To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to step back and review the major New York decisions that have impacted the industry which may shape the year ahead.   Following are several key judicial holdings in New York from 2017 pertaining to:  

• Preemption of PMA Medical Device
• Learned Intermediary Doctrine in Hip Fixation
• Speculative Expert Witness Opinion Evidence of Device Fracture
• Sales Representative Liability for Injectable Device
• Expert Opinion on General Causation Required in Drug MDL

PMA Device Claims Preempted

Implanted neurostimulator medical device approved under FDA’s premarket approval regulations (PMA) gave plaintiff a shock which allegedly caused a fractured hip. Plaintiff’s claims of strict liability and negligence, premised upon design, manufacturing and labeling defects were preempted.  Claims of breach of express and implied warranty were not established under New York law.  Recognizing the split in the circuits on the issue of whether Current Good Manufacturing Practices (cGMPs) are specific FDA regulations on which a parallel violation claim can be based, the federal court found that the federal violations alleged were not sufficiently specific to overcome preemption. Babayez v. Medtronic, Inc., 2017 WL 90403 (E.D.N.Y. Jan. 5, 2017).

Potential implication for future cases: State law claims premised on a violation of cGMPs have the potential to create varying standards that would be different from, or in addition to those required by the federal scheme; this is one more decision on the side of split providing that such claims should be preempted.

Hip Fixation Device Label Adequate; Learned Intermediary’s Independent Awareness of Risk Severed Causal Connection

New York federal court adopted Magistrate’s Report and Recommendation granting FRCP R. 56 summary judgment on behalf of greater trochanter fixation medical device manufacturer and distributor, holding that decision of a physician, as a learned intermediary, not to inform the patient of the risk of medical device fracture does not support the physician’s lack of awareness of the risk, and the surgeon’s independent awareness of the risk severed the required causal connection between an alleged failure to warn and plaintiff’s injury.  Moreover, the instructions for use referred specifically to cable breakage and as such were adequate as a matter of law.  The failures to identify a product defect and offer expert evidence of alternative feasible design or deviation from defendants’ design and engineering specifications were fatal to design and manufacturing defect claims, required summary judgment on negligence and strict product liability claims and breach of implied and express warranty. Tomaselli v. Zimmer, 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017).    Case litigated by Harris Beach attorney Judi Abbott Curry.

Potential implication for future cases: This decision in New York’s Southern District on the adequate warnings of medical device fracture joins the other three New York federal district courts in noting that the mere fracture of the medical device does not impute product defect.  It is incumbent upon plaintiff in the medical device product liability action to offer expert witness evidence to establish proof of product defect.  Moreover, the learned intermediary need not have reviewed product labeling if there is independent awareness of the risk of device fracture.

Endovascular Medical Device Not Defective; Expert Proof Speculative

In a medical device product liability case brought in New York state court on behalf of a severely brain-damaged plaintiff, arising from the fracture of two endovascular retrieval devices used to capture a foreign body (a migrated coil) during an interventional radiology procedure under fluoroscopic guidance, a New York Supreme Court granted summary judgment on all claims, including design defect, failure to warn and breach of warranty. Trial court held that device manufacturer established prima facie evidence that the product labeling conveyed adequate warnings and dismissed the design defect claim on the basis that the endovascular retrieval device was state of the art. While plaintiff’s experts alluded to their own fracture “tests and experiments,” performed under undisclosed conditions, and without providing any data on which the conclusions were based, and failing to even establish that their tests and experiments were based upon accepted industry standards, the court concluded that the expert witness opinion of an unreasonable risk of device fracture was speculative and conclusory, unsupported by any scientific basis, statistics, analysis or empirical data, as the experts failed to disclose the experimental data and test conditions used to generate their opinions.  Ford v. Riina, No. 805242-2012, 2017 WL 1709471 (Sup. Ct. N.Y. Cty, May 2, 2017).  Case litigated by Harris Beach attorney Judi Abbott Curry.

Potential implication for future cases: This decision underscores the importance of expert witness opinion that is grounded in the  scientific method.  Not only must parties support scientific theories with empirical data, but when subjecting a product to litigation-driven tests, the experts must disclose and describe the testing performed and attest that those tests are “generally accepted” in the scientific community, under the Frye rule.

Medical Device Product Liability; Sales Representative Liability

New York state court dismissed dermal filler manufacturer in a combination medical device/medical malpractice action where plaintiff alleged the manufacturer had a duty to ensure the device was used in accordance with FDA guidelines and that its sales representative, who was in the room during plaintiff’s treatment, gave advice and instruction regarding the use of the device.  In granting the medical device manufacturer’s motion to dismiss premised upon failure to state a cause of action, the court recognized that plaintiff could not assert medical malpractice and lack of informed consent claims against a medical device manufacturer, since a manufacturer neither practices medicine nor has a duty to inform a patient of the risks and benefits of a particular treatment. Although plaintiff’s allegations stemmed from the sales representative’s alleged failure to ensure that the physician used the device in a safe manner, according to their own guidelines and the guidelines of the FDA, the court held that while the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.  As such, the representative is not responsible for ensuring the physician uses the device in a particular manner. Greenwood v. Tehrani, 2017 WL 4083099, 2017 NY Slip Op 31963(U) (Sup. Ct. N.Y. Cty, September 15, 2017).  Case litigated by Harris Beach attorney Judi Abbott Curry.

Potential implication for future cases: This decision sets a precedent to dismiss medical device product liability claims based on a sales representative’s statements, especially where, as here, medical malpractice claims are masked as product liability claims.

Absence of General Causation Evidence in IUD Contraceptive MDL

In multi-district litigation (MDL) involving drug eluding intrauterine device (IUD), multiple plaintiffs appealed from an opinion and order of the Southern District of New York which excluded their expert witness opinion evidence on general causation and then granted summary judgment to Bayer Pharmaceuticals, thereby ending the MDL.  General causation evidence consisted of Bayer employee statements, a label change and expert opinion.  Applying Daubert, the District Court excluded plaintiffs’ expert opinions as they assumed the existence of the very fact in dispute, and then worked backwards to hypothesize a mechanism by which it might occur. The experts’ opinions had all been developed for the purpose of litigation, their tests were not replicable and had no known error rates, were not subject to peer review and were not generally accepted in the scientific community. In the absence of expert witness opinion on general causation, summary judgment was granted. The Second Circuit affirmed, noting that the theories proffered by plaintiffs’ experts were not accepted in the wider obstetrics and gynecological scientific community. The experts lacked pre-litigation expertise in the condition at issue and developed their theories for the purposes of the litigation. Without direct support in the literature and having conducted no prior research on the subject, the experts all assumed the existence of the very phenomenon in dispute and then hypothesized how it could occur. Additionally, the putative admissions proffered by plaintiffs from Bayer employees (employee emails, internal PowerPoint presentations, testimony from an employee acknowledging the possibility of causation) and a 2014 label change, were not a substitute for expert testimony and were insufficient to establish general causation.  In Re Mirena IUD Products Liability Litigation, 2017 WL 4785947 (2d Cir. October 24, 2017).

Potential implication for future cases: In adjudicating this dispositive motion in a drug product liability MDL, the Second Circuit observed that in all 50 states, it is incumbent upon plaintiffs to support their general causation claims with expert witness opinion evidence. Cause-and-effect between exposure to a medical product and physical injury cannot be established without it.

The developments of 2017 indicate that it is critical to remain informed about changes in the law in order to develop the strongest product liability defense of pharmaceuticals and medical devices.  We know it takes an enormous investment to develop innovative pharmaceuticals and medical devices to improve life experiences.