Wawrzynek v. Statprobe, Inc.

• Decision Date: 02 September 2005
• Docket Number: No. 05-1342.,05-1342.
• Citation: 422 F.Supp.2d 474
• Parties: Eileen WAWRZYNEK and Joseph Wawrzynek, Plaintiffs v. STATPROBE, INC., et al, Defendants
• Court: U.S. District Court — Eastern District of Pennsylvania

422 F.Supp.2d 474

Eileen WAWRZYNEK and Joseph Wawrzynek, Plaintiffs v. STATPROBE, INC., et al, Defendants

No. 05-1342.

United States District Court, E.D. Pennsylvania.

September 2, 2005.

COPYRIGHT MATERIAL OMITTED

Daniel L. Thistle, Law Offices of Daniel L. Thistle, P.C., Philadelphia, PA, for Plaintiffs.

Jana Michelle Landon, Stradley Ronon Stevens & Young, LLP, Philadelphia, PA, for Defendants.

MEMORANDUM AND ORDER

PRATTER, District Judge.

This litigation concerns a claim that Defendant Statprobe, Inc., and the other Defendants who are successor corporations to Statprobe (collectively referred as "Statprobe"), are liable to Plaintiff Eileen Wawrzynek for breach of contract, fraud, and negligence by removing the doubleblind parameters from a study related to ADCON-L and providing the "unblinded" data, rather than the original blind data, to the Federal Drug Administration ("FDA"). Plaintiff Joseph Wawrzynek is claiming damages for loss of consortium. The inaccurate study, according to Plaintiffs, allowed the product ADCON-L to be approved by the FDA and used by Ms. Wawrzynek's surgeon during her back surgery. Plaintiffs assert that ADCON-L caused an infection in Ms. Wawrzynek's back leading her to suffer severe decomposition of her spinal column. Statprobe seeks dismissal of the Complaint.

In its Motion to Dismiss, Statprobe asserts that Plaintiffs' claims are barred by the relevant statutes of limitation. Alternatively, Statprobe asserts that Plaintiffs are not third party beneficiaries of the agreement between Statprobe (a bioanalysis company) and Gliatech, Inc., the manufacturer of ADCON-L, so Plaintiffs have no standing to bring a breach of contract claim. Further, Statprobe claims that because it did not owe Plaintiffs a duty of care, the negligence claim fails as a matter of law.

For the reasons discussed below, the Motion to Dismiss is denied in part and granted in part. The Motion is granted as to the breach of contract claim, and that claim is dismissed. As to all other arguments in the Motion, the Motion is denied.

I. SUBJECT MATTER JURISDICTION

Statprobe removed this case to federal court based on diversity jurisdiction pursuant to 18 U.S.C. §§ 1441 and 1446. Plaintiffs are citizens of Pennsylvania. All of the Defendants are corporations that are incorporated outside of Pennsylvania and have their principal place of business outside of Pennsylvania. The amount in controversy is alleged to be over $75,000.

II. FACTUAL BACKGROUND

Because this is a motion to dismiss, the Court will recount the facts as alleged in the Complaint. These facts will be presumed true for the purpose of this Motion.

Statprobe is in the business of providing comprehensive data services for manufacturers of drugs and medical devices seeking FDA approval. (Pls.' Compl., at ¶9). Statprobe entered into a contract with Gliatech, Inc., a medical device manufacturer, to provide bio-statistical services for an IDE Clinical Study titled "A Randomized Controlled Double-Blind Multi-Center Study to Evaluate the Safety and Effectiveness of ADCON-L for Inhibition of Post-Operative Peridural Fibrosis Following Spinal Root Decompression."¹ (Pls.' Compl., at ¶14). In the contract Statprobe agreed to assist Gliatech in compliance responsibility for the clinical study and perform the study in accordance with applicable laws and regulations. (Pls.' Compl., at ¶15). The study was initiated on January 19, 1996 and completed in November 1997. (Pls.' Compl., at ¶ 16).

On May 27, 1998, the FDA gave conditional approval to Gliatech to manufacture and distribute ADCON-L. (Pls.' Compl., at ¶18). One of the conditions of approval was that "a final report for your U.S. clinical trial ... must be provided within three Months of study completion ... failure to comply with the conditions of approval invalidates this approval order." (Pls.' Compl., at ¶ 18).

On July 19, 1997, Statprobe became aware of irregularities with respect to the ADCON-L studies, including data manipulation, and requested its name not be used on reports or presentations. (Pls.' Compl., at ¶21). By November 1997, the study was completed and Statprobe informed Gliatech that the data failed to show that the product was effective. (Pls.' Compl., at ¶22). On January 12, 1998, following Gliatech's request, Statprobe provided Gliatech the code to "unblind" the status of patients in the treatment and control groups. (Pls.' Compl., at ¶23). Gliatech personnel performed a second reading of the studies that changed some of the data in a manner that made ADCON-L appear more effective. (Pls.' Compl., at ¶25).

Gliatech provided this new data to Statprobe, which accepted the new study and altered its report to show that ADCON-L was effective. (Pls.' Compl., at ¶27). Statprobe insisted on payment prior to accepting this new data. (Pls.' Compl., at ¶28). Statprobe failed to reveal in the final report that the study was unblinded, that some data was changed, and that the original study had found the product ineffective. (Pls.' Compl., at ¶¶30-32). After receipt of this final study, the FDA approved Gliatech's continued marketing of ADCON-L. (Pls.' Compl., at ¶33).

The study also revealed that approximately 2% of the patients who used ACON-L developed leaks of CSF fluid through the dura following surgery, while none of the control patients developed such leaks. (Pls.' Compl., at ¶35).

On February 18, 1999, Ms. Wawrzynek underwent lumbar surgery. (Pls.' Compl., at ¶37). During the surgery, a minute injury to the dura was discovered and repaired, and Ms. Wawrzynek's surgeon applied ADCON-L to the operative site. (Pls.' Compl., at ¶38). The leak did not heal, and Ms. Wawrzynek underwent a second surgery and developed some complications from the leak. (Pls.' Compl., at ¶¶ 39-41).

In December 2000, Plaintiffs sued Ms. Wawrzynek's surgeon. On July 2, 2002, Plaintiffs sued Gliatech.² (Pls.' Compl., at ¶¶44). Although Gliatech was then in bankruptcy, Plaintiffs were able to circumvent the bankruptcy stay in order to engage in discovery in which 20 CDs containing 200,000 individual documents were provided for the time period between October 15, 2003 and November 26, 2003. (Pls.' Compl., at ¶¶47-48). During this discovery activity, Plaintiffs became aware of Statprobe's involvement and "fraudulent concealment of its improper conduct." (Pls.' Compl., at ¶49). Plaintiffs allege that they could not have determined Statprobe's "identity, conduct and fraudulent concealment prior to review of the CDs which plaintiffs did not obtain until the October-November 2003 time frame." (Pls.' Compl., at ¶ 50).

Plaintiffs allege three counts against Statprobe, Count One for negligence; Count Two for fraud; and Count Three for breach of contract.

III. LEGAL STANDARD

When deciding a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), the Court may look only to the facts alleged in the complaint and its attachments. Jordan v. Fox, Rothschild, O'Brien & Frankel, 20 F.3d 1250, 1261 (3d Cir.1994). The Court must accept as true all well-pleaded allegations in the complaint and view them in the light most favorable to the plaintiff. Angelastro v. Prudential—Bache Sec., Inc., 764 F.2d 939, 944 (3d Cir.1985). A Rule 12(b)(6) motion will be granted only when it is certain that no relief could be granted under any set of facts that could be proved by the plaintiff. Ransom v. Marrazzo, 848 F.2d 398, 401 (3d Cir.1988).

IV. DISCUSSION

A. Statute of Limitations

Under the Pennsylvania statute of limitations, a plaintiff is time-barred if she does not file negligence or fraud claims within two years of injury or a breach of contract claim within four years of injury. 42 PA. CONS.STAT. ANN. §§ 5524-25. Under the "discovery rule," the statute of limitations is tolled until a plaintiff "knew or should have known on the exercise of reasonable diligence of his injury and its cause." Fine v. Checcio, 870 A.2d 850, 858 (Pa.2005). The question of when a plaintiff "should have known on the exercise of reasonable diligence of his injury and its cause" is a question for the jury. Id. at 859. A party asserting the discovery rule "bears the burden of establishing the inability to know of the injury despite the exercise of reasonable diligence." Dalrymple v. Brown, 549 Pa. 217, 224, 701 A.2d 164 (Pa.1997). Reasonable diligence is defined as "a reasonable effort to discover the cause of an injury under the facts and circumstance present in the case." Cochran v. GAF Corp., 542 Pa. 210, 666 A.2d 245, 249 (1995).

A party's fraudulent concealment of its action or identity also will toll the statute of limitations. Ciccarelli v. Carey Can. Mines, Ltd., 757 F.2d 548, 556 (3d Cir.1985). Fraudulent concealment is based on estoppel and "provides that a defendant may not invoke the statute of limitations if, through fraud or concealment, he caused the plaintiff to relax his vigilance or deviate from his right of inquiry into the facts." Drelles v. Manufacturers Life Ins. Co., 2005 PA Super 249, 881 A.2d 822, 832 n. 6 (2005). Fraudulent concealment "does not require fraud in the strictest sense encompassing an intent to deceive, but rather, fraud in the broadest sense, which includes an unintentional deception." Fine, 870 A.2d at 860. However, the standard of reasonable diligence applies equally to the doctrine of fraudulent concealment as to the "discovery rule," so "a statute of limitations that is tolled by virtue of fraudulent concealment begins to run when the injured party knows or reasonably should know of his injury and its cause." Id. at 861. In other words, to prove fraudulent concealment, a plaintiff must allege that the defendant concealed, either intentionally or unintentionally, the existence of the injury or the cause and that plaintiff would not have discovered the injury or cause with reasonable diligence. These allegations must be "stated with particularity." FED. R. CIV. P. 9(b); Byrnes v. DeBolt...