Good v. BioLife Plasma Services, L.P.

District Court, E.D. Michigan·Decided February 13, 2020·No. 1:18-cv-11260·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN NORTHERN DIVISION

TENLEY MCLAUGHLIN GOOD,

Plaintiff, Case No. 18-11260

v. Honorable Thomas L. Ludington

BIOLIFE PLASMA SERVICES, L.P.; and SHIRE PHARMACEUTICALS aka SHIRE US, INC.,

Defendants. _______________________________________/

OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT, DENYING PLAINTIFF’S MOTION FOR PARTIAL SUMMARY JUDGMENT, AND DENYING ALL REMAINING MOTIONS AS MOOT

Plaintiff, Tenley McLaughlin Good, filed a complaint in Isabella County Circuit Court on March 23, 2018 alleging malpractice and ordinary negligence by Defendants, Biolife Plasma Services and Shire Pharmaceuticals. ECF No. 1 at PageID.1, 11-12. Defendants removed the case to federal court based on diversity jurisdiction on April 20, 2018. ECF No. 1 at PageID.2. The parties submitted a joint stipulation dismissing Plaintiff’s medical malpractice claim on August 20, 2019. ECF No. 35. On August 14, 2019 Defendants filed a joint motion for summary judgment. ECF No. 32. Plaintiff also filed a dispositive motion for partial summary judgment. ECF No. 37. Responses and replies were timely filed. ECF Nos. 32, 37, 45, 46, 49, 52, and 53. On December 20, 2019, Defendants’ motion for summary judgment was denied in part as to their premises liability and assumption of the risk doctrine defenses. ECF No. 75. Supplemental briefing was directed on the elements of a general Michigan negligence claim and the application of Michigan comparative negligence law. Id. Supplemental briefing and responses were timely filed. ECF Nos. 76, 77, 78, 79, 80, 81. I. Tenley McLaughlin Good grew up with a tendency to get light-headed and/or faint when she saw blood. When Tenley was seven or eight, she cut her hand on glass and had a negative

reaction to seeing the blood. ECF No. 32-5 at PageID.2162. Tenley once fainted when her father cut the family’s dog’s nails too short and caused the dog to bleed. ECF No. 32-4 at PageID.2159. Tenley became very pale and unstable. Id. Tenley also became dizzy after she had her ears pierced. ECF No. 32-5 at PageID.2163. When Tenley was in junior high, her sister sliced her hand in the kitchen and Tenley passed out after observing the blood. ECF No. 53-2 at PageID.6543. Despite her struggles with the sight of blood, Tenley “had always donated blood [because] it was a big deal to her.” ECF No. 32-5 at PageID.2164. In high school, Tenley and her friend “were racing for their gallon tag because . . . it saves lives.” Id. In 2011 when Tenley was about 16, she tried to donate blood at a MI Blood donation center for the first time. ECF No. 32-5 at

PageID.2162; ECF No. 32-3 at PageID.2152. She fainted after her finger was pricked for a capillary sample to verify her eligibility to donate blood. ECF No. 32-5 at PageID.2162; ECF No. 32-3 at PageID.2152. On June 7, 2012, she tried to donate blood again. Tenley had no observable reaction when the capillary sample was taken, but passed out when the bag began filling with blood. ECF No. 32-3 at PageID.2152. On another occasion, according to Tenley’s mother, she attempted to donate blood at an ice rink in Gladwin, Michigan and later became dizzy. ECF No. 32-5 at PageID.2163. As a result of her difficulty donating blood, MI Blood noted in her internal chart that she had to be supine when donating. ECF No. 32-5 at PageID.2162. A. Biolife Plasma Services describes its mission on its website to be to “provide the highest- quality plasma to meet the expectations of our customers, ensuring the availability of life-saving therapies for patients.” Biolife Plasma Services, Who We Are, https://www.biolifeplasma.com/us/#/about-biolife/who-we-are (last accessed Feb. 10, 2020).

Plasma “is the pale yellow liquid portion of your blood that can be easily replaced by the body. It consists mainly of water and proteins, which help your body control bleeding and infection.” Biolife Plasma Services, What is Plasma, https://www.biolifeplasma.com/us/#/about- plasma/what-is-plasma (last accessed Feb. 10, 2020). “Plasma-based therapeutics are used in the treatment of serious disorders such as hemophilia and immune system deficiencies, and to treat victims of shock and burns.” Id. The plasma donation process involves withdrawing whole blood from the body, separating out the plasma, and returning the remainder of the blood (red blood cells, while blood cells, and platelets) to the donor. Biolife Plasma Services, Working Together to Save Lives, http://www.prod.biolifeplasma.com/downloads/biolife-press-kit.pdf (last accessed Feb. 10,

2020). B. Biolife Plasma has a procedure for assessing new plasma donors. Katie Pietrzak, the Mount Pleasant Center Director, and Amy Parks, an RN, testified about the procedures they follow for plasma donors. The process begins with a customer’s check-in with the receptionist and medical historian, followed by a check for an adequate donation vein by a phlebotomist, a capillary sample taken by a medical historian, and finally a health questionnaire and physical exam with a nurse. ECF No. 32-2 at PageID.2144; ECF No. 49-9 at PageID.5962. Each step of the process helps determine whether the donor meets the criteria to donate plasma. ECF No. 32-2 at PageID.2142. A repeat donor has a shorter process that proceeds in a different order. Id. at PageID.2144-2145. For a first time donor, the receptionist obtains the donor’s identification, social security card, and address. ECF No. 53-3 at PageID.6550. Next, the receptionist or a medical historian completes a new donor chart, determines if the potential donor is on the unacceptable address list

or a NDDR list (a list of donors who were denied at another facility), takes the donor’s picture, and has the donor read the consent to take blood out loud. The donor must then “sign” the consent by digitally scanning their fingerprint. ECF No. 53-3; ECF No. 49-9 at PageID.5962. The consent statement provides: I voluntarily consent to the withdrawal of my blood for the purpose of laboratory testing. It is understood that the blood is to be used solely for the purpose of testing for donor eligibility. I understand that this consent will remain in effect as long as I am a plasmapheresis donor and that I am free to withdraw from the program at any time. ECF No. 53-4 at PageID.6553.

The phlebotomist then completes a vein check of the potential donor and inquires if the donor has donated blood or plasma before and if so, if the donor suffered an adverse reaction. ECF No. 32-2 at PageID.2413; ECF No. 32-6 at PageID.2168. The phlebotomist initials and dates the Donor Identification Form (“DIF”) after completing the vein check. ECF No. 53-5 at PageID.6556-6557. The DIF does not have a specific question about whether the donor has had a reaction to past blood donations. ECF No. 32-2 at PageID.2143. If the donor communicates to the phlebotomist or anyone else during the donor screening process that they have had adverse reactions to donating blood or plasma in the past, the screening process stops and the donor is sent to the nurse. ECF No. 32-6 at PageID.2168. If the donor does not disclose an adverse donation history, the medical historian obtains a capillary sample by pricking the donor’s finger with a lancet to measure the protein levels in the donor’s blood.1 ECF No. 46-11 at PageID.5212; ECF No. 46-8 at PageID.5025. They “take a cleaning swab, a wipe and clean the finger and then [they] poke the blood and then [they] squeeze” the finger and collect the blood. ECF No. 32-8 at PageID.2174. The medical historian talks with donors throughout the process. ECF No. 32-8 at PageID.2175. Medical historians are trained to inform donors that a

capillary sample will be taken, but not to inform the customer of the timing of the finger prick procedure. ECF No. 49-8 at PageID.5958.

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Good v. BioLife Plasma Services, L.P., (E.D. Mich. 2020).

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