Tag Archives: Product Liability

Life Sciences Health Industry China Briefing – June 2012 (July 20, 2012)

Recent posts on www.lifescienceslegalupdate.com include: "Supreme Court Rules That Juries - Not Judges - Must Determine Facts Supporting Large Criminal Fines" The Reed Smith Global Regulatory Enforcement Law blog has an interesting post about a recent U.S. Supreme Court ruling that protects the Sixth Amendment rights of defendants in high-stakes criminal cases. In Southern Union Co. v. United States, the Court ruled that any fact supporting a "substantial" criminal fine must be found by a jury applying the "beyond a reasonable doubt" standard. In this post, Efrem M. Grail and Kyle R. Bahr explain the opinion and discuss the wide impact it will have on criminal actions, from investigation to sentencing. View the entire entry: https://www.lifescienceslegalupdate.com/2012/07/articles/health-care/supreme-court-rules-that-juries-not-judges-must-determine-facts-supporting-large-criminal-fines/ ... and "Life Sciences Health Industry China Briefing - June 2012 (July 20, 2012)" Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading

House Approves ACA Device Tax Repeal Bill in Face of Veto Threat

This post was also written by Ruth N. Holzman and Angelo Ciavarella. Yesterday the House approved by a vote of 270-146 legislation to repeal the ACA’s controversial 2.3% excise tax on the sale price of certain medical devices, which is scheduled to apply to sales after December 31, 2012. The repeal provision is included in H.R. 436, the … Continue Reading

California Supreme Court Limits Recoverable Medical Expenses to Amounts Actually Paid by Tort Plaintiff’s Insurer

In a highly anticipated decision, the California Supreme Court yesterday decided the issue of whether tortuously injured plaintiffs with private health insurance get to recover the full rate charged by their doctors and hospitals or the discounted, contract rate their insurers actually pay. The standard, the California Supreme Court held in Howell v. Hamilton Meats & Provisions, is that personally injured plaintiffs may recover, at most, the dollar amount that actually is paid by their insurers for plaintiffs' medical services, not the larger amount that generally is billed to those not covered by negotiated contracts between insurance companies and medical providers.… Continue Reading

Life Sciences Health Industry China Briefing

Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Food & Health Care Industries. Some important developments during June include: - Chinese drug company to build production and training center in U.S. - Drug company challenged for environmental contamination in China - China's national biomedical plan to be released soon - Issuance of administrative measures for device recalls - Designation of four professional associations to examine Class III medical technology - Extension of Drug GMP certificates - Recall of an antibiotic… Continue Reading

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.… Continue Reading

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 … Continue Reading

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

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.… Continue Reading

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

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 … Continue Reading

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. 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.… Continue Reading

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.… Continue Reading

Tort Reform Heats Up with Hearing in the Senate Judiciary

The National Law Journal's article "Torts once again on the front burner in the House" discusses the March 24, 2011 U.S. House Judiciary subcommittee hearing on tort reform. The hearing, entitled, "Can We Sue Our Way to Prosperity?: Litigation's Effect on America's Global Competitiveness," once again opens the debate regarding the US tort system. Topics included a bill that would cap non-economic damages in cases of medical malpractice, and a hearing on the yet-to-be-introduced Lawsuit Abuse Reduction Act, a proposal to implement mandatory sanctions of attorneys who violate civil procedure's Rule 11 against filing frivolous claims.… Continue Reading

Sunshine in Litigation Act to Senate Judiciary

In February we noted that the perennial "Sunshine in Litigation" bill had been introduced again. The Senate version in S. 623 and the House version is H.R. 592 but there is no real difference. It now is scheduled for consideration in Senate Judiciary on May 5 at 10:00 a.m. A link to the webcast should be available then from the relevant Senate Judiciary Committee hearing and meeting page.… Continue Reading

“Sunshine in Litigation” Bill Introduced Again

Law360 is reporting that Rep. Jerrold Nadler (D-NY) is seeking to revive the 2009 "Sunshine in Litigation Act," a bill we covered previously. H.R. 592 would turn around the Supreme Court's Seattle Times Co. v. Rhinehart, 467 U.S. 20, 33 (1984), which concluded that discovery materials are not public components of a civil trial. As a result, litigation protective orders are permissible to protect the confidential and proprietary information of parties to civil litigation, at least until information produced in discovery is filed with the court or introduced into evidence for determination of a merits issue (such as on a motion for summary judgment or at trial.… Continue Reading

Changes to Rule 26 Make It Easier To Work With Experts

Recent changes to the Federal Rules of Civil Procedure (FRCP) Rule 26 make it easier to communicate with expert witnesses and to prepare them for deposition and trial testimony while still protecting attorney work product. While expert discovery has been a part of federal practice since 1993, the period dedicated to the discovery of attorney-expert communications and draft expert reports has become increasingly time consuming during pre-trial preparation. The amendments to Rule 26 address this development and attempt to create an atmosphere that encourages better communication between attorneys and their experts.… Continue Reading

Federal Court Holds That Voluntary Refund Programs Can Defeat Class Certification Under Rule 23(b)(3)’s Superiority Requirement

This post was written by James C. Martin and Colin E. Wrabley.  Class action defense litigators should be aware of a recent federal district court decision that endorsed and accepted a creative option for defeating class certification—the defendant’s implementation of a voluntary refund and replacement program providing a comparable remedy to what the putative class … Continue Reading

Communications Between Attorney and Testifying Expert Are Discoverable in Pennsylvania

Addressing an issue of first impression in Pennsylvania, the Pennsylvania Superior Court recently concluded that an attorney's communications with a testifying expert are discoverable. This important decision puts Pennsylvania law squarely at odds with the newly amended Federal Rule 26(b)(4), set to take effect December 1, 2010, which prohibits discovery of drafts of an expert's reports as well as communication between counsel and the expert. Now, as much as ever, it is critical to understand the venue-specific rules on communications with experts.… Continue Reading

FDLI Publishes New Guide to International Prescription Product Recalls

Recent events highlight the importance of having a plan for product recalls. The Food and Drug Law Institute's recent monograph entitled, "International Prescription Product Recalls: A Practical Guide, Volume 1, Number 4," provides comprehensive guidance and practical recommendations on dealing with recalls internationally as well as a checklist and valuable "dos and don'ts" for manufacturers facing product recalls. Written by Reed Smith partners James M. Wood and Areta L. Kupchyk, the publication is available for download by series and individual issue subscribers. For more information or to order, see www.fdli.org.… Continue Reading

China’s New Tort Liability Law Takes Effect on July 1, 2010

China's long-awaited Tort Liability Law, passed on December 26, 2009 by the Standing Committee of the National People's Congress of China, will take effect on July 1, 2010. The law, which serves to provide a stronger basis for the development of tort law and practice in China, offers standard guidance on issues ranging from product liability, environmental pollution, medical malpractice to employee-related liabilities. For example, prior to the enactment of the law, defective product recall obligations were only applied to a limited number of products, including medicine, food, toys and automotive products. The new law, however, expands the recall system to cover all products manufactured or sold in China.… Continue Reading

CPSC Continues Stay of Enforcement of Third-Party Testing Laboratory and Certification Requirements for Some Products

Responding to efforts by a number of industry groups, on December 28, 2009, the U.S. Consumer Product Safety Commission ("CPSC") posted a Federal Register notice announcing its continuation of the stay of enforcement of the third-party laboratory testing and certification required under section 14 of the Consumer Product Safety Improvement Act of 2008 ("CPSIA"). The stay was continued until February 10, 2011. The continued stay involves a discrete group of products, including children's toys and child care products with banned phthalates, toys subject to ASTM's F-963 standards, baby walkers, electrically operated toys, youth all-terrain vehicles, carpets and rugs, vinyl plastic film, and children's sleepwear. Most importantly, the stay was continued for the third-party testing and certificate of the lead content limit that applies to all children's products.… Continue Reading

FDA’s Emerging Internet Policy: Themes and Recommendations From Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools

Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications. FDA's Center for Drug Evaluation and Research ("CDER") in collaboration with other divisions within FDA, held a two day hearing on November 12th and 13th to help the Agency determine how the statutory provisions, regulations, and policies governing advertising and promotional labeling should be applied to product-related information on the Internet and emerging technologies...… Continue Reading

Third Circuit Holds That MDL Judges Can’t Reverse Pre-Transfer Orders Absent Extraordinary Circumstances

In a precedential decision issued Thursday, In Re: Pharmacy Benefit Managers Antitrust Litigation (MDL 1782), the U.S. Court of Appeals for the Third Circuit reinstated a district court order compelling arbitration of antitrust claims, an order which another district court judge vacated after the case was transferred to a federal Multi-District Litigation (MDL)s, Based on the law of the case doctrine, the Court of Appeals held that MDL judges may not overturn an order of the transferor court absent a finding of extraordinary circumstances - a conclusion that has broad ramifications for MDL proceedings in general...… Continue Reading

New Developments in Nanotechnology

A recent study suggests that exposure to nanoparticles may have caused the death of two female workers and the illnesses of five others in China. Life science health industry companies that manufacture, integrate, sell or buy products that contain nanomaterials may want to monitor reaction to this report, which may garner attention from media outlets, scientists, regulators and the plaintiffs' bar. For a full discussion of these issues, review the full Client Alert written by Reed Smith attorneys Antony Klapper, Jesse Ash and David Wagner.… Continue Reading
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