Learned Intermediary

Subscribe to Learned Intermediary

By now, the learned intermediary rule is so well established that new opinions addressing core learned intermediary issues, as opposed to applying the rule to specific fact patterns, are relatively uncommon. The last one of those we covered was the Seventh Circuit’s prediction that Wisconsin would adopt the learned intermediary rule, almost a year ago in In re Zimmer, NexGen Knee Implant Products Liability Litigation, 884 F.3d 746 (7th Cir. 2018).

We’ve got another.

In Ideus v. Teva Pharmaceuticals USA, Inc., ___ F. Supp.3d ___, 2019 WL 912121 (D. Neb. Feb. 19, 2019), the court, applying Nebraska law, held that the learned intermediary rule applied to a copper intra-uterine device (“IUD”).  The foundational learned intermediary question in Nebraska was decided in Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841 (Neb. 2000), adopting the rule as enunciated in Restatement (Third) of Torts, Products Liability §6(d) (1998), but the plaintiff in Ideus invoked purported “exceptions” in an attempt to avoid the rule.  The most on-point of those exceptions was “for prescription contraceptives.”  2019 WL 912121, at *2.

Ideus thoroughly trashed that supposed exception, pointing out that the Eighth Circuit got it wrong thirty years ago in Hill v. Searle Laboratories, 884 F.2d 1064, 1070 (8th Cir. 1989), when it predicted that Arkansas would adopt such an exception.  But in West v. Searle Co., 806 S.W.2d 608, 614 (Ark. 1991), the Arkansas Supreme Court rejected the West prediction and the purported contraceptive exception.  2019 WL 912121, at *3.  This discussion reminds us of what recently happened in Arizona, with the en banc Ninth Circuit getting “Spalding” embossed in its collective forehead from the Arizona Supreme Court’s forceful (and unanimous) rejection of its mythical tort “duty to report” to the FDA.

So, with West both non-binding (being a different state’s law) and discredited even in that state, Ideus followed the clear majority rule, and overwhelming recent trend, and rejected the idea of a “contraceptive exception” to the learned intermediary rule. First, “determining what contraceptive fits [a patient’s] particular criteria necessarily requires the knowledge and advice of a physician.” 2019 WL 912121, at *4. Therefore, there was “no reason to distinguish between a patient’s final choice to use a particular contraceptive and a patient’s final decision relating to any other course if treatment.” Id.

[T]he fact that the patient makes the final choice among suggested contraceptives (or decides not to use any at all) does not constitute a distinction which makes the [learned intermediary] rule inapplicable.  [The Court] can readily conceive of situations in which a physician gives the patient a choice of courses to follow.  There is, for example, a patient’s choice between continuing to endure a physical ailment or submitting to surgery or some other course of treatment; an obese person’s choice among diets suggested by the doctor; and a surgery patient’s choice of anesthesia. . . .

In any such situation which may come to mind, the patient is expected to look to the physician for guidance and not to the manufacturer of the products which he may use or prescribe in the course of treatment.

Id. (quoting Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978)).  Nothing inherent in contraceptives justified singling them out for an exception to the learned intermediary rule:

[W]hatever differences there may be between contraceptives and “typical” prescription drugs, they have one important thing in common:  both are always prescribed by a physician or through the services of a physician.  And when a patient relies on the skill and knowledge of a physician in any particular method of treatment, the learned intermediary doctrine ought to apply.  This is no less true for prescription contraceptives as for any other prescription medication.

Id. (citation omitted).

Finally, Ideus relied upon Nebraska’s adoption of the Third Restatement §6(d)’s version of the learned intermediary rule, which did not recognize any exception for contraceptives.

[T]hat section of the Restatement acknowledges circumstances under which the doctrine might not be applicable. . . .  [N]othing in the record or the parties’ arguments . . . suggest[s] with respect to contraceptives in general . . . that a health care provider is not in a position to reduce the risk of any foreseeable harm to the patient.  In other words, the Nebraska Supreme Court did acknowledge the possibility of exceptions to the learned intermediary doctrine, when it expressly adopted § 6(d) of the Restatement − but nothing suggests that such an exception should be recognized here.

2019 WL 912121, at *5 (citations and quotation marks omitted).

Thus, Ideus predicted that “the Nebraska Supreme Court would following the overwhelming majority of decisions that have applied the learned intermediary doctrine to cases involving contraceptives.”  Id.  The court followed with an impressive string citation to well over a dozen cases applying the learned intermediary rule to contraceptives of various types.  Id.  This being the DDLaw Blog, however, we will provide our own, even more extensive, list of such cases:

State Supreme Court Cases:

Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 356-57 (Ill. 1996); Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); West v. Searle & Co., 806 S.W.2d 608, 613-14 (Ark. 1991); Humes v. Clinton, 792 P.2d 1032, 1039-41 (Kan. 1990); Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1228 (Kan. 1987); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1052 (Kan. 1984), McKee v. Moore, 648 P.2d 21, 25 (Okla. 1982); Seley v. G.D. Searle & Co., 423 N.E.2d 831, 839-40 (Ohio 1981); Terhune, 577 P.2d at 978; Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1248 (Or. 1975); McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974).

Other State Cases:

Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App. 2000); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 n.6 (Cal. App. 1992); Taurino v. Ellen, 579 A.2d 925, 928 (Pa. Super. 1990); Brecher v. Cutler, 578 A.2d 481, 485 (Pa. Super. 1990); Rhoto v. Ribando, 504 So.2d 1119, 1123 (La. App. 1987); Eiser v. Feldman, 507 N.Y.S.2d 386, 387-88 (N.Y. App. Div. 1986); Taylor v. Wyeth Laboratories, Inc., 362 N.W.2d 293, 297 & n.11 (Mich. App. 1984); Cobb v. Syntex Laboratories, 444 So.2d 203, 205 (La. App. 1983); Reeder v. Hammond, 336 N.W.2d 3, 5 (Mich. App. 1983); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548-49, 553, 557 (Ind. App. 1979); Hamilton v. Hardy, 549 P.2d 1099, 1110 (Colo. App. 1976), overruled on other grounds, State Board of Medical Examiners v. McCroskey, 880 P.2d 1188 (Colo. 1994); Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 457 (Pa. Super. 1973); Carmichael v. Reitz, 95 Cal. Rptr. 381, 400-01 (Cal. App. 1971) (contraceptive prescribed for other purpose); Hayes-Jones v. Ortho-McNeil Pharmaceutical, 2012 WL 3164558 (N.J. Super. Law Div. Aug. 3, 2012) (applying Virginia law).

Federal Courts of Appeals:

Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292-93 (6th Cir. 2015) (applying New York law); In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (applying Texas law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003-04 (4th Cir. 1992) (applying South Carolina law); Beyette v. Ortho Pharmaceutical Corp., 823 F.2d 990, 992-93 (6th Cir. 1987) (applying Michigan law); Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 656 (1st Cir. 1981) (applying New Hampshire law); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980) (applying New York law).

Federal District Courts:

Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504, at *3 (E.D. La. June 1, 2017); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 813 (S.D. Tex. 2013); Hanhan v. Johnson & Johnson, 2013 WL 5939720, at *3 (N.D. Ohio Nov. 5, 2013) (applying California law); James v. Ortho-McNeil Pharmaceutical, Inc., 2011 WL 3566844, at *3 (N.D. Ohio Aug, 12, 2011) (applying Louisiana law); In Re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 692 F. Supp.2d 1025, 1033-34 (S.D. Ill. 2010), aff’d, 643 F.3d 994 (7th Cir. 2011); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp.2d 222, 228 (D.P.R. 2008); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 809-10 (E.D. Tex. 2002) (applying law of all fifty states); Nelson v. Dalkon Shield Claimants Trust, 1994 WL 255392, at *4 (D.N.H. June 8, 1994); MacPherson v. Searle & Co., 775 F. Supp. 417, 424-25 (D.D.C. 1991); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287, 1291 (E.D. Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1514-15 (S.D. Fla. 1990); Amore v. G.D. Searle & Co., 748 F. Supp. 845, 849-50 (S.D. Fla. 1990); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Or. 1989); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1032 (D.N.J. 1988); Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1305-06 (D. Minn. 1988); Dupre v. G.D. Searle & Co., 1987 WL 158107, at *4 (D.N.H. April 28, 1987); Skill v. Martinez, 91 F.R.D. 498, 507 (D.N.J. 1981), aff’d per curiam, 677 F.2d 368 (3d Cir. 1982); Steinmetz v. A.H. Robins Co., 1981 U.S. Dist. Lexis 14314, at *3-5 (D. Or. Aug. 27, 1981); Goodson v. Searle Laboratories, 471 F. Supp. 546, 548 (D. Conn. 1978); Dunkin v. Syntex Labs, Inc., 443 F. Supp. 121, 123 (W.D. Tenn. 1977); Chambers v. G. D. Searle & Co., 441 F. Supp. 377, 381 (D. Md. 1975), aff’d per curiam, 567 F.2d 269 (4th Cir. 1977) (applying District of Columbia law).

Secondarily, the plaintiff in Ideus tried to assert the so-called “direct to consumer” advertising exception to the learned intermediary rule.  The decision disposed of that contention in a footnote:

For the same reason, to the extent that [plaintiff] claims the direct consumer marketing exception to the learned intermediary doctrine applies, that argument has no merit.  If anything, it further supports the Court’s conclusion the contraceptives and other prescription drugs are not actually distinguishable.

Ideus, 2019 WL 912121, at *4 n.3 (citations omitted).  We don’t have to provide a list of cases here, because we’ve thoroughly addressed the almost universal rejection of the direct-to-consumer exception before.  That post was in January, 2011. However, for the sake of completeness, here are more recent cases also rejecting any direct to consumer exception:

Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 950-51 (Ariz. 2016); Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 159-64 (Tex. 2012) (reversing lower court adoption); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *6 (N.D. Ill. May 26, 2015); Thomas v. Abbott Laboratories, 2014 WL 4197494, at *6 (C.D. Cal. July 29, 2014); McKay v. Novartis Pharmaceuticals Corp., 934 F. Supp.2d 898, 910 (W.D. Tex. 2013), aff’d, 751 F.3d 694 (5th Cir. 2014); In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2013 WL 3486907, at *2 (E.D. Pa. July 10, 2013); Calisi v Abbott Laboratories, 2013 WL 5462274, at *3 (D. Mass. Feb. 25, 2013); DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601, 614-15 (S.D.N.Y. 2012); Swoverland v. GlaxoSmithKline, 2011 WL 6001864, at *2 (D. Conn. Oct. 5, 2011); James, 2011 WL 3566844, at *3.

Why the plaintiff in Ideus was desperate to avoid the learned intermediary rule was obvious from the rest of the opinion – the defendant’s warning was adequate as a matter of law because it warned physicians of exactly the risk that plaintiff blamed for her injuries.  Her only hope was to require a manufacturer warning directly to her (which wasn’t given):

[Plaintiff] has not even named the physician who prescribed and placed her IUD − much less demonstrated that had that physician been given the proper warning, she would not have placed [the device]. . . .  [T]he package insert expressly warned about the possibility of breakage, embedment, and the difficulties of removing [device], making the warning adequate as a matter of law.  A warning is adequate if it accurately and unambiguously coveys the scope and nature of the risk to the prescribing physician.

2019 WL 912121, at *6 (citations omitted).

Astute readers will note that many of the cases in our (and Ideus’) string cites are pretty old – more from the 1970s to 1990s than afterwards.  It’s a stroll down memory lane, and we hope it will stay that way.  As Bexis’ book points out, concerning this erstwhile exception to the learned intermediary rule, “The trend of judicial decisions has shown little acceptance of this exception . . ., and several of the decisions that initially recognized it are now of questionable validity.”  Beck & Vale, “Drug and Medical Device Product Liability Deskbook” §2.03[3][e], at 2.03-70 (2018).  Indeed, subtracting the “questionable” jurisdictions, leaves only one – Massachusetts – definitely still following it.  So it’s no more widely accepted nowadays than the direct to consumer exception peculiar to New Jersey.

You’ll find plenty of decisions from the amiodarone litigation discussed on the blog.  Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing.  But there are cases involving exposure to the branded product as well.  And earlier this month, the brand name manufacturer got about the best ruling it could hope to get – defendant’s warnings were adequate as a matter of law.  Generic defendant also got dismissed after plaintiff tried to argue around Mensing by claiming the generic manufacturer was also a distributor.

Plaintiff in Marroquin v. Pfizer, Inc., 2019 WL 636845, *1 (E.D. Cal. Feb. 14, 2019), brought claims for strict liability, negligence, breach of warranty, and various fraud/misrepresentation claims.  Plaintiff’s wife suffered from fatal pulmonary disease caused by the administration of amiodarone.  Id. at *2.  While the complaint does not state why plaintiff’s wife was prescribed the drug, the decision walks through the Indications and Usage and Warnings section of the drug’s label, of which it took judicial notice.  The labeling states that the drug is to be used only to treat two very serious heart conditions and only when other treatments have failed “because of the life-threatening side effects and the substantial difficulties associated with its use.”  Id. at *5.  The label further states that the drug has “several potentially fatal toxicities, the most important of which is pulmonary toxicity,” which is fatal about 10% of the time.  Id.  The court noted that label discussed pulmonary toxicity at least 15 times.  Id. at *2.

While plaintiff argued that the adequacy of a warning is “generally” a jury question, generally doesn’t mean always.  Id. at *6.  In this case, the warnings were clear, conspicuous, and warned of the exact risk plaintiff’s wife suffered – they were adequate.  Id.  Moreover, plaintiff’s complaint contained no allegations that explain why the warning provided was inadequate.  Certainly a difficult task given the breadth and depth of the warning provided, but an essential element that can’t be overlooked.  Nor could the court overlook plaintiff’s lack of allegations that the alleged inadequate warning was a substantial factor in plaintiff’s wife’s death.  Id. at *5.  Plaintiff also tried to argue that the risks as set forth in the label would not have been understood by the “ordinary consumer.”  But that’s not the standard.  The manufacturer’s duty to warn runs to the physician, not the patient.  Id.  Whether the warning was sufficient to inform plaintiff’s wife’s physician is the appropriate question.  One the court answered in the affirmative.

Finally, on failure to warn, plaintiff tried to argue that the physician may not have read the label defendant relied on.  But failure to read does not equal failure to warn.  “The Court is unaware of any authority that holds a warning is inadequate simply because a person or physician failed to read the warning.”  Id. at *6.  Aside from the implication that physicians aren’t people, we agree with this statement completely.

On his breach of warranty claim, the court again had to remind plaintiff that the learned intermediary doctrine applied.  A core element of breach of warranty of fitness for a particular purpose is the buyer’s reliance on the skill or judgment of the seller.

[I]n a context of prescription drugs, a patient’s expectations regarding the effects of a prescription drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug’s properties.  For breach of warranty claims, ordinarily it is the prescribing doctor who in reality stands in the shoes of the ordinary consumer.  [B]reach of express or implied warranty claims … may not be maintained against a manufacturer of prescription drugs who has properly prepared the product and marketed it with warnings of known or knowable dangers.

Id. at *7 (citations omitted).  In this case, plaintiff did not allege what information his wife’s physician considered when deciding to prescribe the drug.  What the evidence does show is that risk of pulmonary toxicity was adequately warned about.  Id.  And, the only inference that the court could draw was that plaintiff’s wife was relying on the skill and judgment of her physician, not defendant.  Id. at *8.

That left only plaintiff’s fraud and misrepresentation claims which were all based on representations that the drug was “safe, fit, and effective for human use.”  Id. at *9.  Plaintiff conceded that he failed to plead his intentional misrepresentation claim with sufficient particularity to satisfy Rule 9(b).  Id.  Which the court informed him applied equally to negligent misrepresentation and concealment.  The defendants were lumped together and the complaint lacked any allegations of who, where, when, and how the alleged misrepresentations were made.  Id.  As to the “what” was misrepresented – safety and effectiveness – the court expressed “serious concerns over the plausibility of this allegation,” given the FDA approval of the drug as a drug of last resort for two serious heart conditions and the fact that it has been used to treat these conditions for over 30 years.  Id.  And, plaintiff’s lack of reliance on defendant, as opposed to her physician, is another obstacle to the fraud/misrepresentation claims.  Id. at *10.

The generic defendant had all of the brand warning and reliance arguments but of course also had a Mensing preemption argument.  Because plaintiff had no allegation that the generic defendant’s label differed from the brand label, plaintiff instead tried to argue that Mensing preemption does not extend to distributors which the generic defendant also was.  However, the cases plaintiff relied on to draw the distinction between distributors and manufacturers were in the context of motions to remand based on fraudulent joinder.  In those cases, where all doubts are to be resolved in favor of remand and no binding authority had extended Mensing to distributors, the courts were required to find proper joinder and remand the cases to state court.  Id. at *11.  “However, context is key.”  Id.  Outside the removal/remand situation, courts have applied Mensing to distributors.  “[A] mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.”  Id. at *12.  The Supreme Court’s concern about misleading or confusion caused by competing, different labels applies equally, and perhaps even more so, to distributors.  Id.  Mensing requires dismissal of all of plaintiff’s claims against the generic manufacturer that are based on some duty to convey information about the drug – failure to warn, breach of warranty, fraud/misrepresentation.  It would not apply to a manufacturing defect claim if plaintiff was bringing one.  Id.

Despite the court’s “serious concerns” with the plausibility of plaintiff’s claims, it did grant leave to amend based on the allegations being so conclusory that it could not definitively decide that amendment would be futile.  But the court certainly has made it clear that plaintiff has substantial work to do if the amendment is going to overcome the vast shortcomings of plaintiff’s case.

Roy Cohn would have turned 92 today, had he not died in 1986, a few weeks after being disbarred in New York. Cohn’s legal career was legendary. He was on the team that prosecuted the Rosenberg spy trial. He worked closely with Senator Joseph McCarthy. His clients included mafia figures, the owners of Studio 54, and the owner of the New York Yankees. (It is that last one that makes us most queasy.) Cohn mentored the current POTUS, teaching him always to be nice. Just kidding. Cohn actually told Trump that when someone hits you, hit back even harder. Lesson learned, apparently. Cohn is a character in Angels in America. That is quite a resume. Why are we thinking of Cohn today? Why, indeed.

We personally know two lawyers who managed to get in really hot ethical water. One was disbarred, while the other was fired from his firm. Both ghost-wrote affidavits that were later disavowed by the named affiants. [Practice pointer: do not write false affidavits.] Today’s case, Webb v. Zimmer, Inc., 2019 WL 438361 (EDNY Feb. 4, 2019), involves another sketchy affidavit – a “sham” affidavit in the parlance – and the revelation of the sham led to dismissal of a product liability case. The plaintiff claimed injuries from failure of knee flex-system implant. There were various legal claims, but eventually the only claim left was for failure to warn. Then came the dispositive motions.

First came the Daubert motions. What makes the Webb case so interesting is how the implanting physician (designated as an expert by the plaintiff) signed an affidavit that was fully at odds with what he actually believed. The plaintiff used that affidavit to fend off the defendant’s Daubert motion, but struck out when attempting to use it again, this time to fend off summary judgment. The defendant obtained the right to re-depose the implanter, who promptly contradicted everything in his affidavit. It turns out that the surgeon did not write, or even read, the affidavit, which he admitted contained “inaccuracies, errors, and imprecise language.”

Would you like an example? Of course you would. The implanter offered the following opinion in the affidavit: “I reviewed the Package Inserts and find them to be inadequate because they provide a false sense of security to the treating surgeons.” Well, that’s not good for the defendant, is it? But at his second deposition, the implanter contradicted much of what he stated in this paragraph. He did not review either the package inserts or the surgical technique pamphlet prior to reading or signing the affidavit. He also testified that he was unaware of anything that the defendant “failed to do in terms of researching this product” and was “unaware of the existence of clinical data for any problems related to the Plaintiff.”

Want more contradictions? Here they come. In his affidavit, the implanter proffered the opinions that (1) the failures that occurred with the product were foreseeable; and (2) he should have been warned about it. But the implanter testified in his second deposition that he did not have enough information to testify that the failures that occurred in the plaintiff’s case were foreseeable. Further, the affidavit says that the defendant should have warned or contraindicated the use of the knee system “by advising that it was not tested in patients with hyperextension or high posterior tibial slope.” By contrast (you could see this coming by now, right?), here is what the doctor said at his deposition: “Q. But you don’t know, without evidence or whether there’s a problem with articular surface dissociation, that a warning was appropriate? A. Yeah, that’s true.”

Faced with a collection of contradictions that would have made Emerson or Whitman or Mao blush, the court refused to allow the plaintiff to utilize the implanter’s affidavit “to escape summary judgment only to permit him to modify or contradict himself at trial.” The implanter was also “prohibited from testifying as an expert on these matters.”

The implanter went on to bury the plaintiff on the learned intermediary doctrine. Even aside from the contradictions, the evidence showed that the implanter “chose to use the Product for all his primary implants based on his comfort with the Product rather than any of [the defendant’s] marketing materials or warnings contained in the package inserts.” Moreover, the doctor continued to use the knee implant system long after the plaintiff was forced to undergo multiple revision surgeries and “[t]o this day … remains confident in the product.”
The defendant got out of the case. As far as we can tell, nobody was sanctioned for the sham affidavit, and we find that darned near amazing. Why did the doctor contradict himself so badly? The Drug and Device Law Daughter has shared with us the Reddit theory about people occupying alternate dimensions or timelines. Maybe this doctor traipsed between different timelines. We are just about prepared to believe it.

A little over a year ago, we reported on a decision by Judge Rufe (E.D. Pa.) dismissing an Avandia heart attack case on the grounds of the learned intermediary rule (Utah law). All of the plaintiff’s claims boiled down to an alleged failure to warn, and that was a problem for the plaintiff, as the plaintiff’s proposed enhanced warning ended up being discredited by the science after the case was filed. Thus, even though the prescriber had stopped prescribing the product for a period of time after some adverse data came out, by the time of the prescriber’s deposition he testified that he felt comfortable with his decision to prescribe the medicine to the plaintiff. That evidence prompted the district court to bid adieu to the claims. Our defense hack hearts were gladdened by this result.

Those defense hack hearts are even more gladdened by the Third Circuit’s recent affirmance of the district court’s decision. In re: Avandia Marketing, Sales Practices and Products Liability Litigation (Siddoway), 2018 WL 6828423 (3d Cir. Dec. 28, 2018). The Third Circuit did not see fit to publish the affirmance in the West Reporter, but we see fit to publicize it.

As the Third Circuit reminds us, the plaintiff’s claims in Siddoway drew a causal link between prescriptions for Avandia prescribed in 2001 and 2002 and the plaintiff’s two heart attacks in 2003. The case hinges on what the prescribing doctor would have done, with regard to prescribing Avandia, if he had seen the warning the plaintiff preferred. The prescriber testified that he stopped prescribing the drug after learning of a 2007 meta-analysis of 42 clinical trials by Dr. Steven Nissen – a familiar name to many of us — that associated Avandia with an increased risk of heart attack. The prescriber testified that he would have “thought twice” and would have been “much more thoughtful” about prescribing Avandia and would not have prescribed the drug to the plaintiff “in the middle of all these heart attacks” if he knew this information in early 2003.

That testimony is mildly interesting, but does not really mean much because (a) the undisputed record shows that the actual prescription occurred one year before the plaintiff’s heart attacks, not “in the middle” of them, and (b) for the prescriber to say he would have been “much more thoughtful” and would have “thought twice” about prescribing Avandia if he knew in early 2003 the risk information that arose in 2007 does not cut it. The Third Circuit concluded that “the vague and highly speculative nature” of the prescriber’s testimony “suggests no concrete action and it is tied to hypothetical knowledge in 2003.” That is an important ruling, because it is exactly that sort of general, speculative, might’ve-thought-more stuff that plaintiff attorneys usually elicit from prescribers. The plaintiff lawyers then pack up their papers and smugly climb aboard their private jets, sure that they have staved off summary judgment. But they have not (or should not have) staved off summary judgment. Rather, they have walked right into it.

And then there is the inconvenient (for the plaintiff) fact that the prescriber in Siddoway also testified that if he had also known in 2001 and 2002 about the exculpatory information available in 2015, the time of his deposition, when the Food and Drug Administration removed the link between Avandia and an elevated risk of heart attack, he would have made the same choice to prescribe the drug to Siddoway. As we wrote a little more than a year ago, the result in Siddoway seemed “inevitable.” The Third Circuit saw it the same way.

It took us more than a week, but we finally put away the last serving pieces from last week’s family Hanukkah celebration.  We love Hanukkah, a festive holiday that celebrates victory over a tyrant king, a reclaimed temple, and a small quantity of oil that should have lasted only one night but that miraculously burned for eight nights.  In commemoration, we light candles for eight nights. And we use oil.  Lots and lots of oil.  Like, eight dozen potato latkes-worth of oil.   Though the holiday has far less religious significance than does Christmas, it is a time for family and gifts and food and song and celebrating the “miracle” of the bit of oil that improbably shed eight nights of light.

In a similar vein (pun intended), today we celebrate a very short, but surprisingly bountiful, decision out of the inferior vena cava (“IVC”) filter MDL pending in the Southern District of Indiana.  We love warnings causation, a potent doctrine too often rendered toothless by passive judges.  Not so in In re Cook, Inc. IVC Filters Marketing, Sales Practices, and Prods. Liab. Litig. (Tonya Brand), 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018).   In the IVC filter MDL, the plaintiffs allege that the filters are prone to tilting, migrating, fracturing, and perforating the inferior vena cava.  In Brand, the defendants’ IVC filter was inserted in the plaintiff’s inferior vena cava to prevent pulmonary embolism during an upcoming spine surgery.  Two years later, the plaintiff began to experience pain on the inside of her right thigh.  Shortly thereafter, the plaintiff noticed something protruding from her thigh and pulled out a portion of her IVC filter.  The plaintiff was required to undergo open surgery to remove the rest of the filter.  The plaintiff sued, alleging that the instructions for use (“IFU”) that accompanied her filter did not adequately warn her physician of the risks associated with the filter.

The court explained that, under Georgia’s learned intermediary doctrine, the plaintiff could prevail on her warnings claims only by proving both that the warnings in the IFU were inadequate and that the inadequate warnings proximately caused her injuries.  The court emphasized, “Where the learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action the plaintiff contends should have been provided, . . .  the causal link is broken and the plaintiff cannot recover.”  2018 WL 6415585 at *3.  The plaintiff’s physician testified that he was aware of all of the relevant risks when he implanted the Plaintiff’s IVC filter.  His knowledge of the risks was not based on the IFU; rather, it was based on his “education, training, and experience.”  Id.    Moreover, the doctor testified that he continued to use the defendant’s filter even after the plaintiff’s filter fractured, and that nothing about the plaintiff’s experience changed his mind about IVC filters in general or about the specific filter he used in the plaintiff.  The court held, “In the face of this devastating testimony, Plaintiff fails to raise a genuine issue of material fact on the proximate causation element” of her failure-to-warn claims.  Id.  at *4.

The plaintiff also argued that the defendants breached Georgia’s continuing post-sale duty to warn because they did not warn her physician, after he implanted her filter, of the filter’s propensity to  perforate and fracture.  She alleged that, if the defendants had provided such a warning, her doctor “potentially could have removed the filter before it fractured and pieces migrated throughout [her] body.” Id.   The court rejected this argument as well, holding that it was based on speculation and that the evidence, including the fact that the plaintiff’s physician continued to use the same filter in patients even after the plaintiff’s filter fractured, suggested that no post-placement warning would have prompted the doctor to retrieve the plaintiff’s filter any earlier.  As such, the plaintiff “fail[ed] to raise a genuine issue of material fact that any post-implant failure to warn caused her injuries.”   Id.   Because the plaintiff failed to sustain her burden of proving the causation element of her warnings claims, the court granted summary judgment for the defendants on those claims and on the claims that were based on them.

We make these same arguments over and over and over again in our medical device cases.  We often don’t prevail, even on clear records.  We wish that more courts had the clear-eyed approach to warnings causation that this MDL judge employed.  We will keep you posted on similar decisions.  And we still have a couple dozen potato latkes in the freezer, in case you are in our neighborhood.

A federal judge in one of our non-drug or device cases recently informed the parties that he was so busy with his criminal docket that it might be better to let the magistrate judge take over our case, including trial. We fretted over the prospect of losing a judge who had thus far been very attentive, careful, and rigorous, but the issue was mooted when the plaintiff swiftly said “No thanks.”

Over the years, we have had many good experiences with magistrate judges. Indeed, our last trial in Philly was in front of a magistrate judge, and it would be hard to imagine how it could have been any more fair or efficient. The case we are discussing today, Lynch v. Olympus Am., Inc., 2018 U.S. Dist. LEXIS 185595 (D. Colorado Oct. 30, 2018), was handled by a magistrate judge pursuant to the parties’ consent via 28 U.S.C. 636(c). The plaintiff might now regret such consent, in light of the magistrate judge’s decision, but the clarity and logic of that decision is undeniable.

In Lynch, the plaintiff sued three companies for making endoscopes that were allegedly too hard to clean, thereby causing the plaintiff to suffer an infection and illness. One of the companies was a Japanese parent, and the other two were affiliates that did business in the United States. The Japanese parent moved to dismiss the complaint for want of personal jurisdiction. The affiliates moved to dismiss the strict liability and negligence claims on substantive grounds, and to dismiss the misrepresentation claims for failure to plead with specificity.

The magistrate judge’s opinion is exquisitely organized, so we’ll follow its outline faithfully.

    Personal jurisdiction

The Lynch court considered whether the Japanese parent could be hailed into Colorado based on the stream of commerce theory. That theory is not one of our favorites, and the Lynch court correctly described its fuzziness. SCOTUS has not exactly been very exacting in setting forth the contours of the stream of commerce theory. The Tenth Circuit has been better in erecting this key guardrail: “specific jurisdiction must be based on actions by the defendant and not on events that are the result of actions taken by someone else.” Monge v. RG Petro-Machinery (Group) Co., 701 F.3d 598, 618 (10th Cir. 2012). The Tenth Circuit has also been unambiguous that mere corporate affiliation is insufficient to impute one company’s contacts to its parent corporation. Accordingly, the Lynch court did not feel “free to disregard corporate formalities when assessing whether it may properly exercise personal jurisdiction over a defendant.” What we end up with is another successful example of using marketing subsidiaries to insulate the foreign parent from suit.

Are we done with personal jurisdiction? Not yet. The plaintiff tried to invoke non-registration-related consent by the parent corporation, based on things that happened in other cases. Nice try. Not really. The Lynch court reasonably pointed out that other cases are other cases, and what happened in those other cases has no bearing on or similarity with this case. “A consent in one case does not affect the propriety of a court’s exercise of personal jurisdiction in another case, even if related and even if in the same forum.” The court agreed with the plaintiff that it might be entitled to some jurisdictional discovery — if it could successfully plead the substantive claims, but that, as we will see in a moment, is not so clear.

    Design Defect

Beyond bare conclusions, the plaintiff did not manage to allege that the risks of the endoscopes outweigh benefits in all patients. Potential problems with reuse do not affect all patients on whom new devices are used. “[M]erely being difficult to clean does not render the device unsafe for all all patients.” Moreover, causation requires more than the fact that the plaintiff fell ill after encountering the product. The allegations are too conclusory to state a claim for strict liability under a design defect theory.

    Failure to Warn

Lynch is the first case applying Colorado law to apply the learned intermediary rule to a medical device. No prior Colorado court had explicitly done so, though there was at least one case that generally treated prescription drugs and medical devices together. The plaintiff in Lynch contended that the endoscope was a nonprescription device. Even if that contention was “technically correct,” it did not matter. “Clearly, patients are not buying [endoscopes] over the counter” to administer the procedure to themselves at home. It is necessarily a doctor who “decides the procedure is required and performs it.” To our mind, the Lynch court analysis makes good sense. There are a variety of medical devices that might not technically require a prescription, but there is still no doubt that a doctor is a necessary (and learned) intermediary. Think of scalpels. The doctor, not the patient, selects the particular scalpels employed in a procedure. Would it make any sense to permit personal injury plaintiffs to complain that the scalpel manufacturer supplied inadequate warnings? Scalpels are, sharp, sure. But maybe the manufacturer should have warned that they are very, very sharp. Or maybe there is a materials safety data sheet for one of the scalpel’s raw materials that might give the dense or paranoid pause. The mind reels. For now, let’s content ourselves with the Lynch court’s application of the learned intermediary rule to endoscopes, and the court’s conclusion that the plaintiff did “not allege the failure to warn as applied to her physician.”

The Lynch court made another ruling that is pertinent to many drug and device cases: is the failure to warn really about warning at all? What exactly is the warning and what would be the effect of the warning? In Lynch, the warning allegedly lacking seems to be nothing more than telling doctors that the product is defective. “Plaintiff’s claim is, in essence, that the product was defectively designed and therefore the warning was inadequate; as pled, the failure to warn claim cannot be distinguished from the design defect claim.” Thus, the warning claim boils down to, or takes back to, the design defect claim. And we know how that turned out.

    Negligence and Products Liability

The complaint contained “inadequate factual allegations establishing causation. Absent plausible allegations linking the Defendants’ actions to the Plaintiff’s harms, there is no plausible claim for relief.” Well, okay then.

    Misrepresentation

The plaintiff alleged both fraud and negligent misrepresentation, but the Lynch court correctly points out that there was no real difference between those claims. The negligent misrepresentation claim was replete with all sorts of intentionality. The court concluded that both claims needed specificity and both claims lacked it. The acts of the various defendants were jumbled together, and specifics on who, what, where, and when were wholly absent.

*********************

The plaintiff will get a chance to try again. The magistrate judge was perhaps a bit charitable. But she was also smart and careful, so the plaintiff had better do a much better job on the next go around.

We spent yesterday in New York City, helping the Drug and Device Law Rock Climber (now the “Drug and Device Law Software Engineer” – yes, we are kvelling) move from one sublet to another as she continues her quest for the perfect apartment. The day was challenging, as these things tend to be. We lost count of the times we heard, “Why didn’t you tell me?” (That it was going to rain, that we would have to use the freight elevator, that we would be forced to keep moving the borrowed van because here was no legal place to leave it, that the refrigerator would bear the detritus of multiple unintentional science experiments – you get the idea. ) Each time, we responded with, “What difference would it have made?’

The plaintiff in today’s case, a tidy appellate decision in a medical malpractice case out of New Jersey Superior Court, asked the same question, and got the same answer. In Hopper v. Progressive Motion Med. Prod. Solutions, 2018 WL 2270839 (N.J. Super. Unpub. July 18, 2018), the defendant doctor performed arthroscopic knee surgery on the plaintiff. Following surgery, the doctor prescribed a cryotherapy device for the plaintiff to use at home to help control pain and swelling. The device worked by creating a flow of cold water across the plaintiff’s bandaged knee. The doctor and his staff instructed the plaintiff to use the device continuously for the first seventy-two hours after surgery and as needed thereafter, and to contact the doctor with any “issues” involving “drainage, redness, [or] warmth.” Hopper, 2018 WL 2270839 at *2.

The plaintiff used the device for seventy-two hours and intermittently for the next several days. On the fifth day, he saw the defendant doctor for complaints of swelling and bleeding. The doctor reassured the plaintiff that fluid buildup was common after surgery, aspirated the fluid from the knee, and instructed the plaintiff to return in a week. When the plaintiff returned, fluid had accumulated again, and the knee was painful. The doctor drained the fluid, but, he testified, was not “overly concerned.” He instructed the plaintiff to continue to use the device as needed.

Over the next several weeks, the plaintiff developed increased pain and swelling along with black skin and blisters on the knee. About five weeks after surgery, the plaintiff went to the emergency room complaining of nausea and increased knee pain. He was admitted, and ended up remaining in the hospital for a number of weeks. At the time of admission, the plaintiff had “eschar” – dead, necrotic tissue – over a wound in his knee. The eschar was surgically debrided, but it returned. Ultimately, the plaintiff was diagnosed with osteomyelitis, an infection of the bones in his knee. He was in danger of losing his leg, though doctors were able to save the leg by fusing the plaintiff’s knee.

The plaintiff sued the doctor for medical malpractice, alleging that the doctor deviated from the accepted standard of care during the postoperative period and that the deviations proximately caused his injuries. At trial, the plaintiff’s experts testified that the cryotherapy device caused “freezer burn” – a thermal injury – to the plaintiff’s skin, which the doctor did not recognize. According to the plaintiff’s experts, the untreated thermal injury destroyed the skin on the plaintiff’s knee. When the knee was debrided, the plaintiff’s experts testified, bacteria in the hospital environment infected the knee and eventually the bones, necessitating the fusion. The plaintiff’s experts testified that the doctor deviated from the standard of care by, inter alia, failing to warn the plaintiff of the risk of thermal injury and failing to personally instruct the plaintiff on how to use the cryotherapy device instead of allowing his staff to perform this task.

The defendant’s infectious disease expert opined, based on testing performed on tissue removed from the plaintiff’s knee, that the plaintiff was suffering from bullous cellulitis, blistering caused by a staph infection of the knee – not a thermal injury – when he presented to the emergency room, and that the infection would have occurred whether or not the plaintiff used the cryotherapy device. The defendant’s “standard of care” expert conceded that the doctor deviated from the accepted standard of care when he failed to warn the plaintiff of the risk of thermal injury. He testified that it was more likely than not that the plaintiff had sustained a thermal injury, but he did not opine that such injury was the proximate cause of the plaintiff’s damages.

The jury agreed, finding that the defendant had deviated from the applicable standard of care but that the deviations were not the proximate cause of the plaintiff’s injuries. On appeal, the plaintiff argued, inter alia, that, because it was ruled that the learned intermediary doctrine applied (the medical device manufacturer was no longer in the case when it was tried) and because there was sufficient evidence that thermal injury was a risk, the trial court committed error by failing to charge the jury about informed consent. The plaintiff argued that this error was “clearly prejudicial [because] defendant admitted he did not warn plaintiff of the risk of thermal injury.” Id. at *16.

The court disagreed, distinguishing between the product liability concept of “learned intermediary” and the medical monitoring theory of informed consent, explaining that “to prove a physician was negligent premised upon a theory of lack of informed consent, a plaintiff must show (1) the physician failed to comply with the applicable standard for disclosure; (2) the undisclosed risk occurred and harmed the plaintiff; (3) a reasonable person under the circumstances would not have consented and submitted to the [procedure] had he . . . been so informed; and (4) the [procedure] was a proximate cause of plaintiff’s injuries. Id. at *17 (citation omitted).

In any event, the court concluded that, because the jury had found that the doctor’s deviations from the standard of care were not the proximate cause of the plaintiff’s damages, the court’s failure to charge the jury on informed consent was harmless error. Verdict affirmed, and doctor off the hook for failing to warn. Wish it were that easy for the mother of a certain software engineer.

We’ve seen Griffith v. Blatt, 51 P.3d 1256 (Or. 2002), cited – and not just by plaintiffs – for broad propositions, like Oregon abolished the learned intermediary rule in strict liability cases, or that strict liability, generally, is strait-jacketed by legislative adoption of Restatement (Second) of Torts §402A (1965) and its comments.

We don’t think that’s so.

First, let’s start with the Oregon product liability statute that the Oregon Supreme Court applied in Griffith.  There is, indeed, a provision that does exactly what Griffith held – Or. Rev. Stat. §30.920.  This section of the product liability statute provides:

(1) One who sells or leases any product in a defective condition unreasonably dangerous to the user or consumer or to the property of the user or consumer is subject to liability for physical harm or damage to property caused by that condition, if:

(a) The seller or lessor is engaged in the business of selling or leasing such a product; and

(b) The product is expected to and does reach the user or consumer without substantial change in the condition in which it is sold or leased.

(2) The rule stated in subsection (1) of this section shall apply, even though:

(a) The seller or lessor has exercised all possible care in the preparation and sale or lease of the product; and

(b) The user, consumer or injured party has not purchased or leased the product from or entered into any contractual relations with the seller or lessor.

(3) It is the intent of the Legislative Assembly that the rule stated in subsections (1) and (2) of this section shall be construed in accordance with the Restatement (Second) of Torts sec. 402A, Comments a to m (1965). All references in these comments to sale, sell, selling or seller shall be construed to include lease, leases, leasing and lessor.

(4) Nothing in this section shall be construed to limit the rights and liabilities of sellers and lessors under principles of common law negligence or under ORS chapter 72.

In addressing the learned intermediary rule, the Griffith court interpreted Section 30.920(3) strictly to apply only §402A and its comments – which do not reference (they date from 1965) the learned intermediary rule:

Pursuant to ORS 30.920(3), we must construe ORS 30.920(1) and (2) “in accordance with” the cited comments to Restatement (Second) of Torts §402A. . . . , [which] indicate that a seller of a drug may be required to give an adequate warning of the product’s danger to a consumer when the seller has knowledge or should have knowledge of the danger. . . .  It is sufficient for present purposes to conclude that, contrary to Stout’s argument, Oregon’s product liability statute does not create a defense to strict liability based on the learned intermediary doctrine.

51 P.3d at 1262.

Some of our more long-term (and sharp-eyed) readers might notice something unusual about this last quote.  Normally, we don’t leave party names in quotations.  But that’s critical here.  Who are the defendants?

Rugby manufactured the lotion and Stout, a pharmacist, filled the prescription.

Id. at 1258 (emphasis added).  The actual manufacturer was dismissed on the statute of limitations, and that dismissal was affirmed in Griffith.  Id. at 1261.  Thus, the pharmacist, Stout, was the only defendant left in the case.

That’s critical, because the statute distinguishes throughout between four classes of entities in the chain of sale of a product – the “manufacturer,” “distributor,” “seller,” and “lessor” of the product at issue.  See Or. Rev. Stat. §§30.900, 30.902; 30.905(5); 30.907(3)(b); 30.908(4-5); 30.910, 30.915(1,3); 30.927(1,3).

Now look back at the language of §30.920, the provision construed in Griffith.  It is entitled “Liability of seller or lessor of product.”  Neither the title, nor the body of this section is in any way applicable to the “manufacturer” of a product.

This is the key to the widely misunderstood Griffith decision.  The only defendant at issue in Griffith was a pharmacist – a non-manufacturing seller of a prescription drug.  Likewise, the statutory section construed in Griffith is applicable solely to product “sellers” or “lessors” – and by its terms is not applicable to manufacturers.

Griffith’s recognition of a §402A strait-jacket forbidding the adoption of the learned intermediary rule thus only applies to strict liability cases brought against pharmacists (sellers) and should not displace the learned intermediary rule in cases involving manufacturers – to which §30.920 expressly does not apply – where the rule is well-established under Oregon law.  See Oksenholt v. Lederle Laboratories, 656 P.2d 293, 296-97 (Or. 1982); Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1247-48 (Or. 1975); McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974).

So manufacturing defendants in cases under Oregon law should be careful not to fall for overly expansive arguments based on Griffith.  There is no statutory §402A strait-jacket in cases involving manufacturers (as opposed to “sellers” or “lessors”), whether involving the learned intermediary rule or anything else.  Any decision or commentary to the contrary is ignoring the manner in which the Oregon legislature structured its product liability statute.  It expressly adopted §402A and its comments only to define the liability of product sellers and lessors – not manufacturers.

When we were on a jury last month we were warned not to consult any outside sources.  And we didn’t.  When we were in high school last century and studied the works of Eliot, Lawrence, Joyce, Waugh, and (another) Eliot, we were instructed not to consider extraneous issues, such as biography or social conditions.  Our teachers were still in the grip of the New Criticism and, therefore, so were we. 

 

But we found today’s case, Lynch v. State, 2018 Conn. Super. LEXIS 851 (Conn. Superior Ct. April 17, 2018), tough sledding without doing some research beyond the four corners of the opinion.  The case is about a plaintiff who was inseminated by a sperm bank donor, came down with a cytomegalovirus (CMV), and gave birth to children with serious injuries.   What we learned courtesy of the internet is that CMV is fairly common and usually doesn’t cause terrible maladies.  The problem is that if a CMV-negative woman gets infected with CMV during pregnancy, there is a possibility of birth defects.  That is what happened here.  The plaintiff had been CMV negative.  That is something she knew and her doctor knew, but the sperm bank did not know it.  The sperm donor tested as CMV-positive, though he no longer actively suffered from CMV.  The sperm bank accurately disclosed the CMV-positive status of the sperm.  What the sperm bank did not do was tell the plaintiff that if she was CMV-negative, then CMV-positive sperm could pose a risk.  But, presumably, the plaintiff’s doctor would know that.  We know it from reading a Wikipedia article.  We never attended medical school, not even for ten seconds.  Call us a semi-learned, blogging defense hack.

 

The sperm bank moved for summary judgment, arguing that it did not owe the plaintiff a duty of care because a sperm bank does not have a duty to inquire into its clients’ CMV status, nor is it obligated to engage in an informed consent discussion with clients regarding the clients’ CMV status.  The Connecticut court agreed with the sperm bank and dismissed the case.  How is this a drug or device case?  It isn’t, but the scope of duty to warn and the relevance of the learned intermediary doctrine both poke their way into this case, and that is enough for us to stand up and take notice.    

 

Pursuant to the regulations, sperm banks are required to test their donors for certain diseases, including CMV. But the regulations do not impose on sperm banks an obligation to discuss the implication of the tests they run with the purchasers.  The evidence here showed that the sperm bank fulfilled its obligation to test for the sperm donor’s CMV status and to report the results accurately.  The results indicated that the donor was fully recovered and immunized from the virus, and that he was not actively infected with CMV at the time of the donation. Due to these test results, the defendants reported that the donor was CMV-positive.  The evidence did not show any knowledge on the part of the sperm bank that the plaintiff was CMV-negative.  The only duty the sperm bank had to the plaintiff was to conduct the required testing on the donor and to report the results of the tests, which it did.

 

The Connecticut court analogized to the duties that a pharmacy owes to its customers.  A previous Connecticut court applied the learned intermediary doctrine to pharmacists. Yay for the Nutmeg State. The court held that imposing a general duty on pharmacies and pharmacists to investigate and evaluate all of the medications that their customers’ physicians prescribed would impose a burden outside the scope of their normal duties, as the main job of pharmacists is to dispense the medications that their customers’ physicians prescribe. The learned intermediary doctrine makes sense in the pharmacist context given the fact that physicians have more knowledge than pharmacists about their patients’ needs and proclivities. Holding otherwise would put pharmacists between the physician-patient relationship.  The sperm bank is like a pharmacist.  (That’s a sentence we never thought we would write, but there it is.) The plaintiff’s doctor testified that he would typically advise CMV-negative patients to choose CMV-negative sperm. (The opinion does not make clear why that did not happen here.)  The court reasoned that holding that the sperm bank “had a duty to inform the plaintiff parents about the risks that CMV posed would also put the sperm bank in the middle of the physician-patient relationship.” 

 

Most of the Lynch opinion contains a discussion of the scope of duty.  There is a lot about foreseeability. (It throws us back to first year in law school, when we sat in the last row, next to the guy who always added to the seating chart a space for “Garth, the Most Savage Troll of All.”  Only one teacher ever had the temerity to call upon Garth.)  Even beyond foreseeability, the court asked whether the sperm bank might have assumed a duty to the plaintiff because either its failure to exercise care increased the risk of harm or the harm was suffered because of the plaintiff’s reliance upon the defendant’s undertaking. No and no.  First, the information that the sperm bank made available on its website about sperm CMV status did not appear to increase the risk of the type of harm that the plaintiff allegedly suffered. Although the website did arguably give some medical advice by saying that the risk of acquiring CMV from donor sperm is low, the website also informed its customers that this is a medical issue that clients should discuss with their physician. This language “clearly suggests that the sperm bank’s customers should not rely on the information provided on the website and that they should ask their physicians about CMV.”  Back to the learned intermediary.  Second, there is no evidence that the plaintiff relied on this information when selecting the donor’s sperm. The plaintiff testified that she did not discuss her or her donor’s CMV status with any representative from the defendant sperm bank, and there is no indication that she saw the page on the website that allegedly created a duty.  The Lynch court went back to the pharmacy example.  It is possible for a pharmacy or pharmacist to assume a duty when they have “specific knowledge of potential harm to specific persons in particular cases.”  But here, “this exception is not applicable because the defendant sperm bank had no knowledge of the plaintiff mother’s CMV status.” 

 

Applicable federal regulations did not help the plaintiff’s case.  Test results will show that a donor is CMV-positive even if the donor had contracted and then subsequently recovered from the virus. FDA regulations provide that a sperm donor who is actively infected with CMV is ineligible to donate. Here, the sperm bank tested the donor and determined that he was CMV-positive, but that he had fully recovered from the virus and was not actively infected with it at the time of his donation.  There was no violation of the regulations.

 

Finally, there was the usual argument from a plaintiff that summary judgment should be denied until discovery is complete.  But a party requesting more time to conduct discovery bears the burden of establishing a valid reason why the motion should be denied, including some indication as to what steps the party has taken to secure facts necessary to defeat the motion. That burden was not met here.  Thus, the court granted the defendant summary judgment.

This DDL blogger happens to have a relatively new teenager in the house. And said teen has been working on an assignment related to the novel by Lois Lowry, “The Giver.” If you are unfamiliar with the book or the more recent movie adaptation (and if you only know the movie, we recommend the book as the former doesn’t dig deep enough into the source material’s thought-provoking ideas), it is about a seemingly utopian society without war, poverty, pain, or suffering. This state of perfection is achieved through sameness. Everyone dresses the same, speaks the same, acts the same. The goal is to eliminate all conflict and for no one to feel uncomfortable. And to achieve this, free will and freedom of choice are non-existent.

The book’s themes have made for some very interesting dinner table debates about the benefits and drawbacks of sameness. While we’ve managed to identify the obvious benefits, we also always find the benefit comes at a price that we are typically not willing to pay. Sacrificing the ability to feel love to also not have to endure feeling pain. Sacrificing human life so that there is no hunger. So, in this DDL household, sameness has come under considerable attack and it is no surprise that individuality is being championed by the teen (and parent too, with some limitations).

And as we transition from home life to work life, we couldn’t help but acknowledge the parallel as we again find ourselves the advocates of individuality over sameness. This time it’s about a flawed class rather than a dystopian society.

In Andre v. Alere, 2018 U.S. Dist. LEXIS 69045, *3 (S.D. Cal. Apr. 24, 2018), putative class representatives allege that defendants’ marketing of its INRatio products was deceptive and misleading and that defendants are therefore liable under various state’s consumer protection laws. The INRatio products are handheld devices used to monitor blood clotting time in people taking warfarin. Class certification was originally denied back in December as to both a nationwide class and as to alleged state-specific sub-classes. Id. at *4-5. Plaintiffs sought reconsideration as to the six sub-class states (Colorado, Florida, Georgia, Maryland, New York, and Pennsylvania). They allege that based on new facts they can satisfy Federal Rule of Civil Procedure 23(b)(3)’s predominance requirement as to the learned intermediary doctrine, statute of limitations, and damages. The court disagreed.

For a class to be certified, Rule 23(b)(3) requires that “the question of law or fact common to class members predominate over any questions affecting only individual members.” And the court’s analysis is a “rigorous” one that can extend beyond the pleadings. Id. at *6.

Plaintiffs, for the first time in their reply brief, argued that the learned intermediary doctrine did not apply to their claims for several reasons. First, they alleged it does not apply because they are alleging a design defect claim not a failure to warn claim. But, that argument didn’t align with the allegations of their complaint which were about omissions and representations – i.e. failure to warn. Id. at *14. Nor did plaintiffs’ cite any authority for learned intermediary not applying to design defect claims. Id. Next plaintiff argued that the learned intermediary doctrine doesn’t apply where only economic injuries are sought. But again, they offered no legal support for their contention. Id. Finally, plaintiffs argued that because the INRatio product is user-operated, the doctrine doesn’t apply. On this point, it appears plaintiffs and defendants submitted competing examples of how prescribed medical devices that involve some patient operation are treated and concluded plaintiff’s argument was not persuasive. Id. at *15. Regardless of whether the patient has to be the one to use the device daily, it still had to be prescribed by his/her physician warranting application of the learned intermediary doctrine.

So, since the learned intermediary doctrine is applicable, Plaintiffs had to argue that it is subject to “common proof.” They did this by alleging that defendants “failed to warn any physicians.” Id. at *7-8 (emphasis added). But, as defendants argued, the inadequacy of the warning is only part of the equation. Plaintiffs must also show that “the inadequate or lack of warnings were the proximate cause of Plaintiffs’ injuries.” Id. at *8. The court cites at least one case from each of the six states at issue to support the proximate cause arm of the learned intermediary rule. Id. at *10-11. What all of those cases have in common is the conclusion that “proximate cause determination will ultimately lead to individual inquiries into each doctor’s experience with the product.” Id. at *12. Inquiries such as the extent of the physician’s knowledge of the risks and side effects and the source of that knowledge; and whether the physician stands by his/her prescribing decision; and the physician’s individualized medical decision based both on his/her knowledge of the product and of the patient. Id. at *12-13. While warning adequacy might be subject to common proof, individuality predominates on the issue of specific, proximate causation. Also, plaintiffs couldn’t point to a single case where class certification was granted involving the learned intermediary doctrine.

Class certification was also denied due to the lack of predominance as to damages and the statute of limitations. Again, individuality can’t be ignored.

On damages, plaintiffs put forth a full-refund model under California law and argued that it satisfied predominance and that a state-by-state analysis was not necessary. Id. at *16-17. The court, however, found that the cases plaintiffs relied on were not that black and white. See id. at *17-19 (analyzing plaintiff’s cases).      It was not enough to summarily conclude that predominance was satisfied as to all because it was satisfied as to some. The required “rigorous analysis”

is not satisfied by merely arguing that courts in some of the six states allow for a full refund model. Plaintiffs have failed to specifically demonstrate that each of the six sub-class states’ consumer protection statute and claims for implied breach of warranty in four sub-class states are connected to their theory of damages or that these state law causes of action damages provide for a full refund recovery.

Id. at *21. Plaintiffs had to show sameness among the six states, which it failed to do.

As to statute of limitations, plaintiffs argued that because each of the six states recognizes equitable tolling and/or the discovery rule, “then necessarily common proof will prevail over individualized questions” because no plaintiff knew until the product was recalled that the product was defective. Id. at *22-23. But plaintiffs ignore that both equitable tolling and the discovery rule require consideration of whether the plaintiff acted with due diligence – an individualized inquiry. Id. at *23. The court gives an example from the complaint of one of the putative class representative’s experiences with the device that should have alerted him to an issue before recall and points out that plaintiffs have not addressed how equitable tolling or the discovery rule would apply in that situation. Id. at *24. Since it cannot be determined if the statute would be tolled for all plaintiffs from the date of recall, individual issues predominate over common ones.

In “The Giver” sameness is a metaphor for the lack of truth and diversity. The destroyer of creativity, free will, joy, happiness, and love. The things that make life worth living. In DDL world individuality may not be the meaning of life, but it’s enough to ward off class actions which certainly makes us happy.