MG+M Boston Attorneys Eric Skelly and Christos Koutrobis successfully obtained dismissals for two clients in James T. Casey, Jr. v. Apax Partners et al., 1:18-cv-11211-DJC, a case that was pending at the U.S. District Court for the District of Massachusetts. On behalf of MG+M’s foreign client, a motion to dismiss for improper service and lack of personal jurisdiction was granted by Judge Casper. MG+M navigated a voluntary dismissal for its other client through the discovery process by demonstrating, based on the evidence, that the client was not liable for the product at issue.

Plaintiff alleged in his lawsuit that he was ordered to wear an electronic monitoring bracelet as part of his pre-trial probation. In his complaint, he stated that the bracelet wrongfully indicated that he was outside of the approved geographic area, which resulted in two days of imprisonment. As such, he brought forth claims against the defendants under the Massachusetts’ consumer protection laws as well as claims for design defect and negligence.

In its decision on defendant’s motion to dismiss, the Court highlighted Plaintiff’s allegation that the defendant, a foreign entity, was liable because its unidentified affiliate assumed the rights and liabilities of the former manufacturer of the electronic monitoring bracelet. The Court noted that even if the Plaintiff established that this affiliate conducted activities in Massachusetts that would subject it to the Court’s jurisdiction, Plaintiff still would need to prove that the affiliate’s conduct could be imputed to the foreign entity by “piercing the corporate veil.” Under Massachusetts law, corporations are presumed to be separate entities. To ignore corporate separateness a party must demonstrate: 1) “active and direct participation by the representatives of one corporation, apparently exercising some form of pervasive control, in the activities of another and there is some fraudulent or injurious consequence of the intercorporate relationship;” or 2) “a confused intermingling of activity of two or more corporations engaged in a common enterprise with substantial disregard of the separate nature of the corporate entities, or serious ambiguity about the manner and capacity in which the various corporations and their respective representatives are acting.” My Bread Baking Co. v. Cumberland Farms, Inc., 353 Mass. 614, 619 (1968). Plaintiff attempted to satisfy these requirements through evidence that suggested the foreign entity merely advised its unidentified affiliate during the acquisition of the electronic monitoring business. The Court, however, held that this evidence fell short of the threshold to disregard corporate separateness and “pierce the corporate veil.” Accordingly, the Court held that it did not have personal jurisdiction over the foreign entity.

This decision reinforces the long-standing principle of corporate separateness and should be beneficial to foreign defendants challenging personal jurisdiction in the future.

In DeLong v. Rhode Island Sports Center, Inc., et al., a former college hockey player successfully appealed a Rhode Island Superior Court decision granting an ice rink’s motion for summary judgment in a case alleging that he was poisoned by an ice resurfacer after finding that circumstantial evidence present in the record was sufficient to raise a factual dispute. 182 A.3d 1129 (R.I. 2018).

 

The plaintiff alleged that he inhaled noxious fumes that emanated from a malfunctioning ice resurfacer while playing in an ice hockey game at an enclosed arena in February, 2011. However, the plaintiff’s first indication that he had breathed injurious air resurfacing machine air did not come until the following morning when he and a teammate visited an emergency room after coughing up blood, from which doctors deduced that the plaintiff suffered from an acute lung injury as a result of carbon monoxide and nitrogen dioxide poisoning.

 

Accordingly, the plaintiff filed suit alleging that the ice rink defendants: negligently maintained their facility by allowing noxious fumes to permeate the air; failed to exercise reasonable care; or failed to provide adequate warnings. However, following discovery, the defendants successfully persuaded the trial court to grant summary judgment. “They argued that there were no genuine issues of material fact regarding (1) the existence of a dangerous or defective condition; (2) the notice to defendants of any such condition; and (3) the causal connection between that condition and any injury that may have been sustained by plaintiff.” Id. at 1131.

 

Specifically, the defendants pointed to: the plaintiff’s deposition testimony that he neither saw nor smelled any unusual fumes while at the ice rink; the lack of scientific evidence as to the air quality in the arena on the night in question; and evidence that the ice rink attendant’s twice-daily notation of the air quality had shown zero carbon monoxide, which the Rhode Island Department of Health confirmed the following day. Moreover, the ice rink’s facilities manager and the ice resurfacing machine driver each testified that neither was aware of any complaints regarding noxious fumes. The trial court, furthermore, intimated that the plaintiff’s “sickness was from another source, independent of the defendant’s facility” because the Department of Health’s testing was “more objective” and because the only people who fell ill were from the college hockey team. Id. at 1133. Based on this, the trial court granted summary judgment ruling that a lack of evidence that a defective condition existed at the sports center on day of the hockey game and it appeared that no one from the ice rink had notice of any such defect, if there was one.

 

On appeal, however, the plaintiff noted that: (1) the Department of Health does not and did not test nitrogen dioxide levels and did not test carbon monoxide levels until a day after the alleged incident, implying that poisonous ice resurfacer emissions had subsided by the time testing occurred; (2) his teammates and coach stated that they smelled gas in the air the night of the game; (3) the coach executed an affidavit stating that he witnessed the ice resurfacer malfunction and produce visible emissions; and (4) his teammates also ended up suffering very similar symptoms as he did.

 

Moreover—and perhaps most crucially—the plaintiff revealed that the defendants purchased an electric, non-propane-fueled ice resurfacing machine just months after the incident. As such, the plaintiff sought to take advantage of Rhode Island’s minority approach to the subsequent remedial measure rule. That is, unlike the Federal Rules of Evidence and the majority of states, under Rhode Island law:

 

When, after an event, measures are taken which, if taken previously, would have made the event less likely to occur, evidence of the subsequent measures is admissible.

R.I. R. Evid. 407.

 

Thus, the Supreme Court held that the trial court could and should have considered this evidence to reject the ice rink’s motion for summary judgement.

 

In its review of the plaintiff’s appeal, the court clearly indicated that even circumstantial evidence, such as the ice rink upgrading to an electric ice resurfacer, was sufficient to rise to the level of a materially factual dispute and it held that the ultimate determination of whether a dangerous-or-defective-condition existed or whether the ice rink had notice of any alleged defect was best suited for a jury’s review. Additionally, the Supreme Court repeated its caution that “issues of negligence are ordinarily not susceptible to summary adjudication, but should be resolved by trial in the ordinary manner.” Id. at 1137 (quoting Gliottone v. Ethier, 870 A.2d 1022, 1028 (R.I. 2005)).

 

DeLong is an instructive reminder that summary judgment is a powerful, but drastic tool. Even though a court may be presented with compelling, “more objective” evidence, “the purpose of summary judgment is issue finding, not issue determination.” Estate of Giuliano v. Giuliano, 949 A.2d 389, 391 (R.I. 2008). Conflating these two principles only confuses the ultimate question to be decided on summary judgment—whether, based on the evidence presented, there are remaining issues of material fact and whether the matter should proceed to trial or face dismissal on some or all issues.

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).

In a recent case, the Ohio Supreme Court addressed the question of whether the “cumulative-exposure theory” satisfies the “substantial factor” test for a plaintiff to succeed on a claim for asbestos-related injuries. The standard in Ohio requires a plaintiff to demonstrate that exposure to the product of a certain defendant was a substantial factor in causing the plaintiff’s asbestos-related injuries.

 

The decedent, Kathleen Schwartz, was diagnosed with and died from mesothelioma. The alleged main source of her exposure to asbestos occurred as a result of laundering the clothing of her father, who worked as an electrician.  In addition, plaintiff claimed that Ms. Schwartz was exposed to asbestos as a result of her proximity to her father when he changed the brakes on the family vehicle.

 

Plaintiff, decedent’s husband, brought suit against a number of defendants and claimed that the products of each of those defendants were a substantial factor in causing his wife’s mesothelioma. At trial, plaintiff presented evidence, in the form of expert testimony, that there is no known threshold of asbestos exposure at which mesothelioma will not occur, and thus each exposure to asbestos that the decedent experienced from laundering her father’s clothes and being in proximity to brake products contributed to her total dose of asbestos and were substantial contributing factors to the causation of her mesothelioma.

 

The trial court entered judgement against the defendant in the amount of $1,011,639.92, based on this cumulative exposure theory of causation. The Eighth District Court of Appeals affirmed the decision, finding that the cumulative exposure theory was based on “reliable scientific evidence.”

 

In reversing the Court of Appeals, the Ohio Supreme Court held that cumulative exposure theory is inconsistent with a substantial factor test for causation. In its decision, the Ohio Supreme Court noted that R.C. 2307.96 requires a showing that “the conduct of that particular defendant was a substantial factor in causing the injury or loss.” This substantial factor standard requires the trier of fact to consider the manner, proximity, and frequency of exposure. As such, the Ohio Supreme Court held that the cumulative exposure theory is incompatible with the plain language of R.C. 2307.96.  Moreover, the Court held that there must be at least some quantification or means of assessing the amount of exposure to determine if the exposure was in fact sufficient to contribute to the cause of the disease.

 

SLIP OPINION NO. 2018-OHIO-474 SCHWARTZ, EXR., APPELLEE, ET AL. v. HONEYWELL INTERNATIONAL, INC., APPELLANT.[Until this opinion appears in the Ohio Official Reports advance sheets, it may be cited as Schwartz v. Honeywell Internatl., Inc., Slip Opinion No. 2018-Ohio-474.]

A March 22, 2018, denial of a defendant’s summary judgment motion in the New York City Asbestos Litigation (NYCAL) signals a drastic lowering of the product identification standards in that venue (and a possible strategic adjustment necessary in future defendants litigating there).

 

In Trumbull v. Adience, Inc., a former brewer sued Stavo Industries (“Stavo”) as a manufacturer of asbestos-containing products to which the plaintiff was allegedly exposed.  Stavo made, among other products, filters used in breweries. The plaintiff listed Stavo in his interrogatory responses, but not during his deposition testimony.  At his deposition, the plaintiff recalled exposure to filters generally, but only named one specific manufacturer—Cellulo.  However, the plaintiff also referred back, on the record, to his interrogatory responses for the list of filter brands that he supposedly encountered.

 

From Stavo’s perspective, the plaintiff’s general interrogatory mention of Stavo and reference back to those interrogatories during the deposition failed the requirement for product identification. Stavo moved for summary judgment.  Justice Manuel Mendez denied Stavo’s motion, and ruled that a reference back to the interrogatory responses during his deposition did “sufficiently identify” Stavo filters as an exposure source.  The Court found that Stavo’s liability could be inferred from the plaintiff’s testimony that he worked near filters being removed and replaced, considered with Stavo marketing materials from the time at issue claiming widespread usage of Stavo products in the brewing industry.  For the Court, this provided enough evidence to survive summary judgment.

 

After this decision, the bar for product identification in the NYCAL appears dangerously low.  This standard encourages plaintiffs to make blanket references to their vague interrogatory responses in depositions where actual recollection is impossible. It also forces prudent defendants to cross-examine during depositions with or without a specific mention of the defendant’s product occurring. If the NYCAL proceeds with this standard, the number of identifications stands to increase.