Posted on July 15, 2011 by Lisa Baird

The Legal Duties of Clinical Trial Sponsors

In an article entitled, "The Legal Duties Of Clinical Trial Sponsors," published by Law360.com on July 11, 2011, Reed Smith attorney Kevin Lohman addresses the risks involved in human clinical trials and the responsibilities between the clinical study investigator and the manufacturer/sponsor.  Although the unique roles and responsibilities of entities involved with clinical trials are clearly defined, plaintiffs oftentimes attempt to assign legal duties to the wrong entity — sometimes suing the clinical trial sponsor as if it were directly providing medical services to the participant — or attempt to create novel legal duties. Case law that has addressed this issue has consistently held that this is not appropriate. When faced with this scenario, it is important to clearly identify the role that the manufacturer/sponsor played in the clinical trial to determine whether they owed any legal duty to the plaintiff.

To read this article, you may download a .PDF or view on Law360.com (subscription required).

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Posted on June 27, 2011 by Lisa Baird

Supreme Court Holds State Law Failure to Warn Claims Against Generics Preempted

This post was written by Christopher C. Foster.

As many of you no doubt have heard, the United States Supreme Court last week decided that FDA regulations applicable to generic drug manufacturers preempt state law "failure to warn" claims in PLIVA, Inc. v. Mensing, Nos. 09–993, 09–1039, and 09–1501, 564 U.S. ___ (2011). Among other sites, SCOTUSblog, the FDA Law Blog and the PharmaExec blog all have had interesting discussions of the decision.

To recap, Justice Clarence Thomas authored the Supreme Court's majority opinion in PLIVA. The court concluded that federal law preempts state law  "failure to warn" claims asserted against generic drug manufacturers, because those manufacturers are required by federal law to use warnings that are identical to those used by brand name manufacturers. The case, which consolidated actions from Minnesota and Louisiana, involved plaintiffs who developed a condition called tardive diskinesia after taking metoclopramide--a generic of the brand name Reglan--for several years. Slip. op. at 3.

The Court's decision focused on the distinct requirements federal law places on generic drug manufacturers with respect to their labeling. The Court explained that while a brand name drug manufacturer is responsible for the adequacy and accuracy of its label, a generic drug manufacturer is responsible for making sure its warning label matches that of its brand name counterpart. Id. at 6. As the FDA explained in its amicus brief, the duty of generic drug manufacturers with respect to its labeling is one of "sameness." Id. The Court held plaintiffs' claims preempted, concluding it was impossible for the generic manufacturers to comply simultaneously with the federal requirement that their labeling be the same as the brand name drug, and to simultaneously adopt a stronger label to comply with state law. Id. at 10-11.

Further, the Court rejected plaintiffs' argument that generic drug manufacturers should not be permitted to raise preemption as a defense, unless they had discharged their duty to ask the FDA for help in convincing brand name manufacturers to strengthen labeling. Id. at 13. The Court found that such an exception would prove too much, because a scenario can often be imagined where federal law may have allowed a party to also follow state law. Id. at 13-14. Yet the Supremacy Clause does not demand that a court strain to find ways to reconcile federal and state law. Id. at 15. "When the 'ordinary meaning' of federal law blocks a private party from independently accomplishing what state law requires, that party has established preemption." Id. at 17.

The Court recognized the tension this decision created with Wyeth v. Levine, 555 U.S. 555 (2009), which rejected preemption for failure to warn claims against brand name manufacturers just two years ago. It noted that had the plaintiffs taken the brand name drug, Reglan, rather than the generic drug, their lawsuit would not have been preempted under Wyeth. Id. at 19. It nevertheless rejected that as a reason for allowing plaintiffs to pursue their claims, noting that it was not its task to decide whether a statutory scheme adopted by Congress creates bizarre results. Id. at 19.

Much of the discussion about the case so far has focused on this issue of the tension between PLIVA and Wyeth, including what it means for implied preemption and how the lower courts should analyze preemption questions in the future. The decision is all the more interesting because it was authored by Justice Thomas, who garnered a fair amount of attention for stating in his concurring opinion in Wyeth that he was "increasingly skeptical of . . . the Court routinely invalidat[ing] state laws based on perceived conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text of federal law." PLIVA makes clear that Justice Thomas does not require all federal preemption to be express, it is just that he wants implied preemption to also be firmly grounded in text as well.

Looking ahead, it seems likely that the Court's rejection of the argument that the generic manufacturers could have sought FDA assistance in changing the label is likely to create some interesting issues. The Court recognized that, in theory, the generic manufacturers could have acted under federal law to seek a change in its warning labels, but it rejected the argument because, even had the generic manufacturers done so, a label change ultimately depended on subsequent actions of the FDA and the brand name manufacturers. The Court seemed to accept the premise, though, that preemption could be denied to a party that "can act sufficiently independently under federal law to do what state law requires . . ." Slip. op. at 17. Just what "sufficiently independently" means, and the circumstances in which it may arise, remains an open question.

Regardless, this decision gives generic manufacturers a good defense to use in product liability cases going forward.

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Posted on June 17, 2011 by Lisa Baird

Latest Post-Levine Case Holds That Conflict Preemption Bars Plaintiff's Failure-To-Warn Claims

This post was written by Michelle L. Cheng.

One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA's regulations governing the content of labels for prescription drugs. Essentially, defense lawyers argue that the labeling's warnings cannot be altered in a manner sought by the plaintiff when the manufacturer is faced with conflicting directives from the FDA regarding that very content.

In ruling on this very issue, Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009) ("Levine"), the Supreme Court held that a "clear evidence" standard of proof was required to support a manufacturer's claim of conflict preemption defense. The Supreme Court held that unless the manufacturer presents "clear evidence that the FDA would not have approved a change" to the drug's label, which would make compliance with both the federal standard and the state standard espoused by the plaintiff "impossible," conflict preemption could not apply.

Post-Levine cases have grappled with this standard, with defendant manufacturers commonly failing to meet this "clear evidence" standard in asserting the defense of conflict preemption. Except recently. The latest decision from the Western District Court of Oklahoma demonstrates how the "clear evidence" of conflict standard provided (but not defined) in Levine could be met. Dobbs v. Wyeth Pharmaceuticals, No. 5:04-cv-01762 (W.D. Okla. June 13, 2011). In doing so, the District Court distinguished or rejected as unpersuasive five other decisions where courts applied the Levine evidentiary standard in failure to warn claims involving the same class of anti-depressant prescription drugs. Id. at p.21.

Dobbs is a case brought by the widow of a depressed patient who took several days' worth of a prescribed antidepressant called Effexor, before committing suicide. Among her claims, the widow plaintiff contended that Effexor's FDA-approved statements regarding suicidality in patients diagnosed with depression was inadequate in its failure to fully warn of the risk. Id. at p. 2. Wyeth, the manufacturer of Effexor, contested this assertion by pointing to a variety of the factors that the District Court found persuasive: 1) the FDA is statutorily responsible for continually monitoring the safety of approved drugs, and proposed changes to the labeling "must be 'based on 'reasonable evidence of' an association between a hazard and the drug at issue…." [id. at p.10-11]; 2) the FDA had repeatedly considered the "proper scope and content of suicidality warnings for the class of drugs that are used to treat depression [id. at p. 12]; 3) in addition to such consideration, the FDA had "consistently expressed concern that an enhanced suicidality warning [was] not supported by scientific evidence" which could create the adverse consequence of a "potential reduction" in the use of drugs for the treatment of depression [id.]; 4) in 2002, the same year the decedent committed suicide, the FDA concluded that a more extensive suicidiality warning was not supported by scientific evidence (and thus, would not have approved of the warning that the plaintiff argued should have been used) [id. at *16]; and 5) in 2004 and 2006, the FDA concluded that increased suicidal thinking or behavior in pediatric patients and patients under the age of 25 years using these class of drugs was supported by sufficient scientific evidence, but the decedent in this case was 53 years old when he committed suicide [id. at 17]. In sum, the District Court found that the "FDA's ongoing study and analyses" regarding these warnings, and the FDA's lack of any findings regarding scientific evidence to support the addition of suicidality warnings for patients in the decedent's age pool, compelled a finding of conflict preemption. Id. at p. 18-9; see also p. 21.

The District Court's extensive and careful recitation of the facts, along with its review and treatment of the other post-Levine decisions, provides a useful framework in which to advocate and win on the defense of conflict preemption for failure to warn claims.

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Posted on April 1, 2008 by Lisa Baird

The California Supreme Court Adopts the 'Sophisticated User' Doctrine

This post was written by Marilyn A. Moberg and James M. Neudecker.

In April 2008, in Johnson v. American Standard, Inc., 2008 WL 878933 (Cal. Apr. 3, 2008), the California Supreme Court unanimously held that a manufacturer is not liable to a sophisticated user of its product for failing to warn of dangers about which the sophisticated user knew or should have known. In recognizing the so-called “sophisticated user doctrine,” California applied sound and reasoned principles that limit manufacturers’ liability for failure to warn.

The Johnson Decision

In Johnson, plaintiff William Johnson alleged that he had been injured by phosgene gas created during the ordinary maintenance and repair of a commercial air conditioning system. Plaintiff sued American Standard, Inc., the manufacturer of a component used in the system. The crux of each cause of action was that American Standard failed to adequately warn that harmful phosgene gases could be created should workers braze the refrigerant lines during service.

The trial court granted summary judgment for American Standard on two grounds. First, that American Standard had no duty to warn about injuries caused by the refrigerant, because it was another company’s product. Second, that under the sophisticated user doctrine, American Standard had no duty to warn because it reasonably could expect plaintiff—a certified HVAC technician with years of training and experience—to have been aware of the phosgene gas danger.

The Court of Appeals affirmed summary judgment for American Standard on the second ground. See Johnson v. American Standard, 133 Cal. App. 4th 496 (2005). After holding that the sophisticated user doctrine was part of California law, the court concluded that plaintiff’s evidence—consisting of declarations from himself and three coworkers stating that they personally did not know phosgene gas could cause lung damage—“did not create a triable issue of fact on whether American Standard could reasonably expect that the HVAC technicians would know the risk.” Id. at 506.

Finding the sophisticated user doctrine to be the “natural outgrowth” of the Restatement and obvious danger rule, the Johnson Court held that “a manufacturer is not liable to a sophisticated user of its product for failure to warn of a risk, harm or danger, if the sophisticated user knew or should have known of that risk, harm or danger.”

In affirming the Court of Appeals’ judgment, the Supreme Court recognized that while no California court had expressly adopted the sophisticated user doctrine, it was not necessarily creating “new” California law. To the contrary, the Johnson court recognized that, to some extent, the sophisticated user doctrine has long been a part of California law. The Supreme Court noted that it already had adopted Section 388 of the Restatement (Second) of Torts, which provides that a supplier of goods is liable for injuries caused by those goods only where it “has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition.” See Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 64 (1973). The Court also noted that California follows the “obvious danger rule,” which provides that manufacturers need not warn of known risks. See, e.g., Bojorquez v. House of Toys, Inc., 62 Cal.App.3d 930 (1976) (no need to warn of dangers associated with slingshots); Fierro v. International Harvester Co., 127 Cal. App.3d 862, 866 (1982) (no duty to warn that gasoline is volatile).

Finding the sophisticated user doctrine to be the “natural outgrowth” of the Restatement and obvious danger rule, the Johnson Court held that “a manufacturer is not liable to a sophisticated user of its product for failure to warn of a risk, harm or danger, if the sophisticated user knew or should have known of that risk, harm or danger.” 2008 WL 878933 at *8. The Court then noted several unique aspects of the rule in California.

First, the Court made clear that the standard is an objective one that focuses on what users knew or should have known, rather than a subjective standard that focuses on what a particular sophisticated user actually knew. Perhaps anticipating future arguments, the Court explained that the doctrine would apply even if particular sophisticated users fell short of the standards of their profession, perhaps because they “misread their training manuals, failed to study the information in those manuals, or simply forgotten what they were taught.” Id.

Second, the Court stated that the doctrine applies to failure-to-warn claims couched in both negligence and strict liability causes of action. In fact, the Johnson Court entered judgment for American Standard on plaintiff’s causes of action for negligence, strict liability, design defect and breach of warranty, because the “theory” upon which each cause of action was predicated was failure to warn, regardless of the nominal causes of action in the complaint. Id. at *9.

Third, the Court stated that user sophistication is determined at the time of the alleged injury, not the date the product was manufactured. Id. at *10. This provides some additional protection from liability, in circumstances where a safety issue is discovered after a product becomes available, but publicity about the identified issue should put sophisticated users on notice of it.

Future Development of the Doctrine

While the Johnson Court affirmed the Court of Appeals decision, and cited the Restatement with approval, the rule applied by the Johnson Court is that manufacturers are not liable “if the sophisticated user knew or should have known of [the] risk, harm, or danger,” and it affirmed judgment for American Standard because “defendant presented undisputed evidence that HVAC technicians could reasonably be expected to know of the hazard of brazing refrigerant lines.” Id. at *8.

It is interesting to note that by contrast, the Court of Appeals, applying the Restatement’s articulation of the doctrine, affirmed judgment for American Standard because plaintiff’s evidence “[did] not create a triable issue of fact on whether American Standard could reasonably expect that the HVAC technicians would know the risk.” See 133 Cal.App.4th at 506. In other words, the Supreme Court’s decision focused on what the user knew or should have known, given industry standards and training, while the Court of Appeals’ decision and Restatement focused on what the manufacturer had reason to believe.

Because the California Supreme Court cited the Restatement with approval even as it set forth its own standard, manufacturers arguably have two ways to assert the defense:

Defendants can argue that summary judgment should be granted where the sophisticated user knew or should have known of the potential danger (the Supreme Court standard), or where the manufacturer had a reasonable basis for believing that sophisticated users knew of the potential danger, even if, for whatever reason, they did not (the Court of Appeals and Restatement standard).

Conclusion

Johnson provides helpful guidance for manufacturers in failure-to-warn cases, and recognized appropriate limits on the duty to warn. Products made for a particular industry or used by those with training should carry warnings necessary to inform users about unknown hazards. But warnings need not be written as if that heightened level of experience does not exist, and liability should not result where one careless user fails to live up to the expertise of his or her profession. The decision is a significant victory for product manufacturers, and sets out a standard amenable to application by way of summary judgment motion.
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