MRI Dangers

As discussed on the home page, on June 6, 2006 and December 22, 2006, the FDA and GE Healthcare issued a safety advisory for Omniscan® (gadodiamide), its gadolinium-containing contrast agent, warning physicians that the use of Omniscan contrast medium in magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) in patients with pre-existing renal (kidney) issues may lead to that patient developing a rare disease called nephrogenic systemic fibrosis (NSF). The disease is also known as nephrogenic fibrosing dermopathy (NFD).

Omniscan® is a contrast agent commonly used by physicians in MRI and MRA; it is a colorless, non-radioactive, water-like fluid. During an MRI or MRA, gadolinium based contrast agents such as Omniscan are injected into veins of the patient so that the physician can view a clear and detailed picture of a patient’s internal organs, bones, vessels, and/or tissue. Contrast markers bond with damaged or diseased tissues, giving doctors a clearer picture of potential problems. GE Healthcare first launched Omniscan® in the United States in 1993. It is one of a group of five gadolinium-based injections which have been approved by the U.S. Food and Drug Administration (FDA), which also includes Magnevist®, MultiHance®, OptiMARK® and ProHance®.

NSF is an emerging systemic disorder that is characterized by widespread tissue fibrosis. It first became known to the medical community in 1997 and to date, has only been observed in patients with kidney disease. Patients with NSF experience an increase of collagen in the tissues, causing thickening and hardening of the skin of the extremities and often resulting in immobility and tightening or deforming of the joints. NSF can develop rapidly and may result in patients becoming wheelchair bound in just a few weeks. In some cases, there is involvement of other tissues, including the lungs, heart diaphragm, esophagus and skeletal muscles. In some instances NSF can lead to death. Other signs and symptoms of NSF include: Burning, Itching, Swelling, Hardening and tightening of the skin, Red or dark patches on the skin, Yellow spots on the whites of the eyes, Stiffness in joints and difficulty moving limbs, Bone pain in the hips or ribs, Muscle weakness.

Studies investigating the relationship between NSF and gadolinium are currently underway at Yale, the Centers for Disease Control (CDC), the FDA and the medical regulatory agencies of the European Union. After accumulating numerous reports of NSF in patients, the FDA issued public health advisories in June and December 2006 which advised cautionary use of all gadolinium-based contrast agents in patients with moderate to advanced renal disease.

Most recently, on May 23, 2007, the FDA asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents. The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.

There is no effective treatment available for NSF.

Kugel Mesh Injuries

Since late 2005, several different recalls have been issued for the Composix Kugel Mesh Patch over product defects. The FDA sent Advisory letters were sent to the Chief of Surgery, Hospitals, and distributors warning of the . The patches, which are used in the treatment of ventral hernias, have flexible recoil rings that allow the device to be folded for insertion through a small incision and then spring back into shape once in place. The Food and Drug Administration, as well as our firm, has received numerous reports of these rings breaking and exposing rough, jagged edges—a problem that could lead to serious internal injuries in those implanted with defective devices. The problems and risks may not be limited to the recalled batches and have affected Ohio and Cincinnati residents.

More Label Changes for Atypical Antipsychotics

ZYPREXA

Last December, The New York Times reported, “ Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly’s primary concern was that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes ….

Atypical antipsychotic medicines have become one of the biggest and fastest-growing drug classes . Overall sales for the category are projected at close to $13 billion this year, despite little evidence that the new drugs work better than older generics that cost just pennies a pill. Zyprexa, specifically, had global sales of more than $2.3 billion in the first half of this year and nearly 3 million prescriptions in the United States alone.

The Times went on to report that, Lilly documents revealed a 1999 email from Dr. Alan Breir (the chief scientist on the Zyprexa program) stating: “'Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule. In response, Lilly expanded its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness. Furthermore, Lilly’s market research had found that many primary care doctors did not consider themselves qualified to treat people with schizophrenia or severe bipolar disorder.

The FDA has asked Lilly has been asked to add stronger warnings to the label of Zyprexa multiple times The label confirms that the drug has a tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems. The warning comes (a) eleven years after first approval of sales, (b) 12 years after a large Lilly clinical trial first showed that Zyprexa might have negative effects on weight and blood sugar; and (c) after settling over 18,000 claims. Investigations and Third Party Payor claims are ongoing.


Nevertheless, Lilly continues to look for way to expand the market, and has asked the F.D.A. to allow it to begin marketing Zyprexa for adolescents, despite clinical trial data showing that Zyprexa causes weight gain and metabolic problems in teenagers that can be even more severe than in adults. Lilly also tried to expand the market to treat dementia. The FDA has advised against this indication for this class of drugs.

Ohio Claims for Damages to Health Plans

THIRD PARTY PAYOR CAUSES OF ACTION

This summary offers a brief overview of available causes of action under Ohio law. The law in this area is very complicated in that it is a blend of common law and statutory construction, and the theories of recovery overlap between Tort and Contract Principles. Therefore, the law, including the cause of action, remedies, and applicable statute of limitations, must be analyzed within the context of a particular claim, while taking into account the specific facts supporting notice, liability, and damages. In order to allow full flexibility in the initial investigation and scope of the applicable causes of action, the decisions whether to pursue these claims should be made without delay.

Although the cases we are discussing involve products and liability arising from defective products, in the context of commercial payor, the courts generally do not treat TPP claims as product liability claim within the purview of Ohio's product liability statutes. [1] Rather, the trend in Ohio law is that claims for economic damages on behalf of commercial and corporate entities are better classified as contract claims. Regardless of whether the case rests in contract or tort, the fundamental crux of any pharmaceutical case is the corporate misrepresentation. In other words, the primary issues presented is whether the Fund would not have covered the drug or device and incurred the excess cost, if it had been properly informed about the drugs safety and effectiveness. Multiples avenues of relief are available to properly frame and litigate this issue.


As for the remedies, a corporate entity may recover damages which include:
1.1 Uniform Commercial Code (OH)

As with other Sales of Goods Contracts, damages that arise from the sale and purchase of medical products are compensable under the Ohio Revised Code for Sales Contracts. The causes of action include breach of Express and Implied Warranties. Essentially, these claims operate with the same affect as Strict Liability.

Remedies include “Past Direct, Incidental, and Consequential Economic Losses”: e.g, where the product was more expensive than cheaper, safer alternatives, the recovery then is the cost of the difference between the two drug options or reimbursement for the cost of the drug), or lost inventory/ replacement Costs where the Plan has purchased a large inventory of products that cannot be used or need to be replaced, as in the case of medical device cases;

“Future Direct, Incidental, and Consequential Economic Losses” where the plan has incurred additional costs for future health care as a result of the injuries the members suffered (the recovery would be the cost associated with the future care of the Plan’s members for related injuries.);

1.2 Ohio Deceptive Trade Practices Act Ohio has strong statutory causes of action arising from Deceptive Trade Practices. Pursuant to O.R.C. 4165.02, a consumer may recover for damages sustained by a Deceptive Trade Practices Act. “A person [or company] engages in a deceptive trade practice when, in the course of the person's business, vocation, or occupation, the person….Represents that goods …have…. benefits, or quantities that they do not have …or Represents that goods are … of a particular standard, quality …if they are of another

Remedies include: “Past Direct, Incidental, and Consequential Economic Losses”; “Future Direct, Incidental, and Consequential Economic Losses” ; and Punitive.

1.3 Ohio Consumer Sales Practices Act

Under O.R.C. 1345.03 (A), “No supplier shall commit an unconscionable act or practice in connection with a consumer transaction. Such an unconscionable act or practice by a supplier violates this section whether it occurs before, during, or after the transaction.” (B) In determining whether an act or practice is unconscionable, the following circumstances shall be taken into consideration…. Whether the supplier knowingly made a misleading statement of opinion on which the consumer was likely to rely to the consumer's detriment;

Remedies include: “Past Direct, Incidental, and Consequential Economic Losses”; “Future Direct, Incidental, and Consequential Economic Losses”; Treble Damages and Punitive.

1.4 Fraud

Under Ohio law, to maintain a claim of fraud, the plaintiff must plead: (a) a representation or, where there is a duty to disclose, concealment of a fact, (b) which is material to the transaction at hand, (c) made falsely, with knowledge of its falsity, or with such utter disregard and recklessness as to whether it is true or false that knowledge may be inferred, (d) with the intent of misleading another into relying upon it, (e) justifiable reliance upon the representation or concealment, and (f) a resulting injury proximately caused by the reliance. [2]

Remedies include: “Past Direct, Incidental, and Consequential Economic Losses”; “Future Direct, Incidental, and Consequential Economic Losses” ; and Punitive.
1.5 Unjust Enrichment

Under Ohio law, provided that no other cause of action is viable for recovery , the plaintiff by proving three elements, may recover for a claim of unjust enrichment: (1) a benefit conferred by the plaintiff upon the defendant; (2) knowledge by the defendant of the benefit; and (3) retention of the benefit by the defendant under circumstances where it would be unjust to do so without payment.

Remedies include: “Past Direct, Incidental, and Consequential Economic Losses”; “Future Direct, Incidental, and Consequential Economic Losses”. Equitable remedy of disgorgement of profits.

2 SUMMARY CHART OF CAUSES OF ACTION

The below chart outlines summarizes the possible available causes of action and types of damages, as well as includes the applicable statute of limitations to initiate a claim. Please know that the statute of limitations depends on many factors, and these are general time frames. Tolling of the statues is available in some case. [3] These time frames should not be relied on without having an attorney review the case in detail to offer a comprehensive opinion. The law can be confusing to many lawyers and judges in this area because of the overlap between contract and tort law damages. The most conservative approach should be taken in order to preserve all potential claims.

CAUSE OF ACTION
AUTHORITY
DAMAGES
STATUTE OF LIMITATIONS

Breach of Express Warranty
(Sale of Goods)
O.R.C 1302.26
Past and Future direct, incidental, consequential
4 Years from date of breach[4]


Breach of Implied Warranty of Merchantability (Sale of Goods)
O.R.C 1302.27
Past and Future direct, incidental, consequential
4 Years from date of breach

Breach of Implied Warranty for Fitness for a Particular Purpose
(Sale of Goods)
O.R.C 1302.28
Past and Future direct, incidental, consequential
4 Years from date of breach

Fraud
Common Law
Past and Future direct, incidental, consequential, and Punitive
Four Years From Act or Discovery

Unjust Enrichment
Common Law
Equitable remedies available of reimbursement or disgorgement of profits.
Four Years from breach [5]

Deceptive Trade Practices Act
4165.02
Past and Future direct, incidental, and consequential
Two Years from act[6]

Consumer Sales Practices Act
1345.02;1345.03
Past and Future direct, incidental and consequential, Treble Economic Damages
Two Years from act[7]

2.1 The Phases of Case Development

In the event the Fund decides to retain counsel to litigate a TPP claim, the Three firms will form a committee to develop and assign the various tasks. Prior to engaging in formal litigation, the case or cases will be thoroughly investigated to outline all available claims and damages.

Phase One is an internal investigation to gather the specific facts related to your Plan and how it was adversely affected by the product at issue. This phase will include, but is not limited to:

1. Researching all available causes of action on elements of proof, damages, and statutes of limitations for all available venues;
2. Identifying any privacy issues that may complicate the review;
3. Interviewing Plan coordinators and administrators to identity the most efficient manner to search documents and databases;
4. Interviewing any specific medical consultants or physicians involved in selecting the drug/ or device for the plan;
5. Securing any necessary releases to review the relevant materials;
6. Gathering all relevant medical and business records and other materials;
7. Identify the number of prescriptions paid;
8. Identifying the primary costs of the prescriptions or devices;
9. Identifying the wholesale price of the product and whether this compares to other Plans;
10. Identifying alternative products and analyzing the costs difference;
11. Identifying the number of claimants who may have suffered adverse events and have had and/or will require health care to treat the adverse events;
12. Consideration of the value to your plan and strategy of a class action and adding other similarly situated plans to your claim.
13. Identifying any other expense incurred for the particular product.

Once the preliminary information is gathered, and we have a more comprehensive understanding of the value of a claim, we will present a formal paper outlining the value and research that was discovered in the first phase. Assuming the review identifies a valuable claim, will move to Phase II, which is formal litigation. Formal litigation will include:
1. Selecting the most favorable venue.
2. Filing initial pleadings and overcoming various Motions to Dismiss;
3. Issuing discovery and overcoming protective orders and motions to compel;
4. Coordinating our efforts with similar actions in other venues;
5. Obtaining all discovery that has been conducted in other litigations;
6. Issuing formal Discovery for corporate documents and depositions of designees and other corporate witnesses;
7. Presenting the financial impact through retained experts and conducting expert depositions;
8. Presenting the defective aspects of the drug/ device and failure to warn though retained experts and conducting expert depositions;
9. Presenting the related specific adverse events and cost of care for affected individuals though retained experts and conducting expert depositions;
10. Prevailing on Motions for Summary Judgment;
11. Preparing the case for Trial.
12. Engaging in formal mediation or other alternative dispute mechanisms to resolve the case.
13. In the event all settlement efforts fail, successfully presenting the case to a Jury.



[1] LaPuma v. Collinwood Concrete, 75 Ohio St.3d 64, 661 N.E.2d 714, Ohio,1996.
The law could very well be a shift in the courts through TPP cases. The policy considerations for applying strict liability in cases of defective products are consistent with the goals of TPP cases – i.e., that human life and safety are promoted by subjecting manufacturers of defective products to strict liability, to recognize that manufacturers are in a better position than those injured to internalize and redistribute the cost of injuries. Extending strict liability to TPP claims would have a strong deterent affect on the actions of the companies. Moreover, although the entity cannot experience harm, company is composed of its individual members who have suffered harm.

[2] Delahunt v. Cytodyne Technologies, 241 F.Supp.2d 827 (S.D.Ohio,2003.)

[3] Ohio recognizes , American Pipe, where the United States Supreme Court found that “the commencement of a class action suspends the applicable statute of limitations as to all asserted members of the class who would have been parties had the suit been permitted to continue as a class action.”

[4] A cause of action accrues when the breach occurs, regardless of the aggrieved party's lack of knowledge of the breach. O.R.C. 2305.10
[5] An action for breach of any contract for sale must be commenced within four years after the cause of action has accrued. 1302.98 Statute of limitations in contracts for sale:
[6] Discovery does not extend to Deceptive Trade Practices claims; Plumbing and Pipefitting Industry Local 219 Pension Fund v. Buck, Slip Copy, 2007 WL 4287870 (N.D.Ohio,2007).

[7] Discovery rule applies only for Recission. There is no Discovery for money damages or treble Damages. Bales v. Isaac, Not Reported in N.E.2d, 2004 WL 1949419 (Ohio App. 2 Dist.,2004) . Rosenow v. Shutrump & Assoc.163 Ohio App.3d 500, 839 N.E.2d 82 (Ohio App. 7 Dist.,2005)

Health Plans Take More Action To Recover Costs of Defective Drugs

When a drug or medical device company misrepresents the safety and/or efficacy of a drug or medical device, the financial consequences for the parties responsible for past and future health care are extreme. In the context of a Health Care Fund or Plan (“Fund”), a Fund, relying upon the marketing data presented by the manufacturer, unknowingly commits to paying for ineffective and/or unsafe products. The Fund is under the impression that the cost of the drug or device is justified since the benefits of preventative medicine will reduce the health costs from complications in the future.

However, when a company withholds data that is critical to the decision of whether to add a product to a Fund, the Fund is not in the best position to fully assess the risks and benefits of the product. Pharmaceutical recalls and litigations consistently reveal patterns of pharmaceutical companies placing marketing and sales ahead of patient safety. The conduct takes the shape of distorting clinical trial data, limited or no post marketing reporting, manipulating clinical trial design, and engaging in “off label” marketing campaigns. The New York Times reported last December that, “Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved”.

When pharmaceutical companies mislead a Fund, the Fund unknowingly pays for more expensive and dangerous products, while increasing the health risk of its members and its financial exposure. The difference in costs between a quality alternative health care product and a defective product is often tens of millions and in some cases may be hundreds of millions. Lawsuits on behalf of health insurance companies, self insured health plans and union health plans (“Third Party Payors”) are designed to recover the TPP’s loss resulting from the companies’ conduct.

The Lyon Firm is investigation numerous claims for local and national union health plans.

Medical Malpractice: Delay in Diagnosing Breast Cancer

A 38 year old women presents to her primary care physician complaining of a small cyst like bump on her right breast. She has no family history of breast cancer and has a clean medical history. Her physician exams the lump and, while assuring the patient that is looks like nothing, refers her to a surgeon down the hall to perform a simple needle aspiration. The surgeon draws some fluid and tissue and informs the patient that it didn’t seem like it was anything to worry about. He then informed the patient that he would call her if she needed to return for a follow up.

The surgeon proceeded to send the tissue slides to a local pathologist who read the slides as suspicious of cancer and informed the surgeon to contact the patient. Neither the patient nor the family physician was notified of the pathology concern. Two and a half years later, the patient returns to find that she has stage IIIB iinvasive ductal carcinoma, and she has a less than fifty percent chance of survival.

1. She undergoes radiation, chemotherapy, and a radical mastectomy which finds multiple positive lymph nodes. Although cancer free, she is likely to suffer a recurrence in five years at which time the cancer will be metastatic and terminal. During litigation, the treating physician testified that the patient should have called him to get her results. The Lyon Firm represented this women and her family and obtained a favorable settlement before trial. Though currently cancer free, she lived with the fear and reality that recurrence could happen any day.

The key to beating cancer is catching it early. Despite this well recognized concept, every year breast cancer goes undiagnosed and progresses resulting in significant loss of life for the affected patient and the loss of a mother, sister, or friend. The delay in diagnosis can result from a number of mistakes by the health care provider. Often, it is the result of miscommunication as in the case described above. Other examples of medical negligence in this area include:

Radiology Errors ( i.e., the Radiologist misreads films that show early stages.)
Pathology Errors (i.e., the Pathologist misreads slides that show early stages.)
Primary Care Errors (i.e., the PCP fails to identify a suspicious lump, cyst, mole and refer the patient for biopsy or other medical specialist.
Surgical Errors (i.e., the surgeon fails to perform a biopsy.)

For more information, See the following links:

Mayo Clinic
National Cancer Institute
The University of Texas, MD Anderson
US Department of Health and Human Services, Women’s Health
Web MD

Salmonella Outbreak With Mexican Jalapenos

The FDA has determined that mexican jalapenos are responsible for the latest outbreak of salmonella. The outbreak has affected 1,300 people in forty-three states, and new cases are expected to be reported. Agricola Zaragoza, Inc. has recalled its products due to the concern.

Salmonella is a bacteria that causes Salmonellosis. Most people who have an infection with suffer minor symptoms of diarrhea, fever, and abdominal cramps for 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most persons recover without treatment or severe medical problems. However, in some persons, the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics. The elderly, infants, and those with impaired immune systems are more likely to have a severe illness. The Center for Disease Control has additional information.

Tracker Marine Mako Boat Defect Leads to Class Action

In 2004, the Coast Guard began receiving reports that Tracker Marine boat, Mako 282 had structural problems, including the cracks and loosening of the transom. The boat has been reported to flex extensively. A Coast Guard surveyor has declared at least one boat unseaworthy and has an open recall on the product.

However, the problem is not limited to one boat. The design of the boat affects all owners. The recall notice provides "the problem with this boat is not simple gelcoat cracking. There are significant structural problems with this boat that derive directly from design and construction. Specifically, the two feet that was added to the boat to extend it from 26 to 28 feet was not provided with adequate structural support to accommodate the weight of the outboard engines, which results in stresses in the hull that manifest themselves as cracks in the laminate. If left uncorrected, this lack of structural support ultimately will make the hull unseaworthy.” In response to the growing problem of defective boats, Congress addressed the issue.

The Lyon Firm has filed a Class Action on behalf on all owners of the Mako 282 in Federal Court in Florida. I will will update the blog as the case progresses.