fair notice to defendants through the claims made in the

class action, and that no such notice was provided in the present case. It contends that the

type of class action suit at issue today—a mass tort—is generally unsuited for class action

tolling. Second, Novartis argues that the more well-reasoned and widely adopted view of

the doctrine rejects cross-jurisdictional tolling, and therefore, as the class action suit was

filed in Tennessee, it should not toll Montana’s statute of limitations. We address these

arguments in turn.

¶37 We first consider the contention that the doctrine should not apply because

Novartis was not afforded proper notice of Stevens’ claims. Novartis advances both

generic and specific arguments on this point. In general, Novartis argues that mass torts

are unsuited for class action tolling, because a central principle of the tolling doctrine—

notice to defendants—is not present. Specifically, Novartis argues that it did not receive

effective notice of Stevens’ claim through the Becker class action suit. Novartis contends

that the policy of affording notice to defendants through statutes of limitation is not

satisfied where neither the individual plaintiffs’ injuries nor the facts necessary to the

claims are substantially similar. Advocates of this view draw a contrast with other class

action suits, such as for securities offerings, where the facts constituting the individual

claims are all but identical. Several courts have found this distinction persuasive. In Bell

v. Showa Denko K.K., 899 S.W.2d 749 (Tex. App. 1995), a Texas court declined to

extend its existing class action tolling rule to a personal injury class action suit,

15
concluding that the distinction between personal injury class actions and other class

actions “is important in determining whether the defendants have received fair notice of

the existence of a claim by the filing of a class suit,” especially given “the variety of

claims necessarily involved in [personal injury cases].” Bell, 899 S.W.2d at 758.

¶38 Similarly, in Jolly v. Eli Lilly & Co., 751 P.2d 923 (Cal. 1988), the California

Supreme Court reversed a lower court’s application of the class action tolling rule in a

suit for personal injuries caused by a defective pregnancy drug. While the decision

turned on the fact that the individual suit sought damages for personal injury while the

class action suit did not, the court offered a variety of reasons why it considered

American Pipe inapposite. The court noted that the elements of personal injury claims

“vary widely from claim to claim,” and that personal injury class action suits might be

“presumptively incapable of apprising defendants of the substantive claims being brought

against them” as a result. Id. at 937 (citation and internal quotation marks omitted). The

court concluded that the class action suit did not “sufficiently put defendants on notice of

the substance and nature of plaintiff’s claims,” and that such notice was “a prerequisite,

in our view, to the application of American Pipe.” Id. at 936-37.

¶39 Novartis contends that the present facts parallel those in Jolly, and do not support

the rationale behind American Pipe because the class action suit failed to put Novartis on

sufficient notice of Stevens’ claims. While we may later encounter a situation in which a

class action suit does not afford sufficient notice to the defendants of subsequent

plaintiffs’ claims, we do not believe we are faced with such an instance today. Novartis’

alleged failure to warn, and the injury caused as a result, serve as the underpinning for

16
both the class action suit and Stevens’ claim, and the warnings issued by Novartis to

healthcare professionals around the country were presumably the same or substantially

similar.

¶40 More importantly, it is not necessary that the claims be identical. Tosti v.

L.A., 754 F.2d 1485, 1489 (9th Cir. 1985) (“[w]e find no persuasive authority for a rule

which would require that the individual suit must be identical in every respect to the class

suit for the statute to be tolled.”). We are not convinced that the nature of the individual

plaintiffs’ claims in American Pipe and its progeny were of substantially greater variance

than the nature of the plaintiffs’ claims in the Becker class action. Under modern

pleading rules, Novartis is only entitled to be noticed of the nature of claim, rather than

the damages alleged, which need not be pleaded specifically. The argument that mass

torts are unsuited for class action tolling seems to afford too little weight to the critical

distinction between variance in damages and variance in the nature of claims. We are

unpersuaded that mass torts are unsuitable for class action tolling.2 We conclude that

Novartis was effectively put on notice of Stevens’ claim by the Becker suit, and allowing

class action tolling in this context would not unfairly prejudice Novartis for lack of

notice.

¶41 We next consider Novartis’ argument that class action tolling should not be

applied here because the class action suit and Stevens’ suit were filed in different

jurisdictions. Novartis correctly observes that state courts have rarely adopted

2
There have been class certifications in mass tort suits. See e.g. In re Agent Orange Prod. Liab.
Litig., 818 F.2d 145, 166-67 (2d Cir. 1987). Likewise, courts have extended class action tolling
in mass tort cases. See e.g. Staub v. Eastman Kodak Co., discussed infra n. 5.
17
cross-jurisdictional tolling, and that the doctrine has been rejected by courts in several

states. The large majority of courts to consider the issue, however, have stopped short of

outright adoption or rejection. While Novartis claims that the doctrine has been “widely

rejected,” in reality the doctrine has seldom been squarely addressed, and it is clear that

its outlines are still in the process of developing. Many of the cases Novartis cites as

“rejecting” the doctrine, for example, are merely circuit court decisions looking to

existing state law, finding no authority one way or the other, and declining to decide the

issue without guidance from the state’s high court. In Clemens v. DaimlerChrysler

Corp., 534 F.3d 1017, 1025 (9th Cir. 2008), for example, the Ninth Circuit declined to

import the doctrine to California law, observing that “[t]he California Supreme Court has

not adopted such cross-jurisdictional tolling,” and deferring to “California’s interest in

managing its own judicial system.”

¶42 Two recent decisions rejecting the doctrine shed light on the rationale behind

limitation of the class action tolling rule to actions filed in the same jurisdiction. In

Portwood v. Ford Motor Co., 701 N.E.2d 1102 (Ill. 1998), the Illinois Supreme Court

affirmed the dismissal of state court claims brought by plaintiffs, who sought to rely on a

federal class action suit to toll the statute of limitations. The court reasoned that while

class action tolling in the same court system furthered judicial economy and was sound

policy, tolling across jurisdictional boundaries “may actually increase the burden” on the

court system of the state adopting cross-jurisdictional tolling, “because plaintiffs from

across the country may elect to file . . . in that state solely to take advantage of the

generous tolling rule.” Id. at 1104. The Illinois court thus rejected the doctrine, claiming

18
that “[b]y rejecting cross-jurisdictional tolling, we ensure that the protective filings

predicted by plaintiffs will be dispersed throughout the country rather than concentrated

in Illinois.” Id. at 1105.

¶43 In Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805 (Tenn. 2000), the

Tennessee Supreme Court rejected cross-jurisdictional tolling for essentially the same

reason. “Adoption of the doctrine,” opined the court, “would run the risk that Tennessee

courts would become a clearinghouse for cases that are barred in the jurisdictions in

which they otherwise would have been brought . . . [w]e cannot sanction such forum

shopping.” Id. at 808. Fearing a “mass exodus of rejected putative class members from

federal court to Tennessee,” the court affirmed a lower court’s ruling that the plaintiffs’

suit was time-barred. Id. at 809. The court also expressed distaste at a perceived lack of

state sovereignty, observing that adoption of the doctrine would give federal courts

control over the running of Tennessee state statutes of limitation.

¶44 Nearly all other negative treatments of the doctrine have either declined to extend

it in the limited circumstances in which it was presented, or have ruled based on existing

precedent established in cases such as Portwood and Maestas.3 It is clear that the main

3
Many of the cases cited by Novartis, much like Clemens v. DaimlerChrysler, are federal court
decisions that decline to extend the doctrine before the state’s highest court has had the
opportunity to consider the issue. See e.g. In re Vioxx Prods. Liab. Litig., 522 F. Supp. 2d 799,
811 (E.D. La. 2007) (declining to expand Puerto Rico’s class action tolling jurisprudence to
include cross-jurisdictional tolling); In re Urethane Antitrust Litig., 663 F. Supp. 2d 1067, 1082
(D. Kan. 2009) (declining to expand Tennessee’s class action tolling jurisprudence to include
cross-jurisdictional tolling in antitrust cases); Thelen v. Mass. Mut. Life Ins. Co., 111 F. Supp. 2d
688, 694-95 (D. Md. 2000) (same, for Maryland); Wade v. Danek Med., Inc., 182 F.3d 281, 287
(4th Cir. 1999) (same, for Virginia); In re Enron Corp. Secs., 465 F. Supp. 2d 687, 722 (S.D.
Tex. 2006) (same, for Texas); Love v. Wyeth, 569 F. Supp. 2d 1228, 1237 (N.D. Ala. 2008)
(same, for Alabama).
19
reason state courts decline to adopt cross-jurisdictional tolling is the fear that doing so

while the doctrine is not yet widely accepted will trigger a rush on the courts of that state.

Courts rejecting the doctrine have paid scant attention to any perceived unfairness to

defendants, with rare exceptions. See e.g. Bell v. Showa Denko K.K., 899 S.W.2d at 758.

Thus, the reasons for rejection of cross-jurisdictional tolling do not generally include a

perceived incompatibility with principles underlying statutes of limitation.

¶45 We conclude that the Becker class action fairly put Novartis on notice of the

substance of Stevens’ claims. This is doubly true because Stevens’ complaint was filed

ten months after the alleged expiration of the limitations period—in stark contrast to

drastic scenarios such as that confronted by the Portwood court, where the plaintiffs

Other courts have concluded that state legislatures are the proper avenue for adoption of
the doctrine, or have otherwise based their decision on a lack of statutory authority. Senger
Bros. Nursery, Inc. v. E.I. Dupont de Nemours & Co., 184 F.R.D. 674, 683 (M.D. Fla. 1999);
Thoubboron v. Ford Motor Co., 624 A.2d 1210, 1213 (D.C. 1993). The only courts that actually
have rejected the doctrine, besides Portwood and Maestas, are Jolly v. Eli Lilly & Co., 751 P.2d
923, 933-38 (Cal. 1988) (rejecting cross-jurisdictional tolling because the class action suit in
question did not provide adequate notice to the defendants, as the class action only sought
monitoring and the individual action was for personal injury. The court explicitly left the door
open for cross-jurisdictional class action tolling in other contexts, but expressed doubt that it
would ever find the doctrine applicable to mass-tort class action suits.), and Bell v. Showa Denko
K.K., 899 S.W.2d 749, 756-58 (Tex. App. 1995) (declining to toll the Texas statute of limitation
by a personal injury class action filed in New Mexico, as a matter of policy and because it was
not properly preserved for appeal); Ravitch v. Price-Waterhouse, 793 A.2d 939, 941-44 (Pa.
Super. 2002) (denying cross-jurisdictional tolling after examining the split in authority and
finding Portwood’s “reasoning persuasive.”). Other cases rejecting the doctrine have merely
applied these cases as precedent. See e.g. Ottaviano v. Home Depot, Inc., USA, 701 F. Supp. 2d
1005, 1012-13 (N.D. Ill. 2010) (applying Portwood); In re Aredia and Zometa Prods. Liab.
Litig., No. 3-06-MD-1760 (M.D. Tenn.) (applying Maestas).
20
sought to get around a limitations failure of over a decade through a class action suit that

had been pending for a full nine years.4

¶46 We are convinced that the decisions adopting cross-jurisdictional tolling more

effectively balance the considerations at issue.5 In Vaccariello v. Smith & Nephew

Richards, Inc., 763 N.E.2d 160 (Ohio 2002), the Ohio Supreme Court heard the claims of

a plaintiff, Vaccariello, injured by a medical device known as a “pedicle screw,”

implanted in her spine to relieve back pain. The trial court denied the defendant’s motion

for summary judgment, concluding that the statute of limitations was tolled during the

pendency of a nationwide class action against the device manufacturer filed in

Pennsylvania federal district court, of which Vaccariello was a potential class member.

The intermediate court reversed, and the Ohio Supreme Court allowed a discretionary
4
The Portwood plaintiffs filed suit in 1991 for property damages allegedly occurring between
1976 and 1979, when the plaintiffs’ Fords suffered from a defect causing the cars to shift without
warning. The plaintiffs claimed that the statute of limitations was tolled by a class action suit
filed in 1981 and not dismissed until 1990. Portwood, 701 N.E.2d at 1102-03.
5
Hyatt Corp v. Occidental Fire & Casualty Co., 801 S.W.2d 382, 389 (Mo. App. 1990)
(applying cross-jurisdictional tolling in personal injury suit without recognizing a distinction
between intra-jurisdictional and cross-jurisdictional tolling); Staub v. Eastman Kodak Co., 726
A.2d 955, 961-68 (N.J. Super. App. Div. 1999) (applying cross-jurisdictional tolling in a
personal injury suit against a drug manufacturer, wherein the court observed that “[w]e see no
reason for tolling to depend on whether the class action is pending in state or federal court,” and
that application of cross-jurisdictional tolling “would tend to promote the efficiency of both state
and federal court systems because suits asserting the individual claims of the class members
might be filed in either court system or in both.” Id. at 967 n. 4); Vaccariello v. Smith & Nephew
Richards, Inc., 763 N.E.2d 160, 162-63 (Ohio 2002) (discussed above); Lee v. Grand Rapids Bd.
of Educ., 384 N.W.2d 165, 168 (Mich. App. 1986) (applying cross-jurisdictional tolling in a state
equal protection suit for claims which were certified in federal court, without recognizing a
distinction between intra-jurisdictional and cross-jurisdictional tolling). Other decisions have
indicated approval of the doctrine. In re W. Va. Rezulin Litig. v. Hutchison, 585 S.E.2d 52, 66 n.
10 (W. Va. 2003) (deciding the case on other grounds, but stating that the lower court’s concern
over differing limitations periods applying to the numerous plaintiffs was misplaced because of
the probable application of the class action tolling rule, and not recognizing a distinction for
cross-jurisdictional tolling); see also Knouse v. Gen. Am. Life Ins. Co., 391 F.3d 907, 914-15 (8th
Cir. 2004); In re Linerboard Antitrust Litig., 223 F.R.D. 335 (E.D. Pa. 2004).
21
appeal. Noting that Ohio’s own class action rule was virtually identical to the federal

rule, the court concluded that “a class action filed in federal court serves the same

purpose as a class action filed in Ohio,” and “[w]hether a class action is filed in Ohio or

in the federal court system, the defendant is put on notice of the substance and nature of

the claims against it.” Id. at 162-63. “Therefore,” concluded the court, “allowing the

filing of a class action in the federal court system to toll the statute of limitations in Ohio

does not defeat the purpose of the statute.” Id. at 163.

¶47 The Vaccariello court then proceeded to discuss Portwood, explaining why it did

not find the holding persuasive:

In Portwood v. Ford Motor Co. (1998) (citation omitted), the
Supreme Court of Illinois rejected cross-jurisdictional tolling “because
plaintiffs from across the country may elect to file a subsequent suit in that
state solely to take advantage of the generous tolling rule,” thereby
burdening Illinois’ court system. We are not persuaded that this is a
realistic potential problem.

Our holding today merely allows a plaintiff who could have filed
suit in Ohio irrespective of the class action filed in federal court in
Pennsylvania to rely on that class action to protect her rights in Ohio. To
do otherwise would encourage all potential plaintiffs in Ohio who might be
part of a class that is seeking certification in a federal class action to file
suit individually in Ohio courts to preserve their Ohio claims should the
class certification be denied. The resulting multiplicity of filings would
defeat the purpose of class actions.

Id. We agree with these considerations. We do not expand access to Montana’s courts

beyond the access to which out-of-state plaintiffs are already entitled. Our state’s policy

is plainly stated in the Montana Constitution: “[c]ourts of justice shall be open to every

person, and speedy remedy afforded for every injury to person, property, or character.”

Mont. Const. art. II, § 16. The right of access to our court system is “unrestricted by

22
reference to residence or citizenship,” and an out-of-state plaintiff has “the same rights

and duties as a citizen of this state.” LaBella v. Burlington N., 182 Mont. 202, 207, 595

P.2d 1184, 1187 (1979) (internal citations and quotation marks omitted); § 49-1-204,

MCA. Any citizen of the United States may file suit in Montana’s courts, provided that

jurisdiction may properly be asserted over the defendant. Thus, our decision today does

not expand the class of potential plaintiffs in Montana.

¶48 We concede, however, that in adopting cross-jurisdictional tolling we may well

create the incentive complained of in Portwood and Maestas, for out-of-state plaintiffs to

file suit in Montana courts when their claims are time-barred in other jurisdictions. We

do not dismiss this concern lightly. While the Vaccariello court opined that “[o]ur

holding does not invite plaintiffs who have no relationship to Ohio to file suit in our

courts,” we acknowledge that our holding today may indeed encourage plaintiffs with

“no relationship to Montana” to file suit in our courts, if their claims are stale elsewhere.

Vaccariello, 763 N.E.2d at 163. But as we have observed above, all plaintiffs, regardless

of residency, are constitutionally guaranteed the right to file suit in Montana. We

conclude that the best judge of these competing arguments will be experience. As we

have noted when faced with similar situations, “if a substantial increase in this type of

litigation is called to our attention in the future we will reexamine the situation in light of

what we have herein stated.” Labella, 182 Mont. at 207, 595 P.2d at 1187 (quoting State

ex rel. Great N. Ry. v. Dist. Ct., 139 Mont. 453, 457, 365 P.2d 512, 514 (1961), and

concluding that Montana’s open court policy, as set out in Mont. Const. art II, § 16,

guarantees out-of-state plaintiffs the right to file in Montana state courts.).

23
¶49 Thus, although avoiding the possibility of a rush of out-of-state plaintiffs filing in

our court system is concededly a valid policy objective, we consider this objective less

compelling than competing considerations. We suspect that a greater burden on the court

system will be imposed by not adopting the rule, as plaintiffs would be required to file

protective individual suits in Montana courts to avoid limitations defenses, while

otherwise relying on a pending class action suit filed elsewhere. This directly conflicts

with the rationale underlying the class action tolling rule: to promote judicial economy by

encouraging individual plaintiffs to defer to class action suits to protect their claims. We

see no reason why jurisdictional boundaries should operate as a bar to the application of

this policy. Where, as here, the defendants are already on fair notice of the claims against

them through a timely class action suit, the policies underlying the limitations period are

not subverted.

¶50 We recognize that in some instances a class action suit may not fairly put the

defendants on notice. Our adoption of the rule is therefore limited to situations in which

defendants are fairly put on notice of the substantive claims against them. Were we

confronted with a case such as that faced by the California Supreme Court in Jolly, where

the individual claim sought damages for personal injuries but the class action suit sought

only monitoring, we would likely not see fit to extend the doctrine. Jolly, 751 P.2d at

936. Similarly, the present case involved an alleged limitations failure of under a year.

Were we to confront a situation such as the one faced by the Portwood court—where the

class action suit was alleged to have tolled the statute of limitations for over a decade—

we might find the principles of notice and fairness to defendants not met and the doctrine

24
inapplicable. Thus, before tolling the statute of limitations during the pendency of a class

action suit, we must examine the circumstances present in the case to ensure that

defendants are not unfairly prejudiced, regardless of the jurisdictions in which the actions

are filed. On the facts before us today, we conclude that tolling our state statute of

limitations best upholds the competing policies at issue.

¶51 Because we determine that the statute of limitations was tolled during the

pendency of the Becker suit, we conclude that Stevens’ complaint was timely filed. We

thus do not reach the question of whether Novartis was properly named as a fictitious

defendant under § 25-5-103, MCA.

¶52 2. Whether the District Court erroneously instructed the jury as to Novartis’
duty to warn.

¶53 Novartis contends that it is entitled to a new trial because the District Court

incorrectly instructed the jury that it had a duty to warn health care professionals other

than Stevens’ prescribing physician. Under the “learned intermediary” doctrine adopted

by Montana in Hill v. Squibb & Sons, E. R., 181 Mont. 199, 206, 592 P.2d 1383, 1387-88

(1979), Novartis argues, its duty to warn extends only to the prescribing physician—in

this case, Dr. Schmidt. Stevens counters that Novartis misrepresents the holding in Hill,

and that the District Court correctly stated the duty to warn as set out in the Restatement

(Third) of Torts (hereafter, “the Restatement”), which provides that warnings must be

provided to “prescribing and other healthcare providers who are in a position to reduce

risks of harm.” Restatement (Third) of Torts: Products Liability § 6(d)(1) (1998).

Novartis asserts that the Restatement’s version of the doctrine is in conflict with the

25
majority view, which has been adopted by Montana. Novartis supports this contention by

noting that Montana has not adopted this latest version of the Restatement. Stevens

responds that the distinction made by Novartis between Montana law and the

Restatement is a false one, and that the particular facts surrounding Stevens’ care support

the Restatement’s expression of the doctrine.

¶54 The learned intermediary doctrine has been widely accepted, in some form, for the

better part of the past century. Although Novartis asserts that we adopted a controlling

interpretation of the doctrine in Hill, that case was decided on entirely different grounds

and contained no discussion, or even specific mention, of the learned intermediary

doctrine. We thus agree with Stevens that Novartis ascribes improper weight to dicta in

Hill, and conclude that the greater body of common law offers a fuller, more

perspicacious perspective on the doctrine.

¶55 Despite its wide acceptance, the doctrine has constantly been under attack, and has

evolved through the years to confront the changing nature of the healthcare system. Part

of this evolution has been a movement away from limiting the doctrine’s applicability to

the prescribing physician alone. The version of the doctrine set out in the Restatement,

which includes “other healthcare providers” in the possible class of learned

intermediaries, reflects this modern trend. In traditional doctor-patient relationships, the

doctor provides the patient with the resources to make an informed choice, through

explanation of the risks and benefits involved with a certain drug and knowledge of the

patient’s medical history. In these conventional, individualized doctor-patient

relationships, the doctor is in the best position to understand and communicate warnings

26
effectively to the patient—the “learned intermediary” standing in between the patient and

the pharmaceutical company. The modern healthcare system, however, places far less

emphasis on these traditional relationships, and patients today often receive the majority

of their care from nurses, nurse practitioners, physicians’ assistants, and physicians other

than the prescribing physician. Appropriately, in situations where the underlying

rationale of the doctrine—the traditional doctor-patient relationship—is no longer

present, the doctrine has adapted to fit the realities of the situation.

¶56 This evolution has occurred on two principal fronts. The first of these, which has

received the lion’s share of the attention but is not at issue today, is when the duty to

warn is extended not only to other healthcare providers, but to patients—thus, not

applying the doctrine at all.6 The second, which is directly relevant to our discussion, is

6
Three exceptions to the doctrine, imposing a duty to warn the consumer, have arisen in the
courts. First, public health clinics and mass immunization programs have commonly been found
to lack the requisite doctor-patient relationship. See e.g. Davis v. Wyeth Laboratories, 399 F.2d
121, 131 (9th Cir. 1968) (manufacturer of polio vaccine was not protected by the learned
intermediary doctrine because the vaccine was dispensed at a mass immunization clinic, outside
the context of the doctor-patient relationship); accord Reyes v. Wyeth Laboratories, 498 F.2d
1264, 1276-77 (5th Cir. 1974), cert. denied, 419 U.S. 1096, 95 S. Ct. 687 (1974). Second, when
the patient is actively involved in choosing to use a given drug, some courts have not applied the
doctrine. This exception has usually arisen in relation to birth control pills. See e.g. MacDonald
v. Ortho Pharm. Corp., 475 N.E.2d. 65, 68-70 (Mass. 1985); Hill v. Searle Laboratories, 884
F.2d 1064, 1070-71 (8th Cir. 1989). Third, some courts have declined to apply the doctrine
where there has been excessive direct-to-consumer advertising of the drug. See e.g. State ex rel.
Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 901 (W. Va. 2007).
Secondary sources have vigorously argued for both preservation of the doctrine, and for
its elimination in some (or all) circumstances. For a defense of the traditional form of the
doctrine, see Jennifer Girod, Note, The Learned Intermediary Doctrine: An Efficient Protection
for Patients, Past and Present, 40 Ind. L. Rev. 397, 398 (2007) (arguing that while doctor-patient
relationships have changed since the doctrine was first adopted, the doctrine is as relevant as ever
because the disparity between physician and patient knowledge still exists). For arguments
against the doctrine’s continued relevancy, see Susan A. Casey, Comment, Laying an Old
Doctrine to Rest: Challenging the Wisdom of the Learned Intermediary Doctrine, 19 Wm.
Mitchell L. Rev. 931, 934-37 (1993); Teresa Moran Schwartz, Consumer-Directed Prescription
27
the evolution of the doctrine through an expansion of the possible class of learned

intermediaries. This development, likewise spurred by the fact that the medical

professionals with whom patients most commonly interact are often no longer primary

physicians, has led courts and secondary sources such as the Restatement to suggest that

a variety of different healthcare providers may be considered learned intermediaries,

depending on the unique facts of the patients’ treatment scenario.7

Drug Advertising and the Learned Intermediary Rule, 46 Food Drug Cosmetic L. J. 829, 829-31
(1991).
7
See Holley and McEwen, discussed infra ¶¶ 57-58; Whitley v. Cubberly, 210 S.E.2d 289, 292
(N.C. 1974) (requiring warnings to all members of the “medical profession” using the drug);
Singleton v. Airco, 314 S.E.2d 680 (Ga. 1984) (considering the adequacy of warnings directed at
trained nurse anesthesiologists); Mazur v. Merck & Co., 964 F.2d 1348, 1356 (3d Cir. 1992)
(declining to extend the doctrine to a school nurse, but indicating that the doctrine would extend
to nonprescribing physicians, physicians’ assistants, and nurses acting in an area of special
expertise); Walker v. Merck & Co., 648 F. Supp. 931, 934-35 (M.D. Ga. 1986), aff’d, 831 F.2d
1069 (11th Cir. 1987) (finding that Georgia law considered nurse practitioners to be learned
intermediaries); Rohrbough v. Wyeth Labs., 719 F. Supp. 470, 478 (N.D. W. Va. 1989)
(designating registered nurses who administered vaccines as learned intermediaries); Wyeth-
Ayerst Lab Co. v. Medrano, 28 S.W.3d 87, 92-94 (Tex. Ct. App. 2000) (concluding that the
doctrine applies to advanced practice nurses who prescribe medication and treat patients without
the supervision of a physician); Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 142 (3d Cir. 1973)
(extending the duty to warn to treating as well as prescribing physicians).
For secondary sources arguing for or observing the doctrine’s evolution to fit modern
healthcare, see Robert J. Friedman, Take Two of These and Sue Me in the Morning: Efficacy of
the Learned Intermediary Doctrine in Prescription Drug Failure to Warn Cases, 22 St. Thomas
L. Rev. 278 (2010); Ozlem A. Bordes, The Learned Intermediary Doctrine and Direct-to-
Consumer Advertising: Should the Pharmaceutical Manufacturer Be Shielded from Liability?,
81 U. Det. Mercy L. Rev. 267, 267-68 (2004); Timothy S. Hall, Reimagining the Learned
Intermediary Rule for the New Pharmaceutical Marketplace, 35 Seton Hall L. Rev. 193, 198
(2004); Sheryl Calabro, Note, Breaking the Shield of the Learned Intermediary Doctrine:
Placing the Blame Where It Belongs, 25 Cardozo L. Rev. 2241, 2254-56 (2004); Daniel
Richardson, Note, The Lost Child of Products Liability: New Thoughts about Advertising and the
Learned Intermediary Doctrine, 27 Vt. L. Rev. 1017, 1018 (2003); Paul F. Strain & Christina
Gaarder, Direct-to-Consumer Advertising and the Learned Intermediary Doctrine: Unsettling a
Settled Question, 30 U. Balt. L. Rev. 377, 382-83 (2001); Mitchell S. Berger, A Tale of Six
Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned
Intermediary Doctrine to Direct-to-Consumer Drug Promotion, 55 Food & Drug L.J. 525, 551
(2000); Timothy A. Pratt & John F. Kuckelman, The Learned Intermediary Doctrine & Direct-
28
¶57 For example, in Holley v. Burroughs Wellcome Co., 330 S.E.2d 228, 235-36

(N.C. App. 1985), the court considered a registered nurse anesthesiologist who was

responsible for the patient’s anesthesia to be a learned intermediary to whom the

manufacturer owed a duty to warn. The CRNA failed to recognize a known adverse

reaction, which caused permanent brain damage in the patient. Just as Novartis argues

today, the manufacturer asserted that its duty to warn was satisfied because the learned

intermediary doctrine limited the scope of its duty to warn to the prescribing physician.

The court was not persuaded. Noting that it was “standard practice” for CRNAs to be

responsible for monitoring, maintenance, and supervisory care of anesthetized patients,

the court dismissed the argument that the duty to warn only extended to the prescribing

physician as “unpersuasive in the present context,” and “not appropriate in actions like

the present one.” Id. at 235. The court reasoned that while the “[d]efendants’ argument

would be appropriate in cases . . . where a nurse only administered a medicine . . . but

was otherwise not responsible for the patient’s care,” the nurse anesthesiologist in Holley

was responsible for all aspects of patient treatment. Thus, the court concluded, the duty

to warn ought to apply to her as the primary healthcare provider standing in between the

patient and the manufacturer. Id.

To-Consumer Advertising of Prescription Drugs, 51 Fed’n. Ins. & Corp. Counsel Q. 17 (2000),
available at http://www.thefederation.org/documents/pratt.htm (April 5, 2004); Catherine A.
Paytash, Note, The Learned Intermediary Doctrine and Patient Package Inserts: A Balanced
Approach to Preventing Drug-Related Injury, 51 Stan. L. Rev. 1343, 1349 n. 24 (1999); Edward
W. Gerecke & Harvey L. Kaplan, The Restatement (Third) of Torts and its Projected Impact
Upon Manufacturers of Prescription Drugs and Medical Devices, Drug and Medical Device
Litigation: Defense Perspectives, 2 Def. Research Inst. 70, 71 (1998); 63A Am. Jur. 2d Products
Liability §§ 1206-07 (1997); Jerry J. Phillips, Products Liability in a Nutshell 225-29 (4th ed.,
West 1993) (hornbook discussion of the doctrine).
29
¶58 Similarly, in McEwen v. Ortho Pharm. Corp., 528 P.2d 522, 528-30 (Or. 1974),

the court reviewed the underlying premise of the doctrine and extended the duty to warn

beyond the prescribing physician. The plaintiff had been prescribed a contraceptive, but

received treatment for a negative reaction to the drug from other physicians. The court

explained that “[a]lthough the ethical drug manufacturer’s duty to warn has been

discussed most often with reference to the prescribing physician, the [doctrine’s]

reasoning applies with equal force to the treating physician . . . [who] may be more likely

to observe the actual symptoms of the drug’s untoward consequences.” The court

concluded that the manufacturer’s duty to warn “extends, then, to all members of the

medical profession who come into contact with the patient in a decision-making

capacity.” Id. at 529.

¶59 The realities of modern medicine increasingly conflict with the learned

intermediary doctrine’s underlying premises. Unsurprisingly, the doctrine is in a state of

flux as it adapts to new medical practices. We need not set out the precise confines of the

doctrine as it would apply to numerous hypothetical scenarios. We concur with

authorities who consider the learned intermediary to be the healthcare professional

actually responsible for making decisions related to the patient’s care, especially when

the prescribing physician is no longer involved with the continuing treatment and

supervision of the patient. In these instances, the underlying rationale of the

individualized relationship between the prescribing physician and the patient is truly no

longer present. Here, it is clear that Stevens received much of her treatment from nurses,

treating physicians, and nurse practitioners, and that Dr. Schmidt was rarely, if ever, a

30
participant in her continuing care. Most importantly, when Stevens called Dr. Schmidt’s

practice to discuss the risk of dental surgery while on Zometa, she spoke with a locum

tenens physician rather than Dr. Schmidt herself.

¶60 These facts suggest that the scope of Novartis’ duty to warn, in this case, would

presumably include at least the treating locum tenens physicians at Guardian Oncology

who counseled Stevens on dental surgery, if not the nurses who routinely administered

Zometa to Stevens. 8 We do not find the Restatement, nor the District Court’s

instructions, at odds with the body of law in this area, or with any precedent set out by

this Court in Hill. We need not conclusively decide this issue today, however, because

Novartis cannot demonstrate that the instruction resulted in prejudicial error.

¶61 Novartis cannot demonstrate prejudicial error because the jury verdict form

allowed the jury to find Novartis negligent without relying on the allegedly deficient jury

instruction. The jury verdict form asked whether Novartis was negligent “in its label or

information to Dr. Judy Schmidt and Guardian Oncology treating professional staff.”

(Emphasis added.) Accordingly, the jury had two options: (A) the label was inadequate,

or (B) the information provided to Dr. Schmidt and the treating staff was inadequate.

The error complained of—an overbroad scope of the duty to warn—is only implicated

8
The trial court also seemed to include Dr. Morris, the oral surgeon, within the scope of the duty
to warn. Novartis asserts that this was erroneous; however, any such error could not have
affected the verdict, as the jury verdict form asked only whether Novartis was negligent in its
warnings to Dr. Schmidt and Guardian Oncology staff—thus excluding Dr. Morris from
consideration.
31
with regard to (B), the “information,” and not with regard to (A), the label.9 Accordingly,

Novartis cannot demonstrate that the duty to warn was even considered by the jury in

reaching its verdict, and therefore cannot demonstrate prejudicial error as a result of the

instruction.

¶62 Thus, while we would tend to conclude that the jury instruction correctly

instructed the jury on the applicable law, we need not definitively resolve this issue

today. It is clear that because the instruction was not implicated by one of the two

mutually exclusive alternatives, Novartis cannot demonstrate that the instruction resulted

in prejudicial error. We affirm the District Court.

¶63 3. Whether the District Court erred in refusing Novartis permission to amend its
complaint to include an apportionment defense.

¶64 We review the denial of a motion to amend, like other discretionary rulings made

by a district court, for an abuse of discretion. Deschamps v. Treas. St. Trailer Ct., Ltd.,

2010 MT 74, ¶ 18, 356 Mont. 1, 230 P.3d 800. The trial court’s decision will not be

reversed in the absence of an affirmative showing of abuse of that discretion resulting in

prejudice. Id. (citing Callan v. Hample, 73 Mont. 321, 326, 236 P. 550, 551-52 (1925)).

Amendments are permitted by M. R. Civ. P. 15(a), which provides that a party may

amend the party’s pleading by leave of the court. The proposed amendment should be

9
The “information” provided by Novartis appears from the record to consist of two items: 1) the
label, that is, the package insert in every Zometa package, and 2) a letter that Novartis sent to
Dr. Schmidt, in response to an inquiry Dr. Schmidt made regarding two Zometa patients who had
developed ONJ. As Dr. Schmidt was apparently the only recipient of this letter, the
“information” received by Dr. Schmidt and other clinic staff was arguably different, which
implicates the scope of Novartis’ duty to warn. The label, in contrast, was obviously the same
for all and was received by everyone at the clinic, and thus does not implicate the scope of the
duty to warn.
32
permitted, in keeping with the policy that leave to amend “shall be freely given when

justice so requires,” unless: (1) the “motion causes undue delay, is made in bad faith, is

based upon a dilatory motive on the part of the movant, or is futile,” or (2) “the party

opposing the amendment would incur substantial prejudice as a result of the

amendment.” Stundal v. Stundal, 2000 MT 21, ¶ 12, 298 Mont. 141, 995 P.2d 420.

¶65 The District Court denied Novartis permission to amend its complaint to assert a

defense seeking to apportion liability between Novartis and Dr. Schmidt for the damages

suffered by Stevens. The court’s stated basis was that Novartis had not acted with

reasonable promptness, given that almost two months had passed since the notice of

settlement between Dr. Schmidt and Stevens. The court reasoned that to allow

amendment to include a completely new defense with less than a month before trial

would substantially prejudice Stevens, who had repeatedly sought to discover whether

Novartis planned on asserting that any third parties shared responsibility for Stevens’

injuries.

¶66 We conclude that it was within the District Court’s discretion to deny leave to

amend the pleadings. Novartis sought to introduce an entirely new defense shortly before

the trial date and offers no persuasive reason for its delay in doing so. Stevens’ counsel

had clearly been trying for some time to learn whether Novartis sought to add this

defense, which would plainly be a central and vigorously contested issue at trial, in an

effort to prepare adequately should Novartis seek to apportion liability. We see no reason

aside from an attempt to gain an advantage why Novartis should not have made clear its

intention to blame Dr. Schmidt from its initial appearance in the case. Its delay in doing

33
so until Dr. Schmidt no longer had a reason to defend herself speaks volumes. Novartis’

complaint that the District Court’s ruling on this issue caused it irreparable harm by

“preventing it from making the case for the liability of Dr. Schmidt” is a far cry from an

accurate representation of the proceedings below. Novartis easily could have made such

a case, were it upfront about its intention to do so at any time in the eight months after it

was joined as a party. We affirm the District Court’s denial of leave to amend.

¶67 4. Whether the District Court erred in excluding statements made in prior
pleadings that were allegedly inconsistent with Novartis’ liability.

¶68 Novartis argues that it was deprived of a fair trial by the District Court’s exclusion

of two statements made in prior pleadings: a statement made by Stevens in her initial

complaint in the present case, and a statement made by Dr. Morris in an answer filed in

response to Stevens’ complaint against him before the MMLP. We will first set out the

general framework governing admissibility of prior pleadings, and then address each

statement in turn.

¶69 A. Admissibility of prior pleadings in general.

¶70 At common law, statements in pleadings were generally not admissible as

evidence. This rule arose from the former nature of pleadings, which were filled with

hypothetical allegations and legal conclusions framing the issues of the case in terms of

numerous fictional common-law counts.10 These pleadings served technical and

discovery purposes, and statements made therein were rightly considered attributable to

10
Note, The Admission in Evidence of Pleadings Under the Codes and Under the Federal Rules
of Civil Procedure, 106 U. Pa. L. Rev. 98, 98 (1958).
34
the attorney rather than the client on whose behalf the pleading was prepared.11 But with

the adoption of the modern rules eschewing technical pleading in favor of fact-based

pleading, the underlying rationale behind the rule began to fade away. As the modern

system requires parties to plead facts, the statements made in pleadings are now often

considered to have evidentiary value. Modern pleadings also service a notice function

and permit hypothetical and inconsistent claims, however, so some limitations do exist.

¶71 The manner in which these statements are admissible in court depends on a variety

of factors. Such factors may include: whether the statements in the pleadings are sought

as substantive evidence or as impeachment evidence, whether the pleadings have been

since amended or superseded, whether the pleadings were filed in the same case or in an

unrelated action, or whether the statements are of fact or law, among other

considerations. Admissibility is of course also subject to traditional evidentiary

considerations, such as relevance, materiality, and prejudice. The common law rule

barring the evidentiary use of pleadings has survived only as an exception, as some courts

have declined to hold parties responsible for allegations in their pleadings when it is

evident that they truly had little idea of the contents therein.12

11
Patrick Hughes, Evidence: Can What I Said Be Held Against Me?: Admitting Settlement
Agreements and Prior Pleadings in Multiple-Defendant Comparative Negligence Actions, 32
Washburn L.J. 260, 269 n. 58 (1993).
12
81 Am. Jur. 2d Witnesses § 908 (2004) provides:
As a general rule, statements made in a pleading are admissible to discredit or
impeach the pleader when he or she becomes a witness . . . except where the
pleader cannot be personally charged with responsibility for the allegations of the
pleading, as where he or she was not aware of the contents of the pleading, or did
not sign or authorize it or have knowledge of the allegations in question.
35
¶72 B. Stevens’ statement.

¶73 In the present suit, before Novartis was joined to the case, Stevens alleged that

Dr. Schmidt was aware of the risks associated with Zometa and was negligent in failing

to communicate those risks. This statement was made in Stevens’ original complaint,

and was repeated in her amended complaint, expert disclosures, and discovery responses

to Dr. Schmidt. In the lower court, Novartis offered two rationales for the admissibility

of these statements. First, Novartis argued that the statements were admissible as judicial

admissions. Alternatively, Novartis argued that the positions taken in these pleadings

were inconsistent with Stevens’ position at trial and that Stevens should therefore be

judicially estopped from denying their veracity. We discuss these contentions in turn.

¶74 Novartis first argues that the statements made by Stevens in her prior pleadings are

judicial admissions. Montana’s general rule is that “allegations, statements, or

admissions contained in a pleading are conclusive as against the pleader, and are

admissible as against the party making them in the litigation as proof of the facts which

they admit.” Meadow Lake Ests. Homeowners Ass’n v. Shoemaker, 2008 MT 41, ¶ 45,

341 Mont. 345, 178 P.3d 81 (quoting Anderson v. Mace, 99 Mont. 421, 427-28, 45 P.2d

771, 773-74 (1935)). Judicial admissions may clearly be made at “any point during the

litigation process,” including “during discovery, pleadings, opening statements, direct

and cross-examination, as well as closing arguments.” In re Est. of Hill, 281 Mont. 142,

149-50, 931 P.2d 1320, 1325 (1997) (quoting Kohne v. Yost, 250 Mont. 109, 112, 818

P.2d 360, 362 (1991)). In Montana, a judicial admission “has a conclusive effect upon

the party who makes it, and prevents that party from introducing further evidence to

36
prove, disprove, or contradict the admitted fact.” In re Raymond W. George Trust, 1999

MT 223, ¶ 36, 296 Mont. 56, 986 P.2d 427 (quoting DeMars v. Carlstrom, 285 Mont.

334, 337, 948 P.2d 246, 248 (1997)). A judicial admission is not binding, however,

unless it is an unequivocal statement of fact, as opposed to a conclusion of law or the

expression of an opinion. Id. at ¶ 37 (emphasis added) (citing DeMars, 285 Mont. at 338,

948 P.2d at 249; Kohne, 250 Mont. at 113, 818 P.2d at 362).

¶75 In George Trust, we held that a statement made by a party relating to that party’s

ownership of an interest in trust property was a conclusion of law, not a statement of fact,

and was thus not a judicial admission. In the present case, the statements made by

Stevens through her attorney were allegations made on the flawed information available

to Stevens at the time, which demonstrates that they were mere expressions of opinion

and conclusions of law, rather than statements of fact. “[A] judicial admission applies to

facts, not to legal theories or positions.” Stanley L. and Carolyn M. Watkins Trust v.

Lacosta, 2004 MT 144, ¶ 34, 321 Mont. 432, 92 P.3d 620. The District Court correctly

ruled that Stevens’ statements made in prior pleadings were not judicial admissions

because they were not statements of fact.

¶76 Novartis next contends, in the alternative, that Stevens should be judicially

estopped from denying the statements made in her prior pleadings. The doctrine of

judicial estoppel precludes a party from taking a position inconsistent with previously

made declarations in a subsequent action or proceeding. Watkins Trust, ¶ 33. Judicial

estoppel applies only when: (1) the estopped party had knowledge of the facts at the time

he or she took the original position; (2) the estopped party succeeded in maintaining the

37
original position; (3) the position presently taken by the estopped party is inconsistent

with its original position; and (4) the original position misled the adverse party so that

allowing the estopped party to change its position would injuriously affect the adverse

party. Id. (citing Kauffman-Harmon v. Kauffman, 2001 MT 238, ¶ 16, 307 Mont. 45, 36

P.3d 408).

¶77 We conclude that the doctrine of judicial estoppel is not applicable here. First, the

present case is not a “subsequent action or proceeding”—it is the same proceeding, as

Stevens correctly observes. Furthermore, there is nothing to suggest that Novartis was

“misled” by Stevens’ alleged prior positions. Nor has Novartis shown that Stevens had

knowledge of the facts surrounding Novartis’ prior warnings to Dr. Schmidt at the time—

to the contrary, the record suggests that Stevens believed that the failure to warn was

attributable to Dr. Schmidt rather than Novartis.

¶78 Novartis also raises the argument, for the first time on appeal, that the pleadings

are admissible pursuant to M. R. Evid. 801(d)(2), as statements of a party offered against

a party. While sometimes referred to as “admissions against interest,” statements under

Rule 801(d)(2) need not be against the party’s interest at the time the party made the

statement, nor need be a statement of fact rather than a legal opinion or position. Kristine

C. Karnezis, Admissibility of Party’s Own Statement Under Rule 801(d)(2)(A) of the

Federal Rules of Evidence, 191 A.L.R. Fed. 27, 72-78 (2003). Statements made by an

attorney in prior pleadings, discovery materials, and the like are generally admissible

against clients under the federal rule, which is “identical” to the Montana rule. Commn.

Comments, M. R. Evid. 801(d)(2)(A); Karnezis, 191 A.L.R. Fed 27 at 170-81; Totten v.

38
Merkle, 137 F.3d 1172, 1176 (9th Cir. 1998); Dugan v. EMS Helicopters, Inc., 915 F.2d

1428, 1431-34 (10th Cir. 1990). But regardless of the strength or weakness of this

theory, the trial court must be given the opportunity to weigh such an argument against

traditional evidentiary considerations such as prejudice and relevance, which might still

tip the scales in favor of the inadmissibility of the statement. We will not fault the

District Court for failing to rule on an issue it was never given the opportunity to

consider. The rule is well established that this Court will not address an issue raised for

the first time on appeal. State v. Gomez, 2007 MT 111, ¶ 21, 337 Mont. 219, 158 P.3d

442 (citing State v. Peterson, 2002 MT 65, ¶ 24, 309 Mont. 199, 44 P.3d 499).

¶79 For the reasons above, we affirm the District Court’s exclusion of the prior

statements made by Stevens concerning Dr. Schmidt’s alleged culpability.

¶80 C. Dr. Morris’ statement.

¶81 Novartis maintains that the trial court erred by excluding a statement contained in

a pleading filed by Dr. Eugene Morris before the Montana Medical Legal Panel (MMLP).

The response, prepared by Dr. Morris’ attorney, was filed in answer to Stevens’ MMLP

complaint against Dr. Morris. Novartis sought to use the answer, which stated that

extraction of Stevens’ tooth through dental surgery was “the only realistic treatment

option,” to impeach Dr. Morris’ trial testimony that alternatives to extraction did exist.

Novartis maintains that this evidence was critical to its argument as to proximate cause,

because it shows that Stevens had no option but to undergo the dental surgery, and that a

failure to warn could thus not have caused Stevens’ injury.

39
¶82 Two considerations relate to the statement’s admissibility. First, the parties

dispute whether the statement is admissible for impeachment purposes as a prior

inconsistent statement made by Dr. Morris. The trial court supported Stevens’ argument

that the statement should be excluded because it was not a statement of the witness,

Dr. Morris—it was a statement of the witness’ attorney, unsigned by the witness, and

thus could not be used to impeach the witness. Second, the parties dispute the holding in

Linder v. Smith, 193 Mont. 20, 30, 629 P.2d 1187, 1192 (1981), a Montana Supreme

Court case that held a prior statutory bar on use of MMLP proceedings for impeachment

purposes unconstitutional. Novartis maintains that the decision made all parts of the

MMLP proceedings available for impeachment purposes, while Stevens asserts that the

holding is limited to sworn testimony given during a MMLP hearing. We will first

consider whether the statement is available for impeachment purposes as a prior

inconsistent statement.

¶83 M. R. Evid. 801 provides that if a declarant testifies at trial, is subject to

cross-examination, and makes a statement which is inconsistent with a prior statement,

then the prior inconsistent statement is by definition not subject to the hearsay bar.

Clearly, the statement made in Dr. Morris’ prior pleading was inconsistent with his

testimony in trial. But while some jurisdictions condition admissibility of prior pleadings

on whether they are signed or otherwise verified,13 in Montana, parties are responsible for

all statements made by their attorneys within the scope of representation, whether made

13
For a list of cases, see Note, supra n. 10, at 100 nn. 13-14; Floyd E. Lawson, Jr., Pleadings
and Practice—Evidence—Admissibility of Pleadings into Evidence in Missouri, 27 Mo. L. Rev.
258, 265 n. 55 (1962).
40
in pleadings or in open court. Est. of Hill, 281 Mont. at 149, 931 P.2d at 1325; Kohne,

250 Mont. at 112, 818 P.2d at 362; Rasmussen v. Heebs Food Ctr., 270 Mont. 492, 496-

97, 893 P.2d 337, 340 (1995).14 We therefore conclude that the District Court erred to

whatever extent it based its decision to exclude the statement on the fact that the

pleadings were prepared by Dr. Morris’ attorney.15 We will uphold the District Court if it

reaches the right result for the wrong reason, however, and thus we must consider

whether the statement was otherwise inadmissible, and whether any error constitutes

grounds for reversal.

¶84 Dr. Morris’ prior inconsistent statement arose out of the action filed against him

by Stevens before the MMLP. The proceedings of the Panel are similar in form to

regular court actions, but are entirely a creature of statute, separate and distinct from

regular courts and the rules applicable to regular court actions. It is therefore incorrect to

assume that principles applicable to standard proceedings are also applicable to MMLP

proceedings, despite their outward similarity. The Act stresses that MMLP hearings are

“confidential and informal,” and that “the Montana Rules of Evidence shall not apply to

hearings before the Panel.” Section 27-6-502, MCA, Rule 15(c). It is unclear, however,

to what degree the statutorily-mandated confidentiality of the proceedings overrides

competing principles. In Linder, we severed part of the Act sua sponte, on the basis that
14
Stevens’ counsel stressed that the answer filed by Dr. Morris in the MMLP proceeding was
informal and that Dr. Morris had little awareness of its contents, seeking (without stating as
much) an exception in Montana law for situations in which the statements of counsel are not
fairly attributed to the party. We express no opinion on the merits of such an exception—we
merely observe that the position Stevens advanced, and that the District Court apparently agreed
with, is not the law in Montana.
15
We note that the basis for the lower court’s ruling on this matter is somewhat unclear, and may
have included consideration of arguments advanced by counsel but not repeated on the record.
41
it unconstitutionally infringed on the right to impeach the sworn testimony of a witness,

by providing that “[no] statement made by any person during a hearing before the panel

may be used as impeaching evidence in court.” Linder, 193 Mont. at 30, 629 P.2d at

1192. This holding involved testimony before the MMLP panel, and not pleadings in the

proceeding, as Stevens correctly observes. Conversely, however, as pleadings are not

specifically addressed, it is unclear whether the general confidentiality provisions of the

MMLP Act would trump the right to impeach a witness with a prior inconsistent

statement made in the pleadings.16

¶85 Furthermore, assuming that the holding in Linder makes only sworn testimony

available for use for impeachment purposes, it still remains unclear whether inconsistent

statements made during other parts of the proceeding would be available for

16
Our decision in State ex rel. Hufford v. Montana Medical-Legal Panel, 223 Mont. 73, 724 P.2d
186 (1986), provides a slight modicum of clarity on the issue. In Hufford, we considered
plaintiffs’ contention that the right to cross-examine witnesses at trial required that a transcript of
MMLP proceedings be made available to them. The District Court ruled that the inability to
access the transcript amounted to a denial of due process, but we reversed, explaining that “the
very nature of the purpose of the Panel is advisory and therefore confidential,” and that “denial
of a transcript does not destroy the right of a party to fully cross-examine witnesses at trial.” We
cited Linder for the latter proposition, noting that with the exception of the stricken provision
relating to witness testimony, we had upheld the constitutionality of the Act in our prior decision.
Hufford thus suggests, without explicitly stating as much, that only the sworn testimony given
during the MMLP hearing at issue in Linder must be exempted from the Act’s overall imposition
of confidentiality on the proceedings for the Act to give full effect to parties’ rights to fairly
cross-examine witnesses. Under this view, the proceedings would remain confidential, unless of
course “no participant objects,” as we recognized in Hufford. Ultimately, we concluded,
“[w]hile a transcript of Panel proceedings would certainly assist a litigant in cross-examination at
trial, it is not essential to exercise that right.” Hufford, 223 Mont. at 76, 724 P.2d at 188. See
generally Karlen J. Moe, The Montana Medical Malpractice Panel Act: Origin, Procedure, and
Effect, 44 Mont. L. Rev. 281, 285-86 (1983).
42
impeachment should they be voluntarily made available to opposing parties. 17 The

present case suggests no clear resolution. Perhaps understandably, given the breadth and

depth of other issues on appeal, the parties have focused their attention elsewhere and

have made only cursory, largely unsupported arguments on this issue. As we have

previously held, it is not our obligation to conduct legal research, guess at precise

positions, or develop legal analysis that may lend support to the parties’ positions. M. R.

App. P. 23; State v. Lewis, 2007 MT 295, ¶ 44, 340 Mont. 10, 171 P.3d 731. Because we

find that any error alleged by Novartis was harmless, we decline to dive into these

unexplored waters today.

¶86 In order for the erroneous admission of evidence to constitute grounds for a new

trial, the error must be so significant as to materially affect the substantial rights of the

complaining party. Section 25-11-102, MCA; Stevenson v. Felco Indus., 2009 MT 299,

¶ 16, 352 Mont. 303, 216 P.3d 763. Our rule is that no reversible error occurs unless the

evidence in question was of such character as to have affected the outcome of the trial.

Seltzer v. Morton, 2007 MT 62, ¶ 65, 336 Mont. 225, 154 P.3d 561. While the evidence

here may well have assisted Novartis in undermining Dr. Morris’ credibility, we cannot

conclude that this evidence was of such character as to have affected the outcome of the

trial. Dr. Morris was merely one of many medical professionals at trial who testified that

17
In the present case, Novartis’ procurement of the pleading went largely unnoticed until the last
moment, as it was apparently inadvertently produced through a subpoena of Dr. Schmidt’s files
at deposition. The trial court did not address whether the pleading was still protected by the
confidentiality provisions of the Act, or whether it was voluntarily disclosed because no
objection was made by Stevens at the time. These important determinations are properly made at
the trial level, not by an appellate court.
43
there were alternatives to the surgery Stevens ultimately elected, and Novartis had ample

opportunity to cross-examine both Dr. Morris and the other medical professionals, and to

introduce its own evidence that no alternatives existed. Furthermore, the statement arose

in an informal and confidential proceeding where Dr. Morris’ counsel would be expected

to file highly protective initial answers, and as such was likely of low probative value in

any case.

¶87 For the reasons stated above, we affirm the District Court with respect to both the

exclusion of statements made in Stevens’ complaint and Dr. Morris’ answer before the

MMLP.

¶88 5. Whether the District Court erred in admitting testimony regarding a change
to Novartis’ warning label.

¶89 Novartis contends that it is entitled to a new trial because the trial court

erroneously admitted evidence of a change to Novartis’ Zometa warning label, allegedly

in order to demonstrate that Novartis should have given the later warning prior to the

surgery. Novartis argues that the evidence is inadmissible under M. R. Evid. 407, which

provides that evidence of subsequent remedial measures is “not admissible to prove

negligence, culpable conduct, a defect in a product, a defect in a product’s design, or a

need for a warning instruction.” Novartis asserts that the trial court erred in permitting

Nurse Joni Landes, Dr. Schmidt’s office manager, to testify to a change in the label, and

contends that Landes’ testimony was offered as “proof that [Novartis’] prior warnings

were not adequate.”

44
¶90 Stevens paints a starkly different picture. She responds that the “remedial

measure” testified to by Landes, and complained of by Novartis, was actually a change in

Guardian Oncology’s office protocol, not a change in Novartis’ label. Stevens asserts

that any reference to Novartis’ later label was in passing and not offered as substantive

evidence. Furthermore, asserts Stevens, M. R. Evid. 407 is not applicable here because it

only governs subsequent remedial measures taken by a party, not a non-party such as

Guardian Oncology, in keeping with the premise of the rule: to dissuade parties from

failing to remedy dangerous situations out of fear that their remedies will be seen as

admissions of guilt. Lastly, Stevens asserts that even had the remedial measure been

Novartis’, it was not admitted to show liability, but rather to show that adequate warnings

would have been passed on to Stevens were they given to Dr. Schmidt—a point which

Novartis vigorously disputed.

¶91 We agree with Stevens that two distinct remedial measures are referenced by the

parties. The first is the change in Novartis’ warning label in February 2005, which more

explicitly warned about the risk of ONJ. The second is the change in Guardian

Oncology’s office protocol for patients at risk of ONJ, also initiated in February 2005.

We agree with Stevens that M. R. Evid. 407 is not applicable in the latter situation, and

thus any evidence of the change in Guardian Oncology’s office protocol is not prohibited

by the rule. Evidence of Novartis’ subsequent change in label, however, if offered to

demonstrate the insufficiency of the warning that was given at the time of the surgery,

would conceivably fall within the prohibition of the rule.

45
¶92 On closer examination of the trial transcript, it is clear that Novartis significantly

mischaracterizes the uses to which Stevens put evidence of Novartis’ changed label.

While it is true that Landes did reference Novartis’ change in label in early 2005, she did

so only when contrasting information freely available in 2005 to information on the label

at the time of Stevens’ dental surgery in 2004, in an attempt to explain why Guardian

Oncology had changed its office protocol. Landes explained that she initiated the change

in office protocol as a result of receiving an Oncological Nursing Society bulletin

detailing the risk of ONJ, which she received before Novartis changed its label. The

change to the label was referenced only to provide chronological context for the receipt

of the Nursing Society bulletin. Furthermore, Landes’ testimony was introduced in order

to rebut Novartis’ argument that even if Guardian Oncology had received adequate

warnings, the warnings would not have been passed on to patients like Stevens. Thus,

while it is true that Landes spent some time discussing a remedial measure, and true that

she did reference Novartis’ change in label, it is not at all accurate to portray Landes’

testimony as an attempt to introduce evidence of a subsequent remedial measure on

Novartis’ part. Novartis’ attempt to conflate the clinic’s change in procedure with

Landes’ brief reference to the changed label is entirely unpersuasive.

¶93 We conclude that the District Court correctly ruled that M. R. Evid. 407 was not

applicable here. M. R. Evid. 407 does not prohibit evidence of subsequent remedial

measures taken by non-parties. Nor does it prohibit “evidence” of a change in Novartis’

package insert, in this case. Stevens did not use the subsequent label to show negligence

or need for a warning, and thus the evidence is not prohibited by the rule. Rather,

46
Stevens referred to the subsequent Zometa label only in passing while discussing the

change in Guardian Oncology office protocol. It was not offered as substantive evidence.

Novartis’ argument on this issue is utterly misleading and without merit.

¶94 We affirm the District Court.

¶95 6. Whether Novartis is entitled to judgment as a matter of law because Stevens
failed to prove proximate causation.

¶96 Novartis contends that Stevens failed to present evidence establishing proximate

cause, because Stevens did not show that there were any options available to treat her

fractured tooth that would have prevented her from developing ONJ. Given that Stevens

needed an invasive dental procedure, Novartis argues, she did not show that the specific

procedure undertaken was any more likely to cause ONJ than other procedures, such as

crown lengthening, that might have been undertaken.

¶97 Stevens responds by summarizing the testimony of several experts called at trial.

She contends that this expert testimony clearly shows that other procedures were

available, and that the injury which caused her ONJ would not have occurred were she to

have undergone these procedures. While we are sympathetic to the fact that the other

procedures available to Stevens also carried a risk of ONJ, the unstated premise of

Novartis’ argument is that because all procedures carried some risk of ONJ, it would be

impossible for Stevens to establish proximate cause. We do not agree. Expert testimony

at trial showed that the trauma caused by tooth extraction caused Stevens’ ONJ, and that

this particular trauma to Stevens’ jawbone would have been avoided by choosing less

invasive options. The testimony also showed that Dr. Morris would not have undertaken

47
the tooth extraction if he had known of the risks of ONJ in Zometa patients such as

Stevens. Stevens offered evidence of all links in the causal chain. We affirm the District

Court.

¶98 7. Whether the District Court erred in refusing Stevens permission to amend
her complaint to include a claim for punitive damages.

¶99 On cross-appeal, Stevens claims that the District Court abused its discretion by not

allowing her to amend her complaint to include a claim for punitive damages. Stevens

previously petitioned this court for a writ of supervisory control on this issue, which we

denied. The trial court ruled that to allow amendment of the pleadings at the time

Stevens’ petition was filed would unduly prejudice Novartis, because the entirely new

issue of intent would be raised by a punitive damage claim.

¶100 While Stevens claims that the allegations would “not require additional time by

[Novartis] to defend because they arose out of the same operative facts which served as

the basis for [Novartis’] liability,” it is immediately apparent that this is not the case.

Defending against a charge of actual fraud or actual malice would have required Novartis

to address an entirely new argument, and the facts related to such an argument would not

be the same as those already at issue. The defense would have taken careful preparation

and would have involved substantial discovery, and Novartis could not have adequately

prepared in the three weeks before the end of the discovery period. The District Court

had a legitimate interest in ensuring an efficient progression to the trial date, and we

conclude that it did not abuse its broad discretion to deny leave to amend. The matter of

amendment “rests within the sound discretion of the trial court, and its action will not be

48
reversed in the absence of an affirmative showing of abuse of that discretion resulting in

prejudice.” Deschamps v. Treas. St. Trailer Ct., Ltd., 2010 MT 74, ¶ 18, 356 Mont. 1,

230 P.3d 800 (quoting Callan v. Hample, 73 Mont. 321, 326, 236 P. 550, 551-52 (1925)).

No prejudice exists here. Stevens had ample time to alert Novartis to this claim and did

not do so, and was thus properly prevented from adding it at the eleventh hour.

¶101 We affirm the District Court.

¶102 8. Whether the District Court erred in offsetting social security disability
benefits against the general damages awarded by jury.

¶103 Our final inquiry concerns whether the District Court erred in offsetting social

security disability benefits from general damages. Stevens observes that under § 27-1-

308, MCA, a plaintiff’s recovery may only be reduced by “collateral sources,” defined in

§ 27-1-307, MCA, as “. . . something that is later included in a tort award and which is

made to or for the benefit of a plaintiff . . . .” As the jury only awarded general damages,

Stevens argues, it is impossible to determine whether the damages that Novartis seeks to

offset were included in the jury verdict. Novartis counters that the trial court correctly

included all amounts “paid or payable” under the statute, and that the verdict was

properly reduced.

¶104 Our decision in Busta v. Columbus Hosp., 276 Mont. 342, 916 P.2d 122 (1996),

controls resolution of this issue. In Busta, the defendant hospital sought to offset benefits

received by the plaintiff from the Veterans’ Administration against the damages awarded

in the plaintiff’s wrongful death action. As here, the jury was instructed that its award

could include damages for economic loss, reasonable compensation for mental anguish,

49
and loss of “comfort, guidance, . . . care, protection and companionship,” among other

compensable losses. The jury returned a verdict with a single amount for all damages,

without any breakdown of damages allotted to each of the losses. We held that without a

breakdown of damages attributable to each loss, the lower court could not have properly

determined how much of the award was attributable to damages for which the plaintiff

would be compensated by collateral sources, as would be a prerequisite for any offset.

Section 27-1-308, MCA, allows offsets only against “that part of a recovery which . . .

[is] compensated by a collateral source.” Thus, we concluded, “. . . there was no method

by which the District Court could calculate what, if any amount, the hospital was entitled

to offset by the amount of . . . benefits awarded,” and no offset could be applied. Busta,

276 Mont. at 375, 196 P.2d at 142.

¶105 Here, as in Busta, the jury verdict does not set out what portion of its damage

award is attributable to items subject to collateral source offsets—in this instance, losses

due to diminished wage-earning capacity, for which Stevens will be compensated by

social security disability benefits. Without this “line-item” breakdown of the damages

awarded by jury, the District Court could not have complied with the mandate of § 27-1-

308, MCA, that jury awards may only be reduced by amounts attributable to losses which

are compensated by collateral sources. There was no basis on which to conclude that the

disability benefits would compensate Stevens in whole or in part for damages which were

included in the jury’s award. Without a factual basis for the offset, the District Court

erred in concluding that Novartis was entitled to offset the jury award by Stevens’

disability benefits. No offset should have been permitted.

50
¶106 For the reasons above, we reverse the judgment of the District Court as to the

social security disability benefits offset, and remand for further proceedings consistent

with this opinion.

¶107 9. Whether the District Court erred in dismissing Stevens’ negligence claims
against Patrick Doyle, a sales representative for Novartis.

¶108 Because we affirm the District Court on issues 1 through 7, we need not consider

this issue.

¶109 Affirmed in part, reversed in part, and remanded for further proceedings consistent

with this opinion.

/S/W. WILLIAM LEAPHART

We concur:

/S/ MIKE McGRATH
/S/ JAMES C. NELSON
/S/ PATRICIA COTTER
/S/ MICHAEL E WHEAT
/S/ BRIAN MORRIS
/S/ JIM RICE

51