Despite the fact that Johnson
& Johnson is a well-known name in most households, they are currently
laboring under yet another hit to their once squeaky-clean image. While most of
us associate J & J with such things as baby products, the company is in
fact one of the foremost manufacturers of medical devices. The first sign of
trouble occurred when the DePuy (a subsidiary of J & J) ASR metal-on-metal
hip implant was recalled in 2010 amidst a flurry of reports that the device was
defective and responsible for literally thousands of injuries to recipients of
the device. At present, some estimate that as many as 10,000 lawsuits have been
filed since the recall of the ASR, the first of which is currently being tried
in California.
Recalls
and Lawsuits Plague Johnson & Johnson
Another all-metal hip implant
manufactured by DePuy, the Pinnacle, while not yet recalled has had its own
share of problems, leaving J & J to deal with yet another round of
litigation. Very recently yet another Johnson and Johnson
hip implant, the Adept, was recalled from the overseas market, reportedly due
to the high rate of failure. As if all these recalls and lawsuits over J &
J and DePuy’s line of all-metal hip implants were not enough, on February 22,
2013, Johnson & Johnson was notified that the Justice Department and United
States Attorney’s Office were looking into potentially suspect practices
related to the marketing of DePuy’s metal hip implants.
The
First ASR Trial Ongoing
The first ASR trial concerns
Loren Kransky, a retired male, who suffered extremely serious side effects from
the ASR all-metal hip implant. Although attorneys for Johnson & Johnson are
arguing that Kransky’s health issues were due to a history of smoking as well
as other pre-existing conditions, Kransky claims he suffered heavy metal
poisoning as a result of the all-metal DePuy hip implant. Strong evidence in
the case lends credence to the claims by Kransky that DePuy placed the ASR on the
market despite being aware of specific safety hazards related to the all-metal
implant.
Johnson
& Johnson’s Public Image Tarnished
With over two dozen products
recalled by Johnson & Johnson in the past few years, Johnson &
Johnson’s public image has suffered not to mention their bank account. At the
time the ASR was recalled, DePuy claimed it was recalling
the implant due to a failure rate of approximately 12%. Bloomberg reports those
numbers as being as high as 40%. Although there is currently no database in the
United States which tracks hip implants, it is believed that as many as 90,000
ASR hip devices were implanted and recalled.
The Pinnacle hip implant,
although still being marketed, has been buffeted with lawsuits as well from
those who claim they were harmed by the implant, whether from metal poisoning
or inflammation, tissue death and bone loss leading to total implant failure.
When the all-metal hip implants first appeared, they were believed to last from
10-20 years—considerably longer than their ceramic and polyethylene
counterparts. Research shows, however, that one in eight patients implanted
with an ASR will require revision surgery within five years of their original
implant.
Legal
Implications for Johnson & Johnson
The Adept recall is unlikely to
have the same level of financial impact on Johnson & Johnson as the ongoing
lawsuits for the ASR which have already racked up over $900 million dollars in
legal fees and settlement fees. It is estimated there are less than 10,000
Adept hip devices implanted in patients overseas, meaning the liability will be
much less for J & J. Johnson & Johnson is expected to take a much
tougher stance when dealing with Pinnacle lawsuits as compared to the ASR
settlements. Even so, surgeons are hesitant to recommend a Pinnacle implant
considering the number of patients claiming they were harmed by the device. Despite the recalls and lawsuits, Johnson
& Johnson remains the largest manufacturer in the health care industry. The
outcome of the Kransky trial will likely be a predictor of how the future cases
will go, so plaintiffs and their attorneys are following the trial with
interest.
