Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

Since last year, a number of courts have interpreted and applied the express preemption holdings of Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Miller v. DePuy Spine, Inc., 07-cv-01639, 2009 US Dist LEXIS 49602 (D. Nev. May 1, 2009), is another example and, although it was decided on May 1, has just recently been picked up by LEXIS.

In Miller, the Nevada District Court granted summary judgment for the manufacturer of a PMA approved spinal implant disc called the Charite Artificial Disc. While many courts, including this one, correctly follow Riegel and hold that the state law claims challenging the design, manufacture and labeling claims are expressly preempted, this court also entered judgment for the defendant on warranty and misrepresentation claims that have a received a more mixed reception in some courts.

As to express warranty, Miller concluded that the plaintiff failed to establish the receipt of any express warranties, and that such warranty claims directly challenged the safety and effectiveness established through PMA approval of the device. The Court further held that even when couched as a warranty claim , claims are preempted when they would "impose liability for the defendant's use of labeling approved and required by the FDA." 

The plaintiff also claimed to assert "parallel claims" contending  that the implanted device was "out of conformity with the materials or manufacturing specifications approved by the FDA," but the court dismissed these as well because plaintiff failed to meet his burden in demonstrating that there was a genuine issue of fact. As the Court succinctly noted: "Only a departure from such FDA-approved specifications could conceivably escape preemption, and absence of any evidence of such departure justifies summary judgment." 

Plaintiff's claims that the manufacturer allegedly made misrepresentations or omissions of material information to the FDA in order to "secure or maintain the PMA" were also dismissed. Not only had the plaintiff offered only "argument about this hypothesis" rather than admissible evidence, under 21 U.S.C. Section 337(a), any attempt to enforce the FDCA and its regulations were preempted; and any contention that the manufacturer provided inaccurate or incomplete information to the FDA was impliedly preempted under Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). 

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The House Committee on Energy and Commerce's Subcommittee on Health will hold a hearing on Tuesday, May 12, 2009, at 2:00 p.m. regarding a bill to overturn medical device preemption (H.R. 1346 /S. 540), called the "The Medical Device Safety Act of 2009.” Although the hearing is not yet listed on the Subcomittee's website, hearing materials should become available here. (If you are interested, video and transcripts also are available from last year's lopsided House Committee on Oversight and Government Reform preemption hearing held May 14, 2008 and the Senate Judiciary Committee's preemption hearing held June 11, 2008.)

Those in the industry will find H.R.1346/ S. 540 ironically named, as patient access to critical new devices and public health would suffer if this bill passes. These ill effects are detailed in a new economics study, “The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” by Ernst Berndt, PhD, and Mark Trusheim of the Massachusetts Institute of Technology’s Sloan School of Management. As the authors state in the executive summary to their article,

"Eliminating preemption protection for medical devices—as some currently advocate—will impact:

1. Patient access and public health
2. Medical technology innovation rates
3. Industry employment
4. Government expenses as a healthcare payer, regulator and judicial funder

The results from eliminating preemption are likely broad and generally negative across this host of categories."

The article is thoughtful and well worth reading.

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As Point of Law pointed out on February 3, a move is afoot to "Revers[e] Preemption, One Bill At A Time," starting with industries regulated by the FDA.

Section 2 of the FDA Globalization Act OF 2009, H.R. 759, merits the attention of the life sciences industry. It provides:

This Act and the amendments made by this Act may not be construed as modifying or otherwise affecting any action or the liability of any person (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) under the law of any State.
 

 

UPDATE:  Drug and Device Law has posted Bert Rein On The Politics Of Preemption on this issue, and it is definitely worth a read.

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Below are some notes regarding the presentation by the FDA's Gerald Masoudi today at the ACI Drug and Device Conference. Every effort was made to capture his comments accurately, but please excuse any errors created by capturing these comments on a BlackBerry:

PREEMPTION

FDCA gives FDA role of determining safety and efficacy and warnings, considering factors including patient profile and public health considerations.

Labeling is key method by which FDA communicates risks and benefits. FDA decides for populations, not individuals, and requiring safety and efficacy for every individual would lead to the absence of treatments.

Even with proper risk benefit judgment and prescribing, injuries can occur.

Products should neither under- nor over-warn.

State tort lawsuits decrease patient access, limit treatment options and interfere with the agency's judgments.

Preemption does not reach manufacturers' failure to comply with federal requirements (such as contamination with toxic substance) since there would be no interference with the FDA's judgment.

FDA will make mistakes, but allowing juries to make failure-to-warn determinations would not be superior to the current system and the current role of FDA.

In Wyeth v. Levine, the court may issue a narrow decision--we all will have to wait to see. But it is not new for FDA to support preemption. It has been the agency position in litigation, testimony, and preambles to rules. FDA reiterated its support recently in a pregnancy labeling proposed rule and CBE rule from earlier this year. This readoption should answer any question that the agency's Final Rule on drug labeling, which also had preemption in a preamble, was improperly promulgated.

FUTURE OF PREEMPTION

The Wyeth decision, of course.

But what about preemption in off-label cases? Sponsor can't change label without FDA approval. What if physician prescribes off-label because of some prompting by manufacturer? If plaintiff's tort suit says there should have been warnings for the off-label use, the defense is less strong as there is little federal interest in off-label promotion. This area of law needs more development to answer the question.  

RIEGEL

There may be a legislative response, but again we will have to wait to see.

As to any exception for the manufacturer's alleged failure to disclose to the FDA, when the FDA has not found fraud, the preemption defense is stronger. It would create interference with the agency's decisions to allow courts to decide if the FDA was defrauded. Moreover, the FDA should decide what the punishment for it should be for manufacturer nondisclosure.

FDA WARNING LETTERS

FDA warning letters are a statement by the agency that someone is in violation of the law and legal action may be taken. For the past few years, the chief counsel's office has reviewed all of them.

Because they involve a legal determination, and are very serious for the recipients, they are appropriate for attorney review.

Even if counsel review leads to fewer letters, which is not clear, stronger letters with a stronger impact is a beneficial result of counsel review. It adds heft to both the letter and to the agency's decision to take an enforcement action, since recipients and the courts know the agency's counsel has decided that legal action will be appropriate (if the conduct is not remedied) when warning letter issued.

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In its November 2008 issue, the Harvard Law Review will publish "Preemption of State Common Law Claims," 122 Harv. L. Rev. 405, an article that discusses Riegel v. Medtronic, Inc., 128 S.Ct 999 (2008) and its impact on state law claims. 

Of note, the authors state: "Despite criticisms that it leaves tort victims uncompensated, preemption is necessary to ensure that federal regulatory agencies, like the Food and Drug Administration (FDA), are the only governmental actors able to impose requirements on manufacturers – thereby ensuring a nationally standardized system of safety regulations without myriad local variations."

The authors also tackle an issue Riegel left open: "How to treat preemptive force of FDA regulation if agency approval is obtained by fraud." The authors acknowledge Buckman Co. v. Plaintiffs' Steering Committee, 531 U.S. 341 (2001), noting that if a state fraud claim "interferes with FDA regulatory decisions, preemption is likely to be (correctly) found." The authors opine that such actions should go forward only in situations "that would not impede the FDA's ability to choose its own enforcement strategy." Id. 

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Tomorrow's JAMA contains an editorial entitled, "Prescription Drugs, Products Liability, and Preemption of Tort Litigation" (subscription) by Catherine D. DeAngelis; Phil B. Fontanarosa (JAMA. 2008;300(16):1939-1941 (doi:10.1001/jama.2008.513)).

Suffice it to say, the premise that tort litigation safeguards patient health is faulty. Ensuring patient access to innovative and needed medical options is essential. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1009 (2009) (discussing the express preemption statute for medical devices and stating, "the text of the statute - suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.").

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Over at Drug and Device Law Beck and Herrmann muse on the possible impact of a win by Sen. Obama on drug and device law. This blog takes no sides on the election - and this may mean nothing for the future development of the law - but it is interesting to note that in the past, Sen. McCain has supported the criminalization of product liability in certain circumstances, as Victor Schwartz explains in this March 2006 testimony before the Senate Judiciary Committee.
 

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In Parker v. Stryker Corp., 2008 WL 4457864 (D. Colo. Oct. 1, 2008), the District of Colorado addressed Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), and the applicability of the express preemption clause of the Medical Device Amendments in a case where the manufacturer sought a discovery stay pending resolution of its motion to dismiss product liability claims regarding its PMA device, a hip implant. Although the motion to dismiss has not yet been resolved, the court exercised its discretion to decline the stay to allow discovery into plaintiffs' claims which supposedly parallel federal requirements. The case is not reported, and its lack of detail means it has limited value (if any) to future courts. So does Parker's failure to address authorities that shape and define what this so-called "parallel requirements" exception really takes. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (state duty must be "identical" to the corresponding existing federal requirements for a plaintiff to survive preemption); see also McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (even a permitted act that is turned into a state requirement will not constitute a "parallel" requirement).

Preemption issues reach many products in the life sciences industry, and for preemption geeks, one category of over-the-counter (OTC) drugs is frequently featured in preemption jurisprudence: head lice treatments. Mills v. Warner-Lambert Co., --- F.Supp.2d ----, 2008 WL 4488308 (E.D.Tex. Sept. 30, 2008) is the latest. In Mills, the Eastern District of Texas interpreted and applied the express preemption provision for nonprescription drugs, Section 379r of the Federal Food, Drug and Cosmetic Act. Plaintiffs asserted that the lice treatment medications manufactured and sold by the defendants were ineffective, and asserted claims of breach of implied warranty of merchantability and violation of the Texas Deceptive Trade Practices Act. Defendants argued that Section 379r preempted these claims because they constituted a requirement on the marketing and sale of the products that differed from that provided under the FDCA. The district court agreed, holding that (1) while the medication was not approved through the NDA process but through the "monograph system for over-the-counter drugs," the FDA's oversight and review over the medication constituted a federal requirement within the meaning of Section 379r; (2) the plaintiffs' lawsuit would create a state requirement related to the medications, which followed that same holding in Riegel; (3) this state requirement would be different from, and in addition to, the federal requirement that allowed these manufacturers to sell the lice medication labeled as they were; and (4) the savings clause of Section 379r(e), which saved product liability claims from preemption, would not operate the same as for claims that were based on a contractual ground.

Of certain significance to the larger preemption context was the court's understanding of what constituted a federal requirement. As held by the U.S. Supreme Court in Riegel, the premarket approval for Class III medical device has been concluded to create federal requirements, and the court here agreed with the dissenting Justice Ginsberg's comment in Riegel that the premarket approval process paralleled the approval process for drugs, called the New Drug Application process. Id. at *20-*21. Therefore, this court surmised that the "NDA process establishe[d] a requirement with respect to drug labeling under the FDCA." Id. at *21. While the medication at issue here was not approved through the NDA process, but rather through the monograph system governing over-the-counter drugs, the court closely examined the rigor of the labeling regulations for the monograph system and concluded that they, too, created federal requirements with preemptive effect, similar to that found for Class II medical devices. See Papike v. Tambrands, 107 F.3d 737 (9th Cir. 1997) (regulations governing Class II medical devices--tampons--created a federal requirement with respect to the substantive content on labeling); Mills, 2008 WL 4488308, at *22-*23. This specific holding, as well as the court's dicta, goes to the heart of what a "federal requirement" for purposes of preemption means. Rather than clinging to the specific process at issue--i.e., is this premarket approved or not?--the operative question shifted to the rigor of the FDA's review process before it approved drugs and devices for the market.

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This post was written by Michelle Lyu.

The plaintiff in Hearn v. Advanced Bionics Corporation, No. 06cv114-KS-MTP, 2008 WL 3896431 (S.D. Miss. Aug. 19, 2008) attempted to win a do-over of a straightforward defense preemption win.  

The district court had granted in part and denied in part the defendant's motion for summary judgment based on preemption as a result of the Class III PMA approval of the medical device in question, a cochlear implant that malfunctioned and was replaced with surgery. After the court's ruling, the parties settled and the court entered judgment of dismissal. Id. at p. 2. 

Approximately five months later, plaintiff moved for a relief from judgment, arguing that after the settlement, she discovered that the manufacturer had "knowingly misrepresented the true facts of the status of the FDA approval" to induce a settlement. Id. Having relied on such representations and "discovery fraud," plaintiff did not seek a rescindment of the settlement agreement (in fact, she kept the settlement proceeds!), but sought sanctions and damages under various claims for relief. Id. Essentially, the plaintiff argued that the defendant "knowingly misrepresented" that an FDA investigation was commenced post-approval, "at the conclusion of which the FDA would challenge Advanced Bionics' compliance with the pre-market approval process." Id. at p. 5. 

Based on these allegations, the plaintiff unsuccessfully sought to have the judgment vacated using Rule 11, Rule 60 and the court's inherent powers. On denying these requests, the court made clear that even if the plaintiff were to succeed in establishing misconduct, the court's ruling on the motion for summary would be unchanged. That is, even if the plaintiff's claims were accurate, "the Defendant would still be protected by the preemption defense for items that received and complied with pre-market approval from the FDA." Id. at p. 6. Further, the court's order granting the summary judgment did not detail which state law claims were preempted, but only stated a point of law; thus, had the case continued and the evidence demonstrated either non-compliance with the federal requirements or the manufacturer failed to properly obtain the premarket approval for the device, the preemption argument might have "presumably fail[ed]." Id. at p. 8. However, given the procedural status of the case, the court denied the plaintiff's motion and advised that her recourse--if any--was to file a new action against the manufacturer for fraudulent misrepresentation or to seek other similar relief.

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This post was written by Michelle Lyu.

Earlier this week, in Uhm v. Humana, Inc., --- F.3d --- , 2008 WL 3891592, No. 06-35672 (9th Cir. Aug. 25, 2008), the Ninth Circuit upheld a lower court ruling that the express preemption provision of the Medicare Prescription Drug Improvement and Modernization Act preempted state law claims arising from the plaintiffs' prescription drug benefits provided by a Medicare supplement insurer. 

On behalf of a putative class, plaintiffs asserted claims for breach of contract, violation of state consumer protection statutes, unjust enrichment, and fraud arising from allegations that the class enrolled in a plan for prescription drug coverage but the insurer failed to cover their prescription medication purchases as promised. But the Act specifies that for Medicare prescription drug plans and sponsors, "[t]he standards established under this part shall supercede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to MA ["Medicare Advantage"] plans which are offered by MA organizations under this part." 42 U.S.C. § 1395w-26(b)(3). 

Based on this statutory express preemption clause, the Ninth Circuit affirmed that the "plain language of the statute" meant that CMS "standards" will supercede state law or regulations that are " 'with respect to' a 'prescription drug plan' offered by a '[prescription drug plan] sponsor.' " Id. at p. 11557-58. Because the plaintiffs' claims boiled down to a question of whether they were properly enrolled in the insurer's prescription drug plan and then afforded the promised coverage, their claims were explicitly governed by procedures and remedies contained in the Act only, and their civil lawsuit was preempted. 

Notwithstanding the relatively straightforward statutory analysis employed by the court, the case contains additional observations with implications for preemption in other contexts. 

For one, the court noted that while express preemption provisions may reach beyond positive enactments to embrace common law duties (see, e.g., Bates v. Dow Agrosciences L.L.C., 544 U.S. 431, 443 (2005)), the court noted that it also was not "categorically precluded" from applying implied preemption principles to determine what Congress intended to preempt - in other words, would the state law action differing from federal standards stand as an obstacle to the accomplishment and execution of a federal scheme? Id. at p. 11559. At the same time, the court discounted the possibility of field preemption since the express preemption provision itself contains reference to exceptions to the Act's preemption reach (i.e., state licensing laws or state laws relating to plan solvency).

In addition, the court's analysis of the claims involving deceptive marketing could be relevant to other preemption contexts, such as with prescription drug advertising where the FDA's Division of Drug Marketing, Advertising, and Communications often pre-screen drug promotional materials to ensure they are not false and misleading. In Uhm, the plaintiffs' deceptive marketing claims centered on the alleged deceptive marketing and advertising that allegedly induced the plaintiffs to enroll in the prescription drug plan. Id. at p. 11570. The Ninth Circuit held that these claims were preempted, noting that "the Act provides that [the agency overseeing the Medicare and Medicaid Services] must approve all [prescription drug plan] marketing materials before they are made available to [M]edicare beneficiaries."  Therefore, because the regulations will not permit approval of marketing materials or enrollment forms that are "materially inaccurate or misleading or otherwise make material misrepresentations," claims based on the materials' alleged deceptiveness were preempted. Id.

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This post was written by Michelle Lyu.

This case provides an interesting glimpse of what could happen if the plaintiffs are successful in persuading Congress to change the import of Riegel v. Medtronic, Inc.'s, (552 U.S. ___, 128 S.Ct. 999, (Feb. 20, 2008)) holding through legislation. 

In Lundeen v. Canadian Pacific Railway Company, 532 F.3d 682 (8th Cir. July 2, 2008), the Eighth Circuit addresses the retroactive effect of an amendment to the Federal Railroad Safety Act, which removed the Act's preemptive effect over state law claims.  When plaintiffs first brought this case for personal injuries and property damage from a freight train derailment in state court against railroads, the case was first removed and then later dismissed on the basis of preemption under the Federal Railroad Safety Act.  While the cases were pending on appeal, Congress amended FRSA, "clarifying" that the state law causes of action seeking damages for personal injury, death, or property cases were not preempted.  Congress made the amendment retroactive to the day of the derailment at issue, and effectively removed the basis of the court's former holding on preemption.  The Eighth Circuit majority panel held that the amendment was constitutional despite arguments re separation of powers doctrine, due process, equal protection, and the Ex Post Facto Clause, and remanded the case. 

 

Former Section 20106:

§ 20106. National uniformity of regulation

Laws, regulations, and orders related to railroad safety and laws, regulations, and orders related to railroad security shall be nationally uniform to the extent practicable. A State may adopt or continue in force a law, regulation, or order related to railroad safety or security until the Secretary of Transportation (with respect to railroad safety matters), or the Secretary of Homeland Security (with respect to railroad security matters), prescribes a regulation or issues an order covering the subject matter of the State requirement. A State may adopt or continue in force an additional or more stringent law, regulation, or order related to railroad safety or security when the law, regulation, or order--

(1) is necessary to eliminate or reduce an essentially local safety or security hazard;

(2) is not incompatible with a law, regulation, or order of the United States Government; and

(3) does not unreasonably burden interstate commerce.

 

New Section 20106:

(a) National uniformity of regulation.

(1) Laws, regulations, and orders related to railroad safety and laws, regulations, and orders related to railroad security shall be nationally uniform to the extent practicable.

(2) A State may adopt or continue in force a law, regulation, or order related to railroad safety or security until the Secretary of Transportation (with respect to railroad safety matters), or the Secretary of Homeland Security (with respect to railroad security matters), prescribes a regulation or issues an order covering the subject matter of the State requirement. A State may adopt or continue in force an additional or more stringent law, regulation, or order related to railroad safety or security when the law, regulation, or order--

(A) is necessary to eliminate or reduce an essentially local safety or security hazard;
(B) is not incompatible with a law, regulation, or order of the United States Government; and
(C) does not unreasonably burden interstate commerce.
 

(b) Clarification regarding State law causes of action.

(1) Nothing in this section shall be construed to preempt an action under State law seeking damages for personal injury, death, or property damage alleging that a party--

(A) has failed to comply with the Federal standard of care established by a regulation or order issued by the Secretary of Transportation (with respect to railroad safety matters), or the Secretary of Homeland Security (with respect to railroad security matters), covering the subject matter as provided in subsection (a) of this section;

(B) has failed to comply with its own plan, rule, or standard that it created pursuant to a regulation or order issued by either of the Secretaries; or

(C) has failed to comply with a State law, regulation, or order that is not incompatible with subsection (a)(2).

(2) This subsection shall apply to all pending State law causes of action arising from events or activities occurring on or after January 18, 2002.
 

(c) Jurisdiction. Nothing in this section creates a Federal cause of action on behalf of an injured party or confers Federal question jurisdiction for such State law causes of action.

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A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations based on the safety and efficacy of the device itself, not on the alleged conduct of a company representative in the operating room during use of the device.

In Adkins v. Cytyc Corp, No. 4:07CV00053, 2008 WL 2680474 (W.D. Va. July 3, 2008), plaintiff brought suit against the manufacturer of a device called the NovaSure, used during a surgical procedure called endometrial ablation that was performed on plaintiff. In addition to the usual product liability claims, plaintiff pleaded a cause of action implicating direct actions of defendant’s representative (presumably a sales representative; the opinion describes the person simply as a “corporate representative”) during the surgery in mistakenly instructing the operating physician. Id. at 1. Because of an error in measuring the size her uterine wall, plaintiff suffered injuries during the ensuing ablation procedure.

Defendant moved to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure, based upon the Supreme Court’s decision in Riegel v. Medtronic, 128 S. Ct. 999 (2008). Because the NovaSure device is a Class III medical device that received pre-market approval by FDA, the court dismissed with little fanfare all of plaintiff’s causes of action “that sound in negligence or breach of duty related to the design, manufacturing, and labeling of the NovaSure device.” Id. at 2. To allow plaintiff to proceed with her action “would impose requirements that differ from by the FDA on [the manufacturer].” Id.

But the preemption issue was not the end of the court’s analysis. Plaintiff also pleaded that “defendant’s corporate representative” had “a duty to ensure that the NovaSure device was operating correctly and that [the surgeon] followed the proper procedures when using the NovaSure device.” Id. (internal citation omitted). 

The court found that FDA did not regulate plaintiff’s agency theory of liability, and that preemption did not reach this claim. Describing such “localized situations,” id. at 3, as traditional matters for the common law, not FDA’s regulatory approval process, the court held that the agency claim “does not challenge the design, manufacture, and labeling of the NovaSure device so as to implicate Riegel preemption, but rather challenges negligence by a corporate agent acting as a de facto physician’s assistant during a surgical procedure.” Id.

However, plaintiff’s complaint failed to adequately plead, under Bell Atlantic Corp. V. Twombley, 127 S.Ct. 1955 (2007), facts to explain what defendant’s representative did or failed to do as part of his alleged duty. Further, the complaint did not specify whether plaintiff’s alleged injuries were caused by a failure of the NovaSure device or by a treatment error induced by instructions from the corporate representative. Therefore, under Twombley, the complaint fell short and, as a result, the court dismissed the complaint without prejudice and granted plaintiff leave to re-plead only on her agency theory of recovery. Id. (Query whether plaintiff will in fact state an actionable claim if she re-pleads, as some courts have rejected attempts to impose liability on non-physicians for failing to control a physician’s delivery of medical services for policy reasons. See, e.g., Kernke v. The Menninger Clinic, 173 F. Supp. 2d 1117 (D. Kan. 2001) (physician running clinical trial, not clinical trial sponsor, owed study participants duty to provide adequate medical care and duty to obtain informed consent); McKee v. American Home Prods. Corp., 113 Wash. 2d 701, 716 (1989) (non-physician without patient’s medical history not qualified to determine propriety of treatment, as that would require non-physician to improperly interfere with physician-patient relationship, where physician might have sound medical reasons for what appears to be a non-standard treatment); Cottam v. CVS Pharmacy, 436 Mass. 316, 321 (2002)(same)).  

That the majority of this decision is devoted to the issue of whether plaintiff stated a claim against defendant’s corporate representative demonstrates the strength of the Riegeldecision in cases involving PMA-approved devices – as does the court’s willingness to grant a preemption dismissal on a Rule 12(b)(6) motion. Also of significance is the court’s application of Twombley to product liability claims, which all product liability defendants should consider when analyzing whether a plaintiff’s complaint uses mere labels, conclusions, or simply a formulaic recitation of the elements of a cause of action.

Use the following links to read the court's Memorandum Opinion, the original Order, and its Amended Order.

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Reed Smith partners James W. Wood and James C. Martin recently wrote an article regarding pharmaceutical and medical device preemption for the Washington Legal Foundation, discussing such cases as the Third Circuit's Colacicco v. Apotex, Inc. case, as well as activity in the U.S. Supreme Court.

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This post was written by Michael K. Brown, Lisa Baird, and Michelle Lyu.

In This Issue…

• U.S. Supreme Court Activity in Medical Device and Drug Preemption Cases
• Express Preemption in the Lower Courts
• Preemption and Buckman
• Implied Preemption in the Lower Courts
• Recent Legislation
• Miscellaneous Cases

Click here to read more.

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