Friday, August 22, 2014

Dreaming The Impossible Dream

A short history of recent implied preemption “impossibility” decisions:  (1) In Wyeth v. Levine, 555 U.S. 555 (2009), impossibility preemption did not apply to innovator prescription drugs because simultaneous compliance with FDA and state tort law labeling obligations was possible due to the “changes being effected” (“CBE”) exception allowing updated warnings without prior FDA approval.  Id. at 568-69.  (2) In PLIVA v. Mensing, 131 S.Ct. 2567 (2011), the same “impossibility” principle, expressed pithily as a “hold[ing] that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes,” was applied affirmatively to preempt warning claims concerning generic drugs because a verbatim labeling requirement precluded unilateral CBE warning changes.  Id. 2580-81.  (3) In Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), the Court extended impossibility preemption to (at least) generic design defect claims, recognizing that design changes affecting safety and effectiveness also required prior FDA approval, while recognizing that the same restrictions on “major changes” applied to the designs of all “drug[s] − whether generic or brand-name.”  Id. at 2471.

What the implied preemption combination of Levine, Mensing, and Bartlett tells us about preemption due to impossibility is that state tort law can’t create a duty for a defendant to do something immediately that, under supreme federal law, requires the prior approval of a federal agency.  That proposition is in no way limited to generic drugs, since implied preemption isn’t dependent on the language of any particular statute.  We’ve pointed this out in a number of contexts, including “stop selling” claims , “major changes” in drug labeling, innovator drugs, warnings about off-label use.  That’s not counting our posts on individual cases.

We’re now two years post-Mensing and a year post-Bartlett, so we thought we’d take stock and see to what extent defendants have had any success in applying the impossibility preemption principles those decisions recognized outside of the limited context of generic drugs.  It turns out there has been some progress.  Favorable decisions have been rendered in three general areas:

Warning claims against entities other than the NDA holder:  Only the holder of the new drug application (“NDA”) has the right to change that drug’s labeling, whether by CBE or otherwise.  Preemption has been recognized in warning claims asserted against defendants that could not institute a unilateral label change because they did not own the NDA.

One situation where preemption has prevailed is against defendants that sold their NDA to someone else before the drug that the plaintiff bought was made.  The claims in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), were about as strong as any plaintiff could hope to have.  In Darvocet, although the former NDA holder sold out, it also became a contract manufacturer, and thus was still producing the drug.  That didn’t matter, since the former innovator could no longer change its warnings:

[Plaintiff] ingested a product manufactured by [the former NDA-holder] . . ., after [it] had divested its NDAs.  Therefore, her claims against [the former NDA holder] are preempted, failing for the same reasons that the Plaintiffs’ other claims against the Generic Manufacturers do. After the divestiture, [the former NDA holder] had no more power to change the label.

Id. at *19. 

Similarly in In re Fosamax Litigation, 2012 WL 181411 (D.N.J. Jan. 17, 2012), plaintiffs’ claims against alleged distributors of both generic and innovator versions of the drug were dismissed because no distributor had the power to change drug labeling unilaterally.  Whether innovator or generic, “a distributor of Fosamax . . . has no power to change Fosamax labeling.  That power lies with the applicant who filed the New Drug Application (NDA) seeking approval to market Fosamax.  Id. at *3 (citing FDA regulations).

As a result of the scheme set forth by the FDCA, [a distributor] has no authority to initiate a labeling change of Fosamax.  That authority lies with the FDA and/or with [the NDA holder]. . . .  [A] contractual relationship between [a distributor] and [the NDA holder] cannot change the fact that [it] is not the NDA holder.  Consequently, [the distributor] has no power to unilaterally change Fosamax labeling.  Because [the distributor] could not “independently do under federal law what state law requires of it,” the state law claims brought against it are preempted.

Id. at *4 (quoting Mensing).  See also In re Yasmin & Yaz Drospirenone Marketing, Sales Practices & Products Liability Litigation, MDL No. 2100, 2014 WL 1632149, at *7 (S.D. Ill. April 24, 2014) (distributor of generic drugs had no power to change labeling unilaterally); Stevens v. Community Health Care, Inc., 2011 WL 6379298, at *1 (Mass. Super. Oct. 5, 2011) (same).

Black Box Warnings:  FDA regulations explicitly require that all boxed warnings have prior FDA approval.  21 C.F.R. § 201.80(e); 21 C.F.R. § 201.57(c)(1).  While this could be considered a “major” change, because of this additional regulatory support we consider those cases separately.  Claims that the defendant “should have included an aggressive black-box warning” were held preempted by Mensing in Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir. 2013), but that is a generic drug case.  In Ray v. Allergan, Inc., 2012 WL 2120018 (E.D. Va. June 1, 2012), after deciding that, as a general proposition, Mensing did not undercut Levine as to innovator drugs, the court recognized that a black box warning was an exception:

[T]he federal regulations do control what must be in a black box warning and so any theory based on a black box warning as a requirement of state law would be preempted.

Id. at *7.

In Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013), another non-generic case, like Ray, the court found Mensing/Bartlett generally “inapposite” to innovator warnings, but on the black box issue specifically, the plaintiffs failed to “dispute [defendant’s] contention that the FDA regulations preclude a manufacturer from adding a black box warning without preapproval.  Accordingly, the Plaintiffs will not be permitted to argue at trial that [defendant] should have done so.  Id. at *5.  In In re Avandia Marketing, Sales Practices & Products Liability Litigation, 817 F. Supp.2d 535, 553 n.97 (E.D. Pa. 2011), the court noted its “agree[ment]” with the defense position that “unlike other revisions to augment warnings, a boxed warning can be added only with prior FDA approval.”

Major Label Changes:  Not all changes to innovator drug labeling can be done through CBE.  Quite a few changes – some directly impacting safety, some not – are considered “major” and require prior FDA approval.  Several types of changes not falling within the scope of the CBE requirement have been held preempted in innovator cases:

Most notably, in Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014), the plaintiff’s consumer-fraud based “overfilling” allegations were held preempted because the FDA approved the strength of the drug that the defendant was allowed to sell, and the defendant could not change it without going back to the FDA.  If FDA pre-approval was required, a state-law claim based on that product attribute was preempted:

[I]f Defendants were unable, under federal law, to independently lower the volume in each vial of [their drug] to be in compliance with the state duties alleged by Plaintiff, Plaintiff’s state claims would be preempted.  FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.”

The Court concludes that reducing the amount of medicine in each . . . vial is a major change requiring prior FDA approval.  As noted above, FDA Guidelines from 2001 state that a “decrease in the fill volume” of a drug product “involves a change to the specifications and must be submitted in a prior approval supplement” for FDA approval. . . .  [T]he Court agrees that a decrease in the fill volume of a drug product . . . involves a change to the specifications under the plain meaning of the statute.

Id. at *6 (citations and quotation marks omitted).  Thus, since FDA pre-approval of strength changes for all drugs was necessary, any attack on the permissible dosage of an innovator drug was “therefore preempted under the Supremacy Clause.”  Id.

Having proven its entitlement to preemption under Mensing/Bartlett, the defendant was not obligated to go further and provide additional regulatory evidence under the Levine “clear evidence” test:

Moreover, since neither Mensing or Bartlett required any further “clear evidence” beyond establishing the existence of an FDA pre-approval obligation, there was no need to speculate whether the FDA would have approved such a change.  The requirement of pre-approval sufficed:

The Court does not find persuasive Plaintiff’s argument that . . . [their] claims are not preempted unless Defendants show by clear and convincing evidence that the FDA would have rejected such a change . . . .  Applying this standard “would render conflict pre-emption largely meaningless because . . . [w]e can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.”

Id. (citing and quoting Mensing).  See Guenther, 2013 WL 4648449, at *5 (distinguishing between actual change of strength (preempted) and changes of warnings relating to permissible dosage (not preempted). 

Claims that the defendant should have changed the format of its label can also be preempted to the extent that such changes may not occur unilaterally.  In Hill v Novartis Pharmaceuticals Corp., 944 F. Supp.2d 943 (E.D. Cal. 2013), the court “agree[d]” to “bar [plaintiff] from arguing that the FDA-approved label . . . should have placed the warning . . . in a different section of the label, or should have utilized a different font size or bolded text.”  Although the CBE procedure could be used to modify the “contents” of a label, it did not extend to formatting:

FDA regulations for prescription drug labeling extend not only to content but to formatting.  While the case law is clear that manufacturers may modify the contents of a brand-name drug label without FDA approval by adding to or strengthening the warnings, [plaintiff] has provided no authority − and the Court's research reveals no authority − to suggest manufacturers may do the same with the label's formatting.  Accordingly, [defendant’s] motion is hereby granted to the extent it seeks to preclude [plaintiff] from arguing that the [innovator drug’s] labeling should have been formatted differently.

Id. at 957 (citations omitted).

As we’ve discussed in our major changes post, comparative claims (called “superiority” claims) require FDA pre-approval.  FDA regulation specify that a certain level of scientific evidence (essentially statistically significant results from two controlled studies) must exist before a manufacturer may compare the safety (or effectiveness) of its drug to any other.  21 C.F.R. §§201.57(c)(2)(iii), 201.80(c)(3)(v).  Thus, Guenther also indicated (but did not actually hold) that preemption would apply to claims that the defendant should have warned about the relative “safety” of its drug compared to alleged alternative medications in the absence of the requisite studies

[H]aving “indications” that one drug is safer than another is a far cry from having “adequate and well-controlled studies” reaching that conclusion, which the Plaintiffs appear to admit is the applicable standard.  At this juncture, the Court does not know enough about the comparison(s) to be made or the evidence backing them to reach a final conclusion. But it appears that the Plaintiffs' evidence would not satisfy the standard established by [FDA regulations].

2013 WL 4648449, at *6 (regulatory citations omitted).

Stop Selling Arguments:  We haven’t seen any post-Bartlett preemption cases concerning arguments that an FDA-approved drug should simply not have been sold.  Plaintiffs seem to be steering away. The state of Massachusetts, however, recently tried essentially the same thing by legislation and got shot down.  As we discussed here, Zogenix, Inc. v. Patrick, 2014 WL 1454696, at *2 (D. Mass. Apr. 15, 2014), held that – regardless of Levine’s limitations on preemption − a state could not bar the sale of an FDA-approved innovator drug:

[D]efendants [the Commonwealth of Massachusetts] present no evidence or persuasive argument that [Levine’s]  reasoning should control in this different context.  Furthermore, Levine assumed the availability of the drug at issue and analyzed whether stronger state labeling requirements obstructed the FDA's objectives.  Here, the obstruction is clearer because the drug Massachusetts wants [the plaintiff manufacturer] to adopt . . . has not been approved by the FDA.  To satisfy the Commonwealth, [plaintiff] would be required to return to the FDA and seek approval of a drug different from the one the FDA has already deemed safe.  For the reasons described above, Zogenix is likely to prevail on the merits.

Id. at *2.

So by our count, we have seven cases that, in one way or another, apply the Mensing/Bartlett impossibility preemption rationale to some sort of innovator-drug-related claim.  The prevailing argument is always (except for stop selling) some version of the plaintiff demanding something that cannot be done by the defendant without FDA preapproval.

This is still an area where the courts need some “getting used to,” and we hope that defendants will concentrate on claims (such as drastic design changes) where the need for FDA pre-approval is indisputable.  Given that implied preemption is not limited by the language of any particular statutory scheme, plaintiffs should not prevail simply by screaming that “this isn’t a generic drug case.”

Thursday, August 21, 2014

Hindsight is 20/20, And Yet Still So Blind

Would you have bet on the Red Sox to win the 1986 World Series?  Would you have booked passage on the Titanic?  Would you have bought a ticket to see the movie Ishtar?  If someone asked us these questions today, we all would answer in the negative because we already know the outcomes.  The 1986 Red Sox won 95 games that year and were riding the arms of their two young stars, Bruce Hurst and Roger Clemens.  They may have been a good bet at the time, but Bostonians can still see that ground ball wiggling its way between the legs of a certain first baseman.  The Titanic was a modern marvel and highly sought after ticket, but that voyage ended in tragedy (a real tragedy, not a faux tragedy like losing a baseball game).  We actually did buy a ticket to the movie Ishtar when it debuted in 1987 (forgive us, we were young).  It was a big-budget vehicle for two A-list movie stars, Dustin Hoffman and Warren Beatty, but the film was an epic flop. 

We know now how these events in history turned out, yet millions of people placed that bet, booked that passage, or bought that ticket—and they all had good reasons to do so.  Hindsight is 20/20, and if those people said today that they would not have acted that way “if they had known,” they would be met with a smirk and a raised eyebrow.  If you add in a profit motive—such as when a plaintiff stands to recover damages in a lawsuit—a convenient change in position would be more than just irrational, it would be a farce.  When you further add a dire downside—such as leaving cancer untreated (you can see now where we are going with this)—a post hoc claim of different behavior becomes an obvious counterfactual construct aimed at recovering dollars and entitled to no consideration. 

That is why the district court was correct and the Sixth Circuit is wrong in Payne v. Novartis Pharmaceuticals Corp., No. 13-6266, 2014 WL 4056889 (6th Cir. Aug. 18, 2014).  The case is an Aredia and Zometa case in which the plaintiff alleged that the drug manufacturer’s failure to warn regarding the risk of osteonecrosis of the jaw (“ONJ”) resulted in onset of ONJ several years after she first used one of the drugs.  Id. at *2.  The prescribing physician testified that he was not aware of the risk of ONJ when he first prescribed one of the drugs for breast cancer in 1999, but by the time the plaintiff shows jaw-related symptoms in 2005, he was aware of the risk and suspended treatment.  Id.  The plaintiff was later diagnosed with ONJ.  Id.

The district court granted summary judgment on the plaintiff’s failure to warn claims because the plaintiff produced no substantial evidence that a warning regarding ONJ in 1999 would have changed the physician’s decision to prescribe the drug.  Id. at *3.  This of course is a textbook application of the learned intermediary doctrine, under which the manufacturer’s duty to warn runs only to the prescribing physician and under which proximate causation is judged by the impact that a stronger warning would have had on the prescriber’s treatment decisions.

In Payne, there was no evidence that a warning regarding ONJ would have changed anything for this plaintiff, at least no evidence that would justify sending the case to a jury.  The prescribing physician testified that he now warns patients about the risk of ONJ and recommends that they see a dentist before taking bisphosphonates.  Id. at *5.  Fair enough, but there was no evidence that a dental exam would have shown anything noteworthy for this plaintiff, let alone anything that might have prevented the plaintiff’s injury, either in 1999 when the plaintiff started one drug or in 2001 when she switched to the other.

In other words, nothing would have changed in the prescribing physician’s decision making process, which is why the district court was correct to grant summary judgment on the warnings. 

So why did the Sixth Circuit reverse?  It reversed because the doctor said he now instructs patients re ONJ and because the plaintiff filed an affidavit stating that she would not have taken the products if she had been warned.  Id. at *3.  The Sixth Circuit found this to be a “straightforward” argument, under which the plaintiffs had raised a jury issue on whether the lack of a warning on ONJ in 1999 or 2001 caused her injury.

We have two problems with the Sixth Circuit’s analysis.  First, we do not agree with the Sixth Circuit’s gloss on learned intermediary doctrine under the applicable Tennessee law.  According the Sixth Circuit, the learned intermediary rule is a liability-shifting doctrine that can place a duty to warn on the prescribing physician.  As the court explained, “At base, the doctrine can shift liability from drug companies to doctors:  If the drug company adequately warned and instructed the doctor but the doctor did not adequately warn the patient, the patient’s quarrel is with the doctor rather than the drug company.”  Id. at *4. 

This statement misapprehends the law, which probably explains why the Sixth Circuit cited no real support.  (The Sixth Circuit cited only a concurring opinion and a law review article.)  The learned intermediary doctrine imposes no duty on prescribing physicians, nor does it provide patients any basis upon which to “shift liability to” or “quarrel” with doctors.  A healthcare provider’s potential liability to a patient is governed by state law on medical malpractice, which generally requires proof of a breach of a standard of care.  That standard may encompass a duty to provide patients with certain treatment-related information—or it might not.  The learned intermediary doctrine says nothing on that score.  It defines a drug or medical device manufacturer’s duty to warn and the manufacturer’s potential liability, and nothing further. 

Our second problem with the Sixth Circuit’s analysis is more profound.  The district court was absolutely correct in ruling that the plaintiff’s affidavit stating that she would not have used the products if she had been warned of ONJ was not evidence sufficient to defeat summary judgment.  It was very easy for the plaintiff to say that she would not have used the drug after she already knew the outcome, i.e., that she experienced the exact condition about which she claims she should have been warned.  When bearing in mind that this plaintiff was being treated for a potentially fatal disease (breast cancer) and that she now stands to gain financially by saying that she would have refused cancer treatment, her statement is entitled to no weight, even if admissible.  We have commented on plaintiffs' attempts to do an "end run" on warnings causation before, including within the last few days, and we consider such attempts to be idle conjecture based on "evidence" that does not prove anything. 

States define the sufficiency of the evidence differently, but the law typically requires substantial evidence, something more than a mere scintilla or speculation.  The Sixth Circuit glossed past this point too, first by stating that there was no authority “that supports the proposition that this testimony is insufficient to forestall summary judgment.”  Id. at *6.  The problem with this conclusion is that there is no authority supporting the Sixth Circuit’s position either.  The Sixth Circuit therefore again inappropriately blended medical malpractice and product liability and analogized to cases involving informed consent, observing that “we can find no indication that the Tennessee Supreme Court would adopt a different standard.”  Id. at *6.  This is problematic too, because a patient’s consent—or lack thereof—is not an element of a product defect claim, even one based on allegedly inadequate warnings.  The Sixth Circuit again could find no legal support for this extension of Tennessee law, citing another law review article, this time with the telltale “cf.” signal, code for “here's something that is not totally off the wall.” 

We have thought long and hard about whether a plaintiff’s retrospective change of heart can ever be substantial evidence sufficient to reach a jury.  If there is a scenario under which this can be true, we can’t think of it.  We understand that juries hear this sort of evidence somewhat regularly, and maybe there is corroborating evidence from time to time.  But that was not the case in Payne, which came to wrong result.  Now if only we can get a refund for our ticket to Ishtar.  Does anyone know a lawyer? 

Wednesday, August 20, 2014

A Cause for Celebration


Happy birthday to Al Roker, who makes even a rainy day forecast seem jolly.  Happy birthday to Amy Adams, who enchanted audiences in movies as diverse as Drop Dead Gorgeous, The Fighter, and American Hustle.  Happy birthday to the late Jacqueline Susann, who authored one of the key documents of the Mad Men era, Valley of the Dolls (1966).  That novel is what the English majors call a roman a clef – literally, a novel/romance with a ‘key.’  The key is the correspondence to real life.  Valley of the Dolls chronicled show biz women and their adventures in Hollywood, in bed, and in the medicine cabinet.  Some of the characters allegedly are based on real starlets, such as Judy Garland and Ethel Merman.  Most readers of this post are too young to remember what a big deal Valley of the Dolls was in the late 1960’s.  It was a huge success and a huge scandal.  Almost every adult of a certain age read it.  Almost every one of them denied reading it.  Both Susann and her book were subjected to scathing reviews from the literati.  More than one critic said, “That’s not writing, that’s typing.”  If it was typing, it was typing on a cash register.  It rained money all over Ms. Susann.

The film version of Valley of the Dolls came out only a year later.  The plaintiff lawyers would probably call it a rush-to-market.  It starred Patty Duke, Barbara Perkins, and Susan Hayward.  Hayward played a part originally slated for Judy Garland, but Garland turned out to be more of a method actress than was expected, as her dissipations prevented her from doing little things like showing up on the set.  If you haven't yet had your daily dose of trash, take a peek at the movie's trailer.  Sharon Tate was another lead in the movie.  Only a couple of years later, she would become, at the hands of the Manson Family, perhaps the single most iconic victim of 1960's craziness.   

 

Valley of the Dolls is not wholly extraneous to this blog.  The “Dolls” in the title referred both to the female protagonists and the pills that … helped them.  However much you might sniff about the literary deficiencies of Valley of the Dolls, it still reads better than some of the judicial opinions we’ve discussed this month.

 

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

 

And now for a little case analysis.  (At least one of you will send us a rejoinder along the lines of, “That’s not analysis, that’s typing.”)   

 

Thomas v. Abbott Laboratories, 2014 U.S. Dist. LEXIS 109905 (C.D. Cal. July 29, 2014) is about causation – both warning causation and medical causation.  The plaintiff sued two companies that made the anti-cholesterol medications Trilipix and Zetia. The plaintiff claimed  that he developed pancreatitis as a result of ingesting those drugs.  More specifically, the plaintiff alleged that the defendants failed to warn him and his primary care physician that Trilipix and Zetia, when taken together or alone: (1) would not reduce the risk of having heart problems or a stroke; (2) could cause gallstones; and (3) could cause the blockage of common bile duct, severe acute pancreatitis, diabetes, and other ailments.  The defendants filed for summary judgment. 

 

Warning Causation

 

One hurdle in the plaintiff’s way was the learned intermediary doctrine.  He attacked the learned intermediary rule for being outdated and unpersuasive because prescription drugs are now advertised directly to the consumers.  There are some courts that have smiled upon such nonsense, but no California court has, and the federal judge declined to blaze a path to imbecility.  Thus, the plaintiff was stuck with the learned intermediary rule, and stuck with some rather inconvenient testimony by his treating physicians.  Dr. Lake testified that when he first prescribed Trilipix to the plaintiff,  he was aware of Trilipix’s association with pancreatitis (including acute pancreatitis) and gallstones.  Dr. Lake testified that had he been aware in 2008 that Trilipix did not reduce the risk of coronary heart disease, he still would have prescribed it to the plaintiff because he believed that Trilipix was “still barking up the right trail” in helping the plaintiff lower cholesterol.  Thomas v. Abbott Laboratories, 2014 U.S. Dist LEXIS 109905 at *17.   So far so good.

 

But Dr. Lake’s testimony regarding Zetia was different.  He  testified that he did not believe that Zetia’s warnings adequately apprised him of the potential risk for gallstones.  So far so bad.  The plaintiff managed to conjure up a genuine issue on warning adequacy.  But that is not enough to create a genuine issue as to warning causation.  The plaintiff presented no evidence that Dr. Lake’s conduct would have differed if he had been adequately warned.

 
At this point in the Thomas opinion, the court embarks on a discussion of an issue that vexes both plaintiff and defense hacks on an almost daily basis. During the all-important deposition of the prescriber, which side has the obligation – and, more important, the guts -- to ask the doctor the ultimate question of whether a different warning would have changed the prescribing decision? Both sides tend to nibble at the edges of this question. Nobody wants to lose the case in one fell swoop, with ocular proof of the folly in the form of a deathless transcript. Plaintiff lawyers, in particular, are wary, because they like to keep open their options– maybe right up to closing argument – as to what exactly the warning should have said. This juncture in the prescriber deposition is a messy, scary moment. In the Thomas case, the plaintiff never asked what the court called “the key question.” We would say that on that basis alone, the plaintiff should lose. After all, the plaintiff bears the burden of proving causation. Could anything be clearer? No. Does the Thomas court say that? No. Instead, the Thomas court says that if the warning causation issue was necessary to dispose of this case, the court“would invite further briefing on this point or perhaps even authorize a further deposition of Dr. Lake.” Id. at *20. Yikes. That strikes us as a bit soft-headed. It certainly provides no guidance for our future hackery. It also strikes us as a bit … wrong. But for now, we’ll also say that it strikes us as a bit of dicta. That is because the court goes on to say that “even if a genuine issue exists as to whether Dr. Lake would have prescribed Zetia with proper warnings, there is still insufficient evidence of medical causation for both drugs.” Id. at *21.





Talk about burying the lead!

Medical Causation


If there is a key guidance to be seized from the Thomas case, it is this: line up experts who will say what you need them to say. The plaintiff in Thomas introduced zero expert testimony in support of his oppositions to the defendants’ motions for summary judgment. He did not designate any expert during discovery. Instead, he relied on the diagnosis and notes of his treating physicians. That decision might have saved the plaintiff and his lawyers money, but it certainly could not save their case. The treating physicians’ notes and testimony were insufficient to demonstrate that Trilipix and Zetia were a probable cause, not simply a possible cause, of the plaintiff’s pancreatitis.

 
For instance, Dr. Kerekes’s report stated that the plaintiff presented “with acute pancreatitis of unclear etiology, but it is quite possible this may be related to Trilipix which as known to cause pancreatitis.”  Id. at *24.  Dr. Kerekes acknowledged two possible causes of the pancreatitis:  the medications and gallstones.  While he opined that gallstones were the less likely cause, he did not rule them out.  Thus, Dr. Kerekes’s report did not demonstrate that Trilipix and Zetia caused the plaintiff’s pancreatitis within a reasonable medical probability.  Id.

 

There were three other doctors who similarly identified the medications as a possible cause of the pancreatitis, but also could not rule out an alternative cause.  The plaintiff’s counsel argued that based on the notes and reports of the treating physicians, the fact-finder could eliminate all the other possible causes of the plaintiff’s pancreatitis except for his medications.  After all, none of the doctors’ reports stated that the plaintiff had a gallstone.  Thus, the plaintiff's lawyer wanted to argue by inference that the plaintiff’s medications were left as the probable cause of his pancreatitis.  The court did not buy this argument.  The plaintiff’s counsel was essentially asking for the jury to perform a differential etiology that the actual treating doctors could not do.  But “leaving it to the jury to conduct this process of elimination would not establish causation ‘within a reasonable medical probability.’”  Id. at *29.  There was no evidence demonstrating that the plaintiff’s treating physicians completed this process of elimination, and it would be judicial malpractice to entrust that process to a jury. 

 

The lack of warning and medical causation caused the plaintiff’s case to go away.  

 

(Believe us, this is a much better ending than either the book or movie versions of Valley of the Dolls.)

 

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

 

The reason we started off with birthday greetings is because today is the birthday of the DDL Son, and we like him even more than Al Roker, Amy Adams, or Jacqueline Susann.  Our kids are miracles, and they dazzle us daily with the ways in which they are like us and unlike us, and then they ultimately dazzle us by emerging into their own unique personality.  The DDL Son is ready to head back to college, where he is focusing on Marketing and Russian Studies.  (Don’t ask.)  He probably knows that a few other things happened on August 20 besides his birth.  Tchaikovsky’s 1812 Overture premiered on this date in 1882.  On August 20, 1953, Pravda acknowledged that the Soviet Union had detonated a hydrogen bomb.  Fifteen years later, Warsaw Pact tanks rolled into Czechoslovakia and said ‘nyet’ to the Prague Spring.  So even picking out one date in Russian history, we see the vicissitudes of the human story.  It’s clear enough that we cannot count on music and freedom every day.  But we are counting on music and freedom today.  And we are counting on more.  Today and for all of his days, we hope the DDL Son gets plenty of what he has given to us: love, astonishment, and laughter.  (And, yeah, you can count on getting those garish, ludicrously expensive soccer cleats you wanted.)        

 

 

Tuesday, August 19, 2014

Plaintiffs’ Causation Case in The Zoloft MDL: Is Anything Left After A Second Daubert Opinion?

            The week after Weeks II, we are not in position to tout our prognosticating on that decision.  We had certainly hoped that a rehearing would have signaled a smarter approach to considering innovator liability given that the vast majority of jurisdictions have rejected Conte.  We had not predicted a specific result, however, either through reading entrails, the flight patterns of birds, or tea leaves.  In a recent post on a Daubert challenge in the Zoloft MDL, we did make the prediction that we would be seeing “at least one other opinion on mechanism experts.”  This was an easy prediction because the court had stated there was a Daubert hearing on plaintiffs’ experts and the first opinion only addressed the epidemiologist.  We also made a grim prediction for the plaintiffs’ ability to prove causation:  “Dr. Berard’s causation opinions are gone and, it would seem, so is the plaintiffs’ ability to prove general causation, something the court understood requires competent epidemiological expert evidence.  What is left is a decision that should be useful for other Daubert challenges on general cause opinions.”

            Last week, the court in In re: Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, __ F. Supp. 2d. __, 2014 WL 3943916 (E.D. Pa. Aug. 12, 2014), issued an opinion on the Daubert challenge to three mechanism experts.  As expected, the experts were precluded from offering general causation opinions.  They were allowed, however, to offer some of their other opinions “if they are otherwise admissible,” which we do not think they will be because biological plausibility does not matter absent predicate epidemiological evidence that plaintiffs do not have (according to the first Daubert opinion).  It appears that the court had reserved for another day whether plaintiffs can prove general causation for the birth defects at issue in their cases.  They certainly cannot by relying only on the four experts addressed in the two opinions so far.
            The three experts, none of whom is a medical doctor, relied on studies in a variety of animal models and in vitro models to offer fairly similar opinions that it is biologically plausible that Zoloft and other selective serotonin reuptake inhibitors can cause a range of birth defect by affecting serotonin signaling in human embryos.  This sounds like a pretty broad mechanism and the opinions leaves some of our questions unanswered.  How is signaling affected?  Which pathways are affected by altered signaling?  How does could the alteration lead to such a wide range of birth defects?  Why would the alteration only lead to defects in tiny portion of affected embryos?  Like the details of the proposed mechanism, the analysis of why each expert got to offer his opinion is sparse.  For the first, Dr. Cabrera, it did not matter that he had never studied any SSRIs or tested his hypothesis because he did a reanalysis of the data from a rat studies from the drug’s NDA.  Id. at **2-3.  Even though he considered it “questionable whether any reasoned interpretation could be derived from these studies,” and apparently had nothing else on the drug or class of drugs, his methodology was considered reliable.  Id.  Similarly, even though he relied only on in vitro studies on serotonin (as opposed to the drug or class of drug), the court left it to cross-examination to bring out the limitations of the methodology of the second expert, Dr. Sadler.  The third expert, Dr. Levin, actually used SSRIs in his own teratology studies and claimed to have produced certain birth defects in a frog embryo model.  Id. at *4.  That put him ahead of the other experts, but his model reported producing different defects than the plaintiff claims and did not report producing the defects the plaintiffs claimed.  Id. at *5.  Again, the court left it to cross to bring out the lack of relevance of Dr. Levin’s opinion.  The court did exclude Dr. Levin’s opinion that, in addition to serotonin signaling, alterations of ion and calcium channels were plausible biological mechanisms, which the court characterized as a mere “untested hypothesis.”  Id. at *5.  The distinction seemed to be that the studies on which Dr. Levin based his ion and calcium channel opinions involved brain, cancer, and kidney  cells rather than embryonic cells.  Id.  We agree that this is a major methodological shortcoming, but the serotonin signaling mechanisms were not much better.

            We suspect that the relatively free pass on mechanism was driven, at least in part, by the fact that biological plausibility was just one piece of evaluating the general causation opinion each expert hoped to give.  The parties agreed that the inquiry on general causation should be guided by the well-known Bradford-Hill criteria and the more specific Wilson’s principles of teratology.  Our view, derived from the speech that Dr. Bradford-Hill gave almost fifty years ago that popularized his criteria, is that there must be an association demonstrated through epidemiological studies before you go the next step of evaluating whether the association is consistent with a causal relationship.  The defendant advocated the same position, and, while the court noted that “[s]everal courts have held that positive human epidemiological studies are required to reach reliable conclusions as to whether an agent is teratogenic in humans,” the court allowed the plaintiffs’ experts to try to meet an easier standard:  “when epidemiological studies are equivocal or inconsistent with a causation opinions, experts asserting causation opinions must thoroughly analyze the strengths and weaknesses of the epidemiological research and explain why that body of research does not contradict or undermine their opinions.”  Id. at *8.  The experts still failed still failed that standard, with two punting on epidemiology and one just saying epidemiological studies may underestimate associations because of spontaneous and therapeutic abortions.  Id. at **8-9.  We do not think this was the right standard, or that requiring that any other causation expert “address” the epidemiological research on Zoloft because there is “a great deal” available helps much.  Id. at *9.  We do think that “failure to reconcile inconsistent epidemiological research with their opinions regarding human causation is a significant methodological flaw,” but go further in that a plaintiff expert without some reliable epidemiology supporting causation should not be allowed to offer a causation opinion no matter how much reconciling she attempts.  Id.
            The rest of the analysis continued similarly, with the experts failing to meet a somewhat more lenient standard that we think Daubert requires.  The experts relied on animal and in vitro studies, but none of them described birth defects at doses similar to even the maximum clinical dose (in real people).  Id. at *10.  Again, rather than simply determine that studies do not support a reliable causation opinion if they do not involve a relevant dose, the court allowed the experts to try to “reconcile” the different doses, but they could not.  Id. at *11.  The experts tried to rely on studies in species that lay eggs, which mammals (other than monotremes—people always forget about platypuses and echidnas) do not.  Rather than limiting studies to those done in mammals, the court looked to see if the experts could tie in the studies they wanted to rely on—but they could not.  Id.  The experts wanted to rely on studies on serotonin pathways in animals without proof that humans have the same pathways, which the court rightly characterized as speculation.  Id.  Lastly, the experts lacked information about serotonin levels in pregnant women, with or without depression, or in their embryos, which made opinions about the impact of altering those levels mere guesswork.  Id. at *12.

            This all added up to a statement that fairly summarized the experts’ failings:
The Court cannot allow unscientific speculation to be offered, even by genuinely talented scientists.  The Court holds that the evidence upon which the experts rely in their reports is not sufficient to support a non-speculative opinion that Zoloft can cause birth defects in humans when used at conventionally prescribed doses.  The Court notes that in vitro and in vivo animal research is useful for generating hypotheses about human causation, but each hypothesis must be tested and scientifically verified before it can form the basis for a conclusion about causation.  These experts have not demonstrated that such testing and verification has been accomplished to date.  In addition, the Court notes that these scientists have never published their litigation opinions about human causation for their peers, and neither their opinions about human causation nor their methods for reaching those opinions, which bypass crucial hypothesis testing and analysis, are generally accepted by scientists in their fields.  Finally, many essential questions which would connect the animal data to human embryonic development are unanswered at this time.
 
Id. at * 13.  As a result, their causation opinions were excluded in their entirety.  As to their mechanism opinions, most survived Daubert because the defendant’s “argument conflates the sufficiency of the evidence with the admissibility of the testimony.”  Id.  Sufficiency is apparently for another day, but we can say that expert opinions on biological plausibility without more should not get the job done for plaintiffs.

Monday, August 18, 2014

POM Doesn’t Seem to Have Changed Much

Although the Supreme Court’s recent decision in POM Wonderful, which we blogged about here, didn’t involve preemption, we were worried that, at least in Lanham Act cases, it might erode the protection afforded prescription medical products (POM was a food case) by 21 C.F.R. §337(a), granting exclusive enforcement authority to the FDA. 

After the first post-POM Lanham Act decision, Catheter Connections, Inc., v. Ivera Medical Corp., 2014 WL 3536573 (D. Utah July 17, 2014), all we can say is “so far so good.”  A lot of Catheter Connections concerned claims that only affected the “attractiveness” of the defendant’s product in the marketplace (the Lanham Act does not allow recovery for personal injury; it applies solely to commercial competitors), but one claim did more than that.  It challenged the FDA’s approval of the product.  That kind of private enforcement attempt concerns us, no matter what the source.

Fortunately, the Catheter Connections decision got it right.

The product at issue – “disinfectant caps incorporated into intravenous (IV) lines that deliver fluids and drugs to patients” – was cleared for marketing by the FDA under its §510(k) “substantial equivalence” process.  2014 WL 3536573, at *1.  Marketing of the first version of this product was enjoined earlier in the litigation on completely non-FDCA-related, patent infringement grounds.  Id. at *2.  The defendant responded by redesigning the product to avoid the alleged infringement, but did not resubmit the device to the FDA, taking the position that the modifications did not affect the safety and effectiveness of the product.

The plaintiff then attacked that decision (not to resubmit to FDA) under the Lanham Act, alleging that the defendant’s statements that it had FDA clearance were now “false.”  Id. at *3.  That’s where in our minds, the rubber meets the road.  If a plaintiff in private litigation can challenge the lack of an FDA submission, then the same plaintiff could challenge the existence of an FDA submission.  Either situation would set a dangerous precedent breaching the FDA exclusivity provided by § 337(a).

The court refused to allow the claim:

Under the FDCA, the FDA has exclusive jurisdiction over approval of medical devices and courts do not have the authority to decide issues that fall under the FDA’s administrative authority.  To that end, the FDCA provides that no private right of action exists to enforce provisions of the FDCA because the FDA has the exclusive power and discretion to enforce the FDCA. See 21 U.S.C. § 337(a)

2014 WL 3536573, at *3 (citing §337(a)).  It recognized that to decide whether the defendant’s failure to return to the FDA to obtain supplemental clearance would require it to impinge on the FDA’s prerogative to decide what kinds of modifications required additional action.

The relevant regulation (21 C.F.R. §807.81(a)(3)), requires resubmission of “any change” to a device that “could significantly affect the safety or effectiveness.”  Observing that “[t]he FDA allows the manufacturer to make this decision in the first instance,” 2014 WL 3536573, at *3, the court refused to be drawn into the thicket of making safety and effectiveness decisions under the guise of Lanham Act enforcement.

As one would expect, the plaintiff argued that this allegation was allowed under POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014), claiming that it involved nothing more than statutory “overlap.”  Catheter Connection, 2014 WL 3536573, at *4.  The court held that nothing in POM vitiated the previous distinction drawn by almost every court between claims requiring “direct interpretation” of the FDCA (or FDA regulations) and those where the FDA’s regulation is incidental to the competition-related claim.  Id. at *5-6 (relying upon PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 922 (9th Cir. 2010), and Cottrell, Ltd. v. Biotrol International, Inc., 191 F.3d 1248, 1254-55 (10th Cir. 1999)).  The mere fact that the defendant admitted that changes to the device had been made did not speak to safety and effectiveness:

The statements simply acknowledge that changes to the design have been made.  [Defendant], by making those statements, does not in any way admit that those changes could result in a change in the performance of the device that would require a new 510(k) submission.  The court would still need to determine whether [defendant] made the correct choice under the FDA regulations to refrain from submitting another 510(k) notice for FDA approval. That decision is within the FDA's exclusive jurisdiction.

Catheter Connection, 2014 WL 3536573, at *5.

“[E]ssentially,” the plaintiff was accusing the defendant of “not compl[ying] with FDCA Section 510(k).”  Id. at *6.  That it cannot do under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  The “FDA permits Defendants to determine whether their . . . device was covered by clearance previously given.”  Id. (citation and quotation marks omitted).  Since that is how the FDA has chosen to regulate, it is not for a private litigant to countermand the FDA’s procedure in private litigation; the plaintiff’s remedy is to go to the FDA:

The initial decision lay in [defendant’s] hands.  If that decision was wrong, the next step lies with the FDA, which may enforce the section and require a new submission.

Id.

The remaining misrepresentation claims were different.  They did not require second-guessing of anything the FDA did or allegedly failed to do.  Two of them did not involve FDA regulation at all – whether the device operated as claimed and whether it was an effective sterilizer against certain microorganisms.  Id.  The final claim demonstrates the traditional division between FDA-related claims and other claims that merely touch on FDA issues.  It was a variant of the above “microorganisms” claim, with the precise allegation being that the defendant falsely claimed that the FDA had found the device effective against those agents.

Well before POM, most courts had held that Lanham Act claims requiring only a “yes or no” answer, i.e., whether or not the FDA had cleared/approved something, were not precluded by §337(a).  As long as all that was necessary was determining whether a Lanham Act defendant was telling the truth about what the FDA actually cleared/approved, then a court in private litigation is not precluded.  That’s what happened here:  “[A]ffirmative FDA approval of the device’s effectiveness is another characteristic of the product that would attract customers.   The question is not whether the FDA should have granted approval, but whether FDA made a finding of fact about the product.”  Catheter Connection, 2014 WL 3536573, at *7 (emphasis added).

Finally, the court held that the “analysis of the preclusion issue applies with equal force to the state law claims” brought under Utah and California consumer protection statutes (there’s no FDCA express preemption under Lohr).  That’s effectively a finding of Buckman preemption of the disguised FDCA private enforcement claim.  Id.

So so far so good.  We have no doubt that plaintiffs of all sorts will try to stretch POM in ways that the Supreme Court did not intend, but if other courts are as discerning as the Catheter Connection decision, our clients should be okay.

Interesting Cases Sent By Users (Part II) Off-Label Promotion

Here's the second case that was sent to us by our readers.  It is a favorable decision on one of our many pet peeves, off-label promotion, In re Celexa & Lexapro Marketing & Sales Practices Litigation, 2014 WL 3908126 (D. Mass. Aug. 8, 2014).  On this one, the congratulations belong to Debevoise for winning it, and our thanks to J. Robert Abraham for being so kind as to send us a copy of the decision.

In C&L (the official title is too much of a mouthful) the defendant was sued under the California unfair competition statute (“UCL”) for “restitution” of co-payment the plaintiffs paid for Celexa.  The case was initially brought as a class action (most UCL cases these days are), but certification had been denied earlier because of the predominance of individualized issues.  Among other things, C&L demonstrates the correctness of that determination, since the reliance facts were quite peculiar.

Other than the peculiar UCL damages (personal injury is not recoverable), C&L reads like a learned intermediary rule warning causation case and applies largely the same principles.

Of most significance to us, the plaintiff also moved for summary judgment, claiming that a guilty plea by the defendant established liability as a matter of law.  The court rejected the plaintiff’s arguments.

First, C&L rejected the plaintiff’s attempt to distinguish between the UCL’s “fraud” and “unlawful” prongs with respect to the element of reliance:

California courts rejected that very argument . . ., however, and have clarified that the reliance requirement applies both to claims that expressly invoke the “fraud” prong of the UCL and claims that are asserted under the “unlawful” prong but that are based upon misrepresentations or false statements.

2014 WL 3908126, at *6 (citation omitted).

Second, C&L held that the guilty plea did not ipso facto establish liability under the UCL.  The guilty plea was merely to “distributing a misbranded drug” under the FDCA – in other words, to off-label promotion.  Id. at *7.  Mere off-label promotion did not establish that “deceptive and misleading statements and omissions” were made, as the UCL requires:

Plaintiff is incorrect about the extent of [defendant’s] admissions.  [Defendant] did not admit to making false or misleading statements in its plea allocution by its general counsel.  Moreover, false or deceptive conduct was not an element of the strict liability misdemeanor to which Forest pled guilty and promotion of a drug for off-label use is not inherently false or misleading.

Id. (emphasis added).  For this proposition, C&L cited one of our favorite cases:  United States v. Caronia, 703 F.3d 149, 165 (2d Cir. 2012) (“[P]romotion of off-label drug use is not in and of itself false or misleading.”).

That meant that the plaintiff had to prove either actual reliance or that the alleged misrepresentations were material as a matter of law.  Plaintiff failed on both counts.  Typically, he had no evidence of actual reliance, and materiality was for the jury.  2014 WL 3908126, at *7.  “Reasonable physicians” would not necessarily find “material” what the Department of Justice, the FDA, the New York Times, or even the defendant itself did.  Id. at *8.  Plaintiff’s own prescribers certainly did not:

[The first prescriber] testified that it makes no difference to him whether a drug is approved for a certain use by the FDA and that he continues to prescribe [the drug] to pediatric patients for whom he believes the drug might be effective despite his awareness of the negative . . . Study and the fact that [the drug] does not have a pediatric indication.  [The second prescriber] provided similar testimony.

Id.  So the plaintiff’s motion for summary judgment was denied. 

Third, the defendant was entitled to summary judgment against the off-label promotion-based UCL claim.  Plaintiff was allowed to get away with exposure (to the promotion) evidence that was, according to the court, “very weak.”  2014 WL 3908126, at *8.  There was no need to go there because the reliance evidence was even worse.  “[T]he issue of whether or not [minor plaintiff’s] treating physicians were exposed to misrepresentations is moot because the record establishes conclusively that the physicians did not rely.”  Id. at *9.

Both prescribers testified that they didn’t care about the indications in the FDA-approved label.  They prescribed off label because it worked for their patients:

[B]oth doctors testified under oath that they do not attach much if any importance to the fact that a drug does not have an “indication” for the purpose for which it is prescribed, i.e. the FDA has not approved it for a specific use such as use by children or adolescents.  [The first prescriber] prescribed [the drug] to “hundreds” of children, including [minor plaintiff], and testified that he believed [the drug] was effective for [him].  His testimony is supported by the fact that he investigated whether . . . a different SSRI, would be more effective but concluded, based upon [plaintiff’s] self-reported symptoms, that [defendant’s drug] was more effective.

2014 WL 3908126, at *9.  The second prescriber

would “possibly, but not necessarily” give weight to the FDA's rejection of an application for a particular indication, he continued to prescribe [the drug] for use by children even after learning about the [purportedly suppressed] Study and the fact that the FDA rejected the application.

Id.

Ouch.  It’s tough for a plaintiff to win when the prescribers’ testimony is that good for the defense.  Such testimony “establishes conclusively that [minor plaintiff’s] treating physicians did not rely.”  Id.  The plaintiff could not prevail under the UCL with an off-label promotion claim without evidence that such promotion caused the prescriber to prescribe the drug for this particular plaintiff.  Obviously, there’s no way, even in California, that a class action could apply to claims so intimately tied to the decisions of individual physicians.

Fourth, there was no “injury in fact” with respect to any prescriptions written for generic versions of the defendant’s drug:

A plaintiff is entitled to restitution only with respect to money or property that was lost by the plaintiff and acquired by the defendant.  Plaintiff has submitted no evidence to support a finding that the money he spent on generic citalopram inured to the benefit of [the defendant innovator manufacturer].

2014 WL 3908126, at *10.  The infamous Conte decision only dealt with duties to warn and did “not alter the basic requirement that a plaintiff who asserts a claim for restitution under the UCL show that the defendant received the money or property that he lost.”  Id. (emphasis original).

So the result in C&L is just how we like it.  Plaintiff loses; defense wins.

Once again, thanks again to our correspondents in the defense community for letting us know of these decisions.  Keep those defense wins coming!

Friday, August 15, 2014

Breaking News: Weeks II – Lipstick (and Not All That Much) on a Pig

The Alabama Supreme Court redecided Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15, 2014), today.  It’s not all that much different than the original “Weeks Reasoning” decision that we excoriated here.  In fact, the first 54 pages of Weeks II (out of a “pithy” 145 pages, one observer noted) are almost verbatim identical to Weeks I.  So we simply reiterate here everything we said in our original post about what we’ll now call “Weeks I.”  Weeks II made only the following changes to Weeks I:
  • Changing “Wyeth Defendants” to “Wyeth” (causing a lot of spacing differences).
 
  • Adding footnote 2, trying to deny the magnitude of what the court has done – claiming not to “plow new ground.”  Positively Freudian, that.  This footnote would sound less defensive if it could cite some prior Alabama case doing even remotely the same thing.  It doesn’t, because no such opinion exists.
 
  • Spending a couple of pages distinguishing Pfizer, Inc. v. Farsian, 682 So. 2d 405 (Ala. 1996), a case in which it had equated fraud and product liability claims, essentially because, Farsian involved cognizable injury and Weeks involves, not a “defect,” but “what [defendant] said or did not say about [the drug].”  Weeks II, at 12.  Funny, that’s one spot on way of describing what’s otherwise known as a “warning defect.”
 
  • New footnote 6 admitting – contrary to new footnote 2 – that “this is the first time the highest court of a state has addressed the issue.”  Except they then admit that’s not so either, because of Huck v. Wyeth, Inc., ___ N.W.2d ___, 2014 WL 3377071 (Iowa July 11, 2014).  In an exhibition of sheer profundity, Weeks II distinguishes Huck because “Iowa law differs from Alabama law” in precisely the way they are changing Alabama law to become.
  •  
  • A non-substantive new paragraph break (the opinion could use a lot more) on page 46.
Indeed, Weeks II is so much the same as Weeks I that footnote 7 (formerly footnote 5), listing all the other courts reaching opposite results, wasn’t even updated to reflect the 18 months that have passed since Weeks I.  That footnote still cites no decision after 2012.  Thus, while Weeks (I or II) focused most of its fire on Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), as being decided before generic preemption was recognized, it now ignores multiple post-Mensing Court of Appeals decisions (which we’ve listed/discussed here and here).  It’s one thing to disagree with one court of appeals applying the law of one other state; it’s another thing to disagree with (by our count) 14 court of appeals decisions, from seven circuits interpreting the laws of 24 states – except when you're the Alabama Supreme Court.
Unable to distinguish over a dozen new appellate precedents, Weeks II, instead takes refuge in silence.  It doesn’t work.  While it may in some situations be best to remain silent, elsewhere, with all that verbiage, the court has spoken, and thus removed all doubt.
New legal "reasoning" in Weeks II begins on page 54.  It is a discussion of why there actually is a “relationship” between an innovator seller and a generic purchaser because – basically that prescription drugs are “different” from “lawnmowers, automobiles, and other products.”  Weeks II, at 61.  None of these other products are subject to the “unprecedented” control of the FDA.  Id.  Thus, the same opinion that starts out (p.18) quoting Wyeth v. Levine, 555 U.S. 555, 570-71 (2009), about innovator manufacturer’s “responsibility” for their labels, ends up stating that “the FDA has the responsibility of weighing (in terms of extremes) the potential benefit of lifesaving medication against potential severe side effects.”  Weeks II, at 61.  The internal inconsistencies in Weeks II, are almost as breathtaking as its denial that it’s changing the law.
So, if prescription drugs are different from other products, to what situations does Weeks II consider them to be more closely analogous?  Judging by the cases the court relies upon, those would be:  conversion of an insurance claim, medical insurance claims, and selling bonds.  Id. at 46-49.  Definately more analogous than the dozen other appellate Reglan decisions the court doesn't mention.  Essentially, because the federal government requires generic manufacturers to use the same labeling language as innovators, Weeks II declares that this federal fiat will create a new “relationship” under state law despite that the two entities are direct competitors in the marketplace.  There’s really nothing else.  It’s market share liability by virtue of federally-mandated use of the same labeling - look out anybody else subject to similar labeling restrictions (cars, cigarettes, food, chemicals, pesticides?).
Bottom line.  Alabama has more home-grown plaintiff lawyers than pharmaceutical companies – and after Weeks II, it most assuredly always will.  This is the kind of extreme liabilty might even be something that other states might find "contrary to public" policy and thus refuse to apply Alabama law.
There are also a concurrence and a dissent.  We recommend the dissent.  At least it actually discuses the policy reasons why innovator liabity is a very bad thing.  About the only good thing we can say about Weeks II is that instead of a lone dissent, there were three dissenters this time around.