FDA AND HEALTH CANADA STUDYING POTENTIAL HEALTH RISKS OF MEDICAL DEVICES CONTAINING BPA

Medical Device Manufacturers Must Comply with Health Canada Mandate
by June 1, 2009.

The FDA and Health Canada are looking into whether there are health risks associated with certain medical devices that contain BPA (Bisphenol-A) — a monomer used in the manufacture of polycarbonate plastics and epoxy resins. Studies have shown that BPA can leach out of plastic parts in medical devices and contact bodily fluids and tissue. Some of these studies have also concluded that exposure to BPA may be linked to heart disease, diabetes and developmental problems in the endocrine systems of infants and children. Last October, the FDA requested that medical device makers voluntarily identify FDA-regulated products which contain BPA that could come into contact with a patient's tissue, blood or other bodily fluids. In addition, Health Canada has mandated that Class II, III and IV medical device manufacturers inform the agency whether their devices contain more than or equal to 0.1% by mass of DEHP or are manufactured from raw materials containing or derived from BPA.

Manufacturers must comply with Health Canada’s request no later than June 1, 2009. Medical device manufacturers are advised to act quickly in order to meet this regulatory compliance date and to consider whether there are viable alternative materials to use in their devices. There is also reason to anticipate future product liability and consumer fraud litigation against these device makers, especially if the FDA’s current studies validate a health risk from devices containing BPA.

What is BPA?

BPA (Bisphenol-A) is a monomer used in the manufacture of polycarbonate plastics and epoxy resins. It has many applications, including, for example, use in baby bottles and food packaging. It is also used in some implantable and other medical devices.  

Potential Health Risks from BPA?

BPA is an endocrine disrupter which mimics the body’s hormones. Low levels of BPA can leach out into food products and be digested or otherwise contact other bodily fluids, such as blood. In a monograph released in draft form in April 2008 and final form in September 2008, the National Toxicology Program (“NTP”) Center for the Evaluation of Risks to Human Reproduction (“CERHER”) raised concern that exposure to BPA could be linked to developmental problems in the endocrine system in infants and children. This expert report followed a November 2007 CERHER report.  While it is estimated that more than 90 percent of Americans have traces of BPA in their bodies, the level of exposure and attendant adverse health effects of BPA has caused concern.

Health Canada and Environmental Canada also issued a draft screening assessment in April 2008 (later finalized in October 2008) stating that there were potential neurodevelopment effects from low level BPA exposure in rodents.

In September 2008, the Journal of the American Medical Association suggested an additional risk from BPA. The Journal published the results of a health survey of 1,500 adults finding that patients exposed to higher amounts of BPA were more likely to report having heart disease and diabetes.

BPA Litigation and Legislative Activity

There was substantial national media coverage of these BPA reports which prompted several companies to phase out products containing BPA. This public controversy also sparked proposed legislation in Congress with a Senate bill (S. 2928) introduced to ban BPA in children’s products and a House bill (H.R. 6228) was introduced to ban BPA in food-contact materials.

A flurry of lawsuits also erupted in the wake of this publicity about BPA.  In August, the Judicial Panel on Multi-District Litigation consolidated the pending federal BPA actions in the Western District of Missouri (MDL No. 1967). This litigation, which is still in an early pretrial stage, has been brought against companies that make baby products containing BPA.  

The FDA’s Evolving Views on BPA

The FDA’s position regarding BPA has shifted and evolved over the last year. In February 2008, the FDA stated in a letter to the House Energy and Commerce Committee that BPA is “safe as defined in 21 CFR Sec. 170.3(j).” Shortly after the NTP monograph was released, the FDA formed a BPA Task Force. The FDA presented testimony to Congress in May and June reiterating its view that the current level of exposure of BPA to adults and infants is safe. The FDA’s Center for Food Safety and Nutrition prepared an assessment of BPA for use in food contact applications that was released in draft form in August. This assessment was peer reviewed by the BPA Subcommittee of the agency’s Science Board in an October report. This report disagreed with the FDA’s conclusion that BPA is safe and said the agency should revisit its assessment and take into account  studies it had ignored in its assessment.

The FDA responded to this peer review report in a December letter stating that it is reevaluating studies, revising its draft assessment, and planning to conduct further studies.  

FDA and Health Canada Requests for BPA Exposure Information from Medical Device Makers

On October 15, 2008, the FDA published a notice in the Federal Register requesting that medical device makers assist the agency in identifying FDA-regulated products (medical devices and human-use biological products and drugs) containing BPA that would have either direct or indirect contact with patients. The notice described direct contact devices to include direct contact with tissue, blood and other fluids. It described various means of indirect patient contact or external communicating devices.

The notice asked device makers of products containing polycarbonate or BPA to provide information regarding: (1) the rate and extent of BPA release under clinically relevant extraction conditions; (2) what conditions affect the release and leaching of BPA; (3) estimates of patient exposure to BPA from use of the device; and (4) any alternatives to the use of BPA available and the risks of those alternatives. The notice also asked the makers of devices shown to release BPA, including cardiopulmonary bypass circuits, hemodialysis circuits and certain dental devices, to provide certain information about the use of these devices in certain patient populations and any study reports relating to BPA release from these products. Advamed submitted a response to the FDA request on behalf of a number of its device maker members.  

Similarly, Health Canada issued a notice in May 2008 requiring Class II, III and IV medical device manufacturers to inform the agency whether their devices contain more than or equal to 0.1% by mass of DEHP or are manufactured from raw materials containing or derived from BPA. Health Canada sent a survey about this to Class II, III and IV device makers requesting a response by June 1, 2009. 

What's Up-Coming in 2009?

1. FDA Continuing Analysis of Effects of BPA

The FDA continues to study this issue. Last month, the agency’s Science Board met and outlined the multi-step approach it is undertaking to study this issue, including: (1) an exposure assessment; (2) a toxicology assessment; and (3) a risk characterization. 

The Board described two human studies it has initiated as part of its exposure assessment to determine if plastic medical device components might be leaching BPA into the blood of patients during cardiopulmonary bypass surgery and hemodialysis. The first study will track pediatric patients under-going bypass at the Children’s National Medical Center in Washington. During bypass surgery, the blood of a patient is exposed to surfaces containing BPA for hours as a device oxygenates and circulates the blood. The second study will track hemodialysis patients at the University of Michigan in Ann Arbor. The blood of patients undergoing this treatment is similarly exposed to plastic containing BPA for hours at a time. It is thought that these patient populations may face a greater risk from BPA leaching because BPA tends to leach when heated and these procedures involve warmed blood passing through plastic components containing BPA.  

The Board is assessing the toxicology of BPA by undertaking a review of existing literature (more than 100 studies) regarding the effect on animals and human patients exposed to BPA via medical devices. 

The Board is also undertaking a risk-benefit analysis – balancing the risks of BPA exposure versus the clinical benefits of the medical device – and looking at alternatives to BPA for use in medical devices and the risks of such alternatives.

Suffice it to say, the outcome of the FDA’s recent analysis of this issue remains to be seen and may not be known for months or even years. 

2. Future Legislation and Litigation

There are renewed bills in Congress pertaining to BPA this session. A House bill (H.R. 1523) and Senate bill (S. 593) would ban the use of BPA in food and beverage containers. Moreover, a growing number of state legislatures, and even city and county councils, are considering BPA bills. For example, there is a bill in the Minnesota Legislature that would prohibit manufacturers from selling in Minnesota any “children’s product” containing BPA. The original bill defines “children’s product” to include a product, or any component of a product, that is introduced in, or otherwise applied to, the human body or any part thereof which arguably could be construed to apply to medical devices implanted in children.

It also remains to be seen whether BPA litigation will gain traction and broaden to include medical devices. Numerous plaintiff law firms have been soliciting BPA clients/plaintiffs on the Internet. Many of the plaintiffs in MDL No. 1967 have not alleged that BPA has harmed them or their children.  Instead, they have asserted breach of contract, breach of warranty, and state consumer protection statute claims alleging that manufacturers and retailers breached an obligation to disclose potential safety risks from materials like BPA. This is part of a new wave of product liability cases aimed at holding manufacturers/retailers to a higher standard. The outcome of the FDA’s current studies of BPA exposure in cardiopulmonary bypass and hemodialysis could fuel such litigation regarding a host of medical devices containing BPA that come in contact with bodily fluids and tissue.

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