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
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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
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Following the 2012 and 2013 American Bar Association’s amendments to its Model Rules of Professional Conduct, many jurisdictions began to reexamine their own rules.  Massachusetts followed suit, and on July 1, 2015, the Supreme Judicial Court (SJC) adopted several revisions to the Massachusetts Rules of Professional Conduct (Mass. R. Prof. C.) recommended by its Standing Advisory Committee.  This blog post will be the first in a series designed to inform practitioners of several important changes to the Massachusetts rules.

Communicating with Jurors

courtroom-12jury-002b-564x338Last summer then Governor Patrick signed into Massachusetts law House Bill 4123 which made two significant changes to Massachusetts Superior Court procedure involving trials.  The first allowed Plaintiffs’ counsel to request a specific dollar amount as damages; the second allowed for questioning of prospective jurors (voir dire).  This summer, the SJC made a significant change to the Massachusetts Rules relating to communications with jurors after they render their verdicts by amending Mass. R. Prof. C. 3.5 to largely conform to ABA Model Rule 3.5.

The former Mass. R. Prof. C. 3.5, articulated in Commonwealth v. Fidler, 377 Mass. 192 (1979) and reaffirmed in Commonwealth v. Solis, 407 Mass. 398 (1990), prohibited lawyer-initiated, post-verdict juror contact unless authorized by court order for good cause shown.  Although the Standing Committee noted that “good cause” was a relatively low threshold, it remained concerned that a complete prohibition of non-judicially approved lawyer-initiated communications with jurors after a verdict may violate the First Amendment and prevent lawyers from receiving useful feedback.

As such, the SJC followed the Standing Committee’s recommendation and revised Mass. R. Prof. C. Rule 3.5 to largely follow the corresponding Model Rule.  Under the new Rule 3.5, attorneys may communicate with jurors post-verdict unless: (i) the communication is prohibited by law or court order; (ii) the juror has made known to the lawyer, directly or indirectly, a desire not to communicate with the lawyer; or (iii) the communication involves misrepresentation, coercion, duress or harassment.

Clearly, the Standing Committee’s desire for clarity of the rules and concerns over potential First Amendment issues were strong, and unlike several other revision recommendations, unanimously recommended this significant alteration to the rules.  In effectively abrogating Solis and Fidler, the SJC agreed, and appeared to have little concern regarding the impact the new rules may have on jurors’ willingness to serve or the potential for improper challenges to their verdict.

For more information on the revised rules visit:

http://www.mass.gov/courts/docs/sjc/docs/rules/a-sjc-order-rules-of-professional-conduct-adopted-march-2015.pdf

 
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Children's MotrinThe Massachusetts Supreme Judicial Court has affirmed a record $63 million jury verdict against healthcare giant Johnson & Johnson for allegedly inadequate warnings about the health risks associated with Children’s Motrin. The facts underlying this remarkable verdict are undeniably tragic, but they also demonstrate just how important clear and comprehensive warnings are for product manufacturers. Further, as explained in more detail below, this case emphasizes that it is extremely difficult in Massachusetts for manufacturers to prove that the FDA would have rejected a plaintiff’s recommended warning change, a showing that the United States Supreme Court has suggested could shield a manufacturer from a failure to warn claim. With interest, Johnson & Johnson is currently liable for over $130 million to the plaintiffs.

The Case

In November 2003, seven-year-old Samantha Reckis took Children’s Motrin after showing signs of a fever. The popular pain reliever did not improve her condition. Instead, Samantha developed toxic epidermal necrolysis (“TEN”), a life-threatening skin condition that caused her to lose 80 percent of her lung capacity, 90 percent of her skin, and her vision. Since 2003, Samantha has undergone almost 100 surgeries, which have kept her alive.

Samantha and her parents sued Johnson & Johnson, the manufacturer of Children’s Motrin, for allegedly failing to provide adequate warnings about the risks associated with the drug. Specifically, the Reckis family claimed that Children’s Motrin should have included a warning that its use could result in a life-threatening condition. In February 2013, a Plymouth County jury returned a $63 million verdict in favor of the Reckis family.

The Appeal

Johnson & Johnson appealed the verdict, primarily arguing that the United States Supreme Court’s 2009 decision Wyeth v. Johnson & JohnsonLevine preempted the plaintiffs’ claims because the Food and Drug Administration (“FDA”) would have rejected the warning that the Reckis family argued should have been on Children’s Motion. In Wyeth v. Levine, the Supreme Court found that a drug manufacturer could still be liable for failure to warn even after the FDA had approved a drug’s warning label. However, the Court also indicated that if there was “clear evidence” that the FDA would have rejected a manufacturer’s proposed warning change, then the manufacturer would not be liable for failing to include such a warning.

In 2003, when Samantha Reckis took Children’s Motrin for her fever, the warning on the drug advised users to stop using it if an allergic reaction occurred, but did not mention TEN or that its symptoms could be a sign of a life-threatening condition. Thereafter, a group of citizens petitioned the FDA to revise the warning on pain relievers with ibuprofen, such as Children’s Motrin, to reflect that use of the product could lead to potentially life-threatening conditions such as TEN. The FDA rejected this petition and specifically noted that including disease names such as TEN would not be useful to consumers because most consumers would be unfamiliar with such terms. Johnson & Johnson argued that this rejection constituted clear evidence that the FDA would have
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