This is a lawsuit against a pharmacy, arising out of injuries allegedly sustained after ingesting an antibiotic. Jurisdiction is based on diversity of citizenship.
Plaintiff Kevin Carrozza was prescribed levofloxacin (Levaquin ), a quinolone antibiotic. Carrozza had the prescription filled at a CVS Pharmacy in Bridgewater, Massachusetts. The internal patient database at CVS included a "hardstop" warning stating that Carrozza was allergic to quinolones. The pharmacist on duty then investigated further, and found notes stating that Carrozza previously denied having a quinolone allergy and had been prescribed quinolone on multiple prior occasions. The pharmacist ultimately decided to dispense the drug. Carrozza alleges that he had an allergic reaction to the drug, and alleges that it caused him to suffer swollen and disfigured skin, along with Stevens-Johnson Syndrome ("SJS").
CVS has moved to preclude the testimony of Carrozza's sole expert witness, Dr. Kenneth Backman, and for summary judgment. Carrozza has cross-moved for partial summary judgment. He has also moved to take an additional deposition after close of discovery and to strike certain statements made at the May 16, 2019 motion hearing. For the following reasons, CVS's motions to preclude and for summary judgment will be granted; Carrozza's motions for partial summary judgment and to take an additional deposition will be denied; and
I. Background
A. Factual Background
The following facts are as set forth in the record.
Carrozza is a citizen of Massachusetts. CVS Pharmacy, Inc. is a Rhode Island corporation with its principal place of business in Woonsocket, Rhode Island. (ECF No. 1 ¶ 7).
On April 22, 2015, Carrozza went to fill a prescription for Levaquin, a quinolone antibiotic, at a CVS pharmacy in Bridgewater, Massachusetts. (Am. Compl. ¶ 5). He was prescribed the drug by his physician, Dr. George Despines, for a head cold. (Am. Compl. Ex. A).
The CVS computer system contained a "hardstop" warning that Carrozza was allergic to quinolones. (ECF No. 70 at 17).
Carrozza then took the medication. After taking one dose, Carrozza suffered what was later diagnosed as an allergic reaction and sought treatment at Morton Hospital in Taunton, Massachusetts. Medical records from Morton Hospital show that he suffered a "red circular rash with central blisters - atypical appearance for allergic reaction but may represent erythema multiforme /very mild SJS." (ECF No. 62, Ex. 6). There appear to have been two rashes: one on his left arm, and one on his right ankle. (Id. ).
Carrozza filed this suit in 2017. On October 8, 2018, he filed a disclosure identifying one expert witness, Dr. Kenneth Backman, an allergist and immunologist. (ECF
On February 15, 2019, counsel for CVS deposed Dr. Backman. He testified, contrary to his earlier sworn statement, that he did not know "the standard of care [that is] applicable to a pharmacist in this situation." (ECF No. 64 Ex. 3 ("Backman Dep.") at 94:14-18). He further testified that he did not know how Carrozza's rashes appeared (id. at 98:20-22) and whether he had any other symptoms of SJS, including mucosal involvement, epidermal detachment, skin sloughing, target lesions, and a fever (id. at 99:4-101:4). Ultimately, Dr. Backman conceded that he did not have sufficient information to form an opinion as to whether Carrozza had SJS. (Id. at 100:2-8). Moreover, he stated that no physician at Morton Hospital had diagnosed SJS. (Id. at 133:19-24). The only basis for Dr. Backman's belief that Carrozza had SJS was an opinion offered by an ophthalmologist, Dr. Stephen Foster. (Id. at 100:9-13). However, because Carrozza's counsel had failed to comply with the requirements of the Federal Rules of Civil Procedure governing expert disclosures, the Court had previously denied his motion to admit Dr. Foster's affidavit, which was substantively an expert report. (ECF Nos. 44, 51).
Dr. Backman's testimony revealed that he had a limited understanding of the facts of this case and SJS generally. For example, the only source of information concerning SJS he reviewed for this matter was a medical information program called UpToDate. (Backman Dep. at 12:5-21). He was unable to identify the criteria used to diagnose SJS, and has neither diagnosed nor treated any patients with SJS. (Id. at 63:8-12; 68:9-23). He never communicated with Carrozza's medical providers (id. at 15:6-9) and reviewed no medical records other than documents from Morton Hospital and two or three days' worth of notes from Dr. Despines (id. at 15:11-19:2). He did not review photographs taken at Morton Hospital of Carrozza's rashes. (Id. at 22:15-18). Dr. Backman did not review the deposition testimony of Carrozza or CVS personnel. (Id. at 19:4-20:12). He did not know that Carrozza had been prescribed quinolone on multiple occasions prior to April 22, 2015, (id. at 71:13-19), and that Carrozza himself purportedly was unaware of a quinolone allergy before that date (id. at 70:17-20). And, he was unaware of the responsibilities of a CVS pharmacist and the standard of care required of pharmacists who encounter hardstop and softstop warnings. (Id. at 85:14-19; 87:5-11).
CVS has presented three expert reports concerning the issues of standard of care and causation. As relevant here, Melissa Mattison, a pharmacist and Clinical Associate Professor of Pharmacy Practice, has attested that Wokoske acted in accordance with the appropriate standard of care and that Carrozza did not suffer from SJS. (ECF No. 62, Ex. 9). Dr. Daniela Kroshinsky, the Director of Inpatient Dermatology
B. Procedural Background
On May 1, 2015, Carrozza sent CVS a purported Chapter 93A demand letter seeking $650,000 in damages. (Am. Compl. Ex. A). CVS sent a response on July 8, 2015, challenging the demand letter as improper under Chapter 93A because it "fail[ed] to reference the date of the alleged incident" and "fail[ed] to identify any cognizable unfair or deceptive act or practice." (Am. Compl. Ex. B). CVS also disclaimed liability, contending that Dr. Despines was at fault for prescribing the medication and that Carrozza's failure to advise Wokoske of the allergy exceeded any negligence by CVS. (Id. ).
The complaint in this action was filed in Brockton District Court on October 13, 2017. CVS removed the case to this court based on diversity jurisdiction on December 1, 2017. The complaint asserts three claims. Count One asserts a claim for "tort," which the Court will construe to be a claim for negligence. (Am. Compl. ¶¶ 4-17). Count Two asserts a claim under Mass. Gen. Laws ch. 93A. (Id. ¶¶ 18-25). Count Three asserts a claim for product liability, which is in substance a claim for breach of implied warranty. (Id. ¶¶ 26-32).
CVS has moved to preclude the testimony of Dr. Backman under Fed. R. Evid. 702 and Daubert v. Merrell Dow Pharm., Inc. ,
II. Motion to Preclude
Fed. R. Evid. 702 provides as follows:
A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.
Fed. R. Evid. 702. The adoption of Rule 702 in its present form codified the standard of admissibility for expert testimony that was set forth in Daubert. See United States v. Diaz ,
Under Rule 702, district courts considering the admissibility of scientific testimony must "act as gatekeepers, ensuring that an expert's proffered testimony 'both rests on a reliable foundation and is relevant to the task at hand.' " Samaan v. St. Joseph Hosp. ,
The requirement that an expert's testimony must be based on a reliable scientific foundation is often the "central focus of a Daubert inquiry." Ruiz-Troche v. Pepsi Cola of P.R. Bottling Co. ,
Rule 702 further requires the court to examine whether those methods have been reliably applied. In other words, the court must "ensure that there is an adequate fit between the expert's methods and his conclusions." Samaan ,
The focus of the Rule 702 inquiry is on the principles and methodology employed by the expert, not the ultimate conclusions. Daubert ,
It is manifestly clear that Dr. Backman is not qualified to offer an expert opinion on either the appropriate standard of care for a pharmacist or whether Carrozza's consumption of Levaquin caused his injuries, particularly the alleged SJS. As noted, Dr. Backman testified that he could not testify as to whether Wokoske complied with the appropriate standard of care in this case. (Backman Dep. at 94:2-96:19). While he had reviewed some literature on SJS before his deposition, his knowledge of that disorder was minimal and the sole basis for his belief that Carrozza had suffered SJS as a result of consuming
In his opposition, Carrozza raises two arguments, neither of which is persuasive. First, he cites to Cottam v. CVS Pharmacy ,
Second, Carrozza contends that the fact that the Court has precluded admission of Dr. Foster's affidavit does not bar Dr. Backman from relying on it in formulating his own opinion. (Pl. Mem. in Opp. to Mot. to Preclude at 7). In support, he cites Dep't of Youth Servs. v. A Juvenile ,
Here, Dr. Backman conceded that he had almost no understanding of the facts of this case and could not conclude that Carrozza's ingestion of Levaquin resulted in his injuries, including SJS. It should be obvious that Dr. Backman cannot be permitted to testify that Carrozza was afflicted with SJS, regardless of Dr. Foster's opinion.
In summary, Dr. Backman is not qualified to render the opinions at issue, and his opinions are not based on adequate data. His conclusions therefore amount to mere "assumptions, speculation[,] and guesswork," and his testimony must be excluded under Rule 702. Polaino v. Bayer Corp. ,
III. Motions for Summary Judgment
A. Standard of Review
The role of summary judgment is to "pierce the pleadings and to assess the proof in order to see whether there is
B. Analysis
1. Count One-Negligence
To prevail on a negligence claim, a plaintiff must prove by a preponderance of the evidence "(1) a legal duty owed to the plaintiff by the defendant; (2) a breach of that duty by the defendant; (3) causation; and (4) actual loss by the plaintiff." Delaney v. Reynolds ,
Carrozza nevertheless contends that no expert testimony on this issue is required. He appears to reason that the hardstop warning constituted a sufficient warning that no reasonable pharmacist would have dispensed the Levaquin. (Pl. Mem. in Supp. of Mot. for Partial SJ at 6). He argues that "the determination [to dispense] did not involve professional or technical knowledge for which a jury need[s] expert aid. Rather, it involved a commonsense determination." (Id. at 7). However, that misconstrues the central issue underlying the negligence claim-whether it was a breach of duty for Wokoske to dispense Levaquin despite the hardstop warning. Carrozza has put forth no evidence of any kind that a hardstop warning absolutely bars a pharmacist from dispensing prescribed medication. Indeed, the only evidence in the record concerning hardstop warnings is that they require pharmacists to investigate further. (Wokoske Dep. at 53:10-12). Here, Wokoske saw that Carrozza
Furthermore, and in any event, in Massachusetts expert testimony is required "on highly technical medical issues," including "injury causation." Lally v. Volkswagen Aktiengesellschaft ,
In short, in the absence of any expert testimony as to breach of duty or causation, summary judgment will be granted to CVS on the negligence claim.
2. Count Three-Product Liability
Before turning to the Chapter 93A claim, the Court will first address the product liability claim. Carrozza's product liability argument is so thinly briefed and difficult to comprehend that there is a strong argument for waiver. See United States v. Zannino ,
As a preliminary matter, it appears that Carrozza advanced a strict liability theory of recovery in his amended complaint. He first cited Everett v. Bucky Warren, Inc. ,
However, "[i]n Massachusetts, 'there is no strict liability in tort apart from liability for breach of warranty under the Uniform Commercial Code.' " Cruickshank v. Clean Seas Co. ,
Where a plaintiff brings a product liability action premised on a breach of the implied warranties of merchantability or fitness for a particular purpose, he must show that "[the] defendant manufactured or sold the product that injured [him]." Fireman's Fund Ins. Co. v. Bradford-White Corp. ,
However, the UCC applies only to contracts for the sale of goods. See White v. Peabody Constr. Co., Inc. ,
It is pure hyperbole to suggest, as does plaintiff, that the role of the pharmacist is similar to that of a clerk in an ordinary retail store. With a few exceptions, only a licensed pharmacist may dispense prescription drugs, and as indicated above there are stringent educational and professional requirements for obtaining and retaining a license.
...
A key factor is that the pharmacist who fills a prescription is in a different position from the ordinary retailer because he cannot offer a prescription for sale except by order of the doctor. In this respect, he is providing a service to the doctor and acting as an extension of the doctor in the same sense as a technician who takes an X-ray or analyzes a blood sample on a doctor's order.
Murphy v. E.R. Squibb & Sons, Inc. ,
Where, as is here, the underlying sequence of events gives rise to a mixed contract claim, the court must determine whether the contract is predominately one for goods or services. "The test is whether the predominant factor, thrust, or purpose of the contract is (1) the rendition of service, with goods incidentally involved, or is instead (2) a transaction of sale, with labor incidentally involved." Cumberland Farms, Inc. v. Drehmann Paving & Flooring Co. ,
It is undisputable that Wokoske's dispensing of Levaquin was primarily a "rendition of service" immune from the UCC's liability scheme. The Levaquin was prescribed by Dr. Despines; Wokoske had discretion in deciding to ultimately fill the prescription after seeing the hardstop warning, but no input into the suitability of the drug. Cf. In re Rezulin Prods. Liab. Litig. ,
In his opposition memorandum, Carrozza raises a number of disjointed arguments, many of which are poorly developed or irrelevant. (See, e.g. , Pl. Opp. to Def. Mot. for SJ at 4-6 (again disputing the Court's ruling excluding Dr. Foster's affidavit and criticizing defense counsel's citing to out-of-state authorities). To the extent his arguments are on point, they are unpersuasive.
First, Carrozza contends that "CVS knew [that the Levaquin ] was defective, or at least had evidence that [the] product was defective for Mr. Carrozza and failed to warn." (Id. at 3). But nowhere in the amended complaint did Carrozza allege, or even suggest, that this was a failure-to-warn case. A litigant may not posit a theory for the first time in opposition to a summary judgment motion, so this argument must be rejected. See Brooks v. AIG SunAmerica Life Assur. Co. ,
Next, he contends that the Levaquin was defective because a consumer like him would have expected not to suffer an allergic reaction from consuming the drug. (Pl. Opp. to Def. Mot. for SJ at 4). In support, he cites Back , in which the SJC reversed a jury's verdict in favor of the defendant as to certain warranty claims.
3. Count Two-Chapter 93A
Chapter 93A prohibits "[u]nfair methods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce." Mass. Gen. Laws ch. 93A, § 2(a). Conduct is unfair or deceptive if it falls "within any recognized or established common law or statutory concept of unfairness." VMark Software v. EMC Corp. ,
Carrozza has identified no basis for a Chapter 93A claim other than the negligence and product-liability claims rejected above.
IV. Motion to Take Deposition
In an attempt to avoid summary judgment, Carrozza has also moved to conduct an audiovisual deposition of Dr. Foster to be played at trial. He contends that "this expert testimony ... is now needed" because CVS has proffered three expert witnesses. (Pl. Mem. in Supp. of Mot. to Take Deposition at 3). He further blames Dr. Backman for "attitude" and "his lack of preparation" in giving deposition testimony. (Id. ).
This is clearly an improper attempt to reopen discovery. It is true that Rule 56, which governs summary judgment, provides that a court may "allow time to obtain affidavits or declarations or to take discovery" if "a nonmovant shows ... it cannot present facts essential to justify its opposition." Fed. R. Civ. P. 56(d)(2).
V. Motion to Strike
Finally, Carrozza has moved to strike certain statements made by defense counsel at the May 16, 2019 motion hearing. As the Court has not relied on those statements in addressing the other outstanding motions, the motion to strike will be denied as moot.
VI. Conclusion
For the foregoing reasons, defendant's motion to preclude and motion for summary judgment are GRANTED. Plaintiff's motion for partial summary judgment and motion to take Dr. Foster's deposition are DENIED. Plaintiff's motion to strike is DENIED as moot.
So Ordered.
Notes
SJS is a "serious skin disorder," which if treated properly, "can be eliminated within a few days of hospitalization, but severe cases may last several months." Houston v. United States ,
If in fact Carrozza had a cold, rather than a bacterial infection, antibiotics would not have any effect, either curative or palliative. See [cite from CDC]
Dr. Despines's notes as of May 15, 2015, only stated that Carrozza was allergic to "Tetracycline HCl" and "sulfa." (Id. ).
According to Wokoske, a "hardstop" warning requires a pharmacist to conduct "more research on the patient." (Wokoske Dep. at 53:10-12). By contrast, a "softstop" warning suggests that the information in question "may have been checked before" and that the pharmacist may "be able to go by it." (Id. at 53:13-16). Hardstop warnings are stronger than softstop warnings. (Id. at 53:17-19).
The three softstop warnings in Carrozza's file were as follows: (1) a warning about Levaquin's potential interaction with another drug, Escitalopram, (ECF No. 70 at 19); (2) a warning that Levaquin should be used cautiously when "Myocardial Ischemia exists," (id. at 20); and (3) a warning that "[t]he concurrent use of multiple agents that prolong the QTc interval may result in potentially life-threatening cardiac arrhythmias," (id. at 21). None of the softstop warnings are at issue here.
Carrozza later moved to admit Dr. Foster's affidavit under Fed. R. Evid. 803(4) &(6). (ECF No. 58). However, because he again failed to comply with the Federal Rules of Civil Procedure governing expert disclosures, his motion was denied. (ECF No. 61).
Carrozza's supporting memorandum is unclear as to the claims on which he is seeking partial summary judgment. However, he appears to suggest that CVS failed to warn him about the dangers of Levaquin.
Carrozza cites to testimony in Dr. Backman's deposition in which he testified that Wokoske breached an applicable standard of care in filling Carrozza's Levaquin prescription. (Backman Dep. at 147:20-148:15). He appears to contend that this testimony precludes summary judgment on the negligence claim. (Pl. Mem. in Opp. to Mot. to Preclude at 8). But, as explained earlier, Dr. Backman also testified that he was not qualified to state whether Wokoske's conduct met the applicable standard of care. (Backman Dep. at 94:2-96:19). Therefore, this additional argument Carrozza advances is unavailing.
Carrozza contends that there was a Chapter 93A violation because CVS "fail[ed] to notify" him and Dr. Despines about the dangers of Levaquin. (Pl. Opp. to Def. Mot. for SJ at 7). However, this is simply a reframing of the failure-to-warn theory that he introduced for the first time on summary judgment.
Of course, Carrozza also moved for partial summary judgment. However, even if Carrozza was a nonmovant, that would not affect the disposition of this motion.
