Opinion
CIVIL ACTION No. 06-11217-RGS.
August 30, 2007
MEMORANDUM AND ORDER ON HILL LABORATORIES, INC.'S MOTION FOR SUMMARY JUDGMENT
Plaintiff Patricia Haughton brought suit in the Massachusetts Superior Court against defendant Hill Laboratories, Inc. (Hill), the maker of Tri-Luma, a topical prescriptive cream. Haughton alleges that the cream caused "burning" and the "permanent scarring" of her facial skin. Hill, a Florida corporation, removed the case to the federal district court on diversity grounds. After the close of discovery, Hill moved for summary judgment on all claims of Haughton's lawsuit. Haughton has not opposed the motion.
Haughton's Amended Complaint asserts four claims: Count I alleges a negligent failure on the part of Hill to warn; Count II alleges a breach of the implied warranty of merchantability; Count III alleges a breach of the implied warranty of fitness for a particular purpose; and Count IV alleges the intentional infliction of emotional distress.
Even in the absence of an opposition, a district court may grant summary judgment against the nonresponding party only "if appropriate." Mullen v. St. Paul Fire and Marine Ins. Co., 972 F.2d 446, 452 (1st Cir. 1992). See also Fed.R.Civ.P. 56(e). "Under this provision it is clear that where the evidentiary matter in support of the motion does not establish the absence of a genuine issue, summary judgment must be denied even if no opposing evidentiary matter is presented." NEPSK, Inc. v. Town of Houlton, 283 F.3d 1, 7 (1st Cir. 2002).
BACKGROUND
The following are the material undisputed facts as presented by Hill. As Haughton has offered no opposition to Hill's statement of facts, the court will deem them to be admitted. Hill manufactures a dermatological product known as Tri-Luma Cream (Tri-Luma). Gottschalk Aff. ¶ 6. Tri-Luma is a Food and Drug Administration (FDA) approved drug. It is manufactured in compliance with the Current Good Manufacturing Practice[s] prescribed by 21 C.F.R. §§ 210 and 211. The active ingredients of Tri-Luma are fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%. Gottschalk Aff. ¶ 6.The label for Tri-Luma complies with FDA informational requirements. Clark Aff. ¶ 16. The label contains a description of the product and includes information about clinical pharmacology, usage, contraindications, warnings and precautions, adverse reactions, possible dependence, and recommended dosages. Clark Aff. ¶¶ 12 and 17. This type of product labeling is required by the FDA as part of the approval process for any "New Drug Application." Clark Aff. ¶ 14.
Tri-Luma is prescribed for the short-term intermittent treatment of moderate to severe melasma of the face. Gottschalk Aff. ¶ 8. Melasma is a hyperpigmentation disorder of the skin seen more commonly on the faces of females. Id. at ¶ 9. In March of 2003, Haughton was seen by Dr. Katheryn Bowers at Dermatology Associates of Concord, Inc., who prescribed Tri-Luma for "pigmentation changes in certain areas of her body." Haughton applied Tri-Luma directly to her face without reading the written instructions and the warnings that came with the drug. At her deposition, Haughton testified that she did not know the name of the company that manufactured Tri-Luma, and had never communicated with Hill about the proper application or use of Tri-Luma. Haughton Dep. at 197. Haughton could not remember the number of times that she had applied Tri-Luma to her face. Id. at 167. Haughton alleges, however, that on an unspecified occasion after having used Tri-Luma at bedtime, she awoke the next morning with red marks on her cheeks. Id. at 81.
Haughton filed the original Complaint against Hill on March 24, 2006. She filed the Amended Complaint in the federal district court on June 20, 2006. When asked by way of an Interrogatory to "describe each and every alleged defect in Tri-Luma that caused her injuries," Haughton replied that "the product did not work as intended, nor did it forewarn her that it was defective and would result in unfavorable, permanent side effects." Haughton further answered that "[d]ue to insufficient warnings and consequences associated with the medication, she has suffered permanent disfigurement and scarring." Hill Ex. 5, Plaintiff's Response to Interrogatories Nos. 9 and 13. When asked to "state each and every way in which the information provided with Tri-Luma was inadequate and to set forth with specificity what warnings or instructions should have been provided," Haughton replied that "the Defendant neglected to properly inform her and all consumers of the detrimental side effects and disfigurement that would occur by using said product," and that the "failure to provide adequate warnings, precautions and/or instructions resulted in the injuries suffered by Haughton." Hill Ex. 2, Plaintiff's Interrogatory Response No. 14.
Haughton initially brought suit on October 14, 2004, against Dr. Bowers and a second personal physician, Dr. Merill Liteplo. The evidence against the physicians failed to pass muster at a state Medical Malpractice Tribunal. The case against the physicians was dismissed when Houghton failed to post the bond required by Mass. Gen. Laws c. 231, § 60B. See Perez v. Bay State Ambulance Hosp. Rental Service, Inc., 413 Mass. 670, 677 (1992) (court may reduce but not eliminate the bond).
DISCUSSION
Summary judgment is appropriate when, based upon the pleadings, affidavits, and depositions, "there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Gaskell v. Harvard Co-op Soc., 3 F.3d 495, 497 (1st Cir. 1993).
Count I — Negligent Failure to Warn
Massachusetts adheres to the "learned intermediary rule." The rule relieves prescription drug manufacturers of the duty to warn a patient of the possible side effects of a drug where it has adequately informed the prescribing physician of any associated risks. MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 135 (1985). See also Garside v. Osco Drug, Inc., 976 F.2d 77, 81 (1st Cir. 1992) ("Under this doctrine, the manufacturer's duty is fulfilled once it adequately warns the physician."); Knowlton v. Deseret Med., Inc., 930 F.2d 116, 119-120 (1st Cir. 1991) ("It is generally accepted that in a case involving medical products prescribed or used by a physician or trained medical personnel, the warning runs to the physician not the patient.").
There is no evidence suggesting that Hill failed to warn Haughton's physicians of the possible complications that might arise from the use (or misuse) of Tri-Luma or that the instructions and warnings that were provided would not have placed the average dermatologist on notice of these risks. See Lareau v. Page, 840 F. Supp. 920, 932 (D. Mass. 1993) (distinguishing Garside where it was undisputed that the defendant pharmaceutical company failed to warn a physician of a drug's possible side-effects). There is also no evidence that Houghton's doctors were unaware of the risks or that their decision to prescribe Tri-Luma for Houghton would have been influenced by any additional instructions or warnings. Id. at 932-933. Finally, because Haughton never read the information and warnings that came with her prescription of Tri-Luma, "inadequate warnings" could not have been the cause of her purported injuries. Wasylow v. Glock, Inc., 975 F. Supp. 370, 378 (D. Mass 1996) ("[A]s with all negligence actions, failure to warn will not constitute negligence if it is not a proximate cause of the injuries.").
Count II and Count III — Breach of Implied Warranty Claims
Count II of Haughton's Amended Complaint alleges a breach of the implied warranty of merchantability. Count III alleges a breach of the implied warranty of fitness for a particular purpose. Massachusetts law with respect to an implied warranty "is congruent in nearly all respects with the principles expressed in Restatement of Torts (Second) at § 402A."Commonwealth v. Johnson Insulation, 425 Mass. 650, 653-654 (1997), quoting Back v. Wickes Corp., 375 Mass. 633, 639-640 (1978). A seller breaches its warranty obligations when a product that is defective and unreasonably dangerous for the ordinary purposes for which it is intended causes injury. Haglund v. Philip Morris, Inc., 446 Mass. 741, 746 (2006). See also Correia v. Firestone Tire Rubber Co., 388 Mass. 342, 355 (1983) (unlike negligence liability, warranty liability "focuses on whether the product was defective and unreasonably dangerous and not on the conduct of the user or the seller."). Because Haughton has offered no evidence to establish that Tri-Luma was defective or unreasonably dangerous, her warranty claim must fail. See Collins v. Sears, Roebuck and Co., 31 Mass. App. Ct. 961, 962 (1992) (a plaintiff has the burden of showing that a defect existed in the product at the time of sale).
In addressing the issue of a possible defect, Haughton's only evidence is her own statement that "the product did not work as intended." See Hill Ex. 5, Plaintiff's Response to Interrogatory No. 9. In a products liability case of any sophistication, a plaintiff's failure to support her claims of a design defect with expert testimony is almost always fatal. Morrell v. Precise Eng'g, Inc., 36 Mass. App. Ct. 935, 936 (1994) (expert opinion is not required in a products liability case only if "a jury can find of their own lay knowledge that there exists a design defect which exposes users of the product to unreasonable risk of injury."). Cf. Goffredo v. Mercedes-Benz Truck Co., Inc., 402 Mass. 97, 103-104 (1988) ("An expert opinion, stated in terms of possibilities, does not satisfy the plaintiff's burden of proof, namely, to establish by a preponderance of the evidence the existence of a design defect which caused the plaintiff's injuries.").
Moreover, without expert opinion, Haughton cannot meet her burden of showing that her injuries were proximately caused by a defect in Tri-Luma. It is well-settled in Massachusetts that "because understanding medical causation is 'beyond the . . . knowledge of the ordinary layman . . . proof of it must rest upon expert medical testimony.'" Canavan's Case, 432 Mass. 304, 316 (2000), quoting Hachadourian's Case, 340 Mass. 81, 85 (1959). See also Enrich v. Windmere Corp., 416 Mass. 83, 87 (1993) (the opinion testimony of non-experts is no substitute for expert testimony). Count IV — Intentional Infliction of Emotional Distress
An implied warranty of fitness for a particular purpose exists only where at the time of contracting, the seller has reason to know of a particular purpose for which the goods are required and the buyer relies on the seller's skill or judgment to select or furnish goods suited to that purpose. Mass. Gen. Laws c. 106, § 2-315. See Commonwealth v. Johnson Insulation, 425 Mass. 650, 653-654 (1997); Fernandes v. Union Bookbinding, 400 Mass. 27, 33-36 (1987). There is no evidence in the record to support this alternate theory of implied warranty as set out in Count III.
Under Massachusetts law, a plaintiff who alleges intentional infliction of emotional distress must prove: (1) that the defendant intended to inflict emotional distress or that it knew or should have known that emotional distress would be the likely result of its conduct; (2) that the conduct was extreme and outrageous; (3) that the actions of the defendant were the cause of the plaintiff's distress; and (4) that the emotional distress sustained was severe. Haddad v. Gonzalez, 410 Mass. 855, 871 (1991). The intentional tort requires evidence of acts that are reasonably viewed as an attempt "to shock and harm a person's peace of mind," or if not individually such, are part of a pattern of harassment intended to accomplish that same end.Ratner v. Noble, 35 Mass. App. Ct. 137, 139-140 (1993). See also Foley v. Polaroid Corp., 400 Mass. 82, 99 (1987) ("appalling" conduct is required to trigger the tort); Conway v. Smerling, 37 Mass. App. Ct. 1, 8 (1994) (same, "profoundly shocking" conduct).
Whether a defendant's conduct is "beyond all bounds of decency and . . . utterly intolerable in a civilized community" is an issue of law to be decided by the trial court. Sena v. Commonwealth, 417 Mass. 250, 264 (1994). See also Capouto v. Boston Edison Co., 924 F.2d 11, 14 (1st Cir. 1991) (summary judgment appropriate where plaintiff made only conclusory allegations of emotional distress). Because Hill cannot be held liable for the marketing of a defective drug, much less doing so recklessly or deliberately, it follows that there can be no basis upon which it could be found to have caused Haughton intentional emotional distress.
ORDER
For the foregoing reasons, defendant Hill's motion for summary judgment is ALLOWED. The Clerk will enter judgment for Hill and the case will be terminated.
SO ORDERED.