Pharmaceutical and Medical Devices

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).

supreme-court-building-1209701_1280In a groundbreaking decision that follows closely on the heels of its jurisdictional decision in BNSF Railway Co. v. Tyrrell, 581 U.S. __ (May 30, 2017) (“Tyrrell”), the United States Supreme Court held that the California Supreme Court was wrong to let approximately 600 non-California residents join 86 state residents in a pharmaceutical claim against Bristol-Myers in which plaintiffs alleged that it misrepresented the risk of heart attacks and strokes associated with the use of its blood thinner, Plavix. In overturning the decision of the California Court, the Supreme Court premised its holding on the fact that the out-of-state plaintiffs had not shown enough of a connection between their alleged injuries and the company’s activities in California.

 

As previously reported, in an effort to find a way around the restrictions imposed on a court’s exercise of specific personal jurisdiction over a foreign corporation by the U.S. Supreme Court’s Daimler decision,  the California Supreme Court used specific personal jurisdiction as a tool to enlarge the Court’s power to exercise personal jurisdiction over a foreign corporation.  In Bristol-Myers Squibb, the California Supreme Court expressly held that Bristol-Myers Squibb was not subject to general personal jurisdiction in California, as its contacts with the state were not substantial enough to render it “at home” in the jurisdiction. It held, however, that specific personal jurisdiction existed over Bristol-Myers Squibb in California—even for plaintiffs who were not injured in California—based on its “purposeful availment” of the benefits and privileges of the laws of the State of California as a result of its “nationwide marketing, promotion and distribution [that] created a substantial nexus between the non-resident plaintiffs’ claims and the company’s contacts in California . . . .” Bristol-Myers Squibb Co. v. Superior Court, No. S221038, 2016 WL 4506107 (Cal. Aug. 29, 2016).

 

In the Supreme Court’s June 19, 2017 opinion, it reversed the California Supreme Court by a vote of 8-1. It made clear that specific jurisdiction is confined to adjudication of issues deriving from, or connected with, the very controversy that establishes jurisdiction.” If a state has no “legitimate interest” in particular claims, a defendant should not be forced to submit to the coercive power of the state with respect to those claims. Bristol-Myers Squibb Company v. Superior Court of California, San Francisco County, et al., 582 U.S. ___, ____ (2017) (slip op. at 6). The Supreme Court explicitly held that specific jurisdiction requires a connection between the forum and the specific claims at issue. Id. When there is no such connection, specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the State. Id. at ­­­___ (slip op. at 7).  Applying that requirement, the Court found that California could not exercise specific jurisdiction over Bristol-Myers Squibb with respect to non-residents’ claims because: (1) the non-residents did not claim to have suffered harm in California; and (2) all the conduct giving rise to the non-residents’ claims occurred elsewhere. Further, the fact that other plaintiffs were prescribed, obtained and ingested Plavix in California, and allegedly sustained the same injuries as the non-residents, or that Bristol-Myers Squibb conducted research in California on matters unrelated to Plavix, was irrelevant to specific jurisdiction. Id. at __ (slip op. at 7-9).

 

The Supreme Court’s decision had an immediate impact, as a Missouri state court granted Johnson & Johnson’s motion for a mistrial in a multi-plaintiff talcum powder case based on the Bristol-Myers decision that same day. Johnson & Johnson’s motion focused on the lack of connection between the plaintiffs and the forum state, as well as defendants’ ties to Missouri. This is likely just the beginning when it comes to the impact the Bristol-Myers and BNSF Railway decisions have, particularly in mass tort, multi-plaintiff suits. These decisions certainly limit plaintiffs’ ability to forum shop product liability cases, providing more certainty for corporations as to where a suit may be brought against it, and likely resulting in fewer cases filed in plaintiff-friendly jurisdictions. But, one issue that does appear to be left open by the decision is how much of a connection between a plaintiff’s claim and the forum state is required to permit the assertion of specific jurisdiction. In the instant matter, this issue was not decided because there was no connection at all (Plavix was not manufactured in California, and the non-resident plaintiffs did not purchase, obtain and/or ingest the drug in the state of California). Given the complexities this decision raises for plaintiffs who now may be put in a position to bring separate actions in separate states against separate defendants, this issue is likely to be further litigated, particularly in the mass tort and class action context.

blood-pressure-1573037_1920On March 3, 2017, after less than four hours of deliberations, a Massachusetts federal jury found that Fresenius Medical Care was not liable for the 2012 death of one of their patients. The verdict drew to a close a four-week long bellwether trial, the second for plaintiffs who opted out of a $250 million settlement offered by Fresenius relating to dialysis products, NaturaLyte and GranuFlo.

The matter arose out of the death of fifty-seven year old North Carolina man, Carley Dial. The decedent’s wife and representative of the estate, Florella Dial, alleged that Mr. Dial suffered from cardiac arrest as a result of the misuse of NaturaLyte, a dialysis product manufactured and sold by Fresenius. Lead trial counsel, Robert Carey of Hagens Berman Sobol Shapiro, argued in his closing that Fresenius did not adequately warn about their products, nor did they have an understanding of their products to ensure they were safe.

Over the course of the fourteen day trial, several Fresenius staff members, from Mr. Dial’s treating nurse at the Pembroke, North Carolina clinic, to the current Chief Medical Officer of Fresenius, headquartered in Waltham, Massachusetts, testified before the jury to evidence the methods that were used to educate, train, and instruct dialysis clinics on their product, NaturaLyte. Plaintiff challenged this testimony by offering Mr. Dial’s treating physician assistant and staff member of Carolina Kidney Care, and PowerPoint presentations created by Fresenius in her attempt to evidence the alleged confusion regarding NaturaLyte.

Plaintiff expert, Dr. G.M. Samaras, a professional engineer and an expert in the field of industry accepted standards and risk management, testified that Fresenius was aware that the information and training they provided regarding NaturaLyte was confusing. Plaintiff also offered nephrologist, Dr. Borkan, who opined that Mr. Dial died from cardiac arrest as a result of metabolic alkalosis, caused by the mismanagement and overuse of NaturaLyte in Mr. Dial’s dialysis treatment. Ultimately, the jury disagreed and found that the use of NaturaLyte in Mr. Dial’s dialysis treatment was not the proximate cause of Mr. Dial’s death.

During his closing, lead trial counsel for Fresenius, James Bennett of Dowd Bennett LLP, argued that Mr. Dial did not die from cardiac arrest, but suffered a heart attack at home, hours after the conclusion of his dialysis treatment. He referred to Mr. Dial’s medical history which evidenced heart blockages and an undetected prior heart attack. Attorney Bennett argued that Mr. Dial’s blockages had been developing for several decades and Mr. Dial did nothing to correct them. Attorney Bennett highlighted that NaturaLyte has been on the market for more than three decades, contains the same amount of acid concentrates as competitors, and more than 305 million gallons of NaturaLyte were sold between 2000 and 2012.

Dr. William Buchanan, Mr. Dial’s treating nephrologist responsible for prescribing NaturaLyte, testified that he received appropriate training by Fresenius regarding the use of their products and that he had a clear understanding of the acid/base balance and conversions of NaturaLyte. Dr. Buchanan believed he provided individualized care for Mr. Dial based on guidelines set by the clinic’s standard order. As Mr. Dial’s treating physician, Dr. Buchanan was responsible for signing the death certificate. Upon Dr. Buchanan’s review of the ambulance notes indicating Mr. Dial suddenly collapsed and Mr. Dial’s previous diagnosis of coronary artery disease, he concluded that the patient had a major heart attack. No autopsy of Mr. Dial was requested or performed.

Defense expert and cardiologist, Dr. Peter McCullough, reviewed Mr. Dial’s medical records before the jury for over two hours. He agreed with Dr. Buchanan and opined that based on the decedent’s history of untreated heart blockages and comorbidities, Mr. Dial suffered from a heart attack unrelated to his dialysis treatment. During closing arguments, Attorney Bennett argued that Dr. McCullough was the only cardiologist to review Mr. Dial’s medical records and was 100% correct in his testimony. Indeed, the jury concluded, to a fair preponderance of the evidence, that the use of NaturaLyte was not the proximate cause of Mr. Dial’s death.

This is the second defense verdict for Fresenius. In December of 2015, a separate bellwether trial also resulted in a defense verdict before Judge Kirpalani in Massachusetts state court. Although another defense verdict is good news for Fresenius, thousands of other claims remain. Judge Woodlock expressed his intention to schedule the next Fresenius bellwether trial soon.

 

Massachusetts Appeals Court
Massachusetts Appeals Court

On September 21, 2016, the Massachusetts Appeals Court upheld the grant of summary judgment to Johnson & Johnson (“J&J”), the manufacturer of the Ortho-Evra birth control patch at issue in the case of Niedner v. Ortho-McNeil Pharmaceutical, Inc., No. 15-P-1272, 2016 WL 5106479 (Mass. App. Ct. Sept. 21, 2016).  In so doing, the Appeals Court held that J&J had a duty to warn the decedent, but that it adequately did so.

Neidner involved the death of 17-year-old Adrianna Duffy, which resulted from blood clots allegedly caused by the Ortho-Evra birth control patch worn by Ms. Duffy.  Plaintiff claimed that she and Ms. Duffy had not been adequately warned about the increased risk of developing blood clots to those who use the patch.

In June, 2009, Ms. Duffy and her mother met with Ms. Duffy’s doctor to discuss birth control options. Ms. Duffy specifically asked her doctor about the Ortho-Evra patch, as she had previously taken an oral birth control pill but now wanted an easier birth control method. Id. at *1. Ms. Duffy’s doctor prescribed her the patch after this meeting and informed Ms. Duffy and her mother of the risks associated with using the patch, including that of blood clots. The prescription package filled by Ms. Duffy came with an insert from the manufacturer (J&J), as well as a leaflet from the pharmacy at which the prescription was filled, both setting forth the risks associated with the patch, including heart attack, stroke, and blood clots. After approximately three months of use, Ms. Duffy collapsed and died from a massive bilateral pulmonary embolus. Id. at *1.

Ms. Niedner filed suit in October, 2010, alleging, among other things, that her daughter’s death was caused by her use of the patch and that J&J was liable for breach of warranty under the theories of design defect, failure to warn, and manufacturing defect. Id. at *1.  J&J filed a motion for summary judgment, arguing that the patch’s risks, including the increased risk of blood clots, were sufficiently disclosed. Id. at *1. A Superior Court judge agreed, allowing the motion, and plaintiff appealed.

Typically, a manufacturer has a duty to warn product users of dangers associated with the reasonably foreseeable use of its product.  Manufacturers of prescription drugs and medical devices are, however, generally excepted from that rule based on the “learned intermediary” rule, which provides that the manufacturer fulfills its duty by providing physicians with an adequate warning about the risks associated with its product. In these instances, the physician acts as the “learned intermediary” between manufacturer and consumer to ensure the patient understands the potential risks and benefits. In MacDonald v. Ortho Pharmaceutical Corp., however, the Massachusetts Supreme Judicial Court created a narrow exception to this rule for the manufacturer of oral contraceptives, which it held has a duty to directly warn not only medical professionals, but also the consumer, about the risks associated with birth control medications. Id. at *2. The Neidner court held that this same exception to the “learned intermediary” rule applies to birth control patches, such as the Ortho-Evra patch, and as such, J&J had a duty to warn Ms. Duffy directly of the risks associated with the use of the patch. Id. at *2.

The Appeals Court also held, however, that J&J had satisfied that duty.  It noted that the box of patches purchased by Ms. Duffy contained a pamphlet which explained the risks associated with its use and contained instructions to consult a physician concerning information contained in the pamphlet. Both Ms. Duffy and her mother read the insert, though neither then consulted with Ms. Duffy’s doctor. Among other topics, the pamphlet thoroughly discussed in multiple locations the risk of developing blood clots while using the patch, particularly in the lungs like those Ms. Duffy developed. Id. at *3. The Appeals Court found as a matter of law that the pamphlet adequately warned of the increased risk of developing blood clots that could result in death, and described these warnings as “plain, numerous, and comprehensive.” Id. at *4.

Gavel_editOn September 13, 2016, the Massachusetts Appeals Court decided Albright v. Boston Scientific Corporation by vacating a jury’s verdict in favor of Boston Scientific Corporation (BSC) and remanding the matter to the Superior Court for retrial. No. 15-P-633, 2016 WL 4736686 (Mass. App. Ct. Sept. 13, 2016).

By way of background, the Plaintiff, Diane Albright, sued BSC alleging that she suffered serious injuries following a March 2010 surgery in which she had a Pinnacle Pelvic Floor Repair device implanted to correct a pelvic organ prolapse. Id. at *1. That is, after Ms. Albright’s surgery she “developed painful bladder syndrome and other complications” due to the implant’s degradation. Id. at *2. BSC designed, manufactured, and marketed the device in question. Subsequently, Ms. Albright tried her case before a Middlesex County jury, which found in BSC’s favor with respect to Ms. Albright’s defective design and inadequate warning claims.

The plaintiff appealed arguing that the trial justice erred when she (1) excluded from evidence a medical application caution found within a 2004 and 2007 Material Safety Data Sheet (MSDS) concerning the polypropylene material used to form the mesh within the device and (2) prevented the jury’s consideration of two 2012 FDA letters to BSC. Id. at *1. The first letter ordered BSC to conduct a postmarket surveillance study of its Pinnacle devices. In its second letter to BSC, the FDA agreed to the postmarket surveillance study’s suspension following receipt of BSC’s representation that it planned to cease manufacturing and marketing the implant in the United States. Id. at *7.

After reviewing the trial court record, the appeals court agreed with the plaintiff’s position. It reasoned that the medical application caution “was relevant, material evidence for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.” Id. at *6. Thus, the medical application caution was not hearsay for the sole purpose of showing that BSC had notice or knowledge of the foreseeable risks associated with the Pinnacle implant. Id. Likewise, the appeals court concluded that the two FDA letters were admissible “for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial.” Id. at *7. Such a limited purpose use of the FDA letters, the court found, would constitute reasonable cross-examination to show bias or to rebut BSC witness opinion testimony.