Category: Product Recalls

Fallout from Massachusetts Compounding Pharmacy Reaches State Regulator

By Christopher D. Barraza
Published on November 12, 2012

Readers of the Monitor may be aware that we’ve been following events concerning New England Compounding Center, the pharmacy at the center of allegations of a tainted-drug meningitis outbreak.  When the story caught our eye, one of the questions we asked was whether oversight bodies would be put under the microscope.  It appears that question has been answered, at least in part: on Wednesday last week, the head of the Massachusetts Board of Pharmacy was terminated after reports surfaced that he did not act on a July 26 complaint concerning NECC.

In late July, authorities from the Colorado Pharmacy Board forwarded a complaint about NECC to the Massachusetts Pharmacy Board.   The Colorado regulators reported that NECC had been distributing drugs to hospitals in Colorado and Massachusetts in violation of its license.  The head of the Massachusetts Pharmacy Board, however, did not take any action at that time, or at any time before reports of a meningitis outbreak began to surface.

The dismissal is a notable event.  It is not often that regulators are held accountable for perceived lapses in oversight, particularly during the immediate aftermath.  Furthermore, it’s clear that the dust has not yet settled: hearings are currently scheduled before the House and the Senate, where the Commissioner of FDA will testify, the former head of the Massachusetts Pharmacy Board has  been invited to appear, and the co-owner of NECC has been subpoenaed to testify.

Meanwhile, regulators back in Massachusetts have turned their sights on other compounding pharmacies by conducting snap inspections across the state.  Those inspections led to the voluntary surrender of its compounding license by Infusion Resources, another compounding pharmacy.

As we previously noted, compounding pharmacies are not subject to the same level of FDA oversight as regular drug manufacturers.  That, however, could change, particularly in light of the upcoming hearings before Congress.  We will continue to follow this issue as it unfolds and keep you posted here.

 

 

 

Posted in News, Product Recalls

National Research Council Report Recommends Significant Changes to NHTSA’s Handling of Alleged Defects in Automotive Safety Electronics

By Stephen Gibbons
Published on February 8, 2012

It doesn’t take a product liability lawyer to remember the events of 2009 and 2010 involving claims of unintended acceleration in Toyota cars (among others).  What may have been forgotten, however, is the role that the National Highway Traffic Safety Administration (NHTSA) played in those events and their aftermath. 

Faced with hundreds of motorist complaints relating to unintended acceleration, NHTSA opened its own investigation focused on vehicles’ “electronic throttle controls” or ETCs.  These systems, which have become ubiquitous in modern automobiles, have effectively replaced the mechanical link between a car’s pedal and throttle opening.  In other words, the cables and levers that once physically linked the gas pedal to the engine, have been replaced with advanced computer sensors.  During the course of its investigation into the unintended acceleration events, NHTSA turned to an unlikely partner, NASA.  It tasked NASA with investigating potential vulnerabilities in Toyota’s ETCs that could lead to an unintended acceleration.  And while the NASA team found no evidence of a safety-related defect in Toyota’s ETCs, the fact that NHTSA had to look well beyond its own resources raised questions about the agency’s ability to address reported defects in the technologies being used in today’s cars and trucks. 

In March 2010, the auto-safety regulator requested the National Research Council (NRC) to “study how the agency’s regulatory, research, and defect investigation program can be strengthened to meet the safety assurance and oversight challenges arising from the expanding functionality and use of automotive electronics.”  On January 19, the NRC released its report, titled, The Safety Promise and Challenge of Automotive Electronics: Insights from Unintended Acceleration (available for purchase here). 

Generally speaking, the report validates NHTSA’s actions relating to the 2009-2010 incidents of unintended acceleration and its decision to close its investigation into Toyota vehicles after concluding that there was an absence of evidence to suggest that an electronic defect caused the accidents.  The NRC does, however, make a number of recommendations to NHTSA geared toward strengthening its monitoring and enforcement of electronic safety systems, including ETCs.  A few of the notable recommendations made to NHTSA are as follows:

  • Taking a more active role in standard-setting and other efforts aimed at strengthening the means by which manufacturers ensure the safe performance of their automotive electronic systems;
  • Convening a standing technical advisory panel that includes individuals with backgrounds relevant to automotive electronics systems, including software, systems engineering, and electronics hardware.  This panel should be consulted on technical matters arising in connection with NHTSA’s vehicle safety programs; and
  • Reviewing the capabilities of NHTSA’s Office of Defects Investigation (ODI), which will undoubtedly be asked to devote more time and resources to investigating potential defects involving electronics systems and assessing corrective action plans proposed by manufacturers.

Whether the automotive regulatory landscape changes in the coming years will turn on how NHTSA and the entire auto industry responds to the recommendations in the NRC report.  Assuming that those recommendations are adopted in whole or even in part, auto manufacturers are likely to see a NHTSA that is more involved in the evaluation and investigation of electronic safety systems.  In any case, buckle up…we’ll keep you posted.

Posted in News, Product Recalls

Slow And Steady Strides In Defending Lawsuits Related To Infant Formula Recall

By Isabella C. Lacayo
Published on January 26, 2012

In September 2010, Abbott Laboratories, an American company that sells a wide range of pharmaceutical, medical and nutritional products, voluntarily recalled 5 million cans of its Similac-brand powder infant formula because of potential contamination with beetle parts.  If ingested, the insect parts could cause gastrointestinal upset.  (Read CNN’s coverage of the recall here.)

After a large recall like Abbott’s, lawsuits were nearly guaranteed.  And, indeed, plaintiffs cropped up all over the country.  In a significant victory for Abbott, in February 2011, the United States Judicial Panel on Multidistrict Litigation denied plaintiffs’ motion to centralize putative federal class actions in Illinois, New York, California and Louisiana as an MDL in the Northern District of Illinois.  The JPML agreed with Abbott’s arguments and reasoned that the individual facts in the cases would trump any common issues.  (Read the JPML’s order here.)

The putative class action in Louisiana federal court, Brandner v. Abbott Laboratories, No. 10-3242 (E.D. La.), was filed in September 2010 – mere days after Abbott announced the recall.  It includes negligence, strict liability, misrepresentation and breach of warranty claims against Abbott.  (Read the complaint here.)

Just this week, though, the putative class was denied class certification, marking another victory for Abbott.  Following some of the JPML’s reasoning for denying centralization, the Court found that plaintiffs had not met their burden under Federal Rule of Civil Procedure 23.  Abbott argued, and the Court agreed, that plaintiffs failed to establish that common issues predominated and that a class action would be a superior method of adjudicating the claims.  Under Louisiana law, each plaintiff’s claim of medical harm or emotional damage would have to be evaluated separately and each plaintiff would have to prove contamination of the purchased formula.  Thus, the class action mechanism would be unsuitable for the proposed class.  (Read the order denying certification here).

Although Abbott has not seen the end of lawsuits stemming from its September 2010 recall, its victories thus far provide a good model for other defendants dealing with recall-related litigation.

Posted in Class Action Law Suits, Consumer Product Safety, Food and Beverage, Mass Tort, Product Recalls

Listeria Outbreak: Wal-Mart First to be Sued

By Natalie Blazer
Published on September 16, 2011

A deadly multistate listeria outbreak linked to contaminated melons, announced this week, has already resulted in one lawsuit filed, with others likely to follow. The outbreak has infected 22 people from seven states and has resulted in two deaths, according to the Centers for Disease Control and Prevention. The outbreak was first traced to cantaloupes from the Rocky Ford growing region of Colorado, and was then narrowed down to melons from Jensen Farms, the CDC said.

This week, Colorado resident Charles Palmer sued Jensen Farms and Wal-Mart Stores Inc. in state court after he allegedly contracted listeriosis from one of the farm’s melons. Palmer is suing for strict product liability, breach of warranty and negligence. His wife, Tammy, is claiming loss of consortium. Continue reading »

Posted in Consumer Product Safety, Food and Beverage, Product Recalls

President signs bill designed to fix problems with CPSC reform law

By John O'Loughlin
Published on August 15, 2011

Lost among the noise surrounding the debt-ceiling controversy in early August, Congress passed a bill designed to fix many of the issues that had plagued implementation of the Consumer Product Safety Improvement Act of 2008 (CPSIA).  Following bipartisan and near unanimous passage by Congress, President Obama signed the bill into law last Friday.  The CPSIA amendments address a number of flaws or unintended consequences of the 2008 law, particularly provisions that proved too costly for small businesses to implement or that were simply impractical or disproportionate to the perceived risk.  Some parts of the law clarify that the Consumer Product Safety Commission (CPSC) has the authority to implement the law in a common-sense way.  The new law’s key provisions include the following:

  • Lead limits – The 100 parts per million (ppm) limit for lead content that went into effect August 14, 2011, for children’s products will apply to products manufactured after that date and will not apply to products in inventory.  The law also clarifies that the lead limits will not apply to used products donated to charities or sold through second-hand stores, thrift shops, or by individuals.  The new law also clarifies that publishers do not have to test ordinary books for lead content.
  • Phthalates – The 2008 law placed limits on four types of phthalates (additives that make plastics pliable) that can be used in toys and child-care products.  The new law clarifies that mandatory testing for phthalates is only required for products or components that are likely to contain phthalates.  The new law also exempts inaccessible parts of a product from the phthalates limits.  This makes the phthalates requirements consistent with the lead limits in the 2008 law, which exempted inaccessible parts from the lead restrictions.
  • Tracking labels – The new law allows the CPSC to exempt certain products from the need for mandatory tracking labels if such labels prove impractical.
  • Consumer database – The new law builds in more time for the CPSC to track down inaccurate information or a product’s model and serial number before publishing a consumer complaint in its public database.
  • Mandatory third-party testing – The new law prompts the CPSC to make a number of changes to its requirements for product testing, including provisions that allowing the agency to exempt small batch manufacturers and requiring the CPSC to report to Congress on ways to reduce the testing burden on businesses.
  • Bicycles and off-road vehicles – The new law sets a more permissive lead limit for metal components of bikes, relaxes the third-party testing requirements for bikes, exempts all-terrain vehicles (ATVs) from the lead limits, and requires the CPSC to adopt a new ATV safety standard within one year.
  • Standards for durable nursery products and toys – The new law establishes a procedure for the CPSC to evaluate updates to voluntary industry standards that it has adopted as its own.  It also clarifies that toys that comply with certain requirements of the Food and Drug Administration are not also directly regulated under the toy safety standard (known as ASTM 963) adopted by the CPSC.

While some provisions in the law directly amend existing laws and regulations, for the most part the law simply empowers the CPSC to adopt regulations exempting certain products or component parts from regulation.  Whether and how the CPSC will use this power remains to be seen.

Posted in Consumer Product Safety, Legislation, Product Recalls, Uncategorized