Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

A suit over an allegedly defective truck is the stage for the latest entry in the debate whether the claim pleading standards clarified in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), apply to affirmative defenses as well.

In Hayne v. Green Ford Sales Inc., 2009 WL 5171779 (D. Kan. 12/22/09), defendants plead standard affirmative defenses to the breach of warranty claim, including statute of limitations, contributory fault, failure to mitigate damages, assumption of risk, superseding/intervening act, waiver, failure to use product in manner designed or intended, and estoppel. Plaintiffs moved to strike the defenses under Fed. R. Civ. P. 12(f).

The court, sua sponte, noted that the motion to strike raised the issue as to what pleading standard applies to affirmative defenses. Recognizing that the courts have split on the issue so far, the district court found that the Twombly/Iqbal standard for pleading a claim also applies to defenses.

Courts that have applied the heightened pleading standard  to affirmative defenses: CTF Dev., Inc. v. Penta Hospitality, LLC, 2009 WL 3517617, at *7-8 (N.D.Cal. Oct. 26, 2009) Tracy ex rel. v. NVR, Inc., 2009 WL 3153150, at *7-8 (W.D.N.Y. Sept. 30, 2009); FDIC v. Bristol Home Mortg. Lending, LLC, 2009 WL 2488302, at *2-4 (S.D.Fla. Aug. 13, 2009); Teirstein v. AGA Medical Corp., 2009 WL 704138, at *6 (E.D.Tex. Mar. 16, 2009); Greenheck Fan Corp. v. Loren Cook Co., 2008 WL 4443805, at *1-2 (W.D.Wis. Sept. 25, 2008); Stoffels ex rel. SBC Tel. Concession Plan v. SBC Commc'ns, Inc., 2008 WL 4391396, at *1 (W.D.Tex. Sept. 22, 2008); Safeco Ins. Co. of Am. v. O'Hara Corp., 2008 WL 2558015, at *1 (E.D. Mich. June 25, 2008); Holtzman v. B/E Aerospace, Inc., 2008 WL 2225668, at *2, (S.D.Fla. May 28, 2008); United States v. Quadrini, 2007 WL 4303213, at *3-4 (E.D.Mich. Dec. 06, 2007).

The court observed that "parties do not always know all the facts relevant to their claims or defenses until discovery has occurred."  But to equate the plaintiff's knowledge, or lack  of knowledge, after months or perhaps years of possible preparation and investigation, and having full access to plaintiff, the product, and key fact witnesses in most cases, to the defendant's ability in a few short days after being served to know all the relevant facts, is a completely unfair comparison.  While the court said it did not mean to "suggest that heightened pleading requires the assertion of evidentiary facts. A minimal statement of only ultimate facts should suffice," the better reasoned decisions are cases like First Nat'l Ins. Co. of Am. v. Camps Servs., Ltd, 2009 WL 22861, at *2 (E.D.Mich. Jan. 5, 2009) (finding Twombly's analysis of the “short and plain statement” requirement inapplicable to affirmative defenses); and Romantine v. CH2M Hill Eng'rs, Inc., 2009 WL 3417469, at *1 (W.D.Pa. Oct. 23, 2009) (declining to apply Twombly to affirmative defenses).

The Supreme Court addressed in Twombly the requirements for a well-pled complaint under Fed.R.Civ.P. 8(a)'s “short and plain statement” requirement.  No such language, however, appears within Rule 8(c), the applicable rule for affirmative defenses. As such, Twombly 's analysis of the “short and plain statement” requirement of Rule 8(a) is inapplicable to a motion under Rule 8(c).

As posted about before, the plaintiffs' bar is seeking to get these Supreme Court cases overturned in Congress.  The possible application of the rule to affirmative defenses shouldn't make any defendants re-think opposition to the legislation.  But the handful of courts that have applied the standard to defenses raise a yellow flag for defendants.

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A few months ago, we alerted readers to the bill that Sen. Arlen Specter (D-Pa.) had introduced that would undermine the clarified civil pleading standards for plaintiffs set forth by the U.S. Supreme Court in the Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955 (2007) decision, and reaffirmed in Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), decided in May.

The so-called "Notice Pleading Restoration Act of 2009’’ would turn back the clock to the ancient and unrealistic interpretation of Rule 8 of the Civil Rules announced in Conley v. Gibson more than 5 decades ago. The bill is clearly aimed at helping the plaintiffs' bar and making it more difficult for defendants to get courts to dismiss frivolous and ungrounded litigation before expensive discovery. Specter, the newly turned Democrat facing an uphill re-election battle, submitted the bill over the summer. In the Senate, a hearing on the bill is expected in the Judiciary Subcommittee on administrative oversight and the courts, chaired by Sen. Sheldon Whitehouse (D-R.I.).

Last week, Rep. Nadler (D.N.Y.), along with Reps. John Conyers (D-Mich.) and Henry Johnson (D-Ga.), introduced a bill in the House (H.R. 4115) to overturn Iqbal and Twombly. Their version is called the “Open Access to Courts Act of 2009.”  Unlike the Specter bill, the House version incorporates specific language from the Supreme Court's ancient Conley decision. The bill states a court shall not dismiss a complaint “unless it appears beyond doubt that the plaintiff can prove no set of facts in support of the claim which would entitle the plaintiff to relief.”  The House bill also would expressly bar a federal court from using the Iqbal and Twombly analysis, stating a court shall not dismiss a complaint “on the basis of a determination by the judge that the factual contents of the complaint do not show the plaintiff's claim to be plausible or are insufficient to warrant a reasonable inference that the defendant is liable for the misconduct alleged.”  In other words, the claim need not even be plausible, and it is not a problem if no reasonable person could infer that the defendant might actually be liable.

The House bill follows directly from the efforts of the American Association for Justice, formerly the Association of Trial Lawyers of America, which convened a meeting of many of the pro-litigation, anti-business interest groups to map out a strategy to not just turn back the clock, but to replace the current common sense regime. They eventually sent a letter to the members of the House and Senate Judiciary committees, complaining that the current standards are hampering access to the courts and are denying their clients due process.  This coalition must have also thought that the Specter bill did not go far enough in simply trying to turn the clock back to the status quo ante.

In reality, it's hard to argue for overturning the two decisions without resort to hollow sloganeering or vague appeals to a warped definition of due process.  The decisions -- and think about whether you would want a case to proceed against you on this basis -- focus the trial courts' attention on mere “threadbare recitals” and vague and “conclusory statements,” to watch out for a mere re-stating of the hornbook legal elements of the case, and to look for a plaintiff to allege a “plausible” claim for relief that judges can evaluate based on their “judicial experience and common sense.”   In other words, say plaintiffs, please allow us to bring frivolous claims, alleging nothing of substance, and get into expensive protracted discovery so that we can force defendants to settle.  That's "due" process.

The legislation would likely create great confusion over the applicable legal standards for motions to dismiss, and eventually overwhelm the courts with frivolous lawsuits.  It seems the Democrats' goal to make it impossible for defendants to get cases dismissed early.

Not surprisingly, the House bill ignores the national security issues associated with overturning Iqbal, a case in which the plaintiff sought to sue a group of top government officials for allegedly violating his civil rights after he was arrested and detained in the immediate aftermath of the Sept. 11, 2001, attacks.  The Democrats appear to think it is a good idea to subject Justice Department and FBI and Homeland Security officials to suits that are not plausible, are conclusory, are mere recitals of the elements of a cause of action. 

At the very least, any legislative effort is premature, pending a study to measure the possible effects of the Iqbal and Twombly decisions that is being conducted by the Judicial Conference of the United States. A preliminary study, reviewing both district and appellate court cases, concluded there was little evidence to date that courts were dismissing meritorious claims under the Iqbal/Twombly standards.

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A federal court has dismissed (with prejudice) a variety of consumer fraud and unjust enrichment claims in litigation alleging issues with front-loading washers. Butler, et al. v. Sears, Roebuck and Co., No. 06 C 7023 (N.D. Ill. Nov. 4, 2009).

In their Consolidated Complaint, plaintiffs alleged that the washing machines they bought
from Sears suffered from electronic control board failure and an alleged design defect that prevented adequate water drainage and proper self-cleaning. The water drainage and
cleaning defect allegedly resulted in odors on clothes. Plaintiffs contended that the electronic control board failure is manifested by the washing machines prematurely and repeatedly failing mechanically. 

Defendant was alleged to have known about the defects because of allegedly similar problems with other washing machines, and customer complaints of mold problems. As a result, plaintiffs contended that Sears violated their respective home states’ consumer fraud statutes.

The case has a bit of a history, as prior versions of these allegations had been the subject of three motions to dismiss. Although the court did allow plaintiffs to file this consolidated amended complaint (these cases were consolidated for purposes of discovery and pretrial proceedings on January 6, 2009), plaintiffs did not request leave to re-allege the claims that were dismissed with prejudice in the prior rulings, including consumer fraud claims under the laws of California, Illinois, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, and Washington. See 2008 WL 4450307, at *8. Plaintiffs. however, re-alleged these claims in substantially the same form in their Consolidated Complaint.  Without leave to do so, and new details, these claims could not survive.

In order to survive a Rule 12(b)(6) motion, the complaint must not only provide the defendant with fair notice of the claim’s basis, but must also establish that the requested relief is plausible on its
face. Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949, (2009); see also Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). Allegations of fraud are subject to the heightened pleading standard of Rule 9(b), which requires a plaintiff to state with particularity the circumstances constituting fraud. Fed. R. Civ. P. 9(b). This means that the plaintiff must plead the “who, what, when, where, and how" of the alleged fraud.

The court found that the new allegations  were insufficient to meet Rule 9(b)’s pleading requirements. Plaintiffs adequately averred defendant's knowledge, but they did not adequately allege the other required elements. For example, plaintiffs had not indicated how the alleged reported failure rate compares with the failure rates of comparable machines produced by comparable manufacturers. Plaintiffs also failed to specify how often design or manufacturing defects related to self-cleaning features of washers occur. No meaningful engineering explanation had been alleged. The language reproduced in the Consolidated Complaint offered far from a meaningful engineering explanation for the defects; the allegations were vague and indeterminate.

The alleged violation of California’s Song-Beverly Consumer Warranty Act, Cal. Civil Code § 1790 et seq., survived the motion to dismiss.  But, overall, product manufacturers can appreciate the court's application of the Twombly doctrine, the fraud pleading requirements, and its reluctance to give plaintiffs many, many bites of the apple.  Federal court litigation should not be "if at first you do not succeed, try, try again," with the trial court offering plaintiff's counsel a road map how to construct a proper pleading.

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Bayer Healthcare LLC moved last week to dismiss the master complaint in the federal MDL involving combination aspirin products. In Re: Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litigation, No. 1:09-md-02023 (E.D. N.Y.). Aspirin has been sold in the United States for more than a hundred years; a daily regimen of low-dose aspirin is widely recognized as useful in preventing heart attacks and strokes.

Plaintiffs are consumers who claim to have purchased Bayer combination aspirin and dietary supplement products. They do not claim that they were injured by these products or that the products were ineffective. Instead, plaintiffs seek damages because they say they would not have purchased these products if they had known that Bayer, instead of submitting a New Drug Application (“NDA”) for each of these combination products, relied on the preexisting separate regulatory review of aspirin and the supplements. Plaintiffs allege that Bayer misled and deceived
consumers into believing that the products had been proven to be safe and effective for their marketed purposes.
 

The Motion argues that plaintiffs’ claims fail, first, because they are, in essence, private attempts to enforce the FDCA, 21 U.S.C. §301 et seq.  MassTortDefense notes that courts have repeatedly refused to construe such private attempts to enforce the FDCA as valid state law causes of action like the plaintiffs have brought in this litigation. Under the FDCA, the United States government has the exclusive power to enforce the FDA’s regulatory requirements (which include provisions relating to the approval of new prescription and over-the-counter drugs, as well as regulation of dietary supplements and food additives). The FDCA provides that “[a]ll such proceedings for the enforcement, or to restrain violations, of this Act, shall be by and in the name of the United States.” 21 U.S.C. § 337(a) (2009).

Even if a state were to recognize it, a cause of action based on a failure to obtain FDA approval would be preempted as interfering with the FDA’s approval processes. Courts have repeatedly held that private plaintiffs fail to state a claim where they, in essence, seek redress for a violation of the FDCA. Courts have applied this doctrine to dismiss a variety of causes of action, from RICO and the Lanham Act, to state law unfair competition and consumer fraud act claims. See, e.g., Mylan Labs. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993) (dismissing Lanham Act claim); In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp. 2d 1282, 1290 (C.D. Cal. 2008) (dismissing state consumer fraud and false advertising and RICO claims); Ethex v. First
Horizon Pharm. Corp., 228 F. Supp. 2d 1048, 1055 (E.D. Mo. 2002) (dismissing deceptive trade practices claims and Lanham Act claim).

Additionally, defendant argues that plaintiffs, who do not claim harm or that their products did not work, have not alleged a cognizable injury. Accordingly, plaintiffs have not stated a claim for any of the causes of action they have brought. Under Fed. R. Civ. P. 12(b)(6), a complaint must be dismissed if it fails to articulate grounds upon which relief can be granted. Under Rule 8(a), a plaintiff’s obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do. Bell Atlantic Corp. v. Twombly, 550 US 544, 555 (2007).   The Supreme Court recently reaffirmed these principles in Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009).

These standards apply to injury and loss requirements as well as to other elements of a claim. As the Second Circuit recently explained, to state a claim for relief, a plaintiff must do more than simply allege an injury or loss – that theory must be “plausible.” McLaughlin v. American Tobacco Co., 522 F.3d 215, 227 (2d Cir. 2008). Legally cognizable theories of injury must also not require a court to “engage in a series of speculative calculations to ascertain whether, or in what amount, plaintiffs suffered a loss.” Id. at 230.  Like many convoluted consumer fraud actions, plaintiffs' claims here fail to allege a plausible theory that is open to private plaintiffs.
 

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Add to your list of recent cases applying the recent U.S. Supreme Court decisions that clarified pleading standards, the decision in Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471 (S.D.Ohio). 

The federal trial court dismissed a plaintiff's manufacturing and design defect claims against the maker of an epilepsy drug that allegedly caused her to develop multi-organ sensitivity, citing Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Under Iqbal, a claim is facially plausible when the plaintiff  sufficiently “pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” 

Plaintiff  used Trileptal for a short time in 2005. A label change was made in Spring, 2005, adding a precaution regarding multi-organ sensitivity. Novartis sent a Dear Doctor letter, advising of the label change, in April.  Plaintiff contended that the drug caused her to develop multi-organ sensitivity and related complications. Plaintiff sued, alleging various claims, including defective design and manufacture. Novartis moved for a partial dismissal under Fed. R. Civ. P. 12(b)(6).

According to the court, plaintiff's first cause of action for strict liability for defect in the manufacture of Trileptal under Ohio law must be dismissed pursuant to Rule 12(b)(6) for failure to state a plausible claim for relief. Plaintiff did nothing more than provide a formulaic recitation of the elements of a claim under the statute.  She failed to allege any facts that would permit the court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of Frey's alleged injuries. Plaintiff's allegations in this regard fall far short of the sufficiency standard set forth in Twombly.

Similarly, the court said, the design defect claim would be dismissed because plaintiff once again simply provided a formulaic recitation of the elements of a claim under the statute. She did not allege any facts that would permit the court to conclude that there was a defect in the design or formulation of Trileptal and that the defect was the proximate cause of Frey's alleged injuries. Because plaintiff's allegations fall far short of the sufficiency standard set forth in Twombly, the claim for design defect must be dismissed.

Importantly, the court rejected plaintiff's argument that plaintiffs cannot be expected to particularly allege that the scientific makeup of the drug is defective for a specific reason without conducting discovery.

Finally, the court denied the plaintiff's motion to amend the complaint, saying she had not shown that they were able to allege facts that would state plausible claims for relief to satisfy the pleading standard.

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A federal judge in Florida has dismissed the class action claims of plaintiffs asserting economic loss from Bayer's drug Trasylol, ruling that they have failed to adequately plead that their alleged damages flowed directly from the company's alleged conduct in marketing the drug. See Southeast Laborers Health and Welfare Fund, et al. v. Bayer Corporation, et al., 2009 WL 2355747 (S.D. Fla.).

Trasylol was approved by the U.S. Food and Drug Administration to prevent excessive bleeding during coronary artery bypass graft (CABG) surgery. The plaintiffs, including a health and welfare fund responsible for paying for members' prescription drugs, allege that cheaper and safer alternatives were available but that Bayer somehow "over-promoted" the drug for CABG use.  They also allege the company promoted it for unapproved off-label uses, such as orthopedic surgery. They say, bottom line, that they would not have paid for Trasylol had they known the true story.

Such claims are typical of the consumer fraud act claims of plaintiffs in drug litigation, and equally typical is the fact that calculation of plaintiff's alleged losses would be extremely difficult, fact intensive, and absent such facts, purely speculative. Plaintiff must allege the causation element of the claim, and even the requisite short and plain statement of the claim requires more than labels and conclusions, and more than a formulaic recitation of the elements of a cause of action. (citing Twombly, 550 U.S. at 555 ).

In a causation analysis that applies to both the consumer fraud act and RICO allegations, the court noted that there are many factors that a doctor may consider in determining what medication to administer to a given patient. Doctors are presumed to, and actually do, go beyond advertising and marketing and also use their independent knowledge in making medical decisions. Loss calculation, therefore, necessarily would require an analysis of whether or not a particular physician ever received or relied on Bayer's allegedly fraudulent statements, and whether or not a physician, knowing the risks vs. benefit of Trasylol, would still have used it during an operation.

It would require a determination as to how many doses a patient received, and whether or not the number of doses was tied into any fraudulent marketing. It would also require speculation as to what alternative medications a particular physician would have ordered in a particular surgery, and how much that medication would have cost. Such a cost calculation would be problematic, as costs clearly would have fluctuated over the ten year period. Lastly, it would entail determining those patients who received Trasylol who did not suffer any adverse reactions, and who might have been helped by the use of the drug. Plaintiffs plead none of those facts.

The plaintiffs here attempted to rely on a "fraud on the market" theory to avoid this analysis, citing In re Zyprexa Prod Liab. Litig., 493 F.Supp.2d 571 (E.D. N.Y. 2007), but the court called this "simply misplaced." The fraud-on-the-market doctrine in both the Eleventh and Third Circuits has been held to be limited strictly to securities cases and is inappropriate in claims alleging deceptive advertising such as the ones presented by drug litigation.   

Further, on the RICO count, the court said that the plaintiffs' factual allegations were not sufficient to constitute a representative sample of the defendants' allegedly fraudulent acts, when they occurred and who engaged in them.

Judge Middlebrooks granted the plaintiffs leave to amend but said it was "unlikely" they would be able to cure the proximate causation deficiency in their claims.

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The United States District Court for the Eastern District of Pennsylvania issued an interesting medical monitoring ruling last week, which dealt with who is a proper defendant for this type of claim. In Sheridan, et al. v. NGK Metals, No. 06-5510, 2008 WL 2156718 (E.D. Pa. May 22, 2008), the court addressed the potential liability for medical monitoring relief of a unique type of defendant, a consultant hired to sample and monitor air quality. 

The decision is noteworthy in the context of plaintiffs' attempts to expand this non-traditional remedy. (and for another good application of the Twombly pleading decision to a toxic tort context.)

The proposed plaintiff class sought medical monitoring for residents of the Reading, Pennsylvania area who were allegedly exposed to beryllium emitted into the air from one of the defendant’s manufacturing facilities. According to the plaintiffs, members of the proposed class resided and/or regularly worked in close proximity to the Reading Plant at some time during the period from 1950 to 2000.

Defendant Spotts, Stevens & McCoy (SSM) was an engineering firm that, according to the plaintiffs’ Amended Complaint, was involved with testing, sampling, analyzing, and monitoring the air quality and levels of beryllium at the Reading Plant.

The District Court considered SSM’s motion to dismiss, noting that while a complaint need not contain detailed factual allegations, the plaintiff must provide more than labels and conclusions, and more than a formulaic recitation of the elements of a cause of action will not do, under the new Supreme Court guidance in Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1964-65 (2007).

Medical Monitoring

MassTortDefense has posted on this claim before. Medical monitoring is recognized under Pennsylvania law, and a plaintiff must prove:

1. exposure greater than normal background levels;

2. to a proven hazardous substance;

3. caused by the defendant's negligence;

4. as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;

5. a monitoring procedure exists that makes the early detection of the disease possible;

6. the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and

7. the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.

Redland Soccer Club v. Dep't of the Army, 548 Pa. 178, 696 A.2d 137, 145-46 (Pa.1997).

Negligence Element

As the third element listed indicates, a medical monitoring plaintiff must prove the underlying tort of negligence in Pennsylvania.  And an action in negligence is premised upon the existence of a duty owed by one party to another. Here, plaintiffs alleged that the engineering firm owed them a duty under the notion expressed in Section 324A of the Restatement (Second) of Torts regarding Liability to Third Person for Negligent Performance of Undertaking (the so-called "Good Samaritan" rule).  It states:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to protect his undertaking, if

(a) his failure to exercise reasonable care increases the risk of such harm, or

(b) he has undertaken to perform a duty owed by the other to the third person, or

(c) the harm is suffered because of reliance of the other or the third person upon the undertaking.

Restatement (Second) of Torts § 324A (1977).

Pennsylvania is one of many jurisdictions that has adopted Section 324A. See Cantwell v. Allegheny County, 506 Pa. 35, 40, 483 A.2d 1350, 1353 (1984). It has been interpreted to mean that absent any evidence that a defendant assumed an affirmative duty, there can be no liability for negligently performing that duty. See Wenrick v. Schloemann-Siemag Aktiengesellschaft, 523 Pa. 1, 564 A.2d 1244, 1248 (Pa.1989). Section 324A cannot be invoked to create a duty where one does not exist.

Plaintiffs' Allegations/Response

Plaintiffs alleged that SSM was responsible for advising the other defendants with regard to the air quality and for informing and/or warning the other defendants (the plant owners) about the results of air sampling and testing. Thus, a duty allegedly existed for SSM to act with reasonable care and prevent any increased risk of harm to the plaintiffs. Defendants responded that because the plaintiffs failed to allege that SSM undertook the specific duty to warn the plaintiffs, or that they negligently performed its undertaken tasks, no claim existed. SSM never expressly undertook a duty to warn the plaintiffs of the harmful beryllium exposures at the Reading Plant.

The Ruling: No Claim

The Court noted that the Amended Complaint did not allege that SSM was negligent in performing the testing, sampling, analyzing or monitoring of the air quality in the Reading Plant, or that the engineers failed to report, or were negligent in reporting, the results of its research to the plant owners. The pleading did not allege any circumstances under which such a duty, as a matter of law, could arise “implicitly” or “derivatively.” And absent a duty owed to the plaintiffs here, the Court need not reach the question of whether plaintiffs' alleged injuries were foreseeable.

Plaintiffs also needed to properly allege one of the three subsections of Section 324A, (a) failure to exercise reasonable care that increases the risk of harm, or (b) an undertaking to perform a duty owed by the other to the third person, or (c) the harm is suffered because of reliance of the other or the third person upon the undertaking.

On part (a), plaintiffs confused sins of commission rather than omission when they alleged that SSM allowed beryllium levels at the Reading Plant to rise to unsafe levels. Plaintiffs (discovery was well along) could not allege that SSM assumed or had any control over what caused the beryllium concentrations to rise to excessive levels, or contracted to undertake any corrective action to prevent these excesses from occurring. SSM undertook to test the beryllium emission at the plant, and report those emissions to the plant owners. The Amended Complaint did not allege that Plaintiffs' injuries arose from any alleged negligent testing.

With respect to subsection (b), plaintiffs argue that the engineering firm undertook to perform a duty owed by the plant owners to the plaintiffs. However, SSM agreed to take the steps of merely testing, sampling, monitoring, etc. Mere knowledge of a dangerous situation does not suffice to impose liability under Section 324A(b). Finally, as to subsection (c), plaintiffs failed to allege that they suffered any harm because of their reliance upon SSM undertaking to perform certain tests for the plant owners.

The Court concluded that plaintiffs essentially were advancing the proposition that SSM owed a “social duty” to them, and to the public at large. However, the scope of a good Samaritan’s duty is measured by the scope of his or her undertaking. Section 324A does not impose any “social,” “implied” or “derivative” duty. Rather, Section 324A imposes liability, reaching to third persons, upon a party's breach of a specifically undertaken duty. If a defendant did not undertake to perform a specified task, it cannot be held liable under Section 324A for failing to perform that task.

The medical monitoring claim against the engineers was dismissed.

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