Stryker ShapeMatch Cutting Guide Lawsuits

In May 2011, Stryker announced the FDA approval for the ShapeMatch Cutting Guide through 510(k) clearance, an approval shortcut maintained by the US Food and Drug Administration and allowable when a device is found to be substantially similar to a previous device and can be marketed safely. The ShapeMatch Cutting Guides were considered advantageous to standard cutting guides because they were custom fit for an individual patient and not the one-size-fits-all model that was previously on the market.

Within 18 months, Stryker was instructing surgeons to stop using the ShapeMatch Cutting Guide, and to refrain from ordering any more units of the customized cutting guides. The company formally recalled the ShapeMatch Cutting Guides in January 2013.

The FDA responded three months later with a Class I recall of the product. A Class I recall is the most serious of recalls in the FDA response roster. Class I recalls are reserved for “a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.”

The ShapeMatch Cutting Guides were designed to be customized for each patient based on a surgeon’s pre-surgery planning parameters. Once in place, the guide was designed to achieve more efficient and precise cutting of bone in order to place the Triathlon Knee implants.

However, it was found, potentially due to a software glitch, that the customized cutting guides were not manufactured to the surgeon’s specifications for the individual patient.

 Thus, the implant could be misaligned, causing Stryker Triathlon Knee implant pain, and other issues pertaining to mobility and stability, for the patient.



It does not appear that the problematic ShapeMatch Cutting Guides, designed to work with Stryker’s Triathlon Knee implant, adversely affects the Triathlon Knee implant itself. The Triathlon Knee is still on the market and heavily promoted by Stryker.

The ShapeMatch Cutting Guides were mostly implemented on the two coasts; concentrated areas include Pennsylvania.

Pittman, Dutton & Hellums, P.C., is currently investigating claims against Stryker over their ShapeMatch Cutting Guides. If you or a love one was adversely affected by Stryker’s ShapeMatch Cutting Guide, please contact Booth Samuels at booths@pittmandutton.com or call toll free 1-866-515-8880.

Deepwater Horizon News

Halliburton has agreed to pay $1.1 billion to settle a substantial portion of plaintiff claims arising from the 2010 Gulf of Mexico oil spill. Halliburton was British Petroleum’s (“BP”) cement contractor on the drilling rig. The explosion killed 11 workers and triggering the largest offshore oil spill in U.S. history.

The deal will settle claims assigned to Halliburton as a result of BP's settlement in 2012 and punitive damages from the loss of property or commercial fishing activity resulting from the oil spill.

Earlier this month, Judge Barbier, the US District Judge for the Eastern District of Louisiana who is overseeing the BP lawsuits, ruled that BP’s conduct was “reckless”. This has a huge impact on the amount of damages BP will be liable to pay, and could nearly quadruple damages. BP already has agreed to pay billions of dollars in criminal fines and compensation to people and businesses affected by the disaster.

Judge Barbier essentially divided blame among the three companies involved in the spill; ruling that BP bears 67 percent of the blame; Swiss-based drilling rig owner Transocean Ltd. takes 30 percent; and Houston-based cement contractor Halliburton Energy Service takes 3 percent.

The ruling finding BP was reckless instead of merely negligent means BP could face as much as $17.6 billion in civil fines under the Clean Water Act. Under the Act, a polluter can be forced to pay a maximum of either $1,100 or $4,300 per barrel of spilled oil. The higher limit applies if the company is found grossly negligent or reckless. However, penalties can be assessed at amounts lower than those caps.

Government experts estimated that 4.2 million barrels, or 176 million gallons, spilled into the Gulf. BP urged Barbier to use an estimate of 2.45 million barrels, or nearly 103 million gallons, in calculating any Clean Water Act penalties. Both sides agreed that 810,000 barrels, or 34 million gallons, of oil escaped the well but were captured before it could pollute the Gulf.

BP has stated it will appeal the ruling.

Boston Scientific Loses Pelvic Mesh Case

Following up on one of my blog posts from earlier this week, it was announced this morning that Boston Scientific was hit with a $73 Million verdict in a trial that took place in Dallas, Texas. The jury awarded $23 Million in compensatory damages and $50 Million in punitive damages to the Plaintiff. Boston Scientific faces upwards of 12,000 similar lawsuits.

It was reported the Texas jury deliberated for one day.

The defendant will certainly appeal.