Bath Salts Under Siege: Eighth Circuit To Hear Challenge To Analogue Drug Act

Back in 2013, James Carlson, owner of the Last Place of Earth head shop in Duluth, Minnesota, was convicted on 51 counts of peddling synthetic drugs. He was sentenced to 17 1/2 years in prison and ordered to forfeit $6.5 million. Carlson was accused of selling synthetic drugs misbranded as incense, potpourri, bath salts, and glass cleaner, the effects of which mimic illegal narcotics and hallucinogens. Carlson’s defense? The government led him to believe the products he was selling were legal. Carlson feels so strongly that he was in the clear that he has taken his case to the Eighth Circuit Court of Appeals.

According to a report out of CBS Minnesota, Carlson is challenging the constitutionality of the Federal Analogue Drug Act, 21 U.S.C. § 813, a section of the Controlled Substance Act allowing any chemical “substantially similar” to a scheduled controlled substance to be treated as if it were one of the scheduled drugs. Carlson contends that the law is so vaguely worded that it is impossible to know if one is violating it. At his sentencing hearing in 2014, Carlson claimed that over 1,000 other Minnesota businesses were selling the same products.

This White Sands rehabilitation facility says that the purpose of the Analogue Drug Act was to stay ahead of the curve in combating the ever changing molecular formulas of banned substances. With that said, we have grown weary of phrases like “substantially similar.”  What is and is not “substantially similar” is a question of fact opening the door to pickles like the one faced by Carlson.  Just as federal prosecutors can argue that the substances sold by Carlson are substantially similar to scheduled substances, so too can others argue that they are not.  And, there is your dilemma.

Whether or not the Court determines the statute is unconstitutionally vague, this case is yet another example of the problems of federal drug regulation. Again, the overarching principle – to protect the health and safety of the public – is a good one. But we must ask if there is a better way to go about it? Maybe we wouldn’t have to worry about the existence of “synthetic” drugs if we better addressed how we handle the pure ones.

Hot Dogs: New Standard for Food Purity

When we here at Abnormal Use think of “pure” food products, we think of mountain spring water or fresh fruits and vegetables.  Never do we think of hot dogs. Never (despite our love of hot dogs). However, the Hebrew National brand of hot dogs claims to be just that. Kosher beef. No fillers. No byproducts. No artificial flavors. In other words, Hebrew National claims to be as “pure” as a hot dog can get. We have nothing against the brand, but we still are skeptical about placing “pure” and “hot dog” in the same sentence. A class of consumers has taken such skepticism a step further and filed suit against ConAgra Foods, Inc., the manufacturer of the Hebrew National brand, claiming that these hot dogs were not, in fact, “kosher.” Last year, a federal district court in Minnesota dismissed the suit on the grounds that the First Amendment barred him from addressing the underlying religious questions. Recently, the Eighth Circuit nixed the dismissal and remanded the case back to the Minnesota court. The case is captioned Wallace v. ConAgra Foods Inc., No. 13-1485 (8th April 4, 2014).

It will be interesting to see what becomes of this suit now that it has gained new life. As we discussed above, we understand the skepticism surrounding claims of hot dog purity. But, these plaintiffs have taken things beyond mere skepticism and actually challenged the religious nature of the process. Here, the plaintiffs take issue with whether ConAgra followed proper religious procedures, despite packaging that claims to “meet a higher standard,” being made by people who “answer to a higher authority.” Interestingly, according to the Chicago Tribune, the plaintiffs do not claim to eat kosher themselves. We guess they are just looking out for those that do. Or, just want a better hot dog.

We are no experts on kosher foods and do not know exactly which part of the hot dog-making process to which these plaintiffs object.  We do know that these issues are to be taken seriously. Had these plaintiffs actually followed kosher practices, then we would find some merit behind the claims and understand the trial judge’s reasons for dismissing the matter on religious grounds. But that is not what we have here. What we have are plaintiffs that must have some other standard for their hot dogs. Even if Hebrew National’s claims are not 100 percent accurate (and we have no reason to believe they are not accurate, despite our general hot dog purity skepticism), where have these non-kosher practicing plaintiffs been damaged? Certainly, a 75 percent kosher hot dog must be better than any other hot dog. When it comes to hot dogs, standards are low, anyway, right?

We imagine the plaintiffs are claiming that they paid a premium for the kosher hot dogs. Even if they did, let the plaintiffs tour any other company’s hot dog making plants and they will see that they still got a bargain.

First Circuit Gets Creative, Abnormal Use Applauds

Ever so often, an appellate court blesses us with an opinion that is witty and full of subtle humor. With its recent opinion in Bisbano v. Strine Printing Co., Inc., No. 13-1722 (8th Cir. Nov. 27, 2013), the First Circuit did just that. Before diving into the opinion, here is a quick statement of the facts. Bisbano was a commercial printing sales representative who championed a national drug store chain as a major client for nearly two decades. Bisbano worked for several printing firms over the years, bringing the client’s business along with him at each stop. Prior to his employment with Strine Printing Co. (“SPO”), Bisbano had secretly paid the car lease of a printing department employee of the chain while he was working for his former employer. During the course of an internal review of printing practices, the client discovered Bisbano’s roll in the apparent kickback and he confessed to the act. Nonetheless, the client decided that it would no longer do business with him. Shortly thereafter, SPO fired him. In turn, Bisbano filed suit against SPO, asserting claims of unjust enrichment, tortious interference with contract, breach of contract, and intentional and negligent misrepresentation. The district court granted SPO’s motion for summary judgment on each claim, and Bisbano appealed. In the well-drafted opening paragraphs of the opinion, the Eighth Circuit described the same as follows:

[S]ales techniques of this sort are by their nature clandestine; they cannot withstand the sunlight. If the employer learns about the kickback, the consequences are usually unpleasant. This case, in which defendants Michael Strine and his eponymous firm, Strine Printing Company (SPC), first hired and later fired the plaintiff, Richard Bisbano, turns on such a revelation.

When he was cashiered, the plaintiff did not go quietly into obscurity but, rather, brought suit for an oleaginous mass of perceived wrongs, including unjust enrichment, tortious interference with prospective contractual relations, breach of contract, breach of an implied covenant of good faith and fair dealing, and misrepresentation. The district court, deftly sorting wheat from chaff, granted summary judgment in favor of the defendants.

So, right off the bat, you see where this one is going. On appeal, the crux of Bisbano’s arguments were two-fold: (1) SPO interfered with his business relationship with the client by firing him, and (2) SPO misrepresented to him that he would remain employed with the company as long as he brought in the client’s business. The Court wasn’t sympathetic to either theory, finding that Bisbano’s assertions were factually inaccurate and not a basis for relief under any of the causes of action. The Court indicated that the client independently ended its relationship with Bisbano prior to any action by SPO and, thus, SPO did not interfere with the business relationship by firing him. As the Court eloquently stated:

It is a matter of chronology, not a question of disputed fact, that SPC could not have induced [the client] to break off a relationship that [the client] already had relegated to the scrap heap.

Likewise, the Court found that SPO neither breached the employment contract by firing him nor made any misrepresentations by promising to employ him as long as he brought in the client’s business because it had fulfilled its promise. Once the relationship with the client had ended, so to, did any responsibility SPO had to employ Bisbano. According to the Court:

[T]hese losses, by any leap of even the most agile imagination, cannot be said to flow from the plaintiff’s reliance on SPC’s representations. The losses unarguably flowed from [the client”]s discovery of the plaintiff’s corrupt relationship with a [an official of the client] and [the client’]s ensuing decision to sever all ties with the plaintiff. Seen in this light, the plaintiff was the author of his own misfortune.

Well-played, First Circuit. Well-played, indeed.

Eighth Circuit Engages Drug Manufacturer in Semantic Exercise

I know you lawyers can, with ease, twist words and meanings as you please.

John Gay

We here at Abnormal Use imagine the 18th Century wordsmith uttered these words in a derogatory tone, but we can still appreciate his sentiment.  After all, we do pride ourselves in our “interpretations” of laws, contracts, and transcripts.  But, we don’t like to call it “twisting.”  Rather, we are enaging in a “semantic exercise.”

Recently, in Schilf v. Eli Lilly & Co., No. 11-2082, 2012 WL 3139233 (8th. Cir. Aug. 3, 2012), the Eighth Circuit put on a fine display of its own expertise in the linguistical arts.

In that case, the Schilfs filed suit against Eli Lilly and Quintiles Transnational, alleging that Lilly’s failure to warn of a link between an anti-depressant and suicide caused the death of their teenage son.  The 16-year old boy visited his family doctor in November 2004 to discuss his depression.  The doctor gave the boy samples of the antidepressant, Cymbalta.  The medication had been removed from the packaging and, thus, lacked any warnings.  When dispensing the samples, the doctor informed the boy that there may be an increased “association” with anti-depressants and suicidal ideations, but “no completed suicides” occurred during the clinic trials.  The boy began taking the drug and committed suicide a few weeks later.  Thereafter, Lilly revised the literate for Cymbalta to include an FDA-approved black box warning.

The district court granted Lilly’s motion for summary judgment, holding (1) that a warning would not have informed the doctor of anything he did not already know and (2) that the doctor would have prescribed the drug even if he knew of the actual risks.  The Eight Circuit disagreed with both points.

Now, here comes the Olympic-esque semantic exercise.  As to the first point, the Eighth Circuit found that a warning could have pointed the doctor to more knowledge of the drug.  According the Court, the doctor was not aware of a “causal link” between Cymbalta and suicide, but, rather, an “association.”  In support, the Eighth Circuit pointed to the doctor’s deposition testimony, in which he stated that was aware of an FDA study finding such an association, but believed the FDA wasn’t “saying the risk was there.”  Under South Dakota law, warnings of side-effect associations are typically not warnings of causal connections.

Contrary to the doctor’s belief, the FDA press release did, in fact, find a causal connection.  The district court found that the doctor “read” this release and, thus, knew of the risks.  The Eighth Circuit pointed out, however, that the doctor only testified that he was “aware” of its existence. Clearly, a distinction.

On the second point, the district court based its finding on some testimony that the doctor still believed his prescription decision was appropriate.  Not so fast!  Being such fine stewards of the English language, the Eighth Circuit examined the testimony a little more closely.  When asked if there was anything he would differently, the doctor actually answered, “Not at the time.  I did – I did exactly what I would have done.”  “Not at the time” being the operative phase.  If he didn’t know of the suicide related information, he clearly wouldn’t have had reason to alter his decision.

If we were judges, we would have to give the Eighth Circuit high technical marks for its linguistic efforts.  However, instead of lecturing the district court on its interpretation of a deposition transcript, we would still would appreciate some more guidance on that whole failure to warn issue.

Federal Hazardous Substances Act Preempts Recovery on Failure to Warn Claim in Fire Death Case

Last month’s Mwesigwa v. DAP, Inc., —F.3d—, 2011 WL 1584760 (8th Cir., April 28, 2011) [PDF] centered around the warnings on a can of DAP Weldwood Gel Formula Contact Cement. The cement is a construction adhesive, and the can looks harmless enough:The warnings on the can, however, tell a different story and were cited extensively by the Court, which described the instructions as follows:

“WARNING! FLAMMABLE! VAPORS HARMFUL AND MAY CAUSE FLASH FIRE” and “BEFORE USE TURN OFF MAIN GAS VALVE.” The lid further instructs the user to keep the product away from heat, electrical sparks, and flame; to shut off pilot lights; to refrain from smoking; to prevent buildup of vapors by opening windows and doors; and to shut off stoves, heaters, and appliances. In addition, the lid depicts an open can with vapors emanating toward a cigarette labeled “smoking,” a gas valve labeled “gas,” a flame labeled “flame/heat,” and electrical volts labeled
“electricity/sparks.” Each of the four pictures contain a bold red line crossed through the black-and-white image.The can further includes “Precautionary measures for use, handling, storage and disposal”:Use in a well ventilated area. Provide fresh air such that chemical odors cannot be detected during use and while drying. Vapors are heavier than air and will collect in low areas. Check all low areas (basements, sumps, etc.) for vapor before entering. Vapor may ignite explosively. Keep away from heat, sparks, and flames. Do not smoke. Extinguish all flames and pilot lights. Turn off stoves, heaters, electric motors and other sources of ignition during use and until all vapor is gone. Keep container closed when not in use. Do not reuse the empty container. Do not use in areas where static electric sparks may be generated. Empty container may contain explosive vapors. Do not weld, cut or torch on or near this container. Store away from oxidizers and caustics. Wear gloves. Avoid skin contact. Wear eye protection with side shields.


Obviously, when not handled properly, this product can have grave consequences. The plaintiff’s decedent in this case unfortunately learned this fact first-hand. He purchased a can to install new baseboards in his house, and accidentally spilled some of it in his laundry room. When he went to wipe it up, the vapors ignited and caused a flash fire. Mr. Mwesigwa suffered extensive burns and died because of his injuries. His widow and children sued the manufacturer, DAP, for (1) wrongful death on theories of negligence, strict liability, and failure to warn; (2) for negligent misrepresentation; and (3) for violations of the Consumer Product Safety Act. The district court granted summary judgment in favor of DAP. The plaintiffs appealed the summary judgment on the wrongful death failure to warn claims.

DAP’s product is a hazardous substance sold for household use, and therefore, falls under the purview of the Federal hazardous Substances Act (FHSA). The FHSA requires such products to “bear adequate cautionary labels,” but, as the Court pointed out, the statute also preempts any failure to warn claims based on an argument that the label should have included particular warnings not required by the FHSA. Rather, the only claim that the plaintiffs could bring would be an allegation that the label did not comply with the FHSA.

The plaintiffs attempted to assert that the label did not comply with the FHSA because it failed to warn that one of the principal hazards of the cement was the risk of fire from an accidental spill, separate and apart from the general flammability. “Principal hazard” is a defined term under the law, meaning “the principal or primary hazard(s) associated with a hazardous substance.” The Court affirmed the grant of summary judgment as to this argument, since “the risk of fire from an accidental spilling of DAP cement is not a principal hazard that the FHSA requires the label to state affirmatively.”

The plaintiffs also argued that the label failed to state that, in the event of a spill, the product should not be wiped but absorbed with an inert absorbent. The Court also rejected this argument because “the FHSA does not require the DAP cement label to warn consumers against spreading the product after a spill as a precautionary measure.” The term “precautionary measures” is referred to under the statute as steps needing to be followed to avoid or minimize the “principal hazard” of the product.

The Court did a nice job summarizing its findings in this way: “The label complies with the FHSA because the principal hazard to be avoided is flammability, and the way to avoid that hazard is to remove all potential ignition sources.” Because the extensive labeling on the can of DAP complied with those requirements, summary judgment was affirmed as to the failure to warn claims.

Side note: DAP cement apparently also comes in a non-flammable version:

Expert Witness Testimony: The Difference Between Testing Scientific Principles and Determining Cause

We can’t resist writing about recent judicial opinions in which a Plaintiffs’ expert is excluded, and last month, the Eighth Circuit affirmed a lower court’s decision to do just that. In Dunn v. Nexgrill Industries, Inc., —F.3d —, 2011 WL 668062 (8th Cir. Feb. 25, 2011) [PDF], the Eighth Circuit considered whether the trial court abused its discretion when excluding the testimony of an expert witness as well as the trial court’s granting of the defendant’s summary judgment motion. In so doing, the Eighth Circuit held that 1) the district court did not abuse its discretion in excluding the Plaintiffs’ expert’s testimony, and 2) that without the expert testimony, the plaintiffs could not establish that the grill was unreasonably dangerous or defective. As a result, the Court affirmed the trial court’s rulings.

Thomas and Thelma Dunn filed a complaint against Nexgrill Industries, Inc., the designer, manufacturer, and seller of a propane grill they claim caused a fire at their home. They claimed that the grill was defectively designed, such that the grease tray came into contact with the rubber regulator hose, which melted and allowed propane gas vapors to escape and ignite.

To prove their case, the Dunns presented the testimony of purported expert Randy Bicknese. He attended the initial investigation into the cause and origin of the fire, which determined that the fire originated in the bottom cabinet of the grill and was caused by the escape of propane gas from the fuel delivery system. Bicknese also conducted additional tests by using a used grill of the same make and model, since the specific grill at issue was no longer manufactured. In his affidavit, Bicknese stated that the purpose of the testing was as follows:

. . . to establish certain scientific principles: (1) to determine whether or not the propane hose can deteriorate sufficiently to leak when in contact with the grease tray during grill operation; (2) to determine if propane leaking from the deteriorated hose can be ignited by the operating burner; (3) to determine if a propane hose fire in the cabinet can be sustained after the burner controls are turned off; (4) to determine if a propane hose fire in the cabinet is readily detectable from outside the grill with the grill lid open and the cabinet door closed; (5) to document the operating characteristics of the grill’s propane distributing system; (6) to determine the consumption rate of the propane hose as a result of the ignited leak.

Bicknese also performed a subsequent round of testing, after which he reported that “the second test continued to support his theory that the fire was the result of the deterioration of the rubber propane hose caused by contact with the heated grease tray.”

Nexgrill filed a motion to exclude Bicknese’s testimony and testing, which was granted because in the opinion of the district court the testing “was done to recreate the fire at the Dunns‘ residence to determine the cause of the fire, not to test scientific principles.” The court further concluded that the test was not substantially similar to what happened during the fire at the Dunns‘ house. After the court excluded Bicknese’s evidence, Nexgrill filed a motion for summary judgment, which was also granted.

The Eighth Circuit affirmed the ruling, finding that the district court had not abused its discretion. As that court noted, “The Dunns‘ main argument is that the tests were conducted to test scientific principles and Bicknese’s hypothesis, not to show exactly how the accident occurred.” Although the line between these two testing principles is “very difficult to draw,” the Eighth Circuit determined that it was unable to say that the lower court abused its discretion.

Without expert testimony, the Dunns were in a real pickle in terms of proving that the grill was actually defective. They tried the only route they had left: they argued that they should be allowed to present circumstantial evidence of the products defect, despite the fact that they failed to plead res ipsa in their complaint. The Eighth Circuit prohibited this type of proof not only because of the improper pleading, but also because “grills are designed specifically to ignite,” and therefore, the fact that the grill actually ignited did not prove a defect. As a result, the Eighth Circuit affirmed summary judgment for Nexgrill.

Medical Expert’s Testimony Deemed Incompetent, Not Sufficiently Fact-Based

We here at Abnormal Use are here to help. Over at the Drug and Device Law blog, author David Walk directs his readers’ attention to a new Eighth Circuit case about which he could not fully comment due to his firm’s involvement in that case. In light of that, and in the spirit of blogging collegiality, we thought we would do our own summary and analysis of the new opinion.

The facts are these: Plaintiff feels fine; Plaintiff takes prescription medication to reduce his cholesterol; Plaintiff develops symptoms of pain and fatigue. Such facts do not proof of causation make, the Eighth Circuit Court of Appeals affirmed. In re Baycol Products Litigation, —F.3d—, No. 08-3524, 2010 WL 711972 (8th Cir. March 3, 2010) [PDF]. In that case, the appellate court upheld summary judgment in favor of the drug-manufacturer defendant. In so doing, it held that the mere fact that a plaintiff developed physical symptoms in the months following his consumption of a defendant’s drug is insufficient to support a medical expert’s opinion that the drug was responsible for the onset of those symptoms.

The plaintiff was prescribed Baycol in February 2001 after being diagnosed with high cholesterol. On March 15 of that year, he began complaining to his doctor of general body pain and fatigue and of localized lower body pain. His complaints continued throughout July of 2001. In August, after taking the drug for approximately five months, the plaintiff discontinued his use of the drug after reading in the newspaper that Bayer had withdrawn Baycol from the market. He thereafter sent a letter to his doctor, in which he opined that Baycol was the cause of his symptoms. A subsequent blood test did reveal that the plaintiff had increased levels of creatine kinase, which is one indication of the presence of myopathy.

The plaintiff filed suit, alleging theories of strict liability, negligence, breach of express and implied warranties, and unjust enrichment. The court noted that it was the plaintiff’s burden, pursuant to his strict liability and negligence claims, to prove causation through the use of a medical expert. He essentially offered two. The first of those was in the form of “various generic causation experts” who would testify that Baycol was capable of causing myopathy. The report of the second expert garnered the most attention from the court. In it, the expert opined in what the court regarded as “conclusory remarks,” that causation was established because: (1) the pain was of new onset; (2) he had no other explanation for the injury; (3) the pain was “reasonably contemporaneous” with the plaintiff’s ingestion of Baycol; and (4) the pain didn’t get worse after he stopped taking the drug.

The court held that such conclusory remarks of “temporal association,” without sufficient evidentiary support, were wholly insufficient to prove that the defendant’s conduct contributed to the plaintiff’s injury. The court upheld entry of summary judgment in favor of Bayer on the basis of the plaintiff’s failure to present competent expert testimony on the issue of causation.

The court’s analysis with regard to these expert witness issues may provide ammunition for defendants during preliminary stages of litigation. It certainly highlights the importance of attacking the sufficiency of expert reports and of demanding competent, factually based testimony that creates triable issues of fact.