Plaintiffs’ Bar Tries to Run the Option on Res Ipsa Loquitur; Sacked by Supreme Court

The South Carolina Supreme Court recently shut down an attempt by the Plaintiffs’ bar to make an end-run around the rules of evidence. The case centered around the admissibility of expert testimony that would have made Rule 703 about as effective as the Maginot Line. See Graves v. CAS Medical Sys., Inc., Op. No. 27168 (Aug. 29, 2012).

Here’s how the play developed: It was alleged that defendant CAS designed and manufactured a medical device that monitored the breathing and heart rates of newborn children. If either of those rates became too fast or too slow, the device would sound an alarm, and data about the event would be recorded. The device also had a separate system that tracked whether the alarm sounded. On the night of April 10, 2004, Plaintiffs’ daughter, who was being monitored by the device, experienced a significant decline in her breathing and heart rates and ultimately passed away. Her cause of death was later diagnosed as Sudden Infant Death Syndrome.

Make no mistake: this was an unspeakable tragedy for Plaintiffs’ family, and our deepest sympathies go out to them for their loss. It is regrettable that any discussion of products liability cases almost always involves difficult facts. This is especially true in this case and cases like it, where the injured party is a child and the nature of the injury is death. We here at Abnormal Use would much prefer a world where there was no need to report on such cases ever again.

In any event, a case was eventually brought against CAS on the theory that their device failed. Plaintiffs’ testimony (which was ostensibly obtained at deposition) was that the CAS device’s alarm never sounded. As a consequence of the device failing, Plaintiffs did not know that their daughter’s breathing and heart rates were falling, and never had an opportunity to resuscitate her.

Here’s where the theory of the case gets interesting. Plaintiffs’ counsel alleged that the CAS’s alarm did not sound due to defect in the device’s software. In furtherance of this theory, counsel retained three experts in software design to discuss “spaghetti code,” which is apparently when an electronic signal working its way through software code gets misdirected by certain external inputs, resulting in the device’s failure to perform as intended. In this case, it was alleged that the CAS device properly detected that Plaintiffs’ daughter was experiencing respiratory distress, but that due to spaghetti code, the signal to the device’s alarm was misdirected, causing the alarm to never sound.

Let’s stop here for a second. Hypothetically, there are three possible explanations for why the device “failed.” One is that the device was defective. However, the device was tested and found to function properly. Therefore, it was conceded that “hardware error” was not at issue. The second cause of failure is that the software failed, as discussed above. The third cause—which is not really failure—is that the device functioned as intended, but that Plaintiffs never heard the alarm sound. This case essentially boiled down to a contest between “software error” and “complaint error.”

Plaintiffs’ position was that software error must necessarily have been the cause, according to an analysis which was novel in the state of South Carolina: the “reasoning to the best inference” analysis. Or as I like to call it, the Sherlock Holmes analysis. In The Sign of the Four, Sherlock Holmes famously quipped, “When you have eliminated the impossible, whatever remains, however improbable, must be the truth.” And that is the intellectual underpinning of the “reasoning to the best inference” analysis. If all the possible causes for an event can be identified and eliminated, save for one, the one possible cause that remains must have been the actual cause for the event’s occurrence.

In this case, hardware error had been eliminated. And from Plaintiffs’ perspective, complaint error had been eliminated. There was testimony from each adult in the house at the time of the decedent’s passing that no alarm had sounded. Therefore, again from Plaintiffs’ perspective, the only possible cause that remained was software error.

Critically, the Supreme Court seemed willing to accept the Sherlock Holmes analysis as a viable way to establish circumstantial evidence of causation, at least in the abstract. But the Court was not impressed with how it was applied in this case. First, there was the inherent, self-serving nature of the testimony. Of course Plaintiffs’ position would be that the alarm never sounded. It would seem somewhat unfair to allow complaint error to be ruled out by the unilateral testimony of the Plaintiffs. Especially since the device was tested later and found to work properly. Relatedly, there was an equally likely explanation for the device’s alarm to have not been heard: Plaintiffs slept through it. The Court’s opinion notes that the CAS device reported that the alarm had sounded. Ultimately, these questions created an issue of fact that prohibited complaint error from being ruled out as a possible cause of the alarm’s failure.

There was a third problem with Plaintiffs’ case though. None of Plaintiffs’ experts had been able to identify any portion of the source code that would have misdirected the alarm’s signal. Instead, they had merely postulated that, because hardware error and complaint error had (in their opinion) been eliminated, software error must have been the cause. Furthermore, according to their “spaghetti code” theory, a misdirected signal could have been triggered by any type of unanticipated external input, which may never be capable of identification.

As if this weren’t enough to give the Court heartburn, there was more to Plaintiffs’ theory. For proof that the device was subject to software error, Plaintiffs wanted to introduce other complaints (approximately fifty) that had been filed with the federal Food and Drug Administration of the CAS device’s failure. There was no way to determine the underlying circumstances of these other complaints, nor was there any way to substantiate them.

Under these circumstances, the Supreme Court did the only thing it reasonably could do: the Court shut the Plaintiffs’ case down. There was absolutely no evidence that the CAS device failed. At best, there was a question of fact as to causation between software error and complaint error. Ordinarily, for purposes of summary judgment (which is when Plaintiffs’ case was dismissed by the trial court), a question of fact is sufficient to survive and present the case to the jury. But in a products liability case, there must be some evidence that the product in question was defective. In this case, there was none. And it is a matter of black-letter law in South Carolina that products are not presumed defective merely because an injury occurred.

All things considered, it appears reasonably clear that Plaintiffs were trying to use the Sherlock Holmes theory as a back-door way of introducing the doctrine of res ipsa loquitur into South Carolina law. Res ipsa is the theory that an injury would not have occurred but for the fact that some negligent act also occurred which caused the injury. Although res ipsa is a favorite topic of first-year Torts professors, in South Carolina, the doctrine has been expressly rejected. First, in Snow v. City of Columbia, 305 S.C. 544, 409 S.E.2d 79 (Ct. App. 1991), and more recently, in Watson v. Ford Motor Co., 389 S.C. 434, 699 S.E.2d 684 (2010). It is worth noting that the same counsel who represented the plaintiffs in Watson also represented Plaintiffs in Graves. He gets a big ol’ Abnormal Use A+ in persistence.

Graves is an excellent decision for defendants in products liability actions. However, it remains to be seen how the Sherlock Holmes analysis will be used, and perhaps abused, in subsequent litigation, now that it appears to be a viable method of establishing causation.

Jurisdiction of Federal Court Determined by Distributor Liability Analysis

For defendants in products liability actions, the issue of distributor liability is a maddening, state-by-state patchwork of different rules and laws.  The same conduct by one distributor of a product across many states may make it liable for any injuries caused by the product in one state, yet immune from liability in another.  Not only can the role of the distributor be crucial from a liability perspective, but it often has jurisdictional implications as well.  This was the case in Martin v. Medtronic, Inc. and Saracare Corp., 5:11-CV-144/RS-CJK, 2011 WL 2473318 (N.D. Fla. June 22, 2011). The issue was the plaintiff’s motion to remand, i.e. whether the Northern District of Florida had jurisdiction to hear the case at all based on diversity of citizenship.  The plaintiff had sued Medtronic, Inc. and Saracare Corporation on products liability theories, including strict liability, after the death of her decedent allegedly caused by a defective insulin pump.

For diversity purposes, the plaintiff was considered to be a citizen of Florida; Medtronic was a citizen of Minnesota; and SaraCare a citizen of Florida.  No diversity, right?  For all of you with recent memories of law school (which are, alas, distant memories for us), you will understand that the correct answer is always, “Well, it depends!” (For all of you readers who do have recent recollections of law school, be forewarned:  This is also always the right answer in “real life” legal situations, as well). Whatever the case, the jurisdictional question hinged on whether or not SaraCare was a “sham defendant,” in which case the Court would not consider its citizenship for diversity purposes (meaning that there would be diversity after all).  And, since SaraCare was alleged to be a distributor of the insulin pump, the Court’s jurisdictional analysis focused on the potential liability of SaraCare as a distributor. As the Court summarized:

Generally, strict liability extends to those in the “distributive chain” including “retailers, wholesalers, an d distributors.” Strict liability is applicable to distributors of medical products. Strict liability, however, does not generally apply to doctors or hospitals that use a defective medical device incidental to their services.  Similarly, strict liability does not apply to pharmacists who simply dispense prescription drugs and play no role in their preparation.
In this case, SaraCare performed two functions:  first, it confirmed that the letter of necessity met the guidelines of the decedent’s insurance company for reimbursement, and second, it took the order for the pump and routed it to a Medtronic distributor.
The Court determined that SaraCare’s actions were more akin to a traditional distributor than a pharmacist and held that “because Plaintiff claims the pump malfunctioned, the traditional medical device line of strict liability cases governs.”  As such, the strict liability claims could be maintained against SaraCare, and it was determined not to be a sham defendant.  With SaraCare remaining in the case, no complete diversity existed, and the case was remanded to state court.

Artificial Hip Case Prompts Preemption Analysis

As a defense lawyer, I dream about preemption; it can bar a staggeringly wide range of claims. The plaintiffs in Gelber v. Stryker, — F.Supp.2d —-, No. 09-CIV-1322, 2010 WL 4740432 (S.D.N.Y. Sept. 14, 2010), however, do not view preemption so fondly. After Jeannette Gelber’s hip was replaced with a Stryker Trident hip, she began to have pain and noticed a squeaking sound when she walked. She was told the artificial hip was defective, and thereafter, filed suit. The defendants filed a motion to dismiss, and the plaintiff conceded the dismissal of claims based on failure to warn, improper labeling, improper or misleading marketing and/or defective design. Therefore, the only claims remaining in the defendants’ motion to dismiss were those of negligence, strict liability and breach of warranty claims based on alleged violations of the FDA’s manufacturing requirements.

And then, the defendants dropped the atom bomb: federal preemption based on the rigorous review the FDA had used in approving the Trident hip for use and distribution; in fact, as a so-called “Class III” device, the Trident hip had been subject to the “rigorous regime” of premarket approval (“PMA“) within the FDA, a process under which only 1% of devices were scrutinized in 2005:

The PMA process is lengthy-it takes over 1,200 hours to review each application-and involves the submission of volumes of comprehensive information on the device. The FDA only grants premarket approval if it finds there is a reasonable assurance of the device’s safety and effectiveness. After approval, the FDA still retains regulatory control over the device. The manufacturer is prohibited from changing “design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” without first obtaining FDA’s approval.

There is a way around federal preemption, and the plaintiffs tried it in this case: the plaintiffs claimed that the defendants violated FDA manufacturing requirements, a so-called “parallel” claim. Here’s how a parallel claim would work, in the Court’s opinion

Riegel [v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008)] specifically found that claims of strict liability, negligence and breach of implied warranty were expressly preempted. However, there is an absence of Supreme Court guidance on whether the [Medical Device Amendments of 1976] preempts state requirements of general applicability that only incidentally regulate medical devices, e.g., Uniform Commercial Code or unfair trade practice laws, since Riegel refrained from analyzing the exception provided by 21 U.S .C. § 808.1(d)(1). Riegel, 552 U.S. at 328-29 (” § 808.1(d)(1) can add nothing to our analysis but confusion…. Neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally[,] the regulation fails to alter … the outcome of this case”). Post-Riegel, courts have struggled to determine whether state-law claims that only incidentally regulate medical devices are still available insofar as they are “parallel” to federal requirements. . . . This Court finds it persuasive that since the Supreme Court did not carve out a safe harbor for state laws that only incidentally regulate medical devices, the same preemption analysis applies and only those claims that are parallel to federal requirements are permissible.

(internal citations omitted). This might have been a great argument for the plaintiffs, except that the court held that they did not sufficiently plead claims “grounded in violations of federal law and/or requirements.” The pleadings didn’t provide the requisite amount of factual detail and specificity to survive the defendants’ motion to dismiss and, therefore, the remaining claims of the plaintiffs were dismissed. Pesky pleadings. However, the Court stated that “because courts have only recently articulated how a plaintiff can successfully plead a parallel claim,” the plaintiffs would be allowed to replead.

New Jersey’s Products Liability Act as Exclusive Remedy for Claims Based on Harm Caused by a Product

As we previously reported here, harm covered by New Jersey’s Products Liability Act (“PLA“) may not be redressed through a claim under New Jersey’s Consumer Fraud Act (“CFA“). However, based on a recent opinion from the United States District of New Jersey, practitioners should be aware that there are no hard and fast rules for early dismissal when a plaintiff asserts claims under both the PLA and CFA. Shannon v. Howmedica Osteonics Corp., No. 09-4171, 2010 WL 1492857 (D.N.J. Apr. 14, 2010).

In Fellner, discussed in our Tuna A Day post, the United States District Court of New Jersey found that the mere fact that the plaintiff sought damages for the cost of the allegedly defective tuna did not negate the fact that her underlying claim was that the product was defective, which claim was covered by the PLA. Fellner v. Tri-Union Seafoods, LLC, No. 06-0688, 2010 WL 1490927 (D.N.J. Apr. 13, 2010). As a result, on defendant’s motion to dismiss, Judge Cavanaugh found that the plaintiff’s claim under the CFA was subsumed by the PLA and dismissed plaintiff’s CFA claims.

In a matter decided one day after Fellner, Judge Linares was not as easily convinced that the plaintiff’s CFA claim was subsumed by the PLA. In this matter, Dave Shannon (“Shannon”) brought an action against Howmedica Osteonics Corporation (“Howmedica“) asserting that a “tibial insert manufactured and sold by Howmedica and inserted into his knee prematurely failed.” Shannon brought claims under both the PLA and CFA. Howmedica moved to dismiss his CFA claim on the ground that it was subsumed by the PLA.

Howmedica argued that the “essential nature of Plaintiff’s CFA claim is a product liability action,” and that the “damages that he seeks in his CFA claim are recoverable under the PLA.” This is a similar argument to the one defendant made in Fellner, which the Fellner Court accepted. In response, while the Shannon court agreed that generally “where the essential nature of a claim is a products liability claim, all other claims are subsumed by the PLA claim,” it pointed out that it appeared that Shannon was seeking damages for the cost to replace the insert — damages that may not be covered under the PLA. Then, however, the Court acknowledged that Shannon may be seeking the same damages under both the PLA and CFA. The Court denied Howmedica’s motion to dismiss and allowed discovery to proceed. Judge Linares stated the following:

If, after discovery, it is clear that all of the harm for which Mr. Shannon seeks redress is covered by his PLA claim, then Howmedica may move for summary judgment on the CFA claim.

From this decision, it appears that claimants in New Jersey may still be able to survive a motion to dismiss when he or she brings both PLA claims and CFA claims where the damages alleged raise the question whether they are covered by the PLA, even where the essential nature of the claim is that a product is defective. As a result, we may see more and more claimants pleading damages similar to Shannon to at least make defendants litigate both PLA and CFA claims through discovery. It will be interesting if the United States District Court of New Jersey further clarifies this issue, providing more concrete rules when CFA claims are subsumed by the PLA.

Harsh Punishment on the Horizon for Company, and Perhaps its Executives, Who Failed to Warn

A federal judge in Minnesota has rejected a proposed plea agreement between the federal government and Guidant Corporation, in which Guidant had agreed to plead guilty to two criminal misdemeanors and to pay a $296 million fine for continuing to sell heart defibrillators after discovering that some might short-circuit and fail, The New York Times reports. Federal Judge Donovan W. Frank said, in his 37-page opinion [PDF], that provisions of the agreement were not in the best interest of justice and do not serve the public’s interest because they do not adequately address Guidant’s history and the criminal conduct at issue.”

The problems associated with Guidant’s defibrillators, which have reportedly been associated with 6 deaths, came to light in 2005 when The New York Times published an article based on interviews of two Minneapolis cardiologists who treated Joshua Oukrup, a 21-year-old college student who reportedly died when his Guidant defibrillator short-circuited as it was charging to send out its life-saving jolt. Although Guidant had reportedly become aware of the defect associated with its product, its representatives merely fixed the flaw in new devices without warning doctors or regulators about the problem. As such, patients continued to get the potentially flawed older devices because the company did not pull them from hospital shelves.

Guidant’s chief medical officer explained that “the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because the failure rate was very low and replacing the devices might pose greater patient risks.”

Mr. Oukrup’s treating cardiologist said that this was “a statistical argument that has little to do with real people.” In fact, prior to Judge Frank’s April 27 ruling, Mr. Oukrup’s two treating cardiologists wrote a letter [PDF] to the court urging the judge to reject the plea agreement. The doctors wrote that they were “extremely dismayed” with the decision to enter such an agreement with the company rather than to “prosecute the company and the individuals responsible for this egregious act.”

Judge Frank noted in his ruling that it is up to prosecutors, not the court, to decide who should be prosecuted. But his rebuke of the proffered plea deal certainly calls into question: “Who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it?”

Ninth Circuit Reverses Exclusion of Plaintiff’s Expert in Medical Device Case

You know you’re in trouble as defense counsel when the appellate court’s opinion starts with the sentence: “[The Plaintiff] has suffered a miserable ordeal since she had elbow surgery. ” That can only suggest that reading the court’s ruling will be a miserable ordeal for the defendant. So begins the opinion in last week’s Primiano v. Cook, — F.3d —-, 2010 WL 788906 (9th Cir. March 10, 2010) [PDF]. Analyzing the admissibility of expert medical testimony at the summary judgment stage, the Ninth Circuit reversed the ruling of the trial court, which had excluded the Plaintiff’s medical expert and granted the defendants’ motion for summary judgment.

The Plaintiff, a 36 year old woman, suffered a fall in her kitchen, broke her right elbow, and ultimately required elbow replacement surgery. Her surgeon used an artificial elbow manufactured by the Howmedica Osteonics Corporation. Apparently, during the surgery, the surgeon realized that one of the component parts of the artificial elbow was intended to be used for a left elbow, not a right elbow. He then contacted a representative of Howmedica, who indicated that the component part was symmetrical, equally functional, and thus, able to be used for the surgery on the Plaintiff’s right elbow with only minor modifications. Following the surgery, all seemed to be well initially, but the Plaintiff ultimately experienced difficulties with the elbow replacement and required four additional surgeries, including the removal and replacement of the original artificial joint. Subsequent analysis revealed that the original artificial elbow had excessive wear. She then sued Howmedica, as the manufacturer of the device, its parent company, a Howmedica sales representative, and her surgeon under various theories of recovery, including products liability (the only cause of action at issue on the appeal). The suit was heard by the Honorable James C. Mahan of the U.S. District Court for the District of Nevada.

Noting that the prosthesis had been “malaligned,” the defense experts also argued that the life of the device would be limited due to the Plaintiff’s relative youth, level of activity, and her pre-existing rheumatoid arthritis. (Young people wear out artificial joints more quickly than older people, they said.). The district court excluded the testimony of the Plaintiff’s expert, Dr. Arnold-Peter Weiss, who had opined that “the polyethylene bushing had worn through in less than eight months, ‘not a usual or expected circumstance.'” The district court appeared concerned by the fact that Dr. Weiss had neither seen nor spoken with the Plaintiff as well as the fact that he could testify that the device failed but not why it did so. With no expert testimony supporting the Plaintiff’s case, the court granted the defendants’ motion for summary judgment. On appeal, the Ninth Circuit addressed the application of Federal Rule of Evidence 702 and Daubert to the testimony of expert physician witnesses. Analyzing the background, qualifications, and testimony of Dr. Weiss, the Ninth Circuit noted that they “[left] room for only one conclusion regarding its admissibility. It had to be admitted.” In so doing, the court noted:

Nevada law establishes that “those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function.” In Nevada, a plaintiff need not “produce direct evidence of a specific product defect [or] negate any alternative causes of the accident.” An “unexpected, dangerous malfunction” suffices. Since Dr. Weiss, with a sufficient basis in education and experience, testified that the artificial joint “fail[ed] to perform in the manner reasonably to be expected in light of [its] nature and intended function,” that was enough to assist the trier of fact. He did not have to know why it failed.

The district court’s other concerns, that Dr. Weiss never saw or talked to Ms. Primiano, and there was no publication supporting his opinion that the device failed extraordinarily early, might be useful to the jury as impeachment, but neither furnished an adequate basis for excluding his opinion. What he most needed to see was what was inside her arm, not outside it, and he did. He saw the x-rays. He also saw the polyethylene from the implant installed in Primiano’s first surgery. As for lack of a publication backing his opinion up, Daubert offers several reasons why an opinion unsupported by peer-reviewed publication may be admissible, and Dr. Weiss furnished another one: that the phenomenon is so extraordinary that the specialists who publish articles do not see it in their practices.

(Emphasis added).

The Ninth Circuit then reversed the trial court’s granting of the defendants’ motion for summary judgment. An interesting result, as the opinion suggests that an expert who has never examined – or presumably even met – an injured Plaintiff can create a fact issue on summary judgment in a products liability action by claiming that a medical device failed too early without articulating why it did so. The district court had noted that evidence of rapid wear did not necessarily make the device defective. The defense experts did offer an explanation for the wear of the device, namely that devices tend to wear far more quickly when placed in the joints of younger – and presumably, more active – patients. Further, the defense pointed to the fact that this Plaintiff suffered from rheumatoid arthritis which further contributed to the wear. Thus, while the defense posited a specific reason for the rapid wear of the device, the Plaintiff’s expert simply offered the conclusion that the device should have lasted longer than it did. That is now enough to defeat summary judgment. (Interestingly, the Plaintiff did not sue the surgeon for malpractice but only as an agent of the manufacturer of the artificial elbow).

Falling Down

In my daylight-saving-time-induced narcoleptic delirium, I’m glad to invoke my favorite Michael Douglas movie as an introduction to today’s topic: Potentially defective artificial hips. (As an aside, I’m sure that losing one hour of sleep was one of the things that set that film’s protagonist, Foster, over the edge. Few things oppress me more than time.) I’m not sure that Otis Watkins and McKinlee Pruett felt the rage that Foster felt, but the named Plaintiffs in Watkins v. Omni Life Science, Inc., 2010 WL 809820, No. 09-10857 (D. Mass. Mar. 9, 2010) were angry enough to file suit against the manufacturer (successor-in-interest, really) of their artificial hips.

One key point in this case is that the respective hips of Watkins and Pruett had not yet failed, or had experienced any other problems for that matter. Nevertheless, perhaps at the urging of former surgeon general and Life Alert spokesman C. Everett Koop, the plaintiffs filed suit against Omni for multiple causes, including breach of implied warranty, breach of contract, unjust enrichment, et cetera, in conjunction with allegations of fraud. (As another aside, I could have sworn that C. Everett Koop was no longer with us, but I have been informed otherwise.) The Plaintiffs filed as a proposed class, containing people that had experienced no artificial hip failure. The crux of the claim was that the hip’s failure rate was significantly higher than that of other brands of artificial hips. Therefore, the Plaintiffs claimed that they were 1) at increased risk of future harm and 2) that the failure rate “diminished the market value of their hip implants.” I’m no economist, but I’m sure some academic will soon release a white paper discussing the Great Recession’s impact on the slightly-used hip market. Moreover, the Plaintiffs asserted that they “would not have selected the Defective Hip over other alternative devices but for the uniform representations made by Defendant.”

In an amazing legal gambit, Omni’s counsel dared file a motion to dismiss the complaint. Omni argued that the Plaintiffs did not allege (much less suffer) a cognizable injury. The Plaintiffs argued, as noted above, that they did not get the benefit of their bargain. The court looked at the nature of the claims. The Plaintiffs had two problems: First, there had been no physical injury, and, therefore, purely economic damages were not recoverable in tort. Second, the Plaintiffs failed to allege the existence of any contract. Oops. It’s hard to prove breach of contract without a contract. The court also noted that fear of a future injury is not sufficient to support a cause of action.

Thankfully, common sense prevailed in this matter. Causes of action are reserved for plaintiffs who have actually been injured. However, I do feel for the Plaintiffs, as I too feel wronged by those who force me to adhere to Daylight Saving Time, which apparently contributes to “heart attacks, traffic accidents and workplace injuries.” Perhaps I will be lucky enough to suffer an injury giving rise to a viable cause of action.

Caveat Emptor . . . SERIOUSLY!

Average consumers generally trust the notion that the products they purchase “are what they say they are.” But that’s not always the case. Patients at a doctor’s office and home consumers buying medical devices or dietary supplements over the Internet continue to face the issue of misbranding and mislabeling. Recent examples of this disturbing trend abound.

On February 9, 2010, the United States Attorney for the Northern District of New York issued a press release wherein the Department of Justice recounted the sentencing of a group of plastic surgeons using a non-Food and Drug Administration approved TRI-toxin instead of the FDA approved drug, Botox. The sentencing included the following:

THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG’s plea of guilty to one felony count of misbranding drugs, in violation of Title 21,United States Code, Sections 331(k), 352(i)(3), and 333(a)(2) . . . .

Additionally, Doctors WILLIAM F. DE LUCA, Jr., DOUGLAS M. HARGRAVE, JEFFREY L. ROCKMORE, STEVEN M. LYNCH, and JOHN D. NOONAN, were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, and a fine of $5,000. TPSG’s practice administrator, PETER M. SLATTERY, and supervisory nurse SUSAN F. KNOTT, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. All individual defendants were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(1) . . . .

Just the day before, on February 8, 2010, the United States Attorney for the Southern District of California issued a press release regarding the sentencing of a man who sold thousands of unregistered medical devices that he claimed could treat anything from worms to AIDS. That man, James Folsom, was sentenced to 51 months and ordered to pay a fine of $250,000.

The evidence presented at Folsom’s trial indicated that he marketed the device under the names “NatureTronics,” “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness.” The supposed medical device housed a digital readout that consumers could use to adjust the device to certain settings, as indicated in the accompanying manual, to treat a whole host of maladies including diabetes, strokes, ulcers, AIDS, and worms. The U.S. Attorney’s press release stated:

According to the testimony at trial, during the period from 1997 through August 2008, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200, and to retail customers for $1995, with sales totaling over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. The defendant used the false name “Jim Anderson,” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business in an effort to avoid detection by the FDA.

The devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA, prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages.

Finally, this past January, the FDA updated its earlier warning over an unapproved doppelganger of the FDA’s approved weight loss supplement, Alli. In that update, the FDA provided helpful information, including photos, to assist consumers in identifying the counterfeit drug which contained a non-approved dosage of the active ingredient found in Alli and other weight loss pills, sibutramine. As long as criminals suspect that they can profit from selling unapproved drugs and medical devices, they will continue to do so. As such, it becomes all the more important for consumers to exercise the old Latin adage – caveat emptor! This seems to beg the question: did the Romans have the same problem that we have today?

Medical Device: Summary Judgment in Favor of Manufacturer for Lack of Expert Testimony

A Connecticut district court finds that the mere fact a medical device broke is insufficient to withstand summary judgment in a products liability action. On December 17, 2009, the United States District Court for the District of Connecticut in Koger v. Synthes North America, Inc., No. 3:07-CV-01158, 2009 WL 5110780 (D. Conn. Dec. 17, 2009), affirmed the rule that when the alleged defective product is outside of the ordinary consumer’s common knowledge, expert testimony establishing defective condition and causation is required.

Koger suffered a posterior pelvic fracture in a motorcycle accident. The fracture was repaired using “two Synthes fully-threaded cannulated screws.” Approximately two years later, an x-ray of Koger’s pelvic region showed that the two screws had broken. As a result, Koger filed suit against Synthes North America, Inc., the manufacturer of the screws, pursuant to the Connecticut Products Liability Act.

Synthes moved for summary judgment arguing that Koger lacked the necessary expert testimony to prove her claim. The district court agreed with Synthes. Connecticut courts apply the Restatement (Second) of Torts consumer expectation test for strict liability, but use a “modified consumer expectation test” for products not within the ordinary consumer’s common knowledge. The Koger Court found that the Synthes screws were outside the ordinary consumer’s common knowledge and subject to the “modified consumer expectation test.” Therefore, proof of the product’s defective condition and the causal link required expert testimony.

Koger submitted the opinion of a medical doctor that corrosion of the screws “could be the cause of the breakage.” However, Synthes submitted an expert opinion that provided that the screws broke due to nonunion of her pelvic area and not because they were defective. The Court found Koger’s evidence insufficient as it did not establish that it was “more probable than not that a defect caused the injury.”

In a final attempt to survive Synthes’ motion for summary judgment, Koger argued the “malfunction doctrine,” which provides that a defect can be inferred by circumstantial evidence. The Court rejected her argument stating that this case required complex medical and technical expert testimony to determine whether the product was defective and that Koger failed to provide such expert testimony.

This case highlights the rule that a broken product alone, absent any expert testimony as to defect and causation, is not enough to win a products liability action when the product is outside the knowledge of the common consumer. The Drug and Medical Device Blog recently provided an extensive review of precedent around the country reaching similar conclusions as the Koger Court that a broken device is not enough.