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 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.

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.

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 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?

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 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. Id.at *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.

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:

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.

Id.

[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).

(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
consumption.

(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).

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!

Reference: https://kryptoszene.de/bitcoin-robot/bitcoin-profit/

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.