Monday, May 5, 2014

Suits against Genoa clinic in works

At least 14 people injected with tainted steroids at Michigan Pain Specialists could take the Genoa Township clinic to court if an out-of-court agreement isn’t reached by October.
Rochester attorney Alyson Oliver mailed a notice of intent to file suit against the clinic April 3, starting the clock on a six-month window for the parties to reach financial settlements.
The notice of intent was filed on behalf of the patients to avoid expiration of the statute of limitations on the complaints tied to the 2012 fungi-tainted pain injections at the local clinic.
If a settlement isn’t reached by early October, the patients will determine whether to file lawsuits, Oliver said.
She said several other attorneys representing former Michigan Pain Specialists patients also have held off on filing suit in hopes of reaching settlements.
“That’s where we’re at right now,” Oliver said, adding that her office hasn’t received a response from the clinic at 2305 Genoa Business Park Drive.
Oliver said her clients in 2012 at the Genoa Township clinic received tainted methylprednisolone-acetate injections distributed by the New England Compounding Center in Massachusetts.
The injections were among multiple tainted batches of the compounded, or mixed, steroid distributed around the country by the NECC.
The resulting fungal meningitis outbreak led to 19 Michigan deaths, eight of which were of Livingston County residents. Another three Michigan deaths are counted as Indiana deaths because treatment occurred in that state.
The outbreak statewide resulted in 264 cases of illness, which includes the 19 deaths.

Alleged negligence of recalls

Oliver said the former Michigan Pain Specialists patients sought legal counsel after they learned other lawsuits alleged the clinic received but ignored a Sept. 26, 2012, faxed recall notice about the NECC product.
Also central to the cases, Oliver said, is a claim that the Genoa Township clinic created false documentation showing patients were given a brand-name, federal Food and Drug Administration-regulated drug but were actually administered a cheaper drug manufactured by the NECC.
The accusation is based on documentation showing patients were billed for a Pfizer steroid injection but instead received the contaminated NECC product, Oliver said.
Her clients also are awaiting news on what portion, if any, they will receive from a $100 million victim fund created through the NECC’s bankruptcy.
The compounding pharmacy voluntarily removed its products and shut down after tainted batches of the medications were discovered.
The former company’s bankruptcy is still in process, though potential claimants had until Jan. 15 to file claims. The amount of payment will be determined by the number of valid claims filed.
The FBI continues a criminal investigation into the NECC’s actions and is being aided by the Michigan attorney general’s office. The NECC also faces civil litigation.
Randy Hackney, an attorney who represented Michigan Pain Specialists as of September, didn’t return calls or emails Friday.

Proposed regulations

The state Senate Health Policy Committee last week approved legislation that would create tighter restrictions on compounding pharmacies in Michigan and those that are doing business in Michigan.
The legislation would require compounding pharmacies to have one accountable pharmacist licensed in Michigan; maintain records of compounded medicines; be subject to at least one state inspection every two years; and be accredited through a national organization.
The bills also would allow emergency license suspension if an immediate public health risk were identified. Background checks would be required for pharmacy owners who are not yet licensed, and for those licensed prior to Oct. 1, 2008.
Violation of the rules would result in a maximum 15-year prison sentence in cases of patient death.
The bills await a full Senate vote.

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