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Search for “homeopathy” on the Internet, and one quickly discovers that this particular form of “alternative medicine,” does not have the greatest
reputation.  Wikipedia, not always an unimpeachable source, but usually OK for our purposes, has a less than stellar description of the practice:

Homeopathy is a pseudoscience, which is a belief that is incorrectly presented as scientific, but is ineffective for treating any condition. . . .[H]omeopathic preparations . . . involve[] repeatedly diluting a chosen substance . . . well past the point where no molecules of the original substance remain. . . .  Homeopathy is not a plausible system of treatment, as its axioms about how drugs, illness, the human body, liquids and solutions operate are contradicted by a wide range of discoveries across biology, psychology, physics and chemistry made in the two centuries since its invention. . . .  The continued practice of homeopathy, despite a lack of evidence of efficacy, has led to it being characterized within the scientific and medical communities as nonsense, quackery, and a sham.

Wikipedia, “Homeopathy” (Numerous footnotes omitted).  Considerably more along the same lines may be found at Quackwatch.

So why talk about homeopathy here?  Because unlike many other controversial alternatives to modern medicine, homeopathic remedies are still around,
courtesy of Congress when it enacted the Food, Drug & Cosmetic Act.  In the Act, Congress defined a “drug” so as to include “articles recognized in the . . . official Homœopathic Pharmacopœia of the United States.”  21 U.S.C. §321(g)(1); see 21 U.S.C. § 351(b) (“when a drug “is labeled and offered for sale as a homeopathic drug, . . . it shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States”); 21 U.S.C. §360eee(13) (defining “product” as including “homeopathic drugs marketed in accordance with applicable guidance under this Act”).  The FDA has issued standards for the labeling of homeopathic products authorized by the statute.  See generally Compliance Policy Guide §400.400 (setting forth homeopathic labeling requirements).Continue Reading How To Handle Homeopathy?

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On this date in 1896 the Dutch completed the harbor at IJmuiden.  (That capital J is not a mistake.  The I and J go together as a digraph, and they form a ligature that effectively makes up a single letter in the Dutch language.)  The IJmuiden harbor has an interesting history.  It connects Amsterdam to the North Sea via canals.  After the Germans invaded the Netherlands in 1940, the Dutch Royal family left the country from IJmuiden.  The Germans then used the IJmuiden harbor to house their torpedo boats and midget submarines.  After D-Day, the Allies bombed IJmuiden.  The American Air Force employed various weapons to penetrate the German concrete bunkers, including rocket-powered Disney bombs.  The bombs were named after war propaganda efforts by the Disney Studio.  Today IJmuiden harbor welcomes cruise ships.  It is a safe harbor.

(Yes, that is a rather long and pointless windup to get to our safe harbor case, but we are busily planning our Benelux Summer vacation, so you’ll have to excuse the travelogue/history.)

In the past we have had several opportunities to discuss state consumer protection laws containing “safe harbor” provisions that bar suits over conduct that was authorized, approved, or permitted by governmental agencies. Applying these safe harbor provisions, courts have dismissed consumer protection claims that attacked FDA-approved actions (usually labeling) after finding that the challenged conduct had the imprimatur of an agency.  One example was the DePriest case in the Arkansas Supreme Court.  The plaintiff in that case claimed that the defendant fraudulently marketed Nexium as better than older drugs that – allegedly – did essentially the same thing. The case was styled as an economic-loss-only class action.  The Arkansas Supreme Court threw the case out and we blogged about it here in 2009.Continue Reading Consumer Food Fraud Claim Sinks in Arkansas Safe Harbor

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The short answer is “no.”  We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it at all.  (Or from here.)  The titular character in that flick was known as “Rico.”  RICO (Racketeer Influenced and Corrupt Organizations Act), on the other hand, was an anti-gangster law, enacted in 1970 as part of the Organized Crime Control Act.  In a number of posts (like here), we have decried the gangster tactics used by plaintiffs—particularly quasi-public plaintiffs—to use the threat of RICO’s treble damages and cost-shifting provisions to extort settlements from drug and device manufacturers.  Particularly for prescription medical products, RICO seems like an inappropriate vehicle for addressing alleged harms allegedly caused by such standard product liability allegations as inadequate disclosure of risks or off-label promotion.  A small blow to curtail the expansion of RICO was struck in Short v. Janssen Pharms., Inc., No. 1:14-CV-1025, 2015 U.S. Dist. LEXIS 61123 (W.D. Mich. May 11, 2015).

Short is yet another case stemming from pediatric use of Risperdal.  We have posted many times on various Risperdal cases with various theories of recovery, usually tied to the idea that the drug was improperly promoted for off-label use without disclosing the true risk of gynecomastia and other prolactin disorders, like hereherehere and here.  In Short, the plaintiff allegedly took Risperdal as a minor, developed gynecomastia, and sued in his own behalf under RICO and state consumer protection and product liability acts.  His problems were that he never paid a cent for the drug and that he was from Michigan.  We suspect the latter may be why RICO was at issue at all.Continue Reading Is This The End of RICO?

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Safe harbor.  We like the sound of that.  The term connotes a level of calmness and predictability that we find appealing in the regulation of drugs and medical devices, and we find ourselves writing about safe harbors a lot lately.  Bexis recently gave us his survey of safe harbors against state consumer fraud claims, and

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There are several reasons we recommend taking a look at last week’s decision in Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013).  One is that the case involves Stevens Johnson Syndrome, a rare but devastating idiosyncratic reaction which has become something of a litigation flavor du jour, with plaintiffs claiming that a great number of drugs cause this condition.  After showing considerable patience (plaintiff filed 5 motions to amend), the court ruled that plaintiff finally struck out.

Most significantly, Ball was super in dismissing the plaintiff’s warning claim.  The court held that the defendant’s warning about SJS/TENS was adequate as a matter of law – and dismissed the case:

The [relevant] label clearly identifies Stevens-Johnsons syndrome as a potential “adverse reaction” that could result from use of the prescription drug.  Under Virginia law, a manufacturer is obligated to give a reasonable warning, not the best possible one.  Courts have routinely held warnings adequate as a matter of law when they alert a party to the very injury for which the plaintiff seeks relief.  [Defendant] disclosed Stevens-Johnson syndrome as a possible adverse reaction to [the drug] prior to plaintiff’s ingesting the drug. . . .  The failure to disclose this risk is the sine qua non of the plaintiff’s negligence and negligence per se claims to the extent they seek to hold [defendant] responsible for plaintiff’s Stevens-Johnson syndrome.  Those claims are dismissed, with prejudice.

Ball, 2013 WL 4040395, at *5 (citations omitted).  A finding of adequacy as a matter of law is powerful, since warning claims are at the heart of prescription drug litigation.  That this determination was made at the motion to dismiss stage, with the court taking notice of the label, is obviously even better. “A manufacturer does not insure its product’s safety, and need not supply an accident-proof product,”  Id. at *6 (citation and quotation marks omitted).Continue Reading On The Ball In The Old Dominion

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Pom Wonderful continues to be so.  Last year it produced a terrific 9th Circuit opinion reinforcing that only the United States, not private plaintiffs, can enforce the FDCA and FDA regulations.  See Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012).  And so the FDCA and its regulations barred plaintiff’s Lanham

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No, we’re not talking about the McClellan Kerr Project that turned Little Rock and Tulsa, of all places, into seaports. We’re talking consumer protection lawsuits against pharmaceutical companies (aren’t we always).
We’ve mentioned a couple of times before that a lot of consumer protection laws contain “safe harbor” provisions that bar suits over conduct that

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This, that, and the other thing.
Odds and sods.
Whatever. This post is about stuff that we learned about recently that relate to our prior posts. Other than that, they have nothing in common with each other.
Together, they add up to enough material for a decent post.

Rebel Flag Still Flies In Georgia

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Without the question mark, that’s Alaska’s state motto.

With the question mark, it’s our title for a post analyzing the on-going trial in State of Alaska v. Eli Lilly and Company.

The State of Alaska is seeking civil penalties from Lilly under the Unfair Trade Practice Consumer Protection Act of at least $1000 for

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Back in the sixties, those days of the Cold War, flower power, and the creation of strict liability, the Cuban revolutionary Che Guevara was credited with the phrase “create two, three, many Vietnams.” Che was not, as far as we know, a plaintiffs’ lawyer. In Florida, however, Che’s philosophy seems alive and well in the