There will come a time when there is no such thing as the local radio station. Not only will transmission not occur via radio waves, but there will be nothing local about it. There also may be no banter from the DJ, short for “disc jockey”–a reference to placing flat, round pieces of plastic called records on a machine that spun them around and attracted sound through a needle. The songs or other content may just appear one after the other, perhaps interspersed with advertisements or some sort of pre-recorded public service announcements. Back in the day, however, when we used to select what we wanted to hear by turning a dial find the specific frequency (or amplitude) radio wave assigned to a station, the stations were local and the kitsch factor was high. There were lots of ads and giveaways. Focusing on the “classic rock” stations—probably now labeled as “oldies” or “album rock” stations—they had lots of gimmicks to make you think something special was happening when consecutive songs from the same bands were played. (They tended to be bands, not “artists,” and there were very few songs “featuring” someone not in the band for 15-30 seconds, at least not that would be touted as a reason to listen the song. We digress.) There was a Two-fer Tuesday, where songs from perhaps Led Zeppelin would be played back-to-back. For stations that eschewed the Throwback Thursday that apparently is a thing now on social media, they might offer a Double-Shot Thursday, where songs from perhaps Led Zeppelin would be played back-to-back.

That was all an excruciatingly protracted way of saying that we are rolling out two decisions today from the same judge involving summary judgment on similar allegations about the same drug. They were even decided on same day, last Thursday. Were text effects available, the Thursday in the prior sentence might reverberate in some fancy way. After all that, the decisions were mercifully concise and one even cited back to the Trower decision discussed yesterday. (Yes, Trower was also decided last Thursday.)

The decisions in Green v. Janssen Pharmaceuticals, Inc., No. 1:15-cv-00401-RGA, 2019 WL 1567841 (D. Del. Apr. 11, 2019), and Hopkins v. Janssen Pharmaceuticals, Inc., No. 14-cv-01366-RGA, 2019 WL 1567840 (D. Del. Apr. 11, 2019), involved claims of gynecomastia from the pediatric use of Risperdal for a range of psychiatric conditions. We have written quite a bit about these claims in the past and the basic facts of these two cases should be familiar. Each plaintiff was prescribed and took Risperdal on and off over the course of several years, claimed to have developed gynecomastia as an adolescent, and then sued as an adult. Each plaintiff also proceeded under Delaware law and was down to just negligent warning and negligent misrepresentation claims by the time the court considered summary judgment. Delaware has the learned intermediary doctrine and requires proof that a different warning would have changes the prescribing decision. Pretty standard. However, Delaware does have a quirk of its law where a warning that is “inadequate as a matter of law” means the learned intermediary doctrine does not apply. We will bite our proverbial tongue on that and just turn to how it played out in these cases.

The analysis of the issue was in Green, where plaintiff contended that his expert’s opinion and some testimony of one of defendant’s employees established inadequacy as a matter of law. Reviewing the issue as if plaintiff had cross-moved for summary judgment, the court determined that the issue of inadequacy was genuinely disputed. Among other things, the condition was discussed in the labeling in place for most of the time that plaintiff was prescribed the drug by ten different doctors and defendant’s FDA expert opined that the label was adequate and disputed the opinions of plaintiff’s expert. That was enough to turn to the issue of proximate cause.

For whatever reason, the plaintiff in Green deposed only one of his ten prescribing physicians. That physician testified that “additional information on the risks associated with Risperdal would not have impacted his decision to prescribe Plaintiff the drug.” While we might have preferred that the court had made it clear in this situation that plaintiff needed favorable testimony from all the prescribing physicians (or at least those whose prescriptions were reliably linked to development of the gynecomastia), this short analysis was enough to get rid of the remaining claims in Green.

The analysis in Hopkins was even shorter. He did not depose any of his physicians, so he had nothing on proximate cause, which was an issue because he had offered the same evidence on inadequacy as a matter of law rejected in Green. Hopkins had two more problems. He took the generic drug, not the drug made by the company he sued. Because there is no innovator liability in Delaware, as affirmed earlier that same day, that also meant summary judgment. He also did not have evidence that he actually had gynecomastia, let alone proof of gynecomastia from specific drugs that he took. Lacking a diagnosis or case-specific expert, Hopkins tried to rely on a generic expert who said that the use of the drug in general can cause gynecomastia sometimes. The court did not have to dwell long in rejecting that.

Collectively, Green and Hopkins illustrate that it should not take long decisions to get rid of the claims of plaintiffs who did not muster basic evidence and hoped to get past summary judgment anyway. Whether this court’s decisions signal a turning of the tables in Risperdal litigation remains to be seen.

It’s tax week, so expect a lot of cases this week from that wonderful no-tax paradise, Delaware. With light traffic (iffy on I-95, to be sure), one can get from our office to Delaware in under a half hour. That’s a worthwhile trip for buying anything in triple or higher digits. It’s also a worthwhile trip if one hankers for decent court rulings. The Philadelphia Court of Common Pleas is a Hobbesian war of all against all, while Delaware courts are a calm, sensible embodiment of John Locke – protecting life, liberty, and the pursuit of property. They also do a pretty good job of protecting common sense. A recent example of that is Trower v. Janssen Pharmaceuticals, Inc., 2019 WL 1571834 (D. Del. April 11, 2019), where a Delaware federal court said No Thanks to the product liability doctrinal abomination known as innovator liability.

The plaintiff alleged that he developed gynecomastia, breast pain, and discomfort from ingesting generic risperidone. The SCOTUS Mensing case meant that the plaintiff was out of luck against the generic manufacturer. Aggrieved by this deprivation – just as Justice Sotamayor was in her Mensing dissent when she fretted that the majority opinion “strips generic-drug consumers of compensation when they are injured by inadequate warnings” – the plaintiff in Trower proposed that “the appropriate solution is to allow plaintiffs to maintain claims against brand name manufacturers for failure to warn, even when the plaintiffs ingested only the generic manufacturers’ products.” This modest proposal was premised on “two policy reasons: (1) it ensures drug labels are consistent and consumers adequately warned, regardless of whether a generic or brand name drug is dispensed by a pharmacist, and (2) imposing liability on brand name manufacturers better reflects what is actually at issue in failure to warn claims.” In addition to these policy arguments, the plaintiff pointed out that a couple of courts have actually bought this argument. One of those courts, of course, was the California Supreme Court. California is quite similar to Delaware, except in terms of size, taxes, weather, earthquakes, and the judicial embrace of common sense. California is the Beach Boys singing “Wouldn’t It Be Nice.” Delaware is George Thorogood explaining why he prefers to drink alone. We’re right there with George. (Except we aren’t because, you know, he wants to be alone.)

The defendant in Trower argued that Delaware law does not support imposing liability on defendants that did not make the allegedly harmful product. It is fundamental to product liability law in Delaware that “a plaintiff must plead facts that identify the allegedly defective product and the manufacturer of that product.” In re Benzene Litig, 2007 WL 625054, at *6 (Del. Super. Ct. Feb 26, 2007). It is also fundamental to product liability law in Delaware that “generic identification of a product is not enough to establish liability absent some other evidence that that generic product was the specific product of a defendant.” Lee v. A.C. & S., Inc., 1986 WL 15421, at *2 (Del. Super. Ct. Dec. 15, 1986).

Come to think of it, those are fundamental precepts in product liability law pretty much anywhere.

The plaintiff in Trower cited to just one Delaware case, Wilkerson v. Am. Honda Motor Co., 2008 WL 162522, at *2 (Del. Super. Ct. Jan. 17, 2008). In Wilkerson, the Superior Court held that a defendant may be liable for a plaintiff’s asbestos exposure from a third-party product if it was reasonably foreseeable that use of defendant’s product would result in use of the third-party product that would result in exposure to asbestos. Id. at *2. That sounds sort of close to putting a defendant on the hook for someone else’s product, but it really isn’t. As the Trower court observed, “[c]onsistent with other Delaware cases, Wilkerson requires that defendant produced the product at the center of the dispute.” Thus, there is no real authority in Delaware law for innovator liability.

That is particularly important in Trower, which involved a federal court. The Third Circuit, almost as much as Bexis, “disfavors district courts creating new state law while sitting in diversity.” Faced with this modesty principle, and faced with the absence of support in Delaware law for innovator liability, the Trower court concluded that “Delaware law does not support imposing liability on a brand name defendant for a generic manufacturer’s product.” Wouldn’t it be nice if all other courts were so sensible?

Then, as if to prove how Delaware always renders such good value, the Trower court went on to rule that the defendant was entitled to summary judgment on an entirely independent ground that the plaintiff did not establish that an additional warning would have changed the plaintiff’s physician’s decision to prescribe risperidone. None of the plaintiff’s physicians had been deposed for this litigation. That seems like a very odd choice by the plaintiff, and it left the court with no choice but to hold that the plaintiff could not “overcome Delaware’s learned intermediary doctrine.”

In this age of scrolling news, headline news, pop-up news, instant alerts – it’s tough to stay current.  For instance, if you were getting Masters updates on Sunday, the last few hours of lead changes, dropped strokes, balls in the water on 12, and nearly every swing Tiger made on the last 4 holes probably had your phone pinging like a pinball machine.  And, if that wasn’t what was blowing up your phone Sunday, it was likely GOT countdowns, conjecture, and general fandom camaraderie.  Whatever it was – it was always changing.  The unfortunate side of real time reporting (often combined with 260 character reporting), is that it can be out-of-date as soon as you hit send.

That’s what happened to us last week.  No sooner had our post on Lempa v. Eon Labs, Inc., 2019 U.S. Dist. LEXIS 54868 (N.D. Ill. Mar. 29, 2019) hit the blog touting that it’s holding was in opposition to the two circuit court of appeals decisions on the same issue then we learned that a third appellate court had weighed in.  Fortunately, it too leaves Lempa as an outlier.

We posted about the district court’s dismissal of Bean v. Upsher-Smith Pharms., 2017 WL 4348330 (D.S.C. Sept. 29, 2017) here.  The district court dismissed plaintiff’s failure to warn and off-label promotion claims both as preempted and barred by the learned intermediary doctrine.  Plaintiff only appealed the dismissal of his failure to warn claim and the Fourth Circuit only reached the learned intermediary issue finding it was unnecessary to reach preemption.  Bean v. Upsher-Smith Pharms., 2019 U.S. App. LEXIS 10260, *3 (4th Cir. Apr. 8, 2019).

Like the other amiodarone cases we’ve discussed, plaintiff’s decedent was prescribed the drug off-label and suffered pulmonary toxicity leading to his death.  Id. at *2.  Also like the other cases, plaintiff did not allege that defendant failed to warn the prescribing physician of the risk of pulmonary toxicity.  Instead, plaintiff alleged his father was not provided with the Medication Guide.  Essentially that is a claim that the manufacturer had some duty to ensure that the end-user of a drug received a warning.  But the appellate court found that South Carolina recognizes the learned intermediary doctrine – “a duty to warn that extends only to physicians” or other learned intermediaries.  Id. at *4.  It is then up to the physician to use his/her “knowledge, training, and experience to provide the patient” with appropriate information so the “patient can make an informed choice.”  Id. at *5 (following the Restatement (Third) of Torts version of learned intermediary).  In this case it was undisputed that the prescribing physician was aware of the risk of pulmonary toxicity.  Id. at *6.  Therefore, defendant satisfied its duty to warn.

Since plaintiff could not demonstrate that the warnings provided to the prescribing physician were inadequate, he argued that they were “ineffective” due to the manufacturer’s off-label promotion.  Id. at *6-7.  But plaintiff explicitly chose not to appeal his off-label promotion claim.  A failure to warn claim concerns “a misrepresentation of risks.”  Id. at *7.  Plaintiff was arguing a misrepresentation of benefits.  He knew that was a separate claim when he filed his lawsuit.  He pleaded it that way.  Then he chose not to appeal it.  “[H]e cannot revive it now, repackaged as a response to the manufacturer’s invocation of the learned intermediary doctrine.”  Id.

And, even if he could, there is no direct-to-consumer exception to the learned intermediary doctrine.  While it is true that the FDA required end-users to receive a Medication Guide, it was “the FDA’s intent that the Medication Guide rule not ‘alter the duty, or set the standard of care for manufacturers.”  Id. at *9 (citing 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998)).

At the risk of dating this post too, we now have two circuits finding the medication guide claim barred by the learned intermediary doctrine – Fourth and Eleventh – and one that found it preempted – Sixth.  If this post becomes outdated by more decisions like these, we don’t mind pinging you again.

A jurisprudential milestone of sorts was recognized last month when the ever rising tide of federal MDL filings surpassed 50% − that’s right, over half – of all cases currently open in the federal judicial system now are contained in multi-district litigation.  As reported, “the 248 MDL dockets accounted for 52 percent of all pending federal civil cases at the end of the last fiscal year.”  Here’s a more detailed review:

A year ago, civil cases concentrated in MDLs made up 47% of the entire federal civil caseload.  The change to majority MDL continues a trend of growing concentration of the federal civil caseload in MDLs which dates back to the early 1990s. . . .  [T]he largest MDLs comprise an even bigger share of the civil caseload than in past years.  At the end of fiscal year 2018, cases in large MDLs with 1,000 or more cases represented 46% of cases in the federal civil court system, compared to 40% at the end of fiscal year 2017, according to calculations based on data from the Judicial Panel on Multidistrict Litigation (JPML) and United States Courts.  The 140,052 cases pending in 24 large MDLs represented 89% of all the cases across 248 MDL dockets at the end of fiscal year 2018.

Rules4MDLs, “MDL Cases Surge to Majority of Entire Federal Civil Caseload” (3/14/2019).  There are no rules for MDLs.

As we’ve discussed many times before, the ordinary Federal Rules of Civil Procedure apply sporadically, if at all in MDLs.  Likewise, some MDL judges apply Daubert rigorously, and others do not.  Some MDLs are disposed of on the basis of federal preemption, while other MDL judges seem never to have granted a preemption motion in their careers.  Appellate opportunities are few and far between, and almost always arise when plaintiffs lose, since defense losses don’t generate immediately appealable orders.  The current MDL system makes the federal judicial system resemble the baroque Holy Roman Empire – an agglomeration of hundreds of feudal principalities, feigning allegiance to one set of laws, but in reality operating more or less independently – with some of those margraves and palatine counts wielding rather despotic power.

Like some wasps do to caterpillars, agglomerations of “plaintiff steering committees,” assisted by shadowy funded media solicitors, have parasitized the federal judicial system, converting it into a system not for justice, but for converting mass solicitations into mass settlements without the merits of 99+% of the filed “inventory” ever being examined.

But what these stories aren’t telling you is that the situation is only going to get worse.

Why?

Because, for all the faults of federal MDL practice, mass tort practice in many states is even worse. That means that most defendants sued in most state courts will try to remove cases to federal court.

In the ensuing procedural gamesmanship, plaintiffs are in the process of losing one of the main ways they gamed the system to keep diverse cases in state court – the so-called “forum defendant rule” whereby even a diverse action could be kept in state court by the presence of defendant domiciled in the plaintiff’s chosen forum. The forum defendant rule applies only to parties “properly joined and served,” and technologically-savvy defendants have discovered that, by monitoring electronic dockets, they can remove diverse cases faster than plaintiffs can serve forum defendants. We call this “pre-service,” “snap,” or “wrinkle” removal, and we’ve chronicled (and advocated) its rise since 2007.

As we thought it would, pre-service removal degenerated into nationwide guerilla warfare for a while, since (as with MDLs) appellate review of removal controversies (remands are not appealable at all) tends to be sporadic and delayed, since removal can only be appealed as of right when the plaintiff ultimately loses on the merits.

But in the last year, that inherently delayed process began reaching a conclusion.

Two courts of appeals, the Second and the Third, confronted pre-service removal head on, and both decisively rejected the “absurd result” argument the plaintiffs had cobbled together to deny effect to the plain language of the removal statute.  Gibbons v. Bristol-Myers Squibb Co., ___ F.3d ___, 2019 WL 1339013 (2d Cir. March 26, 2019), and Encompass Insurance Co. v. Stone Mansion Restaurant Inc., 902 F.3d 147 (3d Cir. 2018).. We wrote “breaking news” posts for both cases.

Since we had the express statutory language on our side, as well as Congress not modifying the relevant language the last time it tinkered with the statute – after pre-service removal had become a “thing” – we always thought the defense side had the better of this argument.  With two emphatic affirmances, we think the rest of the appellate dominoes eventually tumble, and pre-service removal will become the norm across the country.

But widespread pre-service removal means more cases in federal court.  Since so many of the cases being removed in this fashion involve mass torts, we believe that an even larger percentage of pre-service removal cases will wind up in MDLs than federal cases generally.

A second trend is the recent more rigorous enforcement of constitutional due process limits on personal jurisdiction.  As personal jurisdiction restricts forum shopping, the same result should ensue.  A lot of plaintiffs who once would have been litigation tourists will end up having to file in defendants’ “home” states if they want to benefit (usually by hiding in the weeds and waiting for settlement) from any kind of aggregation.  Thus, enforcing the constitutional limits to personal  jurisdiction (and use of pre-service removal) will likewise move those cases, as well, to federal court.

So, yes, the situation with MDLs is bad, and cries out for reforms to prevent warehousing, allow appeals, and shed light on litigation financiers pulling strings from the shadows.  But we think things are going to get worse before they get better.

Last year, we posted about Pennsylvania going off the personal jurisdictional “deep end” in Hammons v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018), and Webb-Benjamin, LLC v. International Rug Group, LLC, 192 A.3d 1133 (Pa. Super. 2018).  Well, unfortunately they’re still at it, and we’re afraid that the result could well be a lot like the Missouri talc cases, or a bunch of California mass torts – a lot of futile trial activity eventually coming to naught because the trial courts never had jurisdiction to start with.

But maybe not.  Here’s a ray of hope.  Last Wednesday, the Pennsylvania Supreme Court agreed to hear an appeal in the Hammons case.  So whether or not it ultimately takes the United States Supreme Court to straighten Pennsylvania out, the Pennsylvania Supreme Court will have the first opportunity to set things right – which is as it should be.

Today’s decision, In Re: Pelvic Mesh Litigation, Appeal of Ethicon, Inc. & Johnson & Johnson, 2019 WL 1486697 (Pa. Super. April 3, 2019), is – and richly deserves to be – one of the last uncitable, unpublished memorandum decisions issued by the Pennsylvania Superior Court.  On May 1, 2019, new Pa. R.A.P. 126 becomes effective, and thereafter unpublished Pa. Super. memorandum decisions, while still non-precedential, will at least be citable.  Thankfully, Pelvic Mesh falls under the old rule.

Briefly Pelvic Mesh takes Hammons’ wrong-headed approach to post-BMS specific (“case-linked”) personal jurisdiction and applies it to the entire mesh mass tort pending in the Philadelphia Court of Common Pleas.  Once again, the court fails to rely on case specific evidence.  Nowhere in the opinion do we know the names, circumstances, or even the number of so-called “non-resident plaintiffs” whose jurisdictional cases are to be adjudicated.  What was lacking in BMS?  The Supreme Court told us:

The State Supreme Court found that specific jurisdiction was present without identifying any adequate link between the State and the nonresidents’ claims.  As noted, the nonresidents were not prescribed [the product] in California, did not purchase [the product] in California, did not ingest [the product] in California, and were not injured by [the product] in California. . . .  Nor is it sufficient − or even relevant − that [defendant] conducted research in California on matters unrelated to [the product].  What is needed − and what is missing here − is a connection between the forum and the specific claims at issue.

Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773, 1781 (2017) (emphasis added).  In BMS the lower courts had erred by not basing their analysis on the “specific” contacts of the plaintiffs, and instead relying on generalized evidence – including the defendant’s relationship (as here) with a third-party in-state corporate defendant:

[T]he requirements of [personal jurisdiction] must be met as to each defendant over whom a state court exercises jurisdiction. . . .  [T]he nonresidents have adduced no evidence to show how or by whom the [product] they took was distributed [and] dispensed [] to them.”  The bare fact that [defendant] contracted with a [resident] distributor is not enough to establish personal jurisdiction in the State.

Id. at 1783.

As in BMS, the Pennsylvania Superior Court in Pelvic Mesh is creating another “a loose and spurious form of general jurisdiction,” id. at 1781, specifically, a product-related version of “continuous and substantial” contacts with Pennsylvania, but lacking the critical “at home” element.  Any and all plaintiffs in the Pelvic Mesh mass tort, no matter where they reside, and no matter where they “were implanted with one of the [defendants’] eight pelvic mesh devices,” 2019 WL 1486697, at *6, are allowed to establish specific personal jurisdiction based on identical facts:

[Defendant’s] direct oversight of the knitting of the mesh in Pennsylvania, coupled with its reliance on clinical studies performed by a Pennsylvania gynecologist, is sufficient to bring [it] within the jurisdiction of this Commonwealth.

Id.

However, those aren’t plaintiff-specific facts.  Those facts aren’t unique to any plaintiff.  Instead, they are what the Pelvic Mesh court believed to be sufficiently substantial facts connecting the eight mesh products generally to the Commonwealth of Pennsylvania, no matter who the plaintiff happens to be.  Thus, as in BMS, the Pelvic Mesh court created “a loose and spurious form of general jurisdiction” that is woefully insufficient to establish either general or specific jurisdiction.  Under BMS, having an in-state distributor is insufficient, unless the plaintiff used a product so distributed.  137 S. Ct. at 1783.  Other general in-state contacts (conducting research) are not “even relevant.”  Id. at 1781.  See also Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 927 (2011) (rejecting jurisdictional analysis that “elided the essential difference between case-specific and all-purpose (general) jurisdiction”).

“[T]he suit must arise out of or relate to the defendant’s contacts with the forum.”  BMS, 137 S. Ct. at 1780 (citation and quotation marks omitted).  The facts necessary to establish “case linked” jurisdiction, as BMS made clear, are those creating “the specific claims at issue,” id. at 1781, not what a defendant generally does concerning a product.  These non-Pennsylvania plaintiffs, like the non-Californians in BMS, “were not prescribed,” “did not purchase,” “did not ingest” and “were not injured” in Pennsylvania by the product as to which they are seeking compensation.

Those plaintiffs established nothing more than routine business relationships with anyone in Pennsylvania.  Cf. Vaughan v. Olympus America, Inc., ___ A.3d ___, 2019 WL 1549345, at *5 (Pa. Super. April 10, 2019) (conceded “agency relationship” with two subsidiaries having their principal places of business (and thus “at home”) in Pennsylvania).  “[S]pecific jurisdiction is confined to adjudication of issues deriving from, or connected with, the very controversy that establishes jurisdiction. ” BMS, 137 S. Ct. at 1781.  So what if the defendants interacted with a couple of Pennsylvania third parties who had no contact whatever with the plaintiffs.  Those contacts flunk the BMS test.

General jurisdiction involves general (“continuous and substantial”) contacts – such that the defendant is “at home” where suit is brought.  Specific jurisdiction involves specific (“case linked”) contacts that connect the plaintiff’s particular case with the forum.  In most cases, it is that simple.  The jurisdictional mash-up that Pennsylvania courts have so-far created ultimately proves neither.  As in BMS, “the connection between the nonresidents’ claims and the forum [here] is even weaker.  The relevant plaintiffs are not [Pennsylvania] residents and do not claim to have suffered harm in that State.”  Id. at 1872.

As did the California courts, and the Missouri lower courts, it might well take a lot of litigation sound and fury signifying nothing before would-be mass-tort plaintiffs’ last, best hopes are ultimately brought to heel.  It may (or may not, if the Pennsylvania Supreme Court does the right thing) take another United States Supreme Court case, or even two, but eventually Pennsylvania will follow the same constitutional personal jurisdiction standards as the rest of the country.

The decision in Riera v. Somatics, LLC, 2018 WL 6242154 (C.D. Cal. Sept. 14, 2108), comes from California, a place in which private plaintiffs bring claims against medical device companies for violations of the FDCA all the time, despite the fact that the FDCA prohibits that very kind of thing. We won’t—yet again—get into how that came about or why negligence per se claims are allowed at all. We’ll take the Riera decision as it stands and focus on its rulings.

Doctors treated two plaintiffs for severe psychological problems, ultimately employing defendant’s Thymatron System IV to perform electroconvulsive therapy. Plaintiffs claimed that, as a result, they suffered brain trauma, memory loss and other brain-related injuries. They filed product liability claims based, in the main, on the manufacturer’s alleged failure to report adverse events. The decision in Riera addressed summary judgment motions, ones filed by both the plaintiffs and the defendant. You don’t ordinarily see summary judgment motions by plaintiffs, and Riera is an example of why.

Plaintiffs sought only partial summary judgment, asking the court to rule that the manufacturer violated FDA regulations by not maintaining written procedures for evaluating adverse events and by not reporting them. Id. at *4-*7. The Court denied the motions. The court held that there was an issue of fact as to whether the manufacturer’s written procedures were insufficient under FDA regulations, particularly given that the FDA never sent a warning letter or started an enforcement action. Id. at *5. Separately, the court held that plaintiffs were not entitled to a judgment that the manufacturer failed to report adverse events. In one instance, the alleged adverse event was immaterial because it was unrelated to the injury suffered by plaintiffs. In other instances, there were fact issues as to whether the events constituted a reportable adverse event. Id. at *6.

Defendant had some success on its motions, but by no means ran the table. On plaintiffs’ negligence per se claims, defendant got a split decision. The court granted summary judgment against plaintiffs’ negligence per se claims for misbranding, rejecting plaintiffs’ theory that, if defendant had reported the alleged adverse events, the Thymatron would never have entered the stream of commerce and injured plaintiffs. Id. at *8. Nothing in the record suggested that the FDA would have recalled Thymatron if the events were reported. Id. In fact, the FDA already knew of those alleged adverse events and took no action. Id. (This same causation failure also doomed plaintiff’s strict liability misbranding claim. Id. at *10.) On the other hand, the court, denied defendant’s motion on plaintiffs’ negligence per se claim that asserted a failure to investigate and report adverse events. The court found an issue of fact on whether the adverse events, if reported, would have reached plaintiffs’ doctors, who would then have warned plaintiffs. Id. at *8.

Finally, the court denied defendant’s motion for summary judgment on plaintiffs’ (ordinary) negligence claim for failure to warn of potential brain damage and memory loss. There was an issue of fact as to whether the science supported a stronger warning. Id. at *9-*10. For this same reasons, the Court allowed plaintiffs’ two strict liability failure to warn claims to go forward. Id. at *10-11.

And so it was a mixed bag. Some claims get to go to trial, and some don’t. But it’s a bit of a wonder that any would. They each read exactly like efforts by private plaintiffs to enforce the FDCA and FDA regulations, the very thing that the FDCA explicitly prohibits.

We saw recently that Centers for Medicare & Medicaid Services (“CMS”) has sent its proposed “Regulation To Require Drug Pricing Transparency” to the Office of Management & Budget (“OMB”). We’d heard about this proposed regulation, of course, but we hadn’t gotten around to reading it.  We finally took the time.

Many readers probably already know, but for those who don’t, CMS is proposing “to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or “list price”) of that drug or biological product.”  82 Fed. Reg. at 52789.  That’s practically every drug that exists, since most if not all drugs are “available through” Medicare/Medicaid.

Whether that’s a good thing or not, the source of the proposal is definitely unusual.  We’re accustomed to the FDA regulating drug advertising, and sometimes the Federal Trade Commission, but CMS?  One reason might be that the FTC wouldn’t do this, since the WAC is usually out of whack with actual consumer prices, due to all the discounts and other advantages that insurers receive.  E.g., 16 C.F.R. §233.3(d) (where “the list price is significantly in excess of the highest price at which substantial sales in the trade area are made, there is a clear and serious danger of the consumer being misled”); Giant Food Inc. v. FTC, 322 F.2d 977, 982 (D.C. Cir. 1963) (“references to manufacturer’s list price” are “deceptive” when not reflecting the actual price paid).

Thus, either this WAC information in a DTC ad will flash by in a couple of seconds and be meaningless, or the disclosures mandated by the proposed regulation will take up so much time that they will never fly under the compelled speech First Amendment doctrine that we discussed in more detail here and here.  The American Beverage case that we discussed held that a government-required statement taking up 20% of available advertising was “unduly burdensome.”  916 F.3d at 757.  Twenty percent of a thirty second ad is six seconds.

It’s always a good thing to check out the “legal authority” offered for the regulation.  What power did Congress grant CMS over drug advertising?  Well, here’s what the agency cites in terms of statutory authority:

This proposed rule is issued pursuant to sections 1102 and 1871 of the Social Security Act.  Section 1102(a) of the Social Security Act authorizes the Secretary to issue “such rules and regulations, not inconsistent with this Act, as may be necessary to the efficient administration of the functions . . . under this Act[,].”  . . . Section 1871(a) . . . instructs “[t]he Secretary [to] prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title.

82 Fed. Reg. at 52790.  That’s nice, but nothing in there even mentions drug pricing, let alone provides authority over drug advertising.

We’ve been down this road before.  CMS’s reliance on this sort of vague and generic “necessary and proper”-type statutory language to thrust itself into an area it has never regulated is strongly reminiscent of the FDA’s tobacco overreach (eventually addressed by statute) that the Supreme Court shot down in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (“B&W”).  For decades, the FDA had stayed well away from regulating tobacco products, until in 1996 it decided it would regulate them as “combination products” – relying on the general language defining “drugs” and “devices.”  Id. at 126.  Just as nothing in CMS’s organic statute mentions “advertising,” nothing in the statutory language the FDA relied upon mentioned “tobacco.”

Even granting the FDA deference under Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), 529 U.S. at 132, the Supreme Court in B&W could not stomach this degree of administrative overreach.  The Court thoroughly evaluated:  (1) how the FDA was statutorily required to conduct risk/benefit balancing, id. at 130-43; (2) where Congress had statutorily assigned regulatory responsibility for tobacco products, id. at 143-51; and (3) that the FDA had decades to assert authority over tobacco products but had failed to do so.  Id. at 151-56.  The Court concluded:

[W]e are confident that Congress could not have intended to delegate a decision of such economic and political significance to an agency in so cryptic a fashion.  To find that the FDA has the authority to regulate tobacco products, one must . . . ignore the plain implication of Congress’ subsequent tobacco-specific legislation. . . .  [N]o matter how “important, conspicuous, and controversial” the issue . . . an administrative agency’s power to regulate in the public interest must always be grounded in a valid grant of authority from Congress.  And in our anxiety to effectuate the congressional purpose of protecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop. . . .  [I]t is plain that Congress has not given the FDA the authority that it seeks to exercise here.

529 U.S. at 160-61 (citations and quotation marks omitted).

We’re not experts in Medicare and Medicaid, so we did what we could do, which is to scour CMS’s Federal Register publication for the kind of things that B&W stated are necessary to support administrative authority.  The relevant portion of the proposed rule, 83 Fed. Reg. at 52790-91, contains no indication that at any time since these programs were created over fifty years ago, Congress had authorized the agency to regulate drug advertising or otherwise require drug companies to disclose their pricing to the public.  We found only the same kind of general references to “broad” rulemaking powers and how “necessary” the proposed regulation is.  Id.  Tucked in the middle, however, is a telling admission:

Congress has not explicitly provided HHS with authority to compel the disclosure of list prices to the public.

Id. at 52791 (emphasis added).

Far from providing the kind of record that B&W held was necessary to justify “a sharp break with [an agency’s] prior interpretation of” its authority under its organic statute, 529 U.S. at 156, CMS essentially admits that such evidence does not exist.  What CMS did do is cut and paste from disparate Medicare/Medicaid-related statutes that pertain in some way to list prices, 83 Fed. Reg. at 52791 – but nowhere in any of those sections is the grant of authority that the agency needs.  None of those sections address either drug advertising or public pricing disclosure.  Medicare/Medicaid have been around for fifty years.  If the best CMS can do is rely upon a provision or two concerning other forms of price disclosure having nothing to do with advertising, we think it will be B&Wed, and rightly so.  CMS seeks to arrogate to itself an expansive new power to regulate drug advertising that Congress has never given it, but – as in B&W – instead conferred on a different agency, the FDA.  In particular Congress sought to reduce drug pricing by enacting the Hatch-Waxman Act, Pub. L. No. 98-417, 98 Stat. 1585 40, and the Biologics Price Competition & Innovation Act, Pub. L. No. 111-148, 124 Stat. 119, to name two.  Tellingly, the FDA administers both of those acts, with CMS out in the cold.  Perhaps CMS is acting in an ultra vires fashion by “seek[ing] to diminish [a] second statute’s scope in favor of a more expansive interpretation of its own – effectively bootstrap[ping] itself into an area in which it has no jurisdiction.”  Epic Systems Corp. v. Lewis, 138 S. Ct. 1612, 1629 (2018) (citation and internal quotations omitted).

All told, we think that the inevitable litigation that will follow any finalization of the CMS DTC advertising proposal does not bode well for the agency.  CMS “has no expertise in crafting …policy” in this area and thus would not be entitled to much deference from the courts.  King v. Burwell, 135 S. Ct. 2480, 2489 (2015).  There are undoubtedly lots of Chevron-related deference points that could be made here.  We’re not going to make them.  We know that at least one member of the Court, Justice Gorsuch, would be only too happy to abolish the entire complex edifice of Chevron, Auer, et cetera deference.  Any agency seeking to preserve administrative deference would be extremely foolish to allow a Chevron question to come before the Court on this flimsy a record, and with gross agency overreach readily apparent.

No.  It can’t be.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that.  Just look at our generic preemption scorecard – the proof is there.  The warnings on generic drugs must be the “same” as those on branded drugs.  Generic drug manufacturers cannot unilaterally alter, amend, or change any warning and therefore all warning related claims against them are preempted.  Well, that is unless you’re in the Seventh Circuit and the court finds a way to use the express preemption decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) to taint what should otherwise have been a slam dunk implied preemption dismissal.

Lempa v. Eon Labs, Inc., 2019 U.S. Dist. LEXIS 54868 (N.D. Ill. Mar. 29, 2019) is an amiodarone case.  You’ll find lots of amiodarone decisions on our blog.  Most of them, outside Illinois, are favorable.  So what happened here?  Plaintiff alleged that his wife was prescribed amiodarone, a generic drug, to treat her atrial fibrillation.  This was an off-label use.  Id. at *1.  Plaintiff’s wife unfortunately suffered from respiratory failure which was fatal.  Id.  Which we also know from other amiodarone cases is a known and warned of risk of the drug.

Plaintiff brought claims for failure to warn, negligence per se, and fraudulent concealment.  All three claims were based on two allegations – defendant negligently promoted the drug for an off-label use and defendant failed to provide plaintiff with a Medication Guide in violation of FDA regulations.  The decision pays lip-service to both Mensing and Mutual Pharm. Co., Inc. v. Bartlett, 570 U.S. 472 (2013) by saying:

To the extent that [plaintiff’s] claims are premised on an argument that [defendant’s] warnings or labeling (or both) were inadequate, [defendant] is correct.

Lempa, 2019 U.S. Dist. LEXIS 54868 at *9.  And, that sentence should have continued with BUT . . . .  Because what comes next is a complete undermining of those Supreme Court decisions.

Rather than focusing on what plaintiff’s off-label marketing claim really was – a claim that defendant’s label should have contained different information or warnings about off-label uses – an impliedly preempted claim, the court got distracted trying to fit the case in under Bausch and started talking about parallel violation claims.  The court found that because plaintiff was alleging a violation of federal regulations, his claims “run parallel to [defendant’s] state law duties,” and thus were not preempted. Id. at *10-12.  The problem with this is that Mensing is not an express preemption case.  It was an implied preemption case, and the district court had no business applying “parallel claim” analysis to implied preemption, where a “parallel claim” exception does not exist.  It makes no difference whether plaintiff’s off-label promotion claim is “parallel” to federal regulations, defendant could not have offered any different warning so any claim that the warning or information it provided was inadequate is preempted under Mensing.  The court was trying to fit a square peg into a round whole – and the only way that works is to cut off the corners.

As for the claim of failure to provide a Medication Guide.  Two circuit courts have ruled on the issue.  The Eleventh Circuit found the claim failed under the learned intermediary doctrine (Tutwiler v. Sandoz, Inc., 726 F. Appx. 753719024 (11th Cir. 2018) (discussed here)) and the Sixth Circuit found it was preempted (McDaniel v. Upsher-Smith Labs, Inc., 893 F.3d 941 (6th Cir. 2018) (discussed here)).  Either way, it didn’t survive.  We already know where the district court came out on preemption.  It didn’t get learned intermediary correct either.

Again, the court started with an acknowledgement that “prescription drug manufacturers have a duty to warn health-care professionals – but not the ultimate end-consumer – of the risks associated with its product. Lempa at *13.  Here comes another BUT . . . .  The court agreed with plaintiff that the learned intermediary doctrine doesn’t apply if the defendant’s warning was inadequate.  Specifically, the court found:

The Court agrees that there is, at least, a question of fact about [defendant’s] warnings to [plaintiff’s wife’s] doctor about off-label uses of amiodarone. [Plaintiff] alleges, among other things, that [defendant] “did not include warnings to prescribing physicians of amiodarone of the potential dangers associate with amiodarone toxicity and dangers to atrial fibrillation patients.” This precludes application of the learned intermediary doctrine at this stage of the litigation.

Id. at *13-14.  Whoa, whoa, whoa.  The court completely missed that it was basing its learned intermediary ruling on a failure to warn claim that should have been preempted under Mensing.  To go back to before the first BUT – the court did rule that plaintiff was “not permitted to argue that [defendant’s] labels were inadequate, because those claims are preempted under Mensing and Bartlett.  Id. at *12-13.  So, any claim that defendant failed to include any warnings should be preempted.  But more importantly, the court misunderstands how the learned intermediary doctrine works.  That the doctor allegedly received an inadequate warning doesn’t change to whom the warning must be given and spontaneously create a duty to warn the patient directly.  The adequacy of the warning goes to whether the defendant can prevail on the warning claim.  Something that shouldn’t be an issue here because any adequacy claim is preempted.  Since there is no duty to warn a patient directly, plaintiff’s Medication Guide claim is solely based on FDA regulations requiring that one be provided.  As such it’s an impermissible attempt at private enforcement of the FDCA and therefore preempted by Buckman.  In other words, even if you accepted the court’s introduction of “parallel violations” into generic drug warning claims – which you should by no means ever do – the court still got it wrong here by finding the duty to provide a Medication Guide was parallel to a state duty that doesn’t exist.

The whole decision is improperly influenced by Bausch and the mixing of preemption concepts that simply don’t combine.  Parallel violations and generic warning preemption should be considered like oil and water, like forks and power outlets, like orange juice and toothpaste, like celebrities and tweeting.  Two things that shouldn’t be used together.

Say what?

That’s what we thought when we ran across Restatement §920 recently – it was by accident; we were researching something else.

The 900 section of the Second Restatement of Torts is about damages, and §920 has to do with mitigation of damages:

When the defendant’s tortious conduct has caused harm to the plaintiff or to his property and in so doing has conferred a special benefit to the interest of the plaintiff that was harmed, the value of the benefit conferred is considered in mitigation of damages, to the extent that this is equitable.

The black letter is thus quite short.  So, when does this “benefit” rule apply?  The first example given in the commentary is of a surgeon, who violated the patient’s informed consent, but the surgery “averts future pain and suffering.”  That benefit can reduce the amount of any award for pain and suffering caused by the improper surgery.  Restatement §920, Illustration 1.

Lately we’ve seen Restatement §920 used mostly in the context of “wrongful birth” cases – where plaintiffs alleging some form of negligent failure to prevent conception of a child (such as failed sterilization of an ineffective contraceptive), were seeking to recover the expenses of raising a healthy child.  Many states don’t allow such claims at all, but those that do rely on §920 to hold that the “benefits” of raising the child are to be subtracted from any recovery of costs.  E.g., Tomlinson v. Metro. Pediatrics, LLC, 412 P.3d 133, 146 (Or. 2018) (“But allowing a parent to seek emotional distress damages does not require ignoring the emotional benefits that a parent may obtain from having a child.  Instead, the jury may offset an award for emotional distress damages by the extent to which a parent receives emotional benefit from a child who resulted from a pregnancy that, but for the defendant’s negligence, would have otherwise been avoided or terminated.”).

But there’s no reason we can find to limit the use of §920’s mitigation principle to that narrow circumstance.  Mitigation must relate to the “same interest,” so that going through some hellaciously painful experience (like being stranded in the wilderness by a plane crash) is not mitigated by the plaintiff later making money from writing a book about it.  Restatement §920, comment b.  But where we litigate, health is health.  If damages for a faulty contraceptive can be reduced by the benefit of a healthy child, then adverse health effects – say chemotherapy making somebody’s hair fall out – should be reduced by the fact that the drug worked and put the plaintiff’s cancer into remission.  The section’s causation requirement, “the benefit must result from the tortious conduct,” id., comment d, would also be satisfied in a prescription medical product case, since use of the purportedly “defective” drug/device would have produced both the alleged harm and the offsetting benefit.  Likewise, the “equitable” caveat would not seem to preclude mitigation, since that caveat was intended “not to permit the tortfeasor to force a benefit on [a plaintiff] against [plaintiff’s] will.”  Id., comment f.  People use prescription medical products precisely to obtain the benefits that these products offer, so receipt of that benefit cannot be construed as “against [the user’s] will.”

We decided to take a look and see if Restatement §920 has been used in prescription medical product (or analogous) litigation.  Guess what, it has.  The issue was faced head on in Dopson-Troutt v. Novartis Pharmaceuticals Corp., 2013 WL 5304059 (M.D. Fla. Sept. 20, 2013), in a variant of the cancer drug hypothetical we mentioned above.  The drug in question, while not curing cancer, was valuable in cancer treatment.  Its use also had serious side effects, which plaintiff allegedly encountered.  The court denied plaintiff’s attempt to exclude Restatement §920 mitigation evidence at trial, rejecting both equitable and different-interest arguments:

Plaintiffs contend that [the primary plaintiff] took [the drug] to delay the risk. . . . However, in arguing that [the drug] conferred no special benefit, Plaintiffs do not provide any authority showing what constitutes a special benefit and why delaying the risk . . . would not be a special benefit. Nor have Plaintiffs provided any authority supporting their contention that § 920 must be limited to wrongful birth cases.

Id. at *3.  The court also found the surgeon hypothetical in Illustration 1 “at least arguably resembles the situation here.”  Id.  Thus, the Dopson-Troutt court held that the health benefit of a drug could mitigate damages allegedly caused by the health detriment of an adverse reaction:

Here, Plaintiffs contend that [the primary plaintiff] would not have taken the drug had she been adequately warned, and [defendant] “seeks to introduce evidence of medical harm she would have suffered but for taking the drug.”  That seems reasonable to this Court.

Id.

Dopson-Troutt cited Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 4456505 (M.D. Fla. Aug. 16, 2013), another case involving essentially the same facts that yielded the same result:

Courts have long recognized that tortfeasors sometimes cause not just damages but benefits to their victims, and under certain circumstances those benefits should be taken into consideration in calculating the compensation to which the victim is entitled. . . .  The issue tends to arise most often in the context of so-called “wrongful births” . . ., [h]owever, the principle is not limited to this category of cases. . . .  [Plaintiff] is arguing that she would not have consented to take [the drug] if she had been properly warned of its dangers, while [defendant] seeks to introduce evidence of medical harm she would have suffered but for taking the drug.  At this stage of the proceedings, the Court cannot say with certainty that Section 920 of the Restatement (Second) cannot apply.

Id. at *2-3 (quotations from §920 and its comments omitted) (also denying motion in limine).

Beyond those two cases, however, we didn’t find much, and that surprises us.  Notably, we also didn’t find any authority for the contrary proposition – that the health benefits of a drug/device to the plaintiff cannot be considered to reduce damages for an injury caused by the plaintiff’s use of that same product.  When defendants lost Restatement §920 arguments, it was as a matter of law, but usually because:  (1) they failed to meet their burden of proof of establishing the affirmative defense of mitigation, or (2) the benefit and injury involved different interests (as discussed above).

We did find a number of non-prescription medical product cases that applied §920 mitigation in cases not involving wrongful birth, and since they refute a plaintiff-side argument that §920 is somehow limited to those cases, we’ll list them.  Eureka Broadband Corp. v. Wentworth Leasing Corp., 400 F.3d 62, 71 (1st Cir. 2005) (conversion) (applying Massachusetts law); Gawry v. Countrywide Home Loans, Inc., 640 F. Supp.2d 942, 958 (N.D. Ohio 2009) (creditor’s rights), aff’d, 395 F. Appx. 152 (6th Cir. 2010); Benfield, Inc. v. Moline, 2006 WL 1662759, at *1 (D. Minn. June 12, 2006) (conversion); Seippel v. Jenkens & Gilchrist, P.C., 341 F. Supp.2d 363, 384 (S.D.N.Y. 2004) (RICO); Los Angeles County Employees Retirement Ass’n v. Towers, Perrin, Forster & Crosby, Inc., 2002 WL 32919576, at *25 (C.D. Cal. June 20, 2002) (unjust enrichment).

Thus, the only two cases to have directly considered the applicability of the Restatement §920 offsetting benefit rule to benefits conferred by allegedly “defective” prescription medical products have held that it is applicable.  But there’s very little law.  Thus it strikes us that Restatement §920 is something pharmaceutical and medical device defendants should consider more often.  If a medical device lasts 10 years before it breaks, and plaintiff sues for harm from the break, why shouldn’t the benefit conferred – ten years of pain-free use of the affected body part – be subtracted from the plaintiff’s claimed damages?  Or wouldn’t the offsetting benefit zero out a plaintiff’s damages in a gynecomastia case, since the drug successfully treats serious mental conditions that can drive people insane.

Bottom line – the products that our clients make have all sorts of intended, and substantial, benefits.  They ought to get credit for them.

We are occasionally reminded by reader comments that all work and no play makes DDLaw a dull blog.  It’s been a long time since we did one of our “Friday Frivolity” posts, but that doesn’t mean that we can’t.

So what we’re doing today – if you choose to participate − is quizzing our readers about references in rock and roll songs to actual historical figures.  Here are the guidelines:

  • First, the references must be to real people, not characters from fiction.  Thus, references to “Tom Sawyer” would not count, but “Mark Twain” (or Samuel Clemens) could be (we’re not saying it is) a proper answer.
  • Second, we are not including euphemisms for real life people.  Actual names only.  Thus, in Don McLean’s “American Pie,” “in a coat he borrowed from James Dean” is a possibility, but “Jack Flash sat on a candlestick” as a reference to Mick Jagger would not be.
  • Third, we’re not including – because it would make things too easy – songs where the historical individual’s name is the song.  So no “So Long Frank Lloyd Wright” by Simon & Garfunkle, “Hurricane” by Bob Dylan, “James Dean” by the Eagles, or “Mr. Crowley” by Ozzy Osbourne.
  • Fourth, we’re limiting ourselves to rock and roll.  No show tunes, since we could fill this quiz with nothing but lines from “Hamilton” (and no reference to “LBJ” from “Initials” in “Hair”), and no folk, rap (second ding on “Hamilton”), R&B, or c/w, which we just don’t know as well.
  • Fifth, the references must be to a reasonably famous person.  We’re not including references such as to “Funky Claude” from Deep Purple’s “Smoke on the Water,” or “Yasgur’s farm” in CSNY’s “Woodstock,” even though Claude Nobs and Max Yasgur were a real people, because they are too obscure.
  • Finally, to avoid inadvertently taking sides in any religious debates, we’re avoiding references to messiahs or prophets; so no “Jesus Christ Superstar” or “Kung Fu Fighting” − also out due to other rules above.

What follows – in no particular order − are fifty excerpts from lyrics (they’re all available online, whether you cheat or not is your business) from rock songs that reference famous people by name.  Sometimes the lines have asterisks.  The asterisks are in place of lyrics that repeat the title of the song, which would be too much of a giveaway.

Give yourself one point each for the song title, and one point each for the name of the group, for a total of 100 points.  Feel free to tell us how you did, but only if you didn’t cheat.

Finally, you can check your answers, here.

^^^^^^^^^^

#1        “Pope Paul, Malcolm X, British politician sex. JFK blown away. What more do I have to say?”

 

#2        “I tell you one and one makes three. ***** Like Joseph Stalin and Gandhi.”

 

#3        “I stuck around St. Petersburg when I saw it was a time for a change. Killed the czar and his ministers. Anastasia screamed in vain.”

 

#4        “The three nominees for the presidential candidate were Martin Van Buren, a former president and an abolitionist; James Buchanan, a moderate; Lewis Cass, a general and expansionist.”

 

#5        “From the young man in the twenty second row who sees you as something as more than sexual.  More than just our Marilyn Monroe.”

 

#6        “Tin soldiers and Nixon coming.  We’re finally on our own.”

 

#7        “So ‘Say Hey’ Willie, tell the Cobb, and Joe DiMaggio.  Don’t say it ain’t so. You know the time is now.”

 

#8        “I don’t know where to draw the line.  Yeah, I’m makin’ bets that you don’t get John Wayne before he dies.”

 

#9        “Back with my wife in Tennessee.  When one day she called to me, ‘Virgil, quick, come see, there goes Robert E. Lee!’”

 

#10      “***** he sits back, collects his thoughts for a moment.  Scratches his head, and does his best James Dean.”

 

#11      “Do you remember, your President Nixon?  Do you remember, the bills you have to pay?  Or even yesterday?”

 

#12      “You knew it did not cost the earth, but for what it’s worth.  You made me feel a millionaire and *****  Madame Onassis got nothing on you.”

 

#13      But if you go carrying pictures of Chairman Mao.  You ain’t going to make it with anyone anyhow.”

 

#14      “’Let them eat cake’, she says.  Just like Marie Antoinette.  A built-in remedy.  For Kruschev and Kennedy.”

 

#15      “Giant doin’ cartwheels, statue wearin’ high heels.  Look at all the happy creatures dancin’ on the lawn.  Dinosaur Victrola list’nin’ to Buck Owens.”

 

#16      “Now I know how Joan of Arc felt as the flames rose to her roman nose and her Walkman started to melt.”

 

#17      “Commies, pinkos, reds at the windows. Foreign agitators, running elevators.  J. Edgar Hoover in a pink tutu.  Investigating anyone who thinks like you.”

 

#18      My my!  At ***** Napoleon did surrender.  Oh yeah! And I have met my destiny in quite a similar way.

 

#19      Well I heard Mister Young sing about her.  Well I heard ole Neil put her down.  Well, I hope Neil Young will remember.  A southern man don’t need him around anyhow.”

 

#20      “Semolina Pilchard climbing up the Eiffel Tower.  Elementary penguin singing Hare Krishna, man, you should have seen them kicking Edgar Allen Poe.”

 

#21      Greta Garbo, and Monroe, Dietrich and DiMaggio, Marlon Brando, Jimmy Dean. On the cover of a magazine. Grace Kelly; Harlow, Jean. Picture of a beauty queen. Gene Kelly, Fred Astaire, Ginger Rogers, dance on air.  They had style, they had grace.  Rita Hayworth gave good face.  Lauren, Katherine, Lana too.  Bette Davis, we love you.  Ladies with an attitude.  Fellows that were in the mood.

 

#22      “It’s no use.  He sees her.  He starts to shake and cough.  Just like the old man in that book by Nabakov.”

 

#23      “Well, Shakespeare, he’s in the alley, with his pointed shoes and his bells, speaking to some French girl who says she knows me well.”

 

#24      “She’s a good girl, she’s crazy ‘bout Elvis.  Loves horses and her boyfriend too.”

 

#25      “That’s great, it starts with an earthquake.  Birds and snakes and aeroplanes.  And Lenny Bruce is not afraid.”

 

#26      “Where have you gone, Joe DiMaggio?  Our nation turns its lonely eyes to you.”

 

#27      “That time will not allow us to forget.  For there’s Basie, Miller, Sachmo, and the king of all Sir Duke.  And with a voice like Ella’s ringing out, there’s no way the band can lose.”

 

#28      “I asked Bobby Dylan.  I asked the Beatles.  I asked Timothy Leary.  But he couldn’t help me either”

 

#29      “And go-cart Mozart was checkin’ out the weather chart to see if it was safe outside.”

 

#30      “Okay, so you’re Brad Pitt.  *****  So you got the looks but have you got the touch?”

 

#31      “The street sounds like a symphony.  We got John Coltrane and a love supreme.  Miles, and she’s got to be an angel.”

 

#32      “Einstein, disguised as Robin Hood with his memories in a trunk.  Passed this way an hour ago with his friend, a jealous monk.”

 

#33      “Well, I saw Lon Chaney walking with the Queen.  Doing the *****  I saw Lon Chaney, Jr. walking with the Queen.  Doing the *****”

 

#34      “There’s no such thing as a winnable war.  It’s a lie we don’t believe anymore.  Mister Reagan says, ‘We will protect you.’  I don’t subscribe to this point of view.”

 

#35      “Einstein and Shakespeare sitting having a beer.  Einstein trying to figure out the number that adds up to this.  Shakespeare said, ‘Man it all starts with a kiss.’”

 

#36      “To stand within The Pleasure Dome decreed by Kubla Khan.  To taste anew the fruits of life.  The last immortal man.”

 

#37      “If Columbus never sailed the sea, if Longfellow never wrote a rhyme, if leaves have never grown upon a tree, and if the sands have never told the time.”

 

#38      “Six o’clock already?  I was just in the middle of a dream.  I was kissin’ Valentino by a crystal blue Italian stream.”

 

#39      “Genghis Khan and his brother, Don could not keep on keepin’ on.  We’ll climb that bridge after it’s gone, after we’re way past it.”

 

#40      “Space may be the final frontier but it’s made in a Hollywood basement.  And Cobain can you hear the spheres singing songs off Station To Station?

 

41        “I was born in 49.  A cold war kid in the McCarthy times.  Stop ‘em at the 38th parallel.  Blast those yellow reds to hell!”

 

42        “You’re my gangster.  You’re like Al Capone.  You’re like Ceasar stepping onto the throne.  You’re Abe Lincoln, cuz you fight for what’s right.”

 

43        “And while [Lennon][Lenin] read a book on Marx.  The quartet practiced in the park.  And we sang dirges in the dark.”

 

44        “Whatever happened to Leon Trotsky?  He got an ice pick that made his ears burn.”

 

45        “You a grand slammer, but you no Babe Ruth.  You gotta learn how to relate.  Or you’ll be swingin’ from the pearly gate.”

 

46        “Thunderbolt and lightning very very frightening me.  Gallileo, Gallileo, Gallileo, Gallileo, Gallileo, Figaro, magnifico.”

 

47        “Walter and Eric said they’d put him on a network TV show.  The White House said, ‘Put the thing in the blue room.’  The Vatican said, ‘No, it belongs to Rome.’  And Jody said, it’s mine but you can have it for seventeen million.”

 

48        “Luther King and Mahatma Gandhi went to the park to check on the game.  But they was murdered by the other team, who went on to win 50-nil.”

 

49        Tell ‘em to make sure they got their James Brown pass.  And don’t be surprised if Ali is in the White House.  Reverend Ike, Secretary of the Treasure.  Richard Pryor, Minister of Education.  Stevie Wonder, Secretary of Fine Arts.  And Miss Aretha Franklin, First Lady.”

 

50        “Roll over Beethoven that happened to be her favorite song.  But we never did much rollin’.  I didn’t stay there long.”