Running Head: Products Liability

Assignment 4: Products Liability
Name
Law and Ethics in the Business Environment
Professor
February 17, 2013

Products Liability Johnson & Johnson
Johnson & Johnson started out making surgical dressing for hospitals and then that progressed into what Johnson & Johnson is best known for is the Band-Aid brand band aid. They added tape to the dressing and the product was convenient for hospitals as well as mending cuts and scrapes that people get, targeting kids because they are accident prone.
In later years Johnson & Johnson explored other opportunities mainly in the over-the-counter medicinal products. Over the years they have been subject to many lawsuits but the one this paper will focus on is the product liability lawsuit on the DePuy ASR hip implant. DePuy is a company that specializes in orthopedic products and was acquired by Johnson & Johnson in 1998.
The metal on metal hip replacement DePuy ASR was approved by the FDA for use by surgeons on patients that were in need of a hip replacement in 2005. (Meier, 2010). The DePuy ASR hip replacement should have a life of at least 10 years. The device was being used on patients, soon after the DePuy dividion of Johnson & Johnson started receiving complaints of the device with the largest spike of complaints in 2009. (Meier, 2010). Many of the complaints resulted in the patient having to receive another hip replacement only a few years after receiving their first hip replacement. The reason the DePuy ASR hip implant didn’t last is because the device is metal on metal and can cause metal debris as the hip is used. ‘This can cause damage to muscles and other soft tissues which results in the replacement of the device.’ (Meier, 2010). The device was tested on a few patients who were not aware they were ‘testing’ and the device was found to be stable and good with just a few being tested. The main people that have a

Products Liability problem with the DePuy ASR hip replacement are mostly women, small framed individuals, and people who have frail bones. Patients were getting metal poisoning from the metal debris getting into their blood stream as well as bone deterioration. Some patients only needed a partial replacement while others had to have the entire device replaced causing a dangerous situation for the patients. The hip implant caused some people severe pain while standing or walking, the implant would also become dislodged in some cases. There were multiple symptoms that recipients of the DePuy ASR hip replacement had, not always the same symptoms but all resulted from the use of the device.
Legal Theories
The legal theory that applies to the DePuy ASR hip replacement is “design defect theory of product liability.” (Liebhard, 2011). “A design defect is a problem or condition a product has that causes injury to someone who uses the product.” (What is a design defect, 2010-2011). The design of the DePuy ASR hip replacement was metal on metal. The design of the implant caused metal particles to release into the users system through typical and usual use of the product. The metal particles caused the patients to become ill and the DePuy ASP hip replacement resulted in having to be replaced again. The hip replacement should last at least 10 years but patients were having complications within 2 to 5 years of having the procedure. ‘One in eight people needed to have their hip replacement corrected within 5 years.’ (Kelley, 2012).
The rules that a court uses to identify design defects are “A design defect exists if the product is unreasonably dangerous as designed or a design defect exists if the product is not safe for its intended uses.” (What is a design defect, 2010-2011).

Products Liability
The claimants also charge that the DePuy ASR hip replacement was not properly tested. They also charge DePuy ASR hip replacement was not recalled in a timely manner. Johnson &
Johnson was aware of the issue when patients began having problems with the DePuy hip replacement the product was not recalled until 10 years after the defects were made known. This falls under the product liability law. With a product liability lawsuit, the prosecutor must prove that the product was defective. This can be easily proven with the DePuy ASR hip replacement. Johnson & Johnson was aware of the products defects within the first few years of the use of the product and they didn’t recall the product. Patients continued to receive the DePuy ASR hip replacement years after the defect had been exposed. This created many more patients receiving the defective hip replacement than there should have been, putting more patients at risk as well as having to go through the painful surgery again which was unnecessary.
Changes
The DePuy ASR hip replacement has been used in over 93,000 patients. DePuy, the subsidiary of Johnson & Johnson issued a recall for the DePuy ASR hip replacement. The recall was announced in August of 2010. Making hip replacement with metal on metal is no longer the practice for the creation of the hip replacement. With the recall, Johnson & Johnson has offered to patients of the DePuy ASR hip replacement a refund. They also provide a phone number if a patient has a question about the product and what products were recalled. The defects of the DePuy ASR implant will affect 1 out of 8 people. When a patient needs to have the implant replaced only a partial replacement of the implant is performed. DePuy ASR is no longer using metal on metal.
Products Liability
The lawsuits that are filed against DePuy ASR will have different outcomes as to what the patient will be compensated with as patients have had different issues with the product.
Regulatory Agency The regulatory agency that oversees DePuy they subsidiary of Johnson & Johnson is the Federal Drug and Administration (FDA). The FDA oversees food, drugs, medical devices, radiation emitting products, vaccines, blood, biologics, animal & veterinary, cosmetics, and tobacco products. The “FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of the devices and the health and safety of patients.” (Medical Devices, 2013). They list on their website what devices have been recalled and what consumers can do to rectify their situation. It also provides the date the product was recalled, why it was recalled and where to contact to find out if your device is included in the recall. The FDA must approve products before they are marketed to the public. One of the criteria that the FDA uses is if the ‘benefit of the product outweighs the risk.’ (Medical Devices, 2013). The FDA reviews the results of the testing that was done by the company seeking FDA approval and then the FDA will approve the device for use on patients. FDA approval can take up to 6 months and longer. A company will do testing and the results of the testing are then submitted to the FDA for approval. The charges against DePuy ASR hip replacement is that they didn’t do extensive testing on the implant and because of their lack of testing the device it was found to be defective in people only after a few years of having received the device. Nonetheless, the FDA granted approval for the use of the DePuy ASR metal on metal hip replacement.
Products Liability
Testing of the DePuy ASR hip replacement was done on humans and was performed on healthy, strong boned subjects which did not give DePuy the information that was critical for them to utilize and correct. Also, because people were not aware of the issues that metal on metal could cause, they didn’t know to blame the metal on metal for their sickness (if they got sick from the metal getting into their blood stream).
Recommendations
DePuy is being accused of not having substantially evaluating the product before using the implant on people. They stated that they did extensive testing on the product before they used for implants. Not only the issue comes in that they didn’t properly test the product but when there were issues with the product they didn’t recall the product until thousands of people were affected by the product. I would advise for DePuy ASR to consider the daily use of the product before implanting it in someone’s body. This is a difficult task but could be done with a robot such as a crash test dummy. Technology has advanced enough that the human body can be simulated and a dummy can be created and tested after a few years of use. DePuy ASR should also keep statistics on their devices such as how long the device has lasted, the condition of the patient (if they have any other medical issues), if there are any complaints whether they are related to the implant or not. This could be tricky because keeping medical information on people is a violation of consumer’s rights. The medical records would have to be kept anonymously but enough information that if there is an issue it can be traced back to the device. Products Liability
DePuy should also discontinue use of a product that is found to have possible defects and not wait 5 years before 93,000 people are affected by the defect of the device. There still would have been a significant number of people who received the implant however, the sooner a defect is identified; the less people will be damaged by the product. DePuy was receiving feedback on the defects of the devices as early as 2006 and didn’t recall the product until 2010. Although the number of people increased as the years went by, the company should have done more with the information that they had as soon as it was identified. With all products a company has to learn from their mistakes and move forward. They have to use the information that they have and create a product that will benefit the most people. In the real world, not every product is going to be a perfect fit for every person but weighing the risks DePuy can create multiple hip replacements that will be able to be used for different types of people.

Product Liability
References
Kelley, C. (2012, January 19). The Unacceptable Revision Surgery: DePuy Hip Implants. Retrieved March 8, 2013, from The Legal Examiner: http://councilbluffs.legalexaminer.com/medical-devices-and-implants/the-unacceptable-revision-surgery-depuy-hip-implants.aspx?googleid=297640
Liebhard, S. (2011, November 17). DePuy Hip Replacement Lawsuit. Retrieved March 7, 2013, from Bernstein Liebhard LLP: http://www.consumerinjurylawyers.com/DePuy/DePuyHipReplacementLawsuit.html
Medical Devices. (2013, March 7). Retrieved March 8, 2013, from FDA: http://www.fda.gov/MedicalDevices/Safety/default.htm
Meier, B. (2010, March 9). Business. Retrieved March 7, 2013, from The New York Times: http://www.nytimes.com/2010/03/10/business/10device.html?pagewanted=all&_r=0
What is a design defect. (2010-2011). Retrieved March 8, 2013, from Rottenstein Law Group LLP: http://www.rotlaw.com/legal-library/what-is-a-design-defect/