• The Gist: Such a large products liability case would require medical record and literatures reviews, fiscal evidence and numerous expert witnesses.
© The Medical-Legal News, 2007
By Dan Clifford, publisher
Pike County, Ky., is exploring a lawsuit against Purdue Pharma, the maker of OxyContin, to recover costs related to the fiscal woes the powerful painkilling drug has had on the county, the Associated Press has reported.
County officials say their records prove they have spent $7 million on bonds since 2005 to fight the epidemic of addiction to OxyContin, known as “hillbilly heroin.”
In another suit, Purdue Pharma agreed to pay $634.5 million in fines in May for failing to warn of the addictiveness, or “mis-marketing” of OxyContin. That suit emboldened Pike County to seek relief through the courts, the story reported.
Keith McCormick, a former prosecuting attorney and an experienced medical malpractice lawyer in Morehead, Ky., offered some perspective on Pike County’s possible case.
“There is precedent for a mass tort where individuals and a government seek recovery for the medical consequences of a product — it was the big tobacco case.”
McCormick did some research on the $634.5 million OxyContin settlement and said, “In the [existing] OxyContin settlement the lion’s share of it is for restitution to state and federal governments who paid medical bills that they otherwise wouldn’t have paid, to reimburse them.” He noted that the next portion, about $130 million, will go to individuals who claim to be hurt by the drug.
“Something that hasn’t been given tons of press is that Purdue Pharma admits to mis-marketing the drug [stating it was less addictive than it really was] from 1996 to 2001. But this settlement is not an admission of wrongdoing by anyone from 2001 until now.”
“They claim they have resolved those failures after 2001,” warned McCormick, which would complicate Pike County’s case.
When speaking to Pike County’s damages, McCormick noted a weakness in the case would be that Pike County is not a government agency paying Medicare or Medicaid, so could not recover for this, and could not be a part of the existing settlement.
“They would have to bring their own action.”
McCormick pointed out that while it is possible to bring an action against a drug maker, it is also expensive and technical. He questioned if a small rural county could do this on its own.
“But they would not have to start from scratch,” said McCormick, noting Purdue’s previous mis-marketing admissions.
McCormick said the second part of the claim is the “old legal bug-a-boo about foreseeability.”
McCormick warned that OxyContin was cleared by the FDA and was not distributed to end users by Purdue except through doctors and pharmacies, known legally as “learned intermediaries.”
“Is the end user, or abuser, so far down the line that we can no longer go back to the original manufacturer and claim they could have foreseen this, and should have? Now, that’s a tall order, and a big challenge.”
McCormick pointed out that from 1996 to 2001 the drug was marketed as less addictive than it was [mis-marketed]. It has since been packaged in a time-release form as a safety device, but when an abuser defeats this safety, the case is harder to make from a plaintiff perspective. He also noted that if Pike County is seeking damages post-2001, the case will be tougher, and that any damages sought by patients who were managed under post-2001 instructions to doctors from Purdue are less litigable. He said that Pike County has the challenge of showing that the mis-marketing from 1996 to 2001 extends into their claim period.
“No one has said there should be no OxyContin,” McCormick quipped. “Pike County is going to have to go a long way to show that a company that is selling a lawful drug through a lawful system is responsible for the social ills of its misuse, but it’s not impossible.”
McCormick felt that several counties would want to join in with Pike County.
As to the groundwork of discovery, McCormick opined that attorneys would need to look into whether the company adequately warned doctors and the public about its powerful drug. He said it should be questioned if the packaging and literature were accurate and sufficient.
As to experts, McCormick advised, “Pike County would be well served to have experts such as a pharmacologist, probably a doctor, a specialist in addictions and treatment, and a criminal justice expert.”
“A consultant such as a legal nurse consultant (LNC) will want to take a close look at the sales literature and data provided to doctors while they were courted by salespeople and see [if the mis-marketing continued past 2001]. A good review in this case will be of all literature that was sent to physicians — literature that patients never see.”
“What corrective steps were taken to tighten up the warnings on OxyContin?” McCormick asked. “An LNC needs to be prepared to look at medical literature, and ask the physicians what they relied on from the company. Attorneys sometimes are not well educated in the day-to-day functioning of a medical office.”
McCormick said that once Purdue changed the literature they have a responsibility to go back to the well and reach all the people they reached previously in order to correct their mis-marketing.
“An LNC also can take the medical records and translate those into costs, and specific to a region. LNCs could take histories of people who ended up addicted to the product.”
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