Category Archives: Manufacturing

Variables that can affect burn injury cases

Most experienced defense lawyers know that the variables in burn injury cases prevent anything resembling a guarantee of a good result.  The following variables can affect the outcome of a case, including the potential financial exposure that a defendant or its insurer or worker’s compensation carrier may face:

– the different types of skin grafts and skin graft surgical procedures commonly involved in burn cases;

– whether, in high total body surface area (tbsa) burns, complete excision and grafting can be completed in a single principal procedure;

– the treatment technique, surgical technique and treatment philosophy of the physician; and

– the relative size of the burn center, as larger centers tend to be able to perform certain procedures–not because of greater skill, but because of the size and number of  surgical teams necessary.

Skin Graft Classification and Skin Graft Surgical Procedures

In burn injury cases, surgical removal (excision or debridement) of the damaged skin is followed by grafting.  The grafting is designed to reduce the course of hospital treatment and improve function and cosmetic appearance.  There are typically two types of skin grafts–mesh grafts and sheet grafts.  A less-common, third type of graft is a composite graft.

Mesh Grafts

Mesh grafting is known as partial-thickness grafting, or split-thickness grafting.  With mesh grafting, a thin layer of skin is removed from a healthy part of the body, known as the donor site.  It is processed through a mesher, which makes apertures into the graft. The graft then becomes mesh-like, allowing it to expand approximately nine times its original size.  Such grafts are used to cover large areas and the rate of auto-rejection is lower.  Harvesting of these grafts from the same site can occur again after as little as six weeks.  The surrounding skin requires dressings and the donor site heals by reepithelialization.

Using a dermatome, the surgeon usually produces a split-thickness graft which is carefully spread on the bare area to be covered.   It is held in place by a few small stiches or surgical staples.   The graft is initially nourished by a process called plasmatic imbibition in which the graft drinks plasma.  New blood vessels begin growing from the recipient area and into the transplanted skin within 36 hours in what is called capillary inosculation.  To prevent accumulation of fluid, the graft is frequently meshed by making lengthwise rows of short interrupted cuts, each a few millimeters long, with each row offset to prevent tearing.  This allows the graft to stretch and more closely approximate the contours of the affected area.

Sheet Grafts

In the alternative, a sheet graft, which is a full-thickness graft, involves pitching and cutting away skin from the donor section.  Sheet grafts consist of the epidermis and entire thickness of the dermis.  Sheet grafts must be used for the face, head and hands because contraction must be minimized.  If sheet grafting is necessary but the donor sites are insufficient, the outcome is likely to be less satisfactory, and the financial exposure in such cases will be higher.

With sheet grafting, the donor site is either sutured closed directly or covered by a split-thickness graft.  Sheet grafts are more risky in terms of rejection, yet counter-intuitively leave a scar only on the donor section.  Sheet grafts also heal more quickly and are less painful than partial-thickness grafting.

Sheet grafting is usually difficult in severe aviation or manufacturing burns because those involve high-percentage tbsa burns and donor sites are therefore limited.

Composite Grafts

The third type of graft, a composite graft, is a small graft containing skin and underlying cartilage or other tissue.  Donor sites would include the ears and other cartilage to reconstruct, e.g., nasal rim burns.

In High TBSA Burns, When Immediate, Complete Excision and Grafting is Completed in a Single Procedure, Damages Amounts May Be Lower.

In cases involving clearly severe, high tbsa burns, whether full or partial thickness, immediate, complete excision and grafting is usually indicated.  If immediate excision and grafting is complete–that is, done in a single procedure–a much larger surface area surgery can be completed with less blood loss.  This minimizes transfusion needs and dangers and also speeds physiological restoration.

Furthermore, an immediate, complete excision and grafting procedure can often allow use of good skin for grafting that would otherwise need to be excised.  If the procedure is not done immediately, less skin may be available for grafting.  In other words, skin that otherwise may have been healthy and usable when the plaintiff was first admitted to the hospital may die if the procedure is not done immediately, particularly if that skin is close to the burn site.

Immediate, complete excision and grafting also cuts down on the number of procedures and allows important vascular redevelopment to begin occurring sooner and supplying the graft locations with blood flow, which is essential to healing.

 The Treatment Technique, Surgical Technique and Treatment Philosophy of the Physician Can Be Outcome-Determinative

The simple fact is that some surgeons are more skilled than others, so the outcome may be better or worse depending on the skill of the physician.

There are also some advances in burn surgery that particular physicians are able to employ.  For example, in the most serious burn cases, grafts may be taken from other animals.  Such grafts are known as heterografts and, by design, they serve as temporary dressings that the body will unquestionably reject within days to a few weeks.  They are used in severe cases to reduce bacterial concentration of an open wound and reduce fluid loss.

Additionally, some surgeons are able to use cell cultured epithelial autograft (CEA) procedures, which involve removal of skin cells from a patient and the growth of new skin cell sheets in a lab.  Although the new sheets will not be rejected, they are typically only a few cells thick and do not stand up to trauma.  As a result, many such grafts do not take and the procedure must be repeated or an alternate procedure employed.

Furthermore, some physicians prefer to do more sheet grafting versus mesh grafting.  The physicians who prefer mesh grafting like it because they can cover much larger areas in a shorter period of time.  Conversely however, mesh grafting requires more revision surgeries, more of a risk that the grafts don’t take, and more contraction, which is disfiguring and requires further surgery.

Different groups of surgeons have their own philosophies and cultural preferences.  In Portland, Oregon, for example, there is one group of approximately five, highly-skilled burn surgeons who staff the Oregon Burn Center at Emanuel Hospital.  Due to the relatively small size of the burn center, they tend to wait four to seven days before conducting major graft procedures so that they can have a better assessment of the full extent of the injury.

The Relative Size of the Burn Center Can Be Outcome-Determinative

Larger burn centers, such as the ones at UC Davis or Harborview in Seattle, do not necessarily provide better treatment, but they are typically capable of complete excision and grafting at admission when there is a high percentage of the total body that sustains full-thickness burns or a combination of full-thickness and lesser degree burns.  This is a function of burn center size, not the skill of the physicians.  A full excision and grafting procedure is lengthy and generally requires two full surgical teams and at least two attending physicians and two assistant surgeons.  This type of procedure is generally not possible at relatively smaller burn centers such as the Oregon Burn Center.

Using Variables in Burn Cases to Assess Case Value and Adequately Prepare

The variables discussed above vary from case to case.  It is important to assess each one when valuing a burn injury case in order to determine the defendant’s likely exposure and prepare adequately for productive settlement discussions and, if absolutely necessary, trial.

 

An Introduction to Burn Injury Significance and Burn Centers

Burns Are Significant Injuries and Can Lead to Some of the Highest Jury Verdicts

Olson Brooksby appreciates the potential high-exposure value of burn injury cases.  Scott Brooksby has significant experience in serious, total body surface area (tbsa) burn injury and wrongful death cases.  Our lawyers understand the delicate nature of large burn injury cases and work to minimize exposure to our clients.

Defendants potentially subject to burn injuries should employ best safety practices and make every attempt to avoid such injuries.  Burns are one of the most serious injuries in personal injury cases.  They may be the result of chemical fire or exposure, explosions, paints, solvents, or conventional fire.  Sometimes burns are the result of contact with hot equipment or other product liability related events.  The defense of serious burn injuries, including those related to aviation, product liability and heavy manufacturing is a large part of the defense practice of Olson Brooksby.  A bad burn case in an aviation or heavy manufacturing accident, or as the result of a product liability defect can easily present high financial exposure to manufacturers and/or insurers.  Settlement exposure can climb into the millions or tens of millions, with verdicts at least as high.

Even when there appears to be a strong defense, defendants should not underestimate the overwhelming sympathy a jury will feel when it sees a burn victim, particularly with serious facial burns or burns to the extremities.  A good plaintiff’s lawyer will ask the jury to consider things like the profoundly disfiguring effects of a bad facial burn and the pain that everyday exposure to sunshine will cause its victim for life, or the lifelong gawking stares it will draw.

Similarly tragic are severe burns to the hands, which cannot be restored to even near full function or pre-burn aesthetics and result in pain every time the victim is touched.  When liability is clear, burn cases should be settled because, unlike other personal injury cases, deformities caused by burns can incense juries to the point where they cannot put their emotions aside.  The result can be verdicts in the millions or tens of millions, including punitive damages (particularly if children are involved or there is perceived recklessness).  Although the amount of burn verdicts used to depend on the region of the country where the case originated, such verdicts are now generally high in every jurisdiction.

If the burn injury case must be tried, it must be done with great sympathy for the victim  and careful attention to the medical aspects of the case, including future treatment, which may last decades and cost into the six or seven figures.

When trying a burn injury case, it is important to know where the injury occurred.  If a plaintiff has to be air lifted to a burn center, that can radically change the extent of the injury.  Similarly, it is important to know the details of the burn center where the plaintiff was treated because that can also change the extent of the injury and thus affect the jury verdict amount.

The Location of the Accident Can Change the Extent of the Injury and the Jury Verdict

In those industries where serious conventional burns are common, such as aviation disasters or steel or metal manufacturing, “serious” can arbitrarily be defined as full-thickness burns over 20% or more of the tbsa.  The location of a burn center and the length of time to transport the victim to the burn center can be outcome-determinative.  This is also particularly true where babies and children or those over sixty-five are the victims, or where there are serious burns to the face, head, extremities, or internal organs.

Manufacturers and insurers obviously do not choose where burn centers are located.  After an accident, first responders will obviously make needed decisions about transport.  Most heavy manufacturing, including that of aviation hot section components, is done near large metropolitan areas that typically have at least one burn center.  Perhaps some of the greatest danger lies in cases in remote areas where individuals are subject to burns from allegedly defective products.  For example, a person camping in a remote area of the Western United States who is badly burned by kerosene at a remote campsite may not be able to reach a burn center for hours.  There may be no cellular phone service and a helicopter ambulance may have to be dispatched from hundreds of miles away.

Depending on the severity and tbsa burned, the size and related capabilities of the burn center will have a direct impact on the plaintiff’s recovery, and consequently, the ultimate exposure to the manufacturer and/or insurer in any settlement or verdict.

All Burn Centers are Not the Same–They May Have Varying Treatment Philosophies, Training and Capabilities

The size of the burn center can also be outcome-determinative because smaller centers, such as the Oregon Burn Center at Emanuel Hospital, are generally not large enough to perform a full excision and grafting in high tbsa burn cases.  A full excision and grafting is where they do all of the procedures at once instead of one at a time.  Some burn physicians believe that, depending on the case, better outcomes are achieved through full excision and grafting in high tbsa burn cases.

There are approximately 45 regional burn centers in the United States.  Verification of burn centers is a joint program administered in the form of a rigorous review of the applicant centers by the American Burn Association (ABA) and the American College of Surgeons (ACS).  Many states do not have a regional burn center and most states have only one or two.  California has the most, with seven.  Most burn centers are run by a single group or an extremely limited number of groups of burn surgeons who practice at the facility.

Unlike hospitals, burn centers do not typically extend general privileges to physicians.  Most burn surgeons have been trained as general surgeons, and then have gone on to receive additional specialized training in burns.   Along the population corridor running down I-5 between Seattle and Davis, California there are three verified regional burn centers, one each in Seattle (Harborview), Portland (The Oregon Burn Center at Emanuel Hospital), and The UC Davis Regional Burn Center.

Training and available resources vary from center to center.  Burn centers also tend to have more pronounced treatment philosophies and cultures because they are staffed by relatively few surgeons who generally practice in the same group or just a few groups.  However, although burn center practice varies, it is imperative that those who are seriously burned reach a regional burn center as soon as possible because specialized treatment is inarguably outcome-determinative

The mechanics of injury, lots of fire, accelerant, and contact with temperatures in excess of 1,000 degrees are factors that are considered when determining whether burns are graftable from point of admission.  In any serious burn case, most intermediate facilities such as a conventional hospitals will seek to transfer a seriously burned patient, almost always by air, to a regional burn center as soon as stabilization occurs.

 

Federal Government Regulation of Consumer Product Safety and Mandatory Reporting of Consumer Product Defects to the CPSC

Olson Brooksby frequently counsels local and national clients on whether or not the consumer products they manufacture or sell contain a safety defect that they would be required to report to the Consumer Product Safety Commission.

Federal Regulation

The Congress of the United States established the Consumer Product Safety Act (“CPSA”), codified at 15 U.S.C. §§2007-2089.

Complete analysis of the CPSA is beyond the scope of this article.  Pursuant to the CPSA, Congress established the Consumer Product Safety Commission (“Commission”) to regulate consumer product safety in the United States.  Under the CPSA, the Commission has the power to develop regulations related to the safety of consumer products, which are generally contained in the Code of Federal Regulations.

Under 15 USCS § 2052(5), a “consumer product” means “any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise…”

Specifically excluded from regulation by the CPSC are tobacco, motor vehicles, pesticides, aircraft and aircraft components, boats, drugs and medical devices and food.  Even if these excluded products are purchased for consumer use, they are not subject to regulation or jurisdiction by the CPSC.   The Commission does tend to heavily regulate consumer products, especially children’s items, such as: car seats, children’s pajamas, strollers, cribs, toys, some recreational products, certain home appliances, and tools.  The CPSC has passed specific regulatory acts such as the “Children’s Flammable Pajamas Act” associated with consumer products that target vulnerable users, primarily children and vulnerable adults.   A link to the CPSC website, which contains useful product safety information, including information for manufacturers such as current product recalls, is found at http://www.cpsc.gov/.

The Requirement of Reporting Consumer Product Defects to the CPSC

Although complete analysis of reporting requirements are beyond the scope of this article, Section 15(b) of the CPSA establishes reporting requirements (“Section 15(b) reports”) for manufacturers, importers, distributors and retailers of consumer products.  In summary, each must notify the commission (generally within 24 hours) if they obtain information that “reasonably supports the conclusion” that a product (1) fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard, (2) fails to comply with any other rule, regulation, standard or ban under the CPSA or any other Act enforced by the Commission such as the Children’s Gasoline Burn Prevention Act, Refrigerator Safety Act or Flammable Fabrics Act, (3) contains a defect which could create a substantial product hazard, or (4) creates an unreasonable risk of serious injury or death.

Under the CPSA, a private right of action exists for any person injured by violation of a consumer product safety rule promulgated by the Commission.  Manufacturers should be aware that the CPSA contains some sharp teeth and courts may award attorney fees as part of the injured person’s recovery.  15 U.S.C. §2072.  Under the CPSA, the CPSC has broad enforcement powers and a number of tools to ensure the safety of consumer products.  However, under the CPSA, the CPSC is also charged with assisting manufacturers, distributors and retailers of products with known defects in the development of a “Corrective Action Plan” (“CAP”), and although the CPSC enforcement powers have sharp teeth, the CPSC is also focused on working to develop voluntary corrective action plans and engaging in cooperation during corrective action plan implementation.

Olson Brooksby frequently counsels manufacturers on whether to pass along reports they have received or internally-developed information that suggests that a product may contain a defect that would require reporting under Section 15(b) of the CPSA.  While comprehensive analysis of the Section 15(b) reporting requirements are beyond the scope of this article, the Commission has published a useful abbreviated publication that discusses reporting and product recalls.

Why Familiarity And Compliance With CPSC Mandatory Reporting Requirements Matters

Although it should go without saying, manufacturers, especially those focused on products for babies, children and household consumers (such as cleaning products, flammable products, etc.), must be aware of whether the Commission is considering or has established specific rules governing their products.  Manufacturers, distributors and retailers should be aware of the basic reporting requirements to the CPSC under Section 15(b) if they become aware of information that reasonably supports the conclusion that their product contains a defect and should voluntarily report.

The Commission has the power to require mandatory recalls, but will typically offer a manufacturer the option of conducting a voluntary recall before issuing a recall order.  Prudent manufacturers of consumer products, especially those for which the Commission has promulgated specific rules or standards, should have a recall plan developed in advance because, whether voluntary or mandatory, the Commission will expect the company to commence the necessary recall action plan quickly and such plans are typically very involved.  Any action taken by the Commission, whether in the form of corrective action or a recall can have serious consequences for manufacturing cycles and the costs associated with a recall can be very high.  For more on this issue, please feel free to contact our office.