Life Sciences Health Industry China Briefing

This post was written by Jay Yan, Mao Rong, Gordon Schatz and Abraham Sorock.

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

To read the full briefing by Reed Smith China team members, click here.

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.


Upcoming Hearing on Draft Dingell/Waxman Drug Safety Legislation

On September 30, the House Energy and Commerce Committee is holding a hearing on draft drug safety legislation (per, witness list not yet available). The legislation, which was drafted by Reps. John Dingell, Henry Waxman, Frank Pallone, and Bart Stupak, requires parity between foreign and domestic drug facility inspections, increases the number of pre-approval drug inspections, prohibits the entry of drugs into the United States lacking documentation of safety, requires manufacturers to ensure the safety of their supply chain, and grants FDA authority to mandate recalls of unsafe drugs. For background information on the draft legislation (including the text), see

UPDATE:  This hearing has been postponed, and no new date has yet been announced.

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

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.

Reed Smith Beijing Counsel Mao Rong and Michael H. Dardzinski and Consultant Joyce Sun recently drafted a brief summary of China's new tort law provisions regarding product liability, medical-related damages and environmental pollution. Read the full summary here.

Post-Market Surveillance: FDA's "Sentinel Initiative" and Related CMS Rulemaking

This post was written by Catherine A. Durkin and Areta L. Kupchyk.

On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System”—a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. See FDA, “The Sentinel Initiative: National Strategy for Monitoring Medical Product Safety” (May 2008). In addition to a whitepaper on the Sentinel Initiative, FDA has published a “Questions and Answers” document, a fact sheet, and information for the consumer that are all available at

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California Assemblyman Introduces Legislation to Require Notice of Defective Foreign Products

It seems like a rare day when there is not a notice of a foreign-made defective product being recalled in the United States. In recent months, there have been more than 500 recalls of a variety of products including millions of toys coated with lead paint, thousands of illegal fireworks, contaminated meats, and tainted medicines.

The issue has become so enormous that the U.S. Government has created a website——that provides information about recalls coordinated by a variety of agencies including the Consumer Product Safety Commission, the Food and Drug Administration, U.S. Department of Agriculture, the Environmental Protection Agency, and others.

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