Mulhall v. Hannafin

45 A.D.3d 55, 841 N.Y.S.2d 282
CourtAppellate Division of the Supreme Court of the State of New York
DecidedAugust 30, 2007
StatusPublished
Cited by28 cases

This text of 45 A.D.3d 55 (Mulhall v. Hannafin) is published on Counsel Stack Legal Research, covering Appellate Division of the Supreme Court of the State of New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mulhall v. Hannafin, 45 A.D.3d 55, 841 N.Y.S.2d 282 (N.Y. Ct. App. 2007).

Opinion

OPINION OF THE COURT

Sullivan, J.

In this products liability action, plaintiff Victoria Mulhall is alleged to have developed inflammatory conditions known as adhesive capsulitis and synovitis after having arthroscopic shoulder surgery, during which a surgical device was implanted in her right shoulder. The device, known as Suretac, a Smith & Nephew product, is a bioabsorbable tack (in layman’s terms, an absorbable thumbtack) designed to fix or stabilize the attachment of the labrum to the bone and to dissolve slowly within the body, in a manner similar to absorbable sutures. As explained in the record, as the body heals the Suretac slowly dissolves within the joint while continuing to hold the shoulder together, so that by the time the healing process is completed, all that remains in the shoulder is the labrum attached to the bone. The use of Suretac obviates the need for an additional procedure to remove the tack.

All of this plaintiffs claims against Smith & Nephew—design defect, manufacturing defect, breach of warranty, punitive damages, and negligence and strict liability to the extent they are premised on allegations of manufacturing or design defect— have been dismissed on a grant of summary judgment in the order on appeal, except for the failure-to-warn claim. As to the latter, Supreme Court, in denying summary judgment, found that Smith & Nephew had not made a sufficient showing of the adequacy of its warning to warrant summary judgment.

Mrs. Mulhall allegedly injured her shoulder in November 1998 while pulling a heavy box from an overhead shelf; she felt a “pop” in her right shoulder and immediately experienced “dead arm” symptoms. Diagnosed with a torn labrum, she underwent an arthroscopic procedure performed by defendant Hannafin at defendant Hospital for Special Surgery in February 1999, after which she made steady rehabilitative progress, encountering no [57]*57difficulties until some three months later, when she allegedly began to experience a loss of range of motion in her shoulder. An MRI revealed the existence of an acute localized reactive synovitis in the area of the Suretac. As a result, Dr. Hannafin performed another procedure in July 1999 for a “frozen” shoulder and Suretac-related synovitis. Mrs. Mulhall continues to complain of pain and commenced this action in August 2003 against Dr. Hannafin and the hospital, alleging medical malpractice and lack of informed consent, and against Smith & Nephew, alleging strict products liability and the other claims previously noted.

At the conclusion of discovery, Smith & Nephew moved for summary judgment dismissing the complaint against it, arguing that the “undisputed facts demonstrate that the Suretac in Mrs. Mulhall’s shoulder, in all respects, functioned and performed properly and that Smith & Nephew issued appropriate warnings regarding possible adverse reactions, including the exact type of inflammatory response claimed by plaintiffs.” In support of its motion, Smith & Nephew submitted a copy of the package insert accompanying every Suretac, which warned of the following “ADVERSE REACTIONS”:

“As with any bioabsorbable implant, there is a chance of an inflammatory response during the degradation period of the device. A transient inflammatory reaction has been observed in some patients during the second or third post-operative month.
This reaction, which may be associated with polymer breakdown, appears to be self limiting or responds to non-steroidal anti-inflammatory medications in conjunction with physiotherapy. Additional complications are those seen with any method of internal fixation.”

Dr. Hannafin testified that Suretac was the only fixation device she used to repair a labral separation, and that her criteria for selecting Suretac over other devices were that it had been used safely in her procedures since 1992, and that medical literature had documented its effectiveness without any side effects.

Plaintiffs’ expert, whose identity has been redacted, was of the opinion that the Suretac package insert failed to give adequate warning of the severity of the adverse reaction that might occur from the implantation of Suretac in the manner recommended by Smith & Nephew, including the possibility that the [58]*58transient inflammation could in fact evolve into a permanent inflammatory reaction. He also stated that any postoperative synovitis might progress to adhesive capsulitis, significant scarring and a frozen shoulder, requiring manipulation and repeat surgical intervention.

As noted, the motion court dismissed all the claims against Smith & Nephew except for failure to warn, finding that while the motion was supported by a copy of the above-quoted package insert, it offered only excerpts of Dr. Hannafin’s deposition testimony and not an “affidavit of an expert, much less one who is familiar with Suretac or its risks, or . . . [an] affidavit of anyone from the company.” (2006 NY Slip Op 30209[U], at *3.) In that regard, the court noted “[t]here is no indication . . . that Dr. Hannafin . . . was aware that the risks associated with Suretac were other than fleeting” (id. at *6-7). We reverse.

To succeed on their failure-to-warn claim, plaintiffs were required to prove that the product did not contain adequate warnings and that the inadequacy of those warnings was the proximate cause of the injuries (Glucksman v Halsey Drug Co., 160 AD2d 305, 307 [1990]). The manufacturer’s duty, under New York law, is to warn the medical community, not the patient (id.) of the product’s risk. The warning must provide sufficient information to that class of prescribing physicians “who may be expected to have the least knowledge and experience with the” product (Martin v Hacker, 83 NY2d 1, 9 [1993]).

Whether the cause of action for failure to warn is based on negligence or strict liability, the courts of this state have consistently held that a manufacturer’s duty is to warn only of those dangers it knows of or are reasonably foreseeable (see Rastelli v Goodyear Tire & Rubber Co., 79 NY2d 289, 297 [1992]). Knowledge, actual or constructive, of a danger inherent in a product is an essential factor in determining whether a manufacturer is liable (see e.g. Goldberg v Union Hardware Co., 162 AD2d 658, 659 [1990]). The lack of such knowledge is fatal to a failure-to-warn claim, and in the absence thereof, summary judgment is warranted (see Daley v McNeil Consumer Prods. Co., a Div. of McNeil-PPC, Inc., 164 F Supp 2d 367, 373 [SD NY 2001]).

As the record shows, the warning on Smith & Nephew’s Suretac package insert reflected—and thereby conveyed to prescribing physicians—the most current knowledge available concerning the potential risks associated with the product, which is all that the law requires (see Lindsay v Ortho Pharm. Corp., 637 F2d 87, 91 [2d Cir 1980]). In fact, as plaintiffs conceded, Smith [59]*59& Nephew changed its warning level in 1997, only two years before Mrs. Mulhall’s surgery, in response to only six reports, at most, of transient inflammatory reactions, while selling between 10,000 and 20,000 Suretacs each year. Furthermore, as the record shows, Smith & Nephew did not receive any reports of adverse effects from the use of Suretac, other than the six reports that brought about the revised warning of 1997.

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Cite This Page — Counsel Stack

Bluebook (online)
45 A.D.3d 55, 841 N.Y.S.2d 282, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mulhall-v-hannafin-nyappdiv-2007.