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If you have been following along for a while, then you have surely run across our posts making some combination of the following points:  1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture).  One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted.   That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.

The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted.  The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged.  Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection.  Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis.  When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds.  We will address only some of them.

Part of our point here is that the order can matter.  We do not have the briefs, so all we can go off of here is the opinion.  After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this:  “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:

If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.

Id. at *8.  This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary.  Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.

Continue Reading Another Court Tackles Prescription Drug Design Defect

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a branded prescription drug was preempted.  Courts were chilled for a while, but eventually the right sort of cases found their way to judges who understood preemption.  Now, we have a pretty big list of decisions finding preemption of such claims, along with decisions exhibiting supportive reasoning.  We are not yet at the point where preemption of failure to warn claims with branded prescription drugs—for a long time, the core claim in the biggest litigations in our bailiwick—is no longer news.  Preemption is still the exception—limited to cases with a strong regulatory history of FDA rejecting the warning plaintiff wanted—rather than the rule, particularly when it comes to favorable appellate decisions.

Rheinfrank v. Abbott Labs., Inc., __ Fed. Appx. __, 2017 WL 680349 (6th Cir. Feb. 21, 2017), is another favorable appellate decision on preemption.  You may recognize the name—especially if you are a blog aficionado—from our prior posts on the case.  We posted on partial summary judgment being granted as to part of the failure to warn claims being offered—on preemption—and the punitive damages claim—on lack of proof of relevant FDA fraud to meet the exception under the Ohio Product Liability Act provision generally precluding punitives for FDA-approved drugs.  We posted on the expansion of the preemption ruling on motion to reconsider to include design defect.  (These garnered an honorable mention in our list of the best decisions of 2015.)  We even posted on motions in limine rulings.  Even with all of those posts, a brief recap of the facts might help.  The minor plaintiff’s mother took the prescription anti-seizure medication at issue for fifteen years, including through four pregnancies, before she became pregnant with plaintiff.  She kept taking the medication at issue, along with another anti-seizure medication she had been taking, through the birth of plaintiff, who was diagnosed with “physical deformities and cognitive disabilities, including Fetal Valproate Syndrome.”  2017 WL 680349, *1.  The label for the medication at issue had long featured a black box warning and other warnings about birth defects, focusing on neural tube defects like spina bifida and discouraging use during pregnancy unless use of the medications “are clearly shown to be essential in the management of their seizures.” Id. at *2.  Over the course of seven years after plaintiff’s birth, FDA refused the manufacturer’s repeated efforts to revise the label to address developmental delays in offspring based on data from a study that was ultimately published in the New England Journal of Medicine. Id. at **2-4.  A revision of the labeling was ultimately submitted by CBE and accepted by FDA in 2011. Id. at *4.  The prescriber back in 2003 and 2004 testified that she was aware of the black box warning on birth defects, would have relayed it to plaintiff, and would not have relied on other materials outside the label. Id. at *2.

Somehow, on this record, the plaintiff got to trial.  Under the logic of “all’s well that ends well,” we will limit our rant on this point.  After all, we have discussed other birth defect cases that got to trial despite obvious issues, resulted in big verdicts, and got affirmed on appeal. Rheinfrank proceeded to trial under the portion of the strict liability failure to warn claim that was not preempted, a strict liability claim for failure to confirm to representations, the portion of a common law negligent failure to warn claim that was not preempted, and a common law negligent design claim.  Among the reasons why the two failure to warn claims should not have seen a court are that 1) Ohio law requires the allegedly inadequate warning to relate to the injury plaintiff claims, 2) claims relating to developmental delays (including as part of Fetal Valproate Syndrome) were preempted, and 3) the prescriber was aware of black box warnings about really serious birth defects and the recommendation against prescription during pregnancy in most situations.  It is hard to see how plaintiff mustered evidence of proximate cause—that is, that a proposed (non-preempted) alternative warning as to a risk of an injury the plaintiff had (based on evidence that existed when the prescription was written) would have changed the prescriber’s decision to prescribe—to survive summary judgment.  Based on the jury instructions that plaintiff proposed at trial, it seems like a broader discussion of risks and the impact of different warnings about risks was permitted than maybe should have been, which is often a reason why failure to warn claims get past summary judgment.  Given that the prescriber denied reliance on any representations outside the label, it is hard to see how that claim got to the jury.  As for the negligent design claim, it is hard to see how the same reasoning for preempting the strict liability design claim would not have applied or how a design of the drug—without being a different drug—that lacked the same birth defect risk could have been offered.  Anyway, the trial judge may have known what was coming, because the jury listened to the just about the best plaintiff could offer and returned a defense verdict on all counts after two weeks.

Continue Reading Sixth Circuit Affirms Branded Drug Preemption and Trial Win

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy.  Perhaps because of the inherent sympathy for the plaintiff (offspring), it seems that plaintiffs in birth defect cases get extra chances to prove that have enough science to support their claims.  Science in this area is undoubtedly complicated.  For one thing, while ontogeny does not always recapitulate phylogeny, fetal development of placental mammals (of which humans are a relatively recently evolved species) varies, so extrapolation from animal studies on teratogenic effects is even harder than with studies of direct effects on animals.  For another, ethical considerations generally preclude prospective clinical trials designed to study teratogenic effects.  FDA’s treatment of drug labeling on the risks of teratogenic effects has reflected some of this dynamic.

Litigations pursuing birth defect claims seem to follow their own dynamic.  Despite the oft-cited caution from Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996), that “the courtroom is not the place for scientific guesswork, even of the inspired sort.  Law lags science; it does not lead it,” it often seems like cases are pursued before there is science to support them, particularly if specificity of drug, dosage, and injury is going to be required.  This may be due to the impact of statutes of limitations.  It may also be because some courts are lenient on admissibility of causation evidence and there can be years from filing a case a case until Daubert (or equivalent) motions are decided.  Another dynamic seems to be that the only proof as to whether the plaintiff’s mother took the drug during the relevant time can be her word, unless the plaintiff’s expert can argue that the birth defect can itself count as proof of exposure.  We also sometimes see that general causation can be a harder concept for courts to understand than it should be.

Looking through our particular lens, we see all of this in K.E. v. Glaxosmithkline LLC, No. 3:14-cv-1294(VAB), 2017 U.S. Dist. LEXIS 13705 (D. Conn. Feb. 1, 2017), a case that came to the correct result—causation opinions excluded—but took an overly charitable route in arriving there.  The case alleged that maternal use of the defendant’s SSRI during the first trimester of her pregnancy with plaintiff in 2001 caused him to develop a bicuspid aortic valve and accompanying regurgitation.  The plaintiff was diagnosed with a bicuspid aortic valve in September 2010 (after evaluation following his father’s diagnosis with his own heart condition), by which time the drug’s label had been revised to reflect the pregnancy category D—“adverse reaction data from investigational or marketing experience or studies [of the drug] in humans”—and the manufacturer had sent a dear healthcare provider letter describing the basis for the change. Id. at **16-18.  The purported prescribing physician testified that he would not have prescribed the drug to a patient whom he suspected was pregnant or recommended it for a pregnant woman based on the label as it was in 2001. Id. at **16-17.  We say “purported prescribing physician” because he denied prescribing the drug to plaintiff’s mother until after the plaintiff was born, which is what his records and pharmacy records—but not plaintiff’s mother’s testimony—showed. Id. at **9-12.  More on that later.  After the bicuspid valve diagnosis, plaintiff’s records suggested that his mother had used the drug during pregnancy and his mother—plaintiff was still a minor—thought that there was a relationship.  This was reinforced by a lawyer advertisement on television trolling for plaintiffs and she contracted and signed up with a law firm to pursue a lawsuit over plaintiff’s bicuspid aortic valve by September 2011. Id. at **18-19.  Even though the statute of limitations in Connecticut for claims like this was two years, plaintiff waited until late July 2014—close to four years after the diagnosis—to sue.  Within a year—pretty fast for such cases—the manufacturer moved to exclude plaintiff’s sole causation expert and for summary judgment on statute of limitations, lack of causation, and other problems with plaintiff’s proof.  The decision we are discussing followed more than eighteen months later.

Continue Reading Unreliable Expert Causation Evidence Ends Birth Defect Case

It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label.  Recently, a bunch of those have involved Infuse.  Cales v. Baptist Healthcare Sys., Inc., No. 2015-CA-001103-MR, 2017 Ky. App. LEXIS 10 (Ky. Ct. App. Jan. 13, 2017), involves claims against a hospital over alleged off-label use of Infuse by a doctor there.  (The decision gives no indication of a specific alleged injury from the use.)  Why sue the hospital?  Maybe to keep the case against the manufacturer in state court.  Maybe to pursue someone else when the claims against the manufacturer are preempted.  The problem for the plaintiff is that she needs a viable claim against the hospital, at least something that can get by a motion to dismiss.  She offered three claims (two product liability and one medical negligence) premised on the hospital’s alleged knowledge of the possibility of off-label use, and the trial court dismissed them all.

Unfortunately for the hospital, the Kentucky Court of Appeals reversed as to one of the claims.  Product liability claims against the manufacturer of this PMA device have, as the court noted, “been mostly unsuccessful based on federal pre-emption.” Id. at *10.  Plaintiff claimed that preemption does not apply to such claims when made against a healthcare provider.  “This distinction is of no avail.” Id. at *11.  As the court analyzed it, consistent with the majority position, express preemption for PMA devices is based on the device, not how it is used or who uses it.  It stands to reason that strict liability product liability claims about the design and warnings of a PMA device are expressly preempted too.  This may seem obvious, but we think it is the first ruling of its kind in favor of a hospital.  That may be because strict liability claims against hospitals are generally unavailable.

Framing those claims as negligence does not help under the Kentucky Product Liability Act.  Among other things, a distributor or “middleman” is not liable simply based on knowing that there may be off-label use, which is not the same thing as knowing the product is in a defective condition.  Id. at **12-13.

Medical negligence predicated on the hospital not telling the plaintiff that her doctor planned to use the device off-label is neither preempted by the MDA—FDA does not regulate the practice of medicine—nor covered by the Kentucky Product Liability Act.  Kentucky law imposes a duty on hospitals to obtain informed consent from patients in connection with procedures to be performed.  Id. at **15-16.  In essence, the consent process is supposed to inform the patient of the “procedure[,] acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures.”  Id. at *15.  In the context of a motion to dismiss, the Cales appellate court viewed that whether there was a need to inform a patient of off-label us was a question of fact to be addressed as the case progresses and resurrected the medical negligence claim.  Id. at *17.  Not having the complaint in front of us, it is hard to say if there was any allegation of failing to inform the plaintiff of inherent substantial risks and hazards, it is hard to say whether this was a correct result.  We can say, however, as the court acknowledged in its discussion of the product liability claims, that off-label use does not necessarily involve excess risks compared to on-label use.  It may be possible to meet the state law requirements for proper consent without ever mentioning the loaded term “off-label.”  That is why other courts have held that there is no duty to warn that a planned treatment is off-label.

Ponder the following:  A man attends an exercise class at a facility run by a local religious institution.  Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than optimal, and was informed of the need to get medical advice before starting a new and potentially demanding exercise program.  He had a heart attack and collapsed right after leaving the class.  Assume that the heart attack was not a total surprise given his health, but that he had not had a heart attack before and had not informed the people running the class of any particular risk.  The class instructor rushed to the man’s aid while others called 911.  The instructor was certified in cardiopulmonary resuscitation (“CPR”) and did her best to help the man.  When paramedics arrived, they assumed care of the man, but he died despite their best efforts.

Based on these facts and assumptions, answer this question:

Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.

If you answered other than “A,” then you might need to examine your propensity to blame others.

Add in the following to the scenario presented above:  The class instructor tending to the man did not utilize an automated external defibrillator (“AED”) that she knew was present and was certified in using.  She brought the AED to the man’s side, but elected not to use it because, in her judgment, he was having a seizure and not a heart attack.

Based on these additional facts, answer these questions:

1.  Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.  E) The company that sold the AED and offered training to purchasers.

2.  If the man’s estate already sued the religious institution over his death, who should the defendant bring in via third-party complaint?

A)  Nobody.  B)  The class instructor.  C) The entities that operate the 911/EMT system.  D) The company that sold the AED and offered training to purchasers.

In Wallis v. Brainerd Baptist Church, No. E2015-01827-SC-R11-CV, 2016 Tenn. LEXIS 920 (Tenn. Dec. 22, 2016), the estate sued the church that ran the gym and then both turned their attention to the seller of the medical device that was not used.  It is often said that bad cases make bad law, but sometimes egregiously over-reaching cases can make good law.  Ultimately, Wallis fits into the latter category.  A contrary result, which would have allowed a negligence or contract claim against the seller of a device that was not used with the decedent, would have been bad, maybe bad enough to have been mentioned in our bottom ten post last week.

Continue Reading Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters.  One implication is that heeding presumptions typically make little sense for claims about these products.  It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product.  In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff.  In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn.  Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation.  Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided.  In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products.  Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past.  Over time, manufacturers also stop selling specific products or product lines and may even go out of business.  When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly.  We could go on, but we will not.

Continue Reading Heeding Presumption Only Goes So Far In Post-Sale Warning Case

As we head into December, there is quite a bit of attention being paid to when sales start, when shipping occurs, and when gifts are given.  Were one concerned with such an inquiry, one might imagine a few different points in time when gifting might commence.  For purposes of our space-filling exercise, assume the putative gift is tangible, labeled to identify the intended recipient, wrapped such that it must be opened to reveal its contents, and left in a place where the intended recipient is expected to retrieve it.  Has gifting commenced when the giftor leaves the gift in this place, even if it might be removed before the giftee assumes possession?  Need there be some last clear chance when the gift can no longer be removed or replaced with something else before the giftee claims it?  Must there be a direction like “open it” to signal an exchange?  What if the gift has labeling that states that it cannot be opened for another six weeks or so?  If the “gift” is merely a box containing a note that an actual gift will be forthcoming, then was there a gift at all?  What if we droned on and on?

Goldthrip v. DePuy Orthopaedics, Inc., __ Fed. Appx. __, 2016 WL 6933450 (11th Cir. Dec. 28, 2016), involves these exact same issues if one can consider a product liability lawsuit a gift and an Alabama courthouse a suitable place for receiving such a gift.  In Goldthrip, the plaintiff alleged that her implanted prosthetic hip manufactured by defendants injured her on December 25, 2013.  As this was a day when many Alabamians were exchanging gifts, we can guess that the timing of the injury was easy to identify.  The plaintiff filed her case on December 23, 2015, two days before the statute expired and another day of mass gifting.  Her complaint, however, came with a curious note, indicating that she was “‘withholding service of process’ in an effort to avoid expenses and facilitate settlement discussions.” Id. at *1.  The complaint was served on the defendant (without a summons) a week later, a summons was issued about six weeks after that, and the defendant was served with the summons sometime later.  (If you are wondering, Fed. R. Civ. P. 4(c) provides that “A summons must be served with a copy of the complaint. The plaintiff is responsible for having the summons and complaint served within the time allowed by Rule 4(m) and must furnish the necessary copies to the person who makes service.”  Service of the summons and complaint together, absent waiver, is necessary to get things started in federal court.)

Continue Reading Dispensing With Commencing: A Statute of Limitations Gift

What follows is a guest post by John Feldman, a partner in Reed Smith’s Entertainment and Media Industry Group.  John closely follows all things Federal Trade Commission and approached us when he saw the FTC weighing in a group of products that falls under the first word of our title.  We have weighed in before on FDA’s regulation of homeopathic drugs, but FDA is not the only regulator in town.

As always, our guest posters are entitled to all of the credit, and any blame, for their efforts.

********

“Eye of newt, and toe of frog. For a charm of powerful trouble, Like a hell-broth boil and bubble.”  Hey, if it works for you, more power to ya.

That’s the FTC’s attitude toward homeopathic drugs.  Following up on a homeopathic drug workshop in conducted in 2015, the staff at the FTC is apparently convinced that generally there is no medical basis for most claims on homeopathic drug labels and marketing materials.  The FTC recognizes that thousands if not millions of people use and find value in homeopathic drugs.  And it may be that many if not most of the users of such products know that the science underpinning the products is shaky at best and possibly non-existent, but the FTC believes that many people purchasing homeopathic drugs do not even understand what homeopathy is.

Enter: The FTC Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs.

Continue Reading Guest Post — Do It If It Makes You Feel Good: FTC’s Report on Homeopathic Medicine Advertising

People send us things to consider discussing in our posts. Usually, those things are court decisions in drug and device cases.  Sometimes, they are so far afield from our comfort zone that we do not give them much consideration.  This week, we received a motion from a False Claims Act case that we thought was interesting enough to enlist a colleague to add some subject matter expertise while we fretted about the election, work, the election, and some other stuff (i.e., the election).  Much of the credit for this post goes to Andy Bernasconi, a fine lawyer for a crazy Red Sox and Patriots fan.

While we do dabble in the FCA on this blog, we lean on Andy for a quick primer on the FCA’s provisions.  Congress originally passed the FCA in 1863 as a way to deter and punish government contractors’ fraud against the U.S. and Union troops during the Civil War.  The statute (as amended) generally creates liability for any person who knowingly submits a materially false claim demanding payment from the United States. See 31 U.S.C. § 3729(a)(1). An FCA violation is punishable by treble damages, civil penalties of up to $21,563 for each false claim, and an award of attorneys’ fees. Id. §§ 3729(a)(1) &(3); id. § 3730(d)(1); 81 Fed. Reg. 42491 (June 30, 2016).

One of the most notable aspects of the FCA is that it contains unique qui tam provisions that permit a private whistleblower, also known as a “relator,” to file FCA claims on behalf of the federal government. Id. § 3730(b)(1). In doing so, the relator files the case under seal, at which point the Justice Department investigates the allegations and decides whether the government will intervene and take over the case to litigate for itself. Id. §§ 3730(b)(2), (4).  If the government declines to intervene in the case, the relator may litigate the case in the name of, and on behalf of, the government. Id. § 3730(c)(3).

Continue Reading Putting the False in False Claims Act Cases

We sometimes start our posts with disclaimers about how we do not know all the details of a case, perhaps supplemented by a little digging on the internet, or that we are not experts in some substantive area.  We start this post with disclaimers that we (and our respective firms) are not involved in the case we are writing about (or the related cases mentioned in it) and we are not specialists in antitrust or patent law (although others at our respective firms are).  We do know misjoinder, forum shopping, and judicial smackdowns when we see them, though.  We typically encounter misjoinder when a bunch of individual plaintiffs from various places are listed on a single caption because they each are pursuing individual claims over injuries allegedly caused by the same or similar products.  As long as at least one plaintiff is from where they have sued and at least one plaintiff is from the defendant’s home state, they all get to stay where their lawyers chose to sue, at least if they get their way.  (Set aside CAFA for now.)  When confronted with a motion to sever—or another motion that implicates the issue—they argue that joinder is perfectly appropriate because all cases against the manufacturer of product(s) are really about the same set of facts—i.e., the company designed a dangerous product and marketed it without adequate warnings of its risks.

Forum shopping is the other half of litigation tourism, as we often call it—like picking the campground for the family reunion.  The lawyer’s reason for picking the court is typically not revealed, just that a plaintiff gets to pick and their choice should be afforded deference.  We have yet to see a lawyer say they picked the venue where they felt they had the most influence with the bench and/or juries apt to put extra zeros on the damages in a case against an out-of-state defendant.  That the plaintiff lawyers, rightly or wrongly, consider where to file and how to package their clients as part of their desire to maximize the total recovery by verdict or settlement—and their fees—should not be a shock to anyone.  But we might suppose that the government lawyers trying to enforce the Federal Trade Commission Act and the Clayton Act might be above such base considerations.

Continue Reading Misjoinder and Forum Shopping by the Government