Justice Department sues La. pharmaceutical company; the U.S. Food and Drug Administration said it found evidence the company has been making and selling prescription painkillers and over-the-counter cold remedies and wound cleansers without obtaining FDA approval.

article found here

DOJ Press Release

Analysis: Meningitis suits may turn on how injections are defined

By Nick Brown

(Reuters) – Victims of a deadly U.S. meningitis outbreak are starting to sue the physicians and clinics that administered tainted steroid shots, and the success of the suits could hinge on whether judges decide the injections are subject to product liability or medical malpractice laws.
The drug-mixing pharmacy linked to the outbreak, the New England Compounding Center, already faces lawsuits related to the shots, as do its executives. But because the Massachusetts company is relatively small, patients exposed to meningitis are beginning to sue more well-insured defendants.
Plaintiffs have sued at least two physicians and orthopedic clinics in New Jersey that provided the injections, and legal experts predict similar cases against other doctors and clinics.
Such lawsuits, however, may hinge on whether courts define the tainted injections as products that were sold. In that case, hospitals and doctors could be sued for product liability and held responsible regardless of intent to harm. These strict standards are part of most state product liability laws.
However, if courts define an injection as a service, plaintiffs likely would face the tougher task of showing negligence under medical malpractice laws.

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Complaint Filed in K-V v. FDA, case number 12-01105

The Complaint filed in K-V Pharmaceuticals v.  FDA  can be viewed here.
The Motion for Temporary Restraining Order and Preliminary Injunction can be viewed here.
Exhibits to the complaint can be viewed here.
The declaration of Scott Goedeke can be viewed here.
The declaration of Michael Jowiakowsk can be viewed here.
The declaration of Thomas McHugh can be viewed here.
The declaration of Patrick Ronan can be viewed here.
The proposed order for the temporary restraining order can be viewed here.
The proposed order for the permanent injunction can be viewed here.

Deadlines in K-V v. FDA

                On July 5, 2012, the district court entered a minute order, setting the following deadlines:

MINUTE ORDER. Based on the matters discussed with counsel for the parties at a telephone conference held on this date, it is ORDERED that pursuant to Fed. R. Civ. P. 65(a)(2), the motion for temporary restraining order and preliminary injunction [Dkt. # 2] will be consolidated with the merits. It is FURTHER ORDERED that the matter will be briefed in accordance with the following schedule: defendants' dispositive motion and combined memorandum in opposition to plaintiffs' motion and in support of its dispositive motion shall be filed on or before July 20, 2012; plaintiffs' combined reply and opposition to the dispositive motion shall be filed on or before July 27, 2012; defendants' reply in support of its dispositive motion shall be filed on or before August 3, 2012; and a motions hearing is set for August 7, 2012, at 2:00 pm. Since plaintiffs' motion is now consolidated with the merits, the parties need not brief irreparable harm. Signed by Judge Amy Berman Jackson on 7/5/12. 

On July 6, 2012, the district court entered the following additional deadlines:

Set/Reset Deadlines/Hearings: Defendants' Dispositive Motion and Opposition to Plaintiffs' motion is due by 7/20/2012; Plaintiffs' combined Reply and Opposition to Defendants' Dispositive Cross Motion is due by 7/27/2012; Defendants' Reply in support of its Dispositive Cross Motion is due by 8/3/2012; Motions Hearing scheduled for 8/7/2012 at 2:00 PM in Courtroom 3 before Judge Amy Berman Jackson.

K-V sues FDA over Makena in fight for survival

Thu Jul 5, 2012 6:59pm EDT

* Focus on cheaper versions of preterm birth drug Makena * K-V says FDA favored cost over science, safety
* Says will go bankrupt in 3-6 months without FDA action
* FDA has said compounded versions pose no risk
By Anna Yukhananov
WASHINGTON, July 5 (Reuters) - K-V Pharmaceutical Co is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the company's survival.
Makena is an injectable hormonal medicine that reduces the risk of pre-term birth in women who have already delivered early in the past. K-V got approval to sell Makena last year, giving it a new lease on life after it was barred from making and marketing its own drugs due to repeated manufacturing problems.
But pharmacies had already been compounding a similar, and far cheaper, drug for years for people who had a prescription from a doctor. They use the active ingredient hydroxyprogesterone that has been available on the market without formal FDA clearance.
In its lawsuit, K-V said the FDA was addressing the financial concerns of insurance companies that cover the cost of medications instead of the needs of patients in declining to stop pharmacies from making cheaper versions of the Makena drug. By law, the FDA is only allowed to make decisions based on science, not cost.
K-V said Makena's sales are not enough for the company to satisfy its creditors, and it would go bankrupt within three to six months if the FDA failed to act, according to the lawsuit filed on Thursday in the U.S. District Court for the District of Columbia.
FDA spokeswoman Sarah Clark-Lynn said the agency does not comment on pending litigation.
Shares of K-V closed up 2.2 percent at 65 cents on the New York Stock Exchange, above the 45 cents it hit last week, but still a fraction of its value of over $3 a year ago.

FDA DILEMMA
The FDA normally issues warning letters to distributors of unapproved drugs, or may seize their products.
The FDA recently launched a drive to remove all unapproved drugs from the market due to safety issues, and encouraged companies to apply for formal clearance, but has not taken a hard line against the pre-term birth medications.
Patients and insurers preferred the pharmacy compounds, which cost $10 to $20 per injection versus the $1,500 K-V initially sought to charge for Makena after it was approved in February 2011.
K-V reportedly tried to stop pharmacies from compounding the drug by sending them letters saying they were violating the law and threatening to sue them.
But the FDA said it would take no action against pharmacies that offered the cheaper product, following complaints from U.S. lawmakers and health insurers that K-V was price-gouging for a drug already available on the market. K-V then slashed the price of Makena by 55 percent to $690.
K-V still argued that the older pharmacy compounds were not as safe or effective as Makena, as pharmacies don't need to meet the same manufacturing, safety and efficacy guidelines.
The FDA agreed in November to look into the issue, inspecting 16 samples of the compounded drug and of its active ingredient. In an announcement last month, the health regulator said these versions of Makena posed no major safety risks, though they contained some impurities.
"Although the analysis of this limited sample ... did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products," it said at the time.
The agency also said it was applying its "normal enforcement policies" in declining to stop the compounding pharmacies from making Makena, as it focuses its actions on products that are fraudulent or likely to cause harm.
The case is K-V Pharmaceutical Company v. FDA, U.S. District Court, District of Columbia, No. 12-01105.
New Article can be found here.