More Congressional Scrutiny For Medtronic

Multiple eports of problems with medical device manufacturers have been hitting the news recently.   Twin Cities-based Medtronic and researchers is being highly scrutinized following a U.S. Senate report alleging that Medtronic exerted financial pressure  on researchers of its spinal surgery product.  At least $210 million has been paid to doctors conducting research, who were then influenced to give favorable reviews.  Of serious concern relative to this issue is that the FDA had already indicated concerns that both the surgical bone graft technique involved and the product itself  posed significant risks to patients.

The Senate Finance Committee report makes claim to Medtronic being highly involved in both the drafts and editing of the research articles, to the point of substantially influencing content of medical journal articles related to the product, called “Infused.”  It was revealed that those articles had been written by physicans who were paid Medtronic consultants. There was no disclosure at publication of Medtronic’s role in production of the articles.

 

 

Fungal Meningitis Outbreak Still Critical

At least 111 clinics in Minnesota obtained drugs from a Massachusetts facility that is linked to the national fungal meningitis outbreak that has now turned deadly.  According to reports the clinics are located all over the state and not just concentrated in the Twin Cities metro area, which will create challenges for health officials in identifying and containing the outbreak. However, since only one steroid made by New England Compounding Center is involved in the current meningitis scare and while it appears that the outbreak has been correctly identified and isolated the FDA has warned that there is no guarantee that the other drugs produced by this pharmacy are safe.  It appears the investigation has just begun.

According to Minnesota Public Radio reports, health care providers have already been in touch with their patients who have been exposed to NECC products which are potentially contaminated with the fungus.  The Minnesota Department of Health receives daily calls about patients with meningitis symptoms who received other injectable drugs from NECC and they have been in the process of contacting those people they believe may be affected by the outbreak. Clinic officials have also been contacting state public health officials as patients present in emergency rooms and urgent care clinics with possible symptoms of fungal meningitis.

Although to date the only NECC drug linked to fungal meningitis, methylprednisolone acetate, there are possibly other contaminated drugs distributed by the facility.  The FDA is also investigating a transplant case in which a patient developed a fungal infection after being administered a cardiac solution from NECC.

This latest public health crisis is yet another reminder why this country needs a robust regulatory structure. Drug manufacturers face constant pressures to cut corners to produce more product at higher profits, and those priorities are in stark contrast to the public good. The public has no ability to police against contaminated drugs and these are problems a truly free market will correct only after dozens if not hundreds of lives have been lost. Some things just shouldn’t be left to that kind of market correction.

If you or a loved one believe you may have been given the steroid linked to the fungal meningitis outbreak, contact the attorneys at Lord & Faris for a free consultation.

17,000 People have been Exposed to a Tainted Steroid

We are writing to advise our many clients and friends to be aware of the possibility of contracting fungal meningitis if they have received a lumbar epidural steroid injection for the treatment of pain in the lower back, neck or other joints such as ankle, wrist, elbow, or knee.

If you have one of the symptoms listed below and were injected at one of the clinics listed, make sure you go to your doctor immediately to be tested for fungal meningitis. If you have been diagnosed with the disease, you may have a claim against the manufacturer and we encourage you to call us for guidance in a possible legal claim at 612-333-LORD (5673).

At least 17,000 people have been exposed to a tainted steroid that has been linked to fungal meningitis that has killed several people and sickened others.

The following clinics in the Metro area used the drug methylprednisolone acetate for the treatment of back, neck and joint pain:

1. MAPS-Edina Medical Pain Clinic in Minneapolis.
2. MAPS-Medical Advanced Pain in Fridley.
3. Medical Advanced Pain Specialists in Shakopee and Maple Grove.
4. Minnesota Surgery Center in Edina and Maple Grove.

The company that manufactures this drug is the New England Compounding Center (NECC) which is located in Framingham, Mass. The company has closed its business and recalled all its products.

Fungal meningitis is not contagious. The only treatment available is an antifungal drug; voriconazole or amphotericin B.   The incubation period for the disease to appear can be a few days to a month.

According to the New England Journal of Medicine, the signs to look for in a person with meningitis of subacute onset (1 to 4 weeks) following epidural injection on or after May 21, 2012 include the following:

1. Headache, fever, stiff neck, or photophobia and a cerebrospinal fluid profile consistent with meningitis (pleocytosis +/- low glucose, elevated protein).
2. A person with basilar stroke 1 to 4 weeks following epidural injection on or after May 21, 2012, who has not received a diagnostic lumbar puncture. These people, if possible, should have a lumbar puncture.
3. A person with evidence of spinal osteomyelitis or epidural abscess at the site of an epidural injection diagnosed 1 to 4 weeks after epidural injection on or after May 21, 2012.
4. A person with septic arthritis diagnosed 1 to 4 weeks following steroid joint injection on or after May 21, 2012. Clinically diagnosed septic arthritis meaning new or worsening pain with presence of effusion or new or worsening effusion.

While the CDC is only aware of infections occurring in patients who have received epidural steroid injections, patients who received other types of injection (e.g., joint injection) with potentially contaminated methylprednisolone acetate should also be contacted to assess for signs of infection (e.g., swelling, increasing pain, redness, warmth at the injection site) and should be encouraged to seek evaluation (e.g., arthrocentesis) if such symptoms exist.

If you or any of your family and friends have been treated for pain, please alert them or have them contact us with further questions at 612-333-LORD (5673).

 

Yours in Good Health,

Priscilla Lord Faris
priscilla@lordandfaris.com

Lord & Faris Law Firm

Cigarette Warnings Struck By Appeals Court

A divided U.S. Court of Appeals for the D.C. Circuit voted 2-1 to strike down as unconstitutional proposed graphic warning labels on cigarette packaging that the Food and Drug Administration wanted to place on cigarette packs to try and prevent smoking.

R.J. Reynolds Tobacco Co. and others sued the federal government to try and block enforcement of the new FDA label rules, and conservative justice Janice Rogers Brown agreed the label presented problems for the tobacco companies.

“These inflammatory images and the provocatively-named hotline cannot rationally be viewed as pure attempts to convey information to consumers,” Judge Janice Rogers Brown wrote for the majority. “They are unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting.”

In the opinion the court held that “no one doubts the government can promote smoking cessation programs; can use shock, shame, and moral opprobrium to discourage people from becoming smokers; and can use its taxing and regulatory authority to make smoking economically prohibitive and socially onerous.” But, the court said, the graphic labels in the case “raises novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest.”

The dissent, written by Judge Judith Rogers said both the trial court and the court of appeals disregarded evidence of misleading and outright deceptive advertising practices by the tobacco companies and, that given those practices, the FDA was well within its authority to craft the warnings. Furthermore, those warnings, when viewed in light of those misleading practices, serve a necessary role for consumers. The graphic warning labels, Rogers said, “present factually accurate information and address misleading commercial speech.”

The decision is a disappointment for those who would like to see the tobacco companies held accountable for decades of deceptive consumer practices.

Summer Driving Season Could Mean More Headaches For Consumers

More scrutiny for automobile manufacturers as Federal safety regulators are investigating complaints about engine stalling in some Chrysler 200 midsize sedans. The probe includes about 87,000 of the cars from the 2011 model year that have 3.6-liter V-6 engines.

The National Highway Traffic Safety Administration says that it has received 15 complaints that the engines stall without warning while coasting to a stop. So far there are no reported injuries and it would appear that federal regulators and Chrysler are taking a pro-active approach to the problem, unlike Toyota who famously stalled internal and external investigations related to manufacturing defects until thousands of accidents and even some deaths.

According to reports, the probe could lead to a recall but it has not yet. The safety agency says it’s looking into how often the problem happens and if there is any connecting or correlating evidence to tie the problems together. NHTSA hasn’t received any reports of crashes or injuries stemming from the problem, the agency said in documents posted on its website Friday but would be updating that information as needed or necessary as the investigation continues.

Chrysler spokesman Eric Mayne says the company is working with the government to get to the bottom of the issue. He says engine performance can be affected by many things like software and fuel quality and at this point in the investigation it is too early to identify a sole cause. Mayne says the 3.6-liter engine is in 12 Chrysler models and has traveled millions of miles without problems, so at this point investigators have their work cut out for them. Owners who suspect problems with their 200s should take them to dealers for testing, Mayne said and follow safety recommendations from there. Should any additional questions or concerns come up, customers are urged to contact Chrysler or federal regulatory agencies.

Supreme Court Hands Drug Companies Big Win

The Supreme Court handed pharmaceutical companies a big win this month when they held that the industry’s sales representatives are not eligible for overtime pay. The decision marks another victory for employers against wage claims by various employees. The Court, ruling 5-4 in Christopher v. SmithKline Beecham, found that the estimated 90,000 drug sales reps fell within the so-called “outside salesman” exemption from the minimum wage and maximum hours requirements of the Fair Labor Standards Act (FLSA).

The main duty of pharmaceutical sales reps is to obtain nonbinding commitments from doctors to prescribe their company’s prescription drugs in appropriate cases.

Congress did not define “outside salesman” in the FLSA but left it to the Department of Labor to do so through agency regulations. The department issued those regulations in 1938, 1940, 1949 and 2004. It never, however, brought an enforcement action against the drug companies on behalf of their sales reps.

Writing for the majority, Justice Samuel Alito Jr. refused to give deference to the department’s interpretation that pharmaceutical reps are not exempt outside salesmen, criticizing the department for first announcing it in an “uninvited” 2009 amicus brief submitted in the Novartis wage-and-hour litigation at the Second Circuit. To do so, held the court would “impose potentially massive liability” on SmithKline for conduct that occurred long before the interpretation was announced. Deferring to that interpretation in this case, he added, “would seriously undermine the principle that agencies should provide regulated parties ‘fair warning of the conduct [a regulation] prohibits or requires.’”

The decision is a disappointment for the thousands of sales reps who spend significant time and labor working for the benefit of manufacturers and it also illustrates a troubling bias away from regular working folks and for the large companies that employ them.

Have a question about a potential legal claim? Contact the attorneys and Lord & Faris for a free initial consultation.

Consumers Get A Win Against Pharmaceutical Company

The Wisconsin Supreme Court recently upheld a damages award in a lawsuit the state brought against a prescription drug company believed to be inflating its prices. The lawsuit started way back in 2004 when then-Attorney General Peg Lautenschlager sued 36 drug companies alleging they had inflated wholesale prices to get larger payments from Medicaid, private insurers and consumers.

Pharmacia, Inc. was one of the companies sued, and the case against Pharmacia was one of the first in the group to go to trial. In 2009 a jury found that the drug maker violated the state’s Medicaid fraud law 1.44 million times over a decade. After reviewing the evidence, the judge found the actual tally was 4,578 and ordered the company to pay $4.5 million in forfeitures and other costs. The jury also awarded $9 million in damages. Pharmacia appealed, arguing that the jury incorrectly calculated the damages, that the number of violations should be reduced to zero, and that a jury trial was improper.

But the state Supreme Court, in a unanimous opinion written by Justice Michael Gableman, rejected all of those arguments and upheld the lower court’s decision. It sent the case back to the court of appeals to resolve more than a dozen other issues appealed by the state and Pharmacia. The opinion is considered an important win for both consumers and taxpayers.

The case is significant for a couple of reasons. To start, it illustrates just how long it can take for some of these complex issues to get resolved. And indeed, even this case is not over just yet. It is also significant because it shows how quickly violations of the law can add up, both for consumers and for taxpayers and why a robust and vigorous enforcement mechanism is needed to protect those interests.

Pfizer In More Trouble For Trying To Delay Generics

Five separate lawsuits consolidated in federal court in New Jersey allege that drug makers Pfizer and Ranbaxy entered into a “pay for delay” deal to postpone a generic version of the cholesterol-reducing drug Lipitor from reaching consumers.

Pfizer’s patent for Lipitor ran out in March 2012. At that time Ranbazzy was prepared to sell its version of the drug, the suits claim. But the two companies instead reached an agreement that would keep the lower-cost version of the drug off the market until November 2011.

Ranbaxy filed a petition in 2002 to produce generic Lipitor, which had originally been put on the market by Warner-Lambert. In response to the petition, Pfizer, which had acquired Warner-Lambert in 2000, sued Ranbaxy in federal court in Delaware, claiming its petition would infringe on two different patents. The district court found that Ranbaxy had infringed on one patent while the other remained valid. That ruling was affirmed by the U.S. Court of Appeals and resulted in a substantial judgment in Pfizer’s favor.

These recently consolidated suits claim that Pfizer agreed in June 2008 to forgive those judgments and give Ranbaxy the right to sell generic Lipitor in 11 foreign markets. In exchange Ranbaxy would delay the launch of its generic version in the states.

The result to consumers is a two-fold increase in price between Lipitor and the generics.

There is a lot at stake in this litigation. According to the plaintiffs, Lipitor is the best-selling drug in the history of the pharmaceutical business. It has $13 billion in sales a year worldwide, including $7 billion in the United States alone. The drug accounts for 20 percent of Pfizer’s revenue, according to the suits.

So far the company has denied the claims.

If you or a loved one have been injured taking pharmaceuticals, contact the drug injury attorneys at Lord & Faris for a free consultation.

Fen-Phen Settlement Scheme Nabs Two Attorneys

The U.S. Court of Appeals for the Sixth Circuit has affirmed the convictions of two Kentucky lawyers who were disbarred for a scheme to bilk clients out of settlement money in the “fen-phen” diet drug litigation.

Shirley Cunningham Jr. and William Gallion were two of the three lawyers who represented about 431 clients in a Kentucky state court fen-phen case against American Home Products. The third is another former Kentucky attorney, Melbourne Mills Jr. In April, a unanimous Sixth Circuit panel declared that Continental Casualty Co. could rescind Mills’ malpractice policy because he failed to disclose a bar association investigation on a renewal application.

The case, which alleged the drug caused heart valve problems, settlement for approximately $200 million, plus an additional $450,000 to settle new claims. The retainer agreement used by the three with their individual clients called for each client’s lawyer to collect about one-third of what the client recovered.

But according to the Sixth Circuit ruling, the clients ultimately received a total of about $73.5 million-less than 37 percent of the total settlement. Meanwhile Cunningham collected $21 million, Gallion nearly $31 million and Mills over $24 million. Other lawyers that they brought into the case got $30.5 million.

The three main lawyers put another $20 million into a charitable trust, the Kentucky Fund for Healthy Living Inc., without informing the clients how much would be put in the fund. Some clients who asked were told that “it would be a very small amount,” according to the Sixth Circuit ruling.

Cunningham, Gallion and Mills each received nearly $150,000 to serve as a director of the fund from June 2003 and June 2005. The state court judge in the case, Judge Joseph Bamberger, collected more than $50,000 in fees as a paid director of the fund from July 2004 and April 2005.

The experienced and dedicated attorneys at Lord & Faris hate to hear of these stories because they give all lawyers a bad name. If you or a loved one has been injured by a pharmaceutical, contact us for a free consultation and know that our attorneys are working for you.

Pfizer Settles Suit With University Over Celebrex Development

Pfizer Inc. announced it has settled a lawsuit filed by Brigham Young University over a development dispute related to the painkiller Celebrex.

According to a filing with the U.S. Securities and Exchange Commission, Pfizer said it was taking a $450 million charge against first-quarter earnings to settle the case. The other terms of the settlement have not been disclosed.

The settlement comes after six years of battles over the discovery of an enzyme that led to the development of a drug now widely viewed as a breakthrough in the treatment of arthritis and inflammation. BYU was asking for a 15 percent royalty on sales of Celebrex, which would amount to about $9.7 billion. The university was also asking for billions more in punitive damages and interest.

According to the lawsuit, BYU claimed a chemistry profession, Daniel Simmons, discovered the genetic workings of the drug in the early 1990s. The university claims Pfizer violated a research agreement the school had made with predecessor companies. BYU alleged it had a research agreement with Monsanto Co., which was later acquired by Pfizer for the development of a “super aspirin,” or a drug that could reduce pain and inflammation without triggering gastrointestinal effects. Simmons claimed he discovered an enzyme that caused those side effects and the new drug works to disable it.

“We are pleased to resolve this matter and the uncertainty of litigation and to be in a position to support Dr. Simmons’ research efforts at BYU,” Pfizer said in a brief statement. Neither side would comment further. As part of the settlement, BYU plans to endow a Dan Simmons Chair in recognition of his lifelong work advancing human health.

If you or a loved one has been injured by a pharmaceutical, contact the experienced drug injury attorneys at Lord & Faris for a free consultation.