Supreme Court Rejects Expansive "Stream of Commerce" Theory of Personal Jurisdiction

This week, the U.S. Supreme Court issued two opinions clarifying the criteria that must be satisfied before a court may constitutionally exercise personal jurisdiction over a defendant—J. McIntyre Machinery, Ltd. v. Nicastro and Goodyear Dunlop Tires Operations, S.A. v. Brown. Both decisions involved product liability suits asserted against non-U.S. manufacturers, but both have relevance as well for domestic corporations defending lawsuits under any liability theory. The decisions were highly anticipated because the cases, J. McIntyre in particular, were expected to resolve a decades-old debate about the contours of the so-called “stream of commerce” theory of personal jurisdiction. The Court delivered.

To read the full alert by Reed Smith Appellate team members Kim M. Watterson and Paige H. Forster, click here.

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.

Senate Finance Committee Report Inquires into Physician-Owned Distributors

This post was written by Joseph W. Metro, Gina M. Cavalier and Jouya Rastegar.

On June 9, 2011, Senator Orrin Hatch released a report by the Senate Finance Committee Minority Staff that outlines key concerns about Physician-Owned Distributors (“PODs”), specifically regarding the lack of regulatory oversight and clear guidance from the Department of Health and Human Services Office of Inspector General (“OIG”). The Committee Minority’s report, Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight, set forth findings of committee staff who spoke to over fifty people and reviewed thousands of pages of documents. In addition to the report, the Chairman and Ranking Members of the Senate Financial Committee, Special Committee on Aging, and Judiciary Committee sent letters on the same day to the Administrator for Centers for Medicare & Medicaid Services (“CMS”)and the Inspector General of Health and Human Services (“HHS”) requesting further inquiry into the concerns set out in the Senator Hatch’s report.

The crux of the Committee’s concern with PODs is the potential for fraud and abuse the Committee believes to be inherently found in PODs. Historically, implantable medical devices (these are what the report focuses on) have been sold to hospitals and surgery centers directly from the device manufacturers or through independent distributors. More recently, PODs have come into existence to buy the devices from manufacturers and sell them to hospitals or surgery centers. PODs are mostly comprised of small groups of physicians who create companies to distribute, and in some cases manufacture, medical devices for implantation in surgeries. The large majority of products sold by PODs are sold to hospitals where their own physician investors practice. This is where the concern stems from—physicians’ potential ability to profit through distribution markups on products they are selling through the PODs in which they are owners or investors, particularly where the PODs likewise solicit discounts from manufacturers based on preferred positioning or other “captive” volume.

The report: (1) explains the history of PODs and their business models; (2) describes the concerns for fraud and abuse; (3) highlights the regulatory environment in which they exist; and (4) concludes by outlining what the should happen to address concerns. The nature of PODs creates financial incentives for physician owners to use devices that yield personal financial return, which may implicate the federal anti-kickback statute’s prohibition on inducements to purchase or order items covered under federal health care programs. The report listed anecdotal and evidence-based reasons for concern, such as instances of surgeons performing eight to ten procedures on elderly patients despite the serious health risks, stories of surgeons redoing previous surgeries to use their own POD products, an analysis from the Quality Implant Coalition, a coalition of manufacturers of implantable medical devices, which showed claims data from one hospital indicating a 300 percent increase in spinal fusion surgery after a spinal product POD moved into the hospital’s area, and an April 2010 Journal of the American Medical Association study that found a fifteen-fold increase in the number of spinal fusion surgeries for Medicare patients from 2002-2007, the period during which PODs became a more prevalent business model. On the other hand, the report mentioned a paper written by a POD, which was presented at the American Association of Orthopedic Surgeons 2009 annual meeting, in which the POD asserted that its business model helped saved the hospital with which it was affiliated thirty-four percent over a two year-period—a total savings of over one million dollars.

The legal implications of the business of PODs have not been entirely clear because the regulatory environment in which they find themselves is murky. As highlighted in the Senate Finance Committee report, the OIG issued written guidance on the issue of PODs and expressed the need to carefully review and closely scrutinize these entities under fraud and abuse laws and its Special Fraud Alert relating to joint venture arrangements. Similarly, CMS has declined to regulate PODs under the Stark law. However, the Senate Finance Committee report indicated that there has been a lack of any recent or more specific guidance on this topic. Further the report noted that POD arrangements might implicate the Sunshine Act’s reporting requirements relating to manufacturer financial arrangements with physicians, for which HHS has not yet issued guidance.

The report, as well as the letters to the HHS Inspector General and CMS Administrator, call for several measures to address concerns: (1) further inquiring into and closely examining PODs and their current structures and activities; (2) providing additional regulatory guidance from OIG and/or Congress; (3) including the distribution model of PODs into CMS’ final definition of “applicable manufacturers,” in order to require PODs to fall under the Sunshine Act financial reporting requirements; (4) accounting for the POD business model when CMS promulgates the final Accountable Care Organization regulation to protect against abuses posed by PODs; and (5) developing recommendations for further actions.
 

U.S. Supreme Court Strikes Down Vermont Ban on Data Mining; Rules that State Law Interferes with Drug Makers' Right to Free Speech

Today, in a 6-3 decision, the U.S. Supreme Court handed down a verdict in Sorrell vs. IMS Health, striking, on free speech grounds, a 2007 Vermont law that that bans the practice of data mining unless a physician specifically gives his or her permission to use the information. Reed Smith filed an amicus brief in Sorrell supporting IMS Health's position in order to help explain to the Court the public health benefits arising from targeted commercial use of prescription-writing data. Reed Smith's Global Regulatory Enforcement Law Blog discusses the ruling in "Supreme Court Win for Free Speech About Medical Options" by Paul Bond and Joe Metro.

California Awaits Supreme Court Decision About Whether Personal Injury Plaintiffs Can Recover The Face Amount Of Their Medical Bills, Or Only The Lesser Amount Negotiated By Their Health Insurer

This post was written by Farah Tabibkhoei.

The California Supreme Court soon will render its long-awaited decision in Howell v. Hamilton Meats & Provisions, Inc., No. S179115 (review granted March 10, 2010) and declare whether personal injury plaintiffs can recover the full amount of their medical bills versus the lesser amount actually paid by insurers. The Howell decision has garnered national attention as has the potential to dramatically affect personal injury litigants, the insurance industry, large corporations, and consumers.

Howell arose out an automobile collision between the driver of a Hamilton Meats & Provisions truck and motorist Rebecca Howell. A jury awarded Howell the full $130,000 face amount of her medical bills, but the trial court reduced the award to $60,000, the amount actually paid by Howell’s private health insurance. The Fourth District, Division 1 reversed, holding that pursuant to the collateral source rule, Howell was entitled to recover the full amount of her past medical expenses as billed. See Howell v. Hamilton Meats & Provisions, Inc., 179 Cal. App. 4th 686 (2009).

Prior to Howell, California courts traditionally limited personal injury recoveries to the amount actually paid for medical care – not the amount initially billed. For example, in Hanif v. Housing Authority, 200 Cal. App. 3d 635 (1988), the Third District limited recovery to the amount Medi-Cal paid for medical care, even though the reasonable value of the services plaintiff received turned out to be greater and had simply been written off by the hospital. And three years later, in Nishihama v. City and County of San Francisco, 93 Cal. App. 4th 298 (2001), the First District followed Hanif and limited plaintiff’s damages to the amount the insurer contracted to pay instead of damages based on the medical center’s customary rate.

In Howell, however, the court approved an award based on the full amount of the plaintiff’s medical bills rather than what insurance had paid, and thus created a conflict ripe for resolution by the California Supreme Court. Howell first distinguished Hanif on the basis that the plaintiff in Hanif was a minor who had not assumed any personal liability for his medical expenses, and had Medi-Cal insurance, as opposed to private health insurance. The plaintiff in Howell, by contrast, had incurred “pecuniary detriment” by executing financial responsibility agreements with her healthcare providers pursuant to which she became contractually obligated to pay for the costs of the medical care provided to her (notwithstanding that her medical providers later extinguished a portion of her medical bills by agreeing to accept the insurer’s payment of part of the bills as payment in full). The court also distinguished Nishihama, which did involve private health insurance, on the basis that it was decided based on plaintiff’s statutory lien rights as opposed to the collateral source rule.

Depending on which way the California Supreme Court rules, successful plaintiffs stand to lose out on substantial sums of money depending on how skilled their insurers are when they negotiate reimbursement rates with hospitals or other medical providers, and there are arguments on both sides of the issue.

Denying plaintiffs the monetary benefits of having insurance seemingly violates the public policy behind the collateral source rule, which is that injured plaintiffs should recover their medical care costs on an objective basis, determined by the reasonable value of services – usually, the amount that was billed. Otherwise, where two injured plaintiffs each break a hip and are billed $16,000 for the repair, the plaintiff without insurance would be eligible to recover $16,000 while the insured plaintiff’s recovery would be limited to the lesser amount actually paid by the insurance company, thus punishing those who had the foresight to protect themselves by buying insurance.

On the other hand, injured plaintiffs should be made whole, not given a windfall. To the extent medical providers agree to accept less than the amount billed, awarding injured plaintiffs the full amount of their medical bills gives them a windfall at the expense of defendants. Moreover, for insured plaintiffs who pay nothing out-of-pocket for medical care, limiting their recovery to amounts paid by their insurers arguably will not put them in any worse position financially.

Should the California Supreme Court rule that injured plaintiffs are entitled to recover the full billed amount of medical care costs, the prospect of higher jury awards may trigger the filing of more personal injury lawsuits – something unlikely to benefit California businesses. It also may leave defendants with less leverage in settlement negotiations with personal injury plaintiffs. For now, all eyes are on the Supreme Court pending its decision in Howell.

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.

Federal Government Contractors and Grantees Should Take Steps To Protect Their Patent Rights After the U.S. Supreme Court Decision in Stanford v. Roche

The Supreme Court's new Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., et al., 563 U.S. ___ (2011) decision has significant implications for federally-funded inventions and any patents that may result. As Christopher Rissetto, Louis DePaul, and Stephanie Giese explain in this new alert, each federal government contractor and grantee should take the following steps:

  • Establish agreements with employees that require each employee to make present assignments to the contractor or grantee for inventions made during his or her employment.
  • Establish agreements with third parties, including consultants, that protect each party’s rights in inventions developed during collaborative efforts consistent with the terms of the government contract.
  • Recognize that, as a federal contractor or grantee, it may be in breach of its federal contract or grant if it fails to obtain: (1) an assignment (preferably a present assignment) of a federally funded invention from an employee; or (2) an agreement on rights in a federally funded invention from a third-party collaborating organization or consultant.
  • Recognize that the federal government may propose new rulemaking in connection with patent rights that may include regulations that require contractors to obtain (and perhaps certify that they have obtained) the assignments from employees, as well as agreements with collaborating organizations and consultants discussed above.
  • Understand that patent rights are not implemented in federal contracts and grants uniformly across the federal agencies and, as such, a federal government contractor or grantee should carefully review its rights and responsibilities under the patent rights clauses in each of its contracts or grants.
  • Recognize that under certain circumstances, a federal contractor or grantee should negotiate patent rights with the federal government.
  • Recognize that, pursuant to the definition of “subject invention” in a federal government grant or contract, the federal government may obtain rights in inventions conceived at private expense, but first reduced to practice using federal funding, or alternatively, conceived using federal funding, but first reduced to practice at private expense. 
  • Recognize that, as a federal government contractor or grantee, it may need to review the federal government contract or grant, as well as agreements made in connection with the contract or grant, to determine rights to a federally funded invention.
  • Recognize that, to determine rights to a federally funded invention, third parties acquiring patent rights from a federal government contractor or grantee may need to review the federal government contract or grant, as well as agreements made in connection with the contract or grant. 
  • While not specifically addressed by the Supreme Court, recognize that the precedent set in the Stanford v. Roche decision is likely to apply to large, for-profit companies, as well as to small businesses and nonprofit organizations that are performing federal government contracts or grants. See Exec. Order No. 12,591, para. 1(b)(4), 52 Fed. Reg. 13,414 (Apr. 10, 1987) (citingPresident’s Memorandum to the Heads of the Executive Departments and Agencies, Government Patent Policy (Feb. 18, 1983)).

Please contact one of the authors for more information regarding intellectual property rights under federal government contracts and grants.

Vermont Modifies Manufacturer Gift Ban and Reporting Law, Effective July 1, 2011

This post was written by Elizabeth B. Carder-Thompson and Katie C. Pawlitz.

On May 26, 2011, Vermont Governor Peter Shumlin signed into law Senate Bill 104 (“S.104”), significantly modifying Vermont law banning the provision by manufacturers of gifts to health care providers and requiring disclosure of certain allowable expenditures and gifts to health care providers (18 V.S.A. § 4631a and 18 V.S.A. § 4632). S.104 follows amendments made to the Vermont gift ban and disclosure law enacted just last year. This Client Alert includes a summary of the modifications pursuant to S.104. Except as otherwise noted, the changes are effective July 1, 2011. To read the full Alert, click here.

This is a follow-up to our previous Client Alert "Update on Medical Device Manufacturer Marketing Activities: State and Federal Restrictions and Reporting Requirements," which provides a brief overview of the existing state marketing laws that apply to device manufacturers, including recent changes to those laws, as well as federal reporting requirements under the ACA.

Recall Does Not Equal Defect: Another Court Gets It Right

This post was written by Michelle L. Cheng.

As every product liability lawyer knows, a client’s voluntary recall of a product will result in lawsuits. Plaintiffs’ lawyers for pharmaceutical product liability cases love using the fact of a recall as an easy stand-in for proving that the product in a specific case was in fact defective at the time of manufacture. So while equating a voluntary recall with the existence of a defect is a seductively persuasive assumption, defense lawyers should strenuously argue against it because it's an argument they can win.

In a very recent decision issued by the Southern District of Mississippi, Cothren v. Baxter Healthcare Corporation, No. 3:10-CV-347, 2011 WL 2174026 (May 31, 2011), the District Court resisted the temptation to make that very assumption. In Cothren, the plaintiff filed a variety of product liability claims against Baxter based on the injuries she allegedly suffered from use of a dialysis machine. She claimed that her injuries were consistent with the injuries itemized and noted in the two Recall Notices that Baxter had issued with respect to such devices. Id. at *1. Baxter moved for summary judgment – the specific focus being whether the plaintiff satisfied the essential element of a “defect.” Id. at *3-*4. While the plaintiff flippantly asserted that “any layman [] can review the two recall notices, the press release and the Plaintiff’s symptoms and based on common sense, find that the Defendant was negligent as a matter of common sense,” the District Court failed to see common sense. Id. at *3. 

Instead, the District Court flatly rejected this assertion and stated: “Expert testimony is required.” Id. “Evidence of a design defect must be supported by expert testimony, and the failure to designate an expert who is prepared to offer such evidence demonstrates the lack of a prima facie case.” Id. Further, the District Court noted that the “recall notices [] do not constitute admissible evidence to establish liabilitySee, e.g., Rutledge v. Harley-Davidson Motor Co., 2009 WL 1635762, *2 (S.D. miss. 2009), aff'd, 364 Fed. Appx. 103 (5th Cir. 2010) Fed. R. Evid. 407 bars the use of Recall Notes to be used as defendants' admission that a design is defective.)” Id.; see also Drury v. Cardiac Pacemakers, Inc., No. 8:02CV933, 2003 WL 23319650 (M.D. Fla. June 3, 2003) (fact of recall alone does not establish causation and expert testimony is required). Based on the plaintiff’s failure to establish that Baxter breached its duties, the District Court granted summary judgment.  Id. 

To read the full case, click here.

 

American Health Lawyers Association's Annual Meeting

The American Health Lawyers Association's Annual Meeting will be held June 26-29, 2011, in Boston. This year's program will deliver insights from leading practitioners, in-house counsel and government representatives on the latest developments and trends concerning transactions, reimbursement, tax, privacy and security, antitrust, fraud and abuse enforcement, and accountable care organizations, among other key topics.

Elizabeth Carder-Thompson will present a session entitled "Pharma and Device Update and Prognostication: A Regulatory/Fraud and Abuse Year-in-Review and Prediction of Things to Come." Bob Hill will participate in a session devoted to providing a historical understanding of Medicare Parts A, B, C and D and forward-looking analysis of recent reimbursement-related developments ("Parts A, B, C and D Regulatory Reimbursement Update: A Look Back and Ahead").

Recent Developments in Tort Litigation

Law360.com recently published two articles on decisions involving issues with potential to have long-term effects on tort litigation.

In the June 2, 2011 article, "Case Study: Bauman V. DaimlerChrysler Corp.," Mildred Segura and Nabil Bisharat discuss Bauman v. DaimlerChrysler Corp., a case that expands the use of "agency theory" to impose general jurisdiction over foreign corporations that do business in the U.S. solely through their U.S. subsidiaries. The Ninth Circuit's recent decision in Bauman holds that personal jurisdiction existed over DaimlerChrysler Aktiengellschaft (DCAG), a German company, because DCAG maintained the right to control its wholly owned U.S. subsidiary, Mercedes-Benz USA LLC (MBUSA), such that DCAG could be haled into court in California due to MBUSA’s contacts with that state. Bauman increases the likelihood that foreign corporations will be sued in American courts based on the activities of their U.S. subsidiaries. This opinion — if it stands — has the potential to affect any foreign company that does business in the U.S. through subsidiaries regardless of whether those subsidiaries have anything to do with the parent’s alleged actions giving rise to the lawsuit. To read this article, you may download a .PDF or view on Law360.com (subscription required).

In "Reading Between The Lines: Pooshs V. Philip Morris," published in May, Eric Buhr and Kasey Curtis analyze the California Supreme Court's May 5th decision in Pooshs v. Philip Morris USA Inc., the latest California case addressing how statutes of limitations should apply in cases where a plaintiff alleges delayed discovery of only one of multiple claims or injuries. The background issue that appears to be guiding the Supreme Court’s decisions is the little used doctrine of "primary rights." A close reading of the opinions reveals the court’s careful effort to reach an arguably fair result while avoiding issues that could have a larger and devastating effect on tort litigation. To read this article, you may download a .PDF or view on Law360.com (subscription required).

Tort Reform In Texas: Loser Pays Rule Signed Into Law

With a hat tip to the California Civil Justice Blog, earlier this week Texas enacted a "loser pays" system that proponents say will help rid the system of meritless cases. House Bill 274 takes effect September 1, 2011 and directs the Texas Supreme Court to enact rules providing for the early dismissal of "causes of action that have no basis in law or fact on motion and without evidence." For cases that fall within this "no basis in law or fact" category, the trial court may award the prevailing party costs and "reasonable and necessary attorney's fees . . . that the court determines are equitable and just" whenever it grants or denies a motion to dismiss, in whole or in part.

Given the rulemaking yet to occur and the discretion vested in the trial courts in whether to award fees, the exact contours of this law will take some development, and it remains to be seen whether Texas civil litigants will be ordered to pay attorneys fees rarely or with some frequency. Still, an interesting experiment in civil justice reform that will bear watching.

Food and Drug Law Institute's Upcoming US-China Food and Drug Law Conference in Beijing, China

The Food and Drug Law Institute (FDLI) has an interesting upcoming conference on June 13-14 in Beijing, China that will address current legal, regulatory and economic issues regarding food, cosmetics, dietary supplements, pharmaceuticals and medical devices in China and the United States. Speakers are top government officials and internationally renowned experts who will discuss the issues in both countries.  They include Dr. Margaret A. Hamburg (Commissioner of Food and Drugs, US Food and Drug Administration), Wu Zhen (Deputy Commissioner of China's State Food and Drug Administration), Ralph Tyler (Chief Counsel, US Food and Drug Administration), Rosemary Gallant (Principal Commercial Officer Beijing, US Embassy Beijing, Commercial Section), Ding Jianhua (Deputy Director-General, Department of International Cooperation, SFDA), Wang Lanming (Supervisor-General, Department of Medical Devices Supervision, SFDA), Lin Wei (Deputy Director-General, Bureau of Import-Export Food Safety, AQSIQ) and Jinjing Zhang (Deputy Director General, Department of Food Licensing, SFDA).  Reed Smith partner Gordon Schatz will be speaking on the panel "Innovation and Access: Key Success Factors in China."