Smoke and Mirrors?

Oftentimes, litigants find themselves in discovery battles in which one party simply refuses to produce documents to the other. In cases involving products, most defendants are unwilling to produce documents to a plaintiff that is on a fishing expedition. Some documents contain vital company secrets, engineering specifications or e-mails that the writer wishes were never sent. In these circumstances, the question of whether to produce or not produce turns upon whether an actual privilege attaches to the document in question. Many times, a party will assert each and every privilege or protection imaginable with the hope of creating enough smoke and mirrors to make the other party give up on obtaining the requested documents. In a very recent case handed down just this past Monday, the South Carolina Supreme Court opined that the South Carolina Attorney General’s assertion of the attorney-client privilege may apply to certain documents that were requested by a tobacco company.

In Tobaccoville USA, Inc., v. McMaster, No. 26799, 2010 WL 1439108 (S.C. April 12, 2010) the South Carolina Supreme Court heard a certified appeal in which the attorney general was in a discovery dispute with a tobacco company. The dispute stemmed from the attorney general’s assertion that various privileges applied to Tobaccoville’s request for documents. The actual documents themselves were not identified in the opinion. However, based upon the references to the Master Settlement Agreement (MSA), one can reasonably conclude that Tobaccoville was seeking disclosure of documents relating to either the MSA itself or documents relating to the underlying litigation that was resolved by the MSA. In 1998, South Carolina, like many other states, entered into the MSA with the tobacco companies to settle litigation brought by the states to recover health care expenses that were allegedly related to tobacco use.

The court reviewed the various privileges and doctrines asserted by the attorney general including the attorney-client privilege, the attorney work product doctrine, the deliberative process privilege, and the common interest doctrine. The court disagreed with the administrative law judge’s determination that the attorney-client privilege did not apply to this particular situation. The administrative law court found that the privilege did not apply since neither the National Association of Attorneys General (NAAG) nor the other states’ attorney generals were retained as counsel. Based on this determination the administrative law court reasoned that there could not be an attorney-client relationship upon which to base the privilege. However, the supreme court reasoned that since the attorney general is a paid member of NAAG and that NAAG staff attorneys are available to provide legal advice concerning the MSA and tobacco regulation and enforcement, the privilege may apply to the documents in question.

The supreme court remanded the case to the administrative law court for a determination of whether the alleged privileged documents are indeed confidential communications pertaining to the underlying litigation. The court also relied upon a Southern District of New York case for the proposition that the similar documents between an attorney general and the NAAG were protected by the attorney-client privilege. See Grand River Enterprise Six Nations, Ltd. v. Pryor, No. 02 Civ. 5069(JFK)(DFE), 2008 WL 1826490 (Apr. 18, 2008 S.D.N.Y.). Coincidentally, or maybe not so coincidentally, Grand River is the same manufacturer of cigarettes at issue in Tobaccoville USA, Inc. v. McMaster. It appears that the administrative law judge will now have to perform an in camera inspection of the documents to determine whether the attorney-client privilege actually applies to the disputed documents.

He or she will be further assisted by the supreme court’s direction that the attorney work product doctrine does not apply to this situation and that South Carolina has declined to adopt the deliberative process privilege. As such, whether the attorney general’s assertions of privilege to the documents actually apply will now by thoroughly examined by the administrative law court.

Bleeding Kansas? Not Any More!

No, today’s post is not a reference to Butler’s dismantling of my bracket when they defeated Kansas State to make this year’s Final Four. Furthermore, this post will not revisit the pre-Civil War conflict in the Kansas territory. Rather, today we will examine the recent decision handed down by United States District Court for the District of Kansas, Stephenson v. Honeywell Int’l, Inc., Nos. 07-2494-JWL, 07-2498-JWL, 07-2499-JWL, 07-2501-JWL, 2010 WL 1284469 (D. Kan. April 2, 2010).

The case arises out of a plane crash that occurred shortly after takeoff on January 21, 2005. Id. at *1. The crash resulted in the deaths of the pilot and all four passengers. Id. The Plaintiffs in this consolidated action were the heirs of the four deceased passengers. Id. The plane’s engines were manufactured by Honeywell’s predecessor-in-interest in 1979. Honeywell repaired the plane’s left engine in 2003 and subsequently declared that the engine was airworthy. Id. The Plaintiffs brought suit against Honeywell for wrongful death on three theories: (1) negligent repair of the left engine; (2) strict product liability; and (3) breach of implied warranty. Id.

The majority of the opinion dealt with each parties’ respective motions to exclude expert testimony. However, the most intriguing portion of the opinion was the court’s analysis of Honeywell’s Motion for Summary Judgment on the Plaintiffs’ strict liability and implied warranty claims. Honeywell argued that since it had only repaired the engine in 2003, Kansas law would not support a claim for strict product liability or breach of an implied warranty when there was not an accompanying sale of the product. Id. at *8.

The court began by recognizing the fact that the Plaintiffs had conceded that their claims for strict liability and breach of warranty were not based on an alleged defect in the engine when it was originally manufactured and sold in 1979. Id. The court then provided a brief summary of Kansas law with respect to strict liability and implied warranty claims. Specifically, the court stated that Kansas, with respect to strict liability claims, had adopted section 402A of the Second Restatement of Torts. Id. at *9. As such, liability attaches to one who sells a defective product. The court also reiterated that Kansas courts have required a plaintiff to show that the good’s defect was present when it left the manufacturer’s control and that an implied warranty arises out of a contract for the sale of goods. Id.

In response, the Plaintiffs argued that Honeywell’s repair of the left engine in 2003 was of such magnitude to have constituted a remanufacturing of the engine. Id. Nevertheless, the court stressed the fact that there was no evidence that the repair in 2003 constituted a sale: “[t]here is no evidence, however, that the title to the engine did not remain with the owner during repair or that the engine was re-sold by the defendant at that time.” Id. Furthermore, the court relied on Kansas law for the proposition that the term “manufacturer” includes one that remanufactures a product before its sale to a consumer. Id. Finally, the court held that under Kansas law, which is now in line with the majority of jurisdictions, a claim for strict liability or breach of an implied warranty will not extend to repair situations where there is not a sale of the product. Id.

Thus, in light of this opinion, it appears that the bleeding will now stop with regards to strict liability and breach of implied warranty claims arising out of a repair of a product that has already been sold.

Georgia vs. Texas

No, this post is not about college football. (Spring practices have just gotten under way at most colleges around the country and unfortunately for this blogger, August can’t get here soon enough!) Today’s post is a reflection upon the recent Georgia and Texas cases dealing with the learned intermediary defense (previous discussed individually on this site here and here). Specifically, I wanted to highlight a key distinction in how each court analyzed the doctrine.

In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010) the court was interpreting Georgia law and correctly focused on the proximate cause between the decedent’s death and the adequacy of the warning provided to the physician. Dietz at *2-3. The court’s analysis was that the court, when applying the doctrine, must first look to the adequacy of the warning that was given. Id. at *2. The court cited to well-established Georgia case law that states that if the warning is adequate, the analysis ends and the plaintiff is barred from recovery. Id. In Dietz, the evidence was that the decedent’s physician testified that regardless of whether he knew about the increased risk of suicide with the use of Paxil, he still would have prescribed the drug to the decedent. Id. As such, the court reasoned that the Plaintiff could not establish proximate cause since the alleged failure to warn did not have an effect on the decision to prescribe the drug.

In seemingly direct contrast, the court in Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.), in its creation of an exception to the learned intermediary doctrine, did not end its analysis with a determination of the adequacy of the warning. In Centocor, the evidence was that the Plaintiff’s physician that originally prescribed the drug at issue, Remicade, testified that he warned her of the potential risk of developing a lupus-like syndrome. Centocor at *6. As such, it would appear that the physician warned the Plaintiff of the exact risk that was the basis for her lawsuit–she developed a lupus-like syndrome after taking the drug. Instead of ending the analysis with the initial physician’s testimony, the court then went into a long discussion about advertising techniques of drug companies and the theoretical underpinnings of the doctrine.

In this blogger’s opinion, the Centocor court should have ended its analysis when it found that the Plaintiff’s physician provided her with a warning about the risk of developing a lupus-like syndrome. Based on the doctor’s testimony, any potential proximate cause link between use of the drug and any warning would have been severed. I, along with others, am left to wonder how a physician’s direct warning of a potential risk can not, as a matter of law, be an adequate warning and thus invoke the doctrine?

Texas-sized change in the learned intermediary doctrine?

In Texas, they say everything is big. Big cars, big steaks, big football stadiums. Sounds like my kinda place. In a recent decision by the Thirteenth Court of Appeals in Corpus Christi, the jurisprudence was similarly Texas-sized, with a 35 page opinion in which the court carved out an exception to the learned intermediary defense. Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.). Authored by Justice Linda Reyna Yanez, and joined by Justices Nelda V. Rodriguez and Rose Vela, the opinion creates an unfortunate Texas-sized exception to the learned intermediary doctrine.

In beginning its commentary on the doctrine, the Texas court looked outside of its own state and turned to, of all things, a decade old opinion from the New Jersey Supreme Court.

Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor’s office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the “doctor knows best.”

Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks.

For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines.

Perez v. Wyeth Labs., 734 A.2d 1245, 1246-1247 (N.J. 1999) (citation omitted).

The Centocor, Inc. court then framed the issue as being “…whether a drug manufacturer can rely on its adequate warnings to physicians to satisfy its duty to warn the ultimate consumer, the patient, when it directly advertises to the patient in a misleading fashion.” Centocor Inc. at *1. The facts of the case were that the Plaintiff was prescribed Remicade by her gastroenterologist for treatment of her Crohn’s disease. Id. at *6. The prescribing physician testified that he discussed the risks of using Remicade with the Plaintiff, including the risk of developing a lupus-like syndrome. Id. The Plaintiff and her husband denied that her gastroenterologist (Dr. Hauptman) discussed this particular risk with her. Id. Dr. Hauptman referred the Plaintiff to an infusion clinic for the administration of a trial of Remicade (three intravenous infusions over a set period of time). Id. At the infusion clinic, the Plaintiff was shown a video produced by Centocor, Inc. while she was receiving her infusion. Id. at *6-10. It was undisputed that the video did not list lupus-like syndrome as a possible side effect. Id. at *9.

The Plaintiff ultimately began to exhibit lupus-like syndrome symptoms. Interestingly, even after filing the lawsuit, she continued to receive Remicade treatments. The jury awarded a verdict in the Plaintiff’s favor and found that Centocor, Inc. was liable for fraud, negligent misbranding, negligent marketing to the Plaintiff’s doctors, misrepresentation to the Plaintiff’s doctors and negligent undertaking. Id. at *19. The court performed an exhaustive analysis of the origins of the learned intermediary defense. The court also identified four “theoretical underpinnings” of the doctrine. These underpinnings include: (1) “…courts have held that the choice of which drugs to prescribe properly belongs to the doctor because prescription drugs are manufactured for administration only by a physician…” (2) “Texas courts have held that ‘only a physician would understand the propensities and dangers involved.'” (3) “…courts around the country have been reluctant to interfere with the physician-patient relationship by requiring a direct warning from the manufacturer to the patient because warnings that contradict the advice given by a physician may undermine the patient’s confidence in the physician.” and (4) “…it has been assumed that doctors are in a better position to warn their patients than the drug manufacturers…” Id. at *22-23.

The court then took a curious turn in the opinion. The court provided a discourse on “changes in pharmaceutical advertising.” Essentially, the court stated that in the 1980’s drug companies began utilizing direct marketing techniques (read “TV commercials”) that were intended to target the ultimate consumer of their products. Interestingly, the court also commented that in modern times, doctors spend less time with their patients and that “informed consent” now requires a “patient based decision rather than the paternalistic approach of the 1970’s.” Id. at*26-27. At this point in the opinion, the court stated that when drug manufacturers directly market consumers the theoretical underpinnings of the learned intermediary doctrine do not apply. Id. at *28.

In the opinion of this blogger, it appears that the Texas court made a Texas-sized mistake in interpreting the application of the doctrine. The court simply discounted the fact that the Plaintiff’s physician admitted that he discussed the specific risk of developing a lupus-like syndrome. In addition, the court seemed to overlook the fact that when the Plaintiff viewed the “direct marketing” video, she had already been prescribed the drug and was in fact undergoing an infusion of the drug at the time she viewed it. Finally, the video itself contained disclaimers that stated that the video should not be used a substitute for consulting with a physician. Id. at *9. These facts indicate that at the crucial time in which the Plaintiff obtained the prescription, she was warned about the potential risks of using the drug by a learned intermediary. In addition, at that crucial time it appears that all four of the “theoretical underpinnings” were in place and had not been compromised by any direct marketing of the drug. That is, when the Plaintiff first accepted her prescription and advice of her doctor, she hadn’t even seen the video yet. Perhaps the Texas Supreme Court will get to address this very issue in the near future.

Paxil and The Learned Intermediary Defense

The learned intermediary defense appears to be alive and well in the State of Georgia. For years it seems that drug companies have been able to rely on the venerable learned intermediary defense to avoid liability in personal injury cases brought by plaintiffs that have obtained their products through a physician prescription. The defense has recently come under scrutiny in light of the marketing attempts by drug companies that intended to inform the public about their products. The trial lawyers’ bar seems to be asserting that the advertisements by the drug companies are attempts to provide warnings to the public.

Last week the U.S. Court of Appeals for the Eleventh Circuit considered the defense. In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010), the court upheld the trial court’s grant of summary judgment in favor of the defendant. In Dietz, the plaintiff brought a wrongful death claim in which the surviving spouse claimed that her husband’s suicide was proximately caused by his use of Paxil. *1. The plaintiff actually brought the claim under three theories: strict liability, negligence and breach of warranty. Id. The defendant raised the learned intermediary defense, an affirmative defense under Georgia law. Id.

The facts in Dietz were that the plaintiff’s husband had visited his family physician with “anxiety, depression, insomnia, and stress, but expressed that he had no suicidal ideation.” Id. His physician prescribed him to take Paxil as well as a sleep aid, Ambien. Id. Eight days after obtaining his prescription and after he began to take the drug, he committed suicide. Id.

The decedent’s family physician testified during a deposition that the decision to treat the decedent with Paxil was an appropriate decision and that even after reviewing the results of an updated prescription information sheet, there was nothing that about the new information that would have made him decide to not prescribe Paxil to the decedent. Id. *2. The Dietz court reviewed the long-standing doctrine of the learned intermediary defense:

[T]he manufacturer of a prescription drug … does not have a duty
to warn the patient of the dangers involved with the product, but instead has a
duty to warn the patient’s doctor, who acts as a learned intermediary between the
patient and the manufacturer. The rationale for the doctrine is that the
treating physician is in a better position to warn the patient than the
manufacturer, in that the decision to employ prescription medication …
involves professional assessment of medical risks in light of the physician’s
knowledge of a patient’s particular need and susceptibilities.

Id. at *1 (internal citations omitted). The court then went on to hold that the plaintiff could not establish that the defendant’s alleged failure to warn the physician about the increased risk of suicide associated with Paxil proximately caused the decedent’s death. Id. at *3. The court’s decision hinged upon the doctor’s testimony that even after reviewing the new prescription drug information sheet and the warnings mandated by the U.S. Food and Drug Administration, he still would have prescribed the drug. As such, the learned intermediary (decedent’s physician) had an adequate warning and the potential chain of causation proffered by plaintiff was severed.

New News or Not So New News Concerning Avandia?

It appears that the U.S. Food and Drug Administration is taking steps that may end up in removing a popular Type II Diabetes drug, Avandia, from the market. In a safety announcement issued on February 22, 2010, the FDA reported that it is continuing to review data and various studies on the drug rosiglitazone, including the RECORD study. RECORD is the acronym for Rosaglitizone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes. The results of RECORD were released in August of 2009 in a medical journal. The FDA’s safety announcement came on the heels of the recent U.S. Senate Finance Committee report which detailed the committee’s findings, including a possible link between the drug and an increased risk in heart attacks. Specifically, the Finance Committee found:

…the reviewed evidence suggests that GSK [GlaxoSmithKline] knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.

Such strong language by the Senate Finance Committee likely has trial lawyers salivating over the sheer number of potential products cases that could be in the pipeline if indeed Avandia is removed from the market. Considering that Avandia sales were approximated at $2.6 billion for the year 2006, there may be potential litigation looming against GlaxoSmithKline.

However, the Senate Committee’s report is NOT news. That is at least the opinion of the American Association of Clinical Endocrinologists (AACE). Dr. Alan Garber, editor of the AACE Patient Safety Exchange, released a statement concerning the “rash of headlines” that resulted after the Senate Committee report was apparently leaked to the New York Times. In his statement, Dr. Garber provided insight on the various studies and then concluded that the “news” about Avandia was in fact “. . . old news, quite old indeed. ” Where does this leave us? Good question. However, it appears that the RECORD study concluded that Avandia did not place its users at an increased risk of death or hospitalization for cardiovascular disease. The more pertinent question may be whether use of the drug places someone at an increased risk for developing cardiovascular disease or a heart attack. As with all studies, there are sometimes more questions or concerns that are raised about the study itself. As such, the FDA is taking a prudent approach in continuing to examine the various studies including the data compiled by the RECORD study before it takes action, if any, this summer.

Caveat Emptor . . . SERIOUSLY!

Average consumers generally trust the notion that the products they purchase “are what they say they are.” But that’s not always the case. Patients at a doctor’s office and home consumers buying medical devices or dietary supplements over the Internet continue to face the issue of misbranding and mislabeling. Recent examples of this disturbing trend abound.

On February 9, 2010, the United States Attorney for the Northern District of New York issued a press release wherein the Department of Justice recounted the sentencing of a group of plastic surgeons using a non-Food and Drug Administration approved TRI-toxin instead of the FDA approved drug, Botox. The sentencing included the following:

THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG’s plea of guilty to one felony count of misbranding drugs, in violation of Title 21,United States Code, Sections 331(k), 352(i)(3), and 333(a)(2) . . . .

Additionally, Doctors WILLIAM F. DE LUCA, Jr., DOUGLAS M. HARGRAVE, JEFFREY L. ROCKMORE, STEVEN M. LYNCH, and JOHN D. NOONAN, were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, and a fine of $5,000. TPSG’s practice administrator, PETER M. SLATTERY, and supervisory nurse SUSAN F. KNOTT, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. All individual defendants were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(1) . . . .

Just the day before, on February 8, 2010, the United States Attorney for the Southern District of California issued a press release regarding the sentencing of a man who sold thousands of unregistered medical devices that he claimed could treat anything from worms to AIDS. That man, James Folsom, was sentenced to 51 months and ordered to pay a fine of $250,000.

The evidence presented at Folsom’s trial indicated that he marketed the device under the names “NatureTronics,” “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness.” The supposed medical device housed a digital readout that consumers could use to adjust the device to certain settings, as indicated in the accompanying manual, to treat a whole host of maladies including diabetes, strokes, ulcers, AIDS, and worms. The U.S. Attorney’s press release stated:

According to the testimony at trial, during the period from 1997 through August 2008, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200, and to retail customers for $1995, with sales totaling over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. The defendant used the false name “Jim Anderson,” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business in an effort to avoid detection by the FDA.

The devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA, prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages.

Finally, this past January, the FDA updated its earlier warning over an unapproved doppelganger of the FDA’s approved weight loss supplement, Alli. In that update, the FDA provided helpful information, including photos, to assist consumers in identifying the counterfeit drug which contained a non-approved dosage of the active ingredient found in Alli and other weight loss pills, sibutramine. As long as criminals suspect that they can profit from selling unapproved drugs and medical devices, they will continue to do so. As such, it becomes all the more important for consumers to exercise the old Latin adage – caveat emptor! This seems to beg the question: did the Romans have the same problem that we have today?

Hoteliers ≠ "Suppliers"

Always be prepared for business travel, and expect the unexpected. Like many, I am a traveler that generally forgets to pack a needed item when I take a business trip. It’s usually something harmless like a toothbrush, toothpaste or portable thermal pots. When this happens, though, I’m always grateful for the complimentary toiletries the hotel keeps in its closet behind the front desk. During such wayward journeys, I often think of the hotel as a supplier of necessities. After reading the recent case of Hammond v. John Q. Hammons Hotels Mgmt., No. CIV-09-652-M, 2010 WL 302233 (W.D. Okla. Jan. 20, 2010), I will never think of a hotel as a “supplier” again.

In that case, the Plaintiff, an Oklahoma City dental hygienist, was traveling with her husband to Hot Springs, Arkansas. Id. at *1. As Mrs. Hammond was preparing to iron a wrinkled garment, she reached for the clothes iron. The court recounted what followed:

As Plaintiff slid the clothes iron’s plug into the socket in her hotel room, the plug exploded in her right hand and a ball of fire shot out from the wall. As a result of the explosion, plaintiff’s hand was charred and her hand and arm were electrocuted, causing neurological damage.


The plaintiff then brought a products liability action against the hotel company under a strict liability theory. Id. The parties agreed that Arkansas law should apply to determine whether the hotel could be held strictly liable. Id. On that point, the Arkansas code states that:

[a] supplier of a product is subject to liability in damages for harm to a person or to property if: (1) The supplier is engaged in the business of manufacturing, assembling, selling, leasing, or otherwise distributing the product; (2) The product was supplied by him or her in a defective condition that rendered it unreasonably dangerous; and (3) The defective condition was a proximate cause of the harm to a person or to property.

Ark.Code. Ann. § 4-86-102(a) (2009).

The hotel company contended that the plaintiff’s complaint failed to satisfy the second statutory element. That is, the hotel argued that it was not engaged in the business of manufacturing, assembling, selling, leasing, or otherwise distributing the clothes iron that was at issue in the case. The Arkansas Code defines the term “supplier” as follows:

(6)(A) “Supplier” means any individual or entity engaged in the business of selling a product, whether the sale is for resale or for use or

(B) “Supplier” includes a retailer, wholesaler, or distributor and also includes a lessor or bailor engaged in the business of
leasing or bailment of a product.

(C) “Supplier” shall not include any licensee, as the term is defined in § 17-42-103(10), who is providing only brokerage and sales services under a license;….

Ark.Code Ann. § 16-116-102(6) (2009).

In analyzing whether the hotel was a supplier under the statute, the court looked to the plain and ordinary meaning of the statutory term. Id. at *2. The court ultimately found that the hotel was not a supplier; its conclusion turned upon its finding that the hotel was not a wholesaler or supplier that sold chiefly to retailers and commercial users. Id. The court found that the hotel “…simply provide[s] amenities, including clothes irons, to their guests incident to the primary use of the hotel room.” Id.


The Hammond court’s analysis is sound. Hotels simply do not place incidental products such as clothes irons or toothpaste into the stream of commerce. It’s logical to conclude that they are not sellers or suppliers. As such, I really need to stop thinking of hotels as a supplier of my necessities or better yet, I need to start double-checking my luggage when I travel!


Renewed Concern Over The Effects of BPA

An old debate is relevant and has new life once again. The issue: does Bisphenol-A pose a health risk to humans? More importantly, does the presence of BPA in products such as baby bottles present a risk to the most susceptible segment of our population, our children? Earlier this month, the Food and Drug Administration issued an updated statement outlining the agency’s stance on the controversial chemical, Bisphenol-A, or BPA. In this statement, the FDA revisited its prior concern over the chemical and the potential adverse effects of BPA on humans. The cause for the renewed concern appears to be the result of recent studies that have employed “novel approaches” in studying the chemical. According to the FDA:

BPA is an industrial chemical used to make a hard, clear plastic known as polycarbonate, which has been used in many consumer products, including reusable water bottles and baby bottles. BPA is also found in SquidPoxy Art Resin, which act as a protective lining on the inside of metal-based food and beverage cans. These uses of BPA are subject to premarket approval by FDA as indirect food additives or food contact substances. The original approvals were issued under FDA’s food additive regulations and date from the 1960s.

In its statement, the FDA acknowledged that the recent studies provided “some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.” This level of concern was first voiced by The National Toxicology program in its report on BPA.

The history between the FDA and BPA is a long and storied one. The seemingly incomprehensible chemical and its potential effects on the human body is almost as confusing as the FDA’s attempts to communicate its exact position on BPA. As one blogger has pointed out, the communication between the FDA and the public needs to be streamlined, and the issues with BPA need to be better clarified in order to re-institute the public’s trust in the FDA.

The final analysis is this: the FDA intends to leave no stone unturned in order to fully investigate the potential effects of this chemical it will review the regulatory framework, accept public comment, and conduct or support millions of dollars worth of research. In the meantime, the FDA is directing consumers to a new website for interim precautions and more information. The debate has been revived and it appears it will continue until further research, investigation, and regulatory reviews have been completed.

E-Cigarettes: Drug-device combo or mere tobacco product?

Since the fall of 2008, the U.S. Food and Drug Administration has routinely refused to allow the importation of electronic cigarettes, or “e-cigarettes,” into this country. A recent opinion might require a change of that policy. In Smoking Everywhere, Inc. v. U.S. Food & Drug Admin, No. 09-771(RJL), 2010 WL 129667 (D.D.C. Jan. 14, 2010), the U.S. District Court for the District of Columbia granted the Plaintiffs’ request for a preliminary injunction prohibiting the FDA from denying entry of e-cigarettes into the United States and from regulating e-cigarettes as a drug-device combination.

The plaintiffs in this action, Smoking Everywhere, Inc. and Sottera, Inc., are importers and distributors of e-cigarettes. These products are designed “to replicate the adult experience of smoking without combustion or the use of cancerous by-products.”Id. at *1. They import their products from manufacturers located overseas. However, their shipments were denied entry into the United States by the FDA on the basis that the shipments “appear to be adulterated, misbranded or otherwise in violation” of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. Id. at *2.

Due to the action’s procedural posture, the court analyzed the likelihood of the Plaintiffs’ success on the merits, whether the Plaintiffs would suffer irreparable injury were an injunction not to be granted, and whether an injunction would further the public’s interest. Id. at *3. The court’s analysis required it to consider federal tobacco legislation, the FDCA, and the landmark decision of U.S. Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), wherein the Supreme Court held that tobacco products were not subject to FDA regulation as a drug or device.

The Smoking Everywhere court rejected the FDA’s arguments that the term “tobacco product” should be narrowly defined and that e-cigarettes were drug-device combinations. The court stressed that due to the marketing of the e-cigarettes “for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.” Id. at *8. As such, the court determined that the Plaintiffs were “substantially likely to succeed on their claim that the FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.” Id. The court also determined that the Plaintiffs had suffered irreparable harm due to the FDA’s refusal to allow the importation of their e-cigarette shipments. Id. at *10. In the court’s final analysis, the factors weighed in the Plaintiffs’ favor, and therefore, the court granted the Plaintiffs’ request for an order enjoining the FDA from refusing admission into the U.S. e-cigarettes on the basis that such products are unapproved drugs, devices or drug-device combinations under the FDCA.