One of us was asked a question the other day that we couldn’t answer immediately.  “Does the learned intermediary rule apply to a physician’s assistant?”  We didn’t remember any cases actually deciding that issue.  So we did what we usually do in that situation and looked at Bexis’ book.  The book has a section (§2.03[2]) titled “Who Is the Learned Intermediary,” which looked like it would cover this subject.  It did, but while it had cases discussing nurses:

Yes: Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1281 (11th Cir. 2002) (applying Georgia law); Walker v. Merck & Co., 648 F. Supp. 931, 934 (M.D. Ga. 1986), aff’d without op., 831 F.2d 1069 (11th Cir. 1987); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93 (Tex. App. 2000); Holley v. Burroughs Wellcome Co., 330 S.E.2d 228, 235-36 (N.C. App. 1985), aff’d, 348 S.E.2d 772 (N.C. 1986); Singleton v. Airco, Inc., 314 S.E.2d 680, 682 (Ga. App. 1984); In re NuvaRing Litigation, 2013 WL 1874321, at *28 (N.J. Super. L.D. April 18, 2013) (applying California law).  No: Mazur v. Merck & Co., 964 F.2d 1348, 1357 (3d Cir. 1992) (a nurse “not authorized to prescribe drugs”) (applying Pennsylvania law); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277 (5th Cir. 1974) (applying Texas law).

Cases discussing optometrists:

No: Prager v. Allergan, Inc., 1990 WL 70875, at *4 (N.D. Ill. May 2, 1990); Bukowski v. CooperVision Inc., 592 N.Y.S.2d 807, 809 (N.Y.A.D. 1993);

Cases discussing pharmacists:

No: Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1387 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987);

A case discussing veterinarians:

Yes: Haste v. American Home Products Corp., 577 F.2d 1122, 1124 (10th Cir. 1978) (applying Wyoming law);

A case discussing physical therapists:

Yes: Seifried v. The Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App. 2013); and

A case discussing medical societies:

No: Davis v. Wyeth Laboratories, 399 F.2d 121, 130 (9th Cir. 1968) (applying Montana law) . . . .

There were no cases specifically addressing P.A. prescriptions and the learned intermediary rule in Bexis’ book.

As an aside, we note that, while the weird case we discussed last week from Washington State, Taylor v. Intuitive Surgical, Inc., ___ P.3d ___, 2017 WL 532497 (Wash. Feb. 9, 2017), wasn’t phrased in such terms, it is effectively a ruling that a hospital can be a learned intermediary.

The only specific mention of physician’s assistants in Bexis’ book was quoting dictum in Perez v. Wyeth Laboratories, Inc., 713 A.2d 520 (N.J. Super. A.D. 1998), that although limited to “physicians” by statute, the learned intermediary rule might also apply to “dentists, optometrists, podiatrists, nurse practitioners, home health care service firms, physician’s assistants, or others similarly permitted to prescribe or administer drugs on a limited basis.” Id. at 522-23 (statutory citations omitted).  That decision was, of course, famously reversed in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 (N.J. 1999), another weird decision that created a “direct to consumer” exception to the learned intermediary rule (since rejected by every other state to consider it), and thus never had to reach the “who is” question.

The next thing we did was to run a ridiculously broad Westlaw search – looking for “learned intermediary” anywhere in the same case as “physician’s assistant”?

Not too bad, this time. Less than 25 cases, including the two Perez decisions.

The most significant case on P.A.s and the learned intermediary rule is Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010).  As we discussed here and here, while Stevens is not overall a favorable decision for defendants, it did reaffirm the learned intermediary rule and extend it to a P.A.-prescribed drug.  Stevens first mentioned the Third Restatement’s version of the learned intermediary rule, Restatement (Third) of Torts, Products Liability §6(d)(1), which describes the rule in terms of warnings “provided to . . . prescribing and other health-care providers.”  247 P.3d at 492 (emphasis added).  The court then discussed the “evolution” of the rule “away from limiting the doctrine’s applicability to the prescribing physician alone.” Id. A P.A. could thus be a “learned intermediary” when fulfilling the “traditional” role of a physician:

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.

*          *          *          *

[T]he evolution of the doctrine [has been] 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.

*          *          *          *

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. . . . [Plaintiff] received much of her treatment from nurses, treating physicians, and nurse practitioners.

Stevens, 247 P.3d at 492-95 (footnote citing many of the cases in Bexis’ book omitted).

Another case applying the learned intermediary rule to a physician’s assistant is Luke v. Family Care & Urgent Medical Clinics, 246 F. Appx. 421 (9th Cir. 2007) (applying Washington law).  The drug in question in Luke was prescribed by a P.A., id. at 423, and but the learned intermediary rule still applied:

[T]he district court properly decided that the [risk at issue] was not material and that the physician’s assistant had no duty to warn [plaintiff] of the danger.  Under Washington law, it would be contradictory to require a pharmacist to warn of the same danger when the “learned intermediary” had no duty to warn.

Id. at 425.

The learned intermediary rule also applied to a physician’s assistant in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying Ohio law) – a case we usually cite for its preemption holdings.  In Yates the prescriber (“Smith”) was a P.A.  Id. at 288.  Without a lot of discussion of Smith’s P.A. status, Yates found the learned intermediary rule applicable:

Smith testified that it is her custom to use her independent medical judgment when prescribing birth control products to patients, and she specifically testified that she discussed the risks and benefits of several different forms of birth control with [plaintiff].  The mere fact that Smith gave [plaintiff] options and a voice in determining which method of birth control would best fit her needs and lifestyle does not remove Smith from her status as a learned intermediary.

Id. at 293.  Without any separate discussion of P.A. status, Czimmer v. Janssen Pharmaceuticals, Inc., 122 A.3d 1043, 1056-58 (Pa. Super. 2015), treated a prescribing P.A. as a learned intermediary.  See also Canady v. Ortho McNeil Pharmaceutical, Inc., 2014 WL 1653349, at *4 (N.D. Ohio April 24, 2014) (applying learned intermediary rule in negligence action over drug prescribed by a P.A.; not applying learned intermediary rule to strict liability, due to peculiar Oregon statute); Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *2-3 (W.D. Tex. June 23, 2011) (applying learned intermediary rule to prescribing P.A. without regard to P.A. status).

As Stevens in particular demonstrates, expanding the learned intermediary rule to non-physicians such as P.A.s is something of a double-edged sword.  On one hand, recognizing non-physicians who prescribe drugs or devices as learned intermediaries precludes plaintiffs from arguing for direct-to-patient warnings.  On the other hand, the rule requires that adequate warnings be given to the learned intermediary – whoever that might be.  Thus, expanding the categories of medical practitioners who qualify as “learned intermediaries” also expands the scope of a defendant’s warning obligations to such practitioners, although not to plaintiffs themselves.  Given the choice between a plaintiff coached to say whatever is necessary to obtain recovery, and a P.A. who usually won’t be in the plaintiff’s back pocket, we’ll take our chances with the P.A.

A recent case in the Southern District of New York debunks two myths that we see all the time. Myth number one:  A medical device is defective if it fails.  Myth number two:  A plaintiff can prove causation on a failure-to-warn claim by asserting that he or she would not have consented to the procedure if his or her doctor had told her about some risk.  Plaintiffs often assert these positions.  Neither is true.  And the magistrate judge’s report and recommendation granting summary judgment in Tomaselli v. Zimmer Inc., No. 14-CV-04474, 2017 U.S. Dist. LEXIS 9874 (S.D.N.Y. Jan. 20, 2017), does a really nifty job explaining why.

In Tomaselli, the plaintiff was treated with a hip repair device—a Greater Trochanter Reattachment device, or GTR.  A GTR is not like the ball-and-socket total hip replacement devices that have generated so much litigation and with which so many of our readers are familiar.  A GTR consists of a plate and two 1.8 millimeter cables that are surgically implanted to reinforce the top of a patient’s femur—the trochanter—in the event of a fracture. Id. at **1-2.

The plaintiff later complained of hip pain, and imaging revealed that one of the cables broke. Id. at *5.  It is not clear whether the broken cable made any difference:  The cable stayed in place, and removing it would not have alleviated the pain. Id. The evidence also suggests that the pain was not substantial:  The plaintiff went for long periods of time between doctor’s appointments; she was able to exercise and engage in daily activities; and she testified that stretching and taking a few steps would relieve any pain. Id. at *6.  The plaintiff sued the device’s manufacturer and distributor anyway, alleging a variety of product liability claims.

The defendants moved for summary judgment under New York law, and the magistrate recommended granting their motion on every claim. The magistrate’s report and recommendation is particularly interesting on the two issues that we foreshadowed above—failure to warn and product defect.

Continue Reading Hip Case Breaks the Right Way in New York

This is a guest post from Michael Salimbene, an associate at Reed Smith.  It’s about learned intermediary causation, and the need for prescriber testimony.  Not infrequently, in mass torts with lots of solicited plaintiffs, the other side puts off doing anything, including preserving prescriber testimony, for as long as possible.  If the prescriber dies or disappears, plaintiffs don’t have any causation testimony, and since they bear the burden of proof, that’s a problem for them.  The guest post describes the latest example.  As always our guest poster deserves 100% of the credit (it’s not our work), and any blame, for what follows.

*********

This guest blogger lives just outside of Philadelphia. In this neck of the woods, the post-holiday, pre-Spring window is perhaps the most universally loathed time of year.  It’s filled with grey skies and frigid winds.  Partner in-office attendance, which tends to wane during the summer months and late December, hits its yearly high.  The all-important billable hour “clock” resets to 0.  Street corner sales of unlicensed Carson Wentz tee shirts have stalled, and playoff football will feature two of Philadelphia’s most hated rivals, the Giants and the Cowboys.  Your children, if anything like this guest blogger’s, will ignore the Frozen-themed electric car that “Santa” left (but took you 4 hours to assemble) in favor of a $6 pair of pink bunny slippers.  So for today’s post, in search of some good news, we travel to the Middle District of Georgia where the temperature hovers just above 60 degrees.  In a few short months, Northeasterners will also be enjoying warm skies and Georgia’s finest offering, The Masters.  Until then, we’ll have to make due with favorable warning-causation decisions like this one.

Today’s case comes to us from the Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL in the Middle District of Georgia. In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig., No. 4:13-cv-229, 2016 WL 4611572 (M.D. Ga. Sept. 2, 2016).  We’ve blogged about this MDL quite a bit (recently here, here, and here).  As were most plaintiffs in the ObTape litigation, this plaintiff’s prescribing surgeon treated her for a form of incontinence with the relevant device.  If you’ve watched daytime TV in the past 5 years, you’ll be familiar with the typical list of complaints that undergird vaginal mesh lawsuits:  mesh “erosion” or “extrusion” (movement of the mesh material into surrounding tissue); “dyspareunia” (painful intercourse); and the need to have additional surgery to correct mesh-related complications, to name a few.  Plaintiff never had her mesh removed, but alleged, among other things, that the product caused her to suffer from chronic pain.  So what makes this case different from the thousands of other mesh cases pending across the nation?  Plaintiff’s implanting physician died before he could testify in her case.

Continue Reading Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.

Continue Reading 11th Circuit Upholds Stent Defense Verdict

Today’s case is a partially published decision about a partial reversal of a plaintiff verdict in California. So, we are only going to discuss select parts of the decision. It’s a long one and there are large sections about plaintiff’s counsel’s misconduct during trial and excessive damage awards. It is also a joint medical malpractice and product liability case. So, when you strip away the rest, we get down to a handful of legal rulings that we are truly interested in.

The case is Bigler-Engler v. Breg, Inc., 2016 Ca. App. LEXIS 921 (Cal. App. Oct. 28, 2016) and involves the use of a cold therapy medical device, available only upon prescription. Plaintiff underwent arthroscopic knee surgery, following which her surgeon prescribed use of the device to aid in recovery. Id. at *5-6. Plaintiff rented the device from her surgeon’s medical practice. Id. at *7. Upon discharge after surgery, plaintiff was advised to use the device at a certain temperature “as much as possible.” Id. at *8. Plaintiff’s use of the device and the instructions she received from her surgeon are explained in more detail in the opinion, but ultimately, plaintiff developed severe skin damage that required multiple plastic surgeries and scar reduction surgeries. Id. at *9-13.

Plaintiff file suit against her surgeon, the medical practice, and the device manufacturer. The jury found against the manufacturer on plaintiff’s claims for design defect, failure to warn, and intentional concealment. Id. at *19. The jury also awarded punitive damages against the manufacturer on the intentional concealment claim. Id. On appeal, the court overturned the intentional concealment verdict, which also meant reversing the punitive damages verdict. But, the court upheld the trial court’s decision not to instruct the jury on the learned intermediary doctrine finding it did not apply to a medical device intended to be operated directly by the patient.

Continue Reading A Fraudulent Concealment Win Coupled with an Unfavorable Learned Intermediary Ruling

Our learned intermediary rule “head count” lists Oklahoma as solidly in support of the doctrine:

Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997); Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974).

The “head count” lists every state supreme court decision to follow the learned intermediary rule, and the Oklahoma Supreme Court’s four decisions applying the doctrine are exceeded only by Ohio’s six (plus a statute) and Kansas’ five opinions.

Oklahoma courts had never applied the rule to pharmacists, however. As we’ve discussed before, the learned intermediary rule helps pharmacy defendants by precluding claims that pharmacies, as intermediate sellers of prescription drugs, should have some sort of independent duty to warn patients. Just as the rule recognizes physicians as learned intermediaries in passing along relevant warnings from prescription medical product manufacturers to their patients, learned intermediary principles also preserve the physician-patient relationship by precluding imposition of independent warning duties on other possible interlopers – such as pharmacies – who otherwise might be legally required to confuse patients by providing information that conflicts with what prescribing physicians tell their patients. Back in 2011, on occasion of the Arkansas decision Kowalski v. Rose Drugs, Inc., 378 S.W.3d 109 (Ark. 2011), we did a 50-state survey post on this issue, and Oklahoma was missing in action.

Not any longer. In Carista v. Valuck, ___ P.3d ___, 2016 WL 6237855 (Okla. App. Oct. 20, 2016), the court applied the learned intermediary rule to pharmacy-related claims in essentially the same fashion as the previous cases in our survey post. Carista involved a plaintiff (or more precisely, a plaintiff’s decedent) who took too many painkillers – it appears, from the opinion, illegally − overdosed, and then attempted to blame someone else, in this case the pharmacy where the prescriptions were allegedly filled. The case was dismissed, and the plaintiff appealed. Recognizing the issue as one of first impression, the court followed what it concluded, rightly, was the majority rule:

Many other states appear, however, to have adopted the [learned intermediary] doctrine, with limited exceptions, to shield pharmacists from being required to “second guess” a physician’s medical decisions embodied in an otherwise authorized and legally made prescription.

Continue Reading Oklahoma Becomes the Latest State To Apply Learned Intermediary Principles To Pharmacies

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . .  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving.  The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016).  Between these two orders, practically every permutation of causation under the learned intermediary rule is addressed, and the end result is the grant of summary judgment against an impressive 160 of 162 plaintiffs.

For obvious reasons, we’ll call the first (#374) “Accutane I” and the second (#375) “Accutane II” to tell them apart.

Eighty-six plaintiffs’ cases failed in Accutane I because they couldn’t even begin to satisfy their usual burden of proof.  That was because, by the time they got around to bringing their lawsuits, their prescribing physicians had either died (44 plaintiffs) or else simply could not be located (42 plaintiffs).  2016 WL 5958374, at *1-2.  As we’ve discussed before, in one of our “little lists” posts, there’s now quite a bit of law enforcing the burden of proof in dead/missing prescriber cases.  We even feel somewhat paternal feelings in this area, because several of your merry bloggers (Eric A, Steve M, and Bexis), litigated this issue extensively a decade ago in Diet Drug cases at a time when there was practically no directly on-point precedent.  In doing so, we increased the number of favorable decisions from one to seven.

Accutane I represents another giant step forward. The court held that, under the law of no fewer than 35 jurisdictions, a plaintiff who could not obtain any prescriber testimony at all could not meet his/her burden under the learned intermediary rule (now the law, as we’ve pointed out, of all fifty states) of establishing that the absent prescriber would have changed the relevant prescription had s/he received a supposedly “adequate” warning.  The defendant’s causation argument was rather basic:

Defendants argue that without the testimony of the deceased or missing physicians, Plaintiffs cannot establish that [the drug] would not have been prescribed given a different warning and thus they cannot satisfy proximate cause. Absent physicians’ testimony, Defendants argue that the causal link to injury is broken.  Even if the proximate cause standard were as Plaintiffs claim – that their prescriber might hypothetically have altered their risk discussion somehow if only [the manufacturer] had warned differently – Defendants assert that physician testimony is still needed.

2016 WL 5958374, at *3 (citation omitted). Plaintiffs fell back on that old canard, the “heeding presumption.” Id. at *4.  The court, however, was having none of it.

[T]he Court is persuaded by Defendants’ arguments that the heeding presumption within a learned intermediary context does not equate with a decision by the physician to not prescribe the drug.  If it did, medications would never be prescribed when accompanied by warnings because of the various risks associated with their use.

. . .Plaintiffs concede that their physicians are deceased or otherwise unavailable, and they have offered nothing by way of individual opposition papers. . . . Accordingly, the case-specific facts presented by Defendants are undisputed.

Plaintiffs’ reasoning is flawed, especially when one considers the slew of risks associated with and heeded by [prescription drug] users and prescribing physicians. Notably, application of the heeding presumption in the context of a pharmaceutical learned intermediary case where a manufacturer provided a warning and its adequacy remains in issue is not reflected within any of the cited case law.

Id. at 10-11 (citation omitted) (emphasis added).  Regardless of any presumption, all plaintiffs “still have the burden of proof for every element of their claim.”

Continue Reading Warning Causation Potpourri in New Jersey Mass Tort

Sometimes we take routine things for granted. We don’t appreciate the taste of our morning coffee, it’s just always there. We don’t appreciate the softness of our favorite college sweatshirt, it’s just always been that way. We don’t appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn’t always been available, but it’s getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.

In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it’s been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it’s good to be reminded just how important it is.

That is what today’s case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent’s family alleged that the defendant failed to adequately warn decedent’s doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw (“ONJ”), which decedent developed following multiple tooth extractions and other dental procedures. The court’s decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via “Dear Doctor” letters. Those warnings, which pre-dated decedent’s prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.

Continue Reading Aredia/Zometa Plaintiff Can’t Avoid Learned Intermediaries

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes.  See Andren v. Alere, Inc., 2016 WL 4761806, at *9 (S.D. Cal. Sept. 13, 2016) (where “misrepresentations and omissions claims are based on a failure to warn” the learned intermediary rule applies” to claims under the two major California consumer protection statutes (CLRA & UCL)).  Since we haven’t addressed this issue recently (one guest post from 2007), we thought it would be a good idea to examine more generally decisions that also apply the learned intermediary rule to consumer fraud claims. Andren is definitely not an outlier, although in a lot of states precedent is not extensive.

We’ll start with California.  We know of several other cases reaching essentially the same result.  One of them, Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3-4 (C.D. Cal. June 13, 2013), is mentioned in Andren. Saavedra, a multi-plaintiff case also applying the laws of Massachusetts and Missouri (in addition to California), found the learned intermediary rule applicable to all three states’ consumer protection statutes, based on uniform precedent:

Every case that this Court has found, and that the parties have identified, that has specifically addressed the questions has found that the learned intermediary doctrine applies to consumer protection claims predicated on a failure to warn.

Id. at *3.  Thus, Saavedra “concur[ed] with the great weight of authority and conclude[d] that the learned intermediary doctrine applies to the consumer protection claims at issue.”

Another relevant California case was not cited in Andren − the appellate decision in In re Vioxx Class Cases, 103 Cal. Rptr. 3d 83 (Cal. App. 2009). Vioxx held that the individual actions of learned intermediary prescribers physicians precluded class certification in cases under the same statutes:

[A]ll physicians are different and obtain their information about prescriptions from myriad sources. . . . [P]hysicians consider many patient-specific factors in determining which drug to prescribe, including the patient’s history and drug allergies, the condition being treated, and the potential for adverse reactions with the patient’s other medications − in addition to the risks and benefits associated with the drug.  When all of these patient-specific factors are a part of the prescribing decision, the materiality of any statements made by [defendant] to any particular prescribing decision cannot be presumed.

Id. at 99 (footnote omitted).  Thus, the Vioxx court presumed, albeit without holding, that the learned intermediary rule applied so that the physicians – rather than patients – are the recipients of information from manufacturers of prescription medical products.  For other similar California law cases, see Weiss v. Astrazeneca Pharmaceuticals, 2010 WL 3387220, at *5 (Cal. App. Aug. 30, 2010) (similar result in unpublished affirmance of UCL/CLRA class certification denial); In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2012 WL 865041, at *20 (S.D. Ill. March 13, 2012) (denying class certification under UCL “[b]ecause [the drug] is a prescription medication, [so] the question of uniformity must consider representations made to each putative class member and her prescribing physician”) (applying California law); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 751 F. Supp.2d 277, 288 (D. Mass. 2010) (applying learned intermediary prescriber-centric causation principles to UCL; denying summary judgment) (applying California law); In re Paxil Litigation, 218 F.R.D. 242, 246 (C.D. Cal. 2003) (rejecting argument that the learned intermediary rule “becomes irrelevant under [the UCL]”).

Continue Reading The Learned Intermediary Rule in Consumer Protection Claims