In a recent case, a Rhode Island Jury awarded $31.3 million to Brett and Stacie Smith after a 2014 swimming accident in a pond at the University of Rhode Island left Mr. Smith paralyzed from the chest down.  The jury found that the University of Rhode Island was negligent in its failure to post warning signs and to inform its guests that swimming was prohibited.

 

The Smiths were attending a wedding during the weekend of July 25, 2014, at the Whispering Pines Conference Center.  After the rehearsal dinner, several members of the wedding party decided to go swimming in Louttit Pond.  After twenty or so minutes in the water, Mr. Smith and some others swam to, and climbed atop, a large rock in the middle of the pond.  They dove off and began to swim away from the rock.  While swimming underwater, Mr. Smith struck his head on a submerged rock, causing his paralysis.

 

The case focused on whether the defendants owed Mr. Smith a duty of care.  The plaintiffs argued that a duty existed for the defendants to post warning signs indicating that swimming was not allowed or describing the potential danger.  Conversely, the defendants argued that no duty existed as Mr. Smith assumed the risk of his injuries and that the potential dangers were open and obvious.

 

At trial, the major issue primarily focused on whether it was reasonably foreseeable that individuals would swim and be injured in the subject pond.  The plaintiffs put forth evidence that the management of the property had outlawed swimming in the pond due to potentially dangerous conditions, but did not install signs that forbade swimming on the property or warned of the dangers that the pond possessed.   The plaintiffs argued that this failure constituted negligence, as it was foreseeable that: 1) people would swim in the pond; 2) the very nature of the property lent itself to swimming as it promoted access to the outdoors, specifically, the water as well as numerous outdoor activities; and 3) the pond had a dock and a canoe launching point which encouraged people to use the water.

 

The defendants asserted two main defenses: 1) Mr. Smith assumed the risk of his injuries; 2) the condition was open and obvious. In Rhode Island, assumption of the risk is an affirmative defense that absolves a defendant of liability regardless of the defendant’s own negligence.  Loffredo v. Merrimack Mutual Fire Ins. Co., 669 A.2d 1162 (R.I. 1996).  To prevail on the assumption of the risk defense, defendants need to show that a plaintiff voluntarily encountered an unreasonable risk and appreciated its unreasonable character.  Id.  In examining this subjective standard, one must look at what the particular plaintiff saw, knew, understood, and appreciated.  Id.  As for the open-and-obvious defense, a property owner in Rhode Island is not liable for injuries that a guest suffered while on an owner’s premises when that guest was engaging in an open and obvious danger. Bucki v. Hawkins, 914 A.2d 491, 496 (R.I. 2007).

 

In an attempt to establish these defenses, the defendants endeavored to elicit testimony from Mr. Smith that he was aware of the potential dangers associated with swimming in an unfamiliar body of water.  The goal was to demonstrate that he assumed the risk of his injuries, as he knew it was possible that he might strike his head on an underwater obstacle.  Additionally, the defendants argued that the dangers associated with swimming in an unknown body of water should be open and obvious to the reasonable person.  In particular, they asserted that a reasonable person is well aware of the dangers associated with diving into shallow water or with swimming in an unfamiliar body of water.

 

At the conclusion of a three-week trial, the jury rejected both defenses.  In particular, the jury found Mr. Smith did not assume the risk of his injuries as the pond was deep, the submerged rocks were not visible, and he saw other swimmers in the group safely emerge after traversing the water. For similar reasons, the jury concluded that the dangers, as described, were not open and obvious.

 

This case once again reinforces an important reminder to property owners in Rhode Island: it is imperative to warn of known dangers, no matter how unlikely they are to be encountered or how open or obvious the condition may seem to be.

 

The overwhelming majority of courts (including all seven federal circuits that considered the issue) have rejected the so-called “innovator liability” doctrine.[1]  In 2017, however, the California Supreme Court in T.H. v. Novartis Pharm. Corp.[2] unanimously recognized the doctrine holding that brand-name prescription drug manufacturers owe a duty to warn to consumers who use generic drugs.[3]  In March of 2018, the Massachusetts Supreme Judicial Court (SJC) considered the issue, and took a middle ground.  Specifically, in Rafferty v. Merck & Co., Inc.,[4] the SJC held that plaintiffs who ingest the generic form of a drug may bring failure to warn claims against the brand-name manufacturer of the drug if the brand-name defendant acted recklessly by “intentionally fail[ing] to update the label on its drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.”[5]  In so doing, the SJC reasoned that a plaintiff is, in fact, injured by a brand-name product’s label despite never having used said product because statutes require identical labeling of the generically manufactured version.[6]

 

The Facts

 

In 2010, a physician prescribed Finasteride, the generic version of the brand name drug Proscar, to treat Rafferty’s enlarged prostate.[7]  Rafferty experienced anticipated temporary side effects from the drug, causing him to stop taking the medication.[8]  Rafferty, however, continued to experience these side effects and his physician informed him that they could actually continue “indefinitely.”[9]  The potential lifelong side effects of this drug were not disclosed within the brand-name manufacturer’s nor the mirrored generic manufacturer’s warning label.[10]  Rafferty presented evidence that the brand-name manufacturer became aware of these potential long-term side effects by 2008, when it updated Proscar’s warning label in select European markets to include this risk.[11]

 

Rafferty filed suit against the brand-name manufacturer in 2013, asserting a claim of negligence for, inter alia, failure to warn and for violation of the Commonwealth’s Consumer Protection Statute, G.L. c. 93A.[12]  The Superior Court dismissed Rafferty’s claims, “ruling that [the brand-name defendant] owed no duty of care to [him].”[13]  The SJC took over the case by its own motion from the Appeals Court.[14]

 

The SJC Weighs In

 

Traditionally, Massachusetts has not recognized liability for products manufactured by others.[15]  However, the SJC noted that The Restatement (Third) of Torts allows a modification to this general rule in exceptional cases.[16] The SJC considered innovator liability to require such a modification given the certainty that a user of a generic drug will rely on the label fashioned by the brand-name manufacturer and as state law shields failure to warn claims from generic manufacturers, leaving plaintiffs without recourse for their injuries.[17] However, the SJC also recognized that imposing innovator liability could impact the public policy of encouraging innovation in the drug market and a potential increase in drug pricing.[18]

 

Balancing these competing interests, the court held that, “a brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.”[19]  As an added protection to the manufacturers, it will be the trial judge’s responsibility to determine whether an injury constitutes an “unreasonable risk of death or grave bodily injuries.”[20]  The court went on to define recklessness as an act performed while knowing or having reason to know of facts which would lead a reasonable person to realize that his or her conduct creates an unreasonable risk of physical harm to another and that such risk is substantially greater than that which is necessary to make his conduct negligent.[21] In order to meet this threshold with regard to failure to act, there must be “an intentional or unreasonable disregard of a risk that presents a high degree of probability that substantial harm will result.”[22]

 

The court then vacated the dismissals and remanded the case to Superior Court where the plaintiff would be granted leave to amend his complaint should he believe his claims meet the newfound threshold.[23]

 

National Scope

 

In August of 2017, the United States District Court – District of Massachusetts held in In re Zofran[24] that a brand-name manufacturer is not liable for a generic version’s failure to warn claim spawning from an injury caused by the use of the generic.[25]  Judge Dennis F. Saylor IV articulated this point by emphasizing the consistency of the Circuit Courts’ decisions and citing to a Sixth Circuit multi-district litigation holding “affirming the dismissal of claims against brand-name manufacturers under the laws of 22 states.”[26]  Notwithstanding this majority view, in December of 2017, the Supreme Court of California held that a brand-manufacturer is liable for a failure to warn claim arising from “risks about which it knew of reasonably should have known, regardless of whether the consumer is prescribed the brand-name drug or its generic ‘bioequivalent.’”[27]  Here, the SJC has offered a compromise to the majority and minority viewpoints by adopting a recklessness standard, which is a higher threshold than the minority view, while still maintaining failure to warn liability against the brand-name manufacturer, in contrast with the majority.

 

The court’s concern that redress be available to those who ingest generic drugs by establishing liability to the controlling brand-name manufacturer carried the day.  Our hope is that innovators will continue to advance modern pharmaceutical products despite their increased potential for liability. We will be watching this space for further developments.

 

 

[1] In re Zofran (Ondansetron) Products Liability Litigation, 261 F.Supp.3d 62 (D. Mass. 2017) (citing In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, 756 F.3d 917, 938-939 (6th Cir. 2014)).

[2] 407 P.3d 18, 29 (Cal. 2017).

[3] Id. at 47.

[4] Rafferty v. Merck & Co., Inc. & Sidney Rubenstein, No. SJC–12347 (Mass. Mar. 16, 2018).

[5] Id. at 2-3.

[6]Rafferty v. Merck & Co., Inc., No. SJC–12347 at 3-4. The statutory and regulatory constructs pertaining to drug labeling are quite complicated.  Relevant to the matter considered by the SJC, the Drug Price Competition and Patent Term Restoration Act, informally known as the “Hatch-Waxman Act” requires the “manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand-name counterpart.”  Id. at 4.  In accordance with the “federal duty of ‘sameness’” the two opportunities to alter a generic manufacturers preexisting warning are to: (1) update their label in response to their brand-name counterpart’s update; and (2) per specific FDA instruction. Id. at 6-7 (citing PLIVA, Inc. v. Mensing, 564 U.S. 604, 613-616 (2011)).  These federal laws makes it almost impossible for generic manufacturers to follow Massachusetts labeling laws because they do not have the unilateral power to act. See id.

[7] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 8.

[8] Id.

[9] Id.

[10] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 8-9.

[11] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 9.

[12] Id. Plaintiff also asserted a G.L. c.93A § 9 Consumer Protection Act claim and a negligent failure to obtain informed consent action against his physician.

[13] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 10; Rafferty v. Merck & Co., Inc. & Sidney Rubenstein, No. 2013–04459, 4 (Mass. Super. May 23, 2013) (emphasizing that because “Rafferty did not ingest the drug that Merck manufactured, Merck owes Rafferty no duty of care”).

[14] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 11.

[15] See e.g. Mathers v. Midland-Ross Corp., 403 Mass. 688, 691 (Mass. 1989); Mitchell v. Sky Climber, Inc., 396 Mass. 629, 631 (Mass. 1986).

[16] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 16.

[17] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 17. This was especially so given generic products command approximately ninety percent of the market. Id.

[18] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 20-22.

[19] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 29.

[20] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 30.

[21] See Rafferty v. Merck & Co., Inc., No. SJC–12347 at 29 (citing Boyd v. National R.R. Passenger Corp, 446 Mass. 540, 546 (Mass. 2006); Restatement (Second) of Torts, § 500, 587 (1965)).

[22] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 30.

[23] Rafferty v. Merck & Co., Inc., No. SJC–12347 at 36. Additionally, Rafferty’s G.L. c. 93A § 9 claim was vacated because it did not satisfy the “any trade or commerce” provision, which requires that the unfair or deceptive practice is directly related to the advertising, selling, or trade of a Merck product.  Id. at 38.  Thus, because Rafferty used Finasteride, as opposed to Proscar, the claim is beyond the scope of G.L. c. 93A § 9.  Id. at 38-39

[24] 261 F.Supp.3d 62 (D. Mass. 2017). A multi-district litigation matter regarding side effects not purported within the label of Zofran and in-turn not purported on the label of the generic version, Ondansetron.

[25] In re Zofran, 261 F.Supp.3d at 64-65.

[26] In re Zofran, 261 F.Supp.3d at 71-72 (citing In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, 756 F.3d at 938-939.

[27] T.H. Novartis Pharm. Corp., 407 P.3d at 29 (citing Dolin v. SmithKline Beecham Corp., 62 F.Supp.3d 705 (N.D. Ill. 2014); Chatman v. Pfizer, Inc., 960 F.Supp.2d 641, 654 (S.D. Miss. 2013); Kellogg v. Wyeth, Inc., 762 F.Supp.2d 694, 704 (D. Vt. 2010); Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014)). See also Conte v. Wyeth, Inc., 168 Cal.App.4th 89 (Cal. Ct. App. 2008).

On April 16, 2018, a Rhode Island court addressed for the first time whether an entity owes a duty of care to protect non-employees from exposure to the asbestos-tainted work clothes of the entity’s employee.  In a decision denying the defendant Crane Co.’s motion for summary judgment in the matter of Carolyn Nichols, as Executrix of the Estate of Iva Pearl Jones, et al. v. Allis Chalmers Product Liability Trust, et al., C.A. No. PC-2008-1134, Judge Sarah Taft-Carter held that while the existence of such a duty is determined on a case-by-case basis, the plaintiffs had presented sufficient evidence to establish that Crane Co. had a duty to protect against such “secondary” or “take-home” exposure.  The decision is significant in that the Court demonstrated a willingness to impose such a broad duty upon an employer if certain factors are met through the plaintiff’s evidence.

 

In the Jones matter, the plaintiffs alleged that the decedent, Iva Pearl Jones (“Ms. Jones”) was exposed to asbestos from the clothing of her brother-in-law, Stanley Nichols (“Mr. Nichols”) while Mr. Nichols was employed by Crane Co. from 1979 to 1980 and resided in the same home as Ms. Jones and other family members.  The testimony also established that Ms. Jones “always” did the laundry, including Mr. Nichols’ work clothes.  Ms. Jones was diagnosed with mesothelioma in 2005 and passed away in 2007.  The plaintiffs alleged that Crane Co. failed to take adequate precautions to prevent asbestos fibers from leaving the work site and failed to warn employees of a foreseeable risk of take-home exposures to their cohabitants. Following discovery, Crane Co. moved for summary judgment on all counts asserting that it had no duty of care to Ms. Jones, its employee’s sister-in-law, and that the plaintiffs had failed to establish that the alleged exposure to asbestos from Mr. Nichols’ clothing caused Ms. Jones’ disease.

 

The Court, noting that an employer’s duty to protect against “take-home” exposures is an issue of first impression in Rhode Island, recognized the division of existing authority in other jurisdictions that have addressed the issue in NY, MD, GA, TN, NJ, IL, and ND. The Court held that it need not find a “special relationship” between Crane Co. and Ms. Jones to impose a duty because the plaintiffs allegations were based upon Crane Co.’s own alleged misfeasance in utilizing asbestos-containing products and not on an alleged failure of Crane Co. to protect against the actions of a third-party tortfeasor.  Instead, the Court held that under Rhode Island law, the existence of a duty of care is determined on a case-by-case basis considering the following factors: (1) the foreseeability of the harm; (2) the degree of certainty of injury; (3) the closeness of connection between the defendant’s conduct and the plaintiff’s injury; (4) the policy of preventing future harm; (5) the burden to the defendant and consequences to the community in imposing a legal duty; and (6) the relationship between the parties.

 

After considering the above-factors, the Court concluded that Crane Co. owed a duty of care to Ms. Jones. First, the Court found that it was foreseeable to Crane Co. that asbestos fibers could be transmitted on an employee’s clothing and posed a risk to individuals residing with the employee, based on the 1972 Occupational Safety and Health Administration (OSHA) regulation “emphasiz[ing] the importance of preventing asbestos from leaving the worksite on employees’ clothes” and advising employers of measures to prevent such risks including providing employees with protective clothing. (citing Standard for Exposure to Asbestos Dust, 37 Fed. Reg. 110, 11318 (June 7, 1972), amending 29 C.F.R. § 1910, et seq.).  Second, the Court noted that the degree of certainty of injury, namely Ms. Jones’ diagnosis of malignant mesothelioma, was not contested.  Third, with regard to the closeness of the connection between Crane Co.’s conduct and the alleged injury, the Court listed several measures Crane Co. could have taken to prevent take-home exposure, such as providing uniforms, on-site showers and laundry services, and/or requiring employees to change their clothes before leaving the facility. Fourth, the Court  acknowledged that asbestos-related illnesses have a long latency period and therefore, the fact that Ms. Jones’ was not diagnosed until 25 years after the alleged exposures did not reduce the closeness of the connection.  Fifth, as to public policy considerations and the burden of imposing a legal duty on employers under the circumstances presented, the Court commented that asbestos poses a danger to public health and cumulative exposures can cause mesothelioma.  The Court rejected Crane Co.’s assertion that imposing a duty would subject it limitless liability and claims from “a seemingly immeasurable amount of people,” emphasizing that Rhode Island courts determine whether a duty exists on a case-by-case basis.  Moreover, it observed that measures Crane Co. could have undertaken to prevent household exposures were required by OSHA and not burdensome or onerous. Finally, the Court rejected Crane Co.’s argument that Ms. Jones’ relationship with Crane Co., as the sister-in-law of Crane Co.’s employee and household member, was too attenuated to support a duty.  The Court found that the plaintiffs had provided evidence of long-standing cohabitation between Ms. Jones and Mr. Nichols and that they acted as a single household unit during the relevant times with Ms. Jones regularly undertaking laundry duties for the household.

 

The Court further concluded that the plaintiffs had presented sufficient evidence to prevail against Crane Co.’s motion for summary judgment on the issue of causation.  Crane Co. argued that plaintiffs’ evidence was insufficient to meet the “frequency, regularity, proximity” test set forth in Sweredoski v. Alfa Laval, Inc., No. PC 2011-1544, 2013 WL 3010419, *2 (R.I. Super. June 13, 2013) (Gibney, P.J.).  The Court stated, the “issue of proximate causation is usually a question for the trier of fact that cannot be determined on summary judgment” and found that the plaintiffs had provided sufficient evidence of product identification, regular and frequent use, and proximate exposure to asbestos.  Specifically, Mr. Nichols had testified that he regularly worked closely with asbestos-containing insulation for approximately seven months.  He further testified that Ms. Jones “always” laundered his work clothes, and that there was visible dust in the air when she performed this task.  The plaintiffs’ pathology expert, Dr. James A. Strauchen, also opined that Ms. Jones’ cumulative exposure to asbestos caused her mesothelioma.  The Court held that this evidence satisfied the frequency, regularity, proximity test and was sufficient for a jury to conclude that exposure to asbestos from Mr. Nichols’ clothing was a substantial factor in causing of Ms. Jones’ disease.

 

Judge Taft-Carter’s decision denying Crane Co.’s motion for summary judgment is notable as the first instance in which a Rhode Island court has addressed the scope of duty an employer owes for “secondary” or “take-home” exposures.  While the decision demonstrates a willingness of the Court to extend an employer’s duty to household members of employees that demonstrate exposure to asbestos at a worksite that is controlled by the employer, the Court conducted  a multi-factor analysis that it stated it would apply going forward on a case-by-case basis.